INTELLIGENT BLADE APPLICATION FOR REUSABLE AND DISPOSABLE DEVICES

专利摘要:
the present invention relates to an ultrasonic device which may include an electromechanical system defined by a resonance frequency and which further includes an ultrasonic transducer coupled to an ultrasonic blade. the device may consist of two or more components, one of which is reusable and one of which is disposable. a method of detecting the proper installation of the components may include determining a spectroscopic signature of the blade attached to the transducer, comparing the signature with a reference signature, determining an installation status of the components based on the comparison, and controlling a power application to the transducer with basis of comparison. the method may include enabling a device operation when the installation status of the components is adequate. the method may also include disabling the device when the installation status is not adequate and generating an alert. the alert can be visible, audible or tactile.
公开号:BR112020017254A2
申请号:R112020017254-5
申请日:2019-03-04
公开日:2020-12-22
发明作者:Alexander R. Cuti；Matthew S. Schneider
申请人:Ethicon Llc；
IPC主号:

专利说明:

[001] [001] This application claims the benefit of US Non-Provisional Patent Application No. 16 / 144,478, entitled SMART BLADE APPLICATION FOR REUSABLE AND DISPOSABLE DEVICES, filed on September 27, 2018, the description of which is incorporated herein by reference in its wholeness.
[002] [002] This application claims the benefit of US Provisional Patent Application serial number 62 / 640,415, entitled ESTIMATING STATE
[003] [003] In a surgical environment, smart energy devices may be required 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 can 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.
[004] [004] Ultrasonic energy cuts and coagulates tissues using temperatures lower 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.
[005] [005] The ultrasonic transducer can be modeled as an equivalent circuit comprising a first branch that has a static capacitance and a second "in 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 static capacitance at a resonant frequency so that substantially all of the generator's trigger signal current flows to the moving branch. Consequently, using a tuning inductor, the current of the generator's trigger signal represents the current of the branch in motion, 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.
[006] [006] 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.
[007] [007] 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.
[008] [008] 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.
[009] [009] 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
[010] [010] 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.
[011] [011] 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.
[012] [012] 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.
[013] [013] Additional user interfaces to provide feedback, whether to the user or another machine, are contemplated in the subsequent description to provide feedback that indicates a mode of operation or the 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.
[014] [014] Other electrical surgical instruments include, without limitation, irreversible and / or reversible electroporation, and / or microwave technologies, among others. Consequently, the techniques disclosed here are applicable to ultrasonic, bipolar or monopolar RF (electrosurgical), irreversible and / or reversible electroporation and / or microwave-based surgical instruments, among others. SUMMARY OF THE INVENTION
[015] [015] An aspect of an ultrasonic device may include an electromechanical ultrasonic system, defined by a predetermined resonance frequency, the electromechanical ultrasonic system additionally having an ultrasonic transducer coupled to an ultrasonic blade. One aspect of a method for detecting the correct installation of two or more components of an ultrasonic device may include determining, by a processor or control circuit, a spectroscopy signature of the ultrasonic blade attached to the ultrasonic transducer, comparing, through the processor or the control circuit, the spectroscopy signature with a spectroscopy signature reference, determine, by a processor or control circuit, an installation status of the two or more components based on the comparison and control, by the processor or control circuit, an application of energy to the ultrasonic transducer based on the comparison.
[016] [016] In one aspect, the method may further comprise enabling, via the processor or the control circuit, the operation of the ultrasonic device when the installation status of the two or more components is adequate.
[017] [017] In one aspect, the method may additionally include disabling, via the processor or the control circuit, the operation of the ultrasonic device when the installation status of the two or more components is not adequate and generating, through the processor or control circuit, an alert.
[018] [018] In one aspect of the method, the generation, by the processor or the control circuit, of an alert may include generating, by the processor or the control circuit, a visual alert.
[019] [019] In one aspect of the method, the generation, by the processor or the control circuit, of an alert may include generating, by the processor or the control circuit, an audible alert.
[020] [020] In one aspect of the method, the generation, by the processor or the control circuit, of an alert may include generating, by the processor or the control circuit, a tactile alert.
[021] [021] In one aspect of the method, determining, via the processor or the control circuit, a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer may include measuring, through the processor or the control circuit, a complex impedance of the ultrasonic transducer, where the complex impedance is defined as =, receive, through the processor or the control circuit, a data point of measurement of complex impedance, compare, through the processor or the control circuit, the point of complex impedance measurement data with a data point in a characteristic standard of complex impedance reference, classify, using the processor or the control circuit, the complex impedance measurement data point based on an analysis result comparison, and assign, through the processor or the control circuit, a state or condition to an end actuator based on the analysis result comparison.
[022] [022] In one aspect of the method, the comparison, made by the processor or the control circuit, of the complex impedance measurement data point with a data point in a characteristic reference standard complex impedance may include comparing, by the processor or by the control circuit, the spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer with the reference spectroscopic signature.
[023] [023] In one aspect of the method, determining, by means of a processor or a control circuit, a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer may include applying, via a drive circuit, a trigger signal to the ultrasonic transducer, the trigger signal being a periodic signal defined by a magnitude and frequency, sweeping, through a processor or control circuit, the frequency of the trigger signal from a level below the resonance to a level above the resonance of the electromechanical ultrasonic system, measure and record, by means of the processor or the control circuit, the impedance / admittance circle variables Re, Ge, Xe and Be, compare, by means of the processor or the control circuit, the variables the impedance / admittance circle measures Re, Ge, Xe, and Be with the reference impedance / admittance circle variables Rref, Gref, Xref, and Bref, and determine, by means of the processor or control circuit, a state or condition of the end actuator based on the result of the comparison analysis.
[024] [024] An aspect of an ultrasonic surgical instrument may include an ultrasonic electromechanical system that has an ultrasonic transducer coupled to an ultrasonic blade by means of an ultrasonic waveguide, the ultrasonic electromechanical system of which may include two or more components of which at least least one of the two or more components is a disposable device and of which at least one of the two or more components is a reusable device; An aspect of the ultrasonic surgical instrument may additionally include a generator configured to supply power to the ultrasonic transducer, the generator including a control circuit configured to determine a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer, compare the spectroscopic signature with a spectroscopic signature reference, determine an installation status of the two or more components based on the comparison, and control the application of energy to the ultrasonic transducer based on the comparison.
[025] [025] In one aspect of the ultrasonic surgical instrument, the control circuit can be additionally configured to enable operation of the ultrasonic device when the installation status of the two or more components is adequate.
[026] [026] In one aspect of the ultrasonic surgical instrument, the control circuit is additionally configured to disable an operation of the ultrasonic device when the installation status of the two or more components is not adequate and to generate an alert.
[027] [027] In one aspect of the ultrasonic surgical instrument, the alert comprises visual alert.
[028] [028] In one aspect of the ultrasonic surgical instrument, the alert comprises audible alert.
[029] [029] In one aspect of the ultrasonic surgical instrument, the alert comprises a tactile alert.
[030] [030] In one aspect of the ultrasonic surgical instrument, the control circuit is additionally configured to measure a complex impedance of the ultrasonic transducer, the complex impedance being defined as =, receiving a complex impedance measurement data point, comparing the complex impedance measurement data point with a data point in a characteristic standard of complex impedance reference, classify the complex impedance measurement data point based on a comparison analysis result, and assign a state or condition to an end actuator based on the result of the comparison analysis.
[031] [031] In one aspect of the ultrasonic surgical instrument, the control circuit is additionally configured to cause a drive circuit to apply a drive signal to the ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency, scan the trigger signal frequency from a level below the resonance to a level above the resonance of the electromechanical ultrasonic system, measure and record the impedance / admittance circle variables Re, Ge, Xe and Be, compare the impedance / admittance circle variables measured Re, Ge, Xe and Be with reference variables Rref, Gref, Xref and Bref from the impedance / admittance circle and determine a state or condition of the end actuator based on the result of the comparison analysis.
[032] [032] An aspect of a generator for an ultrasonic surgical instrument in which the ultrasonic surgical instrument includes two or more components in a disposable device and in which at least one of the two or more components is a reusable device, may include a control circuit configured to determine a spectroscopic signature of an ultrasonic blade attached to the ultrasonic transducer, compare the spectroscopic signature with a reference spectroscopic signature, determine an installation status of the two or more components based on the comparison, and control the application of energy to the ultrasonic transducer based on the comparison.
[033] [033] In one aspect of the generator for an ultrasonic surgical instrument, the control circuit is additionally configured to enable operation of the ultrasonic device when the installation status of the two or more components is adequate.
[034] [034] In one aspect of the generator for an ultrasonic surgical instrument, the control circuit is additionally configured to disable an operation of the ultrasonic device when the installation status of the two or more components is not adequate and to generate an alert.
[035] [035] In one aspect of the generator for an ultrasonic surgical instrument, the alert includes a visual alert.
[036] [036] In one aspect of the generator for an ultrasonic surgical instrument, the alert includes an audible alert.
[037] [037] In one aspect of the generator for an ultrasonic surgical instrument, the alert comprises a tactile alert.
[038] [038] In one aspect of the generator for an ultrasonic surgical instrument, the control circuit is additionally configured to measure a complex impedance from the ultrasonic transducer, the complex impedance being defined as =, receiving a complex impedance measurement data point , compare the complex impedance measurement data point with a data point in a characteristic standard of complex impedance reference, classify the complex impedance measurement data point based on a comparison analysis result, and assign a state or a condition to an end actuator based on the result of the comparison analysis.
[039] [039] In one aspect of the generator for an ultrasonic surgical instrument, the control circuit is additionally configured to cause a drive circuit to apply a drive signal to the ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and frequency, scan the frequency of the trigger signal from a level below the resonance to a level above the resonance of the electromechanical ultrasonic system, measure and record the impedance / admittance circle variables Re, Ge, Xe and Be,
[040] [040] The features of various 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.
[041] [041] Figure 1 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.
[042] [042] Figure 2 illustrates an example of a generator, according to at least one aspect of the present description.
[043] [043] Figure 3 is a surgical system comprising a generator and several surgical instruments that can be used with it, in accordance with at least one aspect of the present description.
[044] [044] Figure 4 is an end actuator, in accordance with at least one aspect of the present description.
[045] [045] Figure 5 is a diagram of the surgical system in Figure 3, according to at least one aspect of the present description.
[046] [046] Figure 6 is a model that illustrates the branching chain in motion, in accordance with at least one aspect of the present description.
[047] [047] Figure 7 is a structural view of a generator's architecture, according to at least one aspect of the present description.
[048] [048] Figures 8A to 8C are functional views of a generator architecture, in accordance with at least one aspect of the present description.
[049] [049] Figures 9A and 9B are structural and functional aspects of a generator, in accordance with at least one aspect of the present description.
[050] [050] Figure 10 illustrates a control circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present description.
[051] [051] Figure 11 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.
[052] [052] Figure 12 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.
[053] [053] Figure 13 illustrates an aspect of a fundamental architecture for a digital synthesis circuit, such as a digital direct synthesis circuit (DDS) configured to generate a plurality of waveforms for the electrical signal waveform for use in a surgical instrument, in accordance with at least one aspect of the present description.
[054] [054] Figure 14 illustrates an aspect of digital direct synthesis circuit (DDS) configured to generate a plurality of waveforms for the electrical signal waveform for use in a surgical instrument, in accordance with at least one aspect of this description.
[055] [055] Figure 15 illustrates a cycle of a digital electrical signal waveform, in accordance with at least one aspect of the present description of an analog waveform (shown superimposed on the digital electrical signal waveform for comparison purposes. ), in accordance with at least one aspect of the present description.
[056] [056] Figure 16 is a diagram of a control system according to one aspect of this description.
[057] [057] Figure 17 illustrates a feedback control system with proportional, integral, derived controller (PID), according to one aspect of the present description.
[058] [058] Figure 18 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.
[059] [059] Figure 19 is a spectrum of the same ultrasonic device with a variety of different states and conditions of the end actuator where the phase and magnitude of the impedance of an ultrasonic transducer are plotted as a function of frequency, according to at least one aspect of this description.
[060] [060] Figure 20 is a graphical representation of a plot of a 3D training S data set, where the magnitude and impedance phase of the ultrasonic transducer are plotted as a function of frequency, according to at least one aspect of this description.
[061] [061] Figure 21 is a logic flow diagram showing a control program or logic configuration to determine the condition of the gripper based on the characteristic complex impedance pattern (fingerprint) according to at least one aspect of the present description .
[062] [062] Figure 22 is a circular plot of complex impedance plotted as an imaginary component versus the actual components of a piezoelectric vibrator, according to at least one aspect of the present description.
[063] [063] Figure 23 is a circular plot of the complex admittance plotted as an imaginary component versus the actual components of a piezoelectric vibrator, according to at least one aspect of the present description.
[064] [064] Figure 24 is a circular plot of the complex admittance of a 55.5 kHz ultrasonic piezoelectric transducer.
[065] [065] Figure 25 is a graphical display of an impedance analyzer showing circular impedance / admittance plots for an ultrasonic device with the claw open and unloaded, where the complex admittance is shown in dashed line and the complex impedance is shown in continuous line, in accordance with at least one aspect of the present description.
[066] [066] Figure 26 is a graphical display of an impedance analyzer showing plots of the impedance / admittance circle for an ultrasonic device with the claw stuck in dry suede, where the complex admittance is shown in dashed line and the complex impedance is shown in continuous line, in accordance with at least one aspect of the present description.
[067] [067] Figure 27 is a graphical display of an impedance analyzer showing plots of the impedance / admittance circle for an ultrasonic device with the claw tip clamped in wet suede, where the complex admittance is shown in dashed line and the complex impedance it is shown in continuous line, in accordance with at least one aspect of the present description.
[068] [068] Figure 28 is a graphical display of an impedance analyzer showing circular impedance / admittance plots for an ultrasonic device with the claw completely attached to wet suede, where the complex admittance is shown in dashed line and the complex impedance is shown in continuous line, in accordance with at least one aspect of the present description.
[069] [069] Figure 29 is a graphical display of an impedance analyzer showing impedance / admittance plots where the frequency is scanned from 48 kHz to 62 kHz to capture multiple resonances from an ultrasonic device with the claw open where the rectangular overlap shown dashed line is to help you see the circles, in accordance with at least one aspect of this description.
[070] [070] Figure 30 is a logic flow diagram of a process that represents a control program or a logical configuration to determine the condition of the gripper based on the radius and displacement estimates of an impedance / admittance circle, according to with at least one aspect of the present description.
[071] [071] Figure 31 is an ultrasonic device configured to identify the state of the ultrasonic blade and determine the condition of the clamping arm to determine whether a disposable portion of a reusable and disposable ultrasonic device has been installed correctly, according to at least one aspect of this description.
[072] [072] Figure 32 is a portion of the end actuator of the ultrasonic device shown in Figure 31.
[073] [073] Figure 33 is an ultrasonic device configured to identify the state of the ultrasonic blade and determine if the clamping arm is not completely distal to determine whether a disposable portion of a reusable and disposable ultrasonic device has been installed correctly, according to least one aspect of the present description.
[074] [074] Figure 34 is a logic flow diagram representing a control program or logic configuration to identify the state of the components of reusable and disposable devices, in accordance with at least one aspect of the present description. DESCRIPTION
[075] [075] The applicant for the present patent application also holds the following US patent applications filed at the same time, each of which is incorporated herein by reference, in its entirety:
[076] [076] ● US Provisional Patent Application entitled METHODS FOR CONTROLLING TEMPERATURE IN ULTRASONIC DEVICE, Power of Attorney Document No. END8560USNP1 / 180106-1M;
[077] [077] ● US Provisional Patent Application entitled ULTRASONIC SEALING ALGORITHM WITH TEMPERATURE CONTROL, Power of Attorney Document No. END8560USNP3 / 180106-3;
[078] [078] ● US Provisional Patent Application entitled APPLICATION OF SMART ULTRASONIC BLADE TECHNOLOGY, Power of Attorney Document No. END8560USNP4 / 180106-4;
[079] [079] ● US Provisional Patent Application entitled ADAPTIVE ADVANCED TISSUE TREATMENT PAD SAVER MODE, power of attorney document END8560USNP5 / 180106-5;
[080] [080] ● US Provisional Patent Application, entitled SMART BLADE TECHNOLOGY TO CONTROL BLADE INSTABILITY, Power of Attorney Document No. END8560USNP6 / 180106-6; and
[081] [081] ● Provisional US Patent Application entitled START TEMPERATURE OF BLADE, n ° of Power of Attorney Document END8560USNP7 / 180106-7.
[082] [082] The applicant for the present patent application also holds the following US patent applications filed at the same time, each of which is incorporated herein by reference, in its entirety:
[083] [083] ● US Provisional Patent Application entitled METHODS
[084] [084] ● Provisional US Patent Application, entitled IN-THE-JAW CLASSIFIER BASED ON MODEL, Power of Attorney Document No. END8536USNP3 / 180107-3;
[085] [085] ● US Provisional Patent Application entitled APPLICATION OF SMART BLADE TECHNOLOGY, power of attorney document number END8536USNP4 / 180107-4;
[086] [086] ● Provisional US Patent Application, entitled SMART BLADE AND POWER PULSING, number of power of attorney document END8536USNP5 / 180107-5;
[087] [087] ● Provisional US Patent Application entitled ADJUSTMENT
[088] [088] ● Provisional US Patent Application titled USING
[089] [089] ● Provisional US Patent Application, entitled VESSEL SENSING FOR ADAPTIVE ADVANCED HEMOSTASIS, n ° of Power of Attorney Document END8536USNP8 / 180107-8;
[090] [090] ● US Provisional Patent Application entitled CALCIFIED VESSEL IDENTIFICATION, Power of Attorney Document No. END8536USNP9 / 180107-9;
[091] [091] ● Provisional US Patent Application entitled DETECTION
[092] [092] ● Provisional US Patent Application, entitled LIVE TIME TISSUE CLASSIFICATION USING ELECTRICAL PARAMETERS, Power of Attorney Document No. END8536USNP12 / 180107-12; and
[093] [093] ● Provisional US Patent Application, entitled FINE DISSECTION MODE FOR TISSUE CLASSIFICATION, Power of Attorney Document No. END8536USNP13 / 180107-13.
[094] [094] The applicant for this application holds the following US patent applications filed on September 10, 2018, the description of which is incorporated herein by reference in its entirety:
[095] [095] ● US Provisional Patent Application Serial No. 62 / 729,177, entitled AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE TRANSMISSION;
[096] [096] ● US Provisional Patent Application Serial No. 62 / 729,182, entitled SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO-POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO THE HUB;
[097] [097] ● US Provisional Patent Application Serial No. 62 / 729,184, entitled POWERED SURGICAL TOOL WITH A PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING AT LEAST ONE END-EFFECTOR PARAMETER AND A MEANS FOR LIMITING THE ADJUSTMENT;
[098] [098] ● US Provisional Patent Application Serial No. 62 / 729,183, entitled SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION;
[099] [099] ● US Provisional Patent Application Serial No. 62 / 729,191, entitled A CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION OR USAGE;
[100] [100] ● US Provisional Patent Application Serial No. 62 / 729,176, entitled INDIRECT COMMAND AND CONTROL OF A FIRST OPERATING ROOM SYSTEM THROUGH THE USE OF A SECOND OPERATING ROOM SYSTEM WITHIN A STERILE FIELD WHERE THE SECOND OPERATING ROOM SYSTEM HAS PRIMARY AND SECONDARY OPERATING MODES;
[101] [101] ● US Provisional Patent Application Serial No. 62 / 729,186, entitled WIRELESS PAIRING OF A SURGICAL DEVICE WITH
[102] [102] ● US Provisional Patent Application Serial No. 62 / 729,185, entitled POWERED STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE, ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING MEMBER OF THE DEVICE BASED ON SENSED PARAMETER OF FIRING OR CLAMPING.
[103] [103] 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:
[104] [104] ● US Patent Application Serial No. 16 / 115,214, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;
[105] [105] ● US Patent Application Serial No. 16 / 115,205, entitled TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;
[106] [106] ● US Patent Application Serial No. 16 / 115,233, entitled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS;
[107] [107] ● US Patent Application Serial No. 16 / 115,208, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION;
[108] [108] ● US Patent Application Serial No. 16 / 115,220, entitled CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE;
[109] [109] ● US Patent Application Serial No. 16 / 115,232, entitled DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM;
[110] [110] ● US Patent Application Serial No. 16 / 115,239, entitled DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT;
[111] [111] ● US Patent Application Serial No. 16 / 115,247, entitled DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR;
[112] [112] ● US Patent Application Serial No. 16 / 115,239, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;
[113] [113] ● US Patent Application Serial No. 16 / 115,226, entitled MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT;
[114] [114] ● US Patent Application Serial No. 16 / 115,240, entitled DETECTION OF END EFFECTOR EMERSION IN LIQUID;
[115] [115] ● US Patent Application Serial No. 16 / 115,249, entitled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;
[116] [116] ● US Patent Application Serial No. 16 / 115,256, entitled INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP;
[117] [117] ● US Patent Application Serial No. 16 / 115,223, entitled
[118] [118] ● US Patent Application Serial No. 16 / 115,238, entitled ACTIVATION OF ENERGY DEVICES.
[119] [119] The applicant for this 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:
[120] [120] ● US Provisional Patent Application No. 62 / 721,995, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION;
[121] [121] ● US Provisional Patent Application No. 62 / 721,998, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;
[122] [122] ● US Provisional Patent Application No. 62 / 721,999, entitled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;
[123] [123] ● US Provisional Patent Application No. 62 / 721,994, entitled
[124] [124] ● US Provisional Patent Application No. 62 / 721,996, entitled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS.
[125] [125] 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:
[126] [126] ● US Provisional Patent Application No. 62 / 692,747, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;
[127] [127] ● US Provisional Patent Application No. 62 / 692,748, entitled SMART ENERGY ARCHITECTURE; and
[128] [128] ● US Provisional Patent Application No. 62 / 692,768, entitled SMART ENERGY DEVICES.
[129] [129] The applicant for the present application holds the following US patent applications, filed on June 29, 2018, the description of each of which is incorporated herein by way of reference in its entirety:
[130] [130] ● US Patent Application Serial No. 16 / 024,090, entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;
[131] [131] ● US Patent Application Serial No. 16 / 024,057, entitled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;
[132] [132] ● US Patent Application Serial No. 16 / 024,067, entitled SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION;
[133] [133] ● US Patent Application Serial No. 16 / 024,075, entitled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING;
[134] [134] ● US Patent Application Serial No. 16 / 024,083, entitled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING;
[135] [135] ● US Patent Application Serial No. 16 / 024,094, entitled SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES;
[136] [136] ● US Patent Application Serial No. 16 / 024,138, entitled SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE;
[137] [137] ● US Patent Application Serial No. 16 / 024,150, entitled SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;
[138] [138] ● US Patent Application Serial No. 16 / 024,160, entitled VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY;
[139] [139] ● US Patent Application Serial No. 16 / 024.124, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
[140] [140] ● US Patent Application Serial No. 16 / 024,132, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
[141] [141] ● US Patent Application Serial No. 16 / 024,141, entitled SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;
[142] [142] ● US Patent Application Serial No. 16 / 024,162, entitled SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES;
[143] [143] ● US Patent Application Serial No. 16 / 024,066, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;
[144] [144] ● US Patent Application Serial No. 16 / 024,096, entitled SURGICAL EVACUATION SENSOR ARRANGEMENTS;
[145] [145] ● US Patent Application Serial No. 16 / 024,116, entitled SURGICAL EVACUATION FLOW PATHS;
[146] [146] ● US Patent Application Serial No. 16 / 024,149, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;
[147] [147] ● US Patent Application Serial No. 16 / 024,180, entitled SURGICAL EVACUATION SENSING AND DISPLAY;
[148] [148] ● US Patent Application Serial No. 16 / 024,245, entitled COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;
[149] [149] ● US Patent Application Serial No. 16 / 024,258, entitled SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM;
[150] [150] ● US Patent Application Serial No. 16 / 024,265, entitled SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION
[151] [151] ● US Patent Application Serial No. 16 / 024,273, entitled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.
[152] [152] The applicant for this application holds the following provisional US patent applications, filed on June 28, 2018, the description of each of which is incorporated herein by reference in its entirety:
[153] [153] ● US Provisional Patent Application Serial No. 62 / 691,228, entitled A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES;
[154] [154] ● US Provisional Patent Application Serial No. 62 / 691,227, entitled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;
[155] [155] ● US Provisional Patent Application Serial No. 62 / 691,230, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
[156] [156] ● US Provisional Patent Application Serial No. 62 / 691,219, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;
[157] [157] ● US Provisional Patent Application Serial No. 62 / 691,257, entitled COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;
[158] [158] ● US Provisional Patent Application Serial No. 62 / 691,262, entitled SURGICAL EVACUATION SYSTEM WITH A
[159] [159] ● US Provisional Patent Application Serial No. 62 / 691,251, entitled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.
[160] [160] The applicant for this application holds the following provisional US patent applications, filed on April 19, 2018, the description of each of which is incorporated herein by reference in its entirety:
[161] [161] ● US Provisional Patent Application Serial No. 62 / 659,900, entitled METHOD OF HUB COMMUNICATION.
[162] [162] 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.
[163] [163] 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. Adaptive ultrasonic blade control algorithms
[164] [164] In many 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 power devices are described here in connection with Figures 1 and 2, for example. Consequently, the following description of adaptive ultrasonic blade control algorithms should be read in conjunction with Figures 1 and 2 and the description associated with them.
[165] [165] 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 infrared (IR) surface emissivity. 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.
[166] [166] Figure 1 is a system 800 configured to run adaptive ultrasonic blade control algorithms on 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 adaptive ultrasonic slide control algorithm (s) 802 as described here. In another aspect, the device / instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm (s) 804, as described here with reference to Figures 19 to 34. In another aspect, both the device / instrument 235 as well as device / instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804, as described here with reference to Figures 19 to 34.
[167] [167] Generator module 240 may comprise an isolated patient stage in communication with a non-isolated stage via 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 420 V root mean square (RMS) trigger signal for a 241 ultrasonic surgical instrument, and the trigger signal outputs can emit an RF electrosurgical drive signal (for example, a 100 V electrosurgical drive signal) for an RF electrosurgical instrument 241. Aspects of generator module 240 are described herein with reference to Figures 7 to 12.
[168] [168] Generator module 240 or device / instrument 235 or both are coupled to modular control tower 236 connected to multiple operating room devices such as smart surgical instruments, robots and other computerized devices located in the operating room . In some respects, a surgical data network may include a central modular communication controller configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any room in a specially equipped healthcare facility. for surgical operations, to a cloud-based system (for example, cloud 204 which may include a remote server 213 coupled to a storage device).
[169] [169] The modular devices located in the operating room can be coupled to the central controller for modular communication. The network controller and / or the network switch can be coupled to a network router to connect the devices to the cloud 204 or to a local computer system. The data associated with the devices can be transferred to cloud-based computers via the router for remote data processing and manipulation. The data associated with the devices can also be transferred to a local computer system for the processing and manipulation of local data. Modular devices located in the same operating room can also be coupled to a network switch. The network switch can be attached to the controller network and / or the network router to connect the devices to the cloud 204. The data associated with the devices can be transferred to the cloud 204 via the network router for processing and manipulating data. Dice. The data associated with the devices can also be transferred to the local computer system for the processing and manipulation of local data.
[170] [170] 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 delivered to the central controller of modular communication and / or computer system located in the operating room (for example, a fixed, mobile, temporary or field operating room or operating space) and devices connected to the central modular communication controller and / or the computer system over the 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 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.
[171] [171] Figure 1 further illustrates some aspects of a computer-implemented interactive surgical system that comprises a central modular communication controller that can include the 800 system configured to run adaptive ultrasonic blade control algorithms on a surgical data network. The surgical system can include at least one surgical controller communicating with a cloud 204 which can include a remote server
[172] [172] Figure 2 illustrates an example of a 900 generator, which is a form of a generator configured to couple with an ultrasonic instrument and is additionally configured to run adaptive ultrasonic blade control algorithms on a surgical data network that comprises a central modular communication controller as shown in Figure 1. Generator 900 is configured to deliver multiple energy modes 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 provided to an amplifier 906 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 by the power transformer 908 to the secondary side, which is on the patient isolation side. A first signal of a first energy modality is supplied to the surgical instrument 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.
[173] [173] A second 912 voltage detection circuit 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 type of energy. 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 voltage transformers Isolation 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 computing. 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 the 902 processor and the patient's isolated circuits are provided via a 920 interface circuit. The sensors may also be in electrical communication with the 902 processor via the 920 interface circuit.
[174] [174] In one aspect, impedance can be determined by processor 902 by dividing the output of the first voltage detection circuit 912 coupled over the terminals identified as ENERGY1 / RETURN or the second voltage detection circuit 924 coupled over the terminals identified as ENERGY2 / RETURN, by 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 for separate isolation transformers 916, 922 and output from current detection circuit 914 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 shown in Figure 2 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 by current detection circuit 914.
[175] [175] As shown in Figure 2, generator 900 comprising at least one output port can include a single-output, multi-tap 908 power transformer 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 coagulation 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 labeled ENERGY1 and RETURN as shown in Figure 2. 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 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.
[176] [176] Additional details are revealed in US Patent Application Publication No. 2017/0086914 entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING
[177] [177] 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 respects they may not. The communication module can implement any of a number of wireless or wired communication standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long-term evolution (LTE, "long-term evolution"), Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS,
[178] [178] 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 stream. The term is used in the present invention to refer to the central processor (central processing unit) in a computer system or systems (especially systems on a chip (SoCs)) that combine several specialized "processors".
[179] [179] As used here, an integrated circuit system or integrated circuit system (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 signal 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), Wi-Fi module, or coprocessor. A SoC may or may not contain embedded memory.
[180] [180] 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. The program's memory in the form of ferroelectric RAM, NOR flash or OTP ROM is also often included in the integrated circuit, 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 discrete integrated circuits.
[181] [181] As used in the present invention, the term controller or microcontroller can be an integrated circuit device or independent IC (integrated circuit) 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.
[182] [182] Any of the processors or microcontrollers in the present invention can be 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 Cortex-M4F LM4F230H5QR ARM processor core, 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 prefetch 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 2 KB electrically erasable programmable readout (EEPROM), one or more pulse width modulation (PWM) modules, one or more analog quadrature encoder (QEI) inputs, one or more analog-to-digital converters (ADC) ) of 12 bits with 12 channels of analog input, details of which are available in the product data sheet.
[183] [183] 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 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.
[184] [184] Modular devices include the modules (as described in connection with Figure 3, for example) that are receivable in a 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 surgical controller. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, power generators, fans, insufflators and monitors. 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, through a distributed computing architecture). In some examples, the control algorithms of the modular devices control the devices based on the data detected by the modular device itself (that is, by sensors on, over or connected to the modular device). This data can be related to the patient in surgery (for example, tissue properties or insufflation pressure) or to the modular device itself (for example, the speed at which a knife is being advanced, the motor current, or the levels of energy). For example, a control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument's motor drives its knife through the fabric according to the resistance encountered by the knife as it progresses.
[185] [185] Figure 3 illustrates a form of a surgical system 1000 comprising a generator 1100 and various surgical instruments 1104, 1106 and 1108 usable with it, with surgical instrument 1104 being an ultrasonic surgical instrument, surgical instrument 1106 being 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 generator 1100 can be configurable for use with different surgical instruments of different types, including, for example, the ultrasonic surgical instruments 1104, the RF electrosurgical instruments 1106 and the multifunctional surgical instruments 1108 that integrate ultrasonic energies and RF units supplied simultaneously from generator 1100. Although in the form of Figure 3 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.
[186] [186] 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 1140. The handle 1105 comprises a trigger 1143 for operating the clamping arm 1140 and a combination of toggle buttons 1134a , 1134b, 1134c to energize and activate the 1128 ultrasonic blade or other function. Toggle buttons 1134a, 1134b, 1134c can be configured to power the 1120 ultrasonic transducer with the 1100 generator.
[187] [187] 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) grip, 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, and energized by, a bipolar power source inside the generator 1100. The handle 1107 it 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.
[188] [188] 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 handle 1109 comprises a trigger 1147 to operate the clamping arm 1146 and a combination of the 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 a bipolar power source also contained within the 1100 generator.
[189] [189] 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
[190] [190] Figure 4 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 4, 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 4 to a closed position (with the clamping arm 1140 coming in contact with or close to the 1128 blade) any suitable way. 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.
[191] [191] The 1100 generator can be activated to supply the trigger signal to the 1120 ultrasonic transducer in any suitable manner. For example, generator 1100 may comprise a foot switch 1430 (Figure 5) coupled to generator 1100 via a foot switch cable 1432. A clinician can activate the ultrasonic transducer 1120 and, thus, the ultrasonic transducer 1120 and the blade 1128, 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, one or more switches may comprise a pair of toggle buttons 1134, 1134a, 1134b (Figure 3), for example, to determine a mode of operation for the 1104 device. the toggle button 1134a is pressed, for example, the ultrasonic generator 1100 can provide a maximum trigger signal to the transducer 1120, causing it to produce a maximum 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).
[192] [192] In addition or alternatively, one or more switches may comprise a toggle button 1134 which, when pressed, causes generator 1100 to provide a pulse output (Figure 3). 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.
[193] [193] It will be recognized that a device 1104 can comprise any combination of toggle buttons 1134a, 1134b, 1134 (Figure 3). For example, device 1104 can be configured to have only two toggle buttons: a toggle button 1134a to produce a maximum ultrasonic energy output and a toggle button 1134 to produce a pulse output at the maximum power level or less than 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.
[194] [194] In certain respects, a two-position switch can be provided as an alternative to an 1134 toggle button (Figure 3). For example, a device 1104 may include a toggle button 1134a to produce a continuous output at a maximum power level and a two-position toggle button 1134b. In a first predetermined position, the toggle button 1134b can produce a continuous output at a power level less than the maximum, and in a second holding position, the toggle button 1134b can produce an output in pulses (for example, in a maximum or less than maximum power level, depending on the EEPROM configuration).
[195] [195] In some respects, the RF 1124, 1125 electrosurgical end actuator (Figure 3) 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,
[196] [196] In several respects, the 1100 generator can comprise several separate functional elements, such as modules and / or blocks, as shown in Figure 5, a diagram of the surgical system 1000 in Figure 3. Different modules or functional elements can be configured to drive different types of surgical devices 1104, 1106, 1108. For example, an ultrasonic generator module can drive an ultrasonic device, such as the ultrasonic instrument
[197] [197] According to the aspects described, the ultrasonic generator module can produce one or more drive signals with specific voltages, currents and frequencies (for example, 55,500 cycles per second, or Hz). The signal or trigger 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.
[198] [198] 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 using radio frequency (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.).
[199] [199] The generator 1100 can comprise an input device 2150 (Figure 8B) located, for example, on a front panel of the generator console 1100. 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 displayed 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.
[200] [200] Generator 1100 may also comprise an output device 2140 (Figure 8B) located, for example, on a front panel of the generator console 1100. 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).
[201] [201] Although certain modules and / or blocks of the 1100 generator can be described by way of example, it should be considered that
[202] [202] In one respect, the ultrasonic generator drive module and the electrosurgery / RF 1110 drive module (Figure 3) 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 ").
[203] [203] 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 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 determined and used to control 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.
[204] [204] 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 an alternating voltage signal Vg (t) and 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.
[205] [205] As shown in Figure 6, 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 "in 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 static capacitance at a resonant frequency so that substantially all of the generator's trigger signal current flows to the moving branch. Consequently, using a tuning inductor, the current of the generator's trigger signal represents the current of the branch in motion, 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.
[206] [206] Figure 6 illustrates a 1500 equivalent 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, the 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 under 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 through the adequate control of Ig (t) and Vg (t). As explained above, known generator architectures can include a Lt tuning inductor (shown in dashed line in Figure 6) in a parallel resonance circuit to cancel the static capacitance C0 at the resonance frequency, so that substantially all of the generator current Ig (t) flows through the motion branch. In this way, the current control of the motion branch Im (t) is obtained by controlling the output current 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 will need a different Lt tuning inductor. In addition, as the Lt tuning inductor corresponds with the nominal value of the static capacitance C0 at a single resonance frequency, the accurate control of the current of the motion branch 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.
[207] [207] Various aspects of the 1100 generator may not need a Lt tuning inductor to monitor the current of the Im (t) motion branch. Instead, generator 1100 can use the measured value of static capacitance C0 between power applications to a specific ultrasonic surgical device 1104 (along with voltage and current feedback data from the drive signal) to determine the values of current Im ( t) the movement branch in a dynamic and continuous way (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.
[208] [208] Figure 7 is a simplified block diagram of an aspect of the 1100 generator to provide adjustment without an inductor, as described above, among other benefits. Figures 8A to 8C illustrate an architecture of the generator 1100 of Figure 7 according to one aspect. Referring to Figure 7, 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) to define the trigger signal outputs 1600a, 1600b, 1600c so as to output output trigger signals to different surgical devices, such as for example an ultrasonic surgical device 1104 and an electrosurgical device 1106. In particular, the trigger signal outputs 1600a, 1600b and 1600c can output a trigger signal (for example, a 420 V RMS trigger signal) to a surgical device ultrasonic 1104, and the trigger signal outputs 1600a, 1600b and 1600c can emit a trigger signal (for example, a si control unit at 100 V RMS) for 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 1560 power transformer. In some respects, 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 supplying a digital output to a 1680 digital-to-analog converter (DAC) which, in turn, provides an analog signal corresponding to an input of the power amplifier.
[209] [209] Power can be supplied to a power rail of the 1620 power amplifier by a 1700 switching mode regulator. In certain aspects, the 1700 switching mode regulator may comprise an adjustable buck regulator, for example. As discussed above, the non-isolated stage 1540 may further comprise a 1740 processor which, in one respect, may comprise a DSP processor such as an ADSP-21469 SHARC DSP, available from Analog Devices, Norwood, Mass., USA, for example . In some respects, the 1740 processor can control the operation of the 1700 key mode power converter responsive to voltage feedback data received from the 1620 power amplifier by the 1740 processor via a 1760 analog-to-digital converter (DAC). one aspect, for example, the 1740 processor can receive as input, through the ADC 1760, the waveform envelope of a signal (for example, an RF signal) being amplified by the power amplifier 1620. The processor 1740 can, then, control the 1700 key mode regulator (for example, via a pulse-width modulated (PWM) output so that the rail voltage supplied to the 1620 power amplifier follows the envelope By amplifying the 1620 power amplifier's rail voltage dynamically based on the waveform envelope, the efficiency of the 1620 power amplifier can be significantly improved. a with respect to an amplifier scheme with fixed rail voltage. The 1740 processor can be configured for wired or wireless communication.
[210] [210] In certain respects and as discussed in further detail in connection with Figures 9A and 9B, the 1660 programmable logic device, in conjunction with the 1740 processor, can implement a direct digital synthesizer (DDS) control scheme to control the waveform format, the frequency and / or amplitude of the drive signals emitted by the 1100 generator. In one aspect, for example, the programmable logic device 1660 can implement a DDS 2680 control algorithm (Figure 9A) by retrieving of 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. Since other frequencies can excite parasitic resonances, minimizing or reducing the total distortion of the branching current can correspondingly minimize or reduce the undesirable effects of the resonance. As the waveform shape of a drive signal output by the 1100 generator is impacted by various sources of distortion present in the output drive circuit (for example, the 1560 power transformer,
[211] [211] 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, 1840, to respectively sample the voltage and the current of signals of activation emitted by the generator 1100. In certain aspects, ADCs 1780 and 1800 can be configured for sampling at high speeds (for example, 80 Msps) to allow over-sampling of the activation 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 voltage and current input signals through a bidirectional multiplexer. The use of high-speed sampling in certain aspects of the 1100 generator can make it possible, among other things, to calculate the complex current flowing through the branch of motion (which can be used in certain aspects to implement waveform shape control based on the DDS described above), accurate digital filtering of the sampled signals and the calculation of actual power consumption with a high degree of accuracy. The output of voltage and current feedback data 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 the processor 1740. As noted above, voltage and current feedback data can be used as an input for an algorithm for pre-distortion or modification of waveform samples in the LUT, in a dynamic and continuous manner. In some respects, this may require that each stored voltage and current feedback data pair be indexed based on, or otherwise associated with, a corresponding LUT sample that was issued by the 1660 programmable logic device when the data pair feedback on voltage and current was captured. The synchronization of the LUT samples with the voltage and current feedback data in this way contributes to the correct timing and stability of the pre-distortion algorithm.
[212] [212] In certain respects, voltage and current feedback data can be used to control the frequency and / or amplitude (eg current amplitude) of the drive 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 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.
[213] [213] The impedance phase can be determined using Fourier analysis. In one aspect, the phase difference between the voltage trigger signals Vg (t) and current Ig (t) of the generator can be determined using the fast Fourier transform (FFT) or the discrete Fourier transform (DFT) ) as follows: = cos 2 + = cos 2 + = - + +! "# 2 $ 2 2 = - + + exp" # 2 $ 2 2
[214] [214] The evaluation of the Fourier transform at the sinusoid frequency produces:
[215] [215] Other approaches include weighted least square 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, the digital signal samples of the voltage and current signals are transformed by the Fourier technique with an FFT or a DFT. The phase angle φ at any point in time can be calculated by: = 2 +
[216] [216] where φ is the phase angle, f is the frequency, t is the time, and φ0 is the phase at time t = 0.
[217] [217] Another technique for determining the phase difference between voltage signals Vg (t) and current Ig (t) is the zero-crossing method which produces highly accurate results. For voltage signals Vg (t) and current Ig (t) that have the same frequency, 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 for 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 the passages from zero from positive to negative are also used in a similar way, and the results are averaged,
[218] [218] 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.
[219] [219] 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 a control algorithm, for example a proportional-integral-derivative control algorithm (PID), on the 1740 processor. The variables controlled by the control algorithm to properly control the amplitude current values of the drive 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 an 1860 DAC.
[220] [220] The non-isolated stage 1540 may also contain a 1900 processor to provide, among other things, user interface (UI) functionality. 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 a 1430 foot switch, communication with a 2150 input 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 a peripheral serial interface bus (SPI)). 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.
[221] [221] In certain aspects, both the 1740 processor (Figures 7, 8A) and the 1900 processor (Figures 7, 8B) 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.
[222] [222] The non-isolated stage 1540 may additionally comprise a 1960 controller (Figures 7, 8B) for monitoring 2150 input devices (for example, a capacitive touch sensor used to turn generator 1100 on and off, a touch sensitive screen ). In certain aspects, 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
[223] [223] 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 7) discussed below). In this way, the 1960 controller can continue to monitor a 2150 input device (for example, a capacitive touch sensor located on a front panel of the 1100 generator) to turn the 1100 generator on and off. When the 1100 generator 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 7) from power supply 2110) if activation of the input device is detected" on / off "2150 by a user. Therefore, controller 1960 can initiate a sequence to transition the 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 aspects,
[224] [224] In certain respects, the 1960 controller can cause the 1100 generator to provide 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.
[225] [225] In certain respects, 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) based communication link. Power can be supplied to the 1980 instrument interface circuit using, for example, a low-drop voltage regulator powered by an isolation transformer driven from the 1540 non-isolated stage.
[226] [226] In one aspect, the 1980 instrument interface circuit may comprise a programmable logic device 2000 (for example, an FPGA) in communication with a signal conditioning circuit 2020 (Figure 7 and Figure 8C). 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)
[227] [227] 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 7, the first data loop interface 2040 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 2040 data circuit interface can be integral with the programmable logic device 2000.
[228] [228] In some respects, 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.
[229] [229] 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.
[230] [230] 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 triplex 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.
[231] [231] In certain respects, the second data circuit and the second data circuit interface 2100 can be configured so that communication between programmable logic device 2000 and the second data circuit can be achieved without the need to provide conductors for this purpose (for example, dedicated cable conductors connecting a handle 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 the existing wiring, as one of the conductors used transmitting interrogation signals from the signal conditioning circuit 2020 for 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.
[232] [232] In certain respects, the isolated stage 1520 may comprise at least one 2960-1 blocking capacitor (Figure 8C) connected to the trigger signal output 1600b to prevent the passage of DC 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, for example , by 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 7), generator 1100 can determine when at least one of the blocking capacitors 2960-1 and 2960-2 has failed. Consequently, the appearance of Figure 7 can provide a benefit over designs with only one capacitor, having a single point of failure.
[233] [233] In certain respects, the non-isolated stage 1540 may comprise a power supply 2110 to provide DC power 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.
[234] [234] Figures 9A and 9B 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
[235] [235] The multiplexed voltage and current feedback samples can be received by a parallel data capture port ("PDAP" - parallel data acquisition port) implemented inside block 2144 of the 1740 processor. The PDAP can comprise a unit of packaging to implement any of the countless 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 data samples (and any sample address data LUTs, where applicable) in a designated memory location 2180 of the 1740 processor (for example , Internal RAM).
[236] [236] Block 2200 of the 1740 processor can implement a pre-distortion algorithm to pre-distort or modify the LUT samples stored in the 1660 programmable logic device 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.
[237] [237] In block 2220 of the pre-distortion algorithm, the current is determined through the movement branch of the ultrasonic transducer. The current of the movement branch can be determined using the Kirchoff current law based, for example, on the current and voltage feedback information stored in memory 2180 (which, when properly sized, can be representative of Ig and Vg in the model of Figure 6 discussed above), in a value of the static capacitance of the ultrasonic transducer C0 (measured or known a priori) and in a known value of the activation 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.
[238] [238] 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 sample amplitude error, 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 LUT of 2260 waveforms, 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.
[239] [239] Each sample amplitude error value determined in block 2240 can be transmitted to the LUT of programmable logic device 1660 (shown in block 2280 in Figure 9A) 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.
[240] [240] 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, the 2320 filter 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.
[241] [241] In block 2340 (Figure 9B), a calculation of the mean square root (RMS) can be applied to a size of the current feedback samples representing an integer number of cycles of the drive signal, to generate an Irms measurement representing the output current of the drive signal.
[242] [242] In block 2360 (Figure 9B), an average square root (RMS) calculation can be applied to a size of the voltage feedback samples representing an integer number of trigger signal cycles, to determine a Vrms measurement representing the output voltage of the trigger signal.
[243] [243] In block 2380, the current and voltage feedback samples can be multiplied point by point, and an average calculation is applied to the samples representing an integer number of cycles of the drive signal, to determine a Pr measurement of the actual power generator output.
[244] [244] In block 2400, the Pa measurement of the apparent output power of the generator can be determined as the product Vrms · Irms.
[245] [245] In block 2420, the Zm measurement of the magnitude of the load impedance can be determined as the Vrms / Irms quotient.
[246] [246] In certain respects, the quantities Irms, 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 control processes. diagnosis. In certain aspects, any of these quantities can be communicated to a user through, for example, an output device 2140 integral to the generator 1100, or an output device 2140 connected to the generator 1100 through a suitable communication interface (for example , a USB interface). The various diagnostic processes can include, without limitation, cable integrity, instrument integrity, instrument fixation integrity, instrument overload, proximity to instrument overload, frequency locking failure, over voltage condition, over voltage condition current, overpower condition, voltage sensor failure, current sensor failure, audio indication failure, visual indication failure, short circuit condition, power supply failure, or blocking capacitor failure, for example.
[247] [247] Block 2440 of the 1740 processor can implement a phase control algorithm to determine and control 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.
[248] [248] The phase control algorithm receives the current and voltage feedback information stored in memory location 2180 as input. Before being used in the phase control algorithm, feedback feedback can be appropriately sized and, in certain cases, 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.
[249] [249] 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.
[250] [250] In block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized input of samples from the motion branch current 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.
[251] [251] 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.
[252] [252] In block 2560 (Figure 9A) 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.
[253] [253] 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 performed, 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 the memory location
[254] [254] In aspects where the drive signal voltage is the control variable, the demand current 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). Similarly, in aspects where the inverter signal strength is the control variable, the current demand Id can be specified indirectly, for example based on the current required to maintain a desired power setpoint 2620C (Psp) given the voltage Vrms measured in blocks 2360 (for example, Id = Psp / Vrms).
[255] [255] Block 2680 (Figure 9A) can implement a DDS control algorithm to control the trigger signal through the use of LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm can be an numerically-controlled oscillator (NCO) 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.
[256] [256] 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.
[257] [257] Figure 10 illustrates a control circuit 500 configured to control aspects of the instrument or surgical tool according to an aspect of that 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 this description.
[258] [258] Figure 11 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 can 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.
[259] [259] Figure 12 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.
[260] [260] In one aspect, the ultrasonic current or high frequency current generators of the surgical system 1000 can be configured to digitally generate the electrical signal waveform of the desired shape, using a predetermined number of phase points stored in a measurement table. query to scan the waveform. The phase points can be stored in a table defined in a memory, a field programmable port matrix (FPGA) or any suitable non-volatile memory. Figure 13 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 query table 4104, which in turn provides varying 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, multiple RF electrodes simultaneously or a combination of ultrasonic instruments and RF. In addition, multiple 4104 look-up tables representing multiple waveforms can be created, stored and applied to tissue from a generator.
[261] [261] 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.
[262] [262] 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. In this way, the generator circuit can be configured to provide an analog electrical signal waveform to at least one surgical instrument, with the analog electrical signal waveform corresponding to at least one waveform of a plurality of formats. stored in query table 4104. In addition, the analog electrical signal waveform provided to at least two surgical instruments can comprise two or more waveforms. Lookup table 4104 can comprise information associated with a plurality of waveforms and lookup table 4104 can be stored inside the generating circuit or surgical instrument. In one aspect or example, query table 4104 can be a digital direct synthesis table, which can be stored in an FPGA of the generator circuit or surgical instrument. Lookup table 4104 can be addressed in any way that is convenient for categorizing waveforms. According to one aspect, query table 4104, which can be a digital direct synthesis table, is addressed according to a frequency of the desired analog electrical signal waveform. Additionally, the information associated with the plurality of waveforms can be stored as digital information in the query table 4104.
[263] [263] 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 13. In this simplified block diagram, a DDS circuit is coupled to a processor, controller or logic device of the generator circuit and to a memory circuit located on the generator circuit of the surgical system 1000. The DDS 4100 circuit comprises an address counter 4102, a lookup table 4104, a register 4106, a DAC circuit 4108 and a filter 4112. A stable clock signal fc is received by the address counter 4102 and register 4106 drives a programmable read-only memory (PROM) which 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 table query 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 the query table 4104 drives the 4108 DAC circuit, which in turn generates an analog 4110 output signal. The spectral purity of the 4110 analog output signal is mainly determined by the DAC 4108 circuit. The phase noise is basically that of the reference clock fc . 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.
[264] [264] 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 integer number of cycles. The final fout output frequency can be changed by changing the frequency of the reference clock fc or reprogramming the PROM.
[265] [265] 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 lookup tables to provide different tissue treatments based on instrument configurations or tissue feedback.
[266] [266] 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 14. 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.
[267] [267] 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.
[268] [268] A truncated output 4218 of phase accumulator 4206 is supplied to a lookup table of the phase converter for amplitude 4210 and the output of lookup table 4210 is coupled to a DAC circuit
[269] [269] 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 referred to as a phase point at point n. The number of distinct phase points n determines the tuning resolution of the DDS 4200 circuit
[270] [270] Table 1 specifies the digitized electrical signal waveform at a number of phase points. 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 22 4,194,304 24 16,777,216 26 67,108,864 28 268,435,456 ... ... 32 4,294,967,296. .. ... 48 281.474.976.710.656 ... ... Table 1
[271] [271] The generator circuit algorithms and digital controls can scan the addresses in the 4210 lookup table, which in turn provides variable digital input values for the 4212 DAC circuit that powers the 4214 filter and power amplifier. . The addresses can be checked according to a frequency of interest. The use of the look-up table allows the generation of various 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 to the fabric in the form of RF energy or fed to an ultrasonic 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.
[272] [272] Referring again to Figure 13, 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.
[273] [273] For a 4206 phase accumulator configured to accumulate n bits (with n generally in the range of 24 to 32 on most DDS systems but, as previously discussed, n cannot be selected from a wide range of options), there are 2n possible phase points. The digital word in the delta phase recorder, M, represents the amount by which the phase accumulation is increased per clock cycle. If fc is the clock frequency, then the frequency of the output sine wave is equal to:, ∙. = 2 /
[274] [274] The above equation is known as the "tuning equation" DDS. It should be mentioned that the frequency resolution of the system is equal to. For n = 32, the resolution is greater than one part in four billion. In one aspect of the DDS circuit 4200, not all of the bits outside the phase accumulator 4206 pass into query table 4210, but are truncated, leaving only the first 13 to 15 most significant bits (MSBs), for example. This reduces the size of the 4210 lookup table and does not affect the frequency resolution. Phase truncation only adds a small but acceptable amount of phase noise to the final output.
[275] [275] The electrical signal waveform can be characterized by current, voltage or power at a given frequency. In addition, when any of the surgical instruments in the 1000 surgical system comprises ultrasonic components, the electrical signal waveform can be configured to activate at least two modes of vibration of an ultrasonic transducer of at least one surgical instrument. Consequently, the generator circuit can be configured to provide an electrical signal waveform to at least one surgical instrument, the electrical signal waveform being characterized by a predetermined waveform stored in query table 4210 (or in query table 4104 in Figure 13). In addition, the electrical signal waveform can be a combination of two or more waveforms. Lookup table 4210 can comprise information associated with a plurality of waveforms. In one aspect or example, query table 4210 can be generated by the DDS 4200 circuit and can be referred to as a digital direct overview table. Direct digital synthesis (DDS) operates by first storing a large repetitive waveform in the integrated memory. A cycle of a waveform (sinusoidal, triangular, square, arbitrary) can be represented by a predetermined number of phase points, as shown in TABLE 1 and stored in memory. Once the waveform is stored in memory, it can be generated at very precise frequencies. The digital direct synthesis table can be stored in a non-volatile memory of the generator circuit and / or can be implemented with an FPGA circuit in the generator circuit. Lookup table 4210 can be addressed by any suitable technique that is convenient for categorizing waveforms. According to one aspect, the lookup table 4210 is addressed according to a frequency of the electrical signal waveform. In addition, information associated with the plurality of waveforms can be stored as digital information in a memory or as part of query table 4210.
[276] [276] In one aspect, the generator circuit can be configured to provide electrical signal waveforms 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.
[277] [277] Additionally, a method for operating the generator in accordance with the present disclosure comprises generating an electrical signal waveform and providing the generated electrical signal waveform to any of the surgical instruments in the 1000 surgical system,
[278] [278] The generator circuit, as described here, can allow the generation of several types of digital direct 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.
[279] [279] In addition to traditional sine / cosine waveforms, the generator 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.
[280] [280] 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 that have a unique shape can be stored in multiple 4210 lookup tables to provide different tissue treatments based on instrument settings 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 forms of waves stored in different query tables 4210 based on the effect on the desired tissue and / or tissue feedback. Therefore, alternation between waveforms can be based on tissue impedance and other factors, for example. In other aspects, 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 still other aspects, the 4210 look-up tables can store electrical signal waveforms to simultaneously trigger ultrasonic energy and therapeutic and / or subtherapeutic RF energy, while simultaneously maintaining ultrasonic frequency blocking. 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.
[281] [281] Figure 15 illustrates a cycle of a 4300 isolated time digital electrical signal waveform, in accordance with 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 during a cycle or period T0. The waveform of the 4300 digital electrical signal is generated for 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 13 and 14, the digital word is a six-bit word that is capable of storing the amplitude phase points with a resolution of 26 or 64 bits. It will be recognized that the examples shown in Figures 13 and 14 are for illustration purposes and, in current implementations, the resolution may be much higher. The digital amplitude phase points 4302 during a To cycle are stored in memory as a string of words in a query table 4104, 4210, as described with reference to Figures 13 and 14, for example. To generate the analog version of the 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 relation to the Figures 13 and 14. Additional cycles can be generated by repeatedly reading the amplitude phase points 4302 of the waveform of the digital electrical signal 4300 from 0 to To for the desired number of cycles or periods. The smooth analog version of analog waveform 4304 is obtained by filtering the output of the DAC 4108, 4212 circuit through a 4112, 4214 filter (Figures 13 and 14). The filtered analog output signal 4114, 4222 (Figures 13 and 14) is applied to the input of a power amplifier.
[282] [282] Figure 16 is a diagram of a 12950 control system that can be implemented as a nested PID feedback controller. A PID controller is a feedback loop control mechanism (controller) for continuously calculating an error value such as the difference between a desired setpoint and a measured process variable and applying a correction based on proportional, integral and derivative terms. (sometimes referred to as P, I, and D respectively). The feedback control system of the nested PID controller 12950 includes a primary controller 12952, on a primary feedback circuit (external) 12954 and a secondary controller 12955 on a secondary feedback (internal) circuit 12956. Primary controller 12952 can be a PID controller 12972, as shown in Figure 17, and secondary controller 12955 can also be a PID controller 12972 as shown in Figure 17. Primary controller 12952 controls a primary process 12958 and secondary controller 12955 controls a secondary process 12960. The output 12966 from primary process 12958 is subtracted from a primary setpoint SP1 by a first adder 12962. The first adder 12962 produces a single output sum signal that is applied to primary controller 12952. The output from primary controller 12952 is the secondary setting SP2. Output 12968 of secondary processor 12960 is subtracted from a secondary setpoint SP2 by a second adder 12964.
[283] [283] Figure 17 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
[284] [284] According to the PID algorithm, the "P" element 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 current rate of change. For example, continuing with 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.
[285] [285] 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 trigger member, the load of the trigger member, the displacement of the cutting element, the speed of the cutting element, the location of the closing pipe, the loading of the pipe closing, among others.
[286] [286] Figure 18 is an alternative 132000 system 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 132008 crystal oscillator 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.
[287] [287] 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,
[288] [288] Optionally, the tuning voltage Vt, which is proportional to the output frequency fo, can be fed back to processor 132004 via 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. Estimate of the claw state (burning of the block, clamps, broken blade, bone in the claw, tissue in the claw)
[289] [289] A challenge with releasing ultrasonic energy is that the acoustics applied to the wrong materials or the wrong tissue can result in device failure, for example, burning the clamping arm block or breaking the ultrasonic blade. It is also desirable to detect what is located in the jaws of an end actuator of an ultrasonic device and the state of the jaws without adding additional sensors to the jaws. The location of sensors in the claws of an ultrasonic end actuator poses challenges regarding reliability, cost and complexity.
[290] [290] Techniques of the ultrasound spectroscopy smart blade algorithm can be used to estimate the state of the claw (burnt clamp arm block, broken clamps or blade, bone in the claw, tissue in the claw, reverse cut with the claw closed, etc.) .) based on the impedance = of an ultrasonic transducer configured to drive an ultrasonic transducer blade, in accordance with at least one aspect of the present description. The impedance, the magnitude | |, and phase φ are plotted as a function of frequency f.
[291] [291] Dynamic mechanical analysis (DMA), also known as dynamic mechanical spectroscopy or simply mechanical spectroscopy, is a technique used to study and characterize materials. A sinusoidal stress is applied to the material, and the mechanical stress on the material is measured, allowing the determination of the complex modulus of the material. Spectroscopy as applied to ultrasonic devices includes excitation of the tip of the ultrasonic blade with a frequency scan (composite signals or traditional frequency scans) and measurement of the resulting complex impedance at each frequency. The complex impedance measurements of the ultrasonic transducer over a frequency range are used in a classifier or model to infer the characteristics of the ultrasonic end actuator. In one aspect, the present description provides a technique for determining the state of an ultrasonic end actuator (clamping arm, claw) to trigger automation on the ultrasonic device (how to disable power to protect the device, run adaptive algorithms, retrieve information, identify fabric, etc.).
[292] [292] Figure 19 is a 132030 spectrum of an ultrasonic device with a variety of different states and conditions of the end actuator, where impedance, magnitude | Z | and phase φ are plotted as a function of frequency f, according to at least one aspect of the present description. The 132030 spectra are plotted in a three-dimensional space where the frequency (Hz) is plotted along the x axis, the phase (Rad) is plotted along the y axis, and the magnitude (Ohms) is plotted along the z axis.
[293] [293] Spectral analysis of different claw bites and device states produces different characteristic complex impedance patterns (fingerprints) over a frequency range for different conditions and states. Each state or condition has a different characteristic pattern in 3D space when plotted. These characteristic patterns can be used to estimate the condition and state of the end actuator. Figure 19 shows the spectra for air 132032, the clamping arm block 132034, the suede 132036, the clamp 132038 and the broken blade 132040. The suede 132036 can be used to characterize different types of fabric.
[294] [294] The 132030 spectra can be evaluated by applying a low power electrical signal through the ultrasonic transducer to produce non-therapeutic excitation of the ultrasonic blade. The low power electrical signal can be applied in the form of a scan or a composite Fourier series to measure impedance = via the ultrasonic transducer in a frequency range in series (scan) or in parallel (composite signal) using an FFT . New data classification methods
[295] [295] For each characteristic pattern, a parametric line can be fitted to the data used for training using a polynomial, a Fourier series or any other form of parametric equation, as can be dictated by convenience. A new data point is then received and classified using the Euclidean perpendicular distance from the new data point for the trajectory that was adjusted to the training data with a characteristic pattern. The perpendicular distance from the new data point to each of the paths (each path representing a different state or condition) is used to assign the point to a state or condition.
[296] [296] The probability distribution of the distance from each data point in the training data for the fitted curve can be used to estimate the probability of a correctly classified new data point. This essentially builds a two-dimensional probability distribution on a plane perpendicular to the adjusted path at each new data point on the adjusted path. The new data point can then be included in the training set based on its probability of correct classification to make an adaptive learning classifier that readily detects high-frequency changes in states, but adapts to slow the deviations that occur in the system performance, such as a device that gets dirty or the block that wears out.
[297] [297] Figure 20 is a graphical representation of a 132042 plot of a 3D training data set (S), where the ultrasonic transducer impedance, magnitude | Z | and phase φ are plotted as a function of frequency f, according to at least one aspect of the present description. The 3D training data set (S) 132042 is plotted in three-dimensional space where the phase (Rad) is plotted along the X axis, the frequency (Hz) is plotted along the Y axis, the magnitude (Ohms) is plotted along the z axis, and a parametric Fourier series is fitted to the 3D training data set (S). The methodology for classifying the data is based on the 3D training data set (S0 is used to generate the 132042 plot).
[298] [298] The parametric Fourier series fitted to the 3D training data set (S) is defined by::: ! ⃑ = 5⃑ + 6 "5⃑ / 789 + <= ⃑ / 9>: $;; / @
[299] [299] For a new point A⃑, the perpendicular distance from! ⃑ to A⃑ is obtained by:
[300] [300] A probability distribution D can be used to estimate the probability that a point A⃑ belongs to group S. Control
[301] [301] Based on the classification of data measured before, during or after activation of the ultrasonic transducer / ultrasonic blade, a variety of automated tasks and safety measures can be implemented. Similarly, the state of the tissue located in the end actuator and the temperature of the ultrasonic blade can also be inferred to some degree, and used to better inform the user about the state of the ultrasonic device or to protect critical structures etc. The temperature control of an ultrasonic blade is described in US Commonly Provisional Patent Application US No. 62 / 640,417, filed on March 8, 2018, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR, which is incorporated herein by reference in its entirety.
[302] [302] Similarly, the power application can be reduced when there is a high probability that the ultrasonic blade is in contact with the clamping arm block (for example, without fabric between) or if there is a probability that the ultrasonic blade has broken or that the ultrasonic blade is touching the metal (for example, a clamp). In addition, reverse cutting may not be allowed if the claw closes and no tissue is detected between the ultrasonic blade and the clamping arm block.
[303] [303] This system can be used in conjunction with other information provided by sensors, the user, metrics on the patient, environmental factors etc., by combining the data from this process with the aforementioned data using probability functions and a Kalman filter. The Kalman filter determines the maximum probability that a state or condition will occur given a multitude of uncertain measurements of varying confidence. As this method allows a probability assignment for a new classified data point, this algorithm information can be implemented with other measures or estimates in a Kalman filter.
[304] [304] Figure 21 is a 132044 logic flow diagram showing a control program or logic configuration to determine claw conditions based on the characteristic complex impedance pattern (characteristic measure) according to at least one aspect of this description. Before determining the condition of the claw based on the characteristic complex impedance pattern (fingerprint), a database is filled with characteristic reference complex impedance patterns or training data sets (S) that characterize various claw conditions , including, without limitation, air 132032, clamping arm block 132034, suede 132036, clamp 132038, broken blade 132040, as shown in Figure. 82, and a variety of fabric types and conditions. Dry or wet chamois, with full or tip bite, can be used to characterize different types of fabric. The data points used to generate characteristic patterns of complex reference impedance or a set of training data (S) are obtained by supplying a subtherapeutic trigger signal to the ultrasonic transducer, scanning the trigger frequency in a range predetermined frequencies from below resonance to above resonance, measuring the complex impedance at each of the frequencies and recording the data points. The data points are then fitted to a curve using a variety of numerical methods, including adjustment of polynomial curves, Fourier series, and / or parametric equation. An adjustment of the parametric Fourier series to the characteristic standards of complex reference impedance or to a training data set (S) is described in the present invention.
[305] [305] Once the characteristic reference impedance complex patterns or training data sets (S) are generated, the ultrasonic instrument measures the new data points, classifies the new points and determines whether the new data points should be added to the characteristic reference complex impedance standards or training data sets (S).
[306] [306] Turning now to the logical flow diagram of Figure 21, in one aspect, the control circuit measures 132046 a complex impedance from an ultrasonic transducer, the complex impedance being defined as =. The control circuit receives 132048a a complex impedance measurement data point and compares 132050 the complex impedance measurement data point with a data point in a characteristic reference standard complex impedance. The control circuit sorts 132052 the complex impedance measurement data point based on a comparison analysis result and assigns 132054 a state or condition of the end actuator based on the comparison analysis result.
[307] [307] In one aspect, the control circuit receives the characteristic reference pattern of complex impedance from a database or memory coupled to the processor. In one aspect, the control circuit generates the characteristic complex impedance reference pattern as follows. A drive circuit coupled to the control circuit applies a non-therapeutic drive signal to the ultrasonic transducer starting at an initial frequency, ending at a final frequency and a plurality of frequencies between them. The control circuit measures the impedance of the ultrasonic transducer at each frequency and stores a data point that corresponds to each impedance measurement. The control circuit curve adjusts to a plurality of data points to generate a three-dimensional curve representing the characteristic complex impedance reference pattern, where the magnitude | Z | and phase φ are plotted as a function of frequency f. The curve fit includes a polynomial curve fit, a Fourier series and / or a parametric equation.
[308] [308] In one aspect, the control circuit receives a new impedance measurement data point and sorts the new impedance measurement data point using an Euclidean perpendicular distance from the new impedance measurement data point for a path that was adjusted to the characteristic impedance pattern of the reference complex. The control circuit calculates a probability that the new impedance measurement data point is correctly classified. The control circuit adds the new impedance measurement data point to the characteristic complex impedance reference pattern based on the probability of the estimated correct rating of the new impedance measurement data point. In one aspect, the control circuit sorts data based on a training data set (S), where the training data set (S) comprises a plurality of complex impedance measurement data, and adjusts the curve of the training data set (S) using a parametric Fourier series, where S is defined in the present invention and the probability distribution is used to estimate the probability of the new impedance measurement data point belonging to group S. Gripper classifier status based on model
[309] [309] There is an interest in classifying matter within the claws of an ultrasonic device, including tissue types and condition. In several aspects, it can be shown that with high data sampling and sophisticated pattern recognition, it is possible to perform this classification. The approach is based on impedance as a function of frequency, where the magnitude, phase and frequency are plotted in 3D, the patterns look like tapes, as shown in Figures 19 and 20, and the logical flow diagram in Figure 21. This description provides an intelligent blade algorithm approach that is based on a well-established model for piezoelectric transducers.
[310] [310] As an example, the equivalent electrical coupled parameter model is known to be an accurate model of the physical piezoelectric transducer. It is based on the Mittag-Leffler expansion of a tangent close to a mechanical resonance. When complex impedance or complex admittance is plotted as an imaginary component versus an actual component, circles are formed. Figure 22 is a circular plot 132056 of complex impedance plotted as an imaginary component versus the actual components of a piezoelectric vibrator, in accordance with at least one aspect of the present description. Figure 23 is a circular plot of the complex admittance plotted graphically as an imaginary component versus the actual components of a piezoelectric vibrator, according to at least one aspect of the present description. The circles shown in Figures 22 and 23 are taken from the IEEE 177 standard, which is incorporated here as a reference in its entirety. Tables 1-4 are taken from the IEEE 177 standard and are disclosed here for completeness.
[311] [311] The circle is created as the frequency is swept from below the resonance to above the resonance. Instead of stretching the circle out in 3D, a circle is identified and the radius (r) and displacements (a, b) of the circle are estimated. These values are then compared with the values established for certain conditions. These conditions can be: 1) do not open anything in the claws, 2) clamp the tip and 3) clamp everything and the clamp in the claws. If the scan generates multiple resonances, circles of different characteristics are present for each resonance. Each circle will be pulled out of the next if the resonances are separate. Instead of fitting a 3D curve with a series approach, the data is fitted with a circle. The radius (r) and the displacements (a, b) can be calculated using a processor programmed to perform a variety of mathematical or numerical techniques described below. These values can be estimated by capturing an image of a circle and, using image processing techniques, the radius (r) and the displacements (a, b) that define the circle are estimated.
[312] [312] Figure 24 is a circular plot 132060 of the complex admittance for a 55.5 kHz ultrasonic piezoelectric transducer for the aggregated parameter inputs and outputs specified later in this document. The values for an aggregate parameter model were used to generate the complex admittance. A moderate load was applied to the model. The admittance circle obtained and generated in MathCad is shown in Figure 24. The graphical representation of the 132060 circle is formed when the frequency is scanned from 54 to 58 kHz.
[313] [313] The input values for the aggregate parameter are: G8 = 3.0: I
[314] [314] The model outputs based on the inputs are: B ∙ G − R ∙ G 5Q = = 1,013 ∙ 10S ∙ G − R ∙ T − R ∙ B <Q = = −954,585 ∙ G − R 0_ `1 VQ = W6 XY 95í [5 = 5Q + 95í [5 - <Q] a ^! 9, , = 1,012 ∙ 10S
[315] [315] The output values are used to graph the circular plot 132060 shown in Figure 24. The plot of the circle 132060 has a radius (r) and the center 132062 is moved (a, b) from the origin 132064 from the following form: V = 1,012 ∗ 10S 5 = 1,013 ∗ 10S <= −954,585
[316] [316] The sums A-E specified below are necessary to estimate circular plot 132060 plotted for the example given in Figure 24, in accordance with at least one aspect of the present description. There are several algorithms for calculating a fit for a circle. A circle is defined by its radius (r) and the offsets (a, b) from the center from the origin:
[317] [317] The modified least squares method (Umbach and Jones) is convenient in that there is a simple, closed solution for a, b and r.
[318] [318] The caret over the variable "a" indicates an estimate of the true value. A, B, C, D and E are the sum of several products that are calculated from the data. They are included in the present invention for completeness, as follows: 0_ `0_`: =! 9 ∙ 6 8h, - W6 8h, a = 5.453 ∙ 10 0_ `0_` 0_ `R: =! 9 6 8h, ∙ 8h, - jW6 8h, a ∙ W6 8h, ak = 5,461 ∙ 10l 0_ `0_` G: =! 9 6 8h, - W6 8h, a = 5.445 ∙ 10
[319] [319] Z1, i is a first vector of the real components referred to as conductance;
[320] [320] Z2, i is a second of the imaginary components referred to as susceptibility; and
[321] [321] Z3, i is a third vector that represents the frequencies at which admittances are calculated.
[322] [322] The present description will work for ultrasonic systems and can possibly be applied to electrosurgical systems, although electrosurgical systems do not depend on a resonance.
[323] [323] Figures 25 to 29 illustrate images taken from an impedance analyzer showing circular impedance / admittance plots for an ultrasonic device with the end actuator claw in various open or closed and loading configurations.
[324] [324] Complex impedance and complex admittance are exactly reciprocal of each other. No new information should be added by looking at both. Another consideration includes determining how sensitive the estimates are to noise when using complex impedance or complex admittance.
[325] [325] In the examples illustrated in Figures 25 to 29, the impedance analyzer is configured with a range to capture only the main resonance. By scanning over a wider range of frequencies, more resonances can be found and multiple circle plots can be formed. An equivalent circuit of an ultrasonic transducer can be modeled by a first "motion" branch having, serially connected, the inductance Ls, resistance Rs and capacitance Cs that define the electromechanical properties of the resonator, and a second capacitive branch having a static capacitance Co In the impedance / admittance plots shown in Figures 25 to 29 below, the values of the components of the equivalent circuit are: Ls = L1 = 1.1068 H Rs = R1 = 311.352 Ω Cs = C1 = 7.43265 pF C0 = C0 = 3.64026 nF
[326] [326] The oscillator voltage applied to the ultrasonic transducer is 500 mV and the frequency is scanned from 55 kHz to 56 kHz. The impedance scale (Z) is 200 Ω / div and the admittance scale (Y) is 500 µS / div. Measurements of values that can characterize the impedance (Z) and admittance (Y) circle plots can be obtained at the locations on the circle plots as indicated by an impedance cursor and an admittance cursor.
[327] [327] Figure 25 is a graphical display 132066 of an impedance analyzer showing circular plots of complex impedance (Z) / admittance (Y) 132068, 132070 for an ultrasonic device with the claw open and unloaded, where a plot of circle 132068 in continuous line represents the complex impedance and a circular plot 132070 in broken lines shows the complex admittance, according to at least one aspect of the present description. The oscillator voltage applied to the ultrasonic transducer is 500 mV and the frequency is scanned from 55 kHz to 56 kHz. The impedance scale (Z) is 200 Ω / div and the admittance scale (Y) is 500 µS / div. The measurements of the values that can characterize the complex impedance (Z) and admittance (Y) circle plots 132068, 132070 can be obtained at the locations in the circle plots 132068, 132070, as indicated by the impedance cursor 132072 and the admittance cursor
[328] [328] Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the position of the admittance cursor 132074 corresponds to the values of:
[329] [329] Where G is the conductance (real value) and B is the susceptibility (imaginary value). Claw condition: Stuck in dry suede
[330] [330] Figure 26 is a 132076 graphical display of an impedance analyzer showing complex circular impedance (Z) / admittance (Y) plots 132078, 132080 for an ultrasonic device with the end actuator claw stuck in dry suede, where the circular impedance plot 132078 is shown in a continuous line and the circular admittance plot 132080 is shown in a dashed line, in accordance with at least one aspect of the present description. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is a sweep from 55 kHz to 56 kHz. The impedance scale (Z) is 200 Ω / div and the admittance scale (Y) is 500 µS / div.
[331] [331] Measurements of the values that can characterize the complex impedance (Z) and admittance (Y) circle plots 132078, 132080 can be obtained from the locations on the circle plots 132078, 132080, as indicated by the impedance cursor 132082 and the admittance cursor 132084. Thus, the impedance cursor 132082 is located on a portion of the plot of the impedance circle 132078 which is equivalent to about 55.68 kHz and the admittance cursor 132084 is located on a portion of the plot of the circle admittance 132080 which is equivalent to about 55.29 kHz. As shown in Figure 26, the position of the impedance cursor 132082 corresponds to the values of: R = 434.577 Ω
[332] [332] Where R is the resistance (real value) and X is the reactance (imaginary value).
[333] [333] Similarly, the 132084 admittance cursor position corresponds to the values of: G = 85.1712 μS B = 1.49569 mS
[334] [334] Where G is the conductance (real value) and B is the susceptibility (imaginary value). Grip condition: Tip stuck in wet suede
[335] [335] Figure 27 is a graphical display 132086 of an impedance analyzer showing circular plots of complex impedance (Z) / admittance (Y) 132098, 132090 for an ultrasonic device with the claw tip attached to wet suede, where the circular impedance plot 132088 is shown in a continuous line and circular admittance plot 132090 is shown in a dashed line, in accordance with at least one aspect of the present description. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is a sweep from 55 kHz to 56 kHz. The impedance scale (Z) is 200 Ω / div and the admittance scale (Y) is 500 µS / div.
[336] [336] Measurements of the values that can characterize the complex impedance (Z) and complex admittance (Y) 132088, 132090 plots can be obtained from the locations on the 132088, 132090 circle plots, as indicated by the impedance cursor 132092 and the admittance cursor 132094. Thus, the impedance cursor 132092 is located on a portion of the plot of the impedance circle 132088 which is equivalent to about 55.68 kHz and the admittance cursor 132094 is located on a portion of the plot of the admittance circle 132090 which is equivalent to about 55.29 kHz. As shown in Figure 28, the impedance cursor 132092 corresponds to the values of: R = 445.259 Ω X = −750.082 Ω
[337] [337] Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the 132094 admittance cursor corresponds to the values of: G = 96.2179 μS B = 1.50236 mS
[338] [338] Where G is the conductance (real value) and B is the susceptibility (imaginary value). Claw condition: Fully clamped in wet suede
[339] [339] Figure 28 is a 132096 graphical display of an impedance analyzer showing complex circular impedance (Z) / admittance (Y) plots 132098, 132100 for an ultrasonic device with the claw fully attached to wet suede, where the plot impedance circular 132098 is shown in a continuous line and circular admittance plot 132100 is shown in a dashed line, in accordance with at least one aspect of the present description. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is a sweep from 55 kHz to 56 kHz. The impedance scale (Z) is 200 Ω / div and the admittance scale (Y) is 500 µS / div.
[340] [340] Measurements of the values that can characterize the impedance and admittance circle plots 132098, 132100 can be obtained at the locations on the circle plots 132098, 1332100, as indicated by the impedance cursor 13212 and the admittance cursor 132104. , the impedance cursor 132102 is located on a portion of the plot of the impedance circle 132098 which is equivalent to about 55.63 kHz and the admittance cursor 132104 is located on a portion of the plot of the admittance circle 132100 which is equivalent to about 55.29 kHz. As shown in Figure 28, the impedance cursor 132102 corresponds to values of R, the resistance (real value, not shown), and X, the reactance (imaginary value, also not shown).
[341] [341] Similarly, the admittance cursor 132104 corresponds to the values of: G = 137.272 μS B = 1.48481 mS
[342] [342] Where G is the conductance (real value) and B is the susceptance (imaginary value). Gripper status: Open without load
[343] [343] Figure 29 is a 132106 graphical display of an impedance analyzer showing circular impedance (Z) / admittance (Y) plots where the frequency is scanned from 48 kHz to 62 kHz to capture multiple resonances from an ultrasonic device with the claw open and no loading where the area designated by rectangle 132108 shown in dashed line is to help see the circular impedance plots 132110a, 132110b, 132110c shown in continuous line and the circular admittance plots 132112a, 132112b, 132112c, de according to at least one aspect of the present description. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is scanned from 48 kHz to 62 kHz. The impedance scale (Z) is 500 Ω / div and the admittance scale (Y) is 500 µS / div.
[344] [344] Measurements of the values that can characterize the 132110a-c, 132112a-c impedance and admittance circle plots can be obtained from the locations on the 132110a-c, 132112a-c impedance and admittance circle plots, as indicated by the cursor impedance 132114 and admittance cursor 132116. Thus, impedance cursor 132114 is located on a portion of the 132110a-c impedance circle plots equivalent to about 55.52 kHz and the 132116 admittance cursor is located on a portion of the 132112a-c admittance circle plot that is equivalent to about 59.55 kHz. As shown in Figure 29, the impedance cursor 132114 corresponds to the values of: R = 1.86163 kΩ X = −536.229 Ω
[345] [345] Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the 132116 admittance cursor corresponds to the values of: G = 649.956 μS B = 2.51975 mS
[346] [346] Where G is the conductance (real value) and B is the susceptibility (imaginary value).
[347] [347] Because there are only 400 samples in the entire scanning range of the impedance analyzer, there are only a few points around the resonance. Then, the circle on the right side is split. But this is only due to the impedance analyzer and the settings used to cover multiple resonances.
[348] [348] When multiple resonances are present, there is more information to improve the classifier. The plot settings for the 132110a-c, 132112a-c circles can be calculated for each one, as they are found to keep the algorithm running quickly. Thus, whenever there is an intersection with the complex admittance, which implies a circle, during the scan, an adjustment can be calculated.
[349] [349] Benefits include a data-based clamp classifier and a well-known model for ultrasonic systems. The counting and characterization of the circles are well known in visualization systems. Thus, data processing is readily available. For example, a closed form solution exists to calculate the radius and axis displacements for a circle. This technique can be relatively quick.
[350] [350] Table 2 is a list of symbols used for the model of aggregate parameters of a piezoelectric transducer (from IEEE 177 standard). SI Unit References Symbol Meaning Equations Tables Figures Parallel Susceptance mho Bp 2 vibrator equivalent Farad shunt capacitance (parallel) in Co 2, 3, 4, 8 5 1, 4 equivalent electrical circuit Farad Capacitance C1 movement in circuit 2, 3, 4, 6, 8, 9 5 1, 4 electrical equivalent f Hertz frequency 3 Hertz frequency fa antiresonance, 2, 4 2, 3 zero susceptibility fm Hertz admission frequency 2, 4 2, 3
[351] [351] Table 3 is a list of transmission network symbols (IEEE 177 standard). References Symbol Meaning SI Unit Equations Tables Figures Compensation factor b normalized | - dimensionless 4, 10 5 | ˜ ~} ”-} € • •• Dimensional admittance factor B 10 5 normalized Dimensional admittance factor C 10 5 normalized Parallel capacitance CA – B between terminals A and B Farad (Figure 4) CL Load capacitance Farad 6 4 Capacitance CT shunt Farad circuit termination 4, 10 5 4 transmission CL1 Load capacitance Farad 7 CL2 Load capacitance Farad 7 Network output voltage e2 Volt 4 transmission Frequency of fT Hertz 10 maximum transmission Frequency of FsL1 Hertz resonance 7 movement of
[352] [352] Table 4 is a list of solutions for various characteristic frequencies (from the IEEE 177 standard).
[353] [353] TABLE 5 is a loss list of three classes of piezoelectric materials. Type of vibrator Q = Mr r Qr / r min piezoelectric Piezoelectric ceramics 90 to 500 2 to 40 200 Piezoelectric crystals 200 to 50,000 3 to 500 80 water soluble Quartz 104 to 107 100 to 50,000 2,000 Minimum values for the Qr / ra ratio to be expected for various types of piezoelectric vibrators Table 5
[354] [354] Table 6 illustrates the condition of the claw, the estimated parameters of a circle based on real-time measurements of the complex impedance / admittance, radius (re) and displacements (ae and be) of the circle represented by the measured variables Re, Ge, Xe, Be and plot parameters of the reference circle, as described in Figures 25 to 29, based on real-time measurements of the complex impedance / admittance, radius (rr) and displacements (air, br) of the reference circle represented by the reference variables Rref, Gref, Xref, Bref. These values are then compared with the values established for certain conditions. These conditions can be: 1) open with nothing in the claws, 2) clamp the tip and 3) clamp everything and clamp in the claws. The equivalent circuit of the ultrasonic transducer was modeled as follows and the frequency was scanned from 55 kHz to 56 kHz:; 9 =; 1 = 1.1068 L M9 = M1 = 311.352 P G9 = G1 = 7.43265! I G0 = G0 = 3.64026: F
[355] [355] In use, the ultrasonic generator scans the frequency, records the measured variables and determines the Re, Ge, Xe and Be estimates. These estimates are then compared with the reference variables Rref, Gref, Xref and Bref stored in memory (for example, stored in a lookup table) and determine the claw conditions. The conditions of the reference jaw shown in Table 6 are examples only. Additional or fewer reference jaw conditions can be classified and stored in memory. These variables can be used to estimate the radius and displacements of the impedance / admittance circle.
[356] [356] Figure 30 is a 132120 logic flow diagram of a process showing a control program or logic configuration to determine the condition of the gripper based on the radius (r) and displacement estimates (a, b) of a impedance / admittance circle, in accordance with at least one aspect of this description. Initially, a database or query table is filled with reference values based on reference jaw conditions, as described in connection with Figures 25 to 29 and Table 6. A reference jaw condition is defined and the frequency is scanned from below resonance to above resonance. The reference values Rref, Gref, Xref, Bref that define the plot of the corresponding impedance / admittance circle are stored in a database or query table. During use, under the control of a control program or logic configuration, a control circuit of the generator or instrument causes the resonance frequency to sweep 132122 from below the resonance to above the resonance. The control circuit measures and records 132124 (for example, stores in memory) the variables Re, Ge, Xe, Be that define the plot of the corresponding impedance / admittance circle and compares them 132126 with the reference values Rref, Gref, Xref , Bref stored in the database or query table. The control circuit determines 132128, for example, estimates, the condition of the end actuator claw based on the results of the comparison. Application of intelligent ultrasonic foil for reusable and disposable devices
[357] [357] The smart blade algorithm uses spectroscopy to identify the status of an ultrasonic blade. This capability can be applied to disposable and reusable devices with removable clamping arms to distinguish whether the disposable portion of the device has been installed correctly. The state of the ultrasonic blade can be determined using the techniques of the intelligent blade algorithm to estimate or classify the claw state of an ultrasonic device described in connection with Figures 19-21 under the heading CLAIM STATE ESTIMATE (BURNED BLOCK) BROKEN, CLAMPS OR BLADE, BONE IN THE CLAW, TISSUE IN THE CLAW and / or in Figures 22 to 30, under the heading STATE OF JAW CLASSIFIER BASED ON MODEL and / or the techniques for estimating the temperature of the ultrasonic blade that are described in the Related US Provisional Patent Serial No. 62 / 640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND
[358] [358] The smart blade algorithm techniques described in the present invention can be employed to identify the state of components of reusable and disposable devices. In one aspect, the state of the ultrasonic blade can be determined to distinguish whether disposable portions of reusable and disposable devices have been installed correctly or incorrectly.
[359] [359] Figures 31 and 32 show a 132400 reusable and disposable ultrasonic device configured to identify the state of the 132402 ultrasonic blade and determine the activation status of the 132404 clamping arm to determine whether a portion of the 132400 reusable and disposable ultrasonic device has been installed. correctly, in accordance with at least one aspect of the present description. Figure 32 is a portion of the 132406 end actuator of the 132400 reusable and disposable ultrasonic device shown in Figure 31. The similarities and differences between the spectroscopy signatures can be used to determine whether the reusable and disposable components of the 132400 reusable and disposable ultrasonic device. installed correctly or incorrectly.
[360] [360] The 132400 reusable and disposable ultrasonic device shown in Figures 31 and 32 includes a 132408 reusable handle and a 132402 disposable ultrasonic waveguide / blade. Before use, a 132410 proximal end of the 132402 disposable ultrasonic waveguide / blade is inserted 132414 into a distal opening 132414 of the reusable grip 132408 and twisted or rotated clockwise 132416 to lock the disposable ultrasonic blade / guide 132402 into the 132408 grip, as shown in Figure 31. If the disposable ultrasonic blade / guide 132402 is not fully inserted 132414 and / or completely rotated clockwise 132416, the reusable and disposable ultrasonic device 132400 will not function properly. For example, insertion 132414 and improper rotation 132416 of the disposable ultrasonic blade / guide 132402 will result in a weak mechanical coupling of the 132402 disposable ultrasonic blade / guide and will produce a different spectroscopy signature. Therefore, the smart blade algorithm techniques described here can be used to determine whether the disposable portion of the reusable and disposable ultrasonic device 132400 has been inserted 132414 and rotated 132416 completely.
[361] [361] In another misaligned configuration, if the clamping arm 132404 shown in Figure 32 is rotated with respect to the ultrasonic blade 132402, the orientation of the ultrasonic blade 132402 with respect to the nearby arm 132404 will be out of alignment. This will also produce a different spectroscopy signature when the 132400 reusable and disposable ultrasonic device is actuated and / or attached. Therefore, the smart blade algorithm techniques described here can be used to determine whether the disposable portion of the 132400 reusable and disposable ultrasonic device has been properly rotated in relation to the 132404 clamping arm.
[362] [362] In another respect, the smart blade algorithm techniques described here can be used to determine whether a disposable portion of the reusable and disposable ultrasonic device 132400 has been pushed or inserted 132414 along the entire path into the 132408 reusable portion. This can be applicable to the 132400 reusable and disposable ultrasonic device in Figure 33 below, where a reusable portion, such as the 132408 handle, for example, is 132414 inserted into a disposable portion, such as the 132402 ultrasonic blade, for example, prior to operation.
[363] [363] Figure 33 is a reusable and disposable ultrasonic device 132420 configured to identify the status of the ultrasonic blade 132422 and determine whether the clamping arm 132424 is not completely distal to determine whether a disposable portion 132426 of the reusable and disposable ultrasonic device 132420 has been correctly installed in accordance with at least one aspect of this description. If the clamping arm is not installed completely distal to the 132428 reusable component, there will be a different spectroscopy signature when the device is attached. In another aspect, if the disposable portion 132426 is not installed completely distally on the reusable component 132428, the spectroscopy signature of the ultrasonic blade 132422 will be different when it is secured in the use position. Therefore, the smart blade algorithm techniques described herein can be used to determine whether the disposable portion 132426 of the reusable and disposable ultrasonic device 132420 has been fully and properly coupled to the reusable portion 132428.
[364] [364] Figure 34 is a 132430 logic flow diagram representing a control program or logic configuration to identify the status of the components of reusable and disposable ultrasonic devices, in accordance with at least one aspect of the present description. According to the process shown by the logic flow diagram 132430, a generator or instrument control circuit performs an intelligent blade algorithm technique and determines 132432 the spectroscopy signature of the mounted reusable and disposable ultrasonic devices 132400, 132420 (Figures 88 and 89) comprising disposable and reusable components. The 132434 control circuit compares the measured spectroscopic signature to a reference spectroscopic signature, and the reference spectroscopic signature is associated with a reusable and disposable ultrasonic device.
[365] [365] Although various 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 this 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, when materials are revealed for certain components, other materials can be used. It should be understood, therefore, that the preceding description and the appended claims are intended to include all of 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.
[366] [366] The previous detailed description presented various forms of the 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 forms disclosed here, in whole or in part, may 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 the same, and that the design of the circuit set and / or the inscription of 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.
[367] [367] The instructions used to program the logic to execute various revealed aspects 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 for storing or transmitting information in a machine-readable form (for example, a computer), but is not limited to, floppy disks, optical discs, read-only memory compact disc ( CD-ROMs), and magneto-optical discs, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic cards or optical, flash memory, or a machine-readable tangible storage medium used to transmit information over the Internet via an electrical, optical, acoustic cable or other forms of propagated signals (for example, carrier waves, infrared signals, 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).
[368] [368] 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 phones, etc. Consequently, as used in the present invention, "control circuit" includes, but is not limited to, a set of electrical circuits that have at least one discrete electrical circuit, a set of electrical circuits that have at least one integrated circuit, electrical circuits that have at least one integrated circuit for a 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 performs the 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 herein), electrical circuits that form a memory device (for example, forms of random access memory), and / or set of electrical circuits that form a communications device (for example, modem, communication key, or 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.
[369] [369] As used in any aspect of the present invention, the term "logic" 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 non-transitory, computer-readable storage media. The firmware can be embedded as code, instructions or instruction sets and / or hard coded (for example, non-volatile) data in memory devices.
[370] [370] 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.
[371] [371] As used here in any respect, an "algorithm" refers to the self-consistent sequence of steps that lead to the desired result, where a "step" refers to the manipulation of physical quantities and / or logical states that can, although not necessarily necessarily 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.
[372] [372] A network can 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 can include an Ethernet communications protocol that can enable communication using a transmission control protocol / Internet protocol (TCP / IP). The Ethernet protocol may comply with 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 or be compatible with a standard promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or in addition, communication devices may be able to communicate with each other using a frame-relay communications protocol. The frame-relay communications protocol can conform to or be compatible with a standard promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, transceivers may be able to communicate with each other using an ATM communication protocol ("asynchronous transfer mode"). The ATM communication protocol may comply with or be compatible with an ATM standard published by the ATM forum entitled "ATM-MPLS Network Interworking 2.0" published in August 2001, and / or later versions of that standard. Obviously, different and / or post-developed connection-oriented network communication protocols are also contemplated in the present invention.
[373] [373] Unless otherwise stated, as is evident from the preceding description, it is understood that, throughout the preceding description, discussions using 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.
[374] [374] 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 dictates otherwise.
[375] [375] 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.
[376] [376] 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.
[377] [377] 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 (for example, "one 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 (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.). 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".
[378] [378] 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 adjectives participles are not intended in general to exclude these variants, except when the context determines otherwise.
[379] [379] 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 feature, structure or feature described in connection with the aspect is included in at least one aspect. Thus, the use of expressions such as "in one (1) aspect",
[380] [380] 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.
[381] [381] 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 disclosed. 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. It is intended that the claims presented in the annex define the global scope.
[382] [382] Various aspects of the subject described in this document are defined in the following numbered examples:
[383] [383] Example 1. A method for detecting the proper installation of two or more components of an ultrasonic device, the ultrasonic device comprising an electromechanical ultrasonic system defined by a predetermined resonance frequency, the electromechanical ultrasonic system additionally comprising a ultrasonic transducer coupled to an ultrasonic blade, the method comprising: determining, by a processor or a control circuit, a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer; compare, by means of the processor or the control circuit, the spectroscopic signature with a reference spectroscopic signature; determine, by means of the processor or the control circuit, an installation status of the two or more components based on the comparison; and controlling, through the processor or the control circuit, an application of energy to the ultrasonic transducer based on the comparison.
[384] [384] Example 2. The method of Example 1 which further comprises enabling, via the processor or the control circuit, the operation of the ultrasonic device when the installation status of the two or more components is adequate.
[385] [385] Example 3. The method of any one or more of Examples 1 to 2 which further comprises disabling, by means of the processor or the control circuit, the operation of the ultrasonic device when the installation status of the two or more components is not appropriate; and generate, by the processor or the control circuit, an alert.
[386] [386] Example 4. The method of Example 3 in which the generation, by the processor or the control circuit, of an alert comprises generating, by the processor or the control circuit, a visual alert.
[387] [387] Example 5. The method of any one or more of Examples 3 to 4, in which the generation, by the processor or control circuit, of an alert comprises generating, by the processor or control circuit, an audible alert.
[388] [388] Example 6. The method of any one or more of Examples 3 to 5, in which the generation, by the processor or control circuit, of an alert comprises generating, by the processor or control circuit, a tactile alert.
[389] [389] Example 7. The method of any one or more of Examples 1 to 6 in which the determination, by a processor or a control circuit, of a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer comprises: measuring, by the processor or through the control circuit, a complex impedance of the ultrasonic transducer, the complex impedance being defined as =; receiving, through the processor or control circuit, a complex impedance measurement data point; compare, through the processor or control circuit, the data point of measurement of complex impedance with a data point in a characteristic standard of complex reference impedance; classify, through the processor or control circuit, the complex impedance measurement data point based on a comparison analysis result; and assigning, via the processor or the control circuit, a state or condition of an end actuator based on the result of the comparison analysis.
[390] [390] Example 8. The method, of any one or more of Examples 1 to 6, in which the comparison, made by the processor or the control circuit, of the complex impedance measurement data point with a data point in a The characteristic standard of complex reference impedance comprises comparing, by the processor or the control circuit, the spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer with the reference spectroscopic signature.
[391] [391] Example 9. The method of any one or more of Examples 1 to 6 in which the determination, by a processor or a control circuit, of a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer comprises: applying, by a circuit trigger signal, a trigger signal to the ultrasonic transducer, the trigger signal being a periodic signal defined by a magnitude and a frequency; scanning, using a processor or control circuit, the frequency of the triggering signal from a level below the resonance to a level above the resonance of the electromechanical ultrasonic system; measure and record, by the processor or the control circuit, the variables Re, Ge, Xe and Be of the impedance / admittance circle; compare, by means of the processor or the control circuit, the variables of the impedance / admittance circle measured Re, Ge, Xe and Be with the reference impedance / admittance circle variables Rref, Gref, Xref and Bref; and determining, by the processor or the control circuit, a state or condition of the end actuator based on the result of the comparison analysis.
[392] [392] Example 10. An ultrasonic surgical comprising: an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by means of an ultrasonic waveguide, the ultrasonic electromechanical system comprising two or more components of which at least one of the two or more components is a disposable device and of which at least one of the two or more components is a reusable device; and a generator configured to supply power to the ultrasonic transducer, the generator comprising a control circuit configured to: determine a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer; compare the spectroscopic signature with a reference spectroscopic signature; determine an installation status of the two or more components based on the comparison; and controlling an application of energy to the ultrasonic transducer based on the comparison.
[393] [393] Example 11. The ultrasonic surgical instrument of Example 10 in which the control circuit is additionally configured to enable operation of the ultrasonic device when the installation status of the two or more components is adequate.
[394] [394] Example 12. The ultrasonic surgical instrument of any one or more of Examples 10 to 11 in which the control circuit is additionally configured to disable an operation of the ultrasonic device when the installation status of the two or more components is not adequate; and generate an alert.
[395] [395] Example 13. The ultrasonic surgical instrument of Example 12 in which the alert comprises a visual alert.
[396] [396] Example 14. The ultrasonic surgical instrument of any one or more of Examples 12 to 13, in which the alert comprises an audible alert.
[397] [397] Example 15. The ultrasonic surgical instrument of any one or more of Examples 12 to 14, in which the alert comprises a tactile alert.
[398] [398] Example 16. The ultrasonic surgical instrument of any one or more of Examples 10 to 15 in which the control circuit is additionally configured to: measure a complex impedance of the ultrasonic transducer, where the complex impedance is defined as =; receive a complex impedance measurement data point; compare the measurement data point of complex impedance with a data point in a characteristic standard of complex reference impedance; classifying the complex impedance measurement data point based on a comparison analysis result; and assigning a state or condition to an end actuator based on the result of the comparison analysis.
[399] [399] Example 17. The ultrasonic surgical instrument of any one or more of Examples 10 to 16 in which the control circuit is additionally configured to: cause a drive circuit to apply a drive signal to the ultrasonic transducer, the trigger signal is a periodic signal defined by a magnitude and a frequency; scan the trigger signal frequency from a level below the resonance to a level above the resonance of the electromechanical ultrasonic system; measure and record the variables Re, Ge, Xe and Be of the impedance / admittance circle; compare the measured variables Re, Ge, Xe and Be of the impedance / admittance circle with the reference variables Rref, Gref, Xref and Bref of the impedance / admittance circle; and determining a state or condition of an end actuator based on the result of the comparison analysis.
[400] [400] Example 18. A generator for an ultrasonic surgical instrument, in which the ultrasonic surgical instrument comprises two or more components of which at least one of the two or more components is a disposable device and of which at least one of the two or more more components is a reusable device, the generator being characterized by comprising: a control circuit configured to: determine a spectroscopic signature of an ultrasonic blade coupled to an ultrasonic transducer; compare the spectroscopic signature with a reference spectroscopic signature; determine an installation status of the two or more components based on the comparison; and controlling an application of energy to the ultrasonic transducer based on the comparison.
[401] [401] Example 19. The generator for an ultrasonic surgical instrument, according to Example 18, in which the control circuit is additionally configured to enable operation of the ultrasonic device when the installation status of the two or more components is adequate.
[402] [402] Example 20. The generator for an ultrasonic surgical instrument of any one or more of Examples 18 to 19 in which the control circuit is additionally configured to disable an operation of the ultrasonic device when the installation status of the two or more components is not is appropriate; and generate an alert.
[403] [403] Example 21. The generator for an ultrasonic surgical instrument, according to Example 20, in which the alert comprises a visual alert.
[404] [404] Example 22. The generator for an ultrasonic surgical instrument of any one or more of Examples 20 to 21, in which the alert comprises an audible alert.
[405] [405] Example 23. The generator for an ultrasonic surgical instrument of any one or more of Examples 20 to 22, in which the alert comprises a tactile alert.
[406] [406] Example 24. The generator for an ultrasonic surgical instrument of any one or more of Examples 18 to 23 in which the control circuit is additionally configured to: measure a complex impedance of the ultrasonic transducer, the complex impedance being defined as =; receive a complex impedance measurement data point; compare the measurement data point of complex impedance with a data point in a characteristic standard of complex reference impedance; classifying the complex impedance measurement data point based on a comparison analysis result; and assigning a state or condition to an end actuator based on the result of the comparison analysis.
[407] [407] Example 25. The generator for an ultrasonic surgical instrument of any one or more of Examples 18 to 24 in which the control circuit is additionally configured to: cause a drive circuit to apply a drive signal to the ultrasonic transducer, the trigger signal being a periodic signal defined by a magnitude and a frequency; scan the trigger signal frequency from a level below the resonance to a level above the resonance of the electromechanical ultrasonic system; measure and record the variables Re, Ge, Xe and Be of the impedance / admittance circle; compare the measured variables Re, Ge, Xe and Be of the impedance / admittance circle with the reference variables Rref, Gref, Xref and Bref of the impedance / admittance circle; and determining a state or condition of an end actuator based on the result of the comparison analysis.

权利要求:
Claims (25)
[1]
1. Method for detecting the proper installation of two or more components in an ultrasonic device, the ultrasonic device comprising an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system also comprising an ultrasonic transducer coupled to a ultrasonic blade, characterized by comprising: determining, by a processor or a control circuit, a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer; compare, by means of the processor or the control circuit, the spectroscopic signature with a reference spectroscopic signature; determine, by means of the processor or the control circuit, an installation status of the two or more components based on the comparison; and controlling, through the processor or the control circuit, an application of energy to the ultrasonic transducer based on the comparison.
[2]
2. Method, according to claim 1, characterized in that it also comprises enabling, by means of the processor or the control circuit, an operation of the ultrasonic device when the state of installation of the two or more components is adequate.
[3]
3. Method, according to claim 1, characterized by further comprising: disabling, by means of the processor or the control circuit, an operation of the ultrasonic device when the installation status of the two or more components is not adequate; and generate, by the processor or the control circuit, an alert.
[4]
4. Method, according to claim 3, characterized in that the generation, by the processor or the control circuit, of an alert comprises generating, by the processor or the control circuit, a visible alert.
[5]
5. Method, according to claim 3, characterized in that the generation, by the processor or control circuit, of an alert comprises generating, by the processor or control circuit, an audible alert.
[6]
6. Method, according to claim 3, characterized in that the generation, made by the processor or the control circuit, of an alert comprises generating, by the processor or control circuit, a tactile alert.
[7]
7. Method according to claim 1, characterized in that the determination, by means of a processor or a control circuit, of a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer comprises: measuring, by means of the processor or the control, a complex impedance of the ultrasonic transducer, the complex impedance being defined as; receive, through the processor or the control circuit, a complex impedance measurement data point; compare, through the processor or the control circuit, the data point of measurement of complex impedance with a data point in a characteristic standard of complex reference impedance; classify, through the processor or the control circuit, the complex impedance measurement data point based on a result of the comparison analysis; and assign, through the processor or the control circuit,
a state or condition of an end actuator based on the result of the comparison analysis.
[8]
Method according to claim 7, characterized in that the comparison, made by the processor or the control circuit, of the data point of measurement of complex impedance with a data point in a characteristic pattern of complex reference impedance comprises comparing , by the processor or the control circuit, the spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer with the reference spectroscopic signature.
[9]
9. Method according to claim 1, characterized in that the determination, by means of a processor or a control circuit, of a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer comprises: applying, by means of a driving circuit, a trigger signal to the ultrasonic transducer, the trigger signal being a periodic signal defined by a magnitude and a frequency; scan, by means of a processor or a control circuit, the frequency of the trigger signal from a level below the resonance to a level above the resonance of the electromechanical ultrasonic system; measure and record, through the processor or the control circuit, the variables Re, Ge, Xe and Be of the impedance / admittance circle; compare, by means of the processor or the control circuit, the variables of the impedance / admittance circle measured Re, Ge, Xe and Be with the reference impedance / admittance circle variables Rref, Gref, Xref and Bref; and determining, through the processor or the control circuit, a state or condition of an end actuator based on the result of the comparison analysis.
[10]
10. Ultrasonic surgical instrument characterized by comprising: an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by means of an ultrasonic waveguide, with the ultrasonic electromechanical system comprising two or more components, at least one of which two or more components is a disposable device and of which at least one of the two or more components is a reusable device; and a generator configured to supply power to the ultrasonic transducer, the generator comprising a control circuit configured to: determine a spectroscopic signature of the ultrasonic blade coupled to the ultrasonic transducer; compare the spectroscopic signature with a reference spectroscopic signature; determine an installation status of the two or more components based on the comparison; and controlling an application of energy to the ultrasonic transducer based on the comparison.
[11]
11. Ultrasonic surgical instrument, according to claim 10, characterized in that the control circuit is further configured to enable an operation of the ultrasonic device when the installation status of the two or more components is adequate.
[12]
12. Ultrasonic surgical instrument, according to claim 10, characterized in that the control circuit is further configured to:
disable an operation of the ultrasonic device when the installation status of the two or more components is not adequate; and generate an alert.
[13]
13. Ultrasonic surgical instrument, according to claim 12, characterized in that the alert comprises a visible alert.
[14]
14. Ultrasonic surgical instrument, according to claim 12, characterized in that the alert comprises an audible alert.
[15]
15. Ultrasonic surgical instrument, according to claim 12, characterized in that the alert comprises a tactile alert.
[16]
16. Ultrasonic surgical instrument, according to claim 10, characterized in that the control circuit is further configured to: measure a complex impedance of the ultrasonic transducer, the complex impedance being defined as; receive a complex impedance measurement data point; comparing the measurement data point of complex impedance with a data point in a characteristic standard of complex impedance reference; classifying the complex impedance measurement data point based on a comparison analysis result; and assigning a state or condition to an end actuator based on the result of the comparison analysis.
[17]
17. Ultrasonic surgical instrument, according to claim 10, characterized in that the control circuit is further configured to: cause a drive circuit to apply a drive signal to the ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency; sweep the frequency of the trigger signal from a level below the resonance to a level above the resonance of the electromagnetic ultrasonic system; measure and record the variables Re, Ge, Xe and Be of the impedance / admittance circle; compare the measured variables Re, Ge, Xe and Be of the impedance / admittance circle with the reference variables Rref, Gref, Xref and Bref of the impedance / admittance circle; and determining a state or condition of an end actuator based on the result of the comparison analysis.
[18]
18. Generator for an ultrasonic surgical instrument, the ultrasonic surgical instrument comprising two or more components of which at least one of the two or more components is a disposable device and of which at least one of the two or more components is a device reusable, characterized by comprising: a control circuit configured to: determine a spectroscopic signature of an ultrasonic blade coupled to an ultrasonic transducer; compare the spectroscopic signature with a reference spectroscopic signature; determine an installation status of the two or more components based on the comparison; and controlling an application of energy to the ultrasonic transducer based on the comparison.
[19]
19. Generator for an ultrasonic surgical instrument, according to claim 18, characterized in that the control circuit is further configured to enable an operation of the ultrasonic device when the installation status of the two or more components is adequate.
[20]
20. Generator for an ultrasonic surgical instrument, according to claim 18, characterized in that the control circuit is further configured to: disable an operation of the ultrasonic device when the installation status of the two or more components is not adequate; and generate an alert.
[21]
21. Generator for an ultrasonic surgical instrument, according to claim 20, characterized in that the alert comprises a visible alert.
[22]
22. Generator for an ultrasonic surgical instrument, according to claim 20, characterized in that the alert comprises an audible alert.
[23]
23. Generator for an ultrasonic surgical instrument, according to claim 20, characterized in that the alert comprises a tactile alert.
[24]
24. Generator for an ultrasonic surgical instrument, according to claim 18, characterized in that the control circuit is further configured to: measure a complex impedance of the ultrasonic transducer, the complex impedance being defined as; receive a complex impedance measurement data point; comparing the measurement data point of complex impedance with a data point in a characteristic standard of complex impedance reference; classifying the complex impedance measurement data point based on a comparison analysis result; and assigning a state or condition to an end actuator based on the result of the comparison analysis.
[25]
25. Generator for an ultrasonic surgical instrument, according to claim 18, characterized in that the control circuit is further configured to: cause a drive circuit to apply a drive signal to the ultrasonic transducer, with the drive signal being a periodic signal defined by a magnitude and a frequency; sweep the frequency of the trigger signal from a level below the resonance to a level above the resonance of the electromechanical ultrasonic system; measure and record the variables Re, Ge, Xe and Be of the impedance / admittance circle; compare the measured variables Re, Ge, Xe and Be of the impedance / admittance circle with the reference variables Rref, Gref, Xref and Bref of the impedance / admittance circle; and determining a state or condition of an end actuator based on the result of the comparison analysis.

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法律状态:
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