temperature control of the ultrasonic end actuator and control system for the same

专利摘要:
The present invention discloses a generator, an ultrasonic device, and a method of determining an ultrasonic blade temperature. A control circuit coupled to a memory determines an actual resonance frequency of an ultrasonic electromechanical system that comprises an ultrasonic transducer coupled to an ultrasonic blade by an ultrasonic waveguide. The actual resonance frequency is correlated to an actual ultrasonic blade temperature. The control circuit retrieves a reference resonance frequency from the ultrasonic electromechanical system from memory. The reference resonance frequency is correlated to a reference temperature of the ultrasonic sheet. The control circuit then infers the temperature of the ultrasonic blade based on the difference between the actual resonance frequency and the reference resonance frequency.
公开号:BR112020012402A2
申请号:R112020012402-8
申请日:2019-02-28
公开日:2020-11-24
发明作者:Cameron R. Nott；Jacob S. Gee；Frederick E. Shelton Iv；David C. Yates；Fergus P. Quigley；Amrita Singh Sawhney；Stephen M. Leuck；Brian D. Black；Eric M. Roberson；Patrick J. Scoggins；Craig N. Faller；Madeleine C. Jayme
申请人:Ethicon Llc；
IPC主号:

专利说明:

[001] [001] The present application claims priority under 35 U.S.C.§ 119 (e) to provisional patent application n ° 62 / 721,995, entitled
[002] [002] The present application claims priority under 35 USC§ 119 (e) to provisional patent application No. 62 / 721,998, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS, filed on August 23, 2018, the description of which is incorporated herein reference, in its entirety.
[003] [003] The present application claims priority under 35 U.S.C.§ 119 (e) to provisional patent application No. 62 / 721,999, entitled
[004] [004] The present application claims priority under 35 U.S.C.§ 119 (e) to provisional patent application n ° 62 / 721,994, entitled
[005] [005] The present application claims priority under 35 U.S.C.§ 119 (e) to provisional patent application n ° 62 / 721,996, entitled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED
[006] [006] This application claims priority under 35 USC§ 119 (e) to provisional patent application No. 62 / 692,747, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on June 30, 2018, to the application for provisional patent for No. 62 / 692,748, entitled SMART ENERGY ARCHITECTURE, filed on June 30, 2018 and provisional patent application for No. 62 / 692,768, entitled SMART ENERGY DEVICES, filed on June 30, 2018, with the description each of which is incorporated herein by reference, in its entirety.
[007] [007] This application also claims priority benefit under 35 USC§ 119 (e) for US Provisional Patent Application serial number 62 / 640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR, filed on March 8 2018, and to US Provisional Patent Application Serial No. 62 / 640,415, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR filed on March 8, 2018, the description of which is incorporated herein as a reference, in its entirety.
[008] [008] This application also claims the priority benefit under 35 U.S.C.§ 119 (e) for U.S. Provisional Patent Application No. 62 / 650,898 filed on March 30, 2018, entitled
[009] [009] The present application claims priority under 35 USC§ 119 (e) to US Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, with US Provisional Patent Application Serial No. 62 / 611,340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed on December 28, 2017, and US Provisional Patent Application Serial No. 62 / 611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, the description of each of which is incorporated herein by way of reference, in its entirety. BACKGROUND OF THE INVENTION
[0010] [0010] In a surgical environment, smart energy devices may be needed in an intelligent energy architecture environment. Ultrasonic surgical devices, such as ultrasonic scalpels, are finding increasingly widespread applications in surgical procedures, due to their unique performance characteristics. Depending on specific device settings and operational parameters, ultrasonic surgical devices can offer, substantially simultaneously, tissue transection and coagulation homeostasis, desirably minimizing the patient's trauma. An ultrasonic surgical device may comprise a handle containing an ultrasonic transducer, and an instrument coupled to the ultrasonic transducer having a distally mounted end actuator (e.g., a blade tip) to cut and seal the tissue. In some cases, the instrument may be permanently attached to the handpiece. In other cases, the instrument may be separable from the handle, as in the case of a disposable instrument or an interchangeable instrument. The end actuator transmits ultrasonic energy to the tissues placed in contact with it, to perform the cutting and cauterization action. Ultrasonic surgical devices of this nature can be configured for use in open, laparoscopic or endoscopic surgical procedures, including robotically assisted procedures.
[0011] [0011] Ultrasonic energy cuts and coagulates tissues using lower temperatures than those used in electrosurgical procedures and can be transmitted to the end actuator by an ultrasonic generator in communication with the handle. Vibrating at high frequencies (for example, 55,500 cycles per second), the ultrasonic blade denatures the protein present in the tissues to form a sticky clot. The pressure exerted on the tissues by the surface of the slide flattens the blood vessels and allows the clot to form a hemostatic seal. A surgeon can control the cutting and clotting speed through the force applied to the tissues by the end actuator, the time during which the force is applied and the selected excursion level for the end actuator.
[0012] [0012] The ultrasonic transducer can be modeled as an equivalent circuit comprising a first branch that has a static capacitance and a second "motion" branch that has a series connected inductance, resistance and capacitance that define the electromechanical properties of a resonator . Known ultrasonic generators may include a tuning inductor to cancel the static capacitance at a resonant frequency so that substantially all of the generator's trigger signal current flows to the motion branch. Consequently, by using a tuning inductor, the current of the generator's trigger signal represents the current of the motion branch, and the generator is thus able to control its trigger signal to maintain the resonance frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance plot of the ultrasonic transducer to optimize the frequency locking capabilities of the generator. However, the tuning inductor must be combined with the specific static capacitance of an ultrasonic transducer at the operational resonance frequency. In other words, a different ultrasonic transducer having a different static capacitance needs a tuning inductor.
[0013] [0013] Additionally, in some ultrasonic generator architectures, the generator trigger signal has asymmetric harmonic distortion that complicates the magnitude and phase measurements of the impedance. For example, the accuracy of impedance phase measurements can be reduced due to harmonic distortion in current and voltage signals.
[0014] [0014] In addition, electromagnetic interference in noisy environments decreases the generator's ability to maintain locking in the resonance frequency of the ultrasonic transducer, increasing the likelihood of invalid inputs from the control algorithm.
[0015] [0015] Electrosurgical devices for applying electrical energy to tissues in order to treat and / or destroy said tissues are also finding increasingly widespread applications in surgical procedures. An electrosurgical device may comprise a handle and an instrument that has a distally mounted end actuator (for example, one or more electrodes). The end actuator can be positioned against the fabric, so that electric current is introduced into the fabric. Electrosurgical devices can be configured for bipolar or monopolar operation. During bipolar operation, the current is introduced into the tissue and returned from it through the active and return electrodes, respectively, of the end actuator. During monopolar operation, a current is introduced into the tissue by an active electrode of the end actuator and returned through a return electrode (for example, a grounding plate) separately located on the patient's body. The heat generated by the current flowing through the tissue can form hemostatic seals within the tissue and / or between tissues and, therefore, can be particularly useful for cauterizing blood vessels, for example. The end actuator of an electrosurgical device may also comprise a cutting member that is capable of moving in relation to the tissue and the electrodes, to transect the tissue.
[0016] [0016] The electrical energy applied by an electrosurgical device can be transmitted to the instrument by a generator in communication with the handle. The electrical energy may be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that can be in the frequency range of 300 kHz to 1 MHz, as described in EN60601-2-2: 2009 + A11: 2011, Definition
[0017] [0017] During this operation, an electrosurgical device can transmit RF energy at low frequency through the tissue, which causes friction, or ionic agitation, that is, resistive heating, which, therefore, increases the tissue temperature. Due to the fact that a precise boundary can be created between the affected tissue and the surrounding tissue, surgeons can operate with a high level of precision and control, without sacrificing adjacent non-target tissue. The low operating temperatures of RF energy can be useful for removing, shrinking or sculpting soft tissues while simultaneously cauterizing blood vessels. RF energy can work particularly well in connective tissue, which mainly comprises collagen and shrinks when it comes in contact with heat.
[0018] [0018] Due to their unique trigger signal, detection and feedback information, ultrasonic and electrosurgical devices generally require different generators. Additionally, in cases where the instrument is disposable or interchangeable with a handle, ultrasonic and electrosurgical generators are limited in their ability to recognize the configuration of the specific instrument being used and to optimize control and diagnostic processes accordingly. In addition, capacitive coupling between the non-isolated and isolated patient circuits of the generator, especially in cases where higher voltages and frequencies are used, can result in a patient's exposure to unacceptable leakage current levels.
[0019] [0019] In addition, due to their unique trigger signal, detection and feedback information, ultrasonic and electrosurgical devices generally require different user interfaces for different generators. In such conventional ultrasonic and electrosurgical devices, a user interface is configured for use with an ultrasonic instrument whereas a different user interface can be configured for use with an electrosurgical instrument. Such user interfaces include hand and / or foot activated user interfaces, such as hand activated keys and / or foot activated keys. When various aspects of combined generators for use with both ultrasonic and electrosurgical instruments are contemplated in the subsequent description, additional user interfaces that are configured to operate with both ultrasonic and electrosurgical instrument generators are also contemplated.
[0020] [0020] Additional user interfaces to provide feedback, whether to the user or the other machine, are included in the subsequent description to provide feedback that indicates a mode of operation or status of an ultrasonic and / or electrosurgical instrument. Providing feedback to the user and / or the machine to operate an ultrasonic and / or electrosurgical instrument in combination will require providing sensory feedback to a user and electrical / mechanical / electromechanical feedback to a machine. Feedback devices that incorporate visual feedback devices (for example, an LCD display screen, LED indicators), audio feedback devices (for example, a speaker, a bell) or tactile feedback devices (for example, eg haptic actuators) for use in combined ultrasonic and / or electrosurgical instruments are contemplated in the subsequent description.
[0021] [0021] Other electrical surgical instruments include, without limitation, irreversible and / or reversible electroporation, and / or microwave technologies, among others. Consequently, the techniques described here are applicable to ultrasonic, bipolar or monopolar, (electrosurgical), irreversible and / or reversible electroporation and / or microwave-based surgical instruments, among others. SUMMARY OF THE INVENTION
[0022] [0022] In a general aspect, a method is provided to determine an ultrasonic blade temperature. The method comprises: determining, through a control circuit coupled to a memory, a real resonance frequency of an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by means of an ultrasonic waveguide, the actual resonance frequency is correlated to an actual ultrasonic blade temperature; retrieve, from memory through the control circuit, a reference resonance frequency of the ultrasonic electromechanical system, the reference resonance frequency being correlated to a reference temperature of the ultrasonic blade; and infer, by the control circuit, the temperature of the ultrasonic blade based on the difference between the actual resonance frequency and the reference resonance frequency.
[0023] [0023] In another aspect, a generator to determine the temperature of an ultrasonic blade is provided. The generator comprises: a control circuit coupled to a memory, the control circuit being configured to: determine an actual resonance frequency of an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by means of a waveguide ultrasonic, the actual resonance frequency being correlated to an actual ultrasonic blade temperature; retrieving from the memory a reference resonance frequency of the ultrasonic electromechanical system, the reference resonance frequency being correlated to a reference temperature of the ultrasonic blade; and infer the temperature of the ultrasonic sheet based on the difference between the actual resonance frequency and the reference resonance frequency.
[0024] [0024] In yet another aspect, an ultrasonic device for determining an ultrasonic blade temperature is provided. The ultrasonic device comprises: a control circuit coupled to a memory, the control circuit being configured to: determine an actual resonance frequency of an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by means of a guide ultrasonic waves, the actual resonance frequency being correlated to an actual ultrasonic blade temperature; retrieving from the memory a reference resonance frequency of the ultrasonic electromechanical system, the reference resonance frequency being correlated to a reference temperature of the ultrasonic blade; and infer the temperature of the ultrasonic sheet based on the difference between the actual resonance frequency and the reference resonance frequency. FIGURES
[0025] [0025] The features of several aspects are presented with particularity in the attached claims. The various aspects, however, with regard to both the organization and the methods of operation, together with additional objects and advantages of the same, can be better understood in reference to the description presented below, considered together with the attached drawings, as follows.
[0026] [0026] Figure 1 is a block diagram of an interactive surgical system implemented by computer, according to at least one aspect of the present description.
[0027] [0027] Figure 2 is a surgical system being used to perform a surgical procedure in an operating room, in accordance with at least one aspect of the present description.
[0028] [0028] Figure 3 is a central surgical controller paired with a visualization system, a robotic system, and an intelligent instrument, in accordance with at least one aspect of the present description.
[0029] [0029] Figure 4 is a partial perspective view of a central surgical controller enclosure, and of a generator module in combination received slidingly in a central surgical controller enclosure, in accordance with at least one aspect of the present description.
[0030] [0030] Figure 5 is a perspective view of a generator module in combination with bipolar, ultrasonic and monopolar contacts and a smoke evacuation component, in accordance with at least one aspect of the present description.
[0031] [0031] Figure 6 illustrates different power bus connectors for a plurality of side coupling ports of a side modular cabinet configured to receive a plurality of modules, in accordance with at least one aspect of the present description.
[0032] [0032] Figure 7 illustrates a vertical modular housing configured to receive a plurality of modules, according to at least one aspect of the present description.
[0033] [0033] Figure 8 illustrates a surgical data network comprising a central modular communication controller configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a utility facility. specially equipped for surgical operations, to the cloud, in accordance with at least one aspect of the present description.
[0034] [0034] Figure 9 illustrates an interactive surgical system implemented by computer, in accordance with at least one aspect of the present description.
[0035] [0035] Figure 10 illustrates a central surgical controller that comprises a plurality of modules coupled to the modular control tower, according to at least one aspect of the present description.
[0036] [0036] Figure 11 illustrates an aspect of a central controller device of a universal serial bus (USB) network, in accordance with at least one aspect of the present description.
[0037] [0037] Figure 12 illustrates a logical diagram of a control system for an instrument or surgical tool, according to at least one aspect of the present description.
[0038] [0038] Figure 13 illustrates a control circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present description.
[0039] [0039] Figure 14 illustrates a combinational logic circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present description.
[0040] [0040] Figure 15 illustrates a sequential logic circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present description.
[0041] [0041] Figure 16 illustrates an instrument or surgical tool that comprises a plurality of motors that can be activated to perform various functions, according to at least one aspect of the present description.
[0042] [0042] Figure 17 is a schematic diagram of a robotic surgical instrument configured to operate a surgical tool described therein, in accordance with at least one aspect of the present description.
[0043] [0043] Figure 18 illustrates a block diagram of a surgical instrument programmed to control the distal translation of the displacement member, according to an aspect of the present description.
[0044] [0044] Figure 19 is a schematic diagram of a surgical instrument configured to control various functions, according to at least one aspect of the present description.
[0045] [0045] Figure 20 is a system configured to execute adaptive ultrasonic blade control algorithms in a surgical data network that comprises a central modular communication controller, in accordance with at least one aspect of the present description.
[0046] [0046] Figure 21 represents an example of a generator, according to at least one aspect of the present description.
[0047] [0047] Figure 22 is a surgical system comprising a generator and several surgical instruments usable with it, in accordance with at least one aspect of the present description.
[0048] [0048] Figure 23 is a view of an end actuator, in accordance with at least one aspect of the present description.
[0049] [0049] Figure 24 is a diagram of the surgical system of Figure 22, according to at least one aspect of the present description.
[0050] [0050] Figure 25 is a model that illustrates the Movement branch current, according to at least one aspect of the present description.
[0051] [0051] Figure 26 illustrates a structural view of a generator architecture, in accordance with at least one aspect of the present description.
[0052] [0052] Figures 27A to 27C illustrate functional views of a generator architecture, in accordance with at least one aspect of the present description.
[0053] [0053] Figures 28A to 28B are structural and functional aspects of a generator, according to at least one aspect of the present description.
[0054] [0054] Figure 29 is a schematic diagram of an aspect of an ultrasonic drive circuit.
[0055] [0055] Figure 30 is a schematic diagram of the transformer coupled to the ultrasonic drive circuit shown in Figure 29, according to at least one aspect of the present description.
[0056] [0056] Figure 31 is a schematic diagram of the transformer shown in Figure 30 coupled to a test circuit, in accordance with at least one aspect of the present description.
[0057] [0057] Figure 32 is a schematic diagram of a control circuit, according to at least one aspect of the present description.
[0058] [0058] Figure 33 shows a simplified block circuit diagram that illustrates another electrical circuit contained within a modular ultrasonic surgical instrument, in accordance with at least one aspect of the present description.
[0059] [0059] Figure 34 illustrates a generator circuit divided into multiple stages, according to at least one aspect of the present description.
[0060] [0060] Figure 35 illustrates a generator circuit divided into multiple stages, the first stage circuit being common to the second stage circuit, according to at least one aspect of the present description.
[0061] [0061] Figure 36 is a schematic diagram of an aspect of a drive circuit configured to drive a high frequency (RF) current, in accordance with at least one aspect of the present description.
[0062] [0062] Figure 37 is a schematic diagram of the transformer coupled to the RF drive circuit shown in Figure 34, according to at least one aspect of the present description.
[0063] [0063] Figure 38 is a schematic diagram of a circuit comprising separate power supplies for high power drive / energy circuits and low power circuits, in accordance with an aspect of the present description.
[0064] [0064] Figure 39 illustrates a control circuit that allows a dual generator system to alternate between the energy modes of the RF generator and the ultrasonic generator for a surgical instrument.
[0065] [0065] Figure 40 illustrates a diagram of an aspect of a surgical instrument comprising a feedback system for use with a surgical instrument, in accordance with an aspect of the present description.
[0066] [0066] Figure 41 illustrates an aspect of a fundamental architecture for a direct digital synthesis circuit such as a digital direct synthesis circuit (DDS - “direct digital synthesis”) configured to generate a plurality of waveforms for the waveform electrical signal for use in any of the surgical instruments, in accordance with at least one aspect of the present description.
[0067] [0067] Figure 42 illustrates an aspect of the digital direct synthesis circuit (DDS) configured to generate a plurality of waveforms for the electrical signal waveform for use in a surgical instrument, according to at least one aspect of this description.
[0068] [0068] Figure 43 illustrates a cycle of a discrete-time digital electrical signal waveform, according to at least one aspect of the present description, of an analog waveform (shown superimposed over an electrical signal waveform) discrete time digital for comparison purposes), in accordance with at least one aspect of the present description.
[0069] [0069] Figure 44 is a diagram of a control system configured to provide progressive closure of a closing member as it advances distally to close the clamping arm to apply a load of closing force at a desired rate according to a aspect of this description.
[0070] [0070] Figure 45 illustrates a feedback control system for the proportional, integral, derivative controller (PID), according to one aspect of the present description.
[0071] [0071] Figure 46 is an exploded elevation view of the modular handheld ultrasonic surgical instrument showing the left half of the compartment removed from a handle assembly that exposes a device identifier coupled communicatively to the multi-conductor terminal handle assembly , in accordance with an aspect of the present description.
[0072] [0072] Figure 47 is a detailed view of a trigger and key portion of the ultrasonic surgical instrument shown in Figure 46, in accordance with at least one aspect of the present description.
[0073] [0073] Figure 48 is an enlarged fragmentary perspective view of an end actuator from a distal end with a claw member in an open position, in accordance with at least one aspect of the present description.
[0074] [0074] Figure 49 is a system diagram of a segmented circuit comprising a plurality of independently operated circuit segments, in accordance with at least one aspect of the present description.
[0075] [0075] Figure 50 is a circuit diagram of several components of a surgical instrument with motor control functions, in accordance with at least one aspect of the present description.
[0076] [0076] Figure 51 illustrates an aspect of an end actuator comprising RF data sensors located on the claw member, in accordance with at least one aspect of the present description.
[0077] [0077] Figure 52 illustrates an aspect of the flexible circuit shown in Figure 51, in which the sensors can be mounted on or formed integrally with it, according to at least one aspect of the present description.
[0078] [0078] Figure 53 is an alternative system for controlling the frequency of an ultrasonic electromechanical system and detecting its impedance, in accordance with at least one aspect of the present description.
[0079] [0079] Figures 54A to 54B are complex impedance spectra of the same ultrasonic device with a cold (blue) and hot (red) ultrasonic blade, in accordance with at least one aspect of the present description, where
[0080] [0080] Figure 54A is a graphical representation of the impedance phase angle as a function of the resonance frequency of the same ultrasonic device with a cold (blue) and hot (red) ultrasonic blade; and
[0081] [0081] Figure 54B is a graphical representation of the impedance magnitude as a function of the resonance frequency of the same ultrasonic device with a cold (blue) and hot (red) ultrasonic blade.
[0082] [0082] Figure 55 is a diagram of a Kalman filter to improve the temperature estimator and the state space model based on the impedance of an ultrasonic transducer measured at a variety of frequencies, according to at least one aspect of this description.
[0083] [0083] Figure 56 are three probability distributions employed by a Kalman filter state estimator shown in Figure 55 to maximize the estimates, in accordance with at least one aspect of the present description.
[0084] [0084] Figure 57A is a graphical representation of the temperature as a function of time an ultrasonic device with no temperature control does not reach a maximum temperature of 490 ° C.
[0085] [0085] Figure 57B is a graphical representation of the temperature as a function of time of an ultrasonic device in which the temperature control reaches a maximum temperature of 320 ° C, in accordance with at least one aspect of the present description.
[0086] [0086] Figures 58A to 58B are graphical representations of the feedback control to adjust the ultrasonic energy applied to an ultrasonic transducer when a sudden drop in the temperature of an ultrasonic blade is detected, where
[0087] [0087] Figure 58A is a graphical representation of ultrasonic energy as a function of time; and
[0088] [0088] Figure 58B is a graph of ultrasonic sheet temperature as a function of time, according to at least one aspect of the present description.
[0089] [0089] Figure 59 is a logic flow diagram of a process that represents a control program or a logical configuration for controlling the temperature of an ultrasonic blade, according to at least one aspect of the present description.
[0090] [0090] Figure 60 is a graphical representation of the temperature of the ultrasonic sheet as a function of time during the firing of a vessel, according to at least one aspect of the present description.
[0091] [0091] Figure 61 is a logic flow diagram of a process that represents a control program or a logical configuration to control the temperature of an ultrasonic blade between two temperature adjustment points, according to at least one aspect of this description.
[0092] [0092] Figure 62 is a logic flow diagram of a process that represents a control program or a logical configuration to determine the initial temperature of an ultrasonic blade, according to at least one aspect of the present description.
[0093] [0093] Figure 63 is a logic flow diagram of a process that represents a control program or a logical configuration to determine when an ultrasonic blade is approaching instability and then adjust the power applied to the ultrasonic transducer to prevent instability of the ultrasonic transducer, in accordance with at least one aspect of the present description.
[0094] [0094] Figure 64 is a logic flow diagram of a process that represents a control program or a logical configuration to provide ultrasonic sealing with temperature control, in accordance with at least one aspect of the present description.
[0095] [0095] Figure 65 are graphical representations of the current of the ultrasonic transducer and the temperature of the ultrasonic blade as a function of time, according to at least one aspect of the present description.
[0096] [0096] Figure 66 is a graphical representation of the relationship between the initial frequency and the change in frequency necessary to obtain a temperature of approximately 340 ° C, according to at least one aspect of the present description.
[0097] [0097] Figure 67 illustrates a feedback control system that comprises an ultrasonic generator to regulate the electric current set point (i) applied to an ultrasonic transducer of an electromechanical ultrasonic system to prevent the frequency (f) of the transducer sonication decreases below a predetermined limit, in accordance with at least one aspect of the present description.
[0098] [0098] Figure 68 is a logic flow diagram of a process representing a control program or a logical configuration of a controlled thermal management process to protect an end actuator block, in accordance with at least one aspect of this description.
[0099] [0099] Figure 69 is a graphical representation of temperature as a function of time comparing the desired temperature of an ultrasonic blade with an intelligent ultrasonic blade and a conventional ultrasonic blade, in accordance with at least one aspect of the present description.
[00100] [00100] Figure 70 is a timeline that presents the situational perception of a central surgical controller, according to at least one aspect of the present description. DESCRIPTION
[00101] [00101] The applicant for the present application holds the following US Patent Applications, filed on August 28, 2018, the description of each of which is incorporated herein by reference in its entirety: • US Patent Application, n Precedent ° END8536USNP2 / 180107-2, entitled ESTIMATING STATE OF
[00102] [00102] The applicant for the present application holds the following US Patent Applications, filed on August 23, 2018, the description of each of which is incorporated herein by reference in its entirety: • US Provisional Patent Application n ° 62 / 721,995, entitled
[00103] [00103] The applicant for the present application holds the following US patent applications, filed on June 30, 2018, the description of each of which is incorporated herein by reference in its entirety: • US Provisional Patent Application no. 62 / 692,747, entitled
[00104] [00104] The applicant for the present application holds the following US patent applications, filed on June 29, 2018, with the description of each of which is incorporated herein by reference in its entirety: • US Patent Application No. series 16 / 024.090, entitled
[00105] [00105] The applicant for this application holds the following provisional US patent applications, filed on June 28, 2018, with the description of each of which is incorporated herein by reference in its entirety: • US Provisional Patent Application n Serial number 62 / 691,228, entitled A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES; • U.S. Provisional Patent Application Serial No. 62 / 691,227, entitled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS; • U.S. Provisional Patent Application Serial No. 62 / 691,230, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE; • U.S. Provisional Patent Application Serial No. 62 / 691,219, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL; • U.S. Provisional Patent Application Serial No. 62 / 691,257, entitled COMMUNICATION OF SMOKE EVACUATION SYSTEM
[00106] [00106] The applicant for this application holds the following provisional US patent applications, filed on April 19, 2018,
[00107] [00107] The applicant for this application holds the following provisional US Patent Applications, filed on March 30, 2018, the description of which is incorporated herein by reference in its entirety: • US Provisional Patent Application n ° 62 / 650,898 filed on March 30, 2018, entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS; • U.S. Provisional Patent Application Serial No. 62 / 650,887, entitled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES; • U.S. Provisional Patent Application Serial No. 62 / 650,882, entitled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and • U.S. Provisional Patent Application Serial No. 62 / 650,877, entitled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS.
[00108] [00108] The applicant of the present application holds the following US patent applications, filed on March 29, 2018, the description of each of which is incorporated herein by reference in its entirety: • US Patent Application No. series 15 / 940,641, entitled
[00109] [00109] The applicant for the present application holds the following provisional US Patent Applications, filed on March 28, 2018, with the description of each of which is incorporated herein by reference in its entirety: • US Provisional Patent Application n Serial number 62 / 649,302, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES; • U.S. Provisional Patent Application Serial No. 62 / 649,294, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD; • U.S. Provisional Patent Application Serial No. 62 / 649,300, entitled SURGICAL HUB SITUATIONAL AWARENESS; • U.S. Provisional Patent Application Serial No. 62 / 649,309, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER; • U.S. Provisional Patent Application Serial No. 62 / 649,310, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS; • U.S. Provisional Patent Application Serial No. 62 / 649,291, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE
[00110] [00110] The applicant for this application holds the following provisional US Patent Applications, filed on March 8, 2018, with the description of each of which is incorporated herein by reference in its entirety: • US Provisional Patent Application n Serial number 62 / 640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR; and • U.S. Provisional Patent Application Serial No. 62 / 640,415, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.
[00111] [00111] The applicant for the present application holds the following provisional US Patent Applications, filed on December 28, 2017, with the description of each of which is incorporated herein by reference in its entirety: • US Provisional Patent Application n Serial number 62 / 611.341, entitled INTERACTIVE SURGICAL PLATFORM; • U.S. Provisional Patent Application Serial No. 62 / 611,340, entitled CLOUD-BASED MEDICAL ANALYTICS; and • U.S. Provisional Patent Application Serial No. 62 / 611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM.
[00112] [00112] Before explaining in detail the various aspects of surgical instruments and generators, it should be noted that the illustrative examples are not limited, in terms of application or use, to the details of construction and arrangement of parts illustrated in the drawings and description attached. Illustrative examples can be implemented or incorporated into other aspects, variations and modifications, and can be practiced or performed in a variety of ways. Furthermore, except where otherwise indicated, the terms and expressions used in the present invention were chosen for the purpose of describing illustrative examples for the convenience of the reader and not for the purpose of limiting it. In addition, it should be understood that one or more of the aspects, expressions of aspects, and / or examples described below can be combined with any one or more of the other aspects, expressions of aspects and / or examples described below.
[00113] [00113] Several aspects are addressed to improved ultrasonic surgical devices, electrosurgical devices and generators for use with them. Aspects of ultrasonic surgical devices can be configured to transect and / or coagulate tissue during surgical procedures, for example. Aspects of electrosurgical devices can be configured to transect, coagulate, scale, weld and / or dry the tissue during surgical procedures, for example.
[00114] [00114] Referring to Figure 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (for example, cloud 104 which may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one central surgical controller 106 in communication with the cloud 104 which can include a remote server 113. In one example, as illustrated in Figure 1, surgical system 102 includes a visualization system 108, a robotic system 110, a smart handheld surgical instrument 112, which are configured to communicate with one another and / or the central controller 106. In some respects, a surgical system 102 may include a number of central controllers M 106, an N number of visualization systems 108, an O number of robotic systems 110, and a P number of smart, hand-held surgical instruments 112, where M, N, O, and P are whole numbers greater than or equal to one.
[00115] [00115] Figure 3 represents an example of a surgical system 102 being used to perform a surgical procedure on a patient who is lying on an operating table 114 in a surgical operating room 116. A robotic system 110 is used in the surgical procedure as a part of surgical system 102. Robotic system 110 includes a surgeon console 118, a patient car 120 (surgical robot), and a central surgical robotic controller
[00116] [00116] Other types of robotic systems can be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical instruments that are suitable for use with the present description are described in provisional patent application serial number 62 / 611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, whose description is hereby incorporated by reference in its entirety.
[00117] [00117] Various examples of cloud-based analysis that are performed by cloud 104, and are suitable for use with the present description, are described in US Provisional Patent Application Serial No. 62 / 611.340, entitled CLOUD-BASED MEDICAL ANALYTICS , filed on December 28, 2017, the description of which is incorporated herein by reference, in its entirety.
[00118] [00118] In several aspects, the imaging device 124 includes at least one Image sensor and one or more optical components. Suitable image sensors include, but are not limited to, load-coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.
[00119] [00119] The optical components of the imaging device 124 may include one or more light sources and / or one or more lenses. One or more light sources can be directed to illuminate portions of the surgical field. The one or more image sensors can receive reflected or refracted light from the surgical field,
[00120] [00120] The one or more light sources can be configured to radiate electromagnetic energy in the visible spectrum, as well as in the invisible spectrum. The visible spectrum, sometimes called the optical spectrum or light spectrum, is that portion of the electromagnetic spectrum that is visible to (that is, can be detected by) the human eye and can be called visible light or simply light. A typical human eye will respond to wavelengths in the air that are from about 380 nm to about 750 nm.
[00121] [00121] The invisible spectrum (that is, the non-luminous spectrum) is that portion of the electromagnetic spectrum located below and above the visible spectrum (that is, wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the visible red spectrum, and they become invisible infrared (IR), microwaves, radio and electromagnetic radiation. Wavelengths shorter than about 380 nm are shorter than the ultraviolet spectrum, and they become invisible ultraviolet, x-ray, and electromagnetic gamma-ray radiation.
[00122] [00122] In several respects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use with the present description include, but are not limited to, an arthroscope, angioscope, bronchoscope, choledocoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagus-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngoscope neproscope, sigmoidoscope, thoracoscope, and ureteroscope.
[00123] [00123] In one aspect, the imaging device employs multiple spectrum monitoring to discriminate topography and underlying structures. A multi-spectral image is one that captures image data within wavelength bands across the electromagnetic spectrum. Wavelengths can be separated by filters or using instruments that are sensitive to specific wavelengths, including light from frequencies beyond the visible light range, for example, IR and ultraviolet light. Spectral images can allow the extraction of additional information that the human eye cannot capture with its receivers for the colors red, green, and blue. The use of multispectral imaging is described in more detail under the heading "Advanced Imaging Acquisition Module" in US Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, the description of which is here incorporated as a reference in its entirety. Multispectral monitoring can be a useful tool for relocating a surgical field after a surgical task is completed to perform one or more of the tests previously described on the treated tissue.
[00124] [00124] It is axiomatic that strict sterilization of the operating room and surgical equipment is necessary during any surgery. The strict hygiene and sterilization conditions required in an "operating room", that is, an operating or treatment room, justify the highest possible sterilization of all medical devices and equipment. Part of this sterilization process is the need to sterilize anything that comes into contact with the patient or enters the sterile field, including imaging device 124 and its connectors and components. It will be understood that the sterile field can be considered a specified area, such as inside a tray or on a sterile towel, which is considered free of microorganisms, or the sterile field can be considered an area, immediately around a patient, who was prepared to perform a surgical procedure. The sterile field may include members of the brushing team, who are properly dressed, and all furniture and accessories in the area.
[00125] [00125] In several aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays and one or more screens that are strategically arranged in relation to the sterile field, as shown in Figure 2. In one aspect, the display system 108 includes an interface for HL7, PACS and EMR. Various components of the 108 display system are described under the heading "Advanced Imaging Acquisition Module" in US Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, the description of which is incorporated herein as a reference in its entirety.
[00126] [00126] As shown in Figure 2, a primary screen 119 is positioned in the sterile field to be visible to the operator on the operating table 114. In addition, a viewing tower 111 is positioned outside the sterile field. The display tower 111 includes a first non-sterile screen 107 and a second non-sterile screen 109, which are opposite each other. The visualization system 108, guided by the central controller 106, is configured to use screens 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, the central controller 106 can have the visualization system 108 show a snapshot of a surgical site, as recorded by an imaging device 124, on a non-sterile screen 107 or 109, while maintaining a live transmission of the surgical site on main screen 119. Snapshot on non-sterile screen 107 or 109 can allow a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example.
[00127] [00127] In one aspect, central controller 106 is also configured to route a diagnostic input or feedback by a non-sterile operator in the display tower 111 to the primary screen 119 within the sterile field, where it can be seen by a sterile operator on the operating table. In one example, the input may be in the form of a modification of the snapshot shown on the non-sterile screen 107 or 109, which can be routed to main screen 119 by central controller 106.
[00128] [00128] With reference to Figure 2, a 112 surgical instrument is being used in the surgical procedure as part of the surgical system
[00129] [00129] Now with reference to Figure 3, a central controller 106 is shown in communication with a visualization system 108, a robotic system 110 and a smart handheld surgical instrument 112. Central controller 106 includes a central controller screen 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132 and a storage matrix 134. In certain respects, as shown in Figure 3, central controller 106 additionally includes a smoke evacuation module 126 and / or a suction / irrigation module 128.
[00130] [00130] During a surgical procedure, the application of energy to the tissue, for sealing and / or cutting, is generally associated with the evacuation of smoke, suction of excess fluid and / or irrigation of the tissue. Fluid, power, and / or data lines from different sources are often intertwined during the surgical procedure. Valuable time can be wasted in addressing this issue during a surgical procedure. To untangle the lines, it may be necessary to disconnect the lines from their respective modules, which may require a restart of the modules. The modular housing of the central controller 136 offers a unified environment for managing power, data and fluid lines, which reduces the frequency of entanglement between such lines.
[00131] [00131] Aspects of the present description feature a central surgical controller for use in a surgical procedure that involves applying energy to the tissue at a surgical site. The central surgical controller includes a central controller housing and a combination generator module received slidingly at a central surgical controller housing docking station. The docking station includes data and power contacts. The combined generator module includes two or more of an ultrasonic energy generating component, a bipolar RF energy generating component, and a monopolar RF energy generating component which are housed in a single unit. In one aspect, the combined generator module also includes a smoke evacuation component, at least one power application cable to connect the combined generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid , and / or particulates generated by applying therapeutic energy to the tissue, and a fluid line that extends from the remote surgical site to the smoke evacuation component.
[00132] [00132] In one aspect, the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to a suction and irrigation module received slidingly in the central surgical controller enclosure. In one aspect, the central controller housing comprises a fluid interface.
[00133] [00133] Certain surgical procedures may require the application of more than one type of energy to the tissue. One type of energy may be more beneficial for cutting the fabric, while another type of energy may be more beneficial for sealing the fabric. For example, a bipolar generator can be used to seal the tissue while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present description present a solution in which a modular housing of central controller 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the central modular housing 136 is that it allows quick removal and / or replacement of several modules.
[00134] [00134] Aspects of the present description present a modular surgical wrap for use in a surgical procedure that involves applying energy to the tissue. The modular surgical cabinet includes a first energy generator module, configured to generate a first energy for application to the tissue, and a first docking station that comprises a first docking port that includes first data contacts and energy contacts, the the first power generator module is slidably movable in an electric coupling with the power and data contacts and the first power generator module is slidably movable out of the electric coupling with the first power and data contacts.
[00135] [00135] In addition to the above, the modular surgical enclosure also includes a second energy generator module configured to generate a second energy, different from the first energy, for application to the tissue, and a second docking station comprising a second docking port which includes second data and power contacts, the second power generating module being slidably movable in an electrical coupling with the power and data contacts, and the second power generating module being slidingly movable outwards electrical coupling with the second power and data contacts.
[00136] [00136] In addition, the modular surgical cabinet also includes a communication bus between the first coupling port and the second coupling port, configured to facilitate communication between the first power generator module and the second power generator module.
[00137] [00137] With reference to Figures 3 to 7, aspects of the present description are presented for a modular housing of the central controller 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126, and a suction module / irrigation 128. The central modular enclosure 136 further facilitates interactive communication between modules 140, 126, 128. As illustrated in Figure 5, generator module 140 can be a generator module with integrated monopolar, bipolar and ultrasonic components, supported on a single cabinet unit 139 slidably insertable into the central modular housing 136. As shown in Figure 5, generator module 140 can be configured to connect to a monopolar device 146, a bipolar device 147 and an ultrasonic device 148. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar and / or ultrasonic generator modules that interact through the modula housing r central 136. The central modular enclosure 136 can be configured to facilitate the insertion of multiple generators and interactive communication between the generators anchored in the central modular enclosure 136 so that the generators would act as a single generator.
[00138] [00138] In one aspect, the central modular housing 136 comprises a modular power and a rear communication board 149 with external and wireless communication heads to allow removable fixing of modules 140, 126, 128 and interactive communication between them.
[00139] [00139] In one aspect, the central modular housing 136 includes docking stations, or drawers, 151, here also called drawers, which are configured to receive modules 140, 126, 128 in a sliding manner. Figure 4 illustrates a view in partial perspective of a surgical central controller housing 136, and a combined generator module 145 received slidably at a docking station 151 of the central surgical controller housing 136. A docking port 152 with power and data contacts on one side The rear of the combined generator module 145 is configured to engage a corresponding docking port 150 with the power and data contacts of a corresponding docking station 151 of the central controller modular housing 136 as the combined generator module 145 is slid into position at the station matching coupling 151 of the central housing of the central controller 136. In one aspect, the combined generator module 145 includes i a bipolar, ultrasonic and monopolar module and a smoke evacuation module integrated in a single compartment unit 139, as shown in Figure 5.
[00140] [00140] In several respects, the smoke evacuation module 126 includes a fluid line 154 that carries captured / collected smoke fluid away from a surgical site and to, for example, the smoke evacuation module 126. Suction a vacuum that originates from the smoke evacuation module 126 can pull the smoke into an opening of a utility conduit at the surgical site. The utility conduit, coupled to the fluid line, can be in the form of a flexible tube that ends in the smoke evacuation module 126. The utility conduit and the fluid line define a fluid path that extends towards the smoke evacuation module 126 which is received in the central controller housing 136.
[00141] [00141] In several aspects, the suction / irrigation module 128 is coupled to a surgical tool comprising a fluid suction line and a fluid suction line. In one example, the suction and suction fluid lines are in the form of flexible tubes that extend from the surgical site towards the suction / irrigation module 128. One or more drive systems can be configured to cause irrigation and aspiration of fluids to and from the surgical site.
[00142] [00142] In one aspect, the surgical tool includes a drive shaft that has an end actuator at a distal end thereof and at least an energy treatment associated with the end actuator, a suction tube, and a suction tube. irrigation. The suction tube can have an inlet port at a distal end of it and the suction tube extends through the drive shaft. Similarly, an irrigation pipe can extend through the drive shaft and may have an entrance port close to the power application implement. The power application implement is configured to deliver ultrasonic and / or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the drive shaft.
[00143] [00143] The irrigation tube can be in fluid communication with a fluid source, and the suction tube can be in fluid communication with a vacuum source. The fluid source and / or the vacuum source can be housed in the suction / irrigation module 128. In one example, the fluid source and / or the vacuum source can be housed in the central controller housing 136 separately from the control module. suction / irrigation
[00144] [00144] In one aspect, modules 140, 126, 128 and / or their corresponding docking stations in the central modular housing 136 may include alignment features that are configured to align the docking ports of the modules in engagement with their counterparts at the stations coupling of the central modular housing
[00145] [00145] In some respects, the drawers 151 of the central modular housing 136 are the same, or substantially the same size, and the modules are adjusted in size to be received in the drawers
[00146] [00146] In addition, the contacts of a specific module can be switched to engage with the contacts of a specific drawer to avoid the insertion of a module in a drawer with unpaired contacts.
[00147] [00147] As shown in Figure 4, the coupling port 150 of a drawer 151 can be coupled to the coupling port 150 of another drawer 151 via a communication link 157 to facilitate interactive communication between the modules housed in the modular housing central 136. The coupling ports 150 of the central modular housing 136 can, alternatively or additionally, facilitate interactive wireless communication between modules housed in the central modular housing 136. Any suitable wireless communication can be used, such as Air Titan Bluetooth.
[00148] [00148] Figure 6 illustrates individual power bus connectors for a plurality of side coupling ports of a side modular compartment 160 configured to receive a plurality of modules from a central surgical controller 206. Side modular compartment 160 is configured to receive and laterally interconnect modules 161. Modules 161 are slidably inserted into docking stations 162 of side modular compartment 160, which includes a back plate for interconnecting modules 161. As shown in Figure 6, modules 161 are arranged laterally in the side modular cabinet
[00149] [00149] Figure 7 illustrates a vertical modular cabinet 164 configured to receive a plurality of modules 165 from the central surgical controller 106. The modules 165 are slidably inserted into docking stations, or drawers, 167 of the vertical modular cabinet 164, the which includes a rear panel for interconnecting modules 165. Although the drawers 167 of the vertical modular cabinet 164 are arranged vertically, in certain cases, a vertical modular cabinet 164 may include drawers that are arranged laterally. In addition, modules 165 can interact with each other through the coupling ports of the vertical modular cabinet
[00150] [00150] In several respects, the imaging module 138 comprises an integrated video processor and a modular light source and is adapted for use with various imaging devices. In one aspect, the imaging device is comprised of a modular compartment that can be mounted with a light source module and a camera module. The compartment can be a disposable compartment. In at least one example, the disposable compartment is removably coupled to a reusable controller, a light source module, and a camera module. The light source module and / or the camera module can be selected selectively depending on the type of surgical procedure. In one aspect, the camera module comprises a CCD sensor. In another aspect, the camera module comprises a CMOS sensor. In another aspect, the camera module is configured for imaging the scanned beam. Similarly, the light source module can be configured to provide a white light or a different light, depending on the surgical procedure.
[00151] [00151] During a surgical procedure, removing a surgical device from the surgical field and replacing it with another surgical device that includes a different camera or other light source may be inefficient. Temporarily losing sight of the surgical field can lead to undesirable consequences. The imaging device module of the present description is configured to allow the replacement of a light source module or a "midstream" camera module during a surgical procedure, without the need to remove the imaging device from the surgical field.
[00152] [00152] In one aspect, the imaging device comprises a tubular compartment that includes a plurality of channels. A first channel is configured to receive the Camera module in a sliding way, which can be configured for a snap-fit fit (pressure fit) with the first channel. A second channel is configured to slide the camera module, which can be configured for a snap-fit fit (pressure fit) with the first channel. In another example, the camera module and / or the light source module can be rotated to an end position within their respective channels. A threaded coupling can be used instead of a pressure fitting.
[00153] [00153] In several examples, multiple imaging devices are placed in different positions in the surgical field to provide multiple views. Imaging module 138 can be configured to switch between imaging devices to provide an ideal view. In several respects, imaging module 138 can be configured to integrate images from different imaging devices.
[00154] [00154] Various image processors and imaging devices suitable for use with the present description are described in US Patent No. 7,995,045 entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, granted on August 9, 2011 which is incorporated herein as reference in its entirety. In addition, US Patent No. 7,982,776, entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, issued July 19, 2011, which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems can be integrated with imaging module 138. In addition to these, the publication of U.S. Patent Application No. 2011/0306840, entitled CONTROLLABLE
[00155] [00155] Figure 8 illustrates a surgical data network 201 comprising a central modular communication controller 203 configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a healthcare facility. audiences specially equipped for surgical operations, to a cloud-based system (for example, cloud 204 which may include a remote server 213 coupled to a storage device 205). In one aspect, the central modular communication controller 203 comprises a central network controller 207 and / or a network key 209 in communication with a network router. The central modular communication controller 203 can also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 can be configured as a passive, intelligent, or switching network. A passive surgical data network serves as a conduit for the data, allowing the data to be transmitted from one device (or segment) to another and to cloud computing resources. An intelligent surgical data network includes features to allow traffic to pass through the surgical data network to be monitored and to configure each port on the central network controller 207 or network key 209. An intelligent surgical data network can be called a a central controller or controllable key. A central switching controller reads the destination address of each packet and then forwards the packet to the correct port.
[00156] [00156] Modular devices 1a to 1n located in the operating room can be coupled to the central modular communication controller 203. The central network controller 207 and / or the network switch 209 can be coupled to a network router 211 to connect devices 1a through 1n to the 204 cloud or the local computer system
[00157] [00157] It will be understood that the surgical data network 201 can be expanded by interconnecting multiple central network controllers 207 and / or multiple network keys 209 with multiple network routers 211. The central modular communication controller 203 may be contained in a modular control roaster configured to receive multiple devices 1a to 1n / 2a to 2m. The local computer system 210 can also be contained in a modular control tower. The central modular communication controller 203 is connected to a screen 212 to show the images obtained by some of the devices 1a to 1n / 2a to 2m, for example, during surgical procedures. In several respects, devices 1a to 1n / 2a to 2m can include, for example, several modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, an evacuation module smoke 126, a suction / irrigation module 128, a communication module 130, a processor module 132, a storage matrix 134, a surgical device attached to a screen, and / or a non-contact sensor module, among others modular devices that can be connected to the central modular communication controller 203 of the surgical data network 201.
[00158] [00158] In one aspect, the surgical data network 201 may comprise a combination of central network controllers, network switches, and network routers that connect devices 1a to 1n / 2a to 2m to the cloud. Any or all of the devices 1a to 1n / 2a to 2m coupled to the central network controller or network key can collect data in real time and transfer the data to cloud computers for data processing and manipulation. It will be understood that cloud computing depends on sharing computing resources instead of having local servers or personal devices to handle software applications. The word "cloud" can be used as a metaphor for "the Internet", although the term is not limited as such. Consequently, the term "cloud computing" can be used here to refer to "a type of Internet-based computing", in which different services - such as servers, storage, and applications - are applied to the central modular communication controller 203 and / or computer system 210 located in the operating room (for example, a fixed, mobile, temporary, or operating field or operating space) and devices connected to the central modular communication controller 203 and / or computer system 210 via from Internet. The cloud infrastructure can be maintained by a cloud service provider. In this context, the cloud service provider may be the entity that coordinates the use and control of devices 1a to 1n / 2a to 2m located in one or more operating rooms. Cloud computing services can perform a large number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The central controller hardware allows multiple devices or connections to be connected to a computer that communicates with cloud computing and storage resources.
[00159] [00159] The application of cloud computer data processing techniques to data collected by devices 1a to
[00160] [00160] In an implementation, devices in the operating room 1a to 1n can be connected to the central modular communication controller 203 via a wired channel or a wireless channel depending on the configuration of devices 1a to 1n on a network controller central. The central network controller 207 can be implemented, in one aspect, as a LAN transmission device that acts on the physical layer of the OSI model ("open system interconnection"). The central network controller provides connectivity to devices 1a to 1n located on the same network as the operating room. The central network controller 207 collects data in the form of packets and sends it to the router in half - duplex mode. The central network controller 207 does not store any Internet protocol / media access control (MAC / IP) to transfer data from the device. Only one of the devices 1a to 1n at a time can send data via the central network controller
[00161] [00161] In another implementation, operating room devices 2a to 2 m can be connected to a network switch 209 through a wired or wireless channel. The network key 209 works in the data connection layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a to 2m located in the same operation center to the network. The network key 209 sends data in frame form to the network router 211 and works in full duplex mode. Multiple devices 2a to 2m can send data at the same time via network key 209. Network key 209 stores and uses MAC addresses of devices 2a to 2m to transfer data.
[00162] [00162] The central network controller 207 and / or the network key 209 are coupled to the network router 211 for a connection to the cloud
[00163] [00163] In one example, the central network controller 207 can be implemented as a central USB controller, which allows multiple USB devices to be connected to a host computer. The central USB controller can expand a single USB port on several levels so that more ports are available to connect the devices to the system's host computer. The central network controller 207 can include wired or wireless capabilities to receive information about a wired channel or a wireless channel. In one aspect, a wireless wireless, broadband and short-range wireless USB communication protocol can be used for communication between devices 1a to 1n and devices 2a to 2m located in the operating room.
[00164] [00164] In other examples, devices in the operating room 1a to 1n / 2a to 2m can communicate with the central modular communication controller 203 via standard Bluetooth wireless technology for exchanging data over short distances (with the use of short-wavelength UHF radio waves in the 2.4 to 2.485 GHz ISM band) from fixed and mobile devices and build personal area networks (PANs). In other respects, operating room devices 1a to 1n / 2a to 2m can communicate with the central modular communication controller 203 via a number of wireless and wired communication standards or protocols, including, but not limited to a, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long-term evolution (LTE, "long-term evolution"), and Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM , GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond. The computing module can include a plurality of communication modules. For example, a first communication module can be dedicated to short-range wireless communications like Wi-Fi and Bluetooth, and a second communication module can be dedicated to longer-range wireless communications like GPS, EDGE, GPRS, CDMA , WiMAX, LTE, Ev-DO, and others.
[00165] [00165] The central modular communication controller 203 can serve as a central connection for one or all operating room devices 1a to 1n / 2a to 2m and handles a data type known as frames. The tables carry the data generated by the devices 1a to 1n / 2a to 2m. When a frame is received by the central modular communication controller 203, it is amplified and transmitted to network router 211, which transfers data to cloud computing resources using a series of wireless communication standards or protocols or wired, as described in the present invention.
[00166] [00166] The 203 central modular communication controller can be used as a standalone device or be connected to compatible central network controllers and network switches to form a larger network. The 203 central modular communication controller is, in general, easy to install, configure and maintain, making it a good choice for the network of devices 1a to 1n / 2a to 2m from the operating room.
[00167] [00167] Figure 9 illustrates an interactive surgical system, implemented by computer 200. The interactive surgical system implemented by computer 200 is similar in many ways to the interactive surgical system, implemented by computer 100. For example, the interactive, implemented, surgical system per computer 200 includes one or more surgical systems 202, which are similar in many respects to surgical systems 102. Each surgical system 202 includes at least one central surgical controller 206 in communication with a cloud 204 which may include a remote server
[00168] [00168] Figure 10 illustrates a central surgical controller 206 comprising a plurality of modules coupled to the modular control tower 236. The modular control tower 236 comprises a central modular communication controller 203, for example, a network connectivity device, and a computer system 210 for providing local processing, visualization, and imaging, for example. As shown in Figure 10, the central modular communication controller 203 can be connected in a layered configuration to expand the number of modules (for example, devices) that can be connected to the central modular communication controller 203 and transfer data associated with the modules to computer system 210, cloud computing resources, or both. As shown in Figure 10, each of the central controllers / network switches in the central modular communication controller 203 includes three downstream ports and one upstream port. The central controller / network switch upstream is connected to a processor to provide a communication connection to the cloud computing resources and a local display 217. Communication with the cloud 204 can be done via a wired communication channel or wireless.
[00169] [00169] The central surgical controller 206 employs a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room using non-contact measuring devices such as laser or ultrasonic. An ultrasound-based non-contact sensor module scans the operating room by transmitting an ultrasound explosion and receiving the echo when it bounces outside the perimeter of the operating room walls, as described under the heading "Surgical Hub Spatial Awareness Within an Operating Room "in US Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, which is hereby incorporated by reference in its entirety, in which the sensor module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limits. A laser-based non-contact sensor module scans the operating room by transmitting pulses of laser light, receiving pulses of laser light that bounce off the perimeter walls of the operating room, and comparing the phase of the transmitted pulse to the received pulse to determine the size of the operating room and to adjust the Bluetooth pairing distance limits, for example.
[00170] [00170] Computer system 210 comprises a processor 244 and a network interface 245. Processor 244 is coupled to a communication module 247, storage 248, memory 249, non-volatile memory 250, and input / output interface 251 through of a system bus. The system bus can be any of several types of bus structures, including the memory bus or memory controller, a peripheral bus or external bus, and / or a local bus that uses any variety of available bus architectures including, but not limited to, not limited to, 9-bit bus, industry standard architecture (ISA), Micro-Charmel Architecture (MSA), extended ISA (EISA), smart drive electronics (IDE), VESA local bus (VLB), component interconnection peripherals (PCI), USB, accelerated graphics port (AGP), PCMCIA bus (International Personal Computer Memory Card Association, "Personal Computer Memory Card International Association"), Small Computer Systems Interface (SCSI), or any another proprietary bus.
[00171] [00171] Processor 244 can be any single-core or multi-core processor, such as those known under the ARM Cortex trade name available from Texas Instruments. In one respect, the processor may be a Core Cortex-M4F LM4F230H5QR ARM processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz , a seek-ahead buffer to optimize performance above 40 MHz, a 32 KB single cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with the StellarisWare® program, memory only programmable, electrically erasable (EEPROM) reading of 2 KB, one or more pulse width modulation (PWM) modules, one or more analogs of quadrature encoder (QEI) inputs, one or more analog to digital converters (ADC) 12-bit with 12 channels of analog input, details of which are available for the product data sheet.
[00172] [00172] In one aspect, processor 244 may comprise a safety controller comprising two controller-based families, such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also by Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[00173] [00173] System memory includes volatile and non-volatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within the computer system, such as during startup, is stored in non-volatile memory. For example, non-volatile memory can include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM or flash memory. Volatile memory includes random access memory (RAM), which acts as an external cache memory. In addition, RAM is available in many forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct RAM Rambus RAM (DRRAM).
[00174] [00174] Computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card or memory stick (pen drive). drive). In addition, the storage disc may include storage media separately or in combination with other storage media including, but not limited to, an optical disc drive such as a compact disc ROM (CD-ROM) device recordable (CD-R Drive), rewritable compact disc drive (CD-RW drive), or a versatile digital ROM drive (DVD-ROM). To facilitate the connection of disk storage devices to the system bus, a removable or non-removable interface can be used.
[00175] [00175] It is to be understood that computer system 210 includes software that acts as an intermediary between users and basic computer resources described in an appropriate operating environment. Such software includes an operating system. The operating system, which can be stored on disk storage, acts to control and allocate computer system resources. System applications benefit from the management capabilities of the operating system through program modules and program data stored in system memory or on the storage disk. It is to be understood that the various components described in the present invention can be implemented with various operating systems or combinations of operating systems.
[00176] [00176] A user enters commands or information into the computer system 210 through the input device (s) coupled to the I / O interface 251. Input devices include, but are not limited to, a device pointer such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, game pad, satellite board,
[00177] [00177] Computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computers, or local computers. Remote cloud computers can be a personal computer, server, router, personal network computer, workstation, microprocessor-based device, peer device, or other common network node, and the like, and typically include many or all elements described in relation to the computer system. For the sake of brevity, only one memory storage device is illustrated with the remote computer. Remote computers are logically connected to the computer system via a network interface and then physically connected via a communication connection. The network interface covers communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet / IEEE 802.3, Token / IEEE 802.5 ring and the like. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks such as digital integrated service networks (ISDN) and variations in them, packet switching networks and digital subscriber lines (DSL).
[00178] [00178] In several respects, computer system 210 of Figure 10, imaging module 238 and / or display system 208, and / or processor module 232 of Figures 9 to 10, may comprise an image processor, image processing engine, media processor, or any specialized digital signal processor (DSP) used for processing digital images. The image processor can employ parallel computing with single multi-data instruction (SIMD) or multiple multi-data instruction (MIMD) technologies to increase speed and efficiency. The digital image processing engine can perform a number of tasks. The image processor can be an integrated circuit system with a multi-core processor architecture.
[00179] [00179] Communication connections refer to the hardware / software used to connect the network interface to the bus. Although the communication connection is shown for illustrative clarity within the computer system, it can also be external to computer system 210. The hardware / software required for connection to the network interface includes, for illustrative purposes only, internal and external technologies such as modems, including regular telephone serial modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards.
[00180] [00180] Figure 11 illustrates a functional block diagram of an aspect of a USB 300 central network controller device, in accordance with at least one aspect of the present description. In the illustrated aspect, the USB 300 central network controller device uses a TUSB2036 integrated circuit central controller available from Texas Instruments. The USB 300 core network controller is a CMOS device that provides one USB transceiver port 302 and up to three USB transceiver ports downstream 304, 306, 308 in accordance with the USB 2.0 specification. Upstream USB transceiver port 302 is a differential data root port comprising a "minus" (DM0) differential data input paired with a "plus" (DP0) differential data input. The three ports of the downstream USB transceiver 304, 306, 308 are differential data ports, with each port including "more" differential data outputs (DP1-DP3) paired with "less" differential data outputs (DM1-DM3) .
[00181] [00181] The USB 300 central network controller device is implemented with a digital state machine instead of a microcontroller, and no firmware programming is required. Fully compatible USB transceivers are integrated into the circuit for the upstream USB transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full speed as low speed automatically configuring the scan rate according to the speed of the device attached to the doors. The USB 300 central network controller device can be configured in bus-powered or self-powered mode and includes 312 central power logic to manage power.
[00182] [00182] The USB 300 central network controller device includes a 310 series interface engine (SIE). The SIE 310 is the front end of the USB 300 central network controller hardware and handles most of the protocol described in chapter 8 of the USB specification. SIE 310 typically comprises signaling down to the transaction level. The functions it handles could include: packet recognition, transaction sequencing, SOP, EOP, RESET, and RESUME signal detection / generation, clock / data separation, inverted non-zero data encoding / decoding (NRZI) , generation and verification of CRC (token and data), generation and verification / decoding of packet ID (PID), and / or series-parallel / parallel-series conversion. The 310 receives a clock input 314 and is coupled with a suspend / resume logic circuit and frame timer 316 and a central circuit repeat loop 318 to control communication between the upstream USB transceiver port 302 and the transceiver ports Downstream USB 304, 306, 308 through the logic circuits of ports 320, 322, 324. The SIE 310 is coupled to a command decoder 326 through the logic interface to control the commands of a serial EEPROM via an EEPROM interface in series 330.
[00183] [00183] In several aspects, the USB 300 central network controller can connect 127 functions configured in up to six logical layers (levels) to a single computer. In addition, the USB 300 central network controller can connect all peripherals using a standardized four-wire cable that provides both communication and power distribution. The power settings are bus-powered and self-powered modes. The USB 300 central network controller can be configured to support four power management modes: a bus powered central controller, with individual port power management or grouped port power management, and the self-powered central controller, with power management. individual port power or grouped port power management. In one aspect, using a USB cable, the USB 300 central network controller, the USB transceiver port 302 is plugged into a USB host controller, and the USB transceiver ports downstream 304, 306, 308 are exposed to connect compatible USB devices, and so on. Surgical instrument hardware
[00184] [00184] Figure 12 illustrates a logic diagram of a module of a 470 control system of a surgical instrument or tool, according to one or more aspects of the present description. The 470 system comprises a control circuit. The control circuit includes a microcontroller 461 comprising a processor 462 and a memory 468. One or more of the sensors 472, 474, 476, for example, provide real-time feedback to processor 462. A motor 482, driven by a driver motor 492, operationally couples a longitudinally movable displacement member to drive a clamping arm of the closing member. A tracking system 480 is configured to determine the position of the longitudinally movable displacement member. Position information is provided to processor 462, which can be programmed or configured to determine the position of the longitudinally movable drive member as well as the position of the closing member. Additional motors can be provided at the tool driver interface to control the pipe closing path, the rotation of the drive shaft, the joint, or the closing of the clamping arm, or a combination thereof. A 473 screen displays a variety of instrument operating conditions and can include touchscreen functionality for data entry. The information shown on screen 473 can be overlaid with images captured using endoscopic imaging modules.
[00185] [00185] In one aspect, the 461 microcontroller can be any single-core or multi-core processor, such as those known under the ARM Cortex trade name available from Texas Instruments. In one respect, the main microcontroller 461 can be an LM4F230H5QR ARM Cortex-M4F processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single cycle flash memory, or other non-volatile memory, up to 40 MHz, a seek-ahead buffer to optimize performance above 40 MHz, a 32 KB single cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with the StellarisWare® program, memory programmable and electrically erasable read-only (EEPROM) of 2 KB, one or more pulse width modulation (PWM) modules, one or more analogs of quadrature encoder (QEI) inputs, and / or one or more analog converters for 12 bit digital (ADC) with 12 channels of analog input, details of which are available for the product data sheet.
[00186] [00186] In one aspect, the 461 microcontroller may comprise a safety controller that comprises two families based on controllers, such as TMS570 and RM4x known under the trade name Hercules ARM Cortex R4, also available from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[00187] [00187] The 461 microcontroller can be programmed to perform various functions such as precise control of the speed and position of the scalpel, the articulation systems, the clamping arm, or a combination thereof. In one aspect, the microcontroller 461 includes a processor 462 and a memory 468. The electric motor 482 can be a brushed direct current (DC) motor with a gearbox and mechanical connections with an articulation or scalpel system. In one aspect, a motor drive 492 can be an A3941 available from Allegro Microsystems, Inc. Other motor drives can be readily replaced for use in tracking system 480 which comprises an absolute positioning system. A detailed description of an absolute positioning system is given in U.S. Patent Application No. 2017/0296213, entitled SYSTEMS AND METHODS FOR
[00188] [00188] The 461 microcontroller can be programmed to provide precise control of the speed and position of the displacement members and articulation systems. The 461 microcontroller can be configured to compute a response in the 461 microcontroller software. The computed response is compared to a measured response from the real system to obtain an "observed" response, which is used for actual feedback-based decisions. The observed response is a favorable and adjusted value, which balances the uniform and continuous nature of the simulated response with the measured response, which can detect external influences in the system.
[00189] [00189] In one aspect, motor 482 can be controlled by motor driver 492 and can be used by the instrument's trigger system or surgical tool. In many ways, the 482 motor can be a brushed direct current (DC) drive motor, with a maximum speed of approximately 25,000 RPM, for example. In other arrangements, the 482 motor may include a brushless motor, a wireless motor, a synchronous motor, a stepper motor or any other suitable electric motor. Motor starter 492 may comprise an H bridge starter comprising field effect transistors (FETs), for example. The 482 motor can be powered by a feed assembly releasably mounted on the handle assembly or tool compartment to provide control power for the instrument or surgical tool. The power pack may comprise a battery that may include several battery cells connected in series, which can be used as the power source to power the instrument or surgical tool. In certain circumstances, the battery cells in the power pack may be replaceable and / or rechargeable battery cells. In at least one example, the battery cells can be lithium-ion batteries that can be coupled and separable from the power pack.
[00190] [00190] The 492 motor drive can be an A3941, available from Allegro Microsystems, Inc. The 492 A3941 drive is an entire bridge controller for use with external power semiconductor metal oxide field (MOSFET) transistors. , of N channel, specifically designed for inductive loads, such as brushed DC motors. The 492 actuator comprises a single charge pump regulator that provides full door drive (> 10 V) for batteries with voltage up to 7 V and allows the A3941 to operate with a reduced door drive, up to 5.5 V. A capacitor input control can be used to supply the voltage surpassing that supplied by the battery required for the N channel MOSFETs. An internal charge pump for the upper side drive allows operation in direct current (100% duty cycle). The entire bridge can be triggered in fast or slow drop modes using diodes or synchronized rectification. In the slow drop mode, the current can be recirculated through the upper and lower FETs. The energy FETs are protected from the shoot-through effect through resistors with programmable dead time. Integrated diagnostics provide indication of undervoltage, overtemperature and faults in the power bridge, and can be configured to protect power MOSFETs in most short-circuit conditions. Other motor drives can be readily replaced for use in the tracking system 480 comprising an absolute positioning system.
[00191] [00191] The tracking system 480 comprises a controlled motor drive circuit arrangement comprising a position sensor 472 in accordance with an aspect of the present description. The position sensor 472 for an absolute positioning system provides a unique position signal that corresponds to the location of a displacement member. In one aspect, the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for engagement with a corresponding drive gear of a gear reduction assembly. In other respects, the displacement member represents the firing member, which can be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinal displacement member for opening and closing a clamping arm, which can be adapted and configured to include a rack of driving teeth. In other respects, the displacement member represents a closing member of the clamping arm configured to close and open a clamping arm of a stapler, ultrasonic, or electrosurgical device, or combinations thereof. Accordingly, as used in the present invention, the term displacement member is used generically to refer to any movable member of the instrument or surgical tool such as the driving member, the clamping arm, or any element that can be displaced. Consequently, the absolute positioning system can, in effect, track the displacement of the clamping arm by tracking the linear displacement of the movable drive member longitudinally.
[00192] [00192] In other aspects, the absolute positioning system can be configured to track the position of a clamping arm in the opening or closing process. In several other respects, the displacement member can be coupled to any position sensor 472 suitable for measuring linear displacement. In this way, the longitudinally movable drive member, or the clamping arm, or combinations thereof, can be coupled to any linear displacement sensor. Linear displacement sensors can include contact or non-contact displacement sensors. Linear displacement sensors can comprise Variable Differential Linear Transformers (LVDT), Variable Reluctance Differential Transducers (DVRT), a potentiometer, a magnetic detection system comprising a moving magnet and a series linearly arranged in Hall Effect Sensors, a magnetic detection comprising a fixed magnet and a series of movable lines, arranged linearly in Hall Effect Sensors, a mobile optical detection system comprising a mobile light source and a series of linearly arranged photodiodes or photodetectors, an optical detection system which comprises a fixed light source and a mobile series of linearly arranged photodiodes or photodetectors, or any combination thereof.
[00193] [00193] The 482 electric motor may include a rotary drive shaft, which interfaces operationally with a gear set, which is mounted on a coupling coupling with a set or rack of drive teeth on the drive member. A sensor element can be operationally coupled to a gear assembly so that a single revolution of the position sensor element 472 corresponds to some linear longitudinal translation of the displacement member. An array of gears and sensors can be connected to the linear actuator by means of a rack and pinion arrangement, or by a rotary actuator, by means of a sprocket or other connection. A power supply supplies power to the absolute positioning system and an output indicator can show the output from the absolute positioning system. The drive member represents the longitudinally movable drive member comprising a rack of drive teeth formed thereon for engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents the longitudinally movable firing member for opening and closing a clamping arm.
[00194] [00194] A single revolution of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement of d1 of the displacement member, where d1 represents the longitudinal linear distance by which the displacement member moves from point "a" to point "b" after a single revolution of the sensor element coupled to the displacement member. The sensor arrangement can be connected by means of a gear reduction which results in the position sensor 472 completing one or more revolutions for the complete travel of the displacement member. The 472 position sensor can complete multiple revolutions for the full travel of the displacement member.
[00195] [00195] A series of keys, where n is an integer greater than one, can be used alone or in combination with a gear reduction to provide a single position signal for more than one revolution of the position sensor 472. The state of the switches is transmitted back to microcontroller 461 which applies logic to determine a single position signal corresponding to the longitudinal linear displacement of d1 + d2 +… dn of the displacement member. The output of the position sensor 472 is supplied to the microcontroller 461. In several embodiments, the position sensor 472 of the sensor arrangement may comprise a magnetic sensor, an analog rotary sensor, such as a potentiometer, or a series of analog Hall effect elements. , which emit a unique combination of position of signs or values.
[00196] [00196] The position sensor 472 can comprise any number of magnetic detection elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector components of the magnetic field. The techniques used to produce both types of magnetic sensors cover many aspects of physics and electronics. Technologies used for magnetic field detection include flow meter, saturated flow, optical pumping, nuclear precession, SQUID, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piesoelectric compounds, magnetodiode, magnetic transistor, fiber optics, magneto-optics and magnetic sensors based on microelectromechanical systems, among others.
[00197] [00197] In one aspect, the position sensor 472 for the tracking system 480 comprising an absolute positioning system comprises a magnetic rotating absolute positioning system. The 472 position sensor can be implemented as a single-circuit magnetic rotary position sensor, AS5055EQFT, available from Austria Microsystems, AG. The position sensor 472 interfaces with the 461 microcontroller to provide an absolute positioning system. The 472 position sensor is a low voltage, low power component and includes four effect elements in an area of the 472 position sensor located above a magnet. A high-resolution ADC and an intelligent power management controller are also provided on the integrated circuit. A CORDIC (digital computer for coordinate rotation) processor, also known as the digit-for-digit method and Volder algorithm, is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition, subtraction, displacement operations bits and lookup table. The angle position, alarm bits and magnetic field information are transmitted via a standard serial communication interface, such as a serial peripheral interface (SPI), to the 461 microcontroller. The 472 position sensor provides 12 or 14 bits of resolution. The position sensor 472 can be an AS5055 integrated circuit supplied in a small 16-pin QFN package whose measurement corresponds to 4x4x0.85 mm.
[00198] [00198] The tracking system 480 comprising an absolute positioning system can comprise and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply converts the signal from the feedback controller to a physical input to the system, in this case the voltage. Other examples include a voltage, current and force PWM. Other sensors can be provided to measure the parameters of the physical system in addition to the position measured by the position sensor 472. In some respects, the other sensors may include sensor arrangements as described in US Patent No. 9,345,481 entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, granted on May 24, 2016, which is incorporated by reference in its entirety in this document; U.S. Patent Application Serial No. 2014/0263552, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, published September 18, 2014, is incorporated by reference in its entirety into this document; and U.S. Patent Application Serial No. 15 / 628,175, entitled TECHNIQUES FOR ADAPTIVE
[00199] [00199] The absolute positioning system provides an absolute positioning of the displaced member on the activation of the instrument without having to retract or advance the longitudinally movable driving member to the restart position (zero or initial), as may be required by the encoders conventional rotating machines that merely count the number of progressive or regressive steps that the 482 motor has traveled to infer the position of a device actuator, actuation bar, scalpel, and the like.
[00200] [00200] A 474 sensor, such as an effort meter or a micro force meter, is configured to measure one or more parameters of the end actuator, such as, for example, the amplitude of the effort exerted on the anvil during a gripping operation, which may be indicative of tissue compression. The measured effort is converted into a digital signal and fed to the 462 processor. Alternatively, or in addition to the 474 sensor, a 476 sensor, such as a load sensor, can measure the closing force applied by the drive system. anvil closure on a stapler or clamping arm on an electrosurgical or ultrasonic instrument. The 476 sensor, such as a load sensor, can measure the trigger force applied to a closing member coupled to a clamping arm of the instrument or surgical tool or the force applied by means of a clamping arm to the tissue located in the claws of an electrosurgical or ultrasonic instrument. Alternatively, a current sensor 478 can be used to measure the current drained by the motor 482. The displacement member can also be configured to engage a clamping arm to open or close the clamping arm. The force sensor can be configured to measure the grip force on the fabric. The force required to advance the displacement member can correspond to the current drained by the 482 motor, for example. The measured force is converted into a digital signal and supplied to the 462 processor.
[00201] [00201] In one form, a 474 strain gauge sensor can be used to measure the force applied to the tissue by the end actuator. A strain gauge can be attached to the end actuator to measure the force applied to the tissue being treated by the end actuator. A system for measuring forces applied to the tissue attached by the end actuator comprises a 474 strain gauge sensor, such as, for example, a microstrain gauge, which is configured to measure one or more parameters of the end actuator, for example. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain exerted on a claw member of an end actuator during a gripping operation, which can be indicative of tissue compression. The measured effort is converted into a digital signal and fed to the 462 processor of a microcontroller
[00202] [00202] Measurements of tissue compression, tissue thickness and / or force required to close the end actuator on the tissue, as measured by sensors 474, 476, can be used by microcontroller 461 to characterize the selected position of the trigger member and / or the corresponding trigger member speed value. In one case, a 468 memory can store a technique, an equation and / or a look-up table that can be used by the 461 microcontroller in the evaluation.
[00203] [00203] The control system 470 of the instrument or surgical tool can also comprise wired or wireless communication circuits for communication with the central modular communication controller shown in Figures 8 to 11.
[00204] [00204] Figure 13 illustrates a control circuit 500 configured to control aspects of the instrument or surgical tool according to an aspect of the present description. The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 may comprise a microcontroller comprising one or more processors 502 (for example, microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores instructions executable on a machine that, when executed by the processor 502, cause the 502 processor to execute machine instructions to implement several of the processes described here. The 502 processor can be any one of a number of single-core or multi-core processors known in the art. The memory circuit 504 may comprise volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present description.
[00205] [00205] Figure 14 illustrates a combinational logic circuit 510 configured to control aspects of the instrument or surgical tool according to an aspect of the present description. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 may comprise a finite state machine comprising a combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data by combinational logic 512 and provide an output 516.
[00206] [00206] Figure 15 illustrates a sequential logic circuit 520 configured to control aspects of the instrument or surgical tool according to an aspect of the present description. Sequential logic circuit 520 or combinational logic 522 can be configured to implement the process described herein. Sequential logic circuit 520 may comprise a finite state machine. Sequential logic circuit 520 may comprise combinational logic 522, at least one memory circuit 524, a clock 529 and, for example. The at least one memory circuit 524 can store a current state of the finite state machine. In certain cases, the sequential logic circuit 520 may be synchronous or asynchronous. Combinational logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data by combinational logic 522, and provide an output 528. In other respects, the circuit may comprise a combination of a processor (for example , processor 502, Figure 13) and a finite state machine for implementing various processes of the present invention. In other respects, the finite state machine may comprise a combination of a combinational logic circuit (for example, a combinational logic circuit 510, Figure 14) and the sequential logic circuit 520.
[00207] [00207] Figure 16 illustrates an instrument or surgical tool that comprises a plurality of motors that can be activated to perform various functions. In certain cases, a first engine can be activated to perform a first function, a second engine can be activated to perform a second function, a third engine can be activated to perform a third function, a fourth engine can be activated to perform a fourth function, and so on. In certain cases, the plurality of motors of the robotic surgical instrument 600 can be individually activated to cause firing, closing, and / or articulation movements in the end actuator. The firing, closing and / or articulation movements can be transmitted to the end actuator through a drive shaft assembly, for example.
[00208] [00208] In certain cases, the instrument or surgical tool system may include a 602 firing motor. The 602 firing motor can be operationally coupled to a 604 firing motor drive assembly, which can be configured to transmit movements trigger points, generated by the motor 602 to the end actuator, particularly to move the closing member of the clamping arm. The closing member can be retracted by reversing the direction of the motor 602, which also causes the clamping arm to open.
[00209] [00209] In certain cases, the surgical instrument or tool may include a closing motor 603. The closing motor 603 can be operationally coupled to a drive assembly of the closing motor 605 that can be configured to transmit closing movements, generated by the motor 603 to the end actuator, particularly to move a closing tube to close the anvil and compress the fabric between the anvil and the staple cartridge. The closing motor 603 can be operationally coupled to a drive assembly of the closing motor 605 that can be configured to transmit closing movements generated by the motor 603 to the end actuator, particularly to move a closing tube to close the closing arm. clamping and compressing the tissue between the clamping arm and an ultrasonic blade or the clamping arm or the claw member of an electrosurgical device. Closing movements can cause the end actuator to transition from an open configuration to an approximate configuration to capture tissue, for example. The end actuator can be moved to an open position by reversing the direction of the 603 motor.
[00210] [00210] In certain cases, the surgical instrument or tool may include one or more articulation motors 606a, 606b, for example. The motors 606a, 606b can be operationally coupled to the drive assemblies of the articulation motor 608a, 608b, which can be configured to transmit articulation movements generated by the motors 606a, 606b to the end actuator. In certain cases, the articulation movements can cause the end actuator to be articulated in relation to the drive shaft assembly, for example.
[00211] [00211] As described above, the surgical instrument or tool can include a plurality of motors that can be configured to perform various independent functions. In certain cases, the plurality of motors of the instrument or surgical tool can be activated individually or separately to perform one or more functions, while other motors remain inactive. For example, the articulation motors 606a, 606b can be activated to cause the end actuator to be articulated, while the firing motor 602 remains inactive. Alternatively, the firing motor 602 can be activated to fire the plurality of clamps, and / or advance the cutting edge, while the hinge motor 606 remains inactive. In addition, closing motor 603 can be activated simultaneously with firing motor 602 to cause the closing tube or closing member to advance distally as described in more detail later in this document.
[00212] [00212] In certain cases, the surgical instrument or tool may include a common control module 610 that can be used with a plurality of the instrument's instruments or surgical tool. In certain cases, the common control module 610 can accommodate one of the plurality of motors at a time. For example, the common control module 610 can be coupled to and separable from the plurality of motors of the robotic surgical instrument individually. In certain cases, a plurality of surgical instrument or tool motors may share one or more common control modules, such as the common control module 610. In certain cases, a plurality of surgical instrument or tool motors may be individually and selectively engaged to the common control module 610. In certain cases, the common control module 610 can be selectively switched between interfacing with one of a plurality of instrument motors or surgical tool to interface with another among the plurality of instrument motors or surgical tool.
[00213] [00213] In at least one example, the common control module 610 can be selectively switched between the operational coupling with the 606a, 606B articulation motors, and the operational coupling with the 602 firing motor or the 603 closing motor. at least one example, as shown in Figure 16, a key 614 can be moved or transitioned between a plurality of positions and / or states. In the first position 616, the switch 614 can electrically couple the common control module 610 to the trip motor 602; in a second position 617, the switch 614 can electrically couple the control module 610 to the closing motor 603;
[00214] [00214] Each of the motors 602, 603, 606a, 606b can comprise a torque sensor to measure the output torque on the motor drive shaft. The force on an end actuator can be detected in any conventional manner, such as by means of force sensors on the outer sides of the jaws or by a motor torque sensor that drives the jaws.
[00215] [00215] In several cases, as illustrated in Figure 16, the common control module 610 may comprise a motor starter 626 which may comprise one or more H-Bridge FETs. The motor driver 626 can modulate the energy transmitted from a power source 628 to a motor coupled to the common control module 610, based on an input from a microcontroller 620 (the "controller"), for example. In certain cases, the microcontroller 620 can be used to determine the current drawn by the motor, for example, while the motor is coupled to the common control module 610, as described above.
[00216] [00216] In certain examples, the microcontroller 620 may include a microprocessor 622 (the "processor") and one or more non-transitory computer-readable media or 624 memory units (the "memory"). In certain cases, memory 624 can store various program instructions which, when executed, can cause processor 622 to perform a plurality of functions and / or calculations described herein. In certain cases, one or more of the memory units 624 can be coupled to the processor 622, for example. In many ways, the 620 microcontroller can communicate over a wired or wireless channel, or combinations thereof.
[00217] [00217] In certain cases, the power supply 628 can be used to supply power to the microcontroller 620, for example. In certain cases, the 628 power source may comprise a battery (or "battery pack" or "power source"), such as a Li ion battery, for example. In certain cases, the battery pack can be configured to be releasably mounted to the handle to supply power to the surgical instrument 600. Several battery cells connected in series can be used as the power supply
[00218] [00218] In several cases, the 622 processor can control the motor drive 626 to control the position, direction of rotation and / or speed of a motor that is coupled to the common control module 610. In certain cases, the processor 622 can signal the motor driver 626 to stop and / or disable a motor that is coupled to the common control module 610. It should be understood that the term "processor", as used here, includes any microprocessor, microcontroller or other control device. adequate basic computing that incorporates the functions of a central computer processing unit (CPU) in an integrated circuit or, at most, some integrated circuits. The 622 processor is a programmable multipurpose device that accepts digital data as input, processes it according to instructions stored in its memory, and provides results as output. This is an example of sequential digital logic, as it has internal memory. Processors operate on numbers and symbols represented in the binary numeral system.
[00219] [00219] In one example, the 622 processor can be any single-core or multi-core processor, such as those known by the Texas Instruments ARM Cortex trade name. In certain cases, the 620 microcontroller may be an LM 4F230H5QR, available from Texas Instruments, for example. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that comprises a 256 KB single cycle flash integrated memory, or other non-volatile memory, up to 40 MHz, an early seek buffer for optimize performance above 40 MHz, a 32 KB single cycle SRAM, an internal ROM loaded with StellarisWare® software, 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, one or more ADCs 12-bit with 12 channels of analog input, among other features that are readily available for the product data sheet. Other microcontrollers can be readily replaced for use with the 4410 module. Consequently, the present description should not be limited in this context.
[00220] [00220] In certain cases, memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are attachable to common control module 610. For example, memory 624 may include program instructions for controlling the motor trigger 602, closing motor 603 and hinge motors 606a, 606b. Such program instructions can cause the 622 processor to control the trigger, close, and link functions according to inputs from the instrument or surgical tool control algorithms or programs.
[00221] [00221] In certain cases, one or more mechanisms and / or sensors, such as 630 sensors, can be used to alert the 622 processor about the program instructions that must be used in a specific configuration. For example, sensors 630 can alert the 622 processor to use the program instructions associated with triggering, closing, and pivoting the end actuator. In certain cases, sensors 630 may comprise position sensors that can be used to detect the position of switch 614, for example. Consequently, processor 622 can use the program instructions associated with firing the closing member coupled to the clamping arm of the end actuator upon detection, through sensors 630, for example, that switch 614 is in the first position 616; the processor 622 can use the program instructions associated with closing the anvil upon detection through sensors 630, for example, that switch 614 is in second position 617; and processor 622 can use the program instructions associated with the articulation of the end actuator upon detection through sensors 630, for example, that switch 614 is in the third or fourth position 618a, 618b.
[00222] [00222] Figure 17 is a schematic diagram of a robotic surgical instrument 700 configured to operate a surgical tool described in this document, in accordance with an aspect of that description. The robotic surgical instrument 700 can be programmed or configured to control the distal / proximal translation of a displacement member, the distal / proximal displacement of a closing tube, the rotation of the drive shaft, and articulation, either with a single type or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to individually control a firing member, a closing member, a driving shaft member, or one or more hinge members, or combinations thereof. Surgical instrument 700 comprises a control circuit 710 configured to control motor-driven firing members, closing members, driving shaft members, or one or more hinge members, or combinations thereof.
[00223] [00223] In one aspect, the robotic surgical instrument 700 comprises a control circuit 710 configured to control a clamping arm 716 and a closing member 714, a portion of an end actuator 702, an ultrasonic blade 718 coupled to a transducer ultrasonic 719 excited by an ultrasonic generator 721, a drive shaft 740, and one or more hinge members 742a, 742b through a plurality of motors 704a to 704e. A position sensor 734 can be configured to provide feedback on the position of closing member 714 to control circuit 710. Other sensors 738 can be configured to provide feedback to control circuit 710. A timer / counter 731 provides timing information and control circuit 710. A power source 712 can be provided to operate motors 704a to 704e and a current sensor 736 provides motor current feedback to control circuit 710. Motors 704a to 704e can be operated individually by the control circuit 710 in an open loop or closed loop feedback control.
[00224] [00224] In one aspect, the control circuit 710 may comprise one or more microcontrollers, microprocessors or other processors suitable for executing instructions that cause the processor or processors to perform one or more tasks. In one aspect, a timer / counter 731 provides an output signal, such as elapsed time or a digital count, to control circuit 710 to correlate the position of closing member 714 as determined by position sensor 734 with the timer output. / counter 731 so that the control circuit 710 can determine the position of the closing member 714 at a specific time (t) in relation to an initial position or the time (t) when the closing member 714 is in a specific position in relation to a starting position. The timer / counter 731 can be configured to measure elapsed time, count external events, or measure timeless events.
[00225] [00225] In one aspect, control circuit 710 can be programmed to control functions of end actuator 702 based on one or more tissue conditions. Control circuit 710 can be programmed to directly or indirectly detect tissue conditions, such as thickness, as described here. Control circuit 710 can be programmed to select a trigger control program or closing control program based on tissue conditions. A trigger control program can describe the distal movement of the displacement member. Different trigger control programs can be selected to better treat different tissue conditions. For example, when thicker tissue is present, control circuit 710 can be programmed to translate the displacement member at a lower speed and / or with a lower power. When a thinner tissue is present, the control circuit 710 can be programmed to move the displacement member at a higher speed and / or with greater power. A closing control program can control the closing force applied to the fabric by the clamping arm
[00226] [00226] In one aspect, the motor control circuit 710 can generate motor setpoint signals. Motor setpoint signals can be provided for various motor controllers 708a through 708e. Motor controllers 708a to 708e can comprise one or more circuits configured to provide motor drive signals for motors 704a to 704e in order to drive motors 704a to 704e, as described here. In some instances, motors 704a to 704e may be brushed DC electric motors. For example, the speed of motors 704a to 704e can be proportional to the respective motor start signals. In some examples, motors 704a to 704e may be brushless DC electric motors, and the respective motor drive signals may comprise a PWM signal provided for one or more stator windings of motors 704a to 704e. In addition, in some instances, motor controllers 708a through 708e can be omitted and control circuit 710 can directly generate motor drive signals.
[00227] [00227] In one aspect, the control circuit 710 can initially operate each of the motors 704a to 704e in an open circuit configuration for a first open circuit portion of the travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open circuit portion of the stroke, control circuit 710 can select a trigger control program in a closed circuit configuration. The instrument response may include a translation of the distance of the displacement member during the open circuit portion, a time elapsed during the open circuit portion, the energy supplied to one of the motors 704a to 704e during the open circuit portion, a sum pulse widths of a motor start signal, etc. After the open circuit portion, control circuit 710 can implement the selected trigger control program for a second portion of the travel member travel. For example, during a portion of the closed loop course, control circuit 710 can modulate one of the motors 704a to 704e based on the translation of data describing a position of the closed displacement member to translate the displacement member to a constant speed.
[00228] [00228] In one aspect, motors 704a to 704e can receive power from a power source 712. Power source 712 can be a DC power source powered by an alternating main power supply, a battery, a super capacitor, or any other suitable power source. The motors 704a to 704e can be mechanically coupled to individual moving mechanical elements such as the closing member 714, the clamping arm 716, drive shaft 740, joint 742a, and the joint 742b, through the respective transmissions 706a to 706e. Transmissions 706a through 706e may include one or more gears or other connecting components for coupling motors 704a to 704e to moving mechanical elements. A position sensor 734 can detect a position of the closing member 714. The position sensor 734 can be or can include any type of sensor that is capable of generating position data that indicates a position of the closing member 714. In some examples , the position sensor 734 may include an encoder configured to supply a series of pulses to the control circuit 710 as the closing member 714 translates distally and proximally. Control circuit 710 can track pulses to determine the position of the closing member
[00229] [00229] In one aspect, control circuit 710 is configured to drive a firing member as the closing member portion 714 of end actuator 702. Control circuit 710 provides a motor setpoint for control of the motor 708a, which provides a drive signal for motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a which is coupled to the closing member 714. The transmission 706a comprises moving mechanical elements such as rotating elements and a trigger member for distally and proximally controlling the movement of the closing member 714 along a longitudinal geometric axis of the end actuator 702. In one aspect, the motor 704a can be coupled to the knife gear assembly, which includes a knife gear reduction assembly which includes a first knife drive gear and a second gear knife drive. A torque sensor 744a provides a trigger force feedback signal to control circuit 710. The trigger force signal represents the force required to fire or dislodge the closing member
[00230] [00230] In one aspect, control circuit 710 is configured to drive a closing member as the clamping arm portion 716 of end actuator 702. Control circuit 710 provides a motor setpoint for control of the 708b motor, which provides a drive signal for motor 704b. The output shaft of the motor 704b is coupled to a torque sensor 744b. The torque sensor 744b is coupled to a transmission 706b which is coupled to the clamping arm 716. The transmission 706b comprises moving mechanical elements such as rotating elements and a closing member to control the movement of the clamping arm 716 from the open and closed. In one aspect, the 704b motor is coupled to a closing gear assembly, which includes a closing reduction gear assembly that is supported in gear engaged with the closing sprocket. The torque sensor 744b provides a closing force feedback signal for control circuit 710. The closing force feedback signal represents the closing force applied to the clamping arm 716. The position sensor 734 can be configured to provide the position of the closing member as a feedback signal to the control circuit 710. Additional sensors 738 on the end actuator 702 can provide the feedback signal of the closing force to the control circuit 710. The articulating clamping arm 716 it is positioned opposite the ultrasonic blade 718. When ready for use, the control circuit 710 can provide a closing signal to the motor control 708b. In response to the closing signal, the motor 704b advances a closing member to secure the fabric between the clamping arm 716 and the ultrasonic blade 718.
[00231] [00231] In one aspect, control circuit 710 is configured to rotate a drive shaft member, such as drive shaft 740, to rotate end actuator 702. Control circuit 710 provides a motor setpoint for a 708c engine control, which provides a drive signal for the 704c engine. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission 706c which is coupled to the shaft 740. The transmission 706c comprises moving mechanical elements, such as rotary elements, to control the rotation of the drive shaft 740 clockwise or counterclockwise until and above 360 °. In one aspect, the 704c engine is coupled to the rotary drive assembly, which includes a pipe gear segment that is formed over (or attached to) the proximal end of the proximal closing tube for operable engagement by a rotational gear assembly that is supported operationally on the tool mounting plate. The torque sensor 744c provides a rotation force feedback signal for control circuit 710. The rotation force feedback signal represents the rotation force applied to the drive shaft 740. The position sensor 734 can be configured to provide the position of the closing member as a feedback signal to the control circuit 710. Additional sensors 738, such as a drive shaft encoder, can provide the rotational position of the drive shaft 740 to the control circuit 710.
[00232] [00232] In one aspect, control circuit 710 is configured to articulate end actuator 702. Control circuit 710 provides a motor setpoint for a 708d motor control, which provides a drive signal for the motor 704d. The output shaft of the 704d motor is coupled to a 744d torque sensor. The torque sensor 744d is coupled to a transmission 706d which is coupled to a pivot member 742a. The 706d transmission comprises moving mechanical elements, such as pivoting elements, to control the articulation of the 702 ± 65 ° end actuator. In one aspect, the 704d motor is coupled to a pivot nut, which is rotatably seated on the proximal end portion of the distal column portion and is pivotally driven thereon by a pivot gear assembly. The torque sensor 744d provides a hinge force feedback signal to control circuit 710. The hinge force feedback signal represents the hinge force applied to the end actuator 702. The 738 sensors, as a hinge encoder , can provide the pivoting position of end actuator 702 for control circuit 710.
[00233] [00233] In another aspect, the articulation function of the robotic surgical system 700 may comprise two articulation members, or connections, 742a, 742b. These hinge members 742a, 742b are driven by separate disks at the robot interface (the rack), which are driven by the two motors 708d, 708e. When the separate firing motor 704a is provided, each hinge link 742a, 742b can be antagonistically driven with respect to the other link to provide a resistive holding movement and a load to the head when it is not moving and to provide a movement of articulation when the head is articulated. The hinge members 742a, 742b attach to the head in a fixed radius when the head is rotated. Consequently, the mechanical advantage of the push and pull link changes when the head is rotated. This change in mechanical advantage can be more pronounced with other drive systems for the articulation connection.
[00234] [00234] In one aspect, the one or more motors 704a to 704e may comprise a brushed DC motor with a gearbox and mechanical connections to a firing member, closing member or articulation member. Another example includes electric motors 704a to 704e that operate the moving mechanical elements such as the displacement member, the articulation connections, the closing tube and the drive shaft. An external influence is an excessive and unpredictable influence on things like tissue, surrounding bodies, and friction in the physical system. This external influence can be called drag, which acts in opposition to one of the electric motors 704a to 704e. External influence, such as drag, can cause the functioning of the physical system to deviate from a desired operation of the physical system.
[00235] [00235] In one aspect, the position sensor 734 can be implemented as an absolute positioning system. In one aspect, the 734 position sensor can comprise an absolute rotary magnetic positioning system implemented as a single integrated circuit rotary magnetic position sensor, AS5055EQFT, available from Austria Microsystems, AG. The position sensor 734 can interface with the control circuit 710 to provide an absolute positioning system. The position can include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit by digit method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions which only require addition, subtraction, bit shift and lookup table operations.
[00236] [00236] In one aspect, the control circuit 710 can be in communication with one or more sensors 738. The sensors 738 can be positioned on the end actuator 702 and adapted to work with the robotic surgical instrument 700 to measure various derived parameters such as span distance in relation to time, compression of the tissue in relation to time, and deformation of the anvil in relation to time. The 738 sensors can comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor and / or any other sensor suitable for measuring one or more parameters of end actuator 702. Sensors 738 may include one or more sensors. Sensors 738 can be located on the clamping arm 716 to determine the location of tissue using segmented electrodes. The torque sensors 744a to 744e can be configured to detect force such as firing force, closing force, and / or articulation force, among others. Consequently, the control circuit 710 can detect (1) the closing load experienced by the distal closing tube and its position, (2) the trigger member on the rack and its position, (3) which portion of the ultrasonic blade 718 has tissue in it, and (4) the load and the position on both articulation rods.
[00237] [00237] In one aspect, the one or more sensors 738 may comprise a stress meter such as, for example, a microstrain meter, configured to measure the magnitude of the stress on the anvil 716 during a clamped condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. The sensors 738 can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the clamping arm 716 and the ultrasonic blade 718. The sensors 738 can be configured to detect the impedance of a section of tissue located between the clamping arm 716 and the ultrasonic blade 718 which is indicative of the thickness and / or completeness of the fabric located between them.
[00238] [00238] In one aspect, the 738 sensors can be implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magneto-resistive devices (MR) giant magneto-resistive devices (GMR), magnetometers, among others. In other implementations, the 738 sensors can be implemented as solid state switches that operate under the influence of light, such as optical sensors, infrared sensors, ultraviolet sensors, among others. In addition, the switches can be solid state devices such as transistors (for example, FET, junction FET, MOSFET, bipolar, and the like). In other implementations, the 738 sensors can include driverless electric switches, ultrasonic switches, accelerometers and inertia sensors, among others.
[00239] [00239] In one aspect, sensors 738 can be configured to measure the forces exerted on the clamping arm 716 by the closing drive system. For example, one or more sensors 738 may be at an interaction point between the closing tube and the clamp arm 716 to detect the closing forces applied by the closing tube to the clamping arm 716. The forces exerted on the closing arm clamping 716 can be representative of the tissue compression experienced by the tissue section captured between the clamping arm 716 and the ultrasonic blade 718. The one or more sensors 738 can be positioned at various points of interaction throughout the closing drive system to detect the closing forces applied to the clamping arm 716 by the closing drive system. The one or more sensors 738 can be sampled in real time during a gripping operation by the processor of the control circuit 710. The control circuit 710 receives sample measurements in real time to provide and analyze information based on time and evaluate, in real time actual closing forces applied to the clamping arm 716.
[00240] [00240] In one aspect, a current sensor 736 can be used to measure the current drained by each of the motors 704a to 704e. The force required to advance any of the moving mechanical elements such as the closing member 714 corresponds to the current drawn by one of the motors 704a to 704e. The force is converted into a digital signal and supplied to control circuit 710. Control circuit 710 can be configured to simulate the response of the instrument's actual system in the controller software. A displacement member can be actuated to move closing member 714 on end actuator 702 at or near a target speed. The robotic surgical instrument 700 may include a feedback controller, which may be one or any of the feedback controllers, including, but not limited to, a PID controller, state feedback, linear quadratic (LQR) and / or an adaptive controller , for example. The robotic surgical instrument 700 can include a power source to convert the signal from the feedback controller to a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque and / or force, for example. Additional details are described in the U.S. Patent Application
[00241] [00241] Figure 18 illustrates a schematic diagram of a surgical instrument 750 configured to control the distal translation of the displacement member according to an aspect of the present description. In one aspect, the surgical instrument 750 is programmed to control the distal translation of the displacement member as the closing member 764. The surgical instrument 750 comprises an end actuator 752 that can comprise a clamping arm 766, a closing member 764 and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
[00242] [00242] The position, movement, displacement, and / or translation of a linear displacement member, such as closing member 764, can be measured by an absolute positioning system, sensor arrangement, and a position sensor 784. Because the closing member 764 is coupled to a longitudinally movable driving member, the position of the closing member 764 can be determined by measuring the position of the longitudinally mobile driving member using the position sensor.
[00243] [00243] Control circuit 760 can generate a setpoint signal for motor 772. The setpoint signal for motor 772 can be supplied to a motor controller 758. Motor controller 758 can comprise one or more circuits configured to provide a motor 774 drive signal to motor 754 to drive motor 754, as described in the present invention. In some instances, the 754 motor may be a DC motor with a brushed DC electric motor. For example, the speed of motor 754 can be proportional to the drive signal of motor 774. In some instances, motor 754 can be a brushless DC electric motor and the motor drive signal 774 can comprise a PWM signal provided for a or more motor stator windings 754. In addition, in some examples, motor controller 758 may be omitted, and control circuit 760 can generate motor drive signal 774 directly.
[00244] [00244] The 754 motor can receive power from a power source
[00245] [00245] The control circuit 760 can be in communication with one or more sensors 788. The sensors 788 can be positioned on the end actuator 752 and adapted to work with the surgical instrument 750 to measure the various derived parameters, such as span distance in relation to time, compression of the tissue in relation to time and tension of the anvil in relation to time. The 788 sensors can comprise a magnetic sensor, a magnetic field sensor, a stress meter, a pressure sensor, a force sensor, an inductive sensor such as a eddy current sensor, a resistive sensor, a capacitive sensor, a sensor optical and / or any other sensors suitable for measuring one or more parameters of the 752 end actuator. The 788 sensors may include one or more sensors.
[00246] [00246] The one or more sensors 788 may comprise an effort meter such as, for example, a microstrain meter, configured to measure the magnitude of the stress on the anvil 766 during a tight condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. The 788 sensors can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the clamping arm 766 and the ultrasonic blade 768. The 788 sensors can be configured to detect the impedance of a section of tissue located between the clamping arm 766 and the ultrasonic blade 768 which is indicative of the thickness and / or completeness of the fabric located between them.
[00247] [00247] The 788 sensors can be configured to measure the forces exerted on the clamping arm 766 by the closing drive system. For example, one or more sensors 788 may be at an interaction point between the closing tube and the clamp arm 766 to detect the closing forces applied by a closing tube to the clamping arm 766. The forces exerted on the arm clamping 766 can be representative of the tissue compression experienced by the tissue section captured between the clamping arm 766 and the ultrasonic blade 768. The one or more sensors 788 can be positioned at various points of interaction throughout the closing drive system to detect the closing forces applied to the clamping arm 766 by the closing drive system. The one or more 788 sensors can be sampled in real time during a gripping operation by a processor of the control circuit 760. The control circuit 760 receives sample measurements in real time to provide and analyze information based on time and evaluate, in real time, the closing forces applied to the clamping arm 766.
[00248] [00248] A current sensor 786 can be used to measure the current drained by the motor 754. The force required to advance the closing member 764 corresponds to the current drained by the motor
[00249] [00249] The control circuit 760 can be configured to simulate the response of the real system of the instrument in the controller software. A displacement member can be actuated to move a closing member 764 on end actuator 752 at or near a target speed. The surgical instrument 750 may include a feedback controller, which can be one or any of the feedback controllers, including, but not limited to, a PID controller, state feedback, LQR, and / or an adaptive controller, for example. The surgical instrument 750 can include a power source to convert the signal from the feedback controller to a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque and / or force, for example.
[00250] [00250] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, the cutting member or the closing member 764, by a brushed DC motor with gearbox and mechanical connections to an articulation system and / or knife. Another example is the 754 electric motor that operates the displacement member and the articulation drive, for example, from an interchangeable drive shaft assembly. An external influence is an excessive and unpredictable influence on things like tissue, surrounding bodies, and friction in the physical system. This external influence can be called drag, which acts in opposition to the 754 electric motor. External influence, like drag, can cause the functioning of the physical system to deviate from a desired operation of the physical system.
[00251] [00251] Several exemplifying aspects are directed to a surgical instrument 750 that comprises an end actuator 752 with surgical sealing and cutting implements driven by motor. For example, a motor 754 can drive a displacement member distally and proximally along a longitudinal geometry axis of end actuator 752. End actuator 752 may comprise an articulating clamping arm 766 and, when configured for use, a ultrasonic blade 768 positioned opposite the clamping arm 766. A clinician can hold the tissue between the clamping arm 766 and the ultrasonic blade 768, as described in the present invention. When ready to use the 750 instrument, the physician can provide a trigger signal, for example, by pressing a trigger on the 750 instrument. In response to the trigger signal, motor 754 can drive the displacement member distally along the longitudinal geometric axis of the end actuator 752 from a proximal start position to an end position distal from the start position. As the displacement member moves distally, the closing member 764 with a cutting member positioned at a distal end, can cut the fabric between the ultrasonic blade 768 and the clamping arm 766.
[00252] [00252] In several examples, the surgical instrument 750 may comprise a control circuit 760 programmed to control the distal translation of the displacement member, such as the closing member 764, for example, based on one or more tissue conditions. The control circuit 760 can be programmed to directly or indirectly detect tissue conditions, such as thickness, as described here. Control circuit 760 can be programmed to select a control program based on tissue conditions. A control program can describe the distal movement of the displacement member. Different control programs can be selected to better treat different tissue conditions. For example, when a thicker tissue is present, control circuit 760 can be programmed to translate the displacement member at a lower speed and / or with a lower power. When a thinner tissue is present, the control circuit 760 can be programmed to move the displacement member at a higher speed and / or with greater power.
[00253] [00253] In some examples, control circuit 760 may initially operate motor 754 in an open circuit configuration for a first open circuit portion of a travel of the displacement member. Based on an instrument response 750 during the open circuit portion of the course, control circuit 760 can select a trip control program. The response of the instrument may include a travel distance of the displacement member during the open circuit portion, a time elapsed during the open circuit portion, the power supplied to the motor 754 during the open circuit portion, a sum of pulse widths a motor start signal, etc. After the open circuit portion, control circuit 760 can implement the selected trigger control program for a second portion of the travel member travel. For example, during the closed loop portion of the stroke, control circuit 760 can modulate motor 754 based on translation data that describes a position of the displacement member in a closed circuit manner to translate the displacement member into a constant speed. Additional details are described in U.S. Patent Application Serial No. 15 / 720,852, entitled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT, filed on September 29, 2017, which is hereby incorporated by reference in its entirety.
[00254] [00254] Figure 19 is a schematic diagram of a 790 surgical instrument configured to control various functions in accordance with an aspect of the present description. In one aspect, the surgical instrument 790 is programmed to control the distal translation of a displacement member such as the closing member 764. The surgical instrument 790 comprises an end actuator 792 which may comprise a clamping arm 766, a closing member 764, and an ultrasonic blade 768 that can be interchanged with or work in conjunction with one or more RF electrodes 796 (shown in dashed line). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
[00255] [00255] In one aspect, the 788 sensors can be implemented as a limit switch, electromechanical device, solid state switches, Hall effect devices, MRI devices, GMR devices, magnetometers, among others. In other implementations, 638 sensors can be solid state switches that operate under the influence of light, such as optical sensors, infrared sensors, ultraviolet sensors, among others. In addition, the switches can be solid state devices such as transistors (for example, FET, junction FET, MOSFET, bipolar, and the like). In other implementations, 788 sensors can include driverless electric switches, ultrasonic switches, accelerometers and inertia sensors, among others.
[00256] [00256] In one aspect, the position sensor 784 can be implemented as an absolute positioning system, which comprises a rotating magnetic absolute positioning system implemented as a rotary magnetic position sensor, single integrated circuit, AS5055EQFT, available from Austria Microsystems, AG. The position sensor 784 can interface with the control circuit 760 to provide an absolute positioning system. The position can include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit by digit method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions which only require addition, subtraction, bit shift and lookup table operations.
[00257] [00257] In some examples, the position sensor 784 can be omitted. When the motor 754 is a stepper motor, the control circuit 760 can track the position of the closing member 764 by aggregating the number and orientation of the steps the motor has been instructed to perform. Position sensor 784 can be located on end actuator 792 or any other portion of the instrument.
[00258] [00258] The control circuit 760 can be in communication with one or more sensors 788. The sensors 788 can be positioned on the end actuator 792 and adapted to work with the surgical instrument 790 to measure the various derived parameters, such as span distance in relation to time, compression of the tissue in relation to time and tension of the anvil in relation to time. The 788 sensors can comprise a magnetic sensor, a magnetic field sensor, a stress meter, a pressure sensor, a force sensor, an inductive sensor such as a eddy current sensor, a resistive sensor, a capacitive sensor, a sensor optical and / or any other sensors suitable for measuring one or more parameters of the end actuator 792. The 788 sensors may include one or more sensors.
[00259] [00259] An RF power source 794 is coupled to end actuator 792 and is applied to RF electrode 796 when RF electrode 796 is provided on end actuator 792 in place of ultrasonic blade 768 or to work in conjunction with the ultrasonic blade 768. For example, the ultrasonic blade is produced from electrically conductive metal and can be used as the return path for the RF electrosurgical current. The control circuit 760 controls the supply of RF energy to the RF electrode 796.
[00260] [00260] Additional details are described in US Patent Application Serial No. 15 / 636,096, entitled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed on June 28, 2017, which is incorporated herein as a reference in its entirety. Adaptive ultrasonic blade control algorithms
[00261] [00261] In several respects, intelligent ultrasonic energy devices can comprise adaptive algorithms to control the operation of the ultrasonic blade. In one respect, the adaptive ultrasonic blade control algorithms are configured to identify the type of tissue and adjust the device parameters. In one aspect, the ultrasonic blade control algorithms are configured to parameterize the type of tissue. An algorithm to detect the collagen / tissue ratio to adjust the amplitude of the distal tip of the ultrasonic blade is described in the following section of the present description. Various aspects of intelligent ultrasonic devices are described here in connection with Figures 1 to 94, for example. Consequently, the following description of the adaptive ultrasonic blade control algorithms should be read in conjunction with Figures 1 to 94 and the description associated with them. Fabric type identification and device parameter settings
[00262] [00262] In certain surgical procedures it would be desirable to use adaptive ultrasonic blade control algorithms. In one aspect, adaptive ultrasonic blade control algorithms can be used to adjust the parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device can be adjusted based on the location of the tissue within the claws of the ultrasonic end actuator, for example, the location of the tissue between the clamping arm and the ultrasonic blade. The impedance of the ultrasonic transducer can be used to differentiate the percentage of tissue that is located at the distal or proximal end of the end actuator. The reactions of the ultrasonic device can be based on the type of tissue or the compressibility of the tissue. In another aspect, the parameters of the ultrasonic device can be adjusted based on the type of tissue identified or on the parameterization. For example, the amplitude of the mechanical displacement of the distal tip of the ultrasonic sheet can be adjusted based on the ratio between collagen and elastin in the tissue detected during the tissue identification procedure. The ratio of collagen to tissue elastin can be detected using a variety of techniques including reflectance and surface emissivity in infrared (IR) reflectance. The force applied to the fabric by the clamping arm and / or the travel of the clamping arm to produce span and compression. Electrical continuity through a clamp equipped with electrodes can be used to determine the percentage of the clamp that is covered with tissue.
[00263] [00263] Figure 20 is a 800 system configured to execute adaptive ultrasonic blade control algorithms in a surgical data network that comprises a central modular communication controller, in accordance with at least one aspect of the present description. In one aspect, the generator module 240 is configured to execute the 802 ultrasonic adaptive blade control algorithms, as described here with reference to Figures 53 to 105. In one aspect, the device / instrument 235 is configured to execute the control algorithms of the adaptive ultrasonic blade 804, as described here with reference to Figures 53 to 105. In another aspect, both the device / instrument 235 and the device / instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 as described in the present invention with reference to Figures 53 to 105.
[00264] [00264] The generator module 240 may comprise an isolated patient stage in communication with a non-isolated stage by means of a power transformer. A secondary winding of the power transformer is contained in the isolated stage and can comprise a bypass configuration (for example, a central bypass or non-central bypass configuration) for defining the trigger signal outputs in order to deliver trigger signals to different surgical instruments, such as an ultrasonic surgical device and an RF electrosurgical instrument, and a multifunctional surgical instrument that includes RF and ultrasonic energy modes that can be released alone or simultaneously. In particular, the trigger signal outputs can emit an ultrasonic trigger signal (for example, a 420V medium square root trigger signal (RMS) for a 241 ultrasonic surgical instrument, and the trigger signal outputs can emit a electrosurgical trigger signal of
[00265] [00265] The generator module 240 or the device / instrument 235 or both are coupled to the modular control tower 236 connected to multiple operating room devices, such as, intelligent surgical instruments, robots, and other computerized devices located in the operating room. operation, as described with reference to Figures 8 to 11, for example. Generator hardware
[00266] [00266] Figure 21 illustrates an example of a generator 900, which is a form of a generator configured to couple with an ultrasonic instrument and additionally configured to execute adaptive ultrasonic blade control algorithms in a surgical data network comprising a controller central modular communication system as shown in Figure 20. The 900 generator is configured to supply multiple types of energy to a surgical instrument. The 900 generator provides ultrasonic and RF signals to power a surgical instrument, independently or simultaneously. Ultrasonic and RF signals can be provided alone or in combination and can be provided simultaneously. As indicated above, at least one generator output can provide multiple types of energy (for example, ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, and these signals can be supplied separately or simultaneously to the end actuator to treat tissue. The generator 900 comprises a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory coupled to the processor 902 , not shown for clarity of description. The digital information associated with a waveform is provided to the waveform generator 904 that includes one or more DAC circuits to convert the digital input to an analog output. The analog output is powered by an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signals are coupled through the power transformer 908 to the secondary side, which is on the isolation side of the patient. A first signal of a first energy modality the surgical instrument is supplied between the terminals identified as ENERGY1 and RETURN. A second signal of a second energy modality is coupled by a 910 capacitor and is supplied to the surgical instrument between the terminals identified as ENERGY2 and RETURN. It will be recognized that more than two types of energy can be issued and, therefore, the subscript "n" can be used to designate that up to n ENERGY terminals can be provided, where n is a positive integer greater than 1. It will also be acknowledged that up to "n" return paths, RETURN can be provided without departing from the scope of this description.
[00267] [00267] A second voltage detection circuit 912 is coupled through the terminals identified as ENERGY1 and the RETURN path to measure the output voltage between them. A second voltage detection circuit 924 is coupled through the terminals identified as ENERGY2 and the RETURN path to measure the output voltage between them. A current detection circuit 914 is arranged in series with the RETURN leg on the secondary side of the power transformer 908 as shown to measure the output current for any energy modality. If different return paths are provided for each energy modality, then a separate current detection circuit would be provided on each return leg. The outputs of the first and second voltage detection circuits 912, 924 are supplied to the respective isolation transformers 916, 922 and the output of the current detection circuit 914 is supplied to another isolation transformer 918. The outputs of the isolation transformers 916 , 928, 922 on the primary side of the power transformer 908 (non-isolated side of the patient) are supplied to one or more ADC 926 circuits. The digitized output from the ADC 926 circuit is provided to processor 902 for further processing and computation. The output voltages and the output current feedback information can be used to adjust the output voltage and the current supplied to the surgical instrument, and to compute the output impedance, among other parameters. Input / output communications between processor 902 and isolated patient circuits are provided via a 920 interface circuit. The sensors may also be in electrical communication with processor 902 via the 920 interface circuit.
[00268] [00268] In one aspect, impedance can be determined by processor 902 by dividing the output of the first voltage detection circuit 912 coupled to the terminals identified as ENERGY1 / RETURN or the second voltage detection circuit 924 connected to the terminals identified as ENERGY2 / RETURN, through the output of the current detection circuit 914 arranged in series with the RETURN leg on the secondary side of the power transformer 908. The outputs of the first and second voltage detection circuits 912, 924 are provided to separate the insulation transformers 916, 922 and current detection circuit 914 output is provided to another isolation transformer 916. Digitized current and voltage detection measurements from ADC circuit 926 are provided to processor 902 to compute impedance. As an example, the first ENERGIA1 energy modality can be ultrasonic energy and the second ENERGIA2 energy modality can be RF energy. However, in addition to the ultrasonic and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others. In addition, although the example illustrated in Figure 21 shows a single RETURN return path that can be provided for two or more energy modes, in other respects, multiple RETURN return paths can be provided for each ENERGY energy mode. Thus, as described here, the impedance of the ultrasonic transducer can be measured by dividing the output of the first voltage detection circuit 912 by the current detection circuit 914 and the fabric impedance can be measured by dividing the output of the second voltage detection circuit 924 through current detection circuit 914.
[00269] [00269] As shown in Figure 21, generator 900 comprising at least one output port may include a power transformer 908 with a single output and multiple taps to provide power in the form of one or more energy modalities, such as ultrasonic , Bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others, for example to the end actuator depending on the type of tissue treatment being performed. For example, the 900 generator can supply higher voltage and lower current power to drive an ultrasonic transducer, lower voltage and higher current to drive RF electrodes to seal the tissue or with a coagulation waveform for point clotting using electrosurgical electrodes Monopolar or bipolar RF. The output waveform of generator 900 can be oriented, switched or filtered to provide frequency to the end actuator of the surgical instrument. The connection of an ultrasonic transducer to the output of generator 900 would preferably be located between the output identified as ENERGY1 and RETURN, as shown in Figure 21. In one example, a connection of bipolar RF electrodes to the output of generator 900 would preferably be located between the output identified as ENERGY2 and the RETURN. In the case of a monopolar output, the preferred connections would be an active electrode (for example, light beam or other probe) for the ENERGIA2 output and a suitable return block connected to the RETURN output.
[00270] [00270] Further details are described in U.S. Patent Application publication No. 2017/0086914 entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING
[00271] [00271] As used throughout this description, the term "wireless" and its derivatives can be used to describe circuits, devices, systems, methods, techniques, communication channels etc., which can communicate data through the use of electromagnetic radiation modulated using a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some ways they may not. The communication module can implement any of a number of wireless and wired communication standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, evolution long-term evolution (LTE), Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS, CDMA, TDMA,
[00272] [00272] As used in the present invention, a processor or processing unit is an electronic circuit that performs operations on some external data source, usually memory or some other data flow. The term is used in the present invention to refer to the central processor (central processing unit) in a computer system or systems (specifically systems on a chip (SoCs)) that combine several specialized "processors".
[00273] [00273] As used here, a system on a chip or system on the chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all components of a computer or other electronic systems . It can contain digital, analog, mixed and often radio frequency functions - all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), i-Fi module, or coprocessor. An SoC may or may not contain internal memory.
[00274] [00274] As used here, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) can be implemented as a small computer on a single integrated circuit. It can be similar to a SoC; a SoC can include a microcontroller as one of its components. A microcontroller can contain one or more core processing units (CPUs) along with memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash or OTP ROM is also often included on the chip, as well as a small amount of RAM. Microcontrollers can be used for integrated applications, in contrast to microprocessors used in personal computers or other general purpose applications that consist of several separate integrated circuits.
[00275] [00275] As used in the present invention, the term controller or microcontroller can be an independent chip or IC (integrated circuit) device that interfaces with a peripheral device. This can be a connection between two parts of a computer or a controller on an external device that manages the operation of (and connection to) that device.
[00276] [00276] Any of the processors or microcontrollers in the present invention can be any implemented by any single-core or multi-core processor, such as those known under the trade name ARM Cortex by Texas Instruments. In one respect, the processor may be a Core Cortex-M4F LM4F230H5QR ARM processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz , a seek-ahead buffer to optimize performance above 40 MHz, a 32 KB single cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with the StellarisWare® program, memory only programmable, electrically erasable (EEPROM) reading of 2 KB, one or more pulse width modulation (PWM) modules, one or more analogs of quadrature encoder (QEI) inputs, one or more analog to digital converters (ADC) 12-bit with 12 channels of analog input, details of which are available for the product data sheet.
[00277] [00277] In one aspect, the processor may comprise a safety controller that comprises two controller-based families, such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also by Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[00278] [00278] The modular devices include the modules (as described in connection with Figures 3 and 9, for example) that are receivable within a central surgical controller and the devices or surgical instruments that can be connected to the various modules in order to connect or pair with the corresponding central surgical controller. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, power generators, fans, insufflators and displays. The modular devices described here can be controlled by control algorithms. The control algorithms can be executed on the modular device itself, on the central surgical controller to which the specific modular device is paired, or on both the modular device and the central surgical controller (for example, surgical (for example, through a distributed computing.) In some examples,
[00279] [00279] Figure 22 illustrates a form of a surgical system 1000 comprising a generator 1100 and various surgical instruments 1104, 1106 and 1108 usable with it, whereas surgical instrument 1104 is an ultrasonic surgical instrument, surgical instrument 1106 is a electrosurgical RF instrument, and the 1108 multifunctional surgical instrument is a combination of ultrasonic / RF electrosurgical instrument. The 1100 generator is configurable for use with a variety of surgical instruments. According to various forms, the 1100 generator can be configurable for use with different surgical instruments of different types, including, for example, the ultrasonic surgical instrument 1104, the RF electrosurgical instruments 1106 and the multifunctional surgical instrument 1108 that integrates ultrasonic energies and RF signals supplied simultaneously from generator 1100. Although in the form of Figure 22 generator 1100 is shown separately from surgical instruments 1104, 1106, 1108 in one form, generator 1100 can be formed integrally with any of the surgical instruments 1104, 1106 and 1108 to form a unitary surgical system. The 1100 generator comprises an 1110 input device located on a front panel of the 1100 generator console. The 1110 input device can comprise any suitable device that generates signals suitable for programming the operation of the 1100 generator. The 1100 generator can be configured for communication wired or wireless.
[00280] [00280] Generator 1100 is configured to drive multiple surgical instruments 1104, 1106, 1108. The first surgical instrument is a 1104 ultrasonic surgical instrument and comprises a 1105 (HP) handle, an 1120 ultrasonic transducer, a 1126 drive shaft and a end actuator 1122. End actuator 1122 comprises an ultrasonic blade 1128 acoustically coupled to the ultrasonic transducer 1120 and a clamping arm
[00281] [00281] Generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and comprises a 1107 (HP) handle, a 1127 drive shaft and an 1124 end actuator. End actuator 1124 comprises electrodes on the clamping arms 1142a and 1142b and returning through the electrical conductor portion of the drive shaft 1127. The electrodes are coupled to the bipolar power source inside the generator 1100 and energized by it. The handle 1107 comprises a trigger 1145 to operate the clamping arms 1142a, 1142b and a power button 1135 to actuate a power switch to energize the electrodes on the end actuator 1124.
[00282] [00282] Generator 1100 is also configured to drive a multifunctional surgical instrument 1108. The multifunctional surgical instrument 1108 comprises a handle 1109 (HP), a drive shaft 1129 and an end actuator 1125. The end actuator 1125 comprises a blade ultrasonic 1149 and a clamping arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The grip 1109 comprises a trigger 1147 to operate the clamping arm 1146 and a combination of toggle buttons 1137a, 1137b, 1137c to energize and activate the 1149 ultrasonic blade or other function. Toggle buttons 1137a, 1137b, 1137c can be configured to power the 1120 ultrasonic transducer with the 1100 generator and power the 1149 ultrasonic blade with the bipolar power source also contained within the 1100 generator.
[00283] [00283] The 1100 generator is configurable for use with a variety of surgical instruments. According to various forms, the 1100 generator can be configurable for use with different surgical instruments of different types, including, for example, the 1104 ultrasonic surgical instrument, the RF 1106 surgical instrument and the 1108 multifunctional surgical instrument that integrates ultrasonic energies and RF signals supplied simultaneously from the generator
[00284] [00284] Figure 23 is an end actuator 1122 of the exemplary ultrasonic device 1104, in accordance with at least one aspect of the present description. The end actuator 1122 can comprise a blade 1128 that can be coupled to the ultrasonic transducer 1120 through a waveguide. When activated by the ultrasonic transducer 1120, the blade 1128 can vibrate and, when placed in contact with tissues, it can cut and / or coagulate them, as described in the present invention. According to several aspects, and as shown in Figure 23, the end actuator 1122 can also comprise a clamping arm 1140 that can be configured for cooperative action with the blade 1128 of the end actuator 1122. With the blade 1128, the arm clamp 1140 may comprise a set of grippers. The clamping arm 1140 can be pivotally connected to a distal end of a drive shaft 1126 of the instrument portion 1104. The clamping arm 1140 can include a block of fabric from the clamping arm 1163, which can be formed of Teflon ® or other suitable low-friction material. Block 1163 can be mounted for cooperation with blade 1128, with pivoting movement of the clamping arm 1140 that positions the clamping block 1163 in a substantially parallel relationship to, and in contact with, the blade 1128. For this construction, a portion tissue to be clamped can be trapped between the tissue block 1163 and the blade 1128. The tissue block 1163 can be provided with a sawtooth-like configuration including a plurality of gripping teeth 1161 axially spaced and extending proximally to improve the grip of the fabric in cooperation with the 1128 blade. The clamping arm 1140 can transition from the open position shown in Figure 23 to a closed position (with the clamping arm 1140 in contact with or close to the 1128 blade) of any proper manner. For example, handle 1105 may comprise a jaw closure trigger. When operated by a clinician, the clamshell trigger can rotate the clamping arm 1140 in any suitable manner.
[00285] [00285] The 1100 generator can be activated to supply the trigger signal to the 1120 ultrasonic transducer in any suitable way. For example, generator 1100 may comprise a foot switch 1430 (Figure 24) coupled to generator 1100 by means of a foot switch cable 1432. A clinician can activate ultrasonic transducer 1120 and thereby ultrasonic transducer 1120 and blade 1128 by pressing the foot switch 1430. In addition, or instead of the foot switch 1430, some aspects of the ultrasonic device 1104 may use one or more keys positioned on the handle 1105 which, when activated, can cause the generator 1100 activate the 1120 ultrasonic transducer. In one aspect, for example, the one or more keys may comprise a pair of toggle buttons 1134a, 1134b, 1134c (Figure 22), for example, to determine a mode of operation of the device 1104. When the toggle button 1134a is pressed, for example, the 1100 ultrasonic generator can provide a maximum trigger signal to the 1120 transducer, causing it to produce a maximum of ultrasonic energy output. Pressing the 1134b toggle button can cause the 1100 ultrasonic generator to provide a user-selectable drive signal to the 1120 ultrasonic transducer, causing it to produce less than the maximum ultrasonic energy output. The device 1104 additionally or alternatively may comprise a second key for, for example, indicating a position of a clamping trigger to operate the claws through the clamping arm 1140 of the end actuator 1122. In addition, in some respects, the 1100 ultrasonic generator can be activated based on the position of the clamping trigger, (for example, as the clinician presses the clamping trigger to close through the clamping arm 1140, an ultrasonic energy can be applied).
[00286] [00286] Additionally or alternatively, the one or more keys may comprise a toggle button 1134c which, when pressed, causes generator 1100 to provide a pulse output (Figure 22). The pulses can be provided at any suitable frequency and grouping, for example. In some respects, the pulse power level may consist of the power levels associated with the toggle buttons 1134a, 1134b (maximum, less than maximum), for example.
[00287] [00287] It will be recognized that a device 1104 can comprise any combination of toggle buttons 1134a, 1134b, 1134c (Figure 22). For example, device 1104 could be configured to have only two toggle buttons: a toggle button 1134a to produce a maximum ultrasonic energy output and a toggle button 1134c to produce a pulsed output, either at the power level maximum or less than the maximum. Thus, the output setting of the generator 1100 trigger signal could be five continuous signals, or any discrete number of individual pulsed signals (1, 2, 3, 4 or 5). In certain aspects, the specific trigger signal configuration can be controlled based, for example, on the EEPROM settings on the 1100 generator and / or power level selections by the user.
[00288] [00288] In certain respects, a two-position switch can be offered as an alternative to a toggle button 1134c (Figure 22).
[00289] [00289] In some respects, the RF 1124, 1125 electrosurgical end actuator (Figure 22) may also comprise a pair of electrodes. The electrodes may be in communication with the 1100 generator, for example, via a cable. The electrodes can be used, for example, to measure the impedance of a tissue portion present between the clamping arm 1142a, 1146 and the blade 1142b, 1149. Generator 1100 can provide a signal (for example, a non-therapeutic signal) to electrodes. The impedance of the tissue portion can be found, for example, by monitoring the current, voltage, etc. the signal.
[00290] [00290] In several aspects, the 1100 generator can comprise several separate functional elements, such as modules and / or blocks, as shown in Figure 24, a diagram of the surgical system 1000 in Figure 22. Different modules or functional elements can be configured to trigger different types of surgical devices 1104, 1106, 1108. For example, an ultrasonic generator module can drive an ultrasonic device, such as the ultrasonic instrument
[00291] [00291] According to the aspects described, the ultrasonic generator module can produce one or more trigger signals with specific voltages, currents and frequencies (for example, 55,500 cycles per second, or Hz). The one or more drive signals can be supplied to the ultrasonic device 1104 and specifically to the transducer 1120, which can operate, for example, as described above. In one aspect, generator 1100 can be configured to produce a trigger signal for a specific voltage, current and / or frequency output signal that can be performed with high resolution, accuracy and repeatability.
[00292] [00292] According to the aspects described, the generator module for electrosurgery / RF can generate one or more drive signals with sufficient output power to perform bipolar electrosurgery with the use of radiofrequency (RF) energy. In bipolar electrosurgery applications, the trigger signal can be supplied, for example, to the electrodes of the electrosurgical device 1106, for example, as described above. Consequently, generator 1100 can be configured for therapeutic purposes by applying sufficient electrical energy to the tissue to treat said tissue (for example, coagulation, cauterization, tissue welding, etc.).
[00293] [00293] The generator 1100 can comprise an input device 2150 (Figure 27B) located, for example, on a front panel of the generator 1100 console. The input device 2150 can comprise any suitable device that generates signals suitable for programming the operation of the 1100 generator. In operation, the user can program or otherwise control the operation of the 1100 generator using the 2150 input device. The 2150 input device can comprise any suitable device that generates signals that can be used by the generator (for example, by one or more processors contained in the generator) to control the operation of the 1100 generator (for example, the operation of the ultrasonic generator module and / or the generator module for electrosurgery / RF). In many respects, the 2150 input device includes one or more of buttons, keys, rotary controls, keyboard, numeric keypad, touchscreen monitor, pointing device and remote connection to a general purpose or dedicated computer. In other respects, the 2150 input device may comprise a suitable user interface, such as one or more user interface screens shown on a touchscreen monitor, for example. Consequently, through the 2150 input device, the user can adjust or program various generator operational parameters, such as current (I), voltage (V), frequency (f) and / or period (T) of one or more drive generated by the ultrasonic generator module and / or the electrosurgery / RF generator module.
[00294] [00294] The generator 1100 may comprise an output device 2140 (Figure 27B) located, for example, on a front panel of the generator 1100 console. The output device 2140 includes one or more devices to provide the user with sensory feedback. Such devices may comprise, for example, visual feedback devices (for example, a monitor with an LCD screen, LED indicators), auditory feedback devices (for example, a speaker, a bell) or tactile feedback devices ( eg haptic actuators).
[00295] [00295] Although certain modules and / or blocks of the 1100 generator can be described as an example, it should be considered that a greater or lesser number of modules and / or blocks can be used and, even so, be within the scope of aspects. In addition, although several aspects can be described in terms of modules and / or blocks to facilitate description, these modules and / or blocks can be implemented by one or more hardware components, for example, processors, digital signal processors (DSPs) , programmable logic devices (PLDs), application-specific integrated circuits (ASICs), circuits, registers and / or software components, for example, programs, subroutines, logic and / or combinations of hardware and software components.
[00296] [00296] In one aspect, the drive module of the ultrasonic generator and the drive module for electrosurgery / RF 1110 (Figure 22) can comprise one or more integrated applications, implemented as firmware, software, hardware or any combination thereof. The modules can comprise several executable modules, such as software, programs, data, triggers and application program interfaces (API, of "application program interfaces"), among others. The firmware can be stored in non-volatile memory (NVM, of "non-volatile memory"), as in read-only memory (ROM) with bit mask, or flash memory. In many implementations, storing firmware in ROM can preserve flash memory. The NVM can comprise other types of memory including, for example, programmable ROM (PROM, "programmable ROM"), erasable programmable ROM (EPROM, "erasable programmable ROM"), electrically erasable programmable ROM (EEPROM, "electrically erasable" programmable ROM "), or battery backed random-access memory (RAM," random-access memory ") as dynamic RAM (DRAM," dynamic RAM "), DRAM with double data rate (DDRAM," Double " -Data- Rate DRAM "), and / or synchronous DRAM (SDRAM," synchronous DRAM ").
[00297] [00297] In one aspect, the modules comprise a hardware component implemented as a processor for executing program instructions for monitoring various measurable characteristics of devices 1104, 1106, 1108 and generating a corresponding output signal or signals for the operation of devices 1104, 1106, 1108. In aspects where the generator 1100 is used in conjunction with device 1104, the trigger signal can trigger the ultrasonic transducer 1120 in surgical cutting and / or coagulation modes. The electrical characteristics of the 1104 device and / or the fabric can be measured and used to control the operational aspects of the 1100 generator and / or be provided as feedback to the user. In aspects where generator 1100 is used in conjunction with device 1106, the trigger signal can supply electrical energy (for example, RF energy) to end actuator 1124 in cut, coagulation and / or desiccation modes. The electrical characteristics of the 1106 device and / or the fabric can be measured and used to control the operational aspects of the 1100 generator and / or be provided as feedback to the user. In several aspects, as previously discussed, hardware components can be implemented as PSD, PLD, ASIC, circuits and / or registers. In one aspect, the processor can be configured to store and execute computer software program instructions in order to generate the step function output signals for driving various components of devices 1104, 1106, 1108, such as the ultrasonic transducer 1120 and end actuators 1122, 1124, 1125.
[00298] [00298] An electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide, and an ultrasonic blade. The electromechanical ultrasonic system has an initial resonance frequency defined by the physical properties of the ultrasonic transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer is excited by a voltage signal Vg (t) and alternating current Ig (t) equal to the resonance frequency of the electromechanical ultrasonic system. When the electromechanical ultrasonic system is in resonance, the phase difference between the voltage signals Vg (t) and current Ig (t) is zero. In other words, in resonance the inductive impedance is equal to the capacitive impedance. As the ultrasonic blade heats up, the conformity of the ultrasonic blade (modeled as an equivalent capacitance) causes the resonance frequency of the electromechanical ultrasonic system to shift. In this way, the inductive impedance is no longer equal to the capacitive impedance causing a difference between the activation frequency and the resonance frequency of the electromechanical ultrasonic system. The system is now operating "out of resonance". The difference between the drive frequency and the resonance frequency is manifested as a phase difference between the voltage signals Vg (t) and current Ig (t) applied to the ultrasonic transducer. The electronic circuits of the generator can easily monitor the phase difference between the voltage signals Vg (t) and current Ig (t) and can continuously adjust the drive frequency until the phase difference is again equal to zero. At this point, the new drive frequency is equal to the resonance frequency of the new electromechanical ultrasonic system. The change in phase and / or frequency can be used as an indirect measurement of the temperature of the ultrasonic sheet.
[00299] [00299] As shown in Figure 25, the electromechanical properties of the ultrasonic transducer can be modeled as an equivalent circuit comprising a first branch that has a static capacitance and a second "motion" branch that has an inductance, resistance and capacitance connected in series that define the electromechanical properties of a resonator. Known ultrasonic generators may include a tuning inductor to cancel the static capacitance at a resonant frequency so that substantially all of the generator's trigger signal current flows to the motion branch. Consequently, by using a tuning inductor, the current of the generator's trigger signal represents the current of the motion branch, and the generator is thus able to control its trigger signal to maintain the resonance frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance plot of the ultrasonic transducer to optimize the frequency locking capabilities of the generator. However, the tuning inductor must be combined with the specific static capacitance of an ultrasonic transducer at the operational resonance frequency. In other words, a different ultrasonic transducer having a different static capacitance needs a tuning inductor.
[00300] [00300] Figure 25 illustrates an equivalent 1500 circuit of an ultrasonic transducer, such as the 1120 ultrasonic transducer, according to one aspect. Circuit 1500 comprises a first "motion" branch having, connected in series, inductance Ls, resistance Rs and capacitance Cs that define the electromechanical properties of the resonator, and a second capacitive branch having a static capacitance C0. The drive current Ig (t) can be received from a generator at a drive voltage Vg (t), with the movement current Im (t) flowing through the first branch and the current Ig (t) −Im (t) that flows through the capacitive branch. The control of the electromechanical properties of the ultrasonic transducer can be obtained by properly controlling Ig (t) and Vg (t). As explained above, conventional generator architectures can include a Lt tuning inductor (shown in dashed line in Figure 25) to cancel, in a parallel resonance circuit, the static capacitance C0 at a resonance frequency, so that substantially all the current output of the Ig (t) generator flows through the movement branch. In this way, the current control of the motion branch Im (t) is obtained by controlling the current output of the Ig (t) generator. The Lt tuning inductor is specific to the C0 static capacitance of an ultrasonic transducer, however, and a different ultrasonic transducer having a different static capacitance requires a different Lt tuning inductor. In addition, as the Lt tuning inductor correlates to the Nominal value of static capacitance C0 at a single resonance frequency, accurate control of the branching current of motion Im (t) is guaranteed only at that frequency. As the frequency moves downward with the temperature of the transducer, exact control of the current of the motion branch is compromised.
[00301] [00301] The shapes of the 1100 generator may not have a Lt tuning inductor to monitor the Im (t) branching current. Instead, generator 1100 can use the measured value of static capacitance C0 between power applications for a specific ultrasonic surgical device 1104 (along with drive feedback and current voltage feedback data) to determine the current values of motion branch Im (t) on a dynamic and continuous basis (for example, in real time). These forms of the 1100 generator are therefore capable of providing virtual tuning to simulate a system that is tuned or resonated with any C0 static capacitance value at any frequency, and not just at a single resonance frequency imposed by a nominal capacitance value. static C0.
[00302] [00302] Figure 26 is a simplified block diagram of an aspect of generator 1100, to provide tuning without inductor, as described above, among other benefits. Figures 27A to 27C illustrate an architecture of the generator 1100 of Figure 26, according to one aspect. Referring to Figure 26, generator 1100 may comprise an isolated stage of patient 1520 in communication with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of power transformer 1560 is contained in isolated stage 1520 and can comprise a bypass configuration (for example, a central bypass or non-central bypass configuration) for defining the trigger signal outputs 1600a, 1600b, 1600c to provide output trigger signals to different surgical devices, such as an ultrasonic surgical device 1104 and an electrosurgical device 1106. In particular, the trigger signal outputs 1600a, 1600b and 1600c can provide a trigger signal (for example, a 420V RMS trigger signal) to an ultrasonic instrument 1104, and the trigger signal outputs 1600a, 1600b and 1600c can provide a trigger signal (for example, a trigger signal at 1 00V RMS) to an electrosurgical device 1106, with the output 1600b corresponding to the central branch of the power transformer 1560. The non-isolated stage 1540 can comprise a power amplifier 1620 that has an output connected to a primary winding 1640 of the power transformer 1560 In certain aspects, the 1620 power amplifier may comprise a push-pull amplifier, for example. The non-isolated stage 1540 may further comprise a programmable logic device 1660 for providing a digital output to a 1680 digital-to-analog converter (DAC) which, in turn, provides an analog signal corresponding to a power amplifier input.
[00303] [00303] Power can be supplied to a power rail of the 1620 power amplifier by a key mode regulator
[00304] [00304] In certain aspects and as discussed in further detail in connection with Figures 28A to 28B, the programmable logic device 1660, in conjunction with the 1740 processor, can implement a control scheme with direct digital synthesizer (DDS) to control the waveform, frequency and / or amplitude of the supply of trigger signals by generator 1100. In one aspect, for example, programmable logic device 1660 can implement a DDS 2680 control algorithm (Figure 28A) by retrieving waveform samples stored in a dynamically updated lookup table (LUT), such as a RAM LUT that can be integrated into an FPGA. This control algorithm is particularly useful for ultrasonic applications in which an ultrasonic transducer, such as the 1120 ultrasonic transducer, can be driven by a clean sinusoidal current at its resonant frequency. as other frequencies can excite parasitic resonances, minimizing or reducing the total distortion of the current of the motion branch can correspondingly minimize or reduce the undesirable effects of the resonance. As the waveform of a drive signal output by generator 1100 is impacted by various sources of distortion present in the output drive circuit (for example, power transformer 1560, power amplifier 1620), feedback data over voltage and current based on the trigger signal can be provided to an algorithm, such as an error control algorithm implemented by the 1740 processor, which compensates for the distortion through adequate pre-distortion or modification of the waveform samples stored in the LUT dynamically and continuously (for example, in real time). In one aspect, the amount or degree of pre-distortion applied to the LUT samples can be based on the error between a current from the computerized motion branch and a desired current waveform, the error being determined on a basis of sample by sample. In this way, pre-distorted LUT samples, when processed through the drive circuit, can result in a motion branch drive signal that has the desired waveform (for example, sinusoidal) to optimally drive the transducer ultrasonic. In such respects, the LUT waveform samples will therefore not represent the desired waveform of the trigger signal, but rather the waveform that is necessary to ultimately produce the desired waveform of the signal triggering the motion branch, when distortion effects are taken into account.
[00305] [00305] The non-isolated stage 1540 may additionally comprise an ADC 1780 and an ADC 1800 coupled to the output of the power transformer 1560 by means of the respective isolation transformers, 1820 and 1840, to respectively sample the voltage and current of the trigger signals emitted by generator 1100. In certain aspects, ADCs 1780 and 1800 can be configured for sampling at high speeds (for example, 80 Msps) to enable over-sampling of the drive signals. In one aspect, for example, the sampling speed of ADCs 1780 and 1800 can enable an oversampling of approximately 200X (depending on the trigger frequency) of the trigger signals. In certain aspects, the sampling operations of ADCs 1780, 1800 can be performed by a single ADC receiving input voltage and current signals through a bidirectional multiplexer. The use of high-speed sampling in the aspects of the 1100 generator can make it possible, among other things, to calculate the complex current flowing through the motion branch (which can be used in certain aspects to implement the DDS-based waveform control described above), accurate digital filtering of the sampled signals, and calculation of actual energy consumption with a high degree of accuracy. The output of the feedback data about voltage and current through ADCs 1780 and 1800 can be received and processed (for example, FIFO buffering, multiplexing) by the 1660 programmable logic device and stored in data memory for subsequent retrieval, for example, by processor
[00306] [00306] In certain aspects, voltage and current feedback data can be used to control the frequency and / or amplitude (for example, current amplitude) of the trigger signals. In one aspect, for example, voltage and current feedback data can be used to determine the impedance phase, for example, the phase difference between the voltage and current trigger signals. The frequency of the trigger signal can then be controlled to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (eg 0 °), thereby minimizing or reducing the effects of harmonic distortion. and, correspondingly, accentuating the accuracy of the impedance phase measurement. The determination of the phase impedance and a frequency control signal can be implemented in the 1740 processor, for example, with the frequency control signal being supplied as input to a DDS control algorithm implemented by the programmable logic device 1660.
[00307] [00307] The impedance phase can be determined through Fourier analysis. In one aspect, the phase difference between the triggering signals of the generated voltage Vg (t) and the generated current Ig (t) can be determined using the fast Fourier transform (FFT) or the discrete Fourier transform (DFT) as explained below:
[00308] [00308] The evaluation of the Fourier transform in the sinusoidal frequency produces:
[00309] [00309] Other approaches include weighted least squares estimation, Kalman filtering and space and vector based techniques. Virtually all processing in an FFT or DFT technique can be performed in the digital domain with the aid of two-channel high-speed ADC, 1780, 1800, for example. In one technique, samples of digital signals from voltage and current signals are transformed from Fourier with an FFT or DFT. The phase angle φ at any point in time can be calculated by: where φ is the phase angle, f is the frequency, t is the time, and φ0 is the phase at t = 0.
[00310] [00310] Another technique to determine the phase difference between the voltage signals Vg (t) and current Ig (t) is the zero crossing method and produces highly accurate results. For voltage signals Vg (t) and current Ig (t) having the same, each passage through zero from negative to positive of the voltage signal Vg (t) triggers the beginning of a pulse, while each passage through zero from negative to positive current signal Ig (t) triggers the end of the pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage signal and the current signal. In one aspect, the pulse train can be passed through an average filter to produce a measurement of the phase difference. In addition, if zero-pass from positive to negative are also used in a similar way, and the results are averaged, any effects of DC and harmonic components can be reduced. In an implementation, the analog signals of voltage Vg (t) and current Ig (t) are converted into digital signals that are high if the analog signal is positive and low if the analog signal is negative. High accuracy phase estimates require sharp transitions between high and low. In one aspect, a Schmitt trigger together with an RC stabilization network can be used to convert analog signals to digital signals. In other respects, an edge-triggered and auxiliary RS flip-flop circuit can be used. In yet another aspect, the zeroing technique can use an exclusive gate (XOR).
[00311] [00311] Other techniques for determining the phase difference between voltage and current signals include Lissajous figures and image monitoring; methods such as the three voltmeter method, the "crossed-coil" method, the vector voltmeter and vector impedance methods; and the use of standard phase instruments, phase-locked loops and other techniques as described in Phase Measurement, Peter O'Shea, 2000 CRC Press LLC, <http: //www.engnetbase. com>, which is incorporated here for reference.
[00312] [00312] In another aspect, for example, the current feedback data can be monitored in order to maintain the current amplitude of the drive signal at a current amplitude setpoint. The current amplitude set point can be specified directly or indirectly determined based on the specified set points for voltage and power amplitude. In some respects, current amplitude control can be implemented by the control algorithm, such as a proportional-integral-derivative control algorithm (PID), on the 1740 processor. The variables controlled by the control algorithm to properly control the current amplitude of the trigger signal may include, for example, the scaling of the LUT waveform samples stored in the 1660 programmable logic device and / or the full-scale output voltage of the DAC 1680 (which provides input to the power amplifier 1620) through a DAC
[00313] [00313] The non-isolated stage 1540 may also contain a 1900 processor to provide, among other things, the functionality of the user interface (UI). In one aspect, the 1900 processor may comprise an Atmel AT91 SAM9263 processor with an ARM 926EJ-S core, available from Atmel Corporation, of San Jose, California, USA, for example. Examples of UI functionality supported by the 1900 processor may include audible and visual feedback from the user, communication with peripheral devices (for example, via a universal serial bus (USB) interface, communication with the 1430 foot switch, communication with a 2150 data entry device (for example, a touch screen) and communication with a 2140 output device (for example, a speaker). The 1900 processor can communicate with the 1740 processor and the programmable logic device (for example, via serial peripheral interface (SPI) buses). Although the 1900 processor can primarily support UI functionality, it can also coordinate with the 1740 processor to implement risk mitigation in certain aspects. For example, the 1900 processor can be programmed to monitor various aspects of user inputs and / or other inputs (for example, 2150 touchscreen inputs, 1430 foot switch inputs, 2160 temperature sensor inputs) and can disable the generator 1100 drive output when an error condition is detected.
[00314] [00314] In certain aspects, both the 1740 processor (Figure 26, 27A) and the 1900 processor (Figure 26, 27B) can determine and monitor the operational status of the 1100 generator. For the 1740 processor, the operational state of the 1100 generator can determine, for example, which control and / or diagnostic processes are implemented by the 1740 processor. For processor 1900, the operational state of generator 1100 can determine, for example, which elements of a user interface (for example, monitor screens , sounds) are presented to a user. The 1740 and 1900 processors can independently maintain the current operational status of the 1100 generator, as well as recognize and evaluate possible transitions out of the current operational state. The 1740 processor can act as the master in this relationship, and can determine when transitions between operational states should occur. The 1900 processor can be aware of valid transitions between operational states, and can confirm that a particular transition is appropriate. For example, when processor 1740 instructs processor 1900 to transition to a specific state, processor 1900 may verify that the requested transition is valid. If a requested transition between states is determined to be invalid by processor 1900, processor 1900 may cause generator 1100 to enter a fault mode.
[00315] [00315] The non-isolated stage 1540 may further comprise a 1960 controller (Figures 26, 27B) for monitoring the 2150 input devices (for example, a capacitive touch sensor used to turn the generator 1100 on and off, a capacitive screen touch sensitive). In certain respects, the 1960 controller can comprise at least one processor and / or another controller device in communication with the 1900 processor. In one aspect, for example, the 1960 controller can comprise a processor (for example, an 8-bit Mega168 controller available from Atmel) configured to monitor user inputs via one or more capacitive touch sensors. In one aspect, the 1960 controller can comprise a touchscreen controller (for example, a QT5480 touchscreen controller available from Atmel) to control and manage touch data capture from a capacitive sensitive screen to the touch.
[00316] [00316] In certain respects, when generator 1100 is in an "off" state, the 1960 controller can continue to receive operational power (for example, through a line from a generator 1100 power source, such as the power supply 2110 (Figure 26) discussed below). In this way, controller 1960 can continue to monitor an input device 2150 (for example, a capacitive touch sensor located on a front panel of generator 1100) to turn generator 1100 on and off. When generator 1100 is in the off state, the 1960 controller can wake up the power supply (for example, enable the operation of one or more DC / DC voltage converters 2130 (Figure 26) of the power supply 2110), if activation of the "on / off" input device is detected turns off "2150 by a user. Controller 1960 can therefore initiate a sequence to transition generator 1100 to an "on" state. On the other hand, controller 1960 can initiate a sequence to transition the generator 1100 to the off state if activation of the input device "on / off" 2150 is detected, when the generator 1100 is in the on state. In certain respects, for example, controller 1960 may report activation of the "on / off" 2150 input device to processor 1900, which in turn implements the process sequence necessary to transition generator 1100 to the off state. In these respects, the 1960 controller may not have any independent capacity to cause the removal of power from generator 1100, after its on state has been established.
[00317] [00317] In certain aspects, the 1960 controller can cause the 1100 generator to offer audible feedback or other sensory feedback to alert the user that an on or off sequence has been initiated. This type of alert can be provided at the beginning of an on or off sequence, and before the start of other processes associated with the sequence.
[00318] [00318] In certain respects, the isolated stage 1520 may comprise an 1980 instrument interface circuit to, for example, provide a communication interface between a control circuit of a surgical device (for example, a control circuit comprising switches cable) and non-isolated stage 1540 components, such as programmable logic device 1660, 1740 processor and / or processor 1900. Instrument interface circuit 1980 can exchange information with non-isolated stage 1540 components via a link of communication that maintains an adequate degree of electrical isolation between stages 1520 and 1540 such as, for example, an infrared (IR) "infrared" communication link. Power can be supplied to the 1980 instrument's interface circuit using, for example, a low-drop voltage regulator powered by an isolation transformer driven from the non-isolated stage 1540.
[00319] [00319] In one aspect, the instrument interface circuit 1980 can comprise a programmable logic device 2000 (e.g., an FPGA) in communication with a signal conditioning circuit 2020 (Figure 26 and Figure 27C). The signal conditioning circuit 2020 can be configured to receive a periodic signal from the programmable logic device 2000 (for example, a 2 kHz square wave) to generate an interrogation signal that has an identical frequency. The question mark can be generated, for example, using a bipolar current source powered by a differential amplifier. The question mark can be communicated to a control circuit of the surgical device (for example, using a conductive pair on a wire that connects the 1100 generator to the surgical device) and monitored to determine a state or configuration of the control circuit. . The control circuit can comprise numerous switches, resistors and / or diodes to modify one or more characteristics (for example, amplitude, rectification) of the question mark so that a state or configuration of the control circuit is unambiguously discernible, based on that one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may comprise an ADC for generating samples of a voltage signal appearing at the control circuit inputs, resulting from the passage of the interrogation signal through it. The programmable logic device 2000 (or a non-isolated stage component 1540) can then determine the status or configuration of the control circuit based on the ADC samples.
[00320] [00320] In one aspect, the 1980 instrument interface circuit may comprise a first 2040 data circuit interface to enable the exchange of information between programmable logic device 2000 (or another element of the 1980 instrument interface circuit) and a first data circuit disposed in, or otherwise associated with, a surgical device. In certain respects, for example, a first 2060 data circuit may be arranged on a wire integrally attached to a handle of the surgical device, or on an adapter to interface between a specific type or model of surgical device and the 1100 generator. In some respects, the first data circuit may comprise a non-volatile storage device, such as an electrically erasable programmable read-only memory device (EEPROM). In certain respects and again with reference to Figure 26, the first 2040 data circuit interface can be implemented separately from the programmable logic device 2000 and comprises a suitable circuitry (for example, separate logic devices, a processor) to enable communication between programmable logic device 2000 and the first data circuit. In other respects, the first data loop interface 2040 can be integral with the programmable logic device 2000.
[00321] [00321] In certain aspects, the first 2060 data circuit can store information related to the specific surgical device with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical device was used, and / or any other types of information. This information can be read by the instrument interface circuit 1980 (for example, by the programmable logic device 2000), transferred to a component of the non-isolated stage 1540 (for example, to the programmable logic device 1660, processor 1740 and / or processor 1900 ) for presentation to a user by means of an output device 2140 and / or to control a function or operation of the generator 1100. Additionally, any type of information can be communicated to the first data circuit 2060 for storage in the same through the first 2040 data circuit interface (for example, using programmable logic device 2000). This information may include, for example, an updated number of operations in which the surgical device was used and / or the dates and / or times of its use.
[00322] [00322] As discussed earlier, a surgical instrument can be removable from a handle (for example, the instrument 1106 can be removable from the handle 1107) to promote interchangeability and / or disposability of the instrument. In such cases, known generators may be limited in their ability to recognize specific instrument configurations being used, as well as to optimize control and diagnostic processes as needed. The addition of readable data circuits to surgical device instruments to address this issue is problematic from a compatibility point of view, however. For example, it may be impractical to design a surgical device so that it remains compatible with previous versions of generators that lack the indispensable data reading functionality due to, for example, different signaling schemes, design complexity and cost. Other aspects of the instruments address these concerns through the use of data circuits that can be implemented in existing surgical instruments, economically and with minimal design changes to preserve the compatibility of surgical devices with current generator platforms.
[00323] [00323] Additionally, aspects of the 1100 generator may enable communication with instrument-based data circuits. For example, generator 1100 can be configured to communicate with a second data circuit (for example, a data circuit) contained in an instrument (for example, instrument 1104, 1106, or 1108) of a surgical device. The instrument interface circuit 1980 may comprise a second data circuit interface 2100 to enable such communication. In one aspect, the second data circuit interface 2100 may comprise a tri-state digital interface, although other interfaces may also be used. In certain aspects, the second data circuit can generally be any circuit for transmitting and / or receiving data. In one aspect, for example, the second data circuit can store information related to the specific surgical instrument with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and / or any other types of information. Additionally or alternatively, any type of information can be communicated to the second data circuit for storage in it via the second data circuit interface 2100 (for example, using the programmable logic device 2000). This information may include, for example, an updated number of operations in which the surgical instrument was used and / or the dates and / or times of its use. In certain respects, the second data circuit can transmit data captured by one or more sensors (for example, an instrument-based temperature sensor). In certain aspects, the second data circuit can receive data from generator 1100 and provide an indication to the user (for example, an LED indication or other visible indication) based on the received data.
[00324] [00324] In certain respects, the second data circuit and the second data circuit interface 2100 can be configured so that communication between the programmable logic device 2000 and the second data circuit can be achieved without the need to provide conductors for this purpose (for example, dedicated wire conductors connecting a cable to the 1100 generator). In one aspect, for example, information can be communicated to and from the second data circuit using a wire bus communication scheme, implemented in existing wiring, as one of the conductors used to transmit interrogation signals from from the signal conditioning circuit 2020 to a control circuit on a cable. In this way, changes or modifications to the design of the surgical device that may otherwise be necessary are minimized or reduced. In addition, due to the fact that different types of communications can be implemented on a common physical channel (with or without frequency band separation), the presence of a second data circuit can be "invisible" to generators that do not have indispensable data reading functionality, which, therefore, allows the backward compatibility of the surgical device instrument.
[00325] [00325] In certain aspects, the isolated stage 1520 may comprise at least one blocking capacitor 2960-1 (Figure 27C) connected to the output of the trigger signal 1600b, to prevent the passage of direct current to a patient. A single blocking capacitor may be required to comply with medical regulations and standards, for example. Although failures in single-capacitor designs are relatively uncommon, such failures can still have negative consequences. In one aspect, a second 2960-2 blocking capacitor can be placed in series with the 2960-1 blocking capacitor, with one point current leakage between the 2960-1 and 2960-2 blocking capacitors being monitored by, for example, example, an ADC 2980 for sampling a voltage induced by the leakage current. Samples can be received by the programmable logic device 2000, for example. Based on changes in leakage current (as indicated by the voltage samples in the aspect of Figure 26), generator 1100 can determine when at least one of the blocking capacitors 2960-1 and 2960-2 has failed. Consequently, the appearance of Figure 26 can provide a benefit over designs with only one capacitor, having a single point of failure.
[00326] [00326] In certain respects, the non-isolated stage 1540 may comprise a power supply 2110 for DC power output with adequate voltage and current. The power supply may comprise, for example, a 400 W power supply to provide a system voltage of 48 VDC. As discussed above, the power supply 2110 may additionally comprise one or more DC / DC voltage converters 2130 to receive the power supply output to generate DC outputs at the voltages and currents required by the various components of generator 1100. As discussed above In relation to the 1960 controller, one or more of the 2130 DC / DC voltage converters can receive an input from the 1960 controller when the activation of the 2150 "on / off" input device by a user is detected by the 1960 controller, to allow the operation or awakening of the DC / DC 2130 voltage converters.
[00327] [00327] Figures 28A and 28B illustrate certain functional and structural aspects of an aspect of generator 1100. The feedback indicating current and voltage output of secondary winding 1580 of power transformer 1560 is received by ADCs 1780 and 1800, respectively. As shown, ADCs 1780 and 1800 can be implemented in the form of a 2-channel ADC and can sample feedback signals at high speed (eg 80 Msps) to enable oversampling (eg approximately 200x of oversampling) of the trigger signals. Current and voltage feedback signals can be properly conditioned in the analog domain (for example, amplified, filtered) before processing by ADCs 1780 and
[00328] [00328] The multiplexed voltage and current feedback samples can be received by a parallel data capture port (PDAP) implemented inside block 2144 of the 1740 processor. The PDAP can comprise a packaging unit to implement any of the numerous methodologies for correlating multiplexed feedback information with a memory address. In one aspect, for example, the feedback samples corresponding to a specific LUT sample output by the 1660 programmable logic device can be stored in one or more memory addresses that are correlated or indexed to the LUT address in the LUT sample. In another aspect, the feedback data corresponding to a specific LUT sample by the 1660 programmable logic device can be stored, together with the LUT address of the LUT sample, in a common memory location. Either way, the feedback samples can be stored so that the address of the LUT sample from which a specific set of feedback information originated can be subsequently determined. As discussed above, the synchronization of the addresses of the LUT samples and the feedback data in this way contributes to the correct timing and stability of the pre-distortion algorithm. A direct memory access controller (DMA) implemented in block 2166 of the 1740 processor can store the feedback samples (and any LUT sample address data, where applicable) in a designated memory location 2180 of the 1740 processor (for example, Internal RAM).
[00329] [00329] Block 2200 of the 1740 processor can implement a pre-distortion algorithm to pre-distort or modify the LUT samples stored in the programmable logic device 1660 in a dynamic and continuous manner. As discussed above, the pre-distortion of the LUT samples can compensate for various sources of distortion present in the generator output drive circuit.
[00330] [00330] In block 2220 of the pre-distortion algorithm, the current is determined through the movement branch of the ultrasonic transducer. The current of the motion branch can be determined using the Kirchoff current law based, for example, on the current and voltage feedback information stored at the 2180 memory location (which, when properly sized, can be representative of Ig and Vg in the model in Figure 25 discussed above), a value of the static capacitance of the ultrasonic transducer C0 (measured or known a priori) and a known value of the drive frequency. A sample of current from the motion branch can be determined for each set of stored current and voltage feedback information associated with a LUT sample.
[00331] [00331] In block 2240 of the pre-distortion algorithm, each current sample of the motion branch determined in block 2220 is compared to a sample of a desired current waveform to determine a difference, or error, of the sample amplitude, between the compared samples. For this determination, the sample with the desired current waveform can be supplied, for example, from a LUT 2260 waveform containing amplitude samples for a cycle of a desired current waveform. The specific LUT 2260 current waveform sample used for the comparison can be determined by the LUT sample address associated with the current sample of the motion branch used in the comparison. As needed, the current input from the motion branch in block 2240 can be synchronized with the entry of its associated LUT sample address in block 2240. The LUT samples stored in the 1660 programmable logic device and the LUT samples stored in the LUT 2260 waveforms can therefore be equal in number. In some respects, the desired current waveform, represented by the LUT samples stored in the 2260 waveform LUT, can be a fundamental sine wave. Other waveforms may be desirable. For example, it is contemplated that a fundamental sine wave could be used to trigger the main longitudinal movement of an ultrasonic transducer, superimposed on one or more other trigger signals at other frequencies, such as a third order ultrasonic to trigger at least two resonances mechanical in order to obtain beneficial vibrations in transverse or other modes.
[00332] [00332] Each value of the sample amplitude error determined in block 2240 can be transmitted to the LUT of programmable logic device 1660 (shown in block 2280 in Figure 28A) together with an indication of its associated LUT address. Based on the amplitude error sample value and its associated address (and, optionally, the amplitude error sample values for the same LUT address previously received), LUT 2280 (or another programmable logic device control block) 1660) can pre-distort or modify the value of the LUT sample stored at the LUT address, so that the amplitude error sample is reduced or minimized. It should be understood that this pre-distortion or modification of each LUT sample in an iterative way across the LUT address range will cause the waveform of the generator's output current to match or adapt to the waveform of the desired current, represented by the LUT 2260 samples of waveforms.
[00333] [00333] Current and voltage amplitude measurements, power measurements and impedance measurements can be determined in block 2300 of the 1740 processor, based on current and voltage feedback samples stored in memory location 2180. Before In determining these quantities, the feedback samples can be properly sized and, in certain aspects, processed through a suitable 2320 filter to remove the noise resulting, for example, from the data capture process and the induced harmonic components. The filtered voltage and current samples can therefore substantially represent the fundamental frequency of the generator drive output signal. In certain respects, filter 2320 can be a finite impulse response filter (FIR) applied in the frequency domain. These aspects can use the fast Fourier transform (FFT) of the current and voltage output signals of the drive signal. In some respects, the resulting frequency spectrum can be used to provide additional functionality to the generator. In one aspect, for example, the ratio of the second and / or third order harmonic component to the fundamental frequency component can be used as a diagnostic indicator.
[00334] [00334] In block 2340 (Figure 28B), an average square value (RMS) calculation can be applied to a sample size of the current feedback samples representing an integral number of drive signal cycles, to generate an Irms measurement representing the output current of the drive signal.
[00335] [00335] In block 2360, an average square value (RMS) calculation can be applied to a sample size of the voltage feedback samples representing an integral number of trigger signal cycles, to determine a Vrms measurement representing the voltage output of the trigger signal.
[00336] [00336] In block 2380, the current and voltage feedback information can be multiplied point by point, and an average calculation is applied to the samples representing an integral number of cycles of the trigger signal, to determine a Pr measurement of the energy of actual generator output.
[00337] [00337] In block 2400, the measurement Pa of the apparent output power of the generator can be determined as the product Vrms · Irms.
[00338] [00338] In block 2420, the Zm measurement of the magnitude of the load impedance can be determined as the Vrms / Irms quotient.
[00339] [00339] In certain aspects, the quantities lrms, Vrms, Pr, Pa and Zm determined in blocks 2340, 2360, 2380, 2400 and 2420, can be used by generator 1100 to implement any of a number of control and / or processes diagnostics. In certain respects, any of these quantities can be communicated to a user using, for example, an output device 2140 Integral to the generator 1100, or an output device 2140 connected to the generator
[00340] [00340] Block 2440 of the 1740 processor can implement a phase control algorithm for determining and controlling the impedance phase of an electrical charge (for example, the ultrasonic transducer) conducted by the 1100 generator. As discussed above, when controlling the frequency of the trigger signal to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (eg 0 °), the effects of harmonic distortion can be minimized or reduced, and the measurement accuracy is increased phase.
[00341] [00341] The phase control algorithm receives the current and voltage feedback samples stored in memory location 2180 as input. Prior to their use in the phase control algorithm, feedback feedback samples can be appropriately sized and, in certain aspects, processed through a suitable filter 2460 (which can be identical to the filter 2320) to remove the noise resulting from the data capture process and the induced harmonic components, for example. The filtered voltage and current samples can therefore substantially represent the fundamental frequency of the generator drive output signal.
[00342] [00342] In block 2480 of the phase control algorithm, the current is determined through the movement branch of the ultrasonic transducer. This determination can be identical to that described above in connection with block 2220 of the pre-distortion algorithm. Thus, the output of block 2480 can be, for each set of stored current and voltage feedback information associated with a LUT sample, a sample of current from the movement branch.
[00343] [00343] In block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized input of samples from the current of the motion branch determined in block 2480 and corresponding to voltage feedback samples. In some respects, the impedance phase is determined as the average between the impedance phase measured at the rising edge of the waveforms and the impedance phase measured at the falling edge of the waveforms.
[00344] [00344] In block 2520 of the phase control algorithm, the impedance phase value determined in block 2220 is compared to the setpoint of phase 2540 to determine a difference, or phase error, between the compared values.
[00345] [00345] In block 2560 (Figure 28A) of the phase control algorithm, based on a phase error value determined in block 2520 and the impedance magnitude determined in block 2420, a frequency output is determined to control the frequency trigger signal. The frequency output value can be continuously adjusted by block 2560 and transferred to a DDS 2680 control block (discussed below) in order to maintain the impedance phase determined in block 2500 of the phase setpoint (for example, zero phase). In some respects, the impedance phase can be set to a phase setpoint of 0 °. In this way, any harmonic distortion will be centered around the crest of the voltage waveform, accentuating the accuracy of determining the phase impedance.
[00346] [00346] Block 2580 of the 1740 processor can implement an algorithm for modulating the current amplitude of the drive signal, in order to control the current, voltage and power of the drive signal, according to user-specified set points , or according to requirements specified by other processes or algorithms implemented by the 1100 generator. The control of these quantities can be carried out, for example, by dimensioning the LUT samples in the LUT 2280, and / or by adjusting the output voltage in full scale of the DAC 1680 (which provides input to the 1620 power amplifier) via a DAC 1860. Block 2600 (which can be implemented as a PID controller in certain respects) can receive current feedback samples (which can be properly sized and filtered) from memory location 2180. Current feedback samples can be compared to the nte "Id determined by the controlled variable (for example, current, voltage or power) to determine whether the trigger signal is supplying the necessary current. In aspects where the drive signal current is the control variable, the demand for current Id can be specified directly by a current setpoint 2620A (Isp). For example, an RMS value of the current feedback data (determined as in block 2340) can be compared to the RMS Isp current setpoint specified by the user to determine the appropriate action for the controller. If, for example, the current feedback data indicates an RMS value less than the current setpoint Isp, LUT dimensioning and / or full-scale output voltage of the DAC
[00347] [00347] In aspects where the drive signal voltage is the control variable, the current demand Id can be specified indirectly, for example, based on the current required to maintain a desired voltage reference value 2620B (Vsp ) given the magnitude of the load impedance Zm measured in block 2420 (for example, Id = Vsp / Zm). Likewise, in aspects where the signal strength of the inverter is the control variable, the Id of the current demand can be specified indirectly, for example, based on the current required to maintain a desired power setpoint 2620C ( Psp) given the Vrms voltage measured in blocks 2360 (for example, Id = Psp / Vrms).
[00348] [00348] Block 2680 (Figure 28A) can implement a DDS control algorithm to control the trigger signal by retrieving LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm can be an oscillator algorithm numerically controlled (NCO, of "numerically-controlled oscillator") to generate samples of a waveform at a fixed timing rate using a technique of skipping points (locations in memory). The NCO algorithm can implement a phase accumulator, or frequency to phase converter, which functions as an address pointer for retrieving LUT samples from the LUT 2280. In one aspect, the phase accumulator can be a phase accumulator with size from step D, module N, where D is a positive integer representing a frequency control value, and N is the number of LUT samples in LUT 2280. A frequency control value D = 1, for example, can do cause the phase accumulator to point sequentially to each LUT 2280 address, resulting in a waveform output that replicates the waveform stored in LUT 2280. When D> 1, the phase accumulator can skip addresses on LUT 2280, resulting in a waveform output that has a higher frequency. Consequently, the frequency of the waveform generated by the DDS control algorithm can therefore be controlled by varying the frequency control value accordingly. In certain aspects, the frequency control value can be determined based on the output of the phase control algorithm implemented in block 2440. The output of block 2680 can provide DAC input 1680 which, in turn, provides an analog signal corresponding to an input of the 1620 power amplifier.
[00349] [00349] Block 2700 of the 1740 processor can implement a switch mode converter control algorithm to dynamically modulate the 1620 power amplifier rail voltage based on the signal waveform envelope being amplified, thereby improving efficiency of the 1620 power amplifier. In certain respects, the characteristics of the waveform envelope can be determined by monitoring one or more signals contained in the 1620 power amplifier. In one aspect, for example, the characteristics of the waveform envelope. wave can be determined by monitoring the minimum of a drain voltage (for example, a MOSFET drain voltage) that is modulated according to the amplified signal envelope. A minimum voltage signal can be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal can be sampled by the ADC 1760, with the minimum output voltage samples being received in block 2720 of the switching mode converter control algorithm. Based on the values of the minimum voltage samples, the 2740 block can control a PWM signal output by a 2760 PWM generator, which in turn controls the rail voltage supplied to the 1620 power amplifier by the 1700 switching mode regulator In certain respects, as long as the values of the minimum voltage samples are less than a target input for the minimum 2780 in block 2720, the voltage on the rail can be modulated according to the waveform envelope, as characterized by the minimum voltage samples. When voltage samples from the minimum indicate low envelope power levels, for example, block 2740 can cause a low voltage on the rail to be supplied to the 1620 power amplifier, with the total rail voltage being supplied only when the voltage samples are minimum voltage indicates maximum envelope power levels. When voltage samples from the minimum drop below the target to the minimum 2780, the 2740 block can keep the rail voltage at an adequate minimum to ensure the proper operation of the 1620 power amplifier.
[00350] [00350] Figure 29 is a schematic diagram of an aspect of a 2900 electrical circuit, suitable for driving an ultrasonic transducer, such as the 1120 ultrasonic transducer, according to at least one aspect of the present description. The 2900 electrical circuit comprises a 2980 analog multiplexer. The 2980 analog multiplexer multiplexes several signals from the SCL-A, SDA-A upstream channels, such as ultrasonic, battery and power control circuits. A 2982 current sensor is connected in series to the return or ground leg of the power supply circuit to measure the current supplied by the power supply. A 2984 field effect transistor (FET) temperature sensor provides room temperature. A 2988 pulse width modulation (PWM) surveillance timer automatically generates a system restart if the main program periodically fails to repair it. It is provided to automatically restart the 2900 electrical circuit when it crashes or freezes due to a software or hardware failure. It will be recognized that the 2900 electrical circuit can be configured as an RF trigger circuit to drive the ultrasonic transducer or to drive the RF electrodes like the 3600 electrical circuit shown in Figure 36, for example. Consequently, with reference now again to Figure 29, the 2900 electrical circuit can be used to interchangeably drive the ultrasonic transducers and the RF electrodes. If activated simultaneously, filter circuits can be provided on the first corresponding stage circuits 3404 (Figure 34) to select both the ultrasonic waveform and the RF waveform. These filtering techniques are described in U.S. Patent Publication No. US-2017-0086910-A1, commonly owned, entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated herein in full by reference.
[00351] [00351] A 2986 drive circuit provides ultrasonic energy outputs on the left and on the right. A digital signal representing the signal waveform is supplied to the SCL-A, SDA-A inputs of the 2980 analog multiplexer from a control circuit, such as the 3200 control circuit (Figure 32). A 2990 digital to analog converter (DAC) converts the digital input to an analog output to generate a 2992 pulse width modulation circuit coupled to a 2994 oscillator. The 2992 pulse width modulation circuit provides a first signal for a first door drive circuit 2996a coupled to a first output stage of transistor 2998a to drive a first ultrasonic energy output (left). The 2992 pulse width modulation circuit also provides a second signal for a second 2996b gate drive circuit coupled to a second 2998b transistor output stage to drive a second (right) ultrasonic energy output. A 2999 voltage sensor is coupled between the left / right ultrasonic output terminals to measure the output voltage. Drive circuit 2986, first and second drive circuits 2996a, 2996b, and first and second output stages of transistor 2998a, 2998b define a first stage amplifier circuit. In operation, the 3200 control circuit (Figure 32) generates a 4300 digital waveform (Figure 43) that employs circuits such as the 4100, 4200 digital direct synthesis (DDS) circuits (Figures 41 and 42). The 2990 DAC receives the 4300 digital waveform and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.
[00352] [00352] Figure 30 is a schematic diagram of transformer 3000 coupled to electrical circuit 2900 shown in Figure 29, according to at least one aspect of the present description. The left / right ultrasonic input terminals (primary winding) of the transformer 3000 are electrically coupled to the left / right ultrasonic output terminals of the 2900 electrical circuit. The secondary winding of the transformer 3000 is coupled to the positive and negative electrodes 3074a, 3074b. The positive and negative electrodes 3074a, 3074b of transformer 3000 are coupled to the positive terminal (Battery 1) and the negative terminal (Battery 2) of the ultrasonic transducer. In one respect, transformer 3000 has a n1: n2 turn ratio of 1:50.
[00353] [00353] Figure 31 is a schematic diagram of transformer 3000 shown in Figure 30 coupled to a test circuit 3165, according to an aspect of the present description. The test circuit 3165 is coupled to the positive and negative electrodes 3074a, 3074b. A 3167 switch is placed in series with an inductor / capacitor / resistor (LCR) charge that simulates the charge of an ultrasonic transducer.
[00354] [00354] Figure 32 is a schematic diagram of a 3200 control circuit, like the 3212 control circuit, according to at least one aspect of the present description. The 3200 control circuit is located inside a battery pack compartment. The battery pack is the power source for a variety of local 3215 power supplies. The control circuit comprises a 3214 main processor coupled via a 3218 interface master to various circuits downstream via the SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C, for example. In one aspect, the 3218 interface master is a general purpose serial interface, like an I2C serial interface. The 3214 main processor is also configured to trigger the 3224 switches via general purpose input / output (GPIO) 3220, a 3226 screen (for example, an LCD screen), and several 3228 indicators via GPIO 3222. A surveillance 3216 is provided to control the 3214 main processor. A 3230 switch is supplied in series with a 3211 battery to activate the 3212 control circuit by inserting the battery pack into a surgical instrument handle set.
[00355] [00355] In one aspect, the main processor 3214 is coupled to the electrical circuit 2900 (Figure 29) through output terminals SCL-A / SDA-A. The main processor 3214 comprises a memory for storing tables of trigger signals or digitized waveforms that are transmitted to the 2900 electrical circuit to drive the 1120 ultrasonic transducer, for example. In other respects, the 3214 main processor can generate a digital waveform and transmit it to the 2900 electrical circuit, or it can store the digital waveform for later transmission to the 2900 electrical circuit. The 3214 main processor can also provide RF drive via via SCL-B / SDA-B output terminals and various sensors (eg Hall effect sensors, magneto-rheological fluid (MRF) sensors, etc.) via SCL-C / SDA-C output terminals . In one aspect, the 3214 main processor is configured to detect the presence of an ultrasonic drive circuit and / or RF drive circuit to enable the appropriate software and user interface functionality.
[00356] [00356] In one aspect, the 3214 main processor may be an LM 4F230H5QR, available from Texas Instruments, for example. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core comprising an integrated 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a transfer buffer for optimize performance above 40 MHz, 32 KB single cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with the StellarisWare® program, electrically erasable and programmable read-only memory (EEPROM) 2 KB, one or more pulse width modulation (PWM) modules, one or more quadrature encoder (QED) input analogues, one or more 12-bit analog to digital converters (ADC) with 12 input channels analog, among other features that are readily available in the product data sheet. Other processors can be easily replaced and, therefore, the present description should not be limited in this context.
[00357] [00357] Figure 33 shows a simplified circuit block diagram illustrating another 3300 electrical circuit contained within a 3334 modular ultrasonic surgical instrument, in accordance with an aspect of the present description. The 3300 electrical circuit includes a 3302 processor, a 3330 clock, a 3326 memory, a 3304 power supply (for example, a battery), a 3306 switch, such as a semiconductor metal oxide field effect transistor power switch ( MOSFET), a drive circuit 3308 (PLL), a transformer 3310, a signal smoothing circuit 3312 (also called a correspondence circuit and can be, for example, a tank circuit), a detection circuit 3314, a 1120 transducer, and a drive shaft assembly (for example, drive shaft assembly 1126, 1129) comprising an ultrasonic transmission waveguide that ends in an ultrasonic blade (e.g., ultrasonic blade 1128, 1149) that can be called, in the present invention, simply a waveguide.
[00358] [00358] A feature of the present description that stops reliance on high voltage input energy (120 VAC) (a feature of general ultrasonic cut-off devices) is the use of low voltage switching throughout the entire process of forming wave and amplification of the drive signal just directly before the transformer stage. For this reason, in one aspect of the present description, energy is derived from just one battery, or a group of batteries, small enough to fit inside a handle assembly. State-of-the-art battery technology provides powerful batteries a few inches high and a few millimeters deep. By combining the characteristics of this description to provide a self-contained and self-powered ultrasonic device, a reduction in production cost can be achieved.
[00359] [00359] The output of the 3304 power supply is fed to the 3302 processor and energizes it. The 3302 processor receives and sends signals and, as will be described below, works according to custom logic or according to computer programs that are run by the 3302 processor. As discussed above, electrical circuit 3300 can also include memory 3326, preferably, a random access memory (RAM) that stores computer-readable instructions and data.
[00360] [00360] The power supply output 3304 is also directed to switch 3306 having a duty cycle controlled by the processor
[00361] [00361] The drive circuit 3308, which receives the signal from switch 3306, includes an oscillatory circuit that transforms the output of switch 3306 into an electrical signal having an ultrasonic frequency, for example, 55 kHz (VCO). As explained above, a smoothed version of this ultrasonic waveform is ultimately fed to the 1120 ultrasonic transducer to produce a resonant sine wave along the ultrasonic transmission waveguide.
[00362] [00362] At the output of the drive circuit 3308 there is a 3310 transformer that is capable of raising the low voltage signal (s) to a higher voltage. It is observed that the upstream switching, before the 3310 transformer, is carried out at low voltages (for example, battery operated), something that, until now, was not possible for ultrasonic devices for cutting and cauterization. This is at least partially due to the fact that the device advantageously uses low resistance MOSFET switching devices. Low-resistance MOSFET switches are advantageous, as they produce less switching losses and less heat than a traditional MOSFET device and allow greater current to pass through. Therefore, the switching stage (pre-transformer) can be characterized as low voltage / high current. To ensure the lowest resistance of the amplifier's MOSFET (s), the MOSFET (s) is (are) run, for example, at 10 V. In this case, a 10 VDC power supply A separate can be used to power the MOSFET port, which ensures that the MOSFET is fully connected and that a reasonably low resistance is achieved. In one aspect of the present description, the 3310 transformer raises the battery voltage to 120 V average square value (RMS). Transformers are known in the art and are therefore not explained in detail here.
[00363] [00363] In the described circuit configurations, the degradation of the circuit component can negatively affect the circuit performance of the circuit. One factor that directly affects the performance of the component is heat. Known circuits generally monitor switching temperatures (ie, MOSFET temperatures). However, due to technological advances in MOSFET projects and due to the corresponding reduction in size, MOSFET temperatures are no longer a valid indicator of circuit loads and heat. For this reason, according to at least one aspect of the present description, a 3314 detection circuit detects the temperature of the 3310 transformer. This temperature detection is advantageous, as the 3310 transformer is operated at or near its maximum temperature, while using the device. The additional temperature will cause the core material, for example, ferrite, to rupture and permanent damage can occur. The present description can respond to a maximum temperature of transformer 3310, for example, by reducing the drive energy in transformer 3310, signaling the user, turning off the power, pulsating the power or by means of other appropriate responses.
[00364] [00364] In one aspect of the present description, the 3302 processor is communicatively coupled to the end actuator (for example, 1122, 1125) which is used to bring the material into physical contact with the ultrasonic blade (for example, 1128, 1149). Sensors are provided that measure, on the end actuator, a clamping force value (existing within a known range) and, based on the received clamping force value, processor 3302 changes the movement voltage VM. Since high force values, combined with a defined rate of movement, can result in high blade temperatures, a 3332 temperature sensor can be communicatively coupled to the 3302 processor, with the 3302 processor being operable to receive and interpret a signal that indicates a current blade temperature from the 3336 temperature sensor and to determine a target frequency of blade movement based on the received temperature. In another aspect, force sensors, such as mechanical pressure gauges or pressure sensors, can be coupled to the trigger (for example, 1143, 1147) to measure the force applied to the trigger by the user. In another aspect, force sensors, such as mechanical pressure gauges or pressure sensors, can be coupled to a switch button so that the displacement intensity corresponds to the force applied by the user to the switch button.
[00365] [00365] In accordance with at least one aspect of the present description, the PLL portion of the drive circuit 3308, which is coupled to the processor 3302, is able to determine a frequency of movement of the waveguide and communicate that frequency to the processor 3302. Processor 3302 stores the value of that frequency in memory 3326 when the device is turned off. By reading clock 3330, processor 3302 is able to determine an elapsed time after the device is turned off and to retrieve the last waveform movement frequency if the elapsed time is less than a predetermined value. The device can then start at the last frequency, which, presumably, is the ideal frequency for the current load. Modular battery-operated surgical instrument with multistage generating circuits
[00366] [00366] In another aspect, the present description provides a modular battery-powered surgical hand instrument with multistage generating circuits. A surgical instrument is described that includes a battery set, a handle set, and a drive shaft set, the battery set and the drive shaft set being mechanically and electrically connected to the handle set. The battery pack includes a control circuit configured to generate a digital waveform. The grip set includes a first stage circuit configured to receive the digital waveform, convert the digital waveform to an analog waveform and amplify the analog waveform. The drive shaft assembly includes a second stage circuit coupled to the first stage circuit to receive, amplify and apply the analog waveform to a load.
[00367] [00367] In one aspect, the present description provides a surgical instrument, comprising: a battery pack, comprising a control circuit comprising a battery, a memory attached to the battery, and a processor attached to the memory and battery, the processor being configured to generate a digital waveform; a handle set comprising a first stage circuit coupled to the processor, the first stage circuit comprising a digital to analog converter (DAC) and an amplifier first stage circuit, the DAC being configured to receive the form of digital wave and convert the digital waveform into an analog waveform, the first stage amplifier circuit being configured to receive and amplify the analog waveform; and a drive shaft assembly comprising a second stage circuit coupled to the first stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load; the battery pack and the drive shaft set are configured to connect mechanically and electrically to the grip set.
[00368] [00368] The charge can comprise any of an ultrasonic transducer, an electrode or a sensor, or any combination thereof. The first stage circuit may comprise a first stage ultrasonic drive circuit and a first stage high frequency current drive circuit. The control circuit can be configured to drive the first stage ultrasonic drive circuit and the high frequency current drive first stage circuit, independently or simultaneously. The first stage ultrasonic drive circuit can be configured to couple with a second stage ultrasonic drive circuit. The second stage ultrasonic drive circuit can be configured to couple with an ultrasonic transducer. The first stage high frequency current driving circuit of the first stage can be configured to couple with a high frequency second stage circuit. The high-frequency second stage circuit can be configured to couple with an electrode.
[00369] [00369] The first stage circuit may comprise a first stage circuit for triggering the sensor. The first-stage sensor drive circuit can be configured to a second-stage drive circuit. The second-stage sensor drive circuit can be configured to couple with a sensor.
[00370] [00370] In another aspect, the present description provides a surgical instrument, comprising: a battery pack, comprising a control circuit comprising a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery , the processor being configured to generate a digital waveform; a handle set comprising a common first stage circuit coupled to the processor, the common first stage circuit comprising a digital to analog converter (DAC) and a first common stage amplifier circuit, the DAC being configured to receive the digital waveform and convert the digital waveform into an analog waveform, the first common stage amplifier circuit being configured to receive and amplify the analog waveform; and a drive shaft assembly comprising a second stage circuit coupled to the first common stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load; the battery pack and the drive shaft set are configured to connect mechanically and electrically to the grip set.
[00371] [00371] The charge can comprise any of an ultrasonic transducer, an electrode or a sensor, or any combination thereof. The common first stage circuit can be configured to drive ultrasonic, high frequency circuits or sensors. The first common drive stage circuit can be configured to couple with an ultrasonic drive second stage circuit, a high frequency drive second stage circuit, or a sensor drive second stage circuit. The ultrasonic drive second stage circuit can be configured to couple with an ultrasonic transducer, the high frequency drive second stage circuit is configured to couple with an electrode, and the sensor drive second stage circuit is configured to attach to a sensor.
[00372] [00372] In another aspect, the present description provides a surgical instrument, which comprises: a control circuit comprising a memory coupled to a processor, the processor being configured to generate a digital waveform; a handle assembly comprising a common first stage circuit coupled to the processor, the common first stage circuit configured to receive the digital waveform, convert the digital waveform into an analog waveform, and amplify the waveform analog; and a drive shaft assembly comprising a second stage circuit coupled to the common first stage circuit for receiving and amplifying the analog waveform; the drive shaft assembly is configured to connect mechanically and electrically to the handle assembly.
[00373] [00373] The common first stage circuit can be configured to drive ultrasonic, high frequency circuits or sensors. The first common drive stage circuit can be configured to couple with an ultrasonic drive second stage circuit, a high frequency drive second stage circuit, or a sensor drive second stage circuit. The ultrasonic drive second stage circuit can be configured to couple with an ultrasonic transducer, the high frequency drive second stage circuit is configured to couple with an electrode, and the sensor drive second stage circuit is configured to attach to a sensor.
[00374] [00374] Figure 34 illustrates a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406, in accordance with at least one aspect of the present description. In one aspect, the surgical instruments of the surgical system 1000 described herein can comprise a 3400 generator circuit divided into multiple stages. For example, surgical instruments of surgical system 1000 can comprise the 3400 generator circuit divided into at least two circuits: the first stage circuit 3404 and the second stage circuit 3406 of amplification allowing the operation of RF energy only, ultrasonic energy only , and / or a combination of RF energy and ultrasonic energy. A combination 3414 modular drive shaft assembly will be powered by the common 3404 first stage circuit located in a 3412 handle assembly and the 3406 modular second stage circuit integral with the 3414 modular drive shaft assembly. As previously discussed in this description in connection with the surgical instruments of the surgical system 1000, a battery set 3410 and the drive shaft set 3414 are configured to mechanically and electrically connect to the handle set 3412. The end actuator set is configured for mechanically and electrically connect to the 3414 drive shaft assembly.
[00375] [00375] Turning now to Figure 34, the generator circuit 3400 is divided into multiple stages located in multiple modular assemblies of a surgical instrument, like the surgical instruments of the surgical system 1000 described here. In one aspect, a 3402 stage control circuit may be located in the 3410 battery pack of the surgical instrument. The 3402 stage control circuit is a 3200 control circuit as described in connection with Figure 32. The 3200 control circuit comprises a 3214 processor, which includes 3217 internal memory (Figure 34) (for example, volatile and non-volatile memory ), and is electrically coupled to a battery
[00376] [00376] The first 3404 stage circuits (for example, the 3420 ultrasonic drive first stage circuit, the 3422 RF drive first stage circuit, and the 3424 sensor drive first stage circuit) are located in a surgical instrument handle set 3412. The 3200 control circuit provides the ultrasonic drive signal to the 3420 ultrasonic drive first stage circuit via the SCL-A, SDA-A outputs of the 3200 control circuit. The 3420 ultrasonic drive first stage circuit is described in detail in connection with Figure 29. The 3200 control circuit provides the RF drive signal to the RF drive 3422 first stage circuit via the SCL-B, SDA-B outputs of the 3200 control circuit. The first stage circuit RF 3422 drive is described in detail in connection with Figure 36. The 3200 control circuit supplies the sensor trigger signal to the 3424 sensor first stage drive circuit through the SCL-C, SDA-C outputs of the control circuit 3200 control. In general, each of the first 3404 stage circuits includes a digital to analog converter (DAC) and a first stage amplifier section to drive the second stage 3406. The outputs of the first stage circuits 3404 are provided for the inputs of the second stage circuits 3406.
[00377] [00377] The 3200 control circuit is configured to detect which modules are plugged into the 3200 control circuit. For example, the 3200 control circuit is configured to detect whether the 3420 ultrasonic drive first stage circuit, the first RF 3422 drive, or the 3424 sensor drive first stage circuit located in the 3412 handle assembly is connected to the 3410 battery assembly. Likewise, each of the first 3404 stage circuits can detect which second stage circuits 3406 are connected to it and what information is provided back to the 3200 control circuit to determine what type of signal waveform to generate. Similarly, each of the second 3406 stage circuits can detect which third 3408 stage circuits or components are connected to it and what information is provided back to the 3200 control circuit to determine what type of signal waveform to generate .
[00378] [00378] In one aspect, the second stage circuits 3406 (for example, the second stage circuit of ultrasonic drive 3430, the second stage of RF drive 3432, and the second stage of sensor drive 3434) are located on the 3414 drive shaft assembly of the surgical instrument. The 3420 ultrasonic drive first stage circuit provides a signal to the 3430 ultrasonic drive second stage circuit via US-left / US-direct outputs. The 3430 ultrasonic drive second stage circuit is described in detail in connection with Figures 30 and 31. In addition to a transformer (Figures 30 and 31), the 3430 ultrasonic drive second stage circuit can also include filter, amplifier, and signal conditioning circuits. The high frequency 3422 current drive (RF) first stage circuit provides a signal to the 3432 RF drive second stage circuit through the left RF / right RF outputs. In addition to a transformer and blocking capacitors, the 3432 RF drive second stage circuit can also include filter, amplifier, and signal conditioning circuits. The 3424 sensor drive first stage circuit provides a signal to the 3434 sensor drive second stage circuit via sensor-1 / sensor-2 outputs. The 3434 sensor drive second stage circuit can include filter, amplifier, and signal conditioning circuits depending on the type of sensor. The outputs of the second stage 3406 circuits are provided to the inputs of the third stage 3408 circuits.
[00379] [00379] In one aspect, the third stage 3408 circuits (for example, the 1120 ultrasonic transducer, the RF electrodes 3074a, 3074b, and the 3440 sensors) can be located in various 3416 sets of surgical instruments. In one aspect, the 3430 ultrasonic drive second stage circuit provides a drive signal to the piezoelectric battery of the 1120 ultrasonic transducer. In one aspect, the 1120 ultrasonic transducer is located in the ultrasonic transducer assembly of the surgical instrument. In other respects, however, the 1120 ultrasonic transducer can be located on the handle set 3412, the drive shaft set 3414 or the end actuator. In one aspect, the RF 3432 second stage drive circuit provides a trigger signal to RF electrodes 3074a, 3074b, which are generally located in the end actuator portion of the surgical instrument. In one aspect, the 3434 sensor drive second stage circuit provides a trigger signal to several 3440 sensors located on the surgical instrument.
[00380] [00380] Figure 35 illustrates a generator circuit 3500 divided into multiple stages in which a first stage circuit 3504 is common for the second stage circuit 3506, according to at least one aspect of the present description. In one aspect, the surgical instruments of the surgical system 1000 described herein can comprise 3500 generator circuit divided into multiple stages. For example, surgical instruments of surgical system 1000 may comprise the 3500 generator circuit divided into at least two circuits: the first stage circuit 3504 and the second stage circuit 3506 of amplification allowing the operation of high frequency RF energy only, energy ultrasonic only, and / or a combination of RF energy and ultrasonic energy. A combination 3514 modular drive shaft assembly will be powered by the common first stage circuit 3504 located in a 3512 handle assembly and the 3506 modular second stage circuit integral with the 3514 modular drive shaft assembly. As previously discussed in this description in connection with the surgical instruments of the surgical system 1000, a battery set 3510 and the drive shaft set 3514 are configured to mechanically and electrically connect to the handle set 3512. The end actuator set is configured for mechanically and electrically connect to the 3514 drive shaft assembly.
[00381] [00381] As shown in the example of Figure 35, the 3510 battery pack portion of the surgical instrument comprises a first control circuit 3502, which includes the 3200 control circuit previously described. The 3512 handle assembly, which connects to the 3510 battery pack, comprises a common 3420 drive first stage circuit. As previously discussed, the 3420 drive first stage circuit is configured to drive high frequency ultrasonic current (RF) ), and sensor loads. The output of the 3420 common drive first stage circuit can drive any of the 3506 second stage circuits such as the 3430 ultrasonic drive second stage circuit, the 3432 high frequency current (RF) drive second stage circuit, and / or the 3434 sensor drive second stage circuit. The 3420 common drive first stage circuit detects which second stage circuit 3506 is located in the 3514 drive shaft assembly when the 3514 drive shaft assembly is connected to the assembly handle 3512. After the 3514 drive shaft assembly is connected to the 3512 handle assembly, the 3420 common first stage circuit determines which of the 3506 second stage circuits (for example, the ultrasonic drive second stage circuit 3430, RF 3432 second stage drive circuit, and / or sense second stage stage circuit r 3434) is located in the drive shaft assembly 3514. Information is provided to the control circuit 3200 located in the handle assembly 3512 to provide a suitable digital waveform 4300 (Figure 43) to the second stage circuit 3506 to drive the suitable load, for example, ultrasonic, RF or sensor. It will be understood that identification circuits can be included in several 3516 assemblies on the third stage 3508 circuit such as ultrasonic transducer 1120, electrodes 3074a, 3074b, or 3440 sensors. Thus, when a third stage circuit 3508 is connected to a second stage circuit 3506, second stage circuit 3506 recognizes the type of load that is required based on the identification information.
[00382] [00382] Figure 36 is a schematic diagram of an aspect of an electrical circuit 3600 configured to drive a high frequency (RF) current, in accordance with at least one aspect of the present description. The 3600 electrical circuit comprises a 3680 analog multiplexer. The 3680 analog multiplexer multiplexes several signals from the SCL-A, SDA-A upstream channels such as RF, battery and power control circuits. A 3682 current sensor is connected in series to the return or ground leg of the power supply circuit to measure the current supplied by the power supply. A field effect transistor (FET) 3684 temperature sensor provides room temperature. A 3688 pulse width modulation (PWM) surveillance timer automatically generates a system restart if the main program periodically fails to repair it. It is provided to automatically restart the 3600 electrical circuit when it crashes or freezes due to a software or hardware failure. It will be recognized that the 3600 electrical circuit can be configured to drive RF electrodes or to drive the 1120 ultrasonic transducer as described in connection with Figure 29, for example. Consequently, with reference now again to Figure 36, electrical circuit 3600 can be used to drive both ultrasonic and RF electrodes interchangeably.
[00383] [00383] A 3686 drive circuit provides left and right RF energy outputs. A digital signal representing the signal waveform is supplied to the SCL-A, SDA-A inputs of the 3680 analog multiplexer from a control circuit, such as the 3200 control circuit (Figure 32). A 3690 digital to analog converter (DAC) converts the digital input to an analog output to generate a 3692 pulse width modulation circuit coupled to a 3694 oscillator. The 3692 pulse width modulation circuit provides a first signal for a first door drive circuit 3696a coupled to a first output stage of transistor 3698a to drive a first RF + energy output (left). The pulse width modulation circuit 3692 also provides a second signal for a second door drive circuit 3696b coupled to a second output stage of transistor 3698b to drive a second RF- (right) energy output. A 3699 voltage sensor is coupled between the left RF / RF output terminals to measure the output voltage. Drive circuit 3686, the first and second drive circuits 3696a, 3696b, and the first and second output stages of transistor 3698a, 3698b define a first stage amplifier circuit. In operation, the 3200 control circuit (Figure 32) generates a 4300 digital waveform (Figure 43) that employs circuits such as the 4100, 4200 digital direct synthesis (DDS) circuits (Figures 41 and 42). The DAC 3690 receives the digital waveform 4300 and converts it into an analog waveform, which is received and amplified by the first stage amplifier circuit.
[00384] [00384] Figure 37 is a schematic diagram of transformer 3700 coupled to electrical circuit 3600 shown in Figure 36, according to at least one aspect of the present description. The RF + / RF (primary winding) input terminals of transformer 3700 are electrically coupled to the left RF / RF output terminals of electrical circuit 3600. One side of the secondary winding is connected in series to the first and the second blocking capacitor 3706,
[00385] [00385] Figure 38 is a schematic diagram of a 3800 circuit comprising separate power supplies for high power drive / energy circuits and low power circuits, in accordance with at least one aspect of the present description.
[00386] [00386] Additionally, a load circuit liable to be exposed to gamma radiation can be provided, which includes a switched power supply 3827 using diodes and vacuum tube components to minimize voltage drop to a predetermined level. With the inclusion of a minimum voltage drop that is a division of NiMH voltages (3 cells of NiMH), the 3827 switched power supply could be eliminated. Additionally, a modular system can be provided in which the radiation-reinforced components are located in a module, making the module sterilizable by radiation sterilization. Other non-radiation-reinforced components can be included in other modular components and connections made between the modular components, so that the component operates together as if the components are located together on the same circuit board. If only two NiMH cells are desired, the 3827 switched power supply based on diodes and vacuum tubes enables the sterilizable electronic circuit inside the disposable primary battery.
[00387] [00387] Referring now to Figure 39, a 3900 control circuit for operating an RF generator circuit powered by battery 3901 for use with a 3902 surgical instrument is shown, in accordance with at least one aspect of the present description. The surgical instrument is configured to use both ultrasonic vibration and high frequency current to perform surgical coagulation / cutting treatments on living tissue, and uses high frequency current to perform surgical coagulation treatment on living tissue.
[00388] [00388] Figure 39 illustrates the control circuit 3900 that allows a dual generator system to switch between the energy modes of the RF generator circuit 3902 and the ultrasonic generator circuit 3920 for a surgical instrument of the surgical system 1000. In one aspect, a current threshold in an RF signal is detected. When the impedance of the tissue is low, the high frequency current through the tissue is high when the RF energy is used as the source for treating the tissue. According to one aspect, a visual indicator 3912 or light located on the surgical instrument of the surgical system 1000 can be configured to be in a connected state during this period of high current. When the current drops below a threshold, the visual indicator 3912 goes into an off state. Consequently, a 3914 phototransistor can be configured to detect the transition from a switched state to a switched off state and disable RF energy, as shown in the 3900 control circuit shown in Figure 39. Therefore, when the power button is released and a power switch 3926 is opened, control circuit 3900 is reset and both RF and ultrasonic generator circuits 3902, 3920 are kept off.
[00389] [00389] With reference to Figure 39, in one aspect, a method of managing an RF generating circuit 3902 and an ultrasonic generating circuit 3920 is provided. The RF generating circuit 3902 and / or the ultrasonic generating circuit 3920 they can be located in the handle set 1109, in the ultrasonic transducer / RF generator set 1120, in the battery set, in the drive shaft set 1129 and / or in the mouthpiece of the multifunctional electrosurgical instrument 1108, for example. The 3900 control circuit is maintained in a reset state if the 3926 power switch is off (for example, open). This way, when the power switch 3926 is open, the control circuit 3900 is reset and both the RF generating and ultrasonic circuits 3902, 3920 are switched off. When the 3926 power switch is pressed and the 3926 power switch is engaged (for example, closed), the RF energy is distributed to the tissue and the visual indicator 3912 operated by a 3904 current detection surge transformer will be lit while the tissue impedance is low. The visual indicator light 3912 provides a logical signal to maintain the 3920 ultrasonic generator circuit in the off state. Since the tissue impedance increases beyond a threshold and the high frequency current through the tissue decreases below a threshold, the visual indicator 3912 turns off and light goes into an off state. A logic signal generated by this transition turns relay 3908 off, whereby the RF generator circuit 3902 is switched off and the ultrasonic generator circuit 3920 is turned on, to complete the coagulation and cut cycle.
[00390] [00390] Still with reference to Figure 39, in one aspect, the configuration of the double generator circuit employs the RF generator circuit 3902 on-board, which is powered by the battery 3901, for one mode, and a second ultrasonic generator circuit 3920 on-board, which may be included in the 1109 handle set, the battery pack, the 1129 drive shaft assembly, the nozzle and / or the 1120 ultrasonic transducer / RF generator set of the 1108 multifunctional circuit instrument, for example example. The 3920 ultrasonic generator circuit is also battery operated 3901. In several respects, the RF 3902 generator circuit and the 3920 ultrasonic generator circuit can be a component of the 1109 integrated or separable handle assembly. According to several aspects, having the dual RF / ultrasonic generating circuits 3902, 3920 as part of the 1109 handle set can eliminate the need for complicated wiring. The RF / ultrasonic generating circuits 3902, 3920 can be configured to provide the full capabilities of an existing generator while using the capabilities of a wireless generator system simultaneously.
[00391] [00391] Any type of system can have separate controls for modalities that are not communicating with each other. The surgeon activates RF and ultrasonic energy separately and at his discretion. Another approach would be to provide fully integrated communication schemes that share buttons, tissue states, instrument operating parameters (such as a clamping system, forces, etc.) and algorithms to manage tissue treatment. Various combinations of this integration can be implemented to provide the right level of functioning and performance.
[00392] [00392] As discussed above, in one aspect, the 3900 control circuit includes an RF generator circuit 3902 powered by battery 3901 which comprises a battery as a power source. As shown, the RF generator circuit 3902 is coupled to two electrically conductive surfaces here called electrodes 3906a, 3906b (ie, active electrode 3906a and return electrode 3906b) and is configured to drive electrodes 3906a, 3906b with RF energy (for example, high frequency current). A first winding 3910a of the elevation transformer 3904 is connected in series with a pole of the bipolar RF generator circuit 3902 and the return electrode 3906b. In one aspect, the first winding 3910a and the return electrode 3906b are connected to the negative pole of the 3902 bipolar RF generator circuit. The other pole of the 3902 bipolar RF generator circuit is connected to the active electrode 3906a via a 3909 switch contact. relay 3908, or any suitable electromagnetic switching device comprising an armature that is moved by a 3936 electromagnet to operate the 3909 switch contact. The 3909 switch contact is closed when the 3936 electromagnet is energized and the 3909 switch contact is opened when the 3936 electromagnet is de-energized. When the switch contact is closed, the RF current flows through the conductive tissue (not shown) located between electrodes 3906a, 3906b. It will be recognized that, in one aspect, the active electrode 3906a is connected to the positive pole of the 3902 bipolar RF generator circuit.
[00393] [00393] A 3905 visual indicator circuit comprises the 3904 elevation transformer, a R2 series resistor and a 3912 visual indicator. The 3912 visual indicator can be adapted for use with the 1108 surgical instrument and other electrosurgical systems and tools, such as those here described. The first winding 3910a of the elevating transformer 3904 is connected in series to the return electrode 3906b and the second winding 3910b of the elevating transformer 3904 is connected in series to resistor R2 and visual indicator 3912 comprising a neon lamp of the NE-2 type , for example.
[00394] [00394] In operation, when switch 3909 of relay 3908 is opened, the active electrode 3906a is disconnected from the positive pole of the 3902 bipolar RF generator circuit and no current flows through the fabric, the return electrode 3906b and the first winding 3910a of lift transformer 3904. Consequently, visual indicator 3912 is not energized and does not emit light. When switch contact 3909 of relay 3908 is closed, the active electrode 3906a is connected to the positive pole of the bipolar RF generator circuit 3902, allowing current to flow through the fabric, the return electrode 3906b and the first winding 3910a of the transformer lift 3904 to work on the fabric, for example, cut and cauterize the fabric.
[00395] [00395] A first current flows through the first winding 3910a as a function of the impedance of the tissue located between the active and return electrodes 3906a, 3906b providing a first voltage in the first winding 3910a of the elevation transformer 3904. A second increased voltage is induced in the second winding 3910b of elevation transformer 3904. The secondary voltage appears through resistor R2 and energizes the visual indicator 3912, causing the neon lamp to light up when the current through the fabric is greater than a predetermined threshold. It will be recognized that the circuit and component values are illustrative and not limited to them. When switch contact 3909 of relay 3908 is closed, current flows through the fabric and visual indicator 3912 is turned on.
[00396] [00396] Referring now to the 3926 power switch portion of the 3900 control circuit, when the 3926 power switch is in the open position, a high logic is applied to the input of a first 3928 inverter and a low logic is applied to one of the two inputs of the AND 3932 gate. Thus, the output of the AND gate 3932 is low and a transistor 3934 is switched off to prevent current from flowing through the 3936 electromagnet winding. With the 3936 electromagnet in the de-energized state, the switch 3909 of relay 3908 remains open and prevents current from flowing through electrodes 3906a, 3906b. The low logic output of the first 3928 inverter is also applied to a second 3930 inverter, bringing the output to the high logic state and resetting a 3918 flip-flop (for example, a D-type flip-flop). At that time, the Q output is low to turn off the 3920 ultrasonic generator circuit and the output is high and is applied to the other input of the AND 3932 gate.
[00397] [00397] When the user presses the power switch 3926 on the handle of the instrument to apply energy to the tissue between electrodes 3906a, 3906b, the power switch 3926 closes and applies a low logic to the input of the first inverter 3928, which applies a high logic at the other input of the AND 3932 gate causing the output of the AND 3932 gate to go to the high level and turn on the 3934 transistor. In the on state, the 3934 transistor conducts and reduces the current through the 3936 electromagnet winding to energize the electromagnet 3936 and close switch contact 3909 of relay 3908. As discussed above, when switch contact 3909 is closed, current can flow through electrodes 3906a, 3906b and the first winding 3910a of elevation transformer 3904 when the fabric is located between electrodes 3906a, 3906b.
[00398] [00398] As discussed above, the magnitude of the current flowing through electrodes 3906a, 3906b depends on the impedance of the tissue located between electrodes 3906a, 3906b. Initially, the impedance of the fabric is low and the magnitude of the current is high through the fabric and the first winding 3910a. Consequently, a voltage applied to the second winding 3910b is high enough to turn on the visual indicator 3912. The light emitted by the visual indicator 3912 turns on the phototransistor 3914, which reduces the input of a 3916 inverter and causes the output of the 3916 inverter. go to the high level. A high input applied to the CLK of the 3918 flip-flop has no effect on the Q or the 3918 flip-flop outputs and the output remains high. Consequently, while the visual indicator 3912 remains energized, the ultrasonic generating circuit 3920 is turned off and the ultrasonic transducer 3922 and an ultrasonic blade 3924 of the multifunctional electrosurgical instrument are not activated.
[00399] [00399] As the tissue between electrodes 3906a, 3906b dries due to the heat generated by the current flowing through the tissue, the impedance of the tissue increases and the current through it decreases. When the current through the first winding 3910a decreases, the voltage in the second winding 3910b also decreases and when the voltage falls below a minimum threshold required to operate the visual indicator 3912, the visual indicator 3912 and the phototransistor 3914 turn off.
[00400] [00400] As long as the switch contact 3909 of relay 3908 is open, no current flows through electrodes 3906a, 3906b, the fabric and the first winding 3910a of the lift transformer
[00401] [00401] The Q status and the 3918 flip flop outputs remain the same as long as the user presses the 3926 power switch on the instrument handle to keep the 3926 power switch closed. In this way, the 3924 ultrasonic blade remains activated and continues to cut the tissue between the jaws of the end actuator, while no current flows through the 3906a, 3906b electrodes from the 3902 bipolar RF generator circuit. When the user releases the power 3926 on the instrument handle, the power switch 3926 opens and the output of the first inverter 3928 goes to the low level and the output of the second inverter 3930 goes to the high level to reset the flip-flop 3918 causing the output Q switch to the low level and turn off the 3920 ultrasonic generator circuit. At the same time, the output to the high level and the circuit is now in an off state and ready for the user to actuate the 3926 power switch on the instrument handle. to close the 3926 power switch, apply current to the tissue located between the 3906a, 3906b electrodes, and repeat the cycle of applying RF energy to the tissue and ultrasonic energy to the tissue as described the above.
[00402] [00402] Figure 40 illustrates a diagram of a surgical system 4000, which represents an aspect of the surgical system 1000, which comprises a feedback system for use with any of the Surgical Instruments of the surgical system 1000, which can include or implement many of the features described in the present invention. The surgical system 4000 can include a generator 4002 coupled to a surgical instrument that includes a 4006 end actuator, which can be activated when a doctor operates a 4010 trigger. In many ways, the 4006 end actuator can include an ultrasonic blade to apply ultrasonic vibration to perform surgical coagulation / cutting treatments on living tissue. In other respects, the 4006 end actuator may include electrically conductive elements coupled to a high frequency electrosurgical current energy source to perform surgical coagulation or cauterization treatments on living tissue and a mechanical knife with a sharp edge or an ultrasonic blade for perform cutting treatments on living tissue. When the 4010 trigger is actuated, a 4012 force sensor can generate a signal that indicates the amount of force that is applied to the 4010 trigger. In addition to, or instead of, a 4012 force sensor, the surgical instrument may include a sensor of position 4013, which can generate a signal indicating the position of trigger 4010 (for example, how far the trigger has been pressed or otherwise acted). In one aspect, the 4013 position sensor may be a sensor positioned with the outer tubular sheath or a reciprocating tubular actuating member located within the outer tubular sheath of the surgical instrument. In one aspect, the sensor can be a Hall effect sensor or any suitable transducer that varies its output voltage in response to a magnetic field. The Hall effect sensor can be used for proximity switching, positioning, speed detection and current detection applications. In one aspect, the Hall effect sensor works like an analog transducer, directly returning a voltage. With a known magnetic field, its distance from the Hall plate can be determined.
[00403] [00403] A control circuit 4008 can receive signals from sensors 4012 and / or 4013. Control circuit 4008 can include any suitable analog or digital circuit components. The control circuit 4008 can also communicate with the generator 4002 and / or the transducer 4004 to modulate the energy supplied to the end actuator 4006 and / or the generator level or the amplitude of the ultrasonic blade of the end actuator 4006 based the force applied to trigger 4010 and / or the position of trigger 4010 and / or the position of the outer tubular sheath described above in relation to a reciprocating tubular actuating member located within the outer tubular sheath (for example, as measured by a combination Hall effect sensor and magnet). For example, the more force is applied to the 4010 trigger, the more energy and / or greater ultrasonic blade amplitude can be supplied to the 4006 end actuator. According to several aspects, the 4012 force sensor can be replaced with a multi-wrench positions.
[00404] [00404] According to various aspects, the 4006 end actuator may include a gripper or gripping mechanism. When trigger 4010 is initially triggered, the locking mechanism can close, trap the fabric between a clamp arm and end actuator 4006. As the force applied to the trigger increases (for example, as detected by the 4012 force sensor), the control circuit 4008 can increase the energy supplied to the end actuator 4006 by the transducer 4004 and / or the generator level or the amplitude of ultrasonic blade generated in the end actuator
[00405] [00405] According to various aspects, the surgical instrument of the surgical system 4000 can also include one or more feedback devices to indicate the amount of energy supplied to the 4006 end actuator. For example, a 4014 speaker can emit a signal indicative of the energy of the end actuator. According to several aspects, the 4014 loudspeaker can emit a series of pulse sounds, where the frequency of the sounds indicates the energy. In addition to, or instead of, the 4014 loudspeaker, the surgical instrument may include a 4016 visual screen. The 4016 visual screen may indicate the end actuator according to any suitable method. For example, the 4016 visual display may include a series of LEDs, where the power of the end actuator is indicated by the number of LEDs illuminated. The 4014 loudspeaker and / or the 4016 visual display can be activated by the 4008 control circuit. According to several aspects, the surgical instrument may include a ratchet device connected to the 4010 trigger. The ratchet device can generate an audible signal the more force is applied to the 4010 trigger, providing an indirect indication of energy from the end actuator. The surgical instrument may include other features that can increase safety. For example, control circuit 4008 can be configured to prevent power from being supplied to end actuator 4006 beyond the predetermined threshold. In addition, control circuit 4008 can implement a delay between the time when a change in the energy of the end actuator is indicated (for example, by the speaker 4014 or screen 4016) and the time when the change in the energy of the end end actuator is provided. In this way, a physician may be well aware that the level of ultrasonic energy that must be supplied to the 4006 end actuator is about to change.
[00406] [00406] In one aspect, generator 1000 is configured to digitally generate the electrical signal waveform in such a way that the desired, using a predetermined number of phase points stored in a lookup table, digitize the waveform. The phase points can be stored in a table defined in a memory, a field programmable port arrangement (FPGA) or any suitable non-volatile memory. Figure 41 illustrates an aspect of a fundamental architecture for a digital synthesis circuit, such as a 4100 digital direct synthesis circuit (DDS), configured to generate a plurality of waveforms for the electrical signal waveform. The generator's software and digital controls can command the FPGA to scan the addresses in lookup table 4104, which in turn provides variable digital input values for a 4108 DAC circuit that powers a power amplifier. The addresses can be checked according to a frequency of interest. The use of such a 4104 look-up table makes it possible to generate several types of waveforms that can be fed into the tissue or to a transducer, an RF electrode, multiple transducers simultaneously, or a combination of ultrasonic and RF instruments. In addition, multiple 4104 look-up tables representing multiple waveforms can be created, stored and applied to tissue from a generator.
[00407] [00407] The signal waveform can be configured to control at least one of an output current, an output voltage or an output power of an ultrasonic transducer and / or RF electrode, or multiples thereof (for example , two or more ultrasonic transducers and / or two or more RF electrodes). Additionally, where a surgical instrument comprises ultrasonic components, the waveform can be configured to trigger at least two modes of vibration for an ultrasonic transducer of at least one surgical instrument. In this way, the generator can be configured to supply a waveform to at least one surgical instrument, where the waveform signal corresponds to at least one waveform of a plurality of waveforms in the table. In addition, the waveform signal supplied to the two surgical instruments can comprise two or more waveforms. The table can comprise information associated with a plurality of waveforms and the table can be stored inside the generator. In one aspect or example, the table can be a direct digital summary table, which can be stored in a generator FPGA. The table can be addressed in any way that is convenient for categorizing waveforms. According to one aspect, the table, which can be a direct digital synthesis table, is addressed according to a frequency of the waveform signal. Additionally, the information associated with the plurality of waveforms can be stored as digital information in the table.
[00408] [00408] The analog electrical signal waveform can be configured to control at least one of an output current, an output voltage or an output power of an ultrasonic transducer and / or RF electrode, or multiples thereof ( for example, two or more ultrasonic transducers and / or two or more RF electrodes). Additionally, where the surgical instrument comprises ultrasonic components, the analog electrical signal waveform can be configured to trigger at least two vibration modes for an ultrasonic transducer of at least one surgical instrument.
[00409] [00409] With the widespread use of digital techniques in instrumentation and communications systems, a digitally controlled method of generating multiple frequencies from a reference frequency source has evolved and is referred to as direct digital synthesis. The basic architecture is shown in Figure 41. In this simplified block diagram, a DDS circuit is coupled to a processor, controller or logic device in the generator circuit and to a memory circuit located in the generator circuit of the surgical system 1000. The DDS 4100 circuit comprises an address counter 4102, a look-up table 4104, a register 4106, a DAC circuit 4108 and a filter 4112. A stable clock fc is received by the address counter 4102 and register 4106 activates a programmable read-only memory (PROM ) that stores one or more integers of cycles of a sine wave (or other arbitrary waveform) in a query table 4104. As the address counter 4102 travels through memory locations, the values stored in the query table 4104 are recorded in register 4106, which is coupled to DAC circuit 4108. The corresponding digital amplitude of the signal in the memory location of query table 4104 ac ion the DAC circuit 4108, which in turn generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is mainly determined by the DAC circuit 4108. The phase noise is basically that of the fc reference clock. The first analog output signal 4110 of the DAC circuit 4108 is filtered by the filter 4112 and a second analog output signal 4114 produced by the filter 4112 is supplied to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal has a fout frequency.
[00410] [00410] As the DDS 4100 circuit is a sampled data system, problems involved in sampling need to be considered: quantization noise, distortion, filtering, etc. For example, the higher-order harmonics of the output frequencies of the DAC 4108 circuit bend in the Nyquist bandwidth, making them non-filterable, whereas the higher-order harmonics of the output of synthesizers based on phase lock or phase-locked loop (PLL) can be filtered. Lookup table 4104 contains signal data for an integral number of cycles. The final output frequency fout can be changed by changing the frequency of the reference clock fc or reprogramming the PROM.
[00411] [00411] The DDS 4100 circuit can comprise multiple lookup tables 4104, where lookup table 4104 stores a waveform represented by a predetermined number of samples, the samples defining a predetermined shape of the waveform. In this way, multiple waveforms, having a single shape, can be stored in multiple 4104 look-up tables to provide different tissue treatments based on instrument configurations or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for coagulation of surface tissue, low crest factor RF electrical signal waveform for deeper tissue penetration and signal waveforms that promote efficient retouching coagulation. In one aspect, the DDS 4100 circuit can create multiple 4104 waveform lookup tables and during a tissue treatment procedure (for example, simultaneously or in virtual real time based on user or sensor inputs) switch between different formats waves stored in separate 4104 look-up tables based on the effect of the desired tissue and / or tissue feedback.
[00412] [00412] Therefore, the alternation between waveforms can be based on tissue impedance and other factors, for example. In other respects, the 4104 look-up tables can store electrical signal waveforms formatted to maximize the power distributed in the tissue per cycle (i.e., trapezoidal or square wave). In other respects, the 4104 look-up tables can store synchronized waveforms so that they maximize the power supply by the surgical system's multifunctional surgical instrument when it provides RF and ultrasonic trigger signals. In yet other aspects, the 4104 look-up tables can store electrical signal waveforms to simultaneously trigger therapeutic and / or subtherapeutic ultrasonic and RF energy, while maintaining ultrasonic frequency blocking. Custom waveforms specific to different instruments and their tissue effects can be stored in the non-volatile memory of the generator or in the non-volatile memory (for example, EEPROM) of the surgical system 1000 and fetched when connecting the multifunctional surgical instrument to the generator circuit. An example of an exponentially damped sinusoid, as used in many high crest factor "coagulation" waveforms, is shown in Figure 43.
[00413] [00413] A more flexible and efficient implementation of the DDS 4100 circuit employs a digital circuit called the Numerically Controlled Oscillator (NCO, from Numerically Controlled Oscillator). A block diagram of a more flexible and efficient digital synthesis circuit, such as a DDS 4200 circuit, is shown in Figure 42. In this simplified block diagram, a DDS 4200 circuit is coupled to a generator processor, controller or logic device and to a memory circuit located on the generator or any of the surgical instruments in the surgical system 1000. The DDS 4200 circuit comprises a charge register 4202, a parallel delta phase register 4204, an adder circuit 4216, a phase register 4208, a lookup table 4210 (phase-amplitude converter), a DAC circuit 4212 and a filter 4214. The summing circuit 4216 and phase register 4208 form part of a phase accumulator 4206. A fc clock signal is applied to the phase register 4208 and a DAC 4212 circuit. The charge register 4202 receives a tuning word that specifies the output frequency as a fraction of the reference clock frequency signal fc. The output of the load register 4202 is supplied to the parallel delta phase register 4204 with an M tuning word.
[00414] [00414] The DDS 4200 circuit includes a sample clock that generates the clock frequency fc, the phase accumulator 4206 and the query table 4210 (for example, phase to amplitude converter). The content of the 4206 phase accumulator is updated once per fc clock cycle. When the phase accumulator 4206 is updated, the digital number, M, stored in the delta phase register 4204 is added to the number in the phase register 4208 by a 4216 adder circuit. Assuming the number in the parallel delta phase register 4204 is 00 ... 01 and that the initial content of the 4206 phase accumulator is 00 ... 00. The 4206 phase accumulator is updated by 00 ... 01 per clock cycle. If the 4206 phase accumulator is 32 bits wide, 232 clock cycles (more than 4 billion) are required before the 4206 phase accumulator returns to 00 ... 00, and the cycle is repeated.
[00415] [00415] A truncated output 4218 of the phase accumulator 4206 is supplied to a lookup table of the phase converter for amplitude 4210 and the output of the lookup table 4210 is coupled to a DAC circuit
[00416] [00416] In one aspect, the electrical signal waveform can be digitized at 1024 (210) phase points, although the waveform that can be digitized is any suitable number of 2n phase points ranging from 256 (28) to 281.474.976.710.656 (248), where n is a positive integer, as shown in TABLE 1. The waveform of the electrical signal can be expressed as An (θn), where a normalized amplitude An at a point n is represented by a phase angle θn is called a phase point at point n. The number of discrete phase points does not determine the tuning resolution of the DDS 4200 circuit (as well as the DDS 4100 circuit shown in Figure 41).
[00417] [00417] Table 1 specifies the digitized electrical signal waveform at a number of phase points. Table 1 N Number of Phase Points 2n 8 256 10 1,024 12 4,096 14 16,384 16 65,536 18 262,144 20 1,048,576
[00418] [00418] The generator circuit algorithms and digital controls can scan the addresses in the query table 4210, which in return provides variable digital input values for the 4212 DAC circuit that supplies the 4214 filter and the power amplifier. The addresses can be checked according to a frequency of interest. The use of the look-up table makes it possible to generate several types of formats that can be converted into an analog output signal by the DAC 4212 circuit filtered by the 4214 filter, amplified by the power amplifier coupled to the output of the generator circuit and fed into the fabric RF energy or fed to a transducer and applied to the tissue in the form of ultrasonic vibrations that provide energy to the tissue in the form of heat. The amplifier output can be applied to an RF electrode, multiple output electrodes simultaneously, an ultrasonic transducer, multiple ultrasonic transducers simultaneously or a combination of RF and ultrasonic transducers, for example. In addition, multiple waveform tables can be created, stored and applied to the fabric from a generator circuit.
[00419] [00419] With reference again to Figure 41, for n = 32 and M = 1, the phase accumulator 4206 scales each of the possible outputs 232 before overflowing and resetting. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M = 2, then the phase register 1708 "rotates" twice as fast, and the output frequency is doubled. This can be generalized as follows.
[00420] [00420] For a 4206 phase accumulator configured to accumulate n-bits (in general it is in the range of 24 to 32 in most DDS systems, but as previously discussed, n can be selected from a wide range of options), there are 2n possible phase points. The digital word in the delta phase register M represents the amount of phase accumulation that is incremented per clock cycle. If fc is the clock frequency, then the frequency of the output sine wave is equal to:
[00421] [00421] The above equation is known as "tuning equation" DDS. It is observed that the frequency resolution of the system is equal to. For n = 2, the resolution is greater than one part in four billion.
[00422] [00422] The electrical signal waveform can be characterized by current, voltage or power at a given frequency.
[00423] [00423] In one aspect, the generator circuit can be configured to supply waveforms of electrical signal to at least two surgical instruments simultaneously. The generator circuit can also be configured to provide the electrical signal waveform, which can be characterized by two or more waveforms, through an output channel of the generator circuit for the two surgical instruments simultaneously. For example, in one aspect, the electrical signal waveform comprises a first electrical signal to drive an ultrasonic transducer (e.g., ultrasonic trigger signal), a second RF trigger signal and / or a combination thereof. In addition, an electrical signal waveform may comprise a plurality of ultrasonic trigger signals, a plurality of RF trigger signals and / or a combination of a plurality of ultrasonic and RF trigger signals.
[00424] [00424] Additionally, a method for operating the generator in accordance with the present disclosure comprises generating an electrical signal waveform and supplying the generated electrical signal waveform to any of the surgical instruments of the 1000 surgical system, and generating the electrical signal waveform comprises receiving information associated with the electrical signal waveform from a memory. The generated electrical signal waveform comprises at least one waveform. In addition, supplying the generated electrical signal waveform to at least one surgical instrument comprises supplying the electrical signal waveform to at least two surgical instruments simultaneously.
[00425] [00425] The generating circuit, as described here, can allow the generation of several types of direct digital synthesis tables. Examples of waveforms for RF / electrosurgical signals suitable for treating a variety of tissues generated by the generator circuit include RF signals with a high crest factor (which can be used for superficial coagulation in RF mode), RF factor signals low ridge (which can be used for deeper tissue penetration) and waveforms that promote efficient retouching coagulation. The generator circuit can also generate multiple waveforms using a 4210 digital direct synthesis lookup table and, in real time, can switch between particular waveforms based on the desired tissue effect. Alternation can be based on tissue impedance and / or other factors.
[00426] [00426] In addition to the traditional sine / cosine waveforms, the generating circuit can be configured to generate waveform (s) that maximize (m) the power in the tissue per cycle (for example, trapezoidal or square wave). The generator circuit can provide waveforms that are synchronized to maximize the power delivered to the load by simultaneously triggering RF and ultrasonic signals and maintaining the ultrasonic frequency lock, as long as the generator circuit includes a circuit topology that allows simultaneous activation of RF and ultrasonic signals. In addition, instrument-specific custom waveforms and their effects on tissue can be stored in a non-volatile memory (NVM) or an instrument EEPROM and can be sought by connecting any of the surgical instruments in the 1000 surgical system to the generator circuit.
[00427] [00427] The DDS 4200 circuit can comprise multiple lookup tables 4104, where lookup table 4210 stores a waveform represented by a predetermined number of phase points (also called samples), where the phase points define a predetermined waveform format. In this way, multiple waveforms, having a single shape, can be stored in multiple 4210 lookup tables to provide different tissue treatments based on instrument configurations or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for coagulation of surface tissue, low crest factor RF electrical signal waveform for deeper tissue penetration and signal waveforms that promote efficient retouching coagulation. In one aspect, the DDS 4200 circuit can create multiple 4210 waveform lookup tables and during a tissue treatment procedure (for example, simultaneously or in virtual real time based on user or sensor inputs) switch between different formats waves stored in different query tables 4210 based on the effect on the desired tissue and / or tissue feedback.
[00428] [00428] Therefore, the alternation between waveforms can be based on the impedance of the tissue and other factors, for example. In other respects, the 4210 lookup tables can store electrical signal waveforms formatted to maximize the power distributed in the tissue per cycle (i.e., trapezoidal or square wave). In other respects, the 4210 look-up tables can store synchronized waveforms so that they maximize the power supply for any of the surgical instruments in the surgical system 1000 when it provides RF and ultrasonic trigger signals. In yet other aspects, the 4210 lookup tables can store waveforms of electrical signal to simultaneously trigger therapeutic and / or subtherapeutic ultrasonic and RF energy, while maintaining the blocking of the ultrasonic frequency. In general, the output waveform can be in the form of a sine wave, cosine wave, pulse wave, square wave and the like. However, the custom and more complex waveforms specific to different instruments and their tissue effects can be stored in the non-volatile memory of the generating circuit or in the non-volatile memory (eg, EEPROM) of the surgical instrument and fetched when connecting the surgical instrument. in the generator circuit. An example of a custom waveform is an exponentially damped sine wave as used in many high crest factor "coagulation" waveforms, as shown in Figure 43.
[00429] [00429] Figure 43 illustrates a cycle of a waveform of the discrete-time digital electrical signal 4300, according to at least one aspect of the present description, of an analog waveform 4304 (shown superimposed on the waveform of the 4300 isolated time digital electrical signal for comparison purposes). The horizontal geometric axis represents Time (t) and the vertical geometric axis represents digital phase points. The waveform of the 4300 digital electrical signal is a version of the digital time isolated from the desired analog waveform 4304, for example. The waveform of the digital electrical signal 4300 is generated by storing an amplitude phase point 4302 that represents the amplitude per clock cycle Tclk over a cycle or period To. The 4300 digital electrical signal waveform is generated over a To period by any suitable digital processing circuit. Amplitude phase points are digital words stored in a memory circuit. In the example illustrated in Figures 41 and 42, the digital word is a 6-bit word that is capable of storing the amplitude phase points with a resolution of 26 or 64 bits. It will be understood that the examples shown in Figures 41 and 42 are for illustrative purposes and, in current implementations, the resolution can be much higher. The digital amplitude phase points 4302 during a To cycle are stored in memory as a string of the word string in a query table 4104, 4210, as described in connection with Figures 41 and 42, for example. To generate the analog version of analog waveform 4304, the amplitude phase points 4302 are read sequentially from memory 0 to To per clock cycle Tclk and are converted by a DAC circuit 4108, 4212, also described in connection with Figures 41 and 42. Additional cycles can be generated by repeatedly reading amplitude phase points 4302 of the digital electrical signal waveform 4300 from 0 to To for the largest number of cycles or periods that may be desired. The smooth analog version of waveform 4304 is achieved by filtering the output of the DAC 4108, 4212 circuit through a 4112, 4214 filter (Figures 41 and 42). The filtered analog output signal 4114, 4222 (Figures 41 and 42) is applied to the input of a power amplifier.
[00430] [00430] Figure 44 is a diagram of a 12950 control system configured to provide progressive closure of a closing member (eg, closing tube) when the displacement member advances distally and engages a clamping arm (for example, anvil) to decrease the load of the closing force on the closing member at a desired speed and to decrease the load of the firing force on the firing member according to an aspect of the present description. In one aspect, the 12950 control system can be implemented as a nested PID feedback controller. A PID controller is a feedback loop from the control circuit (controller) to continuously calculate an error value such as the difference between a desired setpoint and a measured process variable and apply a correction based on proportional, integral and derived terms (sometimes indicated P, I, and D respectively). The nested PID controller 12950 feedback control system includes a primary controller 12952,
[00431] [00431] In the context of controlling the displacement of a closing tube, the 12950 control system can be configured so that the primary setpoint SP1 is a desired closing force value and the primary controller 12952 is configured to receive the closing force from a torque sensor coupled to the output of a closing motor and determining a motor speed from setpoint SP2 to the closing motor. In other respects, the closing force can be measured with strain gauges, load cells, or other suitable force sensors. The SP2 closing motor speed setpoint is compared to the actual closing tube speed, which is determined by secondary controller 12955. The actual closing tube speed can be measured by comparing the displacement of the closing tube with the sensor of position and measurement of elapsed time with a timer / counter. Other techniques, such as linear or rotary encoders, can be used to measure the displacement of the closing tube. Output 12968 of secondary process 12960 is the actual speed of the closing tube. This speed output from the closing tube 12968 is provided to the primary processor 12958 which determines the force acting on the closing tube and is fed back to the adder 12962, which subtracts the measured closing force from the primary setpoint SP1. The main setpoint SP1 can be an upper threshold or a lower threshold. Based on the output of adder 12962, primary controller 12952 controls the speed and direction of the closing motor. The secondary controller 12955 controls the speed of the closing motor based on the actual speed of the closing tube measured by the secondary process 12960 and the secondary setpoint SP2, which is based on a comparison of the upper and lower trigger force thresholds and of the actual firing force.
[00432] [00432] Figure 45 illustrates a PID 12970 feedback control system, according to one aspect of this description. Primary controller 12952 or secondary controller 12955, or both, can be implemented as a PID controller
[00433] [00433] According to the PID algorithm, the element "P" 12974 represents the present error values. For example, if the error is large and positive, the control output will also be large and positive. According to the present description, the error term e (t) is the difference between the desired closing force and the measured closing force of the closing tube. The "I" element 12976 represents the values passed from the error. For example, if the current output is not strong enough, the integral of the error will accumulate over time, and the controller will respond by applying a stronger action. The "D" element 12978 represents possible future trends of the error, based on its actual rate of change. For example, continuing example P above, when the large positive control output manages to bring the error closer to zero, it also puts the process in a major negative error mode in the near future. In this case, the derivative becomes negative and module D reduces the force of the action to avoid this excess.
[00434] [00434] It will be understood that other variables and set points can be monitored and controlled according to the feedback control systems 12950, 12970. For example, the adaptive closing member speed control algorithm described here can mediate the minus two of the following parameters: the location of the firing member, the firing of the firing member, the displacement of the cutting element, the speed of the cutting element,
[00435] [00435] Several aspects are directed to improved ultrasonic surgical devices, electrosurgical devices and generators for use with them. Aspects of ultrasonic surgical devices can be configured to transect and / or coagulate tissue during surgical procedures, for example. Aspects of electrosurgical devices can be configured to transect, coagulate, scale, weld and / or dry the tissue during surgical procedures, for example.
[00436] [00436] Generator aspects use high speed analog to digital sampling (for example, approximately 200 × over-sampling, depending on frequency) of the generator trigger signal current and voltage, along with digital signal processing, to provide numerous advantages and benefits over known generator architectures. In one aspect, for example, based on current and voltage feedback information, a value of the static capacitance of the ultrasonic transducer, and a value of the frequency of the drive signal, the generator can determine the current of the movement branch of a transducer ultrasonic. This provides the benefit of a virtually tuned system, and simulates the presence of a system that is tuned or resonated with any static capacitance value (for example, C0 in Figure 4) at any frequency. Consequently, the control of the branching current of the movement can be carried out by canceling the effects of static capacitance without the need for a tuning inductor. In addition, the elimination of the tuning inductor cannot degrade the frequency locking capabilities of the generator, since the frequency locking can be performed by properly processing the current and voltage feedback data.
[00437] [00437] High speed analog to digital sampling of the current and voltage of the generator trigger signal, along with digital signal processing, can also enable accurate digital filtering of samples. For example, aspects of the generator may use a low pass digital filter (for example, a finite impulse response filter (FIR) that rolls out between a fundamental trigger signal frequency and a second order harmonic to reduce asymmetric harmonic distortion) and EMI-induced noise in the current and voltage feedback samples The filtered current and voltage feedback samples substantially represent the frequency of the fundamental trigger signal, thus allowing a more accurate measurement of the impedance phase in relation to the signal frequency of fundamental drive and an improvement in the capacity of the generator to maintain the locking of the resonance frequency.The accuracy of the impedance phase measurement can be further optimized by calculating the average of the falling edge and falling edge measurements, and by regulating of the impedance phase measured at 0 °.
[00438] [00438] Various aspects of the generator can also use analog to digital sampling of high speed of the current and voltage of the generator trigger signal, together with digital signal processing, to determine the actual energy consumption and other quantities with a high degree of accuracy. This can allow the generator to implement a number of useful algorithms, such as, for example, controlling the amount of power applied to the tissue as the tissue impedance changes and controlling the application of power to maintain a constant rate of increase in the tissue impedance. Some of these algorithms are used to determine the phase difference between the current and voltage signals of the generator trigger signal. In resonance, the phase difference between the current and voltage signals is zero. The phase changes as the ultrasonic system resonates. Various algorithms can be used to detect the phase difference and adjust the trigger frequency until the ultrasonic system returns to resonance, that is, the phase difference between the current and voltage signals reaches zero. The phase information can also be used to infer the conditions of the ultrasonic sheet. As discussed in particular below, the phase changes as a function of the temperature of the ultrasonic sheet. Therefore, the phase information can be used to control the temperature of the ultrasonic sheet. This can be done, for example, by reducing the power supplied to the ultrasonic sheet when the ultrasonic sheet is very hot and by increasing the power applied to the ultrasonic sheet when the ultrasonic sheet is very cold.
[00439] [00439] Various aspects of the generator may have a wide range of frequencies and increased output power required to drive ultrasonic surgical devices and electrosurgical devices. The lower the voltage, the greater the current demand of the electrosurgical devices can be met by a dedicated branch in a broadband power transformer, thus eliminating the need for a separate power amplifier and output transformer. In addition, the generator's detection and feedback circuits can support a wide dynamic range that meets the needs of ultrasonic and electrosurgical applications with minimal distortion.
[00440] [00440] Several aspects can provide a simple and economical way for the generator to read and optionally write to a data circuit (for example, a single wire bus device, such as a single wire EEPROM protocol, known under the trade name " 1-Wire ") arranged in an instrument fixed to the handpiece using the existing multi-conductor generator / handle cables. In this way, the generator is able to retrieve and process instrument-specific data from an instrument attached to the grip. This can allow the generator to provide better control and improved diagnostics and error detection. In addition, the generator's ability to record data on the instrument enables new functionality in terms of, for example, tracking instrument usage and capturing operational data. In addition, the use of the frequency range allows backward compatibility of instruments containing a bus device with existing generators.
[00441] [00441] Aspects described in the generator provide active leakage current cancellation caused by unintentional capacitive coupling between uninsulated and isolated circuits, from the patient, from the generator. In addition to reducing risks to the patient, reducing the leakage current can also decrease electromagnetic emissions. These and other benefits of aspects of the present description will be evident from the description presented below.
[00442] [00442] It will be recognized that the terms "proximal" and "distal" are used here with reference to the doctor's act of tightening a grip. Thus, an end actuator is distal to the most proximal grip. It will be further recognized that, for the sake of convenience and clarity, spatial terms such as "top" and "bottom" can also be used in the present invention in relation to the physician holding the handle. However, surgical devices are used in many orientations and positions, and such terms are not intended to be limiting and absolute.
[00443] [00443] Figure 46 is an exploded elevation view of the 6480 modular handheld ultrasonic surgical instrument showing the left half of the compartment removed from a 6482 handle assembly and exposing a device identifier communicatively coupled to the cable terminal assembly. multiple conductors in accordance with one aspect of the present description.
[00444] [00444] In one aspect, the communication portion includes a 6493 processor and a 6497 memory that can be separated or a single component. The 6493 processor, in combination with memory, is capable of providing intelligent power management for the 6480 modular handheld ultrasonic surgical instrument. This aspect is particularly advantageous due to the fact that an ultrasonic device, such as the modular handheld ultrasonic surgical instrument 6480, has an energy requirement (frequency, current and voltage) that may be unique to the 6480 modular handheld ultrasonic surgical instrument. In fact, the 6480 modular handheld ultrasonic surgical instrument may have a specific power requirement or limitation for a 6494 external tube size or type and a second different energy requirement for a second type of waveguide having a different size, shape and / or configuration.
[00445] [00445] A 6486 smart battery pack, in accordance with at least one aspect of the present description, therefore, allows a battery pack to be used between various surgical instruments. Due to the fact that the 6486 smart battery pack is able to identify which device it is attached to and is therefore able to change its output, operators of several different surgical instruments using the 6486 smart battery pack no longer have to worry about which power source they are trying to install inside the electronic device being used. This is particularly advantageous in an operating environment where a battery pack needs to be replaced or exchanged with another surgical instrument in the middle of a complex surgical procedure.
[00446] [00446] In another aspect of the present description, the 6486 smart battery pack stores, in a 6497 memory, a record each time a specific device is used. This record can be useful for evaluating the end of life or allowable life of a device. For example, after a device has been used 20 times, the batteries in the 6486 smart battery pack connected to the device will refuse to supply power to the device - since the device is defined as a "no longer reliable" surgical instrument. Reliability is determined based on several factors. One factor may be wear and tear, which can be estimated in several ways, including the number of times the device has been used or activated. After a number of uses, the device parts can become worn and the tolerances between the parts can be exceeded. For example, the 6486 smart battery pack can detect the number of times the button is pressed by the 6482 handle set and can determine when a maximum number of times the button is pressed has been reached or exceeded. The 6486 smart battery pack can also monitor an impedance of the button mechanism that can change, for example, if the handle is contaminated, for example, with saline.
[00447] [00447] This wear can lead to an unacceptable failure during a procedure. In some ways, the 6486 smart battery pack can recognize which parts are combined in a device and even how many uses a part has experienced. For example, if the 6486 smart battery pack is a smart battery, according to this description, it can identify the 6482 handle set, the 6490 drive shaft waveguide set, as well as the transducer / 6484 ultrasonic generator, long before the user tries to use the composite device. The 6497 memory inside the 6486 smart battery pack can, for example, record a time when the 6484 ultrasonic transducer / generator set is operated and how, when and for how long it is operated. If the 6484 ultrasonic transducer / generator set has an individual identifier, the 6486 smart battery pack can monitor the use of the 6484 ultrasonic transducer / generator set and refuse to supply power to that 6484 ultrasonic transducer / generator set when the 6482 handle or the 6484 ultrasonic transducer / generator set exceeds its maximum number of uses. The 6484 ultrasonic transducer / generator assembly, the 6482 handle assembly, the 6490 drive shaft waveguide assembly, or other components may include a memory integrated circuit (chip) that also records this information. In this way, any number of smart batteries in the 6486 smart battery pack can be used with any number of 6484 ultrasonic transducer / generator sets, staplers, vessel seals, etc. and still be able to determine the total number of uses, or the total time of use (through the use of the clock), or the total number of operations, etc. the 6484 ultrasonic transducer / generator set, the stapler, the vessel seal, etc. or loading or unloading cycles. The smart functionality can reside outside the 6486 battery pack and can reside in the 6482 handle set, the 6484 ultrasonic transducer / generator set and / or the 6490 drive shaft set, for example.
[00448] [00448] When accounting for the uses of the 6484 ultrasonic transducer / generator set to intelligently end the service life of the 6484 transducer / ultrasonic generator set, the surgical instrument makes a precise distinction between completing a real use of the transducer set / 6484 ultrasonic generator in a surgical procedure and a momentary lapse in the performance of the 6484 ultrasonic transducer / generator set due to, for example, a battery change or a temporary delay in the surgical procedure. Therefore, as an alternative to simply counting the number of activations of the 6484 ultrasonic transducer / generator set, a real-time clock (RTC) circuit can be implemented to monitor the amount of time that the 6484 ultrasonic transducer / generator set is in fact turned off. From the measured length of time, it can be determined, through appropriate logic, whether the shutdown was significant enough to be considered the end of a real use or whether the shutdown was too short in terms of time to be considered the end of a use. Thus, in some applications, this method can be a more accurate determination of the useful life of the 6484 ultrasonic transducer / generator set than a simple "activation-based" algorithm, which can, for example, report that ten "activations" occur in a surgical procedure and, therefore, ten activations should indicate that the counter is incremented by one. Generally speaking, this type and internal timekeeping system will prevent the misuse of the device that is designed to circumvent a simple "activation-based" algorithm and will prevent the incorrect recording of a complete use in cases where there was only a simple loss matching the 6484 ultrasonic transducer / generator set or the 6486 smart battery pack that was required for legitimate reasons.
[00449] [00449] Although the 6484 ultrasonic transducer / generator sets of the 6480 surgical instrument are reusable, in one aspect a finite number of uses can be defined since the 6480 surgical instrument is subject to strict conditions during cleaning and sterilization. More specifically, the battery is configured to be sterilized. Regardless of the material used for external surfaces, there is a limited expected service life for the actual materials used. This useful life is determined by several characteristics that could include, for example, the number of times the battery was actually sterilized, the time since the battery was manufactured and the number of times the battery was recharged, to name a few. In addition, the life of the battery cells themselves is limited. The software of the present description incorporates algorithms of the invention that verify the number of uses of the 6484 ultrasonic transducer / generator set and the 6486 smart battery set and disable the device when that number of uses has been reached or exceeded. The analysis of the outside of the battery in each of the possible sterilization methods can be performed. Based on the most stringent sterilization procedure, the maximum number of sterilizations allowed can be set and that number can be stored in a 6486 smart battery pack memory. If a charger is assumed to be non-sterile and the smart battery pack 6486 must be used after being charged, so the charge count can be set to be equal to the number of sterilizations found by that specific battery.
[00450] [00450] In one aspect, the hardware in the battery can be disabled to minimize or eliminate security issues due to the continuous depletion of the battery cells after the battery has been disabled by the software. There may be a situation where the battery's internal hardware is unable to disable the battery under certain low voltage conditions. In this situation, in one respect, the charger can be used to "kill" the battery. Due to the fact that the battery microcontroller is switched off while the battery is in its charger, non-volatile, programmable and electrically erasable read-only memory (EEPROM) based on the System Management Bus (SMB) can be used to exchange information between the battery microcontroller and the charger. In this way, a serial EEPROM can be used to store information that can be written and read even when the battery microcontroller is turned off, which is very beneficial when trying to exchange information with the charger or other peripheral devices. This example EEPROM can be configured to contain enough memory records to store at least (a) a usage count limit at which the battery must be disabled (Battery Usage Count), (b) the number of procedures to which the battery has been subjected (Battery Procedure Count) and / or (c) a number of charges to which the battery has been subjected (Load Count), among others. Some of the information stored in the EEPROM, such as the Usage Count Register and the Load Count Register, is stored in protected EEPROM write sections to prevent users from changing the information. In one respect, usage and counters are stored with corresponding bit-inverted secondary records to detect data corruption.
[00451] [00451] Any residual voltage on the SMBus lines (system management bus) could damage the microcontroller and corrupt the SMBus signal. Therefore, to ensure that the SMBus lines of a battery controller do not contain a voltage while the microcontroller is switched off, relays are provided between the external SMBus lines and the battery controller microplate.
[00452] [00452] When charging the 6486 smart battery pack, an "end of charge" condition of the batteries inside the 6486 smart battery pack is determined when, for example, the current flowing into the battery falls below a threshold determined in a tapered manner when employing a constant current / constant voltage charging scheme. To accurately detect this "end of charge" condition, the battery microcontroller and the lowering plates are de-energized and turned off during battery charging to reduce any current drain that may be caused by the plates and that may interfere with current detection decreasing. In addition, the microcontroller and the lowering plates are de-energized during charging to prevent any corruption resulting from the SMBus signal.
[00453] [00453] Regarding the charger, in one aspect, the 6486 smart battery pack is prevented from being inserted into the charger in a different way from the correct insertion position. Consequently, the exterior of the 6486 smart battery pack is provided with fastening features for the charger. A container for securely attaching the 6486 smart battery pack to the charger is configured with a tapered contour geometry to prevent accidental insertion of the 6486 smart battery pack in any way other than the correct one (intended). It is further contemplated that the presence of the 6486 smart battery pack can be detectable by the charger itself. For example, the charger can be configured to detect the presence of the SMBus transmission from the battery protection circuit, as well as the resistors that are located on the protection plate. In this case, the charger would be able to control a voltage that is exposed on the pins of the charger until the 6486 smart battery pack is properly seated or in place on the charger. This is due to the fact that a voltage present on the pins of the charger can present a danger and a risk that an electrical short circuit can occur between the pins and cause the charger to begin to be inadvertently charged.
[00454] [00454] In some respects, the 6486 smart battery pack can communicate with the user through auditory and / or visual feedback. For example, the 6486 smart battery pack can cause LEDs to emit light in a predefined way. In this case, although the microcontroller in the 6484 ultrasonic transducer / generator set controls the LEDs, the microcontroller receives instructions to be executed directly from the 6486 smart battery pack.
[00455] [00455] In yet another aspect of the present description, the microcontroller in the 6484 ultrasonic transducer / generator set, when not in use for a predetermined period, enters suspended mode. Advantageously, when in suspended mode, the clock speed of the microcontroller is reduced, significantly cutting current drain. Some current continues to be consumed because the processor continues to send a signal, waiting to detect an input. Advantageously, when the microcontroller is in this suspended energy saving mode, the microcontroller and the battery controller can directly control the LEDs. For example, a decoder circuit could be built into the 6484 ultrasonic transducer / generator set and connected to the communication lines so that the LEDs can be independently controlled by the 6493 processor while the 6484 ultrasonic transducer / generator set microcontroller is "OFF" "or in a" suspended mode ". This is an energy-saving feature that eliminates the need to drive the microcontroller on the 6484 ultrasonic transducer / generator set. Energy is saved by allowing the generator to be turned off while still being able to actively control the user interface indicators.
[00456] [00456] Another aspect slows down one or more of the microcontrollers to conserve energy when not in use. For example, the clock frequencies of both microcontrollers can be reduced to save energy. In order to maintain synchronized operation, microcontrollers coordinate the change of their respective clock frequencies so that they occur at approximately the same time, both the reduction and the subsequent increase in frequency when full speed operation is required. For example, when entering idle mode, clock frequencies are decreased and when leaving idle mode, frequencies are increased.
[00457] [00457] In an additional aspect, the 6486 smart battery pack is able to determine the amount of useful energy remaining inside its cells and is programmed to only operate the surgical instrument to which it is connected if it determines that there is battery power remaining enough to predictably operate the device throughout the intended procedure. For example, the 6486 smart battery pack is able to remain in a non-operational state if there is not enough energy inside the cells to operate the surgical instrument for 20 seconds. According to one aspect, the 6486 smart battery pack determines the amount of energy remaining inside the cells at the end of its most recent previous function, for example, a surgical cut. In this respect, therefore, the 6486 smart battery pack would not allow a subsequent function to be performed if, for example, during that procedure, the pack determines that the cells do not have enough energy. Alternatively, if the 6486 smart battery pack determines that there is enough power for a subsequent procedure and falls below that threshold during the procedure, it does not interrupt the procedure in progress and instead allows the procedure to end and subsequently prevents new procedures to occur.
[00458] [00458] The following explains an advantage of maximizing the use of the device with the 6486 smart battery pack of this description. In this example, a set of different devices has different ultrasonic transmission waveguides. By definition, waveguides could have a respective maximum allowable energy limit, in which exceeding said energy limit overloads the waveguide and ultimately causes it to break. A waveguide in the waveguide set will, of course, have the lowest maximum energy tolerance. Since prior art batteries do not have smart battery power management, the prior art battery output needs to be limited by a value of the lowest allowable maximum energy input for the smaller / narrower / more fragile waveguide in the set to be used with the device / battery. This would be true even if larger and thicker waveguides were later attached to that grip and, by definition, allow greater force to be applied. This limitation is also true for the maximum battery power. For example, if a battery is designed to be used on multiple devices, its maximum output energy will be limited to the lowest maximum energy rating of any of the devices on which it is to be used. With this configuration, one or more devices or device configurations would not be able to maximize battery usage, since the battery does not know the specific limits of the specific device.
[00459] [00459] In one aspect, the 6486 smart battery pack can be employed to intelligently circumvent the aforementioned limitations of the ultrasonic device. The 6486 smart battery pack can produce an output for a specific device or device configuration, and the same 6486 smart battery pack can later produce a different output for a second device or device configuration. This universal system of intelligent surgical battery lends itself well to modern operating rooms where space and time are limited. By having a smart battery that powers several different devices, nursing teams can easily manage the storage, recovery and inventory of these batteries. Advantageously, in one aspect, the intelligent battery system, according to the present description, can employ a type of charging station, thereby increasing the ease and efficiency of use and decreasing the costs of the charging equipment of the operating rooms. .
[00460] [00460] In addition, other surgical instruments, for example, an electric stapler, may have a different energy requirement than the modular handheld ultrasonic surgical instrument 6480. According to various aspects of this description, a 6486 smart battery pack can be used with any of a number of surgical instruments and can be produced to adapt its own energy output to the specific device in which it is installed.
[00461] [00461] Figure 47 is a detailed view of a 6483 trigger portion and a key for the 6480 ultrasonic surgical instrument shown in Figure 46, in accordance with an aspect of the present description. The 6483 trigger is operationally coupled to the 6495 claw member of the 6492 end actuator. The 6496 ultrasonic blade is powered by the 6484 ultrasonic transducer / generator set by activating the 6485 activation switch. Now continuing with Figure 46, and also looking for Figure 47, trigger 6483 and activation key 6485 are shown as components of the 6482 handle set. The 6483 trigger activates the 6492 end actuator, which has a cooperative association with the 6496 ultrasonic blade of the waveguide set. drive shaft 6490 to allow various types of contact between the grapple member
[00462] [00462] The 6485 activation key, when pressed, places the 6480 modular handheld ultrasonic surgical instrument in an ultrasonic operating mode, which causes ultrasonic movement in the 6490 drive shaft waveguide assembly. In one aspect, the pressing the 6485 activation switch causes the electrical contacts inside the switch to close, thus completing a circuit between the 6486 smart battery pack and the 6484 ultrasonic transducer / generator set, so that electrical power is applied to the transducer ultrasonic, as previously described. In another aspect, pressing the 6485 activation key closes the electrical contacts for the smart battery pack
[00463] [00463] Figure 48 is an enlarged fragmentary perspective view of a 6492 end actuator, according to at least one aspect of the present description, from a distal end with a 6495 claw member in an open position. Referring to Figure 48, a partial perspective view of the distal end 6498 of the 6490 drive shaft waveguide assembly is shown. The 6490 waveguide drive shaft assembly includes an outer tube 6494 that surrounds a portion of the waveguide. The ultrasonic blade portion 6496 of the 6499 waveguide protrudes from the distal end 6498 of the outer tube
[00464] [00464] Figure 49 is a 7400 system diagram of a 7401 segmented circuit comprising a plurality of independently operated circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440, in accordance with at least one aspect of this description. A circuit segment of the plurality of circuit segments of the segmented circuit 7401 comprises one or more circuits and one or more sets of machine executable instructions stored in one or more memory devices. The one or more circuits in a circuit segment are coupled for electrical communication through one or more means of connecting wired or wirelessly. The plurality of circuit segments is configured to transition between three modes comprising a suspended mode, a standby mode and an operational mode.
[00465] [00465] In one aspect shown, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 starts, first, in standby mode, secondly, it goes into suspended mode and in third, it goes into operational mode. However, in other respects, the plurality of circuit segments can transition from any of the three modes to any of the other three modes. For example, the plurality of circuit segments can transition directly from standby to operational mode. Individual circuit segments can be placed in a specific state by the voltage control circuit 7408 based on execution, by a machine executable instruction processor. The states comprise a de-energized state, a low-energy state and an energized state. The de-energized state corresponds to the suspended mode, the low energy state corresponds to the standby mode and the energized state corresponds to the operational mode. The transition to the low energy state can be achieved, for example, by using a potentiometer.
[00466] [00466] In one aspect, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 can carry out the transition from suspended or standby mode to operational mode according to a sequence of energization. The plurality of circuit segments can also transition from the operational mode to the standby mode or to the suspended mode according to the de-energization sequence. The energizing sequence and the de-energizing sequence can be different. In some respects, the energizing sequence comprises energizing only a subset of circuit segments of the plurality of circuit segments. In some respects, the de-energizing sequence comprises de-energizing only a subset of circuit segments of the plurality of circuit segments.
[00467] [00467] Again with reference to the 7400 system diagram in the Figure. 49, segmented circuit 7401 comprises a plurality of circuit segments comprising a transition circuit segment 7402, a processor circuit segment 7414, a handle circuit segment 7416, a communication circuit segment 7420, a segment of circuit 7424 screen circuit, 7428 motor control circuit segment, 7434 power treatment circuit segment, and 7440 drive shaft circuit segment. The transition circuit segment comprises a 7404 activation circuit, a stepping current circuit 7406, a voltage control circuit 7408, a safety controller 7410 and a POST controller 7412. Transition circuit segment 7402 is configured to implement a de-energizing sequence and an energizing sequence, a protocol security detection and a POST.
[00468] [00468] In some aspects, the activation circuit 7404 comprises an accelerometer button sensor 7405. In aspects, the transition circuit segment 7402 is configured to be in an energized state, while other circuit segments of the plurality of segments of 7401 segmented circuit circuit are configured to be in a low energy state, a de-energized state or an energized state. The 7405 accelerometer button sensor can monitor the movement or acceleration of the 6480 surgical instrument described in the present invention. For example, the movement may be a change in the orientation or rotation of the surgical instrument. The surgical instrument can be moved in any direction in relation to a three-dimensional Euclidean space, for example, by a user of the surgical instrument. When the 7405 accelerometer button sensor detects movement or acceleration, the 7405 accelerometer button sensor sends a signal to the 7408 voltage control circuit to cause the 7408 voltage control circuit to apply voltage to the processor circuit segment. 7414 to transition the processor and volatile memory to a powered state. In aspects, the processor and volatile memory are in an energized state before the 7409 voltage control circuit applies voltage to the processor and volatile memory. In operational mode, the processor can initiate an energizing sequence or a de-energizing sequence. In many ways, the 7405 accelerometer button sensor can also send a signal to the processor to cause the processor to initiate an energizing sequence or a de-energizing sequence. In some respects, the processor initiates an energizing sequence when most of the individual circuit segments are in a low energy or de-energized state. In other respects, the processor initiates a de-energizing sequence when most of the individual circuit segments are in an energized state.
[00469] [00469] Additionally or alternatively, the 7405 accelerometer button sensor can detect external movement within a predetermined vicinity of the surgical instrument. For example, the 7405 accelerometer button sensor can detect the hand movement of a user of the 6480 surgical instrument described here, which moves within the predetermined neighborhood. When the 7405 accelerometer button sensor detects this external movement, the 7405 accelerometer button sensor can send a signal to the 7408 voltage control circuit and a signal to the processor, as previously described. After receiving the signal sent, the processor can initiate an energizing sequence or a de-energizing sequence to transition one or more circuit segments between the three modes. In aspects, the signal sent to the voltage control circuit 7408 is sent to verify that the processor is in operational mode. In some ways, the 7405 accelerometer button sensor can detect when the surgical instrument has been dropped and send a signal to the processor based on the detected drop. For example, the signal may indicate an error in the operation of an individual circuit segment. One or more sensors can detect damage or failure of the affected individual circuit segments. Based on the detected damage or failure, the POST controller 7412 can perform a POST of the corresponding individual circuit segments.
[00470] [00470] An energizing sequence or a de-energizing sequence can be defined based on the 7405 accelerometer button sensor. For example, the accelerometer button sensor
[00471] [00471] In several respects, the 7405 accelerometer button sensor can send a signal to the 7408 voltage control circuit and a signal to the processor only when the 7405 accelerometer button sensor detects movement of the 6480 surgical instrument described here or the movement within a predetermined neighborhood above a predetermined threshold. For example, a signal can only be sent if the movement is detected for 5 or more seconds or if the surgical instrument is moved 5 or more inches. In other respects, the 7405 accelerometer button sensor can send a signal to the 7408 voltage control circuit and a signal to the processor only when the 7405 accelerometer button sensor detects oscillatory movement of the surgical instrument. A predetermined threshold reduces the inadvertent transition of the surgical instrument's circuit segments. As previously described, the transition can comprise a transition to the operational mode according to an energizing sequence, a transition to low energy mode according to a de-energizing sequence, or a transition to the suspended mode according to a sequence de-energizing. In some aspects, the surgical instrument comprises an actuator that can be actuated by a user of the surgical instrument. The actuation is detected by the 7405 accelerometer button sensor. The actuator can be a sliding element, a toggle switch or a momentary contact switch. Based on the detected performance, the 7405 accelerometer button sensor can send a signal to the 7408 voltage control circuit and a signal to the processor.
[00472] [00472] The amplification current circuit 7406 is coupled to the battery. The amplification current circuit 7406 is a current amplifier, like a relay or transistor, and is configured to amplify the magnitude of a current in an individual circuit segment. The magnitude of the initial current corresponds to the source voltage supplied by the battery to the 7401 segmented circuit. Suitable relays include solenoids. Suitable transistors include field effect transistors (FET), MOSFET and bipolar junction transistors (BJT). The amplification current circuit 7406 can amplify the magnitude of the current corresponding to an individual circuit segment or the circuit that requires more current extraction during the operation of the 6480 surgical instruments described herein. For example, an increase in current for the 7428 motor control circuit segment can be provided when a surgical instrument motor requires more input power. The increase in the current supplied to an individual circuit segment can cause a corresponding reduction in the current of another circuit segment or circuit segments. Additionally or alternatively, the increase in current may correspond to the voltage supplied by an additional voltage source that operates in conjunction with the battery.
[00473] [00473] The voltage control circuit 7408 is coupled to the battery. The voltage control circuit 7408 is configured to supply voltage or remove voltage from the plurality of circuit segments. The voltage control circuit 7408 is also configured to increase or decrease a voltage supplied to a plurality of circuit segments of the segmented circuit 7401. In several aspects, the voltage control circuit 7408 comprises a combinational logic circuit such as a multiplexer (MUX ) to select the inputs, a plurality of electronic switches and a plurality of voltage converters. An electronic switch from the plurality of electronic switches can be configured to switch between an open and a closed configuration to disconnect or connect an individual circuit segment to or from the battery. The plurality of electronic switches can consist of solid state devices such as transistors or other types of switches, such as wireless switches, ultrasonic switches, accelerometers, inertia sensors, among others. The combinational logic circuit is configured to select an individual electronic switch to switch to an open configuration to allow voltage to be applied to the corresponding circuit segment. The combined logic circuit is also configured to select an individual electronic switch to switch to a closed configuration to allow removal of voltage from the corresponding circuit segment. By selecting a plurality of individual electronic switches, the combined logic circuit can implement a de-energizing sequence or an energizing sequence. The plurality of voltage converters can provide a stepped upward voltage or a stepped downward voltage to a plurality of circuit segments. The voltage control circuit 7408 may also comprise a microprocessor and a memory device.
[00474] [00474] The 7410 safety controller is configured to perform safety checks on the circuit segments. In some respects, the 7410 safety controller performs safety checks when one or more individual circuit segments are in operational mode. Safety checks can be carried out to determine whether or not there are any errors or defects in the operation or operation of the circuit segments. The 7410 safety controller can monitor one or more parameters of the plurality of circuit segments. The 7410 safety controller can verify the identity and operation of the plurality of circuit segments by comparing the one or more parameters to predefined parameters. For example, if an RF energy modality is selected, the 7410 safety controller can check whether a drive shaft articulation parameter matches a predefined articulation parameter to verify the operation of the 6480 surgical instrument's RF energy modality. described in the present invention. In some respects, the 7410 safety controller can monitor, through the sensors, a predetermined relationship between one or more properties of the surgical instrument to detect a defect. A defect can occur when the one or more properties are inconsistent with the predetermined relationship. When the 7410 safety controller determines that there is a defect, an error or that some operation of the plurality of circuit segments has not been verified, the 7410 safety controller prevents or disables the operation of the specific circuit segment where the fault, error or failure verification code originated.
[00475] [00475] The POST controller 7412 performs a POST to verify the proper operation of the plurality of circuit segments. In some respects, POST is performed for an individual circuit segment of the plurality of circuit segments before voltage control circuit 7408 applies a voltage to the individual circuit segment to transition the individual circuit segment from standby or from suspended mode to operational mode. If the individual circuit segment does not pass POST, the specific circuit segment does not transition from standby or suspended mode to operational mode. The POST of the handle circuit segment 7416 may comprise, for example, testing whether the handle control sensors 7418 detect an actuation of a handle control of the surgical instrument 6480 described in the present invention. In some ways, the 7412 POST controller can transmit a signal to the 7405 accelerometer button sensor to verify the operation of the individual circuit segment as part of the POST. For example, after receiving the signal, the 7405 accelerometer button sensor can instruct a surgical instrument user to move the surgical instrument to a plurality of variable locations to confirm the operation of the surgical instrument. The 7405 accelerometer button sensor can also monitor an output of a circuit segment or a circuit of a circuit segment as part of the POST. For example, the 7405 accelerometer button sensor can detect an incremental engine pulse generated by the 7432 engine to verify operation. A motor controller from the 7430 motor control circuit can be used to control the 7432 motor to generate the incremental motor pulse.
[00476] [00476] In several respects, the 6480 surgical instrument described here may comprise additional accelerometer button sensors. The POST controller 7412 can also execute a control program stored in the memory device of the voltage control circuit 7408. The control program can cause the POST controller 7412 to transmit a signal requesting a correlated encrypted parameter from a plurality of circuit segments. Failure to receive a correlated encrypted parameter from an individual circuit segment indicates to the POST 7412 controller that the corresponding circuit segment is damaged or defective. In some respects, if the POST 7412 controller determines, based on POST, that the processor is damaged or defective, the POST 7412 controller can send a signal to one or more secondary processors to cause one or more secondary processors perform critical functions that the processor is unable to perform. In some respects, if the POST 7412 controller determines, based on POST, that one or more circuit segments do not operate properly, the POST 7412 controller may initiate a reduced performance mode from those circuit segments that operate properly, while blocking those circuit segments that do not pass the POST or that do not operate properly. A blocked circuit segment can function similarly to a circuit segment in standby or suspended mode.
[00477] [00477] The processor circuit segment 7414 comprises the processor and volatile memory. The processor is configured to initiate an energizing sequence or a de-energizing sequence. To initiate the energizing sequence, the processor transmits an energizing signal to voltage control circuit 7408 to cause voltage control circuit 7408 to apply voltage to the plurality or to a subset of the plurality of circuit segments according to the power-up sequence. To initiate the de-energizing sequence, the processor transmits a de-energizing signal to voltage control circuit 7408 to cause voltage control circuit 7408 to remove voltage from the plurality or a subset of the plurality of circuit segments according to the de-energizing sequence.
[00478] [00478] The 7416 handle circuit segment comprises 7418 handle control sensors. The 7418 handle control sensors can detect the actuation of one or more handle controls of the 6480 surgical instrument described here. In several respects, the one or more grip controls comprise a grapple control, a release button, a toggle switch, an energy activation button, and / or any other suitable grip control. The user can activate the power activation button to select between an RF energy mode, an ultrasonic energy mode or a combined RF and ultrasonic energy mode. The 7418 handle control sensors can also facilitate the attachment of a modular handle to the surgical instrument. For example, the 7418 handle control sensors can detect proper attachment of the modular handle to the surgical instrument and indicate the detected attachment to a user of the surgical instrument. The 7426 LCD screen can provide a graphic indication of the detected fixation. In some respects, the 7418 grip control sensors detect the activation of one or more grip controls. Based on the detected performance, the processor can initiate both an energizing sequence and a de-energizing sequence.
[00479] The communication circuit segment 7420 comprises a communication circuit 7422. The communication circuit 7422 comprises a communication interface to facilitate the communication of the signal between the individual circuit segments of the plurality of circuit segments. In some respects, the 7422 communication circuit provides a path for the modular components of the 6480 surgical instrument described here to communicate electrically. For example, a modular drive shaft and a modular transducer, when attached together to the handle of the surgical instrument, can load control programs for the handle through the 7422 communication circuit.
[00480] [00480] The 7424 screen circuit segment comprises a 7426 LCD screen. The 7426 LCD screen may comprise a liquid crystal display, LED indicators, etc. In some ways, the 7426 LCD screen is an organic light-emitting diode (OLED) screen. A screen can be placed on, embedded or remotely located in relation to the 6480 surgical instrument described here. For example, the screen can be placed on the handle of the surgical instrument. The screen is configured to provide sensory feedback to a user. In several respects, the 7426 LCD screen additionally comprises a backlight. In some respects, the surgical instrument may also comprise audio feedback devices such as a loudspeaker or an audible signal and tactile feedback devices such as a haptic actuator.
[00481] [00481] The 7428 motor control circuit segment comprises a 7430 motor control circuit coupled to a motor
[00482] [00482] In several respects, the 7430 motor control circuit comprises a force sensor to measure the force and torque generated by the 7432 motor. The 7432 motor is configured to act on a mechanism of the 6480 surgical instruments described here. For example, the 7432 motor is configured to control the actuation of the operating shaft of the surgical instrument to perform the gripping, rotation and articulation functionalities. For example, the 7432 motor is configured to control the actuation of the operating shaft of the surgical instrument to perform the gripping, rotation and articulation functionalities. The motor controller can determine whether the material caught by the claws is fabric or metal. The motor controller can also determine the extent to which the claws hold the material. For example, the motor controller can determine how to open or close the jaws based on the derivation of the detected motor current or motor voltage. In some respects, the 7432 motor is configured to drive the transducer to cause the transducer to torque the handle or to control the articulation of the surgical instrument. The motor current sensor can interact with the motor controller to define a motor current limit. When the current meets the predefined threshold limit, the motor controller initiates a corresponding change in a motor control operation. For example, exceeding the motor current limit causes the motor controller to reduce the motor current draw.
[00483] [00483] The 7434 energy treatment circuit segment comprises an RF amplifier and the 7436 safety circuit and a 7438 ultrasonic signal generating circuit to implement the modular energy functionality of the 6480 surgical instrument described here. In several respects, the RF amplifier and the 7436 safety circuit are configured to control the RF modality of the surgical instrument by generating an RF signal. The 7438 ultrasonic signal generator circuit is configured to control the ultrasonic energy mode by generating an ultrasonic signal. The RF amplifier and 7436 safety circuit and a 7438 ultrasonic signal generator circuit can operate together to control the combined RF and ultrasonic energy mode.
[00484] [00484] The drive shaft circuit segment 7440 comprises a drive shaft module controller 7442, a modular control actuator 7444, one or more end actuator sensors 7446 and a non-volatile memory 7448. The module controller drive shaft 7442 is configured to control a plurality of drive shaft modules comprising the control programs to be executed by the processor. The plurality of drive shaft modules implement a drive shaft modality, for example, ultrasonic, combination of ultrasonic and RF, blade in profile I of RF and opposite claw by RF. The 7442 drive shaft module controller can select the drive shaft mode by selecting the corresponding drive shaft module for the processor to operate. The 7444 modular control actuator is configured to actuate the drive shaft according to the selected drive shaft modality. After actuation is initiated, the drive shaft articulates the end actuator according to one or more parameters, routines or programs specific to the selected axis mode and the selected end actuator mode. The one or more 7446 end actuator sensors, located on the end actuator, can include force sensors, temperature sensors, current sensors or motion sensors. The one or more end actuator sensors 7446 transmit data about one or more end actuator operations, based on the energy modality implemented by the end actuator. In several respects, the energy modalities include an ultrasonic energy modality, an RF energy modality or a combination of the ultrasonic energy modality and the RF energy modality. The 7448 non-volatile memory stores the drive shaft control programs. A control program comprises one or more parameters, routines or programs specific to the drive axis. In many ways, the 7448 non-volatile memory can be a ROM, EPROM, EEPROM or flash memory. The non-volatile memory 7448 stores the drive shaft modules corresponding to the selected drive shaft of the 6480 surgical instrument described here. The drive shaft modules can be changed or updated in the non-volatile memory 7448 by the drive shaft module controller 7442, depending on the drive shaft of the surgical instrument to be used in the operation.
[00485] [00485] Figure 50 is a schematic diagram of a 7925 circuit of various components of a surgical instrument with motor control functions, in accordance with at least one aspect of the present description. In several respects, the 6480 surgical instrument described herein can include a 7930 drive mechanism that is configured to drive drive shafts and / or gear components in order to perform the various operations associated with the 6480 surgical instrument. In one aspect, the mechanism drive unit 7930 includes a rotating drive train 7932 configured to rotate an end actuator, for example, about a longitudinal geometric axis in relation to the handle housing. The drive mechanism 7930 further includes a drive train for the closing system 7934 configured to close a claw member to secure the fabric to the end actuator. In addition, the drive mechanism 7930 includes a drive train 7936 configured to open and close a clamp arm portion of the end actuator to secure the fabric with the end actuator.
[00486] [00486] The drive mechanism 7930 includes a gearbox set with selector 7938 that can be located in the handle set of the surgical instrument. Proximal to the 7938 selector gearbox assembly there is a function selection module that includes a first 7942 motor that works to selectively move gear elements within the 7938 selector gearbox assembly to selectively position one of the drive trains 7932, 7934, 7936 in conjunction with an input drive component of an optional second motor 7944 and a motor drive circuit 7946 (shown on a dotted line to indicate that the second motor 7944 and the motor drive circuit 7946 are components optional).
[00487] [00487] Still referring to Figure 50, motors 7942 and 7944 are coupled to motor control circuits 7946, 7948, respectively, which are configured to control the operation of motors 7942 and 7944, including the flow of electrical energy from one 7950 power supply for 7942 and 7944 engines. The 7950 power supply may be a DC battery (for example, a lead-based, nickel-based, lithium-ion, etc.) or any other suitable power source to supply electrical power to the surgical instrument.
[00488] [00488] The surgical instrument additionally includes a 7952 microcontroller ("controller"). In certain examples, controller 7952 may include a microprocessor 7954 ("processor") and one or more computer-readable media or memory units 7956 ("memory"). In certain cases, memory 7956 can store various program instructions which, when executed, can cause processor 7954 to perform a plurality of functions and / or calculations described herein. A 7950 power supply can be configured to supply power to the 7952 controller, for example.
[00489] [00489] Processor 7954 may be in communication with motor control circuit 7946. In addition, memory 7956 can store program instructions which, when executed by processor 7954 in response to user input 7958 or feedback elements 7960 , can cause the 7946 engine control circuit to induce the 7942 engine to generate at least one rotary motion to selectively move the gear elements within the 7938 selector gearbox assembly to selectively position one of the 7932 drive trains , 7934, 7936 to engage the input drive component of the second motor 7944. In addition, processor 7954 can be in communication with the control circuit of motor 7948. Memory 7956 can also store program instructions that, when executed by the processor 7954 in response to user input 7958, can cause the 7948 motor control circuit to induce the 7944 minus a rotating motion to drive the drive train engaged in the input drive component of the second 7948 engine, for example.
[00490] [00490] The 7952 controller and / or the other controllers of the present description can be implemented using integrated and / or distinct hardware elements, software elements and / or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor devices, integrated circuits, microcircuits, chipsets, microcontrollers, system on an integrated circuit (chip ) (SoC) and / or single online package (SiP). Examples of different hardware elements may include circuits and / or circuit elements, such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors and / or relays. In certain embodiments, the 7952 controller may include a hybrid circuit comprising elements or components of integrated circuits and isolated on one or more substrates, for example.
[00491] [00491] In certain examples, the 7952 controller and / or the other controllers of the present description may be an LM 4F230H5QR, available from Texas Instruments, for example. In certain instances, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core comprising a 256 KB single cycle flash integrated memory or other non-volatile memory, up to 40 MHz, a prefetch buffer to optimize performance above 40 MHz, a 32 KB single cycle SRAM, internal ROM loaded with StellarisWare® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs, one or more 12-bit ADCs with 12 analog input channels, among other features that are readily available. Other microcontrollers can be readily replaced for use with the present description. Consequently, the present description should not be limited in that context.
[00492] [00492] In several examples, one or more of the various steps described here can be performed by a finite state machine comprising a combinational logic circuit or a sequential logic circuit, where the combinational logic circuit or the sequential logic circuit is coupled, to the least, to a memory circuit. The at least one memory circuit stores a current state of the finite state machine. The combinational or sequential logic circuit is configured to make the finite state machine perform the steps. The sequential logic circuit can be synchronous or asynchronous. In other examples, one or more of the various steps described herein can be performed by a circuit that includes a combination of the 7958 processor and the finite state machine, for example.
[00493] [00493] In several cases, it may be advantageous to be able to assess the state of functionality of a surgical instrument to ensure its proper function. It is possible, for example, that the drive mechanism, as explained above, which is configured to include various motors, drive trains and / or gear components to perform the various operations of the surgical instrument, will wear out over time. This can occur through normal use and, in some cases, the drive mechanism can wear out more quickly due to conditions of abuse. In certain cases, a surgical instrument can be configured to perform self-assessments to determine the state, that is, the health, of the drive mechanism and its various components.
[00494] [00494] For example, self-assessment can be used to determine when the surgical instrument is able to perform its function before a new sterilization or when some of the components must be replaced and / or repaired. The evaluation of the drive mechanism and its components, including, but not limited to, the 7932 rotating drive train, the closing system 7934 drive train and / or the 7936 trigger drive train, can be performed in a variety of ways shapes. The magnitude of the deviation from predicted performance can be used to determine the probability of a detected failure and the severity of that failure. Several metrics can be used, including: Periodic analysis of repeatedly predictable events, increases or decreases that exceed an expected threshold and the extent of failure.
[00495] [00495] In several cases, a signature waveform of a drive mechanism operating properly or one or more of its components can be used to assess the state of the drive mechanism or one or more of its components. One or more vibration sensors may be arranged in relation to a drive mechanism operating properly or one or more of its components to record various vibrations that occur during the operation of the drive mechanism operating properly or one or more of its components. The recorded vibrations can be used to create the signature waveform. Future waveforms can be compared to the signature waveform to assess the state of the drive mechanism and its components.
[00496] [00496] Still referring to Figure 50, the surgical instrument 7930 includes a failure detection module of the drive train 7962 configured to record and analyze one or more acoustic outputs from one or more of the drive trains 7932, 7934, 7936. The 7954 processor may be communicating with or otherwise controlling the 7962 module. As described in more detail below,
[00497] [00497] Again with reference to Figure 51, end actuator 8400 comprises RF data sensors 8406, 8408a, 8408b located on claw member 8402. End actuator 8400 comprises claw member 8402 and an ultrasonic blade
[00498] [00498] In one aspect, the first sensor 8406 is a force sensor for measuring a normal force F3 applied to tissue 8410 by claw member 8402. The second and third sensors 8408a, 8408b include one or more elements for applying energy RF to tissue 8410, measure tissue impedance, downward force F1, transverse forces F2, and temperature, among other parameters. Electrodes 8409a, 8409b are electrically coupled to a power source and apply RF energy to the 8410 tissue. In one aspect, the first 8406 sensor and the second and third 8408a, 8408b sensors are effort meters for measuring force or force by area unit. It will be recognized that the down force measurements F1, lateral forces F2 and normal force F3 can be easily converted into pressure by determining the surface area on which the force sensors 8406, 8408a, 8408b are acting. In addition, as described in particular here, the flexible circuit 8412 can comprise temperature sensors incorporated in one or more layers of the flexible circuit 8412. The one or more temperature sensors can be arranged symmetrically or asymmetrically, and provide temperature feedback from the 8410 fabric for control circuits of an ultrasonic drive circuit and an RF drive circuit.
[00499] [00499] Figure 52 illustrates an aspect of flexible circuit 8412 shown in Figure 51, in which sensors 8406, 8408a, 8408b can be mounted thereon or formed integrally with it. The flexible circuit 8412 is configured to connect securely to the jaw member 8402. As shown particularly in Figure 52, the asymmetric temperature sensors 8414a, 8414b are mounted on the flexible circuit 8412 to allow measurement of the fabric temperature 8410 (Figure 51).
[00500] [00500] Figure 53 is an alternative system 132000 for controlling the frequency of a 132002 ultrasonic electromechanical system and detecting its impedance, in accordance with at least one aspect of the present description. The 132000 system can be incorporated into a generator. A 132004 processor coupled with a 132026 memory programs a programmable counter 132006 to tune to the output frequency fo of the 132002 ultrasonic electromechanical system. The input frequency is generated by a crystal oscillator 132008 and is inserted into a fixed counter 132010 to scale the frequency to an appropriate value. The outputs of the fixed counter 132010 and the programmable counter 132006 are applied to a phase / frequency detector 132012. The output of the phase / frequency detector 132012 is applied to an active amplifier / filter circuit 132014 to generate a Vt tuning voltage that it is applied to a 132016 voltage controlled oscillator (VCO, "voltage controlled oscillator"). VCO 132016 applies the output frequency fo to an ultrasonic transducer portion of the 132002 ultrasonic electromechanical system, shown here modeled as an equivalent electrical circuit. The voltage and current signals applied to the ultrasonic transducer are monitored by a 132018 voltage sensor and a 132020 current sensor.
[00501] [00501] The outputs of the voltage and current sensors 132018, 13020 are applied to another phase / frequency detector 132022 to determine the phase angle between voltage and current as measured by voltage and current sensors 132018, 13020. A output of the 132022 phase / frequency detector is applied to a channel of a 132024 high-speed analog to digital converter (ADC) and is supplied to the 132004 processor through it. Optionally, the outputs of the voltage and current sensors 132018, 132020 can be applied to the respective channels of the two channels of ADC 132024 and supplied to the processor 132004 for zero crossing, FFT, or another algorithm described here to determine the phase angle between the voltage and current signals applied to the 132002 ultrasonic electromechanical system.
[00502] [00502] Optionally the tuning voltage Vt, which is proportional to the output frequency fo, can be fed back to processor 132004 through ADC 132024. This provides processor 132004 with a feedback signal proportional to the output frequency fo and you can use this feedback to adjust and control the fo output frequency. Temperature inference
[00503] [00503] Figures 54A to 54B are graphical representations 133000, 133010 of complex impedance spectra of the same ultrasonic device with a cold (room temperature) and hot ultrasonic blade, in accordance with at least one aspect of the present description. As used in the present invention, a cold ultrasonic blade refers to an ultrasonic blade at room temperature and a hot ultrasonic blade refers to an ultrasonic blade after it is heated by friction during use. Figure 54A is a 133000 graphical representation of the impedance phase angle φ as a function of the resonance frequency fo of the same ultrasonic device with a cold and hot ultrasonic blade and Figure 54B is a 133010 graphic representation of impedance magnitude | Z | as a function of the resonant frequency fo the same ultrasonic device with a cold and hot ultrasonic blade. The phase angle of the impedance φ and the magnitude of the impedance | Z | are at least at the fo resonance frequency.
[00504] [00504] The impedance of the Zg (t) ultrasonic transducer can be measured as the ratio between the voltage activation signals of the generator Vg (t) and the current of the generator Ig (t):
[00505] [00505] As shown in Figure 54A, when the ultrasonic blade is cold, for example, at room temperature and not heated by friction, the resonant electromechanical frequency fo the ultrasonic device is approximately 55,500 Hz and the excitation frequency of the ultrasonic transducer is adjusted to 55,500 Hz. Thus, when the ultrasonic transducer is excited at the resonant electromechanical frequency fo and the ultrasonic blade is cold, the phase angle φ is at least or approximately 0 Rad as indicated by the cold slide plot 133002. As shown in Figure 54B, when the ultrasonic blade is cold and the ultrasonic transducer is excited at the resonant electromechanical frequency fo, the magnitude of impedance | Z | is 800 Ω, for example, the magnitude of impedance | Z | is at a minimum of impedance, and the amplitude of the trigger signal is at a maximum due to the equivalent series resonance circuit of the ultrasonic electromechanical system as shown in Figure 25.
[00506] [00506] With reference now again to Figures 54A and 54B, when the ultrasonic transducer is activated by voltage signals from generator Vg (t) and current signals from generator Ig (t) at the resonant electromechanical frequency fo of 55,500 Hz, the angle phase φ between generator voltage signals Vg (t) and generator current Ig (t) is zero, the magnitude of impedance | Z | it is at a minimum impedance, for example, 800 Ω, and the signal amplitude is at a peak or maximum due to the equivalent series resonance circuit of the ultrasonic electromechanical system. As the temperature of the ultrasonic blade increases, due to the frictional heat generated in use, the resonant electromechanical frequency fo 'of the ultrasonic device decreases. Since the ultrasonic transducer is still driven by the voltage signals of generator Vg (t) and current of generator Ig (t) at the previous resonant electromechanical frequency (cold blade) fo 55,500 Hz, the ultrasonic device operates out of resonance at fo 'causing a shift in the phase angle φ between the generator voltage signals Vg (t) and the generator current Ig (t). There is also an increase in the magnitude of impedance | Z | and a drop in the peak magnitude of the trigger signal in relation to the previous electron mechanical frequency (cold blade) of 55,500 Hz. Consequently, the temperature of the ultrasonic blade can be inferred by measuring the phase angle φ between the voltage signals of the generator Vg (t) and current of generator Ig (t) when the resonant electromechanical frequency fo changes due to changes in the temperature of the ultrasonic blade.
[00507] [00507] As previously described, an electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide and an ultrasonic blade. As previously discussed, the ultrasonic transducer can be modeled as an equivalent series resonant circuit (see Figure 25) comprising a first branch having a static capacitance and a second "motion" branch having a series connected inductance, resistance and capacitance that define the electromechanical properties of a resonator. The electromechanical ultrasonic system has an initial electromechanical resonance frequency defined by the physical properties of the ultrasonic transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer is excited by a voltage signal Vg (t) and alternating current Ig (t) at a frequency equal to the electromechanical resonance frequency, for example, the resonance frequency of the electromechanical ultrasonic system. When the electromechanical ultrasonic system is excited at the resonance frequency, the phase angle φ between the voltage signals Vg (t) and current Ig (t) is zero.
[00508] [00508] Put another way, in resonance, the analog inductive impedance of the electromechanical ultrasonic system is equal to the analog capacitive impedance of the electromechanical ultrasonic system. As the ultrasonic blade heats up, for example due to frictional engagement with the tissue, the conformity of the ultrasonic blade (modeled as an analog capacitance) causes the resonance frequency of the electromechanical ultrasonic system to change. In the present example, the resonance frequency of the electromechanical ultrasonic system decreases as the temperature of the ultrasonic blade increases. In this way, the analog inductive impedance of the electromechanical ultrasonic system is no longer equal to the analog capacitive impedance of the electromechanical ultrasonic system, causing a mismatch between the activation frequency and the new resonance frequency of the electromechanical ultrasonic system. In this way, with a hot ultrasonic blade, the electromechanical ultrasonic system operates "out of resonance". The difference between the drive frequency and the resonance frequency is manifested as a phase angle φ between the voltage signals Vg (t) and current Ig (t) applied to the ultrasonic transducer.
[00509] [00509] As previously discussed, the electronic circuit of the generator can easily monitor the phase angle V between the voltage signals Vg (t) and current Ig (t) applied to the ultrasonic transducer. The phase angle φ can be determined using Fourier analysis, estimation of weighted least squares, Kalman filtration, space-vector based techniques, zero crossing method, Lissajous figures, three voltmeter method, "crossed-coil method ", vector voltmeter and vector impedance methods, standard phase instruments, phase-locked loops and other techniques previously described. The generator can continuously monitor the phase angle φ and adjust the trigger frequency until the phase angle φ is zero. At this point, the new drive frequency is equal to the resonance frequency of the new electromechanical ultrasonic system. The change in phase angle φ and / or frequency of activation of the generator can be used as an indirect or inferred measurement of the temperature of the ultrasonic blade.
[00510] [00510] A variety of techniques are available to estimate the temperature from the data in these spectra. Most notably, a nonlinear, time-varying set of state space equations can be used to model the dynamic relationship between the ultrasonic blade temperature and the measured impedance: across a range of generator drive frequencies, with the frequency range of the generator trigger is specific to the device model. Temperature estimation methods
[00511] [00511] An aspect of estimating or inferring the temperature of an ultrasonic blade can include three steps. First, define a temperature and frequency state space model that is dependent on time and energy. To model temperature as a function of frequency content, a set of nonlinear state space equations are used to model the relationship between the frequency of electromechanical resonance and the temperature of the ultrasonic blade. Second, apply a Kalman filter to improve the accuracy of the temperature estimator and the state space model over time. Third, a state estimator is provided in the feedback circuit of the Kalman filter to control the power applied to the ultrasonic transducer, and consequently the ultrasonic blade, to regulate the temperature of the ultrasonic blade. The three steps are described later in this document. Step 1
[00512] [00512] The first step is to define a temperature and frequency state space model that is dependent on time and energy. To model temperature as a function of frequency content, a set of nonlinear state space equations are used to model the relationship between the frequency of electromechanical resonance and the temperature of the ultrasonic blade. In one aspect, the state space model is defined by:
[00513] [00513] The state space model represents the rate of change of the natural frequency of the electromechanical ultrasonic system and the rate of change of the temperature of the ultrasonic blade with respect to the natural frequency, temperature, energy, and time t. represents the observability of variables that are measurable and observable such as the natural frequency of the electromechanical ultrasonic system, the temperature of the ultrasonic blade, the energy applied to the ultrasonic blade, and the time t. The temperature of the ultrasonic sheet is observable as an estimate. Step 2
[00514] [00514] The second step is to apply a Kalman filter to improve the temperature estimator and the state space model. Figure 55 is a diagram of a Kalman 133020 filter to improve the temperature estimator and the state space model based on impedance according to the equation: representing the impedance of an ultrasonic transducer measured at a variety of frequencies, from according to at least one aspect of the present description.
[00515] [00515] The Kalman 133020 filter can be used to improve the performance of the temperature estimate and allows the increase of external sensors, models, or previous information to improve the temperature forecast in the midst of noisy data. The Kalman 133020 filter includes a 133022 regulator and a 133024 plant. In control theory, a 133024 plant is the combination of process and actuator. A 133024 plant can be called a transfer function that indicates the relationship between an input signal and the output signal of a system. The 133022 regulator includes a 133026 state estimator and a 133028 K controller. The 133026 state regulator includes a 133030 feedback circuit. The 133026 state regulator receives y, the plant output 133024, as an input and feedback variable u . The state estimator 133026 is an internal feedback system that converges to the real state value of the system. The output of the state estimator 133026 is, the complete feedback control variable including the electromechanical ultrasonic system, the ultrasonic blade temperature estimate, the energy applied to the ultrasonic blade, the phase angle φ, and the time t. The input into the K 133028 controller is and the K 133028 u controller output is fed back to the 133026 and t plant estimator 133024.
[00516] [00516] Kalman filtration, also known as linear quadratic estimation (LQE), is an algorithm that uses a series of measurements observed over time, containing noise and other statistical inaccuracies, and produces estimates of unknown variables that tend to be more accurate than those based on a single measurement only, by estimating a joint probability distribution over the variables for each time period and thereby calculating the maximum probability estimate of actual measurements. The algorithm works in a two-step process. In a forecasting stage, the Kalman 133020 filter produces estimates of the current state variables, together with their uncertainties. After the result of the next measurement (necessarily corrupted with some amount of error, including random noise) is observed, these estimates are updated using a weighted average, with more weight being given to the estimates with greater certainty. The algorithm is recursive and can be executed in real time, using only the input measurements present and the previously calculated state and its uncertainty matrix; no additional past information is required.
[00517] [00517] The Kalman 133020 filter uses a dynamic model of the electromechanical ultrasonic system, known control inputs for that system, and multiple sequential measurements (observations) of the natural frequency and phase angle of the applied signals (for example, magnitude and phase of the impedance ultrasonic transducer) to the ultrasonic transducer to form an estimate of the varying amounts of the electromechanical ultrasonic system (its state) to predict the temperature of the ultrasonic blade portion of the electromechanical ultrasonic system that is better than an estimate obtained using just one single measurement only. As such, the Kalman 133020 filter is an algorithm that includes sensor and data fusion to provide the maximum probability estimate of the ultrasonic blade temperature.
[00518] [00518] The Kalman 133020 filter effectively estimates uncertainty due to noise measurements of signals applied to the ultrasonic transducer to measure natural frequency and phase shift data and also effectively estimates uncertainty due to external random factors. The Kalman 133020 filter produces an estimate of the state of the electromechanical ultrasonic system as a weighted average of the predicted state of the system and the new measurement. Weighted values provide better (that is, less) estimated uncertainty and are more "reliable" than unweighted values. Weights can be calculated from covariance, a measure of the estimated uncertainty of predicting the state of the system. The result of the weighted average is a new estimate of the state that lies between the predicted and measured state, and has a better estimated uncertainty than one or the other alone. This process is repeated at each stage of time, with the new estimate and its covariance generating the prediction used in the next iteration. This recursive nature of the Kalman 133020 filter requires only the last "best guess", rather than the whole story, of the state of the electromechanical ultrasonic system to calculate a new state.
[00519] [00519] The relative certainty of the measurements and the estimation of the current state is an important consideration, and it is common to discuss the filter response in terms of the K gain of the Kalman filter 133020. The Kalman K gain is the relative weight assigned to measurements and the estimation of the current state, and can be "adjusted" to obtain a specific performance. With a high K gain, the Kalman 133020 filter puts more weight on the most recent measurements, and thus follows them more responsively. With a low K gain, the Kalman 133020 filter follows the model's predictions more closely. From both extremes, a high gain close to one will result in a more irregular estimated trajectory, while a low gain close to zero will level the noise but decrease the responsiveness.
[00520] [00520] When real calculations are performed for the Kalman filter 133020 (as discussed below), the state estimate and covariance are encoded in covariance matrices to deal with the multiple dimensions involved in a single set of calculations. This allows a representation of the linear relationships between variables of different states (such as position, speed, and acceleration) in any of the transition models or covariance. The use of a Kalman 133020 filter does not assume that the errors are Gaussian. However, the Kalman 133020 filter produces the exact conditional probability estimate in the special case that all errors are distributed Gaussians. Step 3
[00521] [00521] The third step uses an estimator 133026 in the 133032 feedback state of the Kalman filter 133020 to control the power applied to the ultrasonic transducer, and consequently the ultrasonic blade, to regulate the temperature of the ultrasonic blade.
[00522] [00522] Figure 56 is a graphical representation 133040 of three probability distributions employed by a state estimator 133026 of the Kalman filter 133020 shown in Figure 55 to maximize the estimates, in accordance with at least one aspect of the present description. Probability distributions include the previous probability distribution 133042, the prediction probability (state) distribution 133044 and the observation probability distribution 133046. The three probability distributions 133042, 133044, 1330467 are used in an energy feedback control applied to an ultrasonic transducer to regulate the temperature based on the impedance of the ultrasonic transducer measured at a variety of frequencies, in accordance with at least one aspect of the present description. The estimator used in the feedback control of the power applied to an ultrasonic transducer to regulate the temperature based on the impedance is defined by the expression: which is the impedance of the ultrasonic transducer measured at a variety of frequencies, according to at least one aspect of this description.
[00523] [00523] The previous probability distribution 133042 includes a state variation defined by the expression:
[00524] [00524] The state variance is used to predict the next state of the system, which is represented as the forecast probability distribution (state) 133044. The observation probability distribution 133046 is the probability distribution of the actual observation of the state of the system where the observation variance is used to define the gain, which is defined by the following expression: Feedback feedback circuit
[00525] [00525] The energy input is decreased to ensure that the temperature (as estimated by the state estimator and the Kalman filter) is controlled.
[00526] [00526] In one aspect, the first proof of concept assumed a static linear relationship between the natural frequency of the electromechanical ultrasonic system and the temperature of the ultrasonic blade. By reducing the power as a function of the natural frequency of the electromechanical ultrasonic system (ie, temperature regulation with feedback feedback), the temperature of the tip of the ultrasonic blade can be controlled directly. In this example, the temperature of the distal tip of the ultrasonic blade can be controlled to not exceed the melting point of the Teflon block.
[00527] [00527] Figure 57A is a 133050 graphical representation of the temperature as a function of time of an ultrasonic device without temperature feedback control. The temperature (° C) of the ultrasonic sheet is shown along the vertical axis and the time (sec) is shown along the horizontal axis. The test was conducted with a chamois located in the claws of the ultrasonic device. One claw is the ultrasonic blade and the other claw is the clamping arm with a Teflon pad. The ultrasonic blade was excited at the resonance frequency while in friction engagement with the chamois stuck between the ultrasonic blade and the clamping arm. Over time, the temperature (° C) of the ultrasonic blade increases due to friction coupling with the suede. Over time, the temperature profile 133052 of the ultrasonic blade increases until the chamois sample is cut after about 19.5 seconds at a temperature of 220 ° C as indicated in point 133054. Without temperature feedback control, after the cutting of the suede sample, the temperature of the ultrasonic blade increases to a temperature well above the melting point of the Teflon ~ 380 ° C to ~ 490 ° C. At point 133056, the temperature of the ultrasonic blade reaches a maximum temperature of 490 ° C until the Teflon block is completely melted. The temperature of the ultrasonic sheet drops slightly from the temperature peak at point 133056 after the block has completely disappeared.
[00528] [00528] Figure 57B is a graph of temperature as a function of time of an ultrasonic device with temperature feedback control, according to at least one aspect of the present description. The temperature (° C) of the ultrasonic sheet is shown along the vertical axis and the time (sec) is shown along the horizontal axis. The test was conducted with a chamois sample located in the claws of the ultrasonic device. One claw is the ultrasonic blade and the other claw is the clamping arm with a Teflon pad. The ultrasonic blade was excited at the resonance frequency while in friction engagement with the chamois stuck between the ultrasonic blade and the clamping arm block. Over time, the temperature profile 133062 of the ultrasonic blade increases until the chamois sample is cut after about 23 seconds at a temperature of 220 ° C as indicated in 133064. With temperature feedback control, the temperature of the blade ultrasound increases to a maximum temperature of about 380 ° C, just below the melting point of TEFLON, as indicated in point 133066 and is then lowered to an average of about 330 ° C as indicated generically in region 133068, thus preventing merger of the TEFLON block. Application of intelligent ultrasonic blade technology
[00529] [00529] When an ultrasonic sheet is immersed in a surgical field filled with fluid, the ultrasonic sheet cools during activation becoming less effective for sealing and cutting tissue in contact with it. Cooling the ultrasonic sheet can lead to longer activation times and / or hemostasis problems because adequate heat is not applied to the tissue. To overcome the cooling of the ultrasonic blade, more energy may be needed to shorten the transection times and achieve adequate hemostasis under these fluid immersion conditions. With the use of a frequency-temperature feedback control system, if the temperature of the ultrasonic blade is detected to start below, or remain below a certain temperature for a certain period of time, the output power of the generator can be increased to compensate for the cooling due to blood / saline / other fluid present in the surgical field.
[00530] [00530] Consequently, the temperature-frequency feedback control system described here can optimize the performance of an ultrasonic device especially when the ultrasonic blade is located or immersed, partially or totally, in a surgical field filled with fluid. The frequency-temperature feedback control system described here minimizes long activation times and / or potential problems with the performance of the ultrasonic device in the fluid-filled surgical field.
[00531] [00531] As previously described, the temperature of the ultrasonic blade can be inferred by detecting the impedance of the ultrasonic transducer given by the following expression: or equivalently, the detection of the phase angle φ between the voltage signals Vg (t) and current Ig (t) applied to the ultrasonic transducer. Phase angle information φ can also be used to infer ultrasonic sheet conditions. As discussed in particular here, the phase angle φ changes as a function of the temperature of the ultrasonic sheet. Therefore, phase angle information φ can be used to control the temperature of the ultrasonic sheet. This can be done, for example, by reducing the power supplied to the ultrasonic sheet when the ultrasonic sheet is very hot and by increasing the power applied to the ultrasonic sheet when the ultrasonic sheet is very cold. Figures 58A to 58B are graphical representations of the temperature feedback control to adjust the ultrasonic energy applied to an ultrasonic transducer when a sudden drop in the temperature of an ultrasonic blade is detected.
[00532] [00532] Figure 58A is a graphical representation of the ultrasonic energy output 133070 as a time function, in accordance with at least one aspect of the present description. The energy output of the ultrasonic generator is shown along the vertical axis and the time (s) is shown along the horizontal axis. Figure 58B is a graphical representation of the temperature of the 133080 ultrasonic sheet as a function of time, in accordance with at least one aspect of the present description. The temperature of the ultrasonic sheet is shown along the vertical axis and the time (sec) is shown along the horizontal geometric axis. The temperature of the ultrasonic blade increases with the application of constant power 133072 as shown in Figure 58A. During use, the temperature of the ultrasonic blade drops suddenly. This can result from a variety of conditions, however, during use, it can be inferred that the temperature of the ultrasonic blade drops when it is immersed in a surgical field filled with fluid (eg, blood, saline, water, etc.). At time t0, the temperature of the ultrasonic blade falls below the desired minimum temperature 133082 and the frequency-temperature feedback feedback algorithm of the temperature feedback algorithm detects the drop in temperature and begins to increase or "raise" the power as shown by the increase in energy 133074 supplied to the ultrasonic blade to initiate the rise in temperature of the ultrasonic blade above the desired minimum temperature 133082.
[00533] [00533] With reference to Figures 58A and 58B, the ultrasonic generator provides substantially constant power outputs 133072 while the temperature of the ultrasonic blade remains above the desired minimum temperature 133082. In t0, the processor or the control circuit in the generator or instrument , or both, detects the drop in temperature of the ultrasonic blade below the desired minimum temperature 133072 and initiates a frequency-temperature feedback control algorithm to raise the temperature of the ultrasonic blade above the minimum desired temperature 133082. Consequently, the generator energy begins to rise 133074 at t1 corresponding to the detection of a sudden drop in the temperature of the ultrasonic sheet at t0. Under the frequency-temperature feedback control algorithm, the energy continues to rise 133074 until the temperature of the ultrasonic blade is above the desired minimum temperature 133082.
[00534] [00534] Figure 59 is a 133090 logic flow diagram of a process that represents a control program or a logical configuration for controlling the temperature of an ultrasonic blade, according to at least one aspect of the present description. According to the process, the processor or control circuit of the generator or instrument, or both, performs an aspect of a frequency-temperature feedback control algorithm discussed in connection with Figures 58A and 58B to apply a power level 133092 to the ultrasonic transducer to achieve a desired temperature on the ultrasonic blade. The 133094 generator monitors the phase angle φ between the voltage Vg (t) and current Ig (t) signals applied to drive the ultrasonic transducer. Based on the phase angle φ, the generator infers 133096 infers the temperature of the ultrasonic blade using the techniques described here in connection with Figures 54A to 56. The generator determines 133098 if the temperature of the ultrasonic blade is below a desired minimum temperature by comparing the inferred temperature of the ultrasonic sheet with a predetermined desired temperature. The generator then adjusts the level of power applied to the ultrasonic transducer based on the comparison. For example, the process continues along the "NO" branch when the ultrasonic sheet temperature is at or above the desired minimum temperature and continues along the "YES" branch when the ultrasonic sheet temperature is below the desired minimum temperature. When the temperature of the ultrasonic blade is below the desired minimum temperature, the generator increases the power level for the ultrasonic transducer by 133100, for example, by increasing the voltage signals Vg (t) and / or current Ig (t), to raise the temperature of the ultrasonic blade and continues to increase the power level applied to the ultrasonic transducer until the temperature of the ultrasonic blade increases above the desired minimum temperature. Adaptive advanced tissue treatment block saving mode
[00535] [00535] Figure 60 is a 133110 graphical representation of the temperature of the ultrasonic blade as a function of time during the firing of a vessel, according to at least one aspect of the present description. A 133112 graph of the ultrasonic temperature blade is plotted along the vertical axis as a function of time along the horizontal axis. The frequency-temperature feedback control algorithm combines the control temperature of the ultrasonic blade with the claw detection capability. The frequency-temperature feedback control algorithm provides optimal balanced hemostasis with device durability and can intelligently distribute energy for better sealing while protecting the clamping arm block.
[00536] [00536] As shown in Figure 60, the optimum temperature 133114 for sealing the vessel is marked as a first target temperature T1 and the optimum temperature 133116 for the "infinite" life of the clamping arm block is marked as a second life at the target temperature T2. The frequency-temperature feedback control algorithm infers the ultrasonic blade temperature and maintains the ultrasonic blade temperature between the first and second target temperature thresholds T1 and T2. The energy output of the generator is thus activated to obtain optimal temperatures from the ultrasonic blade to seal the vessels and prolong the life of the clamping arm block.
[00537] [00537] Initially, the temperature of the ultrasonic sheet increases as the sheet heats up and eventually exceeds the first target temperature threshold T1. The frequency-temperature feedback control algorithm takes control of the slide temperature to T1 until the vessel transection is completed 133118 at t0 and the ultrasonic slide temperature falls below the second target temperature threshold T2. A processor or generator or instrument control circuit, or both, detects when the ultrasonic blade comes into contact with the clamping arm block. When vessel transfection is completed at t0 and detected, the frequency-temperature feedback control algorithm changes to control the temperature of the ultrasonic blade at the second target threshold T2 to extend the life of the clamping arm block. The optimum temperature of the clamping arm block for a TEFLON clamping arm block is approximately 325 ° C. In one aspect, advanced tissue treatment can be announced to the user in a second activation tone.
[00538] [00538] Figure 61 is a 133120 logic flow diagram of a process that represents a control program or a logical configuration for controlling the temperature of an ultrasonic blade between two temperature adjustment points, as shown in Figure 60, according to with at least one aspect of the present description. According to the process, the generator performs an aspect of the frequency-temperature feedback algorithm to apply 133122 a first power level to the ultrasonic transducer, for example, by adjusting the voltage signals Vg (t) and / or current Ig (t) applied to the ultrasonic transducer, to adjust the ultrasonic blade to a first target temperature T1 optimized for vessel sealing. As previously described, the generator monitors 133124 phase angle φ between voltage signals Vg (t) and current Ig (t) applied to the ultrasonic transducer and based on phase angle φ, generator 133126 infers the temperature of the ultrasonic blade using the techniques described here in connection with Figures 54A to 56. According to the frequency-temperature feedback feedback algorithm, a generator or instrument control circuit or processor, or both, maintains the ultrasonic blade temperature at the first target temperature T1 until the transection is completed. The frequency-temperature feedback control algorithm can be used to detect the completion of the vessel's transection process. The processor or control circuit of the generator or instrument, or both, determines 133128 when the vessel's transection is complete. The process continues along the NO branch when the vessel transection is not complete and continues along the YES branch when the vessel transection is complete.
[00539] [00539] When the transection of the vessel is not complete, the processor or control circuit of the generator or instrument, or both, determines 133130 whether the temperature of the ultrasonic blade is set at the temperature T1 optimized for sealing and transection of the vessel. If the temperature of the ultrasonic blade is set to T1, the process continues along the SIM branch and the processor or generator or instrument control circuit, or both, continues to monitor 133124 the phase angle φ between voltage signals Vg ( t) and Ig current (t) applied to the ultrasonic transducer and based on the phase angle φ. If the temperature of the ultrasonic blade is not adjusted to T1, the process continues along the NO branch and the processor or control circuit of the generator or instrument, or both, continues to apply 133122 a first power level to the ultrasonic transducer.
[00540] [00540] When the vessel transection is complete, the processor or control circuit of the generator or instrument, or both, 133132 applies a second power level to the ultrasonic transducer to adjust the ultrasonic blade to a second target temperature T2 optimized to preserve or extend the life of the clamping arm block. The processor or control circuit of the generator or instrument, or both, determines 133134 whether the temperature of the ultrasonic blade is at the set temperature T2. If the temperature of the ultrasonic blade is set to T2, the process completes the 133136 vessel transection procedure. Blade Start Temperature
[00541] [00541] Knowing the temperature of the ultrasonic blade at the beginning of a transection can allow the generator to provide the adequate amount of energy to heat the blade for a quick cut or if the blade is already hot add energy only in the amount that would be needed. This technique can achieve more consistent transection times and extends the life of the claw arm block (for example, a TEFLON clamping arm block). Knowing the temperature of the ultrasonic blade at the beginning of the transection can allow the generator to supply the right amount of energy to the ultrasonic transducer to generate a desired amount of displacement of the ultrasonic blade.
[00542] [00542] Figure 62 is a 133140 logic flow diagram of a process that represents a control program or a logical configuration to determine the initial temperature of an ultrasonic blade, according to at least one aspect of the present description. To determine the initial temperature of an ultrasonic blade, at the manufacturing facilities, the resonance frequencies of ultrasonic sheets are measured at room temperature or at a predetermined room temperature. Baseline frequency values are recorded and stored in a lookup table for the generator or instrument or both. Baseline values are used to generate a transfer function. At the start of an ultrasonic transducer activation cycle, the generator measures 133142 the resonance frequency of the ultrasonic blade 133144 and compares the resonance frequency measured to the resonance frequency value in the baseline and determines the frequency difference (Δf). Δf is compared to a look-up table or transfer function to obtain the corrected temperature of the ultrasonic sheet. The resonance frequency of the ultrasonic blade can be determined by scanning the frequency of the voltage signals Vg (t) and current Ig (t) applied to the ultrasonic transducer. The resonance frequency is the frequency at which the phase angle φ between the voltage signals Vg (t) and current Ig (t) is zero as described in the present invention.
[00543] [00543] After the resonance frequency of the ultrasonic blade is determined, the processor or control circuit of the generator or instrument, or both, determines 133146 the initial temperature of the ultrasonic blade based on the difference between the measured resonance frequency and the frequency of baseline resonance. The generator sets the power level supplied to the ultrasonic transducer, for example, by adjusting the voltage trigger signals Vg (t) or current Ig (t) or both, to one of the following values before activating the ultrasonic transducer.
[00544] [00544] The processor or control circuit of the generator or instrument, or both, determines 133148 if the initial temperature of the ultrasonic blade is low. If the initial temperature of the ultrasonic blade is low, the process continues along the SIM branch and the processor or generator or instrument control circuit, or both, 133152 applies a high power level to the ultrasonic transducer to increase the temperature of the ultrasonic blade and complete 133156 the vessel transection procedure.
[00545] [00545] If the initial temperature of the ultrasonic blade is not low, the process continues along the NO branch and the processor or control circuit of the generator or instrument, or both, determines 133150 if the initial temperature of the ultrasonic blade is high. If the initial temperature of the ultrasonic blade is low, the process continues along the YES branch and the processor or generator or instrument control circuit, or both, 133154 applies a low power level to the ultrasonic transducer to decrease the temperature of the ultrasonic blade and complete 133156 the vessel transection procedure. If the initial temperature of the ultrasonic blade is not high, the process continues along the NO branch and the processor or control circuit of the generator or instrument, or both, completes the vessel's transection. Intelligent blade technology to control blade instability
[00546] [00546] The temperature of an ultrasonic blade and the contents within the claws of an ultrasonic end actuator can be determined using the frequency-temperature feedback control algorithms described in the present invention. The frequency / temperature ratio of the ultrasonic blade is used to control the instability of the ultrasonic blade instability with temperature.
[00547] [00547] As described here, there is a well-known relationship between frequency and temperature in ultrasonic sheets. Some ultrasonic sheets have instability or modal shift instability in the presence of increased temperature. This known relationship can be used to interpret when an ultrasonic blade is approaching instability and then adjust the power level by triggering the ultrasonic transducer (for example, by adjusting the trigger signals for voltage Vg (t) or current Ig (t), or both, applied to the ultrasonic transducer) to modulate the temperature of the ultrasonic blade to avoid instability of the ultrasonic blade.
[00548] [00548] Figure 63 is a 133160 logic flow diagram of a process that represents a control program or a logical configuration to determine when an ultrasonic blade is approaching instability and then adjust the power applied to the ultrasonic transducer to prevent instability of the ultrasonic transducer, in accordance with at least one aspect of the present description. The frequency / temperature relationship of an ultrasonic blade that presents a displacement or modal instability is mapped by scanning the frequency of the triggering signals of voltage Vg (t) or current Ig (t), or both, in the temperature of the ultrasonic blade and record the results. A function or relation is developed that can be used / interpreted by a control algorithm executed by the generator. Trigger points can be established using the relationship to notify the generator that an ultrasonic blade is approaching known blade instability. The generator performs a processing function of the frequency-temperature feedback control algorithm and the closed-loop response so that the power level of the drive is reduced (for example, by lowering the voltage Vg (t) or current Ig ( t) drive, or both, applied to the ultrasonic transducer) to modulate the temperature of the ultrasonic blade at or below the drive point to prevent a given blade from reaching instability.
[00549] [00549] The advantages include simplifying the settings of the ultrasonic blade so that the instability characteristics of the ultrasonic blade do not need to be designed and can be compensated with the use of the present instability control technique. The present instability control technique also allows for new ultrasonic sheet geometries and can improve the stress profile in heated ultrasonic sheets. In addition, ultrasonic sheets can be configured to decrease the performance of the ultrasonic sheet if used with generators that do not use this technique.
[00550] [00550] According to the process shown by logic flow diagram 133160, the processor or control circuit of the generator or instrument, or both, monitors 133162 the phase angle φ between voltage signals Vg (t) and current Ig ( t) applied to the ultrasonic transducer. The processor or control circuit of the generator or instrument, or both, infers 133164 the temperature of the ultrasonic blade based on the phase angle φ between the voltage signals Vg (t) and current Ig (t) applied to the ultrasonic transducer. The processor or control circuit of the generator or instrument, or both, compares 133166 the inferred temperature of the ultrasonic blade to an ultrasonic blade instability trigger point threshold. The processor or control circuit of the generator or instrument, or both, determines 133168 whether the ultrasonic blade is approaching instability. If not, the process proceeds along the NO branch and monitors 133162 the phase angle φ, infers 133164 the temperature of the ultrasonic blade, and compares 133166 the inferred temperature of the ultrasonic blade to a trigger point threshold of instability of the ultrasonic blade up to the ultrasonic sheet approaches instability. The process then proceeds along the SIM branch and the processor or control circuit of the generator or instrument, or both, adjusts the 133170 power level applied to the ultrasonic transducer to modulate the temperature of the ultrasonic blade. Ultrasonic sealing algorithm with temperature control
[00551] [00551] Ultrasonic sealing algorithms for temperature control of the ultrasonic blade can be used to optimize the hemostasis using a frequency-temperature feedback control algorithm described here to explore the frequency / temperature relationship of the ultrasonic sheets.
[00552] [00552] In one aspect, a frequency-temperature feedback control algorithm can be used to change the applied power level of the ultrasonic transducer based on the measured resonance frequency (using spectroscopy) that refers to the temperature, as described in various aspects of this description. In one respect, the frequency-temperature feedback control algorithm can be activated by a power button on the ultrasonic instrument.
[00553] [00553] It is known that great tissue effects can be obtained by increasing the power level that drives the ultrasonic transducer (for example, by increasing the voltage Vg (t) or current Ig (t), or both, applied to the ultrasonic transducer) at the beginning of the sealing cycle to quickly heat and dry the tissue, then lower the power level that drives the ultrasonic transducer (for example, by lowering the voltage Vg (t) or driving current Ig (t), or both, applied to the ultrasonic transducer) to slowly allow the formation of the final seal. In one aspect, a frequency-temperature feedback feedback algorithm according to the present description sets a threshold in the temperature threshold that the tissue can reach as the tissue warms up during the higher power level stage and then reduces the power level to control the temperature of the ultrasonic blade based on the melting point of the clamping clamp block (eg Teflon) to complete the seal. The control algorithm can be implemented by activating a power button on the instrument for a more responsive / adaptive seal to further reduce the complexity of the hemostasis algorithm.
[00554] [00554] Figure 64 is a 133180 logic flow diagram of a process that represents a control program or a logical configuration to provide ultrasonic sealing with temperature control, in accordance with at least one aspect of the present description. According to the control algorithm, the processor or control circuit of the generator or instrument, or both, activates 133182 ultrasonic blade detection using spectroscopy (for example, smart blade) and measures 133184 the resonance frequency of the blade ultrasonic (for example, the resonance frequency of the ultrasonic electromechanical system) to determine the temperature of the ultrasonic blade using a frequency-temperature feedback control algorithm (spectroscopy) as described in the present invention. As previously described, the resonance frequency of the ultrasonic electromechanical system is mapped to obtain the temperature of the ultrasonic blade as a function of the resonance frequency of the electromechanical ultrasonic system.
[00555] [00555] A first desired resonance frequency fx of the ultrasonic electromechanical system corresponds to a first desired temperature Z ° of the ultrasonic blade. In one aspect, the first temperature of the desired ultrasonic blade Z ° is the optimum temperature (for example, 450 ° C) for tissue coagulation. A second desired frequency fY of the ultrasonic electromechanical system corresponds to a second desired temperature ZZ ° of the ultrasonic blade. In one aspect, the second temperature of the desired ultrasonic blade ZZ ° is a temperature of 330 ° C, which is below the melting point of the clamping arm block, approximately 380 ° C which is for TEFLON.
[00556] [00556] The processor or control circuit of the generator or instrument, or both, compares 133186 the measured resonance frequency of the ultrasonic electromechanical system to the first desired frequency fx. In other words, the process determines whether the temperature of the ultrasonic blade is less than the temperature for optimal tissue coagulation. If the resonance frequency measurement of the ultrasonic electromechanical system is less than the first desired frequency fx, the process continues along the NO branch and the processor or generator or instrument control circuit, or both, 133188 increases the applied power level to the ultrasonic transducer to increase the temperature of the ultrasonic blade until the measured resonance frequency of the ultrasonic electromechanical system exceeds the first desired frequency fx. In this case, the tissue coagulation process is completed and the process controls the temperature of the ultrasonic sheet to the second desired temperature corresponding to the second desired frequency fy.
[00557] [00557] The process continues along the YES branch and the processor or control circuit of the generator or instrument, or both, decreases 133190 the power level applied to the ultrasonic transducer to decrease the temperature of the ultrasonic blade. The generator or instrument control processor or circuit, or both, measures 133192 the resonance frequency of the ultrasonic electromechanical system and compares the measured resonance frequency to the second desired frequency fY. If the measured resonance frequency is not less than the desired second frequency fY, the processor or control circuit of the generator or instrument, or both, decreases the ultrasonic power level 133190 until the measured resonance frequency is less than the second frequency desired fY. The frequency-temperature feedback control algorithm keeps the measured resonance frequency of the ultrasonic electromechanical system below the desired second frequency fY, for example, the temperature of the ultrasonic blade is less than the melting point temperature of the clamping arm block the generator then performs the power level increases applied to the ultrasonic transducer to increase the temperature of the ultrasonic blade until the completion of the tissue transection process
[00558] [00558] Figure 65 is a 133200 graphical representation of the ultrasonic transducer current and the ultrasonic blade temperature as a function of time, in accordance with at least one aspect of the present description. Figure 65 illustrates the results of the application of the frequency-temperature feedback control algorithm described in Figure 64. Graphical representation 133200 represents a first plot 133202 of the ultrasonic blade temperature as a function of time in relation to a second plot 133204 of the current of the ultrasonic transducer Ig (t) as a function of time. As shown, the Ig (t) transducer is kept constant until the temperature of the ultrasonic blade reaches 450 °, which is an optimal coagulation temperature. When the temperature of the ultrasonic blade reaches 450 °, the frequency-temperature feedback feedback algorithm decreases the current of the Ig (t) transducer until the temperature of the ultrasonic blade drops below 330 °, which is below the melting point of a Teflon block, for example. Controlled thermal management (CTM) for block protection
[00559] [00559] In one aspect, the present description provides a controlled thermal management algorithm (CTM) to regulate the temperature with feedback feedback. The output of the feedback control circuit can be used to prevent the clamping arm block of the ultrasonic end actuator from burning, which, for ultrasonic surgical instruments, is not a desirable effect. As previously discussed, in general, the consumption of the block is caused by the continuous application of ultrasonic energy to an ultrasonic blade in contact with the block after the tissue tightened on the end actuator has been transected.
[00560] [00560] The CTM algorithm emphasizes the fact that the resonance frequency of an ultrasonic blade, in general, made of titanium, varies in proportion to the temperature. As the temperature increases, the modulus of elasticity of the ultrasonic sheet decreases, as does the natural frequency of the ultrasonic sheet. One factor to be considered is that when the distal end of the ultrasonic blade is hot, but the waveguide is cold, there is a frequency difference (delta) to reach a predetermined temperature that is different from the frequency difference when the distal end of the ultrasonic blade and waveguide are both hot.
[00561] [00561] In one aspect, the CTM algorithm calculates a change in the frequency of the trigger signal of the ultrasonic transducer that is necessary to reach a certain predetermined temperature as a function of the resonance frequency of the ultrasonic electromechanical system at the start of the activation (when locking) ). The ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by an ultrasonic waveguide has a predefined resonance frequency that varies with temperature. The resonance frequency of the ultrasonic electromechanical system in the "lock" can be used to estimate the change in the activation frequency of the ultrasonic transducer that is necessary to obtain an end temperature point to consider the initial thermal state of the ultrasonic blade. The resonance frequency of the ultrasonic electromechanical system can vary as a function of the temperature of the ultrasonic transducer or the ultrasonic waveguide or the ultrasonic blade or a combination of these components.
[00562] [00562] Figure 66 is a 133300 graphical representation of the relationship between the initial resonance frequency (locking frequency) and the change in frequency (delta frequency) necessary to obtain a temperature of approximately 340 ° C, according to at least an aspect of the present description. The change in frequency required to achieve an ultrasonic blade temperature of approximately 340 ° C is shown along the vertical axis and the resonance frequency of the electromechanical ultrasonic system in the lock is shown along the horizontal axis. Based on the measurement data points 133302 shown as a scatter plot there is a 133304 linear relationship between the change in frequency required to achieve an ultrasonic blade temperature of approximately 340 ° C and the resonance frequency on locking.
[00563] [00563] When locking the resonance frequency, the CTM algorithm uses the 133304 linear relationship between the locking frequency and the delta frequency necessary to obtain a temperature just below the melting point of a TEFLON block (approximately 340 ° C ).
[00564] [00564] Figure 68 is a 133320 flow diagram of a process or configuration of a controlled thermal management algorithm (CTM) to protect the clamping arm block in an ultrasonic end actuator, according to at least one aspect of this description. The configuration process or logic illustrated by means of flow diagram 133320 can be performed by the ultrasonic generator 133312 as described in the present invention or by control circuits located in the ultrasonic instrument or a combination thereof. As previously discussed, the generator
[00565] [00565] In one aspect, initially the control circuit on generator 133312 activates the ultrasonic instrument by applying an electric current to the ultrasonic transducer. The resonance frequency of the ultrasonic electromechanical system is initially locked in initial conditions where the temperature of the ultrasonic blade is cold or close to the ambient temperature. As the temperature of the ultrasonic blade increases due to frictional contact with the tissue, for example, the control circuit monitors the change or delta in the resonance frequency of the ultrasonic electromechanical system and determines 133324 whether the delta frequency threshold for a temperature predetermined blade has been reached. If the delta frequency is below the threshold, the process continues along the NO branch and the control circuit continues to search for the new resonance frequency and monitor the delta frequency. When the delta frequency meets or exceeds the delta frequency threshold, the process continues along the YES branch and calculates 133326 a new lower limit frequency (threshold), which corresponds to the melting point of the clamping arm block. In a non-limiting example, the clamp arm block is made of Teflon and the melting point is approximately 340 ° C.
[00566] [00566] When a new lower frequency limit is calculated 133326, the control circuit determines 133328 if the resonance frequency is close to the newly calculated lower frequency limit. For example, in the case of a TEFLON clamping arm block, the control circuit determines 133328 whether the temperature of the ultrasonic blade is approaching 350 ° C, for example, based on the current's resonant frequency. If the resonant frequency of the current is above the lower frequency limit, the process continues along the NO branch and applies a normal level of electrical current to the ultrasonic transducer suitable for tissue transection. Alternatively, if the current resonance frequency is at or below the lowest lower frequency limit, the process continues along the YES branch and regulates the resonance frequency 133332 by modifying the electrical current applied to the ultrasonic transducer. In one aspect, the control circuit uses a PID controller as described with reference to Figures 44 to 45, for example. The control circuit regulates the frequency in a circuit 133332 to determine 133328 when the frequency is close to the lower limit until the "seal and cut" surgical procedure is complete and the ultrasonic transducer is deactivated. Since the CTM algorithm represented by logic flow diagram 133320 only has an effect at or near the melting point of the clamping arm block, the CTM algorithm is activated after the tissue is transected.
[00567] [00567] The burst pressure of tests conducted with samples indicates that there is no impact on the seal burst pressure when the CTM process or the logical configuration represented by the 133320 logic flow diagram is used to seal and cut vessels or other fabric. In addition, based on test samples, the transection times were affected. In addition, temperature measurements confirm that the temperature of the ultrasonic blade is delimited by the CTM algorithm compared to devices without CTM feedback algorithm control and devices that have undergone 10 shots at full power for ten seconds against the block with 5 seconds of rest between shots showed significantly reduced wear of the block while no devices without CTM algorithm feedback control lasted more than 2 shots in this abuse test.
[00568] [00568] Figure 69 is a 133340 graphical representation of temperature versus time comparing the desired temperature of an ultrasonic blade with an intelligent ultrasonic blade and a conventional ultrasonic blade, in accordance with at least one aspect of the present description. The temperature (steps C) is shown along the vertical axis and the time (sec) is shown along the horizontal axis. In the plot, the dash-dot line is a temperature threshold 133342 that represents the desired temperature of the ultrasonic sheet. The solid line is a temperature curve versus time 133344 of an intelligent ultrasonic slide under the control of the CTM algorithm described with reference to Figures 67 and 68. The dotted line is a temperature curve versus time 133346 of a slide. regular ultrasound that is not under the control of the CTM algorithm described with reference to Figures 67 and 68. As shown. When the temperature of the intelligent ultrasonic blade under the control of the CTM algorithm exceeds the desired temperature threshold (~ 340 ° C), the CTM algorithm takes control and regulates the temperature of the intelligent ultrasonic blade to match the threshold as strictly as possible until the transection procedure is completed and the power to the ultrasonic transducer is disabled or interrupted.
[00569] [00569] In another aspect, the present description provides a CTM algorithm for an effect of "sealing only" the tissue by an ultrasonic device, such as ultrasonic scissors, for example. In general, ultrasonic surgical instruments typically seal and cut tissue simultaneously. Creating an ultrasonic device configured for sealing only without cutting has not been difficult to obtain with the use of ultrasonic technology only due to the uncertainties of knowing when the sealing was completed before starting the cutting. In one aspect, the CTM algorithm that can be configured to protect the end actuator's clamping arm block by allowing the temperature of the ultrasonic blade to exceed the temperature required for cutting (transecting) the tissue, but not to exceed the point of fusion of the clamping arm block.
[00570] [00570] In another aspect, the present description provides a cold temperature monitoring algorithm (CTMo) configured to detect when it is possible to hold in an atraumatic manner. Acoustic ultrasonic energy results in an ultrasonic blade with a temperature of approximately 230 ° C to approximately 300 ° C to obtain the desired effect of cutting or transecting the tissue. Since heat is retained in the metallic body of the ultrasonic blade for a period of time after disabling the ultrasonic transducer, residual heat stored in the ultrasonic blade can cause tissue damage if the ultrasonic end actuator is used to secure the tissue before ultrasonic blade have had a chance to cool.
[00571] [00571] In one aspect, the CTMo algorithm calculates a change in the natural frequency of the ultrasonic electromechanical system from the natural frequency in a warm state to a natural frequency at a temperature where atraumatic gripping is possible without damaging the tissue trapped by the end actuator. Directly or at a predetermined time after activation of the ultrasonic transducer, a non-therapeutic signal (approximately 5 mA) is applied to the ultrasonic transducer containing a frequency bandwidth, approximately 48,000 Hz to 52,000 Hz, for example, in which expects the natural frequency to be found. An FFT algorithm, or another mathematically efficient algorithm for detecting the natural frequency of the ultrasonic electromechanical system, of the impedance of the ultrasonic transducer measured during stimulation of the ultrasonic transducer with the non-therapeutic signal will indicate the natural frequency of the ultrasonic blade as the frequency in which the magnitude of impedance is at a minimum. The continuous stimulus of the ultrasonic transducer in this way provides continuous feedback of the natural frequency of the ultrasonic blade within a frequency resolution of the FFT or other algorithm to estimate or measure the natural frequency. When a change in natural frequency is detected that corresponds to a temperature that is feasible for atraumatic grasping, a tone, or an LED, or a screen display or other form of notification, or a combination thereof, is provided to indicate that the device is capable of atraumatic gripping.
[00572] [00572] In another aspect, the present description provides a CTM algorithm configured to notify the sealing and the end of the cut or transection. Providing "sealed fabric" and "end of cut" notifications is a challenge for conventional ultrasonic devices because temperature measurement cannot be easily mounted directly on the ultrasonic blade and the clamping arm block is not explicitly detected by the blade with use of sensors. A CTM algorithm can indicate the temperature state of the ultrasonic blade and can be used to indicate the "end of cut" or "sealed fabric" states, or both, because these states are temperature-based events.
[00573] [00573] In one aspect, a CTM algorithm according to the present description detects the "final cut" state and activates a notification. The fabric typically cuts at approximately 210 ° C to approximately 320 ° C with high probability. A CTM algorithm can activate a tone at 320 ° C (or similar) to indicate that additional activation on the tissue is not productive since the tissue is likely to be cut and the ultrasonic blade is moving against the clamping arm block, which is acceptable when the CTM algorithm is active as it controls the temperature of the ultrasonic blade. In one aspect, the CTM algorithm is programmed to control or regulate power to the ultrasonic transducer to maintain the ultrasonic blade temperature up to approximately 320 ° C when it is estimated that the ultrasonic blade temperature has reached 320 ° C. Starting a tone at this point provides an indication that the fabric has been cut. The CTM algorithm is based on a variation in frequency with temperature. After determining an initial state temperature (based on the initial frequency), the CTM algorithm can calculate a change in frequency that corresponds to a temperature that implies when the tissue is cut. For example, if the starting frequency is 51,000 Hz, the CTM algorithm will calculate the change in frequency required to reach 320 ° C, which can be -112 Hz. Then it will start control to maintain the frequency setpoint (for example, example, 50,888 Hz) thus regulating the temperature of the ultrasonic blade. Similarly, a change in frequency can be calculated based on an initial frequency that indicates when the ultrasonic sheet is at a temperature that indicates that the tissue is likely to be cut. At this point, the CTM algorithm does not have to control the power, but simply initiates a tone to indicate the state of the tissue or the CTM algorithm can control the frequency at this point to maintain that temperature if desired. In any case, the "end of cut" is indicated.
[00574] [00574] In one aspect, a CTM algorithm according to the present description detects the "sealed tissue" state and activates a notification. Similar to the end of the cut detection, the fabric seals between approximately 105 ° C and approximately 200 ° C. The change in frequency from an initial frequency required to indicate that an ultrasonic blade temperature has reached 200 ° C, which indicates a sealing state only, can be calculated at the beginning of the activation of the ultrasonic transducer. The CTM algorithm can activate a tone at this point and if the surgeon wishes to obtain a sealing state only, the surgeon could stop the activation or to achieve a sealing state he can only stop the activation of the ultrasonic transducer and automatically start a sealing algorithm only specific from this point onwards or the surgeon could continue activating the ultrasonic transducer to obtain a tissue cutting state. Situational recognition
[00575] [00575] Figure 70 shows a 5200 timeline representing the situational recognition of a central controller, such as the central surgical controller 106 or 206, for example. Timeline 5200 is an illustrative surgical procedure and the contextual information that the central surgical controller 106, 206 can derive from data received from data sources at each stage in the surgical procedure. Timeline 5200 represents the typical steps that would be taken by nurses, surgeons, and other medical personnel during the course of a pulmonary segmentectomy procedure, starting with the setup of the operating room and ending with the transfer of the patient to an operating room. postoperative recovery.
[00576] [00576] The central surgical controller with situational recognition 106, 206 receives data from data sources throughout the course of the surgical procedure, including the data generated each time medical personnel use a modular device that is paired with the central surgical controller 106 , 206. Central surgical controller 106, 206 can receive this data from the paired modular devices and other data sources and continuously derives inferences (ie contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is being performed at any given time. The situational recognition system of the central surgical controller 106, 206 is capable of, for example, recording data related to the procedure to generate reports, checking the steps being taken by medical personnel, providing data or warnings (for example, through a display) that may be relevant to the specific step of the procedure, adjust the modular devices based on the context (for example, activate monitors, adjust the field of view (FOV) of the medical imaging device, or change the energy level of a ultrasonic surgical instrument or RF electrosurgical instrument), and take any other action described above.
[00577] [00577] In the first step 5202, in this illustrative procedure, members of the hospital team retrieve the electronic patient record (PEP) from the hospital's PEP database. Based on patient selection data in the PEP, the central surgical controller 106, 206 determines that the procedure to be performed is a thoracic procedure.
[00578] [00578] In the second step 5204, the team members scan the entry of medical supplies for the procedure. Central surgical controller 106, 206 cross-references the scanned supplies with a list of supplies that are used in various types of procedures and confirms that the supply mix corresponds to a thoracic procedure. In addition, the central surgical controller 106, 206 is also able to determine that the procedure is not a wedge procedure (because the inlet supplies have an absence of certain supplies that are necessary for a thoracic wedge procedure or, otherwise, that inlet supplies do not correspond to a thoracic wedge procedure).
[00579] [00579] In the third step 5206, the medical staff scans the patient's band with a scanner that is communicably connected to the central surgical controller 106, 206. The central surgical controller 106, 206 can then confirm the patient's identity based on the scanned data.
[00580] [00580] In the fourth step 5208, the medical staff turns on the auxiliary equipment.
[00581] [00581] In the fifth step 5210, the team members fix the electrocardiogram (ECG) electrodes and other patient monitoring devices on the patient. ECG electrodes and other patient monitoring devices are able to pair with central surgical controller 106, 206. As central surgical controller 106, 206 begins to receive data from patient monitoring devices, central surgical controller 106, 206 thus confirming that the patient is in the operating room.
[00582] [00582] In the sixth step 5212, the medical personnel induced anesthesia in the patient. Central surgical controller 106, 206 can infer that the patient is under anesthesia based on data from modular devices and / or patient monitoring devices, including ECG data, blood pressure data, ventilator data, or combinations of themselves, for example. After the completion of the sixth step 5212, the preoperative portion of the lung segmentectomy procedure is completed and the operative portion begins.
[00583] [00583] In the seventh step 5214, the lung of the patient being operated on is retracted (while ventilation is switched to the contralateral lung). The central surgical controller 106, 206 can infer from the ventilator data that the patient's lung has been retracted, for example. Central surgical controller 106, 206 can infer that the operative portion of the procedure started when it can compare the detection of the patient's lung collapse at the expected stages of the procedure (which can be accessed or retrieved earlier) and thus determine that the retraction of the patient lung is the first operative step in this specific procedure.
[00584] [00584] In the eighth step 5216, the medical imaging device (for example, a display device) is inserted and the video from the medical imaging device is started. Central surgical controller 106, 206 receives data from the medical imaging device (i.e., video or image data) through its connection to the medical imaging device.
[00585] [00585] In the ninth step 5218 of the procedure, the surgical team starts the dissection step. Central surgical controller 106, 206 can infer that the surgeon is in the process of dissecting to mobilize the patient's lung because he receives data from the RF or ultrasonic generator that indicate that an energy instrument is being fired. The central surgical controller 106, 206 can cross-check the received data with the steps retrieved from the surgical procedure to determine that an energy instrument being fired at that point in the process (that is, after the completion of the previously discussed steps of the procedure) corresponds to the step of dissection. In certain cases, the energy instrument may be a power tool mounted on a robotic arm in a robotic surgical system.
[00586] [00586] In the tenth step 5220 of the procedure, the surgical team proceeds to the connection step. Central surgical controller 106, 206 can infer that the surgeon is ligating the arteries and veins because he receives data from the surgical stapling and cutting instrument indicating that the instrument is being fired. Similar to the previous step, the central surgical controller 106, 206 can derive this inference by crossing the reception data of the stapling and surgical cutting instrument with the steps recovered in the process. In certain cases, the surgical instrument can be a surgical tool mounted on a robotic arm of a robotic surgical system.
[00587] [00587] In the eleventh step 5222, the segmentectomy portion of the procedure is performed. Central surgical controller 106, 206 can infer that the surgeon is transecting the parenchyma based on data from the surgical stapling and cutting instrument, including data from its cartridge. The cartridge data can correspond to the size or type of clamp being triggered by the instrument, for example. As different types of staples are used for different types of fabrics, the cartridge data can thus indicate the type of fabric being stapled and / or transected. In this case, the type of clamp that is fired is used for the parenchyma (or other similar types of tissue), which allows the central surgical controller 106, 206 to infer which segmentectomy portion of the procedure is being performed.
[00588] [00588] In the twelfth step 5224, the node dissection step is then performed. The central surgical controller 106, 206 can infer that the surgical team is dissecting the node and performing a leak test based on the data received from the generator that indicates which ultrasonic or RF instrument is being fired. For this specific procedure, an RF or ultrasonic instrument being used after the parenchyma has been transected corresponds to the node dissection step, which allows the central surgical controller 106, 206 to make this inference. It should be noted that surgeons regularly switch between surgical stapling / cutting instruments and surgical energy instruments (that is, RF or ultrasonic) depending on the specific step in the procedure because different instruments are better adapted for specific tasks. Therefore, the specific sequence in which the cutting / stapling instruments and surgical energy instruments are used can indicate which stage of the procedure the surgeon is performing. In addition, in certain cases, robotic tools can be used for one or more steps in a surgical procedure and / or Hand held surgical instruments can be used for one or more steps in the surgical procedure. The surgeon can switch between robotic tools and hand-held surgical instruments and / or can use the devices simultaneously, for example. After the completion of the twelfth stage 5224, the incisions are closed and the post-operative portion of the process begins.
[00589] [00589] In the thirteenth stage 5226, the patient's anesthesia is reversed. The central surgical controller 106, 206 can infer that the patient is emerging from anesthesia based on ventilator data (i.e., the patient's respiratory rate begins to increase), for example.
[00590] [00590] Finally, in the fourteenth step 5228 is that medical personnel remove the various patient monitoring devices from the patient. Central surgical controller 106, 206 can thus infer that the patient is being transferred to a recovery room when the central controller loses ECG, blood pressure and other data from patient monitoring devices. As can be seen from the description of this illustrative procedure, the central surgical controller 106, 206 can determine or infer when each step of a given surgical procedure is taking place according to the data received from the various data sources that are communicably coupled to the controller central surgery 106, 206.
[00591] [00591] Situational awareness is further described in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, which is hereby incorporated by reference in its entirety. In certain cases, the operation of a robotic surgical system, including the various robotic surgical systems described here, for example, can be controlled by the central controller 106, 206 based on its situational perception and / or feedback from its components and / or based on information from the cloud
[00592] [00592] Although several forms have been illustrated and described, it is not the applicant's intention to restrict or limit the scope of the claims attached to such detail. Numerous modifications, variations, alterations, substitutions, combinations and equivalents of these forms can be implemented and will occur to those skilled in the art without departing from the scope of the present description. In addition, the structure of each element associated with the shape can alternatively be described as a means of providing the function performed by the element. In addition, where materials for certain components are described, other materials can be used. It should be understood, therefore, that the preceding description and the appended claims are intended to cover all these modifications, combinations and variations that fall within the scope of the modalities presented. The attached claims are intended to cover all such modifications, variations, alterations, substitutions, modifications and equivalents.
[00593] [00593] The previous detailed description presented various forms of devices and / or processes through the use of block diagrams, flowcharts and / or examples. Although these block diagrams, flowcharts and / or examples contain one or more functions and / or operations, it will be understood by those skilled in the art that each function and / or operation within these block diagrams, flowcharts and / or examples can be implemented, individually and / or collectively, through a wide range of hardware, software, firmware or virtually any combination thereof. Those skilled in the art will recognize, however, that some aspects of the aspects described here, in whole or in part, can be implemented in an equivalent manner in integrated circuits, such as one or more computer programs running on one or more computers (for example, as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (for example, as one or more programs running on one or more microprocessors), as firmware, or virtually as any combination of them, and that designing the circuitry and / or writing the code for the software and firmware would be within the scope of practice of those skilled in the art, in the light of this description. In addition, those skilled in the art will understand that the mechanisms of the subject described herein can be distributed as one or more program products in a variety of ways and that an illustrative form of the subject described here is applicable regardless of the specific type of transmission medium. signals used to effectively carry out the distribution.
[00594] [00594] The instructions used to program the logic to execute various aspects described can be stored in a memory in the system, such as dynamic random access memory (DRAM), cache, flash memory or other storage. In addition, instructions can be distributed over a network or through other computer-readable media. Thus, machine-readable media can include any mechanism to store or transmit information in a machine-readable form (for example, a computer), but is not limited to, floppy disks, optical discs, read-only compact disc ( CD-ROMs), and optical discs- dynamo discs, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), cards magnetic or optical, flash memory, or machine-readable tangible storage media used to transmit information over the Internet via an electrical, optical, acoustic cable or other forms of propagation signals (for example, carrier waves, infrared signal, digital signals, etc.). Consequently, computer-readable non-transitory media includes any type of machine-readable media suitable for storing or transmitting instructions or electronic information in a machine-readable form (for example, a computer).
[00595] [00595] As used in any aspect of the present invention, the term "control circuit" can refer to, for example, a set of wired circuits, programmable circuits (for example, a computer processor comprising one or more cores individual instruction processing units, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic matrix (PLA), or field programmable port arrangement ( FPGA)), state machine circuits, firmware that stores instructions executed by the programmable circuit, and any combination thereof. The control circuit can, collectively or individually, be incorporated as an electrical circuit that is part of a larger system, for example, an integrated circuit (IC), an application-specific integrated circuit (ASIC), an on-chip system (SoC ), desktop computers, laptop computers, tablet computers, servers, smart headsets, etc. Consequently, as used in the present invention, "control circuit" includes, but is not limited to, electrical circuits that have at least one discrete electrical circuit, electrical circuits that have at least one integrated circuit, electrical circuits that have at least one circuit integrated for specific application, electrical circuits that form a general purpose computing device configured by a computer program (for example, a general purpose computer configured by a computer program that at least partially executes processes and / or devices described herein, or a microprocessor configured by a computer program that at least partially performs the processes and / or devices described here), electrical circuits that form a memory device (for example, forms of random access memory), and / or electrical circuits that form a communications device (for example, a modem, communication key, or eq optical-electrical equipment). Those skilled in the art will recognize that the subject described here can be implemented in an analog or digital way, or in some combination of these.
[00596] [00596] As used in any aspect of the present invention, the term "logical" can refer to an application, software, firmware and / or circuit configured to perform any of the aforementioned operations. The software may be incorporated as a software package, code, instructions, instruction sets and / or data recorded on the computer-readable non-transitory storage media. The firmware can be embedded as code, instructions or instruction sets and / or data that are hard-coded (for example, non-volatile) in memory devices.
[00597] [00597] As used in any aspect of the present invention, the terms "component", "system", "module" and the like may refer to a computer-related entity, be it hardware, a combination of hardware and software, software or software running.
[00598] [00598] As used here in one aspect of the present invention, an "algorithm" refers to the self-consistent sequence of steps leading to the desired result, where a "step" refers to the manipulation of physical quantities and / or logical states that can, although they do not necessarily need to, take the form of electrical or magnetic signals that can be stored, transferred, combined, compared and manipulated in any other way. It is common use to call these signs bits, values, elements, symbols, characters, terms, numbers or the like. These terms and similar terms may be associated with the appropriate physical quantities and are merely convenient identifications applied to these quantities and / or states.
[00599] [00599] A network may include a packet-switched network. Communication devices may be able to communicate with each other using a selected packet switched network communications protocol. An exemplary communications protocol may include an Ethernet communications protocol that may be able to allow communication using a transmission control protocol / Internet protocol (TCP / IP). The Ethernet protocol can conform to or be compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) entitled "IEEE 802.3 Standard", published in December 2008 and / or later versions of this standard. Alternatively or in addition, communication devices may be able to communicate with each other using an X.25 communications protocol. The X.25 communications protocol can conform to or be compatible with a standard promulgated by the International
[00600] [00600] Unless otherwise stated, as is evident from the preceding description, it is understood that, throughout the preceding description, discussions that use terms such as "processing", or "computation", or "calculation", or " determination ", or" display ", or similar, refer to the action and processes of a computer, or similar electronic computing device, that manipulates and transforms the data represented in the form of physical (electronic) quantities in records and memories of the computer in other data represented in a similar way in the form of physical quantities in the memories or records of the computer, or in other similar devices for storing, transmitting or displaying information.
[00601] [00601] One or more components in the present invention may be called "configured for", "configurable for", "operable / operational for", "adapted / adaptable for", "capable of", "conformable / conformed for", etc. Those skilled in the art will recognize that "configured for" may, in general, cover components in an active state and / or components in an inactive state and / or components in a standby state, except when the context determines otherwise.
[00602] [00602] The terms "proximal" and "distal" are used in the present invention with reference to a physician who handles the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the doctor, and the term "distal" refers to the portion located opposite the doctor. It will also be understood that, for the sake of convenience and clarity, spatial terms such as "vertical", "horizontal", "up" and "down" can be used in the present invention with respect to the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[00603] [00603] Persons skilled in the art will recognize that, in general, the terms used here, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as "open" terms (for example, the term "including" should be interpreted as "including, but not limited to", the term "having" should be interpreted as "having, at least", the term "includes" should be interpreted as "includes, but is not limited to ", etc.). It will also be understood by those skilled in the art that, when a specific number of a claim statement entered is intended, that intention will be expressly mentioned in the claim and, in the absence of such mention, no intention will be present. For example, as an aid to understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim statements. However, the use of such phrases should not be interpreted as implying that the introduction of a claim statement by the indefinite articles "one, ones" or "one, ones" limits any specific claim containing the mention of the claim entered to claims that contain only such a mention, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles, such as "one, ones" or "one, ones" (for example, "one, ones" and / or "one, ones" should typically be interpreted as meaning "at least one" or "one or more"); the same goes for the use of defined articles used to introduce claims.
[00604] [00604] Furthermore, even if a specific number of an introduced claim statement is explicitly mentioned, those skilled in the art will recognize that that statement must typically be interpreted as meaning at least the number mentioned (for example, the mere mention of "two mentions ", without other modifiers, typically means at least two mentions, or two or more mentions). In addition, in cases where a convention analogous to "at least one of A, B and C, etc." is used, in general this construction is intended to have the meaning in which the convention would be understood by (for example, "a system that has at least one of A, B and C "would include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B and C together, etc.). In cases where a convention analogous to "at least one of A, B or C, etc." is used, in general this construction is intended to have the meaning in which the convention would be understood by (for example, "a system that have at least one of A, B and C "would include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A , B and C together, etc.). It will be further understood by those skilled in the art that typically a disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, in the claims or in the drawings, should be understood as contemplating the possibility of including one of the terms, any of the terms or both terms, except where the context dictates something different. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B".
[00605] [00605] With respect to the attached claims, those skilled in the art will understand that the operations mentioned in them can, in general, be performed in any order. In addition, although several operational flow diagrams are presented in one or more sequences, it must be understood that the various operations can be performed in other orders than those shown, or can be performed simultaneously. Examples of such alternative orderings may include overlapping, merged, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, inverse or other variant orders, unless the context otherwise requires. In addition, terms such as "responsive to", "related to" or other adjectival participles are not intended in general to exclude these variants, unless the context otherwise requires.
[00606] [00606] It is worth noting that any reference to "one (1) aspect", "one aspect", "an exemplification" or "one (1) exemplification", and the like means that a particular resource, structure or characteristic described in connection with the aspect is included in at least one aspect. Thus, the use of expressions such as "in one (1) aspect", "in one aspect", "in an exemplification", "in one (1) exemplification", in several places throughout this specification does not necessarily refer the same aspect. In addition, specific resources, structures or characteristics can be combined in any appropriate way in one or more aspects.
[00607] [00607] Any patent application, patent, non-patent publication or other description material mentioned in this specification and / or mentioned in any order data sheet is hereby incorporated by reference, to the extent that the materials incorporated are not inconsistent with that. Accordingly, and to the extent necessary, the description as explicitly presented herein replaces any conflicting material incorporated by reference to the present invention. Any material, or portion thereof, which is incorporated herein by reference, but which conflicts with the definitions, statements, or other description materials contained herein, will be incorporated here only to the extent that there is no conflict between the embedded material and the existing description material.
[00608] [00608] In summary, numerous benefits have been described that result from the use of the concepts described in this document. The previously mentioned description of one or more modalities has been presented for purposes of illustration and description. This description is not intended to be exhaustive or to limit the invention to the precise form described. Modifications or variations are possible in light of the above teachings. One or more modalities were chosen and described in order to illustrate the principles and practical application to, thus, allow those skilled in the art to use the various modalities and with various modifications, as they are convenient to the specific use contemplated. The claims presented in the annex are intended to define the general scope.
[00609] [00609] Various aspects of the subject described in this document are defined in the following numbered examples:
[00610] [00610] Example 1. A method of determining the temperature of an ultrasonic blade, the method comprising: determining, by a control circuit coupled to a Memory, a real resonance frequency of an ultrasonic electromechanical system comprising a transducer ultrasonic coupled to an ultrasonic blade by means of an ultrasonic waveguide, the actual resonance frequency being correlated to an actual ultrasonic blade temperature; retrieve, from memory through the control circuit, a reference resonance frequency of the ultrasonic electromechanical system, the reference resonance frequency being correlated to a reference temperature of the ultrasonic blade; and infer, by the control circuit, the temperature of the ultrasonic blade based on the difference between the actual resonance frequency and the reference resonance frequency.
[00611] [00611] Example 2. The method of Example 1, in which the determination, by the control circuit, of the actual resonance frequency of the ultrasonic electromechanical system comprises: determining, by the control circuit, a phase angle φ between a voltage signal Vg (t) and Ig current (t) applied to the ultrasonic transducer.
[00612] [00612] Example 3. The method of Example 2, which further comprises generating, by the control circuit, a temperature estimator and a state space model of the inferred temperature of the ultrasonic blade as a function of the resonance frequency of the ultrasonic electromechanical system based on a set of nonlinear state space equations.
[00613] [00613] Example 4. The method of Example 3, in which the state space model is defined by:
[00614] [00614] Example 5. The method of Example 4, which further comprises applying, by the control circuit, a Kalman filter to improve the temperature estimator and the state space model.
[00615] [00615] Example 6. The method of Example 5, which further comprises: applying, by the control circuit, a state estimator in a feedback circuit of the Kalman filter; control, through the control circuit, the power applied to the ultrasonic transducer; and regulate, by the control circuit, the temperature of the ultrasonic blade.
[00616] [00616] Example 7. The method of Example 6, in which a state variance of the Kalman filter state estimator is defined by: and a K gain of the Kalman filter is defined by:
[00617] [00617] Example 8. The method of Example 1, in which the control circuit and the memory are located in a central surgical controller in communication with the ultrasonic electromechanical system.
[00618] [00618] Example 9. A generator to determine a temperature of an ultrasonic blade, the generator comprising: a control circuit coupled to a memory, the control circuit being configured to: determine a real resonance frequency of an electromechanical system ultrasonic, comprising an ultrasonic transducer coupled to an ultrasonic blade by means of an ultrasonic waveguide, the actual resonance frequency being correlated to an actual ultrasonic blade temperature; retrieving from the memory a reference resonance frequency of the ultrasonic electromechanical system, the reference resonance frequency being correlated to a reference temperature of the ultrasonic blade; and infer the temperature of the ultrasonic sheet based on the difference between the actual resonance frequency and the reference resonance frequency.
[00619] [00619] Example 10. The generator of Example 9, in which to determine the actual resonance frequency of the ultrasonic electromechanical system, the control circuit is additionally configured to: determine a phase angle φ between a voltage signal Vg (t) and Ig (t) current applied to the ultrasonic transducer.
[00620] [00620] Example 11. The generator of Example 10, in which the control circuit is additionally configured to generate a temperature estimator and a state space model of the inferred temperature of the ultrasonic blade as a function of the resonance frequency of the electromechanical system ultrasonic based on a set of nonlinear state space equations.
[00621] [00621] Example 12. The generator of Example 11, in which the state space model is defined by:
[00622] [00622] Example 13. The generator of Example 12, in which the control circuit is additionally configured to apply a Kalman filter to improve the temperature estimator and the state space model.
[00623] [00623] Example 14. The generator of Example 13, in which the control circuit is additionally configured to: apply a state estimator to a Kalman filter feedback circuit; control the power applied to the ultrasonic transducer; and regulate the temperature of the ultrasonic sheet.
[00624] [00624] Example 15. The generator of Example 14, in which a state variance of the Kalman filter state estimator is defined by: and a K gain of the Kalman filter is defined by:
[00625] [00625] Example 16. The method of Example 9, in which the control circuit and the memory are located in a central surgical controller in communication with the generator.
[00626] [00626] Example 17. An ultrasonic device for determining a temperature of an ultrasonic blade, the ultrasonic device comprising: a control circuit coupled to a memory, the control circuit being configured to: determine a real resonance frequency of a ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by means of an ultrasonic waveguide, the actual resonance frequency being correlated to an actual ultrasonic blade temperature; retrieving from the memory a reference resonance frequency of the ultrasonic electromechanical system, the reference resonance frequency being correlated to a reference temperature of the ultrasonic blade;
[00627] [00627] Example 18. The ultrasonic device of Example 17, in which to determine the actual resonance frequency of the ultrasonic electromechanical system, the control circuit is additionally configured to: determine a phase angle φ between a voltage signal Vg (t ) and Ig (t) current applied to the ultrasonic transducer.
[00628] [00628] Example 19. The ultrasonic device of Example 18, in which the control circuit is additionally configured to generate a temperature estimator and a space model of the inferred temperature of the ultrasonic blade as a function of the resonance frequency of the system ultrasonic electromechanical based on a set of nonlinear state space equations.
[00629] [00629] Example 20. The ultrasonic device of Example 19, in which the state space model is defined by:
[00630] [00630] Example 21. The ultrasonic device of Example 20, in which the control circuit is additionally configured to apply a Kalman filter to improve the temperature estimator and the state space model.
[00631] [00631] Example 22. The ultrasonic device of Example 21, in which the control circuit is additionally configured to: apply a state estimator to a Kalman filter feedback circuit; control the power applied to the ultrasonic transducer; and regulate the temperature of the ultrasonic sheet.
[00632] [00632] Example 23. The ultrasonic device of Example 22, in which a state variance of the state estimator the Kalman filter is defined by: and a K gain of the Kalman filter is defined by:
[00633] [00633] Example 24. The ultrasonic instrument of Example 17, in which the control circuit and the memory are located in a central surgical controller in communication with the ultrasonic instrument.

权利要求:
Claims (24)
[1]
1. Method for determining the temperature of an ultrasonic blade, characterized by the fact that it comprises: determining, by means of a control circuit coupled to a memory, a real resonance frequency of an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to a ultrasonic blade by means of an ultrasonic waveguide, in which the actual resonance frequency is correlated to an actual ultrasonic blade temperature; retrieve, from memory through the control circuit, a reference resonance frequency of the ultrasonic electromechanical system, in which the reference resonance frequency is correlated to a reference temperature of the ultrasonic blade; and infer, by the control circuit, the temperature of the ultrasonic blade based on the difference between the actual resonance frequency and the reference resonance frequency.
[2]
2. Method, according to claim 1, characterized by the fact that the determination, by the control circuit, of the actual resonance frequency of the ultrasonic electromechanical system comprises: determining, by the control circuit, a phase angle φ between the signal voltage Vg (t) and current Ig (t) applied to the ultrasonic transducer.
[3]
3. Method, according to claim 2, characterized by the fact that it additionally comprises: generating, by the control circuit, a temperature estimator and a state space model of the inferred temperature of the ultrasonic blade as a function of the resonance frequency of the ultrasonic electromechanical system based on a set of nonlinear equations of state space.
[4]
4. Method, according to claim 3, characterized by the fact that the state space model is defined by:
[5]
5. Method, according to claim 4, characterized by the fact that it additionally includes applying, through the control circuit, a Kalman filter to improve the temperature estimator and the state space model.
[6]
6. Method, according to claim 5, characterized by the fact that it additionally comprises: applying, by the control circuit, a state estimator in a feedback circuit of the Kalman filter; control, through the control circuit, the power applied to the ultrasonic transducer; and regulate, by the control circuit, the temperature of the ultrasonic blade.
[7]
7. Method, according to claim 6, characterized by the fact that a state variance of the Kalman filter state estimator is defined by: and a K gain of the Kalman filter is defined by:
[8]
8. Method, according to claim 1, characterized by the fact that the control circuit and the memory are located in a central surgical controller in communication with the ultrasonic electromechanical system.
[9]
9. Generator, characterized by the fact that it is to determine the temperature of an ultrasonic blade, comprising: a control circuit coupled to a memory, the control circuit being configured to: determine a real resonance frequency of an ultrasonic electromechanical system that it comprises an ultrasonic transducer coupled to an ultrasonic blade by means of an ultrasonic waveguide, in which the actual resonance frequency is correlated to an actual ultrasonic blade temperature; retrieving from the memory a reference resonance frequency of the ultrasonic electromechanical system, in which the reference resonance frequency is correlated to a reference temperature of the ultrasonic blade; and infer the temperature of the ultrasonic sheet based on the difference between the actual resonance frequency and the reference resonance frequency.
[10]
10. Generator according to claim 9, characterized by the fact that, in order to determine the actual resonance frequency of the ultrasonic electromechanical system, the control circuit is additionally configured to: determine a phase angle V between the voltage signal Vg (t) and Ig current (t) applied to the ultrasonic transducer.
[11]
11. Generator, according to claim 10, characterized by the fact that the control circuit is additionally configured to generate a temperature estimator and a state space model of the inferred temperature of the ultrasonic blade as a function of the resonance frequency of the ultrasonic electromechanical system based on a set of nonlinear equations of state space.
[12]
12. Generator, according to claim 11, characterized by the fact that the state space model is defined by:
[13]
13. Generator according to claim 12, characterized by the fact that the control circuit is additionally configured to apply a Kalman filter to improve the temperature estimator and the state space model.
[14]
14. Surgical instrument, according to claim 13, characterized by the fact that the control circuit is configured to: apply a state estimator to a Kalman filter feedback circuit; control the power applied to the ultrasonic transducer; and regulate the temperature of the ultrasonic sheet.
[15]
15. Generator according to claim 14, characterized by the fact that a state variance of the Kalman filter state estimator is defined by: and a K gain of the Kalman filter is defined by:
[16]
16. Method, according to claim 9, characterized by the fact that the control circuit and the memory are located in a central surgical controller in communication with the generator.
[17]
17. Ultrasonic device, characterized by the fact that it is to determine a temperature of an ultrasonic blade, comprising: a control circuit coupled to a memory, the control circuit being configured to: determine a real resonance frequency of an ultrasonic electromechanical system which comprises an ultrasonic transducer coupled to an ultrasonic blade by means of an ultrasonic waveguide, in which the actual resonance frequency is correlated to an actual ultrasonic blade temperature; retrieving from the memory a reference resonance frequency of the ultrasonic electromechanical system, in which the reference resonance frequency is correlated to a reference temperature of the ultrasonic blade; and infer the temperature of the ultrasonic sheet based on the difference between the actual resonance frequency and the reference resonance frequency.
[18]
18. Ultrasonic device, characterized by the fact that, to determine the actual resonance frequency of the ultrasonic electromechanical system, the control circuit is additionally configured to: determine a phase angle φ between the voltage signal Vg (t) and current Ig (t) applied to the ultrasonic transducer.
[19]
19. Ultrasonic device according to claim 18, characterized by the fact that the control circuit is additionally configured to generate a temperature estimator and a state space model of the inferred temperature of the ultrasonic blade as a function of the resonance frequency of the ultrasonic electromechanical system based on a set of nonlinear equations of state space.
[20]
20. Ultrasonic device, according to claim 19, characterized by the fact that the state space model is defined by:
[21]
21. Ultrasonic device according to claim 20, characterized by the fact that the control circuit is configured to apply a Kalman filter to improve the temperature estimator and the state space model.
[22]
22. Surgical instrument, according to claim 21, characterized by the fact that the control circuit is additionally configured to: apply a state estimator to a Kalman filter feedback circuit; control the power applied to the ultrasonic transducer; and regulate the temperature of the ultrasonic sheet.
[23]
23. Ultrasonic device according to claim 22, characterized by the fact that a state variance of the Kalman filter state estimator is defined by: and a K gain of the Kalman filter is defined by:
[24]
24. Ultrasonic instrument, according to claim 17, characterized by the fact that the control circuit and the memory are located in a central surgical controller in communication with the ultrasonic instrument.

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US11096688B2|2018-03-28|2021-08-24|Cilag Gmbh International|Rotary driven firing members with different anvil and channel engagement features|

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US11219453B2|2018-03-28|2022-01-11|Cilag Gmbh International|Surgical stapling devices with cartridge compatible closure and firing lockout arrangements|

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US11197668B2|2018-03-28|2021-12-14|Cilag Gmbh International|Surgical stapling assembly comprising a lockout and an exterior access orifice to permit artificial unlocking of the lockout|

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US11207067B2|2018-03-28|2021-12-28|Cilag Gmbh International|Surgical stapling device with separate rotary driven closure and firing systems and firing member that engages both jaws while firing|

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US11259807B2|2019-02-19|2022-03-01|Cilag Gmbh International|Staple cartridges with cam surfaces configured to engage primary and secondary portions of a lockout of a surgical stapling device|

法律状态:
2021-12-07| B350| Update of information on the portal [chapter 15.35 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201762611341P| true| 2017-12-28|2017-12-28|

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US201762611339P| true| 2017-12-28|2017-12-28|

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US201762611340P| true| 2017-12-28|2017-12-28|

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US62/611,340|2017-12-28|

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US62/611,341|2017-12-28|

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US62/611,339|2017-12-28|

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US201862640415P| true| 2018-03-08|2018-03-08|

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US201862640417P| true| 2018-03-08|2018-03-08|

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US62/640,415|2018-03-08|

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US62/640,417|2018-03-08|

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US201862650882P| true| 2018-03-30|2018-03-30|

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US201862650887P| true| 2018-03-30|2018-03-30|

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US201862650877P| true| 2018-03-30|2018-03-30|

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US201862650898P| true| 2018-03-30|2018-03-30|

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US62/650,877|2018-03-30|

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US62/650,887|2018-03-30|

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US62/650,898|2018-03-30|

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US62/650,882|2018-03-30|

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US201862692748P| true| 2018-06-30|2018-06-30|

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US201862692768P| true| 2018-06-30|2018-06-30|

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US201862692747P| true| 2018-06-30|2018-06-30|

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US62/692,747|2018-06-30|

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US62/692,748|2018-06-30|

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US62/692,768|2018-06-30|

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US201862721995P| true| 2018-08-23|2018-08-23|

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US201862721996P| true| 2018-08-23|2018-08-23|

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US201862721994P| true| 2018-08-23|2018-08-23|

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US201862721998P| true| 2018-08-23|2018-08-23|

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US201862721999P| true| 2018-08-23|2018-08-23|

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US62/721,995|2018-08-23|

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US62/721,996|2018-08-23|

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US62/721,999|2018-08-23|

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US62/721,994|2018-08-24|

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US62/721,998|2018-08-24|

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US16/115,205|2018-08-28|

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US16/115,205|US20190201036A1|2017-12-28|2018-08-28|Temperature control of ultrasonic end effector and control system therefor|

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PCT/US2019/020142|WO2019134006A1|2017-12-28|2019-02-28|Temperature control of ultrasonic end effector and control system therefor|

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