radio frequency energy device for the release of combined electrical signals

专利摘要:
The present invention relates to an electrosurgical device that may comprise a controller that includes an electrical generator, a surgical probe that has a distal active electrode in electrical communication with an electrical source terminal of the electrical generator, and a return block in communication. power supply with an electrical return terminal from the electrical generator. the electrical generator may be configured to deliver an electrical current from the electrical source terminal, the electrical current combining the characteristics of a therapeutic electrical signal and the characteristics of an excitable tissue stimulus signal. the device may be configured to determine a distance between the electrode and an excitable tissue, based at least in part on an output signal generated by a sensing device in the pad. the device can also be configured to change one or more characteristics of the therapeutic signal when the distance between the electrode and tissue is less than a predetermined value.
公开号:BR112020013074A2
申请号:R112020013074-5
申请日:2019-02-28
公开日:2020-12-01
发明作者:David C. Yates；Cameron R. Nott；Kevin L. Houser；Frederick E. Shelton Iv；Jason L. Harris；Verne E. Kreger
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 Serial No. 16/115,233, entitled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS, filed on August 28, 2018, the description of which is incorporated herein as a reference in its entirety.
[002] [002] The present application claims priority under 35 USC$ 119(e) to provisional patent application No. 62/721,995, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION, filed on August 23, 2018, the description of which is incorporated herein by way of reference, in its entirety.
[003] [003] The present application claims priority under 35 USC$119(e) to provisional patent application No. 62/721,998, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS, filed on August 23, 2018, the description of which is incorporated herein by reference title in its entirety.
[004] [004] The present application claims priority under 35 USC$ 119(e) to provisional patent application No. 62/721,999, entitled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING, filed on August 23, 2018, whose The description is incorporated herein by reference in its entirety.
[005] [005] The present application claims priority under 35 U.S.C.$ 119(e) to provisional patent application No. 62/721,994, entitled BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY, filed on August 23,
[006] [006] The present application claims priority under 35 U.S.C.$119(e) to provisional patent application No. 62/721,996 entitled RADIO
[007] [007] The present application claims priority under 35 USC$ 119(e) to provisional patent application No. 62/692,747, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on June 30, 2018, to the application provisional patent application for No. 62/692,748, entitled SMART ENERGY ARCHITECTURE, filed on June 30, 2018 and provisional patent application for No. 62/692,768, entitled SMART ENERGY DEVICES, filed on June 30, 2018, with the description of each of which is incorporated herein by way of reference, in its entirety.
[008] [008] This application also claims the priority benefit under USC$119(e) for US Provisional Patent Application Serial No. 62/640,417 entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR filed March 8, 2018 , and the provisional US patent application Serial No. 62/640,415, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR filed on March 8, 2018, the description of each of which is incorporated herein by way of reference , in its entirety.
[009] [009] This application also claims priority benefit under 35 U.S.C.$119(e) for US Provisional Patent Application No. 62/650,898 filed March 30, 2018 entitled CAPACI-
[0010] [0010] The present application claims priority under 35 USC$ 119(e) to the provisional patent application US Serial No. 62/611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, to the application of Provisional US Patent Serial No. 62/611,340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed on December 28, 2017, and provisional US Patent Application Serial No. 62/611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, the description of each of which is incorporated herein by way of reference, in its entirety. BACKGROUND OF THE INVENTION
[0011] [0011] In some surgical procedures, a medical professional may employ an electrosurgical device to seal or cut tissue such as blood vessels. Such devices perform medical therapy by passing electrical energy, for example, a radiofrequency (RF) current, through the tissue to be treated. Some electrosurgical devices are called bipolar devices because they contain an electrode to deliver electrical energy (the active electrode) and a return electrode housed in the same surgical probe. The electrosurgical device may include a generator to generate electrical energy and supply it to the active electrode on the surgical probe. The return electrode on the surgical probe can receive the current flowing through the patient's tissue and provide an electrical return path to the generator. Such bipolar devices can provide a short current path through the patient's tissue, and the medical professional can readily determine the tissues that can receive electrical energy from the electrosurgical device.
[0012] [0012] Alternative devices can be called monopolar devices. In such devices, only the active electrode is housed in the surgical probe. The electrical current that enters the patient's tissue can return to the electrical energy generator through an electrical path through the stretcher on which the patient rests, or through a specific return electrode pad. In some aspects, the patient may rest on the electrode pad, or the electrode pad may be placed on the patient at a location close to the surgical site where the surgical probe is positioned. The possibility is admitted that the current path through a patient undergoing a procedure using a monopolar device may be less well characterized than the current path through a patient undergoing a procedure using a monopolar device. of a bipolar device. Consequently, non-target tissue can be unintentionally cauterized, cut, or otherwise damaged by a monopolar electrosurgical device. Such non-target tissue may include electrically excitable tissue including, but not limited to, ganglia, sensory nerve tissue, motor nerve tissue, and muscle tissue. This unintentional injury to excitable tissues can result in the patient experiencing muscle weakness, pain, numbness, paralysis, and/or other undesired outcomes. SUMMARY OF THE INVENTION
[0013] [0013] In one aspect, an electrosurgical device includes a controller that has an electrical generator, a surgical probe that includes a distal active electrode in electrical communication with an electrical source terminal of the electrical generator, and a return block in electrical communication. - trica with an electrical return terminal of the electrical generator. The electrical generator is configured to deliver an electrical current from the electrical source terminal, and the electrical current provided by the electrical generator combines the characteristics of a therapeutic electrical signal and the characteristics of an excitable tissue stimulus signal.
[0014] [0014] In one aspect of the electrosurgical device, the therapeutic electrical signal is a radio frequency signal that has a frequency greater than 200 kHz and less than 5 MHz.
[0015] [0015] In one aspect of the electrosurgical device, the excitable tissue stimulus signal is an AC signal that has a frequency less than 200 kHz.
[0016] [0016] In one aspect of the electrosurgical device, the electrical current supplied by the electrical generator includes at least one alternating therapeutic electrical signal and at least one alternating excitable tissue stimulus signal.
[0017] [0017] In one aspect of the electrosurgical device, the electrical current provided by the electrical generator includes a therapeutic electrical signal amplitude modulated by the excitable tissue stimulus signal.
[0018] [0018] In one aspect of the electrosurgical device, the electrical current supplied by the electrical generator includes a DC shift of the therapeutic electrical signal by the excitable tissue stimulus signal.
[0019] [0019] In one aspect of the electrosurgical device, the feedback block additionally includes at least one sensing device that has a sensing device output, and the sensing device is configured to determine a stimulus from an excitable tissue by the excitable tissue stimulus signal.
[0020] [0020] In one aspect of the electrosurgical device, the controller is configured to receive output from the sensing device.
[0021] [0021] In one aspect of the electrosurgical device, the controller includes a processor and at least one memory component in data communication with the processor, with the at least one memory component storing one or more instructions. which, when performed by the processor, cause the processor to determine a distance between the active electrode and an excitable tissue based, at least in part, on the sensor output received by the controller.
[0022] [0022] In one aspect of the electrosurgical device, the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to change a value of at least one characteristic of the therapeutic electrical signal when the distance between the active electrode and an excitable tissue is less than a predetermined value.
[0023] [0023] In one aspect, an electrosurgical system includes a processor and memory coupled to the processor, the memory being configured to store instructions executable by the processor to cause an electrical generator to match one or more characteristics of a therapeutic signal having one or more characteristics of an excitable tissue stimulus signal to form a combined signal, to cause the electrical generator to transmit the combined signal to a tissue of a patient through an active electrode in physical contact with the patient, and for receiving a detection device output signal from a detection device disposed in a feedback block in physical contact with the patient.
[0024] [0024] In one aspect of the electrosurgical system, memory is configured to additionally store instructions executable by the processor to determine, based at least in part on the output signal of the detection device, a distance between the electrode active and an excitable tissue.
[0025] [0025] In one aspect of the electrosurgical system, the memory is configured to additionally store instructions executable by the processor to cause the controller to change one or more characteristics of the therapeutic signal when the distance between the active electrode and the excitable tissue is less than one default value.
[0026] [0026] In one aspect of the electrosurgical system, processor-executable instructions for causing an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal include processor-executable instructions to cause the electrical generator to alternate between the therapeutic signal and the excitable tissue stimulus signal.
[0027] [0027] In one aspect of the electrosurgical system, processor-executable instructions for causing an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal include processor-executable instructions to cause the electrical generator to modulate an amplitude of the therapeutic signal by an amplitude of the excitable tissue stimulus signal.
[0028] [0028] In one aspect of the electrosurgical system, processor-executable instructions for causing an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal include instructions executable by the processor to cause the electrical generator to shift a DC value of the therapeutic signal by an amplitude of the excitable tissue stimulus signal.
[0029] [0029] In one aspect, an electrosurgical system includes a control circuit configured to: control an electrical output of an electrical generator, wherein the electrical output includes one or more characteristics of a therapeutic signal and one or more characteristics of a therapeutic signal. excitable tissue stimulus; receiving a sensing device signal from at least one sensing device configured to measure an excitable tissue activity of a patient; determining a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into a patient's tissue and a location of the at least one sensing device; and changing the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the active electrode site configured to transmit the electrical output of the electrical generator into the patient's tissue and the location of the at least one device detection is less than a predetermined value.
[0030] [0030] In one aspect of the electrosurgical system, the control circuit configured to change the electrical output of the electrical generator by at least one characteristic of the therapeutic signal when the distance between the active electrode site configured to transmit the electrical output of the electrical generator into the patient's tissue and the location of the at least one detection device is less than a predetermined value includes a control circuit configured to minimize the at least one characteristic of the therapeutic signal.
[0031] [0031] In one aspect, a computer-readable non-transient storage medium stores computer-readable instructions that, when executed, make a machine: control an electrical output of an electrical generator, the electrical output including a one or more features of a therapeutic signal and one or more features of an excitable tissue stimulus signal; receiving a sensing device signal from at least one sensing device configured to measure an excitable tissue activity of a patient; determining a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into a patient's tissue and a location of at least one detection device; and altering the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the active electrode site configured to transmit the electrical output of the electrical generator into the patient's tissue and the site of at least a detection device is less than a predetermined value. FIGURES
[0032] [0032] Resources of various aspects are particularly presented in the attached claims. The various aspects, however, as regards both the organization and the methods of operation, together with objects and additional advantages thereof, can be better understood by referring to the description presented below, considered in conjunction with the attached drawings, as follows.
[0033] [0033] Figure 1 is a block diagram of an interactive computer-implemented surgical system, in accordance with at least one aspect of the present disclosure.
[0034] [0034] Figure 2 illustrates a surgical system being used to perform a surgical procedure in an operating room, in accordance with at least one aspect of the present description.
[0035] [0035] Figure 3 illustrates a central surgical controller paired with a visualization system, a robotic system and an intelligent instrument, in accordance with at least one aspect of the present description.
[0036] [0036] Figure 4 is a partial perspective view of a central surgical controller compartment, and a combined generator module slidably received in a drawer of the central surgical controller compartment, according to at least one aspect of the present description.
[0037] [0037] Figure 5 is a perspective view of a generator module in combination with bipolar, ultrasonic and monopolar contacts and a smoke evacuation component, in accordance with at least one aspect of the present description.
[0038] [0038] Figure 6 illustrates a surgical data network that comprises a modular communication center configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in which a healthcare facility specially equipped for surgical operations, to the cloud, in accordance with at least one aspect of the present description.
[0039] [0039] Figure 7 illustrates an interactive computer-implemented surgical system, in accordance with at least one aspect of the present description.
[0040] [0040] Figure 8 illustrates a central surgical controller comprising a plurality of modules coupled to the modular control tower, in accordance with at least one aspect of the present description.
[0041] [0041] Figure 9 illustrates an aspect of a universal serial bus (USB) network central controller device, in accordance with at least one aspect of the present description.
[0042] [0042] Figure 10 illustrates a control circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present description.
[0043] [0043] Figure 11 illustrates a combinatorial logic circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present description.
[0044] [0044] Figure 12 illustrates a sequential logic circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present disclosure.
[0045] [0045] Figure 13 is a system configured to run adaptive ultrasonic blade control algorithms in a surgical data network comprising a modular communication center, in accordance with at least one aspect of the present description.
[0046] [0046] Figure 14 illustrates an example of a generator, in accordance with at least one aspect of the present description.
[0047] [0047] Figure 15 is a surgical system comprising a generator and various surgical instruments that may be used with the generator, in accordance with at least one aspect of the present description.
[0048] [0048] Figure 16 is a diagram of the surgical system of Figure 15, in accordance with at least one aspect of the present disclosure.
[0049] [0049] Figure 17 illustrates a structural view of a generator architecture, according to at least one aspect of the present description.
[0050] [0050] Figures 18A to 18C illustrate functional views of a generator architecture, in accordance with at least one aspect of the present description.
[0051] [0051] Figures 19A and 19B are structural and functional aspects of a generator, in accordance with at least one aspect of the present description.
[0052] [0052] Figure 20 is a schematic diagram of a control circuit, in accordance with at least one aspect of the present description.
[0053] [0053] Figure 21 illustrates a generator circuit divided into multiple stages, according to at least one aspect of the present description.
[0054] [0054] Figure 22 illustrates a generator circuit divided into multiple stages, where a first stage circuit is common to the second stage circuit, according to at least one aspect of the present description.
[0055] [0055] Figure 23 is a schematic diagram of an aspect of a drive circuit configured to drive a high frequency (RF) current, in accordance with at least one aspect of the present disclosure.
[0056] [0056] Figure 24 is a schematic diagram of the transformer coupled to the RF drive circuit shown in Figure 15, in accordance with at least one aspect of the present description.
[0057] [0057] Figure 25 is a schematic diagram of a circuit comprising separate power supplies for high power drive/power circuits and low power circuits, in accordance with at least one aspect of the present disclosure.
[0058] [0058] Figure 26 illustrates a control circuit that enables a dual generator system to switch between RF generator and ultrasonic generator power modalities for a surgical instrument in accordance with at least one aspect of the present description.
[0059] [0059] Figure 27 illustrates an aspect of a fundamental architecture for a digital synthesis circuit as a direct digital 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.
[0060] [0060] Figure 28 illustrates an aspect of the direct digital synthesis (DDS) circuit 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.
[0061] [0061] Figure 29 illustrates a cycle of an electrical signal digital waveform of distinct time, in accordance with at least one aspect of the present description, of an analog waveform (shown superimposed on a digital waveform different-time electrical signal for purposes of comparison), in accordance with at least one aspect of the present description.
[0062] [0062] Figure 30 illustrates a surgical procedure that uses an electrosurgical system, in accordance with at least one aspect of the present description.
[0063] [0063] Figure 31 illustrates a block diagram of the electrosurgical system used in Figure 30, according to at least one aspect of the present description.
[0064] [0064] Figure 32 illustrates a return block of the electrosurgical system of Figure 30 including a plurality of electrodes, in accordance with at least one aspect of the present description.
[0065] [0065] Figure 33 illustrates an array of detection devices in the feedback block shown in Figure 31, in accordance with at least one aspect of the present description.
[0066] [0066] Figure 34 is a graphical representation of the therapeutic RF signal that may be used in an electrosurgical system, in accordance with at least one aspect of the present description.
[0067] [0067] Figure 35 is a graphic representation of a nerve stimulus signal that can be incorporated into an electrosurgical system, in accordance with at least one aspect of the present description.
[0068] [0068] Figures 36A to 36C are graphical representations of signals used by an electrosurgical system that may incorporate features of both the therapeutic RF signal of Figure 34 and the nerve stimulation signal of Figure 35, according to at least one aspect of the present description.
[0069] [0069] Figure 37 summarizes a method in which such control for an intelligent electrosurgical device may be effected in accordance with at least one aspect of the present description.
[0070] [0070] Figure 38 is a timeline representing the situational recognition of a central surgical controller, in accordance with at least one aspect of the present description.
[0071] [0071] DESCRIPTION
[0072] [0072] The applicant of 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: º US patent application, no. of — precedent END8536USNP2/180107-2, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR; the US patent application, precedent number END8560USNP2/180106-2, entitled "TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THE-REFOR"; º US patent application, no. - precedent END8563USNP1/180139-1, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION; º US patent application, no. - precedent END8563USNP2/180139-2, entitled CONTROLLING ACTIVATION OF
[0073] [0073] The applicant of the present application holds the following US patent applications, filed on August 23, 2018, the description of each of which is incorporated herein by reference in its entirety:
[0074] [0074] The applicant of 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: e US Provisional Patent Application No. 62/692,747, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE; and US Provisional Patent Application No. 62/692,748 entitled SMART ENERGY ARCHITECTURE; and and US Provisional Patent Application No. 62/692,768, entitled SMART ENERGY DEVICES.
[0075] [0075] The applicant of the present application holds the following US patent applications, filed on June 29, 2018, the description of each of which is incorporated herein by reference in its entirety:
[0076] [0076] The applicant of the present application holds the following US provisional patent applications, filed on June 28, 2018, the description of each of which is incorporated herein by reference in its entirety:
[0077] [0077] The applicant of the present application holds the following US provisional patent applications, filed on April 19, 2018, the description of each of which is incorporated herein by reference in its entirety: e Provisional patent application US Serial No. 62/659,900, entitled METHOD OF HUB COMMUNICATION.
[0078] [0078] The applicant of the present application holds the following US provisional patent applications, filed on March 30, 2018, the description of each of which is incorporated herein by reference in its entirety:
[0079] [0079] The applicant of the present application holds the following US patent applications, filed on March 29, 2018, the description of each of which is incorporated herein by reference in its entirety: and US Patent Application No. serial 15/940,641 entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES; and US Patent Application Serial No. 15/940,648 entitled
[0080] [0080] The applicant of the present application holds the following US provisional patent applications, filed on March 28, 2018, the description of each of which is incorporated herein by reference in its entirety:
[0081] [0081] The applicant of the present application holds the following provisional US patent applications, filed on March 8, 2018, the description of each of which is incorporated herein by reference in its entirety: e Provisional patent application US Serial No. 62/640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR; and e US Provisional Patent Application Serial No. 62/640,415 entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.
[0082] [0082] The applicant of the present application holds the following provisional US patent applications, filed on December 28, 2017, the description of each of which is incorporated herein by reference in its entirety: and Application for US Provisional Patent Serial No. 62/611,341 entitled INTERACTIVE SURGICAL PLATFORM;
[0083] [0083] 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 in the attached description. The illustrative examples may be implemented or incorporated in other aspects, variations and modifications, and may be practiced or performed in various ways. Furthermore, except where otherwise indicated, the terms and expressions used in the present invention have been chosen for the purpose of describing the illustrative examples for the convenience of the reader and not for the purpose of limiting the same. In addition, it is to be understood that one or more of the aspects, aspect expressions, and/or examples described below may be combined with any one or more of the other aspects, aspect expressions, and/or examples described below. guide
[0084] [0084] Various aspects are directed towards improved ultrasonic surgical devices, electrosurgical devices and generators for use therewith. Aspects of ultrasonic surgical devices can be configured to transection and/or coagulate tissue during surgical procedures, for example. Aspects of electrosurgical devices can be configured to transect, coagulate, stagger, weld and/or desiccate tissue during surgical procedures, for example.
[0085] [0085] Referring to Figure 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., cloud 104 which may include a remote server 113 coupled to a device storage 105). Each surgical system 102 includes at least one central surgical controller 106 communicating with the cloud 104 which may include a remote server 113. In one example, as illustrated in Figure 1, the surgical system 102 includes a visualization system 108, a robotic system 110, a handheld smart surgical instrument 112, which are configured to communicate with each other and/or with the central controller 106. In some aspects, a surgical system 102 may include a number M of central controllers 106, a number N of visualization systems 108, a number O of robotic systems 110, and a number P of smart handheld surgical instruments 112, where M, NO, and P are integers greater than or equal to 1.
[0086] [0086] Figure 2 shows an example of a surgical system 102 that is used to perform a surgical procedure on a patient who is lying on an operating table 114 in a surgical operating room 116. A robotic system 110 is used in the procedure as a part of the surgical system 102. The robotic system 110 includes a surgeon's console 118, a patient carriage 120 (surgical robot), and a robotic central surgical controller 122. at least one removable attached surgical tool 117 through a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. An image of the surgical site may be obtained by a medical imaging device 124 , which can be manipulated by patient cart 120 to orient imaging device 124. Robotic central controller 122 can be used to process site images. surgical file for subsequent display to the surgeon via the surgeon's console 118.
[0087] [0087] Other types of robotic systems can be readily adapted for use with the Surgical System 102. Several examples of robotic systems and surgical instruments that are suitable for use with the present description are described in Provisional Patent Application Serial No. 62 /611,339, titled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.
[0088] [0088] Several examples of cloud-based analysis that are performed by cloud 104, and suitable for use with the present description, are described in US Provisional Patent Application Serial No. 62/611,340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed on December 28, 2017, the description of which is incorporated herein by way of reference, in its entirety.
[0089] [0089] In various aspects, the imaging device 124 includes at least an image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.
[0090] [0090] The optical components of the imaging device 124 may include one or more light sources and/or one or more lenses. One or more light sources can be directed to illuminate portions of the surgical field. The one or more image sensors can receive reflected or refracted light from the surgical field, including reflected or refracted light from tissue and/or surgical instruments.
[0091] [0091] The one or more lighting sources can be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum, sometimes called the optical spectrum or light spectrum, is that portion of the electromagnetic spectrum that is visible to (that is, can be detected by) the human eye and may be called visible light or simply light. A typical human eye will respond to wavelengths in air that are from about 380 nm to about 750 nm.
[0092] [0092] The invisible spectrum (ie the non-luminous spectrum) is that portion of the electromagnetic spectrum lying below and above the visible spectrum (ie wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths longer than about 750 nm are longer than the visible red spectrum, and they become invisible infrared (IR), microwave, radio, and electromagnetic radiation. Wavelengths shorter than about 380 nm are shorter than the ultraviolet spectrum, and they become invisible ultraviolet, x-ray, and gamma-ray electromagnetic radiation.
[0093] [0093] In many respects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, an arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagus-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and ureteroscope. Some aspects of spectral and multispectral imaging are described in more detail under the heading "Advanced Imaging Acquisition Module" in US Provisional Patent Application Serial No. 62/611,341 entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017 , the description of which is incorporated herein by reference in its entirety.
[0094] [0094] It is axiomatic that strict sterilization of the operating room and surgical equipment is necessary during any surgery. The strict hygiene and sterilization conditions necessary in a
[0095] [0095] In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more screens that are strategically arranged with respect to the field. sterile, as illustrated in Figure 2. In one aspect, the visualization system 108 includes an interface for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the title "Advanced Imaging Acquisition Module" in US Provisional Patent Application Serial No. 62/611,341 entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, the description of which is here incorporated by way of reference in its entirety.
[0096] [0096] As illustrated in Figure 2, a primary screen 119 is positioned in the sterile field to be visible to the operator at the operating table 114. In addition, a viewing tower 111 is positioned outside the sterile field. Viewing tower 111 includes a first non-sterile screen 107 and a second non-sterile screen 109, which are opposite each other. The display system 108, guided by the central controller 106, is configured to use screens 107, 109 and 119 to coordinate the flow of information for operators in and out of the sterile field. For example, the central controller 106 may cause the visualization system 108 to display a snapshot of a surgical site, as recorded by an imaging device 124, on a non-sterile screen 107 or 109, while maintaining a live stream. of the surgical site on the main screen 119. The non-sterile screen snapshot 107 or 109 may allow a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example.
[0097] [0097] In one aspect, the central controller 106 is also configured to route diagnostic input or feedback by a non-sterile operator at the viewing tower 111 to the primary screen 119 within the sterile field, where the input or feedback can be seen by a sterile operator on the operating table. In one example, the input may be in the form of a modification of the snapshot displayed on the non-sterile screen 107 or 109, which may be routed to the main screen 119 by the central controller 106.
[0098] [0098] With reference to Figure 2, a surgical instrument 112 is being used in the surgical procedure as part of the surgical system
[0099] [0099] Now referring to Figure 3, a central controller 106 is shown in communication with a display system 108, a robotic system 110 and a handheld smart surgical instrument 112. The central controller 106 includes a central controller screen 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage matrix 134. In certain aspects, as illustrated in Figure 3, the central controller 106 additionally includes an imaging module. smoke evacuation 126 and/or a suction/irrigation module 128.
[00100] [00100] During a surgical procedure, the application of energy to tissue, for sealing and/or cutting, is usually associated with evacuation of smoke, suction of excess fluid and/or tissue irrigation. Fluid, power, and/or data lines from different sources are often intertwined during the surgical procedure. Valuable time can be lost in addressing this issue during a surgical procedure. To untangle the lines it may be necessary to disconnect the lines from their respective modules, which may require a restart of the modules. The 136 central controller's modular enclosure provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of entanglement between such lines.
[00101] [00101] Aspects of the present description feature a central surgical controller for use in a surgical procedure that involves
[00102] [00102] In one aspect, the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to a suction and irrigation module slidably received in the central controller housing. In one aspect, the central controller housing comprises a fluid interface.
[00103] [00103] Certain surgical procedures may require the application of more than one type of energy to tissue. One type of energy may be more beneficial for cutting tissue, while a different type of energy may be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue while an ultrasonic generator can be used to cut sealed tissue. Aspects of the present description present a solution in which a modular central controller compartment 136 is configured to accommodate different
[00104] [00104] Aspects of the present description present a modular surgical compartment for use in a surgical procedure that involves application of energy to tissue. The modular surgical cabinet includes a first power generating module configured to generate a first power for application to tissue, and a first docking station comprising a first docking port that includes first data contacts and power contacts, the the first power generating module is slidingly movable into an electrical coupling with the power and data contacts and the first power generating module being slidingly movable out of the electrical coupling with the first power and data contacts. Dice.
[00105] [00105] In addition to the above, the modular housing also includes a second power generating module configured to generate a second power, different from the first power, for application to tissue, and a second docking station comprising a second docking port that includes second power and data contacts, the second power generating module being slidingly movable in electrical engagement with the power and data contacts, and the second power generating module being slidingly movable. sliding out of electrical engagement with the second power and data contacts.
[00106] [00106] In addition, the modular surgical cabinet also includes a communication bus between the first docking port and the second docking port, configured to facilitate communication between the first power generating module and the second power generating module. .
[00107] [00107] With reference to Figures 3 to 5, aspects of the present description are presented for a central controller modular compartment 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126 and a suction/irrigation module. - tion 128. The modular housing of the central controller 136 further facilitates interactive communication between modules 140, 126, 128. As illustrated in Figure 5, the generator module 140 can be a generator module with monopolar, bipolar and ultrasonic components. integrated, supported in a single 139 cabinet unit that can be slidably inserted into the central controller modular bay
[00108] [00108] In one aspect, the central controller modular housing 136 comprises a modular communication and power backplane 149 with external and wireless communication heads to allow the removable connection of modules 140, 126, 128 and the interactive communication between them.
[00109] [00109] In one aspect, the central controller modular housing 136 includes docking stations, or units, 151, here also called units, which are configured to slide-receive modules 140, 126, 128. Figure 4 illustrates a partial perspective view of a central surgical controller housing 136, and a combined generator module 145 slidably received in a docking station 151 of the central surgical controller housing 136. A docking port 152 with the power and data contacts on a rear side of the combined generator module 145 is configured to engage a corresponding docking port 150 with the power and data contacts of a corresponding docking station 151 of the central controller modular compartment 136 as per the combined generator module 145 is slid into position in the corresponding docking station 151 of the central controller modular compartment 136. In one aspect, the combined generator module 145 includes a bipolar, ultrasonic, and monopolar module and a smoke evacuation module integrated into a single bay unit 139, as illustrated in Figure 5.
[00110] [00110] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that transports trapped smoke/fluid collection away from a surgical site and to, for example, the smoke evacuation module 126. Vacuum suction originating from the smoke evacuation module 126 can draw smoke into an opening of a utility conduit in the surgical site. The utility conduit, coupled to the fluid line, may be in the form of a flexible tube terminating at the smoke evacuation module 126. The utility conduit and fluid line define a fluid path that extends toward the smoke evacuation module 126 that is received in the central controller compartment
[00111] [00111] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that transports trapped smoke/fluid collection away from a surgical site and to, for example, the smoke evacuation module 126. Vacuum suction originating from the smoke evacuation module 126 can draw smoke into an opening of a utility conduit in the surgical site. The utility conduit, coupled to the fluid line, may be in the form of a flexible tube terminating at the smoke evacuation module 126. The utility conduit and fluid line define a fluid path that extends toward the smoke evacuation module 126 that is received in the central controller compartment
[00112] [00112] In one aspect, the surgical tool includes a drive shaft that has an end actuator at a distal end thereof and at least one energy treatment associated with the end actuator, a suction tube, and a irrigation tube. The suction tube may have an inlet port at a distal end thereof and the suction tube extends through the drive shaft. Similarly, an irrigation tube may extend through the drive shaft and may have an inlet port near the power application implement. The power delivery implement is configured to deliver ultrasonic and/or RF power to the surgical site and is coupled to generator module 140 by a cable that initially extends through the drive shaft.
[00113] [00113] The irrigation tube can be in fluid communication with a fluid source, and the suction tube can be in fluid communication with a vacuum source. The fluid source and/or the vacuum source may be housed in the suction/irrigation module 128. In one example,
[00114] [00114] In one aspect, the modules 140, 126, 128 and/or their corresponding docking stations in the central controller modular compartment 136 may include alignment features that are configured to align the docking ports of the modules in engagement with their counterparts in the docking stations of the central controller modular compartment 136. For example, as illustrated in Figure 4, the combined generator module 145 includes side brackets 155 that are configured to slidably engage the corresponding brackets 156 of the corresponding docking station. - pendant 151 of central controller module housing 136. The brackets cooperate to guide the docking port contacts of the combined generator module 145 into electrical engagement with the docking port contacts of the central controller modular housing 136.
[00115] [00115] In some respects, the units 151 of the modular compartment of the central controller 136 are the same or substantially the same size, and the modules are adjusted in size to be received in the units 151. For example, the side supports 155 and/or 156 can be larger or smaller depending on the module size. In other respects, the 151 drawers are different in size and are each designed to accommodate a specific module.
[00116] [00116] Additionally, the contacts of a specific module can be keyed to engage with the contacts of a specific unit to avoid inserting a module into a unit with contact misalignment.
[00117] [00117] As illustrated in Figure 4, the docking port 150 of one drawer 151 can be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate interactive communication between modules housed in the central controller modular compartment 136. The docking ports 150 of the central controller modular compartment 136 can alternatively or additionally facilitate interactive wireless communication between modules housed in the central controller modular compartment 136 Any suitable wireless communication can be used, eg Air Titan Bluetooth.
[00118] [00118] Various image processors and imaging devices suitable for use with the present disclosure are described in US Patent No. 7,995,045 entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, issued August 9, 2011 which is incorporated herein as a reference in its entirety. In addition, US Patent No. 7,982,776 entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, issued July 19, 2011, which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from data. of image. Such systems can be integrated with the imaging module 138. In addition to these, the publication of US patent application No. 2011/0306840, entitled CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRA-CORPOREAL APPARATUS, published on December 15, 2011, and the publication of the application US Patent No. 2014/0243597, entitled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, published August 28, 2014, which are each incorporated herein by reference in their entirety.
[00119] [00119] Figure 6 illustrates a surgical data network 201 comprising a modular communication center 203 configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a healthcare facility. utility facility specially equipped for surgical operations, to a cloud-based system (e.g., cloud 204 which may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communication center 203 comprises a central network controller 207 and/or a network switch 209 in communication with a network router. Modular communication center 203 may also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 can be configured as a passive, intelligent, or switching network. A passive surgical data network serves as a conduit for data, allowing data to be transmitted from one device (or segment) to another and to cloud computing resources. An intelligent surgical data network includes facilities for allowing traffic to pass through the surgical data network to be monitored and for configuring each port on the network central controller 207 or network switch 209. An intelligent surgical data network may be called an intelligent surgical data network. a central controller or controllable switch. A central switching controller reads the destination address of each packet and then forwards the packet to the correct port.
[00120] [00120] Modular devices 1a to 1n located in the operating room can be coupled to the modular communication center 203. The central network controller 207 and/or the network switch 209 can be coupled to a network router 211 to connect devices 1a to 1n to cloud 204 or local computer system 210. Data associated with devices 1a to 1n can be transferred to cloud-based computers via the router for remote data processing and manipulation. Data associated with devices 1a to 1n can also be transferred to the local computer system
[00121] [00121] —It will be recognized that the surgical data network 201 may be expanded by interconnecting the multiple central network controllers 207 and/or the multiple network switches 209 with multiple network routers 211. The modular communication center 203 may be contained in a modular control tower configured to receive multiple devices 1a to 1n/2a to 2m. The local computer system 210 may also be contained in a modular control tower. The modular communication center 203 is connected to a screen 212 to display the images obtained by some of the devices 1a to 1n/2a to 2m, for example during surgical procedures. In various aspects, devices 1a to 1n/2a to 2m may include, for example, various modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction/irrigation module 128, a communication module 130, a processor module 132, a storage matrix 134, a surgical device coupled to a screen and/or a contactless sensor, among other modular devices that can be connected to the modular communication center 203 of the surgical data network 201.
[00122] [00122] In one aspect, the surgical data network 201 may comprise a combination of central network controllers, network switches, and network routers that connect 1a to 1n/2a to 2m devices to the cloud.
[00123] [00123] Applying cloud computer data processing techniques to data collected by 1a to 1n/2a to 2m devices, the surgical data network provides better surgical outcomes, reduced costs, and better patient satisfaction. .
[00124] [00124] In one implementation, operating room devices 1a to 1n can be connected to the modular communication center 203 via a wired channel or a wireless channel depending on the configuration of devices 1a to 1h in a central network controller . The central network controller 207 can be implemented, in one aspect, as a local network transmission device that acts on the physical layer of the OS model! | ("open system interconnection", or open systems interconnection). The network central controller provides connectivity to devices 1a to 1n situated on the same network as the operating room. The central network controller 207 collects data in the form of packets and sends them to the router in "half-duplex" mode. The network central controller 207 does not store any media access control/internet protocol (MAC/IP) to transfer the device data. Only one of the devices 1a to 1n at a time can send data through the network central controller 207. The network central controller 207 has no routing tables or intelligence about where to send information and transmits all network data over each connection and to a remote server 213 (Figure 9) on the cloud 204. The central network controller 207 can detect basic network errors such as collisions, but having all the information transmitted to multiple input ports can be a security risk and cause strangulation. wails.
[00125] [00125] In another implementation, operating room devices 2a to 2m can be connected to a network switch 209 via a wired or wireless channel. Network key 209 works at the data connection layer of the OSI model. Network switch 209 is a multicast device for connecting 2a to 2m devices located in the same operation center to the network. Network switch 209 sends data in the form of frames to network router 211 and operates in full duplex mode. Multiple devices 2a to 2m can send data at the same time via network key 209. Network key 209 stores and uses MAC addresses of devices 2a to 2m to transfer data.
[00126] [00126] Network central controller 207 and/or network switch 209 are coupled to network router 211 for a connection to the cloud
[00127] [00127] In one example, the network central controller 207 can be implemented as a USB central controller, which allows multiple USB devices to be connected to a host computer. The USB central controller can expand a single USB port to several levels so that there are more ports available for connecting devices to the system's host computer. The central network controller 207 may include wired or wireless facilities to receive information about a wired channel or a wireless channel. In one aspect, a wireless USB short-range, broadband, wireless radio communication protocol can be used for communication between devices la to In and devices 2a to 2m situated in the living room. operation.
[00128] [00128] In other examples, operating room devices 1a to 1n/2a to 2m can communicate with the modular communication center 203 via standard wireless Bluetooth technology for exchanging data over short distances (using short-wavelength UHF radio waves in the 2.4 to 2.485 GHz ISM band) from fixed and mobile devices and build personal area networks (PANs). In other respects, operating room devices 1a to 1n/2a to 2m can communicate with the modular communication center 203 via a number of wireless and wired communication standards or protocols, including, but not limited to, , Wi-Fi (IEEE family
[00129] [00129] Modular communication center 203 can serve as a central connection for one or all of the operating room devices 1a to 1n/2a to 2m and handles a type of data known as frames. Frames carry the data generated by devices 1a to 1n/2a to 2m. When a frame is received by modular communication center 203, it is amplified and transmitted to network router 211, which transfers the data to cloud computing resources using a series of communication standards or protocols. wireless or wired communication as described herein.
[00130] [00130] Modular communication center 203 can be used as a standalone device or be connected to network central controllers and compatible network switches to form a larger network. The Modular Communication Center 203 is generally easy to install, configure and maintain, making it a good choice for networking devices 1a to 1n/2a to 2m from the operating room.
[00131] [00131] Figure 7 illustrates an interactive computer-implemented surgical system 200. The interactive computer-implemented surgical system 200 is similar in many respects to the interactive computer-implemented surgical system 100. For example, the interactive computer-implemented surgical system 200 includes one or more surgical systems 202, which are similar in many respects to surgical systems 102. Each surgical system 202 includes at least one central surgical controller 206 in communication with a cloud 204 which may include a remote server 213. In one aspect , the computer-implemented interactive surgical system 200 comprises a 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. operations. As shown in Figure 8, the modular control tower 236 comprises a modular communication center 203 coupled to a computer system 210. As illustrated in the example of Figure 7, the modular control tower 236 is coupled to an imaging module 238 that is coupled to an endoscope 239, a generator module 240 that is coupled to a power device 241, a smoke evacuation module 226, a suction/irrigation module 228, a communication module 230 , a processor module 232, a storage array 234, an intelligent device/instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. Operating room devices are coupled to computing resources in cloud and data storage through the modular control tower
[00132] [00132] Figure 8 illustrates a central surgical controller 206 comprising a plurality of modules coupled to the modular control tower 236. The modular control tower 236 comprises a modular communication center 203, for example a network connectivity device, and a computer system 210 to provide local processing, display and imaging, for example. As shown in Figure 8, the modular communication center 203 can be connected in a layered configuration to expand the number of modules (e.g. devices) that can be connected to the modular communication center 203 and transfer to the communication system. computer 210 data associated with modules, cloud computing resources, or both. As shown in Figure 8, each of the central controllers/network switches in the modular communication center 203 includes three downstream ports and one upstream port. The central controller/upstream network switch is connected to a processor to provide a communication link with cloud computing resources and a local display 217. Communication with the cloud 204 can be done via a communication channel. wired or wireless.
[00133] [00133] The central surgical controller 206 employs a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room using non-contact laser or ultrasonic measurement devices. An ultrasound-based non-contact sensor module scans the operating room by transmitting a burst of ultrasound and receiving the echo as it bounces off the surrounding walls of an operating room, as described under the heading "Surgical Hub Spatial Awareness Within an Operating Room" in US Provisional Patent Application Serial No. 62/611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, which is incorporated herein by reference in its entirety, the sensor module being configured to determine the operating room size and to adjust Bluetooth pairing distance limits. A laser-based non-contact sensor module scans the operating room by transmitting pulses of laser light, receiving pulses of laser light that bounce off the perimeter walls of the operating room, and comparing the phase of the transmitted pulse to the received pulse. to determine the size of the operating room and to adjust Bluetooth pairing distance limits, for example.
[00134] [00134] The computer system 210 comprises a processor 244 and a network interface 245. The processor 244 is coupled to a communication module 247, storage 248, memory 249, non-volatile memory 250, and input/output interface 251 over a system bus. The system bus can be any of several types of bus structures, including the memory bus or memory controller, a peripheral bus or external bus, and/or local bus using any variety of available bus architectures including , but not limited to, 9-bit bus, Industry Standard Architecture (ISA), Micro-Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronic Circuits (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), PCMCIA (Personal Computer Memory Card International Association) bus, Personal Computer Memory Card International Association small computer systems (SCSI), or any other proprietary bus.
[00135] [00135] The 244 processor may be any single-core or multi-core processor such as those known under the tradename ARM Cortex available from Texas Instruments. In one aspect, the processor may be a Core Cortex-M4F LM4F230H5QR ARM processor, available from Texas Instruments, for example, comprising 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 StellarisWareO program, memory only programmable and electrically erasable readout (EEPROM) 2 KB, one or more pulse width modulation (PWM) modules, one or more analog quadrature encoder (QEI) inputs, one or more analog converters to 12-bit digital (ADC) with 12 analog input channels, details of which are available for the product data sheet.
[00136] [00136] In one aspect, the processor 244 may comprise a safety controller comprising two controller-based families, such as TMS570 and RM4x, known under the tradename Hercules ARM Cortex R4, also available from Texas Instruments. Safety controller can be configured specifically for IEC 61508 and ISO safety critical applications
[00137] [00137] System memory includes volatile memory and non-volatile memory. The basic input/output system (BIOS), containing the basic routines for transferring information between elements within the computer system, such as during startup, is stored in non-volatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. Additionally, RAM is available in many forms such as SRAM, Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDR SDRAM), Enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and Direct RAM Rambus RAM (DRRAM).
[00138] [00138] Computer system 210 also includes removable/non-removable, volatile/non-volatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card, or memory stick (pen- drive). In addition, the storage disc may include storage media separately or in combination with other storage media including, but not limited to, an optical disc drive such as a compact disc ROM (CD-ROM) drive. recordable compact disc (CD-R Drive), rewritable compact disc drive (CD-RW drive), or a digital versatile disc ROM (DVD-ROM) drive. To facilitate the connection of disk storage devices to the system bus, a removable or non-removable interface can be used.
[00139] [00139] It is to be understood that the computer system 210 includes software that acts as an intermediary between the users and the basic computer resources described in a suitable operating environment. Such software includes an operating system. The operating system, which can be stored on disk storage, acts to control and allocate computer system resources. System applications benefit from management capabilities by the operating system through program modules and “program data stored in system memory or storage disk. It is to be understood that various components described in the present invention may be implemented with various operating systems or combinations of operating systems.
[00140] [00140] A user enters commands or information into the computer system 210 through the input device(s) coupled to the 1/O interface 251. Input devices include, but are not limited to, a pointing device such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, game pad, satellite board, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like . These and other input devices connect to the processor via the system bus via the interface port(s). Interface ports include, for example, a serial port, a parallel port, a game port, and a USB. Output devices use some of the same types of ports as input devices. In this way, for example, a USB port can be used to provide input to the computer system and to provide information from the computer system to an output device. An output adapter is provided to illustrate that there are some output devices such as monitors, displays, speakers, and printers, among other output devices, that need special adapters. Output adapters include, by way of illustration and not limitation,
[00141] [00141] Computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computers, or local computers. Remote cloud computers can be a personal computer, server, router, network personal computer, workstation, microprocessor-based device, peer device, or other common network node, and the like, and typically include many or all of the elements described in relation to the computer system. For the sake of brevity, only one memory storage device is illustrated with the remote computer. Remote computers are logically connected to the computer system through a network interface and then physically connected through a communication connection. The network interface covers communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5 and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as integrated services digital networks (ISDN) and variations thereof, packet-switched networks, and digital subscriber lines (DSL).
[00142] [00142] In various aspects, the computer system 210 of Figure 8, the imaging module 238 and/or the visualization system 208, and/or the processor module 232 of Figures 7 and 8, may comprise an image processor, an image processing engine, a media processor, or any specialized digital signal processor (DSP) used to process digital images. The image processor can employ parallel computing with single instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) technologies to increase speed and efficiency. The digital image processing engine can perform a number of tasks. The image processor can be a system on an integrated circuit with a multi-core processor architecture.
[00143] [00143] Communication connections refer to the hardware/software used to connect the network interface to the bus. Although the communication connection is shown for illustrative clarity within the computer system, it may also be external to the computer system 210. The hardware/software required for connection to the network interface includes, for illustrative purposes only, internal technologies. and external ones such as modems, including regular serial telephone modems, cable modems and DSL modems, ISDN adapters and Ethernet cards.
[00144] [00144] Figure 9 illustrates a functional block diagram of an aspect of a USB 300 network central controller device, in accordance with at least one aspect of the present disclosure. In the illustrated aspect, the USB 300 network central controller device uses a TUSB2036 integrated circuit central controller available from Texas Instruments. The USB 300 Network Central Controller is a CMOS device that provides one USB upstream transceiver port 302 and up to three USB downstream transceiver ports 304, 306, 308 in compliance with the USB 2.0 specification. Upstream USB transceiver port 302 is a differential data root port comprising a "minus" differential data input (DMO) paired with a "plus" differential data input (DPO). The three downstream USB transceiver ports 304, 306, 308 are differential data ports, with each port including "plus" differential data outputs (DP1-DP3) paired with "minus" differential data outputs (DM 1 -DM3).
[00145] [00145] The USB 300 network central controller device is implemented with a digital state machine instead of a microcontroller, and no firmware programming is required. Fully compatible USB transceivers are integrated in the circuit for USB upstream transceiver port 302 and all USB downstream transceiver ports 304, 306, 308. USB downstream transceiver ports 304, 306, 308 support both full speed and low speed by automatically setting the scan rate according to the speed of the device attached to the ports. The USB 300 network central controller device can be configured in either bus-powered or self-powered mode and includes central controller 312 power logic to manage power.
[00146] [00146] The USB 300 network central controller device includes a 310 Serial Interface Engine (SIE). The SIE 310 is the hardware front end of the USB 300 network central controller and handles most of the protocol described in Chapter 8 of the USB specification. The SIE 310 typically understands signaling down to the transaction level. The functions it handles could include: packet recognition, transaction sequencing, SOP, EOP, RESET, and RESUME signal detection/generation, clock/data separation, non-return data encoding/decoding to inverted zero (NRZI), CRC generation and verification (token and data), packet ID (PID) generation and verification/decoding, and/or serial-parallel/parallel-series conversion. The SIE 310 receives a clock input 314 and is coupled to a 316 suspend/resume and frame timer logic circuit and a central controller 318 replay circuit to control communication between the upstream USB transceiver port 302 and downstream USB transceiver ports 304, 306, 308 via port logic circuits 320, 322,
[00147] [00147] In many respects, the USB 300 network central controller can connect 127 functions configured in up to six logical layers (levels) to a single computer. In addition, the USB 300 network central controller can connect all peripherals using a standard four-wire cable that provides both communication and power distribution. Power settings are bus-powered and self-powered modes. The USB 300 network central controller can be configured to support four power management modes: a bus-powered central controller, with single port power management or grouped port power management, and the self-powered central controller, with single port power management or grouped port power management. In one aspect, with the use of a USB cable, the USB network central controller 300, the USB upstream transceiver port 302 plugs into a USB host controller, and the USB downstream transceiver ports 304, 306, 308 are exposed for connecting USB compatible devices, and so on.
[00148] [00148] Surgical instrument hardware control
[00149] [00149] Figure 10 illustrates a control circuit 500 configured to control aspects of the surgical instrument or tool in accordance with an aspect of the present disclosure. Control circuit 500 can be configured to implement various processes described here. Control circuit 500 may comprise a microcontroller comprising one or more processors 502 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 504. Memory circuit 504 stores machine-executable instructions which, when executed by processor 502, cause processor 502 to execute machine instructions to implement various of the processes described herein. Processor 502 can be any of a number of single-core or multi-core processors known in the art. The 504 memory circuit may comprise volatile and non-volatile storage media. Processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure. Figure 11 illustrates a combinatorial logic circuit 510 configured to control aspects of the surgical instrument or tool in accordance with an aspect of the present disclosure. Combinational logic circuit 510 can be configured to implement various processes described herein. Combinational logic circuit 510 may comprise a finite state machine comprising combinational logic 512 configured to receive data associated with the instrument or surgical tool at an input 514, process the data by combinational logic 512, and provide an output 516.
[00150] [00150] Figure 12 illustrates a sequential logic circuit 520 configured to control aspects of the surgical instrument or tool in accordance with an aspect of the present disclosure. Sequential logic circuit 520 or combinational logic 522 can be configured to implement the process described here. The sequential logic circuit 520 may comprise a finite state machine. The sequential logic circuit 520 may comprise a combinational logic 522, at least a 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 aspects, the circuit may comprise a combination of a processor (e.g. , processor 502, Figure 10) and a finite state machine for implementing various processes of the present invention. In other aspects, the finite state machine may comprise a combination of a combinatorial logic circuit (e.g., a combinatorial logic circuit 510, Figure 11) and sequential logic circuit 520.
[00151] [00151] Figure 13 illustrates a system 800 configured to perform adaptive ultrasonic blade control algorithms on a surgical data network comprising a modular communication center, in accordance with at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute one or more adaptive ultrasonic blade control algorithms. In another aspect, the device/instrument 235 is configured to run the one or more adaptive ultrasonic blade control algorithms. In another aspect, the device/instrument 235 is configured to execute the one or more adaptive ultrasonic blade control algorithms.
[00152] [00152] — Generator module 240 may comprise an isolated patient stage communicating with a non-isolated stage via a power transformer. A secondary winding of the power transformer is contained in the isolated stage and may comprise a tapped configuration (e.g. a center tapped or non center tapped configuration) to define the drive signal outputs to deliver signals. different surgical instruments, such as an ultrasonic surgical device and an RF electrosurgical instrument, and a multifunctional surgical instrument that includes ultrasonic and RF energy modes that can be released alone or simultaneously. In particular, the trigger signal outputs can output an ultrasonic trigger signal (e.g., a 420V root mean square (RMS) trigger signal for a 241 ultrasonic surgical instrument, and the triggers can output an RF electrosurgical trigger signal (eg, a 100V electrosurgical trigger signal) to an RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to Figures 14 through 19B.
[00153] [00153] 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 localized computerized devices in the operating room, as described with reference to Figures 6 to 9, for example.
[00154] [00154] Figure 14 illustrates an example of a generator 900, which is a form of a generator configured to couple with an ultrasonic instrument and additionally configured to run adaptive ultrasonic blade control algorithms on a data network. surgical instruments comprising a modular communication center as shown in Figure 13. Generator 900 is configured to supply multiple modalities of energy to a surgical instrument. The 900 generator provides both 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 supply multiple energy modalities (e.g., 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. Generator 900 comprises a processor 902 coupled to a waveform generator 904. Processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in memory coupled to the terminator 902, not shown for clarity of description. The digital information associated with a waveform is fed to the 904 waveform generator which includes one or more DAC circuits to convert the digital input to an analog output. The analog output is fed to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of amplifier 906 is coupled to a power transformer 908. Signals are coupled by power transformer 908 to the secondary side, which is on the patient isolation side. A first signal of a first power mode is provided to the surgical instrument between the terminals labeled POWER1 and RETURN. A second signal from a second power mode is coupled to a capacitor 910 and is supplied to the surgical instrument between the terminals labeled POWER and RETURN. It will be recognized that more than two modes of energy can be emitted, and therefore the subscript "n" can be used to denote that up to n ENERGY terminals can be supplied, where n is a positive integer greater than 1. It will also be recognized that up to "n" return paths, RETURNon may be provided without departing from the scope of the present description.
[00155] [00155] A first voltage sensing circuit 912 is coupled to the terminals identified as POWER1 and the RETURN path to measure the output voltage between them. A second detection circuit
[00156] [00156] In one aspect, the impedance can be determined by the processor 902 by dividing the output of the first voltage sensing circuit 912 coupled to the terminals labeled POWER/RETURN or the second voltage sensing circuit 924 coupled to the terminals identified as POWER2/RETURN by the output of the current sensing circuit 914 arranged in series with the RETURN leg of the secondary side of the power transformer 908. The outputs of the first and second voltage sensing circuits 912, 924 are provided to separate the isolation transformers 916, 922 and the output of the current sensing circuit 914 is supplied to another isolation transformer 916. The digitized voltage and current sensing measurements of the ADC circuit 926 are supplied to the processor 902 to calculate the impedance. As an example, the first energy modality ENERGY1 could be ultrasonic energy and the second energy modality ENERGY2 could be RF energy. However, in addition to ultrasonic and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and/or reversible electroporation and/or microwave energy, among others. Furthermore, while the example illustrated in Figure 21 shows a single RETURN return path that can be provided for two or more energy modes, in other respects, multiple RETORNOn return paths can be provided for each ENERGY energy mode. Thus, as described herein, the impedance of the ultrasonic transducer can be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914, and the tissue impedance can be measured by dividing the output from the second voltage sensing circuit 924 by the current sensing circuit 914.
[00157] [00157] As shown in Figure 14, the generator 900 comprising at least one output port may include a power transformer 908 with a single output and multiple taps to provide power in the form of one or more modes of operation. energy, such as ultrasonic, bipolar or monopolar RF, irreversible and/or reversible electroporation and/or microwave energy, among others, for example, to the extremity actuator, depending on the type of tissue treatment being performed. For example, generator 900 can supply power with higher voltage and lower current to drive an ultrasonic transducer,
[00158] [00158] Additional details are described in US patent application publication No. 2017/0086914 titled TECHNIQUES FOR OPERATING
[00159] [00159] — As used throughout this description, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc., which can communicate data through the use of of electromagnetic radiation modulated through 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 and wired communication standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20 , long-term evolution (LTE, "long-
[00160] [00160] 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 (specifically systems on a chip (SoCs)) that combine several specialized "processors".
[00161] [00161] As used here, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all the components of a computer or other components. electronic systems. It can contain digital, analog, mixed and often radio frequency functions — all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), Wi-Fi module, or coprocessor. A SoC may or may not contain internal memory.
[00162] [00162] 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 may include a microcontroller as one of its components. A microcontroller may contain one or more core processing units (CPUs) along with memory and programmable input/output peripherals. Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM is also often included on the chip, as well as a small amount of RAM. Microcontrollers can be used for integrated applications, in contrast to microprocessors used in personal computers or other general-purpose applications that consist of several distinct integrated circuits.
[00163] [00163] As used in the present invention, the term controller or microcontroller can be an independent chip or IC (integrated circuit) device that interfaces with a peripheral device. This could be a link between two parts of a computer or a controller on an external device that manages the operation of (and connection to) that device.
[00164] [00164] Any of the processors or microcontroller in the present invention may be any implemented by any single-core or multi-core processor, such as those known under the trade name ARM Cortex by Texas Instruments. In one aspect, the processor may be a Core Cortex-M4F LM4F230H5QR ARM processor, available from Texas Instruments, for example, comprising 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 StellarisWareO program, memory only programmable readout and erase
[00165] [00165] In one aspect, the processor may comprise a security controller comprising two controller-based families, such as TMS570 and RM4x, known under the tradename Hercules ARM Cortex R4, also by Texas Instruments. The safety controller can be configured specifically for safety critical applications IEC 61508 and ISO 26262, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[00166] [00166] Modular devices include modules (as described in connection with Figures 3 and 9, for example) that are receivable within a central surgical controller and surgical devices or instruments that can be connected to the various modules in order to connect or pair with the corresponding central surgical controller. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, power generators, fans, insufflators and displays. The modular devices described here can be controlled by control algorithms. Control algorithms can be run on the modular device itself, on the central surgical controller to which the specific modular device is paired, or both on the modular device and on the central surgical controller (e.g. via a distributed computing architecture). In some examples, the modular devices' control algorithms control the devices based on data detected by the modular device itself (ie, by sensors in, on, or connected to the modular device). This data may be related to the patient being operated on (e.g. tissue properties or insufflation pressure) or the modular device itself (e.g. the rate at which a knife is being advanced, motor current, or pressure levels). energy). For example, a control algorithm for a surgical stapling and cutting instrument might control the rate at which the instrument's motor drives its knife through tissue according to the resistance encountered by the knife as it advances.
[00167] [00167] Figure 15 illustrates one form of a surgical system 1000 comprising a generator 1100 and various surgical instruments 1104, 1106, 1108 that can be used therewith, the surgical instrument 1104 being an ultrasonic surgical instrument, the 1106 surgical instrument is an RF electrosurgical instrument, and the 1108 multipurpose surgical instrument is an ultrasonic/RF electrosurgical instrument combination. The 1100 generator is configurable for use with a variety of surgical instruments. In various ways, the generator 1100 can be configurable for use with different surgical instruments of different types, including, for example, the 1104 Ultrasonic Surgical Instrument, 1106 RF Electrosurgical Instruments, and 1108 Multifunctional Surgical Instrument that integrates ultrasonic and RF energies delivered simultaneously from the generator
[00168] [00168] The generator 1100 is configured to drive multiple surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and comprises a handle 1105 (HP), an ultrasonic transducer 1120, a shaft of drive 1126 and an end actuator 1122. The end actuator 1122 comprises an ultrasonic blade 1128 acoustically coupled to the ultrasonic transducer 1120 and a grip arm 1140. The grip 1105 comprises a trigger 1143 for operating the grip arm 1140 and a combination of toggle buttons 1134a, 1134b, 1134c to energize and trigger 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.
[00169] [00169] The 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 handle 1107 (HP), a drive shaft 1127, and an actuator. end 1124. End actuator 1124 comprises electrodes on gripping arms 1142a and 1142b and return through the electrically conductive portion of drive shaft 1127. The electrodes are coupled to and energized by a bipolar power source within the generator. - pain 1100. Handle 1107 comprises a trigger 1145 for operating the gripping arms 1142a, 1142b and a power button 1135 for actuating a power switch to energize the electrodes on the end actuator 1124.
[00170] [00170] The generator 1100 is also configured to drive a multi-purpose surgical instrument 1108. The multi-purpose surgical instrument 1108 comprises a handle 1109, a drive shaft 1129 and an end actuator 1125. The end actuator 1125 comprises a 1149 ultrasonic blade and 1146 grip arm. The 1149 ultrasonic blade/blade is acoustically coupled to the 1120 ultrasonic transducer. The 1109 grip comprises a trigger 1147 for operating the grip arm 1146 and a toggle switch combination 1137a , 1137b, 1137c to power and drive 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. 1105, 1107, 1109 can be replaced by a robotically controlled instrument. Consequently, the grip should not be limited to that context.
[00171] [00171] 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 instrument 1104, the RF surgical instrument 1106 and the multifunctional surgical instrument. 1108 that integrates ultrasonic and RF energies delivered simultaneously from generator 1100. While in the form of Figure 15 generator 1100 is shown separate from surgical instruments 1104, 1106, 1108, in another form, generator 1100 may be formed integrally with any of the surgical instruments 1104, 1106, 1108 to form a unitary surgical system. As discussed above, generator 1100 comprises an input device 1110 located on a front panel of generator console 1100. Input device 1110 may comprise any suitable device that generates signals suitable for programming the operation of generator 1100. Generator 1100 may also comprise one or more output devices 1112. Other aspects of generators for digitally generating electrical signal waveforms and surgical instruments are described in patent publication US-2017-0086914-A1, which is incorporated herein. by way of reference, in its entirety.
[00172] [00172] In various aspects, the generator 1100 may comprise several separate functional elements, such as modules and/or blocks, as shown in Figure 16, a diagram of the surgical system 1000 of Figure 15. Different modules or functional elements may 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
[00173] [00173] 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 one or more trigger signals may be provided to the ultrasonic device 1104 and specifically to the transducer 1120, which may operate, for example, as described above. In one aspect, generator 1100 can be configured to produce a drive signal of a specific voltage, current, and/or frequency output signal that can be performed with high resolution, accuracy, and repeatability.
[00174] [00174] According to the aspects described, the generator module for electrosurgery/RF can generate one or more trigger signals with sufficient output power to perform bipolar electrosurgery using radio frequency (RF) energy. In bipolar electrosurgery applications, the trigger signal can be provided, for example, to the electrodes of the 1106 electrosurgical device, for example, as described above. Accordingly, generator 1100 can be configured for therapeutic purposes by applying sufficient electrical energy to tissue to treat said tissue (eg, coagulation, cauterization, tissue welding, etc.).
[00175] [00175] Generator 1100 may comprise an input device 2150 (Figure 18B) situated, for example, on a front panel of generator console 1100. Input device 2150 may comprise any suitable device that generates suitable signals. to program the operation of the generator 1100. In operation, the user may program or otherwise control the operation of the generator 1100 using input device 2150. Input device 2150 may comprise any suitable device that generates signals that can be used by the generator (e.g., by one or more processors contained in the generator) to control the operation of the 1100 generator (e.g., 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, switches, rotary controls, keyboard, numeric keypad, touchscreen monitor, pointing device, and remote connection to a general-purpose computer. or dedicated. In other aspects, input device 2150 may comprise a suitable user interface,
[00176] [00176] Generator 1100 may comprise an output device 2140 (Figure 18B) situated, for example, on a front panel of generator console 1100. Output device 2140 includes one or more devices for providing the user with sensory feedback. serial. These devices may comprise, for example, visual feedback devices (eg, a monitor with an LCD screen, LED indicators), auditory feedback devices (eg, a loudspeaker, a doorbell) or feedback devices. - tactile information (eg haptic actuators).
[00177] [00177] Although certain modules and/or blocks of the generator 1100 can be described by way of example, it must be considered that a greater or lesser number of modules and/or blocks can be used and still be in the scope of the aspects. Additionally, although various aspects can be described in terms of modules and/or blocks for ease of description, these modules and/or blocks can be implemented by one or more hardware components, e.g. processors, digital signal processors ( PSDs), programmable logic devices (PLDs), application-specific integrated circuits (ASICs), circuits, registers, and/or software components, e.g., programs, subroutines, logic, and/or combinations of hardware and software components .
[00178] [00178] In one aspect, the ultrasonic generator drive module and the 1110 electrosurgery/RF drive module (Figure 15) may comprise one or more integrated applications, implemented as firmware, software, hardware, or any combination thereof. Modules can comprise various executable modules, such as software, programs, data, triggers, and application program interfaces (APIs), among others. Firmware can be stored in non-volatile memory (NVM), such as bitmasked read-only memory (ROM), or flash memory. In many implementations, storing firmware in ROM can preserve flash memory. NVUM may comprise other types of memory including, for example, programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable read-only memory (EEPROM, for "electrically erasable programmable ROM"), or battery-powered random-access memory (RAM), such as dynamic RAM (DRAM), dual-rate DRAM (DDRAM, for "Double-Data-Rate DRAM"), and/or synchronous DRAM (SDRAM, for "synchronous DRAM").
[00179] [00179] 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 trigger signal or signals for operation. of devices 1104, 1106, 1108. In aspects where generator 1100 is used in conjunction with device 1104, the trigger signal may drive ultrasonic transducer 1120 in surgical cutting and/or coagulation modes. The electrical characteristics of the device 1104 and/or tissue can be measured and used to control the operational aspects of the generator 1100 and/or be provided as feedback to the user. In aspects where generator 1100 is used in conjunction with device 1106, the trigger signal may supply electrical energy (eg, RF energy) to end actuator 1124 in cutting, coagulation, and/or desiccation modes. The electrical characteristics of the device 1106 and/or the tissue can be measured and used to control the operational aspects of the generator 1100 and/or be provided as feedback to the user. In many respects, as previously discussed, hardware components can be implemented as PSD, PLD, ASIC, circuits and/or registers. In one aspect, the processor may be configured to store and execute computer software program instructions so as to generate the step function output signals for driving various components of devices 1104, 1106, 1108, such as the 1120 ultrasonic transducer and 1122, 1124, 1125 end actuators.
[00180] [00180] Figure 17 is a simplified block diagram of one aspect of the generator 1100 to provide inductorless tuning as described above, among other benefits. Figures 18A through 18C illustrate an architecture of the generator 1100 of Figure 17 according to one aspect. Referring to Figure 17, generator 1100 may comprise an isolated patient stage 1520 in communication with an unisolated stage 1540 via a power transformer 1560. A secondary winding 1580 of power transformer 1560 is contained in isolated stage 1520 and may comprise a tapped configuration (e.g. a center tapped or non center tapped configuration) to set trigger signal outputs 1600a, 1600b, 1600c to provide trigger signals for different surgical devices, such as a device ultra-surgical
[00181] [00181] Power can be supplied to a 1620 power amplifier power rail by a switch mode regulator
[00182] [00182] In certain respects and as discussed in further detail in connection with Figures 19A and 19B, programmable logic device 1660, in conjunction with processor 1740, can implement a direct digital synthesizer (DDS) control scheme. ) to control the waveform shape, frequency, and/or amplitude of trigger signals emitted by generator 1100. In one aspect, for example, programmable logic device 1660 may implement a DDS control algorithm 2680 (Figure 14A). ) by retrieving waveform samples stored in a dynamically updated lookup table (LUT), such as a LUT RAM that can be integrated into an FPGA.
[00183] [00183] The uninsulated stage 1540 may additionally comprise an ADC 1780 and an ADC 1800 coupled to the output of the power transformer 1560 by means of the respective isolation transformers, 1820 and 1840, to sample respectively the voltage and current of drive signals output from the 1100 generator. In certain respects, the 1780 and 1800 ADCs can be configured to sample at high speeds (eg, 80 Msps) to allow oversampling of the trigger signals. In one respect, for example, the sampling speed of the 1780 and 1800 ADCs can enable approximately 200X oversampling (depending on the trigger frequency) of the trigger signals. In certain respects, the sampling operations of the 1780, 1800 ADCs can be performed by a single ADC receiving input voltage and current signals through a bidirectional multiplexer. The use of high-speed sampling on aspects of the 1100 generator can make it possible, among other things, to calculate the complex current flowing through the motion branch (which can be used in certain aspects to implement waveform shape control). based on the DDS described above), accurate digital filtering of the sampled signals, and calculation of the actual power consumption with a high degree of accuracy. Voltage and current feedback data provided by the 1780 and 1800 ADCs can be received and processed (e.g., FIFO-type buffering, multiplexing) by the 1660 programmable logic device and stored in data memory for subsequent recovery, for example, by the 1740 processor. As noted above, the voltage and current feedback data can be used as input to an algorithm for pre-distorting or modifying waveform samples in the LUT, dynamically and to be continued. In certain respects, this may require that each pair of stored voltage and current feedback data be indexed based on, or otherwise associated with, a corresponding sample of the LUT that was provided by the 1660 programmable logic device when the pair of voltage and current feedback data was captured. Synchronizing 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.
[00184] [00184] In certain respects, voltage and current feedback data can be used to control the frequency and/or amplitude (eg current amplitude) of 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 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 set point (e.g. 0°), thus minimizing or reducing the effects of distortion. harmonic and correspondingly enhancing the accuracy of the impedance phase measurement. Phase impedance determination and a frequency control signal can be implemented in the 1740 processor, for example, with the frequency control signal being provided as input to a DDS control algorithm implemented by the programmable logic device. 1660.
[00185] [00185] The impedance phase can be determined through Fourier analysis. In one aspect, the phase difference between the generator voltage drive signals Va,(t) and the generator current /1(t) can be determined using the fast Fourier transform.
[00186] [00186] The evaluation of the Fourier transform at the frequency of the sinusoid produces: A : Vac) = 2"5(0) expGo) arg V(fo) = q, Tg) = Bs(0) exp(ip2) arg 1(fo) = 2
[00187] [00187] Other approaches include weighted least squares estimation, Kalman filtering, and space- and vector-based techniques. Virtually all processing in an FFT or DFT technique can be performed in the digital domain with the aid of the high speed two-channel ADC, 1780,1800, for example. In one technique, digital signal samples of voltage and current signals are Fourier transformed with an FFT or a DFT. The phase angle q at any point in time can be calculated by: q =2n7nft+qo, where q is the phase angle, f is the frequency, t is the time, and qo is the phase not=0.
[00188] [00188] “Another technique for determining the phase difference between the voltage signals V,(t) and current /74(t) is the zero-crossing method and it produces highly accurate results. For voltage signals V,(t) and current /7(t) having the same, each zero crossing from negative to positive of voltage signal V,(t) triggers the start of a pulse, while each zero crossing of negative to positive current signal /7(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 averaging filter to produce a measure of the phase difference. Furthermore, if the positive to negative zero crossings are also used in a similar way, and the results are averaged, any effects of dc components and harmonics can be reduced. In an implementation, the analog voltage signals Va(t) and current /7(t) are converted into digital signals that are high if the analog signal is positive and low if the analog signal is negative. High-accuracy phase estimates require sharp transitions between highs and lows. In one aspect, a Schmitt trigger together with an RC stabilization network can be used to convert analog signals to digital signals. In other respects, an auxiliary and edge-triggered RS flip-flop circuit can be used. In yet another aspect, the zero crossing technique can use an exclusive gate (XOR).
[00189] [00189] — 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 cross-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
[00190] [00190] In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the trigger signal at a current amplitude setpoint. The current span setpoint can be specified directly or determined indirectly based on the specified voltage and power span setpoints. In certain respects, control of the current amplitude may be implemented by the control algorithm, such as a proportional-integral-derived (PID) control algorithm, in the 1740 processor. The variables controlled by the control algorithm to properly control the current amplitude of the trigger signal may include, for example, scaling the LUT waveform samples stored in the programmable logic device 1660 and/or the full scale output voltage of the DAC 1680 circuit (which provides input to the power 1620) through a DAC 1860 circuit.
[00191] [00191] The non-isolated 1540 stage may also contain a 1900 processor to provide, among other things, user interface (UI) functionality. In one aspect, the processor 1900 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 user feedback, communication with peripheral devices (for example, through a universal serial bus (USB) interface), communication with the footswitch 1430, communication with an input device 2150 (e.g. a touch screen) and communication with an output device 2140 (e.g.
[00192] [00192] In certain aspects, both the processor 1740 (Figures 17, 18A) and the processor 1900 (Figures 17, 18B) can determine and monitor the operational state of the generator 1100. For the processor 1740, the operational state of the generator 1100 may determine, for example, which control and/or diagnostic processes are implemented by processor 1740. For processor 1900, the operating state of generator 1100 may determine, for example, which elements of a user interface (e.g. , monitor screens, sounds) are presented to a user. Processors 1740 and 1900, respectively, can independently maintain the current operational state of the generator 1100, and 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 given transition is appropriate. For example, when processor 1740 instructs processor 1900 to transition to a specific state, processor 1900 can 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 failure mode.
[00193] [00193] The non-isolated stage 1540 may further comprise a controller 1960 (Figures 17, 18B) for monitoring input devices 2150 (e.g., a capacitive touch sensor used to turn generator 1100 on and off, a capacitive display touch sensitive). In certain aspects, controller 1960 may comprise at least one processor and/or other controller device in communication with processor 1900. In one aspect, for example, controller 1960 may comprise a processor (e.g., an 8-bit Mega168 controller). available from Atmel) configured to monitor user actions via one or more capacitive touch sensors. In one aspect, the 1960 controller may comprise a touchscreen controller (e.g., a QT5480 touchscreen controller available from Atmel) to control and manage the capture of touch data from a capacitive touch screen.
[00194] [00194] In certain respects, when generator 1100 is in a "off" state, controller 1960 may continue to receive operating power (e.g., through a line from a power source to generator 1100, such as the source 2110 (Figure 17) discussed below). In this way, the 1960 controller can continue to monitor an input device 2150 (for example, a capacitive touch sensor located on a front panel of the generator 1100) to turn the generator 1100 on and off. When the generator 1100 is in the off state, On, the 1960 controller can wake up the power supply (e.g. enable one or more 2130 DC/DC voltage converters (Figure 17) from the 2110 power supply to operate), if activation of the power supply is detected. 2150 "on/off" input device by a user. Controller 1960 can therefore initiate a sequence to transition generator 1100 to an "on" state. On the other hand, controller 1960 may initiate a sequence to transition generator 1100 to the off state if activation of "on/off" input device 2150 is detected when generator 1100 is in the on state. . In certain respects, for example, controller 1960 may report activation of "on/off" input device 2150 to processor 1900 which, in turn, implements the process sequence necessary to transition generator 1100 to the off state. In these respects, the controller 1960 may not have any independent capability to cause the generator 1100 to remove power after its on state has been established.
[00195] [00195] In certain respects, the controller 1960 may cause the generator 1100 to provide audible 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.
[00196] [00196] In certain aspects, the isolated stage 1520 may comprise an instrument interface circuit 1980 to, for example, provide a communication interface between a control circuit of a surgical device (e.g., a control circuit that comprises cable switches) and non-isolated stage 1540 components, such as programmable logic device 1660, processor 1740, and/or processor 1900. Instrument interface circuit 1980 can exchange information with non-isolated stage 1540 components via a communication link that maintains an adequate degree of electrical isolation between stages 1520 and 1540, such as an infrared (IR) based communication link. Power can be supplied to the 1980 instrument interface circuit using, for example, a low-loss voltage regulator powered by an isolation transformer driven from the non-isolated 1540 stage.
[00197] [00197] In one aspect, the instrument interface circuit 1980 may comprise a programmable logic device 2000 (e.g., an FPGA) in communication with a signal conditioning circuit 2020 (Figure 17 and Figure 18C). Signal conditioning circuit 2020 may be configured to receive a periodic signal from programmable logic device 2000 (e.g., a 2 kHz square wave) to generate a bipolar interrogation signal that has an identical frequency. The interrogation signal can be generated, for example, using a bipolar current source powered by a differential amplifier. The interrogation signal may be communicated to a surgical device control circuit (for example, by using a lead pair on a wire connecting the 1100 generator to the surgical device) and monitored to determine a state or configuration of the surgical device. control circuit. The control circuit may comprise a number of switches, resistors and/or diodes to modify one or more characteristics (e.g. amplitude, rectification) of the interrogation signal so that a state or configuration of the control circuit is discernible, so that unequivocal, based on this one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may comprise an ADC for generating samples of a voltage signal appearing between inputs of the control circuit that result from the interrogation signal passing therethrough. The programmable logic device 2000 (or a component of the non-isolated stage 1540) can then determine the state or configuration of the control circuit based on the ADC samples.
[00198] [00198] In one aspect, the instrument interface circuit 1980 may comprise a first data circuit interface 2040 to enable the exchange of information between the programmable logic device 2000 (or another element of the instrument interface circuit 1980). ) and a first data circuit disposed or otherwise associated with a surgical device. In certain aspects, for example, a first data circuit 2060 may be disposed on a wire integrally attached to a surgical device handle, or in an adapter to interface a specific type or model of surgical device and the generator 1100. In certain aspects, the first data circuit may comprise a non-volatile storage device, such as an electrically erasable programmable read-only memory (EEPROM) device. In certain respects and again with reference to Figure 17, the first data circuit interface 2040 can be implemented separately from the programmable logic device 2000 and comprises a suitable circuit (e.g. discrete logic devices, a processor) to enable communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 may be integral to the programmable logic device 2000.
[00199] [00199] In certain aspects, the first data circuit 2060 may 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 (e.g., programmable logic device 2000), transferred to a component of non-isolated stage 1540 (e.g., programmable logic device 1660, processor 1740 and/or processor 1900) for presentation to a user via an output device 2140 and/or for controlling a function or operation of generator 1100. Additionally, any type of information may be communicated to the first data circuit 2060 for storage thereon via first data circuit interface 2040 (e.g. 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.
[00200] [00200] — As discussed earlier, a surgical instrument may be removable from a handle (eg, instrument 1106 may be removable from handle 1107) to promote instrument interchangeability and/or disposability. In such cases, known generators may be limited in their ability to recognize specific instrument settings being used, as well as to optimize control and diagnostic processes as needed. Adding readable data circuitry 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 backwards compatible with generators lacking 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.
[00201] [00201] — Additionally, aspects of the 1100 generator may enable communication with instrument-based data circuits. For example, generator 1100 may be configured to communicate with a second data circuit (e.g., a data circuit) contained in an instrument (e.g., instrument 1104, 1106, or 1108) of a surgical device. 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 three-state digital interface, although other interfaces may also be used. In certain aspects, the second data circuit may generally be any circuit for transmitting and/or receiving data. In one aspect, for example, the second data circuit may store information related to the specific surgical instrument with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and/or any other types of information. Additionally or alternatively, any type of information may be communicated to the second data circuit for storage therein through the second data circuit interface 2100 (e.g., using programmable logic device 2000). This information may include, for example, an up-to-date number of operations in which the surgical instrument was used and/or the dates and/or times of its use. In certain aspects, the second data circuit may transmit data captured by one or more sensors (eg, an instrument-based temperature sensor). In certain aspects, the second data circuit may receive data from generator 1100 and provide an indication to the user (eg, an LED indication or other visible indication) based on the data received.
[00202] [00202] In certain aspects, the second data circuit and the second data circuit interface 2100 can be configured so that communication between the programmable logic device 2000 and the second data circuit can be effected without the need to provide control. additional conductors for this purpose (for example, dedicated conductors of a cable 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 one-wire bus communication scheme, implemented in existing wiring, as one of the conductors used transmitting interrogation signals. from the 2020 signal conditioning circuit to a control circuit in a cable. In this way, changes or modifications to the design of the surgical device that might otherwise be necessary are minimized or reduced. Furthermore, 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 the indispensable data read-out functionality, which therefore allows for surgical device instrument backward compatibility.
[00203] [00203] In certain respects, isolated stage 1520 may comprise at least one blocking capacitor 2960-1 (Figure 18C) connected to the trigger signal output 1600b, to prevent direct current passing 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, this type of failure can still have negative consequences. In one aspect, a second blocking capacitor 2960-2 can be placed in series with the blocking capacitor 2960-1, with one point leakage current between the blocking capacitors 2960-1 and 2960-2 being monitored by, for example, an ADC 2980 for sampling a voltage induced by the leakage current. Samples can be received by programmable logic device 2000, for example. Based on changes in leakage current (as indicated by the voltage samples in Figure 17 aspect), generator 1100 can determine when at least one of blocking capacitors 2960-1 and 2960-2 has failed. Consequently, the appearance of Figure 17 can provide a benefit over single-capacitor designs that have a single point of failure.
[00204] [00204] In certain respects, the unisolated stage 1540 may comprise a power supply 2110 to supply 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 for receiving output from the power supply to generate DC outputs at the voltages and currents required by the various components of the generator 1100. As discussed above with respect to the 1960 controller, one or more of the 2130 DC/DC voltage converters can receive an input from the 1960 controller when activation of the "on/off" input device 2150 by a user is detected by the 1960 controller, to allow the 2130 DC/DC voltage converters to run or wake up.
[00205] [00205] —Figures 19A and 19B illustrate certain functional and structural aspects of an aspect of generator 1100. Feedback indicating current and voltage output from secondary winding 1580 of power transformer 1560 is received by ADCs 1780 and 1800, respectively. As shown, the 1780 and 1800 ADCs can be implemented as a 2-channel ADC and can sample the feedback signals at a high speed (e.g. 80 Msps) to allow for oversampling (e.g. approx. 200x oversampling) of the trigger signals. Current and voltage feedback signals can be suitably conditioned in the analog domain (eg, amplified, filtered) prior to processing by the 1780 and 1800 ADCs. The current and voltage feedback samples from the 1780 and 1780 ADCs 1800 can be individually stored in a temporary memory ("buffer") and subsequently multiplexed or interleaved into a single data stream within block 2120 of programmable logic device 1660. In the aspect of Figures 19A and 19B, programmable logic device 1660 comprises an FPGA.
[00206] [00206] The multiplexed current and voltage feedback samples can be received by a data capture parallel port (PDAP) implemented inside the processor block 2144
[00207] [00207] Block 2200 of processor 1740 may implement a pre-warping algorithm to pre-warp or modify LUT samples stored in programmable logic device 1660 on a dynamic and continuous basis. As discussed above, pre-distortion of LUT samples can compensate for various sources of distortion present in the output drive circuit of generator 1100. Pre-distorted LUT samples, when processed through the drive circuit, will result, therefore, in a trigger signal having the desired waveform (eg sinusoidal) to optimally trigger the ultrasonic transducer.
[00208] [00208] “In block 2220 of the pre-distortion algorithm, the current through the motion branch of the ultrasonic transducer is determined. The motion branch current can be determined using Kirchoff's current law based, for example, on current and voltage feedback samples stored in memory location 2180 (which when properly sized, can be representative of of lg and Vg in the model of Figure 25 discussed above), a value of the static capacitance of the ultrasonic transducer Co (measured or known a priori) and a known value of the drive frequency. A motion branch current sample can be determined for each set of stored current and voltage feedback samples associated with a LUT sample.
[00209] [00209] In block 2240 of the pre-distortion algorithm, each motion branch current sample 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 shape of the current waveform can be supplied, for example, from a LUT 2260 of waveforms containing amplitude samples for one cycle of a desired shape of the waveform. of the current. The specific sample 2260 LUT current waveform shape used for the comparison can be determined by the LUT sample address associated with the motion branch current sample used in the comparison. Consequently, the motion branch current input in block 2240 can be synchronized with the input of its associated LUT sample address in block 2240. LUT samples stored in programmable logic 1660 and LUT samples stored in the LUT of 2260 waveform formats can therefore be equal in number. In certain aspects, the desired current waveform shape represented by the LUT samples stored in the 2260 waveform shape LUT may be a fundamental sine wave. Other waveform formats may be desirable. For example, it is contemplated that a fundamental sine wave could be used to drive the main longitudinal motion of an ultrasonic transducer, superimposed on one or more other drive signals at other frequencies, such as a third-order ultrasonic to drive at least two mechanical resonances in order to obtain beneficial vibrations in transverse or other modes.
[00210] [00210] 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 19A) along 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), the LUT 2280 (or other device control block programmable logic 1660) can pre-distort or modify the LUT sample value stored in the LUT address, so that the sample amplitude error is reduced or minimized. It should be understood that this pre-distortion or modification of each LUT sample iteratively over the LUT address range will cause the waveform shape of the generator output current to match or adapt to the current waveform. - desired shape of the current waveform, represented by the LUT 2260 samples of waveform formats.
[00211] [00211] Current and voltage amplitude measurements, power measurements, and impedance measurements can be determined in block 2300 of processor 1740, based on current and voltage feedback samples stored in memory location 2180. Prior to the determination of these quantities, the feedback samples can be suitably sized and, in certain respects, processed through a suitable 2320 filter to remove noise resulting from, for example, the data capture process and components. induced harmonics. The filtered voltage and current samples can therefore substantially represent the fundamental frequency of the generator drive output signal. In certain aspects, filter 2320 may be a finite impulse response (FIR) filter 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 certain aspects, the resulting frequency spectrum can be used to provide additional functionality to the generator. In one aspect, for example, the ratio between the second and/or third order harmonic component in relation to the fundamental frequency component can be used as a diagnostic indicator.
[00212] [00212] In block 2340 (Figure 19B), a root-mean-square (RMS) calculation can be applied to a sample size of current feedback samples representing an integral number of cycles of the trigger signal, to generate a lms measurement representing the drive signal output current.
[00213] [00213] In block 2360, a root-mean-square (RMS) calculation can be applied to a sample size of voltage feedback samples representing an integral number of cycles of the trigger signal, to determine a Vrms measurement representing the output voltage of the trigger signal.
[00214] [00214] 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 integral number of cycles of the trigger signal, to determine a measurement Pr; of the actual output power of the generator.
[00215] [00215] — In block 2400, the measurement P,a of the apparent output power of the generator can be determined by the product Vrms'lrms.
[00216] [00216] In block 2420, the load impedance magnitude Zm measurement can be determined as the quotient Vrms/lrms.
[00217] [00217] In certain respects, the quantities lrms, Vrms, Pr, Pa € Zm determined in blocks 2340, 2360, 2380, 2400 and 2420, can be used by generator 1100 to implement any of a number of control processes and/or diagnoses. In certain respects, any of these quantities may be communicated to a user through, for example, an output device 2140 integral to generator 1100, or an output device 2140 connected to generator 1100 via a suitable communication interface ( eg a USB interface). The various diagnostic processes may include, without limitation, cable integrity, instrument integrity,
[00218] [00218] Block 2440 of processor 1740 may implement a phase control algorithm for determining and phase controlling the impedance of an electrical load (eg, the ultrasonic transducer) driven by generator 1100. As discussed above, By controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and an impedance phase set point (e.g. 0°), harmonic distortion effects can be minimized or reduced. , increasing the accuracy of the phase measurement.
[00219] [00219] The phase control algorithm receives as input the current and voltage feedback samples stored in memory location 2180. Prior to their use in the phase control algorithm, the feedback samples can be properly sized and, in certain respects, processed through a suitable filter 2460 (which may be identical to the filter 2320) to remove noise resulting from the data capture process and induced harmonic components, for example. The filtered voltage and current samples can therefore substantially represent the fundamental frequency of the generator drive output signal.
[00220] [00220] In block 2480 of the phase control algorithm, the current through the motion branch of the ultrasonic transducer is determined. This determination may be identical to that described above in connection with block 2220 of the pre-distortion algorithm. Thus, the output of block 2480 may be, for each set of stored current and voltage feedback samples associated with a sample of the LUT, a current sample of the motion branch.
[00221] [00221] In block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized input of motion branch current samples determined in block 2480 and corresponding to voltage feedback samples. In certain respects, the phase of the impedance is determined as the average between the phase of the impedance measured at the rising edge of the waveforms and the phase of the impedance measured at the falling edge of the waveforms.
[00222] [00222] In block 2520 of the phase control algorithm, the impedance phase value determined in block 2220 is compared to the phase setpoint 2540 to determine a difference, or phase error, between the compared values.
[00223] [00223] In block 2560 (Figure 19A) 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 of the trigger signal. The frequency output value can be continuously adjusted by block 2560 and transferred to a DDS control block 2680 (discussed below) in order to keep the phase of the impedance determined in block 2500 at the phase set point (e.g., zero phase error). In certain respects, the impedance phase can be regulated to a phase set point of 0º. In this way, any harmonic distortion will be centered around the crest of the voltage waveform, enhancing the accuracy of the phase impedance determination.
[00224] [00224] Block 2580 of processor 1740 can implement an algorithm for modulating the current amplitude of the trigger signal in order to control the current, voltage and power of the trigger signal according to setpoints specified by the user, or in accordance with requirements specified by other processes or algorithms implemented by the generator 1100. Control of these quantities can be performed, for example, by scaling the LUT samples in the LUT 2280, and/or by adjusting of the full-scale output voltage of the DAC 1680 (which provides the input to the power amplifier 1620) via a DAC 1860. Block 2600 (which can be implemented as a PID controller in certain respects) can receive as input stream feedback samples (which can be appropriately sized and filtered) from memory location
[00225] [00225] In aspects where the drive signal voltage is the control variable, the current demand lg can be specified indirectly, for example, based on the current required to maintain a voltage setpoint value of 2620B (Vs ,) desired given the magnitude of load impedance Zm measured at block 2420 (eg, li=Vsp/Zm). Similarly, in aspects where the drive signal power is the control variable, the current demand la can be specified indirectly, for example, based on the current required to maintain a 2620C power setpoint ( Psp) desired given the voltage V;ms measured at block 2360 (eg li=PsplVrms).
[00226] [00226] Block 2680 (Figure 19A) can implement a DDS control algorithm to control the trigger signal by retrieving LUT samples stored in LUT 2280. In certain respects, the DDS control algorithm can being a numerically-controlled oscillator (NCO) algorithm for generating samples of a waveform at a fixed timing rate using a point-skipping technique (local in memory). The NCO algorithm can implement a phase accumulator, or frequency-to-phase converter, which functions as an address pointer for retrieving samples from the LUT 2280 LUT. In one aspect, the phase accumulator can be an accumulator. phase with step size D, modulo N, where D is a positive integer representing a frequency control value, and N is the number of samples from the LUT in the LUT
[00227] [00227] Block 2700 of the 1740 processor can implement a switch-mode converter control algorithm to dynamically modulate the rail voltage of the 1620 power amplifier based on the waveform envelope of the signal being amplified, thus improving the efficiency of the power amplifier 1620. In certain aspects, the characteristics of the waveform envelope can be determined by monitoring one or more signals contained in the power amplifier 1620. In one aspect, for example, the characteristics of the waveform envelope can be determined by monitoring the minimum of a drain voltage (eg, a MOSFET drain voltage) that is modulated according to the envelope of the amplified signal. A low voltage signal can be generated, for example, by a low voltage detector coupled to the drain voltage. The minimum voltage signal can be sampled by the ADC 1760, and the output minimum voltage samples are received in block 2720 of the switching mode converter control algorithm. Based on the values of the minimum voltage samples, block 2740 can control a PWM signal supplied by a PWM generator 2760 which, in turn, controls the rail voltage supplied to power amplifier 1620 by the mode regulator. 1700 switching. In certain respects, as long as the values of the minimum voltage samples are less than a target input for the 2780 minimum in block 2720, the voltage on the rail can be modulated according to the waveform envelope, as characterized by the minimum voltage samples. When minimum voltage samples indicate low envelope power levels, for example, block 2740 can cause a low rail voltage to be supplied to power amplifier 1620, with the total rail voltage being provided only when the minimum voltage samples indicate maximum envelope power levels. When the voltage samples from the minimum drop below the target to the minimum 2780, the 2740 block can cause the rail voltage to be kept at a suitable minimum value to ensure proper operation of the 1620 power amplifier.
[00228] [00228] In some respects, an electrical circuit may be used to drive both ultrasonic transducers and RF electrodes interchangeably. If these features are activated simultaneously, filter circuits can be provided to select the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned US Patent Application Publication No. US-2017-0086910-A1, titled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated in its entirety by reference.
[00229] [00229] Figure 20 is a schematic diagram of a control circuit 3200, like control circuit 3212, in accordance with at least one aspect of the present description. The 3200 control circuit is located inside a battery pack compartment. The battery pack is the power supply for a variety of 3215 local power supplies. The control circuit comprises a 3214 main processor coupled via a 3218 interface master to various downstream circuits via the outputs. SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C, for example. In one aspect, the 3218 interface master is a general-purpose serial interface, like an IPC serial interface. The 3214 main processor is also configured to drive 3224 switches via the 3220 General Purpose Input/Output (GPIO), a 3226 display (e.g., an LCD display), and various 3228 indicators via the 3222 GPIO. A 3216 surveillance processor is provided to control the main processor
[00230] [00230] The main processor 3214 comprises a memory for storing tables of drive signals or digitized waveforms that are transmitted to an electrical circuit that can be used to drive an ultrasonic transducer, for example. In other aspects, main processor 3214 may generate a digital waveform and transmit it to electrical circuit 2900 or may store the digital waveform for later transmission to electrical circuit 2900. Main processor 3214 may also provide RF triggering by via SCL-B/SDA-B output terminals and various sensors (e.g. Hall effect sensors, magneto-rheological fluid (MRF) sensors, etc.) via SCL-C/SDA-C output terminals . In one aspect, the 3214 main processor is configured to detect the presence of an ultrasonic drive circuit and/or RF drive circuit to enable proper software and user interface functionality.
[00231] [00231] In one aspect, the 3214 main processor may be an LM 4F230H5QR, available from Texas Instruments, for example. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core comprising an integrated 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz, a buffer of transfer to oti-
[00232] [00232] Battery-powered modular hand-held surgical instrument with multi-stage generator circuits
[00233] [00233] In another aspect, the present disclosure provides a battery-powered modular hand-held surgical instrument with multistage generator circuits. A surgical instrument is described that includes a battery pack, a grip assembly, and a drive shaft assembly, wherein the battery pack and drive shaft assembly are configured to mechanically and electrically connect the grip assembly. The battery pack includes a control circuit configured to generate a digital waveform. The grip assembly includes a first stage circuit configured to receive the digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform. The drive shaft assembly includes a second stage circuit coupled to the first stage circuit for receiving, amplifying and applying the analog waveform to a load.
[00234] [00234] In one aspect, the present description provides a surgical instrument, comprising: a battery pack, comprising a control circuit comprising a battery, a battery-coupled memory, and a battery-coupled memory processor, the processor being configured to generate a digital waveform; a handle assembly comprising a first stage circuit coupled to the processor, the first stage circuit comprising a digital-to-analog converter (DAC) and a first stage amplifier circuit, the DAC being configured to receiving the digital waveform and converting the digital waveform into an analog waveform, the first stage amplifier circuit being configured to receive and amplify the analog waveform; and a drive shaft assembly comprising a second stage circuit coupled to the first stage amplifier circuit for receiving the analog waveform, amplifying the analog waveform, and applying the analog waveform to a load; where the battery pack and drive shaft assembly are configured to connect mechanically and electrically to the grip assembly.
[00235] [00235] The load may comprise any one of an ultrasonic transducer, an electrode or a sensor, or any combinations thereof. The first stage circuit may comprise an ultrasonic driving first stage circuit and a high frequency current driving first stage circuit. The control circuit can be configured to drive the first stage ultrasonic drive circuit and the first stage high frequency current drive circuit independently or simultaneously. The first stage ultrasonic drive circuit can be configured to mate with a second stage circuit ultrasonic drive circuit. The second stage ultrasonic drive circuit can be configured to mate with an ultrasonic transducer. The first stage high frequency current driving stage circuit can be configured to mate with a second stage high frequency circuit. The second stage high frequency drive circuit can be configured to mate with an electrode.
[00236] [00236] The first stage circuit may comprise a sensor trigger first stage circuit. The first sensor trigger stage circuit can be configured to a second trigger stage circuit. The second sensor trigger stage circuit can be configured to mate with a sensor.
[00237] [00237] In another aspect, the present description provides a surgical instrument, comprising: a battery pack, which comprises a control circuit comprising a battery, a memory coupled to the battery, and a processor coupled to memory and battery, and the processor is configured to generate a digital waveform; a handle assembly comprising a first common-stage circuit coupled to the processor, the first common-stage circuit comprising a digital-to-analog converter (DAC) and a first common-stage amplifier circuit, the DAC being configured to receive the digital waveform and convert the digital waveform to an analog waveform, the first common-stage amplifier circuit being configured to receive and amplify the analog waveform; and a drive shaft assembly comprising a second stage circuit coupled to the first common stage amplifier circuit for receiving the analog waveform, amplifying the analog waveform, and applying the analog waveform to a load; where the battery pack and drive shaft assembly are configured to connect mechanically and electrically to the grip assembly.
[00238] [00238] The load may comprise any one of an ultrasonic transducer, an electrode or a sensor, or any combination thereof. The first common stage circuit can be configured to drive ultrasonic, high frequency circuits or sensors. The common first stage drive circuit can be configured to mate with a second stage ultrasonic drive circuit, a second stage high-frequency drive circuit, or a second stage sensor drive circuit. The second stage ultrasonic drive circuit can be configured to couple to an ultrasonic transducer, the second stage circuit of high frequency drive is configured to couple to an electrode, and the second stage circuit to drive a sensor is configured to mate with a sensor.
[00239] [00239] In another aspect, the present description provides a surgical instrument, which comprises: a control circuit that comprises a memory coupled to a processor, the processor being configured to generate a waveform digital; a grip assembly comprising a first common stage circuit coupled to the processor, the first common stage circuit configured to receive the digital waveform, convert the digital waveform to an analog waveform, and amplify the form analog waveform; and a drive shaft assembly comprising a second stage circuit coupled to the common first stage circuit for receiving and amplifying the analog waveform; where the drive shaft assembly is configured to connect mechanically and electrically to the grip assembly.
[00240] [00240] The common first stage circuit can be configured to drive ultrasonic, high frequency, or sensor circuits. The common first stage drive circuit can be configured to mate with an ultrasonic second stage drive circuit, a second high frequency drive stage circuit, or a second sensor drive stage circuit. The second stage ultrasonic drive circuit can be configured to couple to an ultrasonic transducer, the second stage high frequency drive circuit is configured to couple to an electrode, and the second stage drive circuit sensor is configured to mate with a sensor.
[00241] [00241] Figure 21 illustrates a generator circuit 3400 partitioned into a first stage circuit 3404 and a second stage circuit 3406, in accordance with at least one aspect of the present description. In one aspect, the surgical instruments of the surgical system 1000 described herein may comprise a generator circuit 3400 divided into multiple stages. For example, surgical instruments of surgical system 1000 may comprise generator circuit 3400 divided into at least two circuits: first stage 3404 circuit and second stage 3406 amplifier circuit allowing operation of RF power only, ultrasonic power only , and/or a combination of RF energy and ultrasonic energy. A combination 3414 modular drive shaft assembly will be powered by the 3404 first common stage circuit located in a 3412 grip assembly and the 3406 modular second stage circuit integral with the 3414 modular drive shaft assembly. previously discussed in this description in connection with the surgical instruments of the surgical system 1000, a battery pack 3410 and drive shaft assembly 3414 are configured to mechanically and electrically connect to the handle assembly 3412. The End Actuator Assembly is configured to mechanically and electrically connect to the 3414 drive shaft assembly.
[00242] [00242] — Now referring to Figure 21, the generator circuit 3400 is divided into multiple stages located in multiple modular assemblies of a surgical instrument, such as the surgical instruments of the surgical system 1000 described herein. In one aspect, a stage control circuit 3402 may be located in the battery pack 3410 of the surgical instrument. The 3402 stage control circuit is a 3200 control circuit as described in connection with Figure 20. The 3200 control circuit comprises a 3214 processor, which includes an internal memory 3217 (Figure 21) (e.g., volatile and non-volatile memory). volatile), and is electrically coupled to a battery
[00243] [00243] The first 3404 stage circuits (e.g., the 3420 ultrasonic first stage trigger circuit, the 3422 RF first stage trigger circuit, and the 3424 first sensor trigger stage circuit) are located in a 3412 surgical instrument handle assembly. The 3200 control circuit supplies the RF trigger signal to the 3422 first stage RF trigger circuit through the SCL-B, SDA-B outputs of the 3200 control circuit. The first RF trigger stage circuit 3422 is described in detail in connection with Figure 23. The 3200 control circuit supplies the sensor trigger signal to the 3424 sensor trigger stage first circuit through the SCL-C, SDA-C outputs of the 3200 control circuit. In general, each of the 3404 first stage circuits includes a digital-to-analog converter (DAC) and a first stage amplifier section to drive the 3406 second stage circuits. The outputs of the 3404 first stage circuits are provided. to the inputs of the second stage 3406 circuits.
[00244] [00244] The 3200 control circuit is configured to detect which modules are plugged into the 3200 control circuit. For example, the 3200 control circuit is configured to detect whether the 3420 ultrasonic drive first stage circuit, the first circuit 3422 RF drive stage, or the 3424 first stage sensor drive circuit located in the 3412 grip assembly is connected to the 3410 battery pack. Likewise, each of the 3404 first stage circuits can detecting which second stage 3406 circuits are connected thereto and what information is fed back to the control circuit 3200 to determine what type of signal waveform to generate. Similarly, each of the 3406 second stage circuits can detect which 3408 third stage circuits or components are connected to it and what information is fed back to the 3200 control circuit to determine what kind of form of signal wave generate.
[00245] [00245] In one aspect, the 3406 second stage circuits (e.g., the 3430 ultrasonic trigger stage second circuit, the 3432 RF trigger stage second circuit, and the 3434 sensor trigger stage second circuit) are located on the surgical instrument drive shaft assembly 3414. The 3420 ultrasonic drive first stage circuit provides a signal to the 3430 ultrasonic drive second stage circuit via US-Left/US-Direct outputs. In addition to a transformer, the 3430 ultrasonic drive second stage circuit can also include filter, amplifier, and signal conditioning circuits. The 3422 high frequency current (RF) first stage drive circuit provides a signal to the 3432 RF second stage drive circuit via the RF-Left/RF-Right outputs. In addition to a transformer and blocking capacitors, the 3432 RF trigger second stage circuit may also include filter, amplifier, and signal conditioning circuits. The 3424 sensor trigger stage first circuit provides a signal to the 3434 sensor trigger stage second circuit via sensor-1/sensor-2 outputs. The second 3434 sensor trigger stage circuit may include filter, amplifier, and signal conditioning circuits depending on the sensor type. The outputs of the second stage 3406 circuits are supplied to the inputs of the third stage 3408 circuits.
[00246] [00246] In one aspect, third stage circuits 3408 (e.g., ultrasonic transducer 1120, RF electrodes 3074a, 3074b, and sensors 3440) may be located in various assemblies 3416 of the surgical instruments. In one aspect, the 3430 ultrasonic drive second stage circuit provides a drive signal to the piezoelectric stack of the 1120 ultrasonic transducer. In one aspect, the 1120 ultrasonic transducer is located in the ultrasonic transducer assembly of the surgical instrument. In other respects, however, the 1120 ultrasonic transducer may be located on the 3412 grip assembly, 3414 drive shaft assembly, or end actuator. In one aspect, the 3432 RF trigger second stage circuit provides a trigger signal to the RF electrodes 3074a, 3074b, which are generally located on the end actuator portion of the surgical instrument. In one aspect, the second sensor trigger stage circuit 3434 provides a trigger signal to various sensors 3440 located on the surgical instrument.
[00247] [00247] Figure 22 illustrates a multistage partitioned generator circuit 3500, wherein a first stage circuit 3504 is common to the second stage circuit 3506, in accordance with at least one aspect of the present description. In one aspect, the surgical instruments of the surgical system 1000 described herein may comprise generator circuit 3500 divided into multiple stages. For example, the surgical instruments of the surgical system 1000 may comprise the generator circuit 3500 divided into at least two circuits: the first stage 3504 circuit and the second stage 3506 amplifier circuit allowing high frequency power operation. RF only, ultrasonic energy only, and/or a combination of RF energy and ultrasonic energy. A combination 3514 modular drive shaft assembly will be powered by the 3504 common stage first circuit located in a 3512 grip assembly and the 3506 modular second stage circuit integral with the 3514 modular drive shaft assembly. previously discussed in this description in connection with the 1000 Surgical System Surgical Instruments, a 3510 Battery Pack and 3514 Drive Shaft Assembly are configured to connect mechanically and electrically to the 3512 Handle Assembly. end actuator is configured to mechanically and electrically connect to the 3514 drive shaft assembly.
[00248] [00248] “As shown in the example of Figure 22, the battery pack portion 3510 of the surgical instrument comprises a first control circuit 3502, which includes the control circuit 3200 previously described. The grip assembly 3512, which connects to the battery pack 3510, comprises a common first stage drive circuit 3420. As previously discussed, the first stage drive circuit 3420 is configured to drive the ultrasonic current of high frequency (RF), and sensor loads. The output of the 3420 common drive first stage circuit can drive any of the 3506 second stage circuits such as the 3430 ultrasonic drive second stage circuit, the 3432 high frequency current (RF) drive second stage circuit , and/or the second sensor trigger stage circuit
[00249] [00249] Figure 23 is a schematic diagram of an aspect of an electrical circuit 3600 configured to drive a high frequency (RF) current, in accordance with at least one aspect of the present description. The 3600 electrical circuit comprises an analog multiplexer
[00250] [00250] A 3686 drive circuit provides left and right RF power outputs. A digital signal representing the signal waveform is supplied to the SCL-A, SDA-A inputs of the 2980 analog multiplexer from a control circuit such as the 3200 control circuit (Figure 20). A 3690 digital-to-analog converter (DAC) converts the digital input to an analog output to generate a 3692 pulse-width modulation circuit coupled to an oscillator
[00251] [00251] Figure 24 is a schematic diagram of the transformer 3700 coupled to the electrical circuit 3600 shown in Figure 23, in accordance with at least one aspect of the present description. The RF+/RF input terminals (primary winding) of the 3700 transformer are electrically coupled to the left RF/RF output terminals of the 3600 electrical circuit. One side of the secondary winding is coupled in series to the first and second voltage capacitors. lock 3706,
[00252] [00252] Figure 25 is a schematic diagram of a 3800 circuit comprising separate power sources for high power drive/power circuits and low power circuits, in accordance with at least one aspect of the present disclosure. The 3812 power supply includes a primary battery comprising first and second primary batteries 3815, 3817 (e.g. Li-ion batteries) which are connected to circuit 3800 by a switch 3818 and a secondary battery comprising a 3820 secondary battery that is connected to the circuit by a 3823 switch when the 3812 power supply is inserted into the battery pack. The 3820 secondary battery is a fall arrest battery that has components resistant to sterilization by gamma radiation or other radiation. For example, a 3827 switching power supply and an optional charging circuit within the battery pack can be incorporated to allow the 3820 secondary battery to reduce the voltage drop of the 3815, 3817 primary batteries. fully loaded at the start of surgery that are easy to introduce into the sterile field. The 3815, 3817 primary batteries can be used to power the 3826 engine control circuits and 3832 power circuits directly. The 3826 motor control circuits are
[00253] [00253] Additionally, a gamma radiation exposure load circuit can be provided that includes a 3827 switching power supply utilizing diodes and vacuum tube components to minimize voltage drop to a predetermined level. With the inclusion of a minimum voltage drop which is a division of the NiMH voltages (3 NiMH cells), the 3827 switching power supply could be eliminated. Additionally, a modular system can be provided in which the radiation-hardened components are situated in a module, making the module sterilizable by radiation sterilization. Other non-radiation hardened components may be included in other modular components and connections made between the modular components so that the component operates together as if the components were situated together on the same circuit board. If only two NIMH cells are desired, the 3827 switching power supply based on diodes and vacuum tubes enables sterilizable electronic circuitry within the disposable primary battery.
[00254] [00254] Referring now to Figure 26 , there is shown a control circuit 3900 for operating a battery powered RF generator circuit 3901 for use with a surgical instrument 3902, in accordance with at least one aspect of the present disclosure. The surgical instrument is configured to use both ultrasonic vibration and high frequency current to perform surgical coagulation/cut treatments on living tissue, and uses high frequency current to perform surgical coagulation treatment on living tissue.
[00255] [00255] Figure 26 illustrates the 3900 control circuit that allows a dual generator system to switch between the 3902 RF generator circuit and 3920 ultrasonic generator circuit power modes for a surgical instrument of the 1000 surgical system. In effect, a threshold current in an RF signal is detected. When tissue impedance is low, the high frequency current through tissue is high when RF energy is used as the source for tissue treatment. In at least one aspect, a visual indicator 3912 or light on the surgical instrument of the surgical system 1000 may be configured to be in an on state during this period of high current. When the current drops below a threshold, the 3912 visual indicator enters an off state. Consequently, a 3914 phototransistor can be configured to detect the transition from an on state to an off state and deactivate RF energy, as shown in the 3900 control circuit of Figure 26. Therefore, when the power button is released and a 3926 power switch is opened, the 3900 control circuit is reset, and both the 3902, 3920 RF and ultrasonic generator circuits are kept off.
[00256] [00256] Referring to Figure 26, in one aspect, a method of managing a 3902 RF generator circuit and a 3920 ultrasound generator circuit is provided. The 3902 RF generator circuit and/or the 3920 ultrasound generator circuit they may be located on the 1109 handle assembly, 1120 ultrasonic transducer/RF generator assembly, 1120 battery pack, 1129 drive shaft assembly, and/or mouthpiece, of the 1108 multifunctional electrosurgical instrument, for example. The 3900 control circuit is maintained in a reset state if the 3926 power switch is off (eg, open). Thus, when the 3926 power switch is open, the 3900 control circuit is reset and both the 3902, 3920 RF and ultrasonic generator circuits are turned off. When the 3926 power switch is pressed and the 3926 power switch is engaged (e.g. closed), RF energy is delivered to the tissue and the 3912 visual indicator operated by a 3904 current-sensing boost transformer will turn off. lit while tissue impedance is low. The 3912 visual indicator light provides a logic signal to keep the 3920 ultrasonic generator circuit in the off state. When tissue impedance increases beyond a threshold and the HF current through tissue drops below a threshold, the 3912 visual indicator turns off and the light switches to an off state. A logic signal generated by this transition turns off the 3908 relay, whereby the 3902 RF generator circuit is turned off and the 3920 ultrasonic generator circuit is turned on, to complete the clot and cut cycle.
[00257] [00257] — Still referring to Figure 26, in one aspect, the dual generator circuit configuration employs the built-in 3902 RF generator circuit, which is powered by the 3901 battery, for one mode, and a second RF generator circuit. built-in 3920 ultrasound, which may be built into the 1109 handle assembly, battery pack, 1129 drive shaft assembly, mouthpiece, and/or 1120 ultrasonic transducer/RF generator assembly of the multifunctional electrosurgical instrument 1108, for example. The 3920 ultrasonic generator circuit is also operated by the 3901 battery. In various aspects, the 3902 RF generator circuit and the 3920 ultrasonic generator circuit can be an integrated or separable component of the 1109 handle assembly. , having the 3902, 3920 dual RF/ultrasonic generator circuits as part of the 1109 grip assembly can eliminate the need for complicated wiring. The 3902, 3920 RF/ultrasonic generator circuits can be configured to provide the full capabilities of an existing generator while simultaneously utilizing the capabilities of a wireless generator system.
[00258] [00258] “Any type of system can have separate controls for modalities that are not communicating with each other. The surgeon activates RF and ultrasonic energy separately and at his discretion. Another approach would be to provide fully integrated communication schemes that share buttons, tissue states, instrument operating parameters (such as clamping system, forces, etc.) and algorithms for managing tissue treatment. Various combinations of this integration can be implemented to provide the proper level of functioning and performance.
[00259] [00259] — As discussed above, in one aspect, the control circuit 3900 includes an RF generator circuit 3902 powered by the battery 3901 which comprises a battery as a power source. As shown, the RF generator circuit 3902 is coupled to two electrically conductive surfaces here called electrodes 3906a, 3906b (i.e., active electrode 3906a and return electrode 3906b) and is configured to drive electrodes 3906a, 3906b with RF energy. (eg high frequency current). A first transformer winding 3910a
[00260] [00260] A 3905 visual indicator circuit comprises the 3904 step-up transformer, a series resistor R2 and a visual indicator
[00261] [00261] In operation, when switch contact 3909 of relay 3908 is open, the active electrode 3906a is disconnected from the positive pole of the bipolar RF generator circuit 3902 and no current flows through the tissue, the return electrode 3906b and the first winding 3910a of step-up transformer 3904. Consequently,
[00262] [00262] A first current flows through the first winding 3910a as a function of the tissue impedance located between the active and return electrodes 3906a, 3906b providing a first voltage through the first winding 3910a of the step-up transformer 3904. A second high voltage is induced through the second winding 3910b of the step-up transformer 3904. The secondary voltage appears across resistor R2 and energizes the visual indicator 3912, causing the neon lamp to light up when the current through the tissue is greater than one predetermined limit. It will be recognized that the circuit and component values are illustrative and not limited thereto. When the 3909 switch contact of the 3908 relay is closed, current flows through the tissue and the 3912 visual indicator is on.
[00263] [00263] Referring now to the 3926 power switch portion of the 3900 control circuit, when the 3926 power switch is in the open position, high logic is applied to the input of a first 3928 inverter and low logic is applied to one of the two inputs of AND gate 3932. Thus, the output of AND gate 3932 is low and a transistor 3934 is turned off to prevent current from flowing through the winding of electromagnet 3936. With electromagnet 3936 in the de-energized state, the switch contact 3909 of relay 3908 remains open and prevents current from flowing through electrodes 3906a, 3906b. The logic low output of the first inverter 3928 is also applied to a second inverter 3930, causing the output to increase and resetting a "flip-flop" 3918 (eg, a "flip-flop" of type D). At this time, the Q output goes low to turn off the 3920 ultrasound generator circuit and the Q output goes high and is applied to the other input of the AND gate 3932.
[00264] [00264] When the user presses the 3926 power switch on the instrument handle to apply power to the tissue between the 3906a, 3906b electrodes, the 3926 power switch closes and applies a low logic to the input of the first inverter 3928 , which applies high logic to the other input of AND gate 3932 causing the output of AND gate 3932 to increase and turn on transistor 3934. In the on state, transistor 3934 conducts and reduces current through the winding of electromagnet 3936 to energize the electromagnet 3936 and close switch contact 3909 of relay 3908. As discussed above, when switch contact 3909 is closed, current can flow through electrodes 3906a, 3906b and first winding 3910a of lift transformer 3904 when tissue is located between electrodes 3906a, 3906b.
[00265] [00265] — As discussed above, the magnitude of current flowing through electrodes 3906a, 3906b depends on the impedance of the tissue situated between electrodes 3906a, 3906b. Initially, the tissue impedance is low and the magnitude of the current is high through the tissue and the first winding 3910a. Consequently, a voltage applied to the second winding 3910b is high enough to turn on visual indicator 3912. The light emitted by visual indicator 3912 turns on phototransistor 3914, which reduces the input of a 3916 inverter and causes the output of the inverter 3916 increase. A high input applied to the CLK of the 3918 flip-flop has no effect on the Q or the Q outputs of the 3918 flip-flop, and the Q output remains high. Consequently, while the 3912 visual indicator remains energized, the 3920 ultrasound generator circuit is turned off and the 3922 ultrasonic transducer and 3924 ultrasonic blade of the multifunctional electrosurgical instrument are not activated.
[00266] [00266] As the tissue between the electrodes 3906a, 3906b dries due to the heat generated by the current flowing through the tissue, the tissue impedance increases and the current through it decreases. When the current through the first winding 3910a decreases, a voltage across the second winding 3910b also decreases, and when a voltage drops below a minimum threshold required to operate the visual indicator 3912, the visual indicator 3912 and the phototransistor 3914 turns off. When the 3914 phototransistor turns off, high logic is applied to the input of the 3916 inverter and low logic is applied to the CLK input of the 3918 flip-flop to register high logic to output Q and logic low to output Q. The high output Q turns on the 3920 ultrasound generator circuit to activate the 3922 ultrasonic transducer and the 3924 ultrasonic blade to start cutting the tissue located between the 3906a, 3906a electrodes. Simultaneously or almost simultaneously with the ultrasound generator circuit 3920 turning on, the Q output of the flip-flop 3918 passes the logic low state and causes the output of the AND gate 3932 to go to the logic low state and turns off transistor 3934 , thereby de-energizing electromagnet 3936 and opening key contact 3909 of relay 3908 to cut off current flow through electrodes 3906a, 3906b.
[00267] [00267] While switch contact 3909 of relay 3908 is open, no current flows through electrodes 3906a, 3906b, fabric, and first winding 3910a of step-up transformer
[00268] [00268] The state of the Q and Q outputs of the 3918 flip-flop remains the same while the user presses the 3926 power switch on the instrument handle to keep the 3926 power switch closed.
[00269] [00269] In one aspect, the ultrasonic generator or the high frequency current generator of the surgical instrument 1000 can be configured to generate the electrical signal waveform digitally as desired using a predetermined number of points of phase stored in a lookup table to digitize the waveform format. Phase points can be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. Figure 27 illustrates an aspect of a fundamental architecture for a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit 4100, 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 the 4104 lookup table, which in turn provides variable digital input values to a 4108 DAC circuit that powers a power amplifier. Addresses can be scanned according to a frequency of interest. Using such a 4104 lookup table makes it possible to generate various types of waveforms that can be fed into tissue or to a transducer, an RF electrode, multiple transducers simultaneously, or a combination of ultrasonic instruments. and RF. In addition, multiple lookup tables 4104 representing multiple waveforms can be created, stored, and applied to tissue from one generator.
[00270] [00270] 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 may be configured to drive at least two modes of vibration of an ultrasonic transducer of at least one surgical instrument. In this way, the generator can be configured to provide 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. . Additionally, the waveform signal supplied to the two surgical instruments may comprise two or more waveforms. The table may comprise information associated with a plurality of waveforms and the table may be stored within the generator. In one aspect or example, the table may be a direct digital synthesis table, which may be stored on an FPGA of the generator. The table can be addressed in any way that is convenient for categorizing waveforms. According to one aspect, the table, which can be a digital direct synthesis table, is addressed according to a frequency of the waveform signal.
[00271] [00271] The analog electrical signal waveform may 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 (e.g. 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 drive at least two modes of vibration of an ultrasonic transducer of at least one surgical instrument. In this way, the generator circuit can be configured to supply 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 waveforms stored in lookup table 4104. Additionally, the analog electrical signal waveform supplied to the at least two surgical instruments may comprise two or more waveforms. Look-up table 4104 may comprise information associated with a plurality of waveforms, and look-up table 4104 may be stored in the generator circuit or in the surgical instrument. In one aspect or example, lookup table 4104 may be a direct digital synthesis table, which may be stored on an FPGA of the generator circuit or the surgical instrument. Lookup table 4104 can be addressed in any way that is convenient for categorizing waveforms. According to one aspect, lookup table 4104, which may be a direct digital synthesis table, is addressed according to a desired analog electrical signal waveform frequency. Additionally, information associated with the plurality of waveforms can be stored as digital information in the lookup table.
[00272] [00272] With 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 27. In this simplified block diagram, a DDS circuit is coupled to a processor, controller, or logic device in the generator circuit and to a memory circuit located in the generator circuit of surgical system 1000. The DDS circuit 4100 comprises an address counter 4102, a lookup table 4104, a register 4106, a DAC circuit 4108 and a filter 4112. A stable clock! fc. is received by address counter 4102 and register 4106 drives a programmable read-only memory (PROM) that stores one or more whole numbers of cycles of a sine wave (or other arbitrary waveform) in a lookup table 4104 As address counter 4102 cycles through memory locations, the values stored in lookup table 4104 are written to register 4106, which is coupled to DAC circuit 4108. The corresponding digital amplitude of the signal at the memory location from the lookup table 4104 drives the DAC circuit 4108, which in turn generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The phase noise is basically the of the reference clock f.. 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. ador having an output coupled to the output of the generator circuit. The second analog output signal has a frequency of fout.
[00273] [00273] As the DDS 4100 circuit is a sampled data system, problems involved in sampling need to be considered:
[00274] [00274] The DDS circuit 4100 may comprise multiple look-up tables 4104, the look-up table 4104 storing a waveform represented by a predetermined number of samples, the samples defining 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 surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and signal waveforms electrical devices that promote efficient touch-up coagulation. In one aspect, the DDS 4100 circuit can create multiple 4104 and waveform lookup tables during a tissue treatment procedure (e.g., simultaneously or in virtual real-time based on user or sensor actions) switch between different waveforms stored in separate 4104 lookup tables based on desired tissue effect and/or tissue feedback. Therefore, switching between waveforms can be based on tissue impedance and other factors, for example. In other respects, lookup tables 4104 can
[00275] [00275] A more flexible and efficient implementation of the DDS 4100 circuit employs a digital circuit called a Numerically Controlled Oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit, such as a DDS 4200 circuit, is shown in Figure 28. In this simplified block diagram, a DDS 4200 circuit is coupled to a processor, controller, or logic device in the generator and to a memory circuit located in the generator or in any of the surgical instruments of the surgical system 1000. The DDS circuit 4200 comprises a load register 4202, a parallel delta phase register 4204, an adder circuit 4216, a 4208 phase register, a 4210 lookup table (phase-to-amplitude converter), a 4212 DAC circuit, and a filter
[00276] [00276] The DDS circuit 4200 includes a sample clock that generates the clock frequency fc, the phase accumulator 4206, and the look-up table 4210 (eg, phase to amplitude converter). The contents of the 4206 phase accumulator are updated once per fc clock cycle. When phase accumulator 4206 is updated, the digital number, M, stored in delta phase register 4204 is added to the number in phase register 4208 by an adder circuit 4216. Assuming the number in parallel delta phase register 4204 is 00 ...01 and that the initial content of phase accumulator 4206 is 00...00. Phase accumulator 4206 is updated by 00...01 per clock cycle. If the 4206 phase accumulator is 32 bits wide, it takes 232 clock cycles (over 4 billion) before the 4206 phase accumulator returns to 00...00, and the cycle repeats.
[00277] [00277] A truncated output 4218 of phase accumulator 4206 is supplied to a look-up table of phase to amplitude converter 4210 and the output of look-up table 4210 is coupled to a DAC circuit
[00278] [00278] In one aspect, the electrical signal waveform can be digitized into 1024 (210) phase points, although the waveform can be digitized into 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 electrical signal waveform can be expressed as An(8n), where a normalized amplitude Ar at a point n represented by a phase angle 8, is called the phase point at point n. The number of distinct n-phase points determines the tuning resolution of the DDS 4200 circuit (as well as the DDS 4100 circuit shown in Figure 21).
[00279] [00279] Table 1 specifies the electrical signal waveform digitized at a number of phase points. Example 1 | the | the |
[00280] [00280] Generator circuit algorithms and digital controls can scan addresses in lookup table 4210, which in return provides variable digital input values to the 4212 DAC circuit that powers the 4214 filter and power amplifier. Addresses can be scanned according to a frequency of interest. The use of the lookup table makes it possible to generate several types of formats that can be converted into an analog output signal by the DAC circuit 4212 filtered by the filter 4214, amplified by the power amplifier coupled to the output of the generator circuit and supplied to the tissue in the form of RF energy or delivered to an ultrasonic transducer and applied to tissue in the form of ultrasonic vibrations that deliver 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 tissue from a generator circuit.
[00281] [00281] Again with reference to Figure 21, paran=32e M=1, phase accumulator 4206 passes through 232 possible outputs before overflowing and resetting. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M=2, then the 1708 phase register "runs" twice as fast, and the output frequency is doubled. This can be generalized as follows.
[00282] [00282] “For a 4206 phase accumulator configured to accumulate n bits (generally, n is in the range 24 to 32 on most DDS systems, but as previously discussed, n cannot be selected from a wide range of options), there are 2" possible phase points. The digital word in the delta phase register M represents the amount of phase buildup that is incremented per clock cycle. If f. is the clock frequency, then the frequency of the output sine wave is equal to: h= TF
[00283] [00283] The above equation is known as the "tuning equation" of DDS. It is observed that the frequency resolution of the system is equal to &. For n = 2, the resolution is greater than one part in four billion. In one aspect of the 4200 DDS system, not all bits outside the 4206 phase accumulator are passed to the 4210 lookup table, 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 frequency resolution. Phase truncation only adds a small but acceptable amount of phase noise to the final output.
[00284] [00284] —The electrical signal waveform can be characterized by current, voltage or power at a given frequency. Additionally, when any of the surgical instruments of the surgical system 1000 comprises ultrasonic components, the electrical signal waveform can be configured to drive at least two modes of vibration of an ultrasonic transducer of at least one surgical instrument. In this way, the generator circuit can be configured to provide an electrical signal waveform to at least one instrument.
[00285] [00285] In one aspect, the generator circuit may be configured to provide electrical signal waveforms to at least two surgical instruments simultaneously. The generator circuit may also be configured to provide the electrical signal waveform, which may be characterized by two or more waveforms, through an output channel of the generator circuit to the two surgical instruments simultaneously.
[00286] [00286] — Additionally, a method of 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 of the surgical system 1000, wherein generating the electrical signal waveform comprises receiving information associated with the electrical signal waveform from a memory. The generated electrical signal waveform comprises at least one waveform. Furthermore, providing the generated electrical signal waveform to at least one surgical instrument comprises providing the electrical signal waveform to at least two surgical instruments simultaneously.
[00287] [00287] The generator circuit as described here can allow the generation of various types of direct digital synthesis tables. Examples of waveforms for RF/electrosurgical signals suitable for treating a variety of tissues generated by the generator circuit include RF signals with a high crest factor (which can be used for surface coagulation in RF mode), RF signals of low crest (which can be used for deeper tissue penetration) and waveforms that promote efficient touch-up coagulation. The generator circuit can also generate multiple waveforms employing a 4210 digital direct synthesis lookup table and, in real time, can switch between specific waveforms based on the desired tissue effect. Alternation may be based on tissue impedance and/or other factors.
[00288] [00288] In addition to traditional sine/cosine waveforms, the generator circuit can be configured to generate waveform(s) that maximize(s) tissue power per cycle (e.g. trapezoidal or square wave). ). The generator circuit can provide waveforms that are synchronized to maximize the power delivered to the load by simultaneously driving RF and ultrasonic signals and maintain the ultrasonic frequency lock, as long as the generator circuit includes a circuit topology. that allows the 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 instrument EEPROM and can be retrieved by connecting any of the system's surgical instruments. 1000 to the generator circuit.
[00289] [00289] The DDS circuit 4200 can comprise multiple look-up tables 4104, with the look-up table 4210 storing a waveform represented by a predetermined number of phase points (also called samples), with the phase points defining a predetermined waveform shape. 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 configurations or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and signal waveforms that promote efficient touch-up coagulation. In one aspect, the DDS 4200 circuit can create multiple
[00290] [00290] Figure 29 illustrates a cycle of a discrete-time electrical signal digital waveform 4300, in accordance with at least one aspect of the present description, of an analog waveform 4304 (shown superimposed on the digital waveform of distinct time electrical signal 4300 for comparison purposes). The horizontal axis represents Time (t) and the vertical axis represents the digital phase points.
[00291] [00291] — As noted above, in some surgical procedures, a medical professional may employ an electrosurgical device to seal or cut tissue such as blood vessels. Such devices perform medical therapy by passing electrical energy, for example, a radiofrequency (RF) current, through the tissue to be treated. Some electrosurgical devices are called bipolar devices because they contain an electrode to deliver electrical energy (the active electrode) and a return electrode housed in the same surgical probe. It will be recognized that a surgical probe may comprise a robotically controlled handle or instrument, or a combination thereof.
[00292] [00292] Alternative devices may be called monopolar devices. In such devices, only the active electrode is housed in the surgical probe. The electrical current that enters the patient's tissue can return to the electrical energy generator through an electrical path through the stretcher on which the patient rests, or through a specific return electrode pad. In some aspects, the patient may rest on the electrode pad, or the electrode pad may be placed on the patient at a location close to the surgical site where the surgical probe is positioned. It can be recognized that the current path through a patient undergoing a procedure using a monopolar device may be less well characterized than the current path through a patient undergoing a procedure using the use of a bipolar device. Consequently, a
[00293] [00293] It is therefore desirable for a monopolar electrosurgical device to incorporate features to determine if the device is close enough to excitable tissue to cause unintentional injury. Such features can be used by one or more subsystems of the electrosurgical device as a basis for notifying the medical professional of the proximity of such tissue to the monopolar lead. Additionally, such features can be used by one or more subsystems of an intelligent electrosurgical device to reduce or eliminate the amount of therapeutic energy applied to tissue considered too close to non-target excitable tissue. In some smart medical devices that combine electrosurgical (RF) modes with ultrasonic therapy, the capabilities to determine if the device is close enough to excitable tissue to cause unintentional injury when the device is operating in electrosurgical (RF) mode may result in the device switching to ultrasonic mode.
[00294] [00294] 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 typically includes a surgical probe, an instrument with a distally mounted end actuator (eg, one or more electrodes). The end actuator can be positioned against the tissue so that the electrical current is introduced into the tissue. Electrosurgical devices can be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into the tissue and returned from it by the active and return electrodes, respectively, of the end actuator. During monopolar operation, a current is introduced into the tissue by an active electrode located at a distal end of the surgical probe and returned through a return electrode (eg, a grounding plate) located separately 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 thus can be particularly useful for cauterizing blood vessels, for example. The end actuator of an electrosurgical device sometimes also comprises a cutting member that is movable with respect to tissue and electrodes to transection the tissue.
[00295] [00295] Figure 30 shows a typical 136000 monopolar electrosurgical system. The 136000 electrosurgical system may include a 136010 controller, a 136012 generator, a 136015 electrosurgical instrument, and a 136020 return pad that includes one or more return electrodes . Typically, generator 136012 may provide an electrical signal to electrosurgical instrument 136015 along a first conductive electrical path 136017 and may receive a feedback signal from one or more return electrodes along a second conductive electrical path 136023 Figure 30 shows an example of a 136025 healthcare professional treating a 136027 patient using a 136015 electrosurgical instrument as a monopolar active electrode.
[00296] [00296] Figure 316 is a schematic block diagram of the patient and electrical components shown in Figure 30. The 136012 generator may be a separate component of the 136010 controller, or the 136010 controller may include the 136012 electrical generator. control the operation of the 136012 generator, including controlling an electrical output of the generator. As described below, the controller
[00297] [00297] Electrical energy can be supplied by the electrical generator 136012 and received by a surgical instrument 136015 as a monopolar active electrode. In some respects, the active electrode may be in electrical communication with an electrical source terminal of the 136012 electrical generator to receive electrical power. In some aspects, the surgical instrument 136015 may receive an electrical signal along a first conductive electrical path 136017 such as wire or other cabling.
[00298] [00298] “During the procedure, patient 136027 may lie supine on a return block 136020. The return block
[00299] [00299] In some aspects, the 136012 generator can supply alternating current at radio frequency levels to the 136015 electrosurgical instrument. In some alternative aspects, the 136015 electrosurgical instrument may also incorporate features for ultrasonic therapeutic modes, and the 136012 generator can also be configured to generate power to drive one or more ultrasonic therapeutic components. The 136015 electrosurgical instrument, which typically includes an electrode tip (i.e., an active electrode) that can be positioned on a target tissue of a 136027 patient, receives the alternating current from the 136012 generator and supplies the alternating current. - connected to the target tissue through the electrode tip. The alternating current received by the electrode tip can be supplied by the generator 136012 through a first conductive electrical path 136017. The alternating current is received in the target tissue, and the tissue resistance creates heat that provides the desired effect ( e.g. sealing and/or cutting) at the surgical site. The alternating current received at the target tissue is conducted through the patient's body and is finally received by one or more return electrodes of the return block 136020. The alternating current received by the return block 136020 can be conducted from returns to the generator through a second electrically conductive path 136023 to complete the closed path followed by the alternating current. The one or more return electrodes are configured to carry the amount of current introduced by the electrode tip. Return block 136020 can be attached to the patient's body or can be separated by a small distance from the patient's body (ie capacitive coupling). The alternating current received by the one or more return electrodes is passed back to the 136012 generator to complete the closed path followed by the alternating current.
[00300] [00300] For a 136000 electrosurgical system that uses capacitive coupling to complete the current path between the patient's body and the return electrode, the patient's body effectively acts as a capacitive first plate of a capacitor, and the return electrode block effectively acts as a second capacitive plate of a capacitor.
[00301] [00301] In some aspects, the return block 136020 may include a single return electrode that incorporates an array of multiple detection devices. In some alternative aspects, the return block 136020 may include an array of return electrodes, whereby an array of detection devices may be incorporated into the array of return electrodes. In a non-limiting example, the return block 136020 may include multiple return electrodes, each of the return electrodes including a sensing device.
[00302] [00302] By incorporating an array of sensing devices within the 136020 return electrode block, the sensing devices can be used to detect a nerve control signal applied to the patient or a movement of an anatomical feature of the patient resulting from an application of the nerve control signal. Sensing devices may include, but are not limited to, one or more pressure sensors, one or more accelerometers, or combinations thereof. In some non-limiting respects, a sensing device may be con-
[00303] [00303] In some respects, for example as shown in Figure 32, a return block 136120 may include a plurality of electrodes 136125 which may be capacitively coupled to the patient's body and collectively configured to carry the amount of current introduced into the patient's body by the electrosurgical instrument. For this capacitive coupling, the patient's body effectively acts as one plate of a capacitor and collectively the electrodes of the plurality of electrodes 136125 of the return block 136120 effectively act together as the other plate of the capacitor. A more detailed description of capacitive coupling can be found, for example, in US Patent No. 6,214,000 entitled CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE, issued April 10, 2001, and in US Patent No. 6,582,424, entitled CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE, granted on June 24, 2003, the contents of which are incorporated herein by reference and in their entirety.
[00304] [00304] Figure 31 illustrates a plurality of electrodes 136125a-d of the return block of Figure 30, in accordance with at least one aspect of the present description. Although four electrodes 136215a-d are shown in Figure 31, it will be understood that return block 136120 may include any number of electrodes 136125. For example, in various respects, return block 136120 may include two electrodes.
[00305] [00305] The 136125a-d electrodes of the 136120 return block can serve as the return electrodes of the electrosurgical system of Figures 30 and 31, and can also be considered segmented electrodes, since the 136125a-d electrodes can be selectively decoupled from the patient's body and/or the generator. In some respects, the 136125a-d electrodes of the 136120 return block can be coupled together to effectively act as one large electrode. For example, according to various aspects, each of the electrodes 136125a-d of the return block 136120 can be connected by the respective conductive elements 136130a-d to the inputs of a switching device 136135 as shown in Figure 32. When the switching device 136135 is in an open position, as shown in Figure 32, the respective electrodes 136125a-d of the return block 136120 are decoupled from each other, as well as from the patient's body and/or the generator. In contrast, when the switching device 136135 is in a closed position, the respective electrodes 136125a-d of the return block 136120 are coupled together to effectively act as a single large electrode. It can be recognized that different combinations of electrodes 136125a-d can be coupled together by the switching device 136135 to form any group or groups of electrodes. For example, if a patient is positioned supine on return pad 136120 with their head adjacent to switching device 136135, electrodes 136125a and 136125c can be coupled together, and electrodes 136125b and 136125d can be coupled together. , thereby detecting electrical currents flowing through the lower torso and through the upper torso, respectively. Alternatively, if a patient is positioned supine on the 136120 return block with their head adjacent to the 136135 switching device, electrodes 136125a and 136125b can be coupled together, and electrodes 136125c and 136125d can be coupled together, thus being able to detect electrical currents flowing through the right part of the trunk and through the left part of the trunk, respectively.
[00306] [00306] The 136135 switching device can be controlled by a processing circuit (eg, an electrosurgical system generator processing circuit, a central controller of an electrosurgical system, etc.). For simplicity purposes, the processing circuit is not shown in Fig. 32. According to several aspects, the switch 136135 can be incorporated in the return block 136120. According to other aspects, the switch device 136135 may be incorporated into the second electrically conductive path of the electrosurgical system of Figures 30 and 31. Return block 136120 may also include a plurality of sensing devices.
[00307] [00307] Figure 33 illustrates an array of return block detection devices 136140a-d, in accordance with at least one aspect of the present description. According to various aspects, the number of sensing devices 36140a-d can match the number of electrodes 36125a-d so that there is one sensing device for each electrode (for example, the sensing device 36140a with the electrode 136125a, sensing device 36140b with electrode 136125b, sensing device 36140c with electrode 136125c, and sensing device 36140d with electrode 136125d). Each detection device 36140a-d can be mounted or integrated with a corresponding electrode 136125a-d, respectively. However, although the number of sensing devices 36140a-d associated with the corresponding electrodes 136125a-d may correspond to the number of electrodes, it will be understood that the return block can include any number of sensing devices. For example, for aspects of the return block that include sixteen electrodes, the return block may include only four or eight detection devices. Although the sensing devices 136140a-d are shown in Figure 33 as being centered over the corresponding electrodes 136125a-d, respectively, it will be recognized that the sensing devices 136140a-d may be positioned on any portion of the corresponding electrodes 136125a-d . It can be further recognized that the position of a specific sensing device on a specific electrode is independent of a position of any other sensing device on its respective electrode.
[00308] [00308] The 136140a-d detection devices are configured to detect a monopolar nerve control signal applied to the patient and/or a movement of an anatomical feature of the patient (e.g., a muscle contraction) resulting from the application of the signal. of nerve control. The monopolar nerve control signal may be applied by the surgical instrument of the electrosurgical system of Figures and 31, or it may be applied by a different surgical instrument that is coupled to a different generator. Each 136140a-d sensing device may include, for example, a pressure sensor, an accelerometer, or combinations thereof, and is configured to output a signal indicative of the detected nerve control signal and/or a motion. detection of an anatomical feature of the patient. In some non-limiting examples, a sensing device comprising a pressure sensor may include, for example, a piezoresistive strain gauge, a capacitive pressure sensor, an electromagnetic pressure sensor and/or a piezoelectric pressure sensor, alone or in combination. In some non-limiting examples, a sensing device comprising an accelerometer may include, for example, a mechanical accelerometer, a capacitive accelerometer, a piezoelectric accelerometer, an electromagnetic accelerometer, and/or a microelectromechanical system (MEMS) accelerometer, either alone or in combination. combination. The respective output signals from the respective detection devices 136140a-d may be in the form of analog and/or digital signals.
[00309] [00309] "As use of the Coulomb law and the respective locations of the active electrode of the surgical instrument, the patient's body and the respective detection devices, the respective output signals of the respective detection devices 136140a-d, which are indicative of a detected nerve control signal and/or movement of a patient's anatomical feature, can be analyzed to determine the location of a nerve within the patient's body. Coulomb's law states that E=K(Q/r ), where E is the threshold current required applied to a nerve to stimulate it, K a constant, Q is the minimum current supplied by the nerve stimulation electrode er is the distance to the nerve. The further the nerve stimulation electrode is from the nerve (r increases), the current required to stimulate the nerve is proportionately greater. Thus, the amount of stimulation of an excitable tissue measured by a 136150a-d sensing device may be related to the distance between the nerve stimulation electrode and the excitable tissue under a constant stimulation current. In some aspects, an output signal from a sensing device 136140a-d may also be dependent on the distance between the excitable tissue and the sensing device 136140a-d. It may be recognized that multiple sensing devices 136140a-d can be used to triangulate the position of an electrically stimulated excitable tissue based on the geometry and position of the multiple sensing devices 136140a-d. A constant stimulus current can thus be used to estimate the distance between the nerve stimulus electrode and the nerve. Alternatively, a current stimulus composed of varying amounts of current can be used to improve the positional determination of excitable tissue through the triangulation method associated with the multiple sensing devices 136140a-d. In general, the respective intensities of the output signals from the respective sensing devices are indicative of how close or far the respective sensing devices are from the patient's stimulated nerve.
[00310] [00310] According to various aspects, the analysis of the respective output signals of the respective detection devices can be performed by a processing circuit of the generator of the electrosurgical system of Figures 30 and 31, by a processing circuit of a nerve monitoring system that is separated from the generator of the electrosurgical system, by a processing circuit of a central controller of an electrosurgical system, etc. The analysis can be done in real time or near real time. According to various aspects, the respective output signals serve as inputs to a monopolar nerve stimulation algorithm that is executed by the processing circuit.
[00311] [00311] — As shown in Figure 33, according to various aspects, the output signals from the respective detection devices 136140ad-d can be input to a multi-input switching device and a 136137 output (for example, a multiplexer) via respective conductive elements 136142a-d, respectively. By controlling the selection signals SO, S1 for the multi-input switch and one 136137 output, the multi-input switch with one 136137 output can be controlled to output only one of the 136137 output signals. output from the respective detection devices 136140a-d at a time for the analysis described above. As a non-limiting example, with reference to Figure 33, by setting the selection signals SO, S1 to 0.0, the output signal of the detection device 136140c can be provided by the multi-input switching device and one output 136137 for analysis by the applicable processing circuit. In another non-limiting example, by setting the selection signals SO, S1 to 0.1, the output signal from the detection device 136140a can be provided by the multi-input switching device and an output 136137 for analysis by the switching circuit. applicable processing. Similarly, by setting the selection signals SO, S1 to 1.0, the output signal of the detection device 136140d can be provided by the multi-input switching device and an output 136137 for analysis by the processing circuit. applicable. And, by extension, by setting the selection signals SO, S1 to 1.1, the output signal of the detection device 136140b can be provided by the multi-input switching device and an output 136137 for analysis by the switching circuit. applicable processing.
[00312] [00312] Selection signals SO, S1 can be supplied to the multi-input switching device and a 136137 output by a processing circuit such as, as non-limiting examples, an electrosurgical system generator processing circuit. Figure 30 and 31, a processing circuit of a nerve monitoring system that is separated from the generator of the electrosurgical system, by a processing circuit of a central controller of an electrosurgical system, and the like. For simplicity purposes, the processing circuit is not shown in Fig. 33. By providing the various selection signals at a sufficiently fast rate, the output signals of the respective detection devices 136125a-d can be efficiently swept at a fast enough rate. rate that allows proper analysis of all output signals from the respective 136125a-d detection devices to determine the position of the stimulated nerve.
[00313] [00313] According to various aspects, the switching device of multiple inputs and one output 136137 can be incorporated in the return block. In other respects, the multi-input, single-output switching device 136137 may be incorporated into the second conductive electrical path 136023 of the electrosurgical system 136000 of Figure 30.
[00314] [00314] The control of the multiple-input one-output switching device 136137 shown in Figure 33 may be in the context of a four-input one-output switching device, which corresponds to the four detection devices 136140a -d represented in Figure 33. It will be recognized that for aspects where there are more than four sensing devices (e.g., sixteen sensing devices), the output signals from more than four sensing devices may serve as inputs to a multi-input switching device and an output that has more than two selection signals (eg SO, S1, S2 and S3).
[00315] [00315] For aspects where the output signals from the sensing devices (e.g. 136140a-d) are analog signals, the multi-input switching device and a 136137 output can be converted to a corresponding digital signal by an analog converter. - gico to digital 136145 before performing the analysis of the output signals of the applicable processing circuit.
[00316] [00316] Again with reference to Figure 30, according to various aspects, the detection of the nerve control signal and/or the movement of a patient's anatomical feature by the detection devices can be performed while the electrodes 136125a-d of return block 136120 are coupled to each other or while the electrodes are
[00317] [00317] Again with reference to Figure 31, regarding the execution of the detection when the respective electrodes of the return block
[00318] [00318] Electrical energy applied to tissue by a surgical probe of an electrosurgical device may be in the form of radiofrequency (RF) energy that may be in a frequency range described in document EN 60601-2-2:2009 +A11:2011, under the heading "Definition
[00319] [00319] It can be recognized that an electrosurgical device can take advantage of the response of excitable tissue at electrical frequencies below 200 kHz to determine whether such excitable tissue is close enough to the end actuator of the electrosurgical device to be potentially damaged by the actuator. Figure 34 illustrates a 136210 RF signal that can be used in an electrosurgical device to cut or cauterize tissue. This type of RF 136210 signal can be called a therapeutic signal because it has a frequency that can affect a therapeutic outcome such as cauterization or tissue cutting. For purely illustrative purposes, the x-axis can represent time, with each division representing 10 us, and the y-axis (amplitude) having an arbitrary value. The RF signal 136210 shown in Figure 34 may therefore have a frequency of about 1 MHz. It should be understood that a therapeutic RF signal may have any frequency, amplitude and/or phase characteristics sufficient to effect a therapeutic application, such as sealing, cauterizing, ablating, or cutting tissue.
[00320] [00320] Figure 35 represents a 136220 signal that can be used to stimulate excitable tissue such as nerves or a muscle. Again, for illustrative purposes only, the 136220 signal shown in Figure 35 can span about 20 us and, if repeated, would constitute a waveform with a frequency of about 50 kHz. Such an electrical signal 136220 can be called a stimulus signal because it has a frequency that can simulate excitable tissue such as nerve or muscle tissue. It can be understood that a waveform of a stimulus signal may differ from the signal 136220 shown in Figure 35 in any aspect such as duration, frequency or amplitude. In general, a 136220 stimulus signal can have any suitable waveform or amplitude and at the same time have a frequency within a range that is capable of stimulating such excitable tissue. As indicated, such waveforms, as depicted in Figures 34 and 35, are illustrative only. In an alternative example, a therapeutic RF signal might have a frequency of about 330 kHz, and a waveform for stimulating excitable tissue might have a frequency of about 2 kHz.
[00321] [00321] It can be understood that an intelligent electrosurgical device can be configured to emit a therapeutic signal or a stimulus signal or a combination thereof. Figures 36A to 36C show examples of combinations of therapeutic signals and stimulus signals. The electrical generator can provide an output current comprised of any number or combination of characteristics of the therapeutic signal and characteristics of a tissue stimulus signal. Non-limiting examples of characteristics of a therapeutic signal may include a therapeutic signal frequency, a therapeutic signal amplitude, and a therapeutic signal phase. Non-limiting examples of characteristics of a tissue stimulus signal may include a stimulus signal frequency, a stimulus signal amplitude, and a stimulus signal phase. It can be recognized that a therapeutic signal can be characterized by any number of frequencies, phases and amplitudes. Additionally, it can be recognized that a tissue stimulus signal can be characterized by any number of frequencies, phases and amplitudes. In some aspects, the controller may be configured to control an electrical generator to provide an electrical output comprised of a combination or combinations of characteristics of a therapeutic signal and characteristics of a tissue stimulus signal.
[00322] [00322] Figure 36A shows a non-limiting example of a combined first signal 136230 composed of a first therapeutic signal 136212a, a stimulus signal 136222, and a second therapeutic signal 136212b. As shown, one or more stimulus signals (such as signal 136220, Figure 35) can alternate with one or more therapeutic signals (such as signal 136210, Figure 34). It can be understood that the time for the application of one or more therapeutic signs (such as 136212a,b) may be arbitrary and may depend on the time at which a medical professional may wish to make such an application. It can also be understood that the stimulus signal 136222 may be transmitted at any time during the application of a therapeutic signal. It can be further understood that one or more zero-amplitude signals may be interleaved between one or more therapeutic signals and one or more stimulus signals. Multiple stimulus signals may be transmitted in succession before a subsequent therapeutic signal is transmitted.
[00323] [00323] Figure 36B shows a non-limiting example of a second combined signal 136240 composed of a therapeutic signal and a stimulus signal. In Figure 36B, the stimulus signal (136220, shown in Figure 35) can be used to modulate the amplitude of the therapeutic signal (136210, shown in Figure 34). In some respects, the 136220 stimulus signal can be applied directly to an amplitude modulation circuit to modulate the amplitude of a therapeutic signal.
[00324] [00324] Figure 36C shows a non-limiting example of a third combined signal 136250 composed of a therapeutic signal and a stimulus signal. In Figure 36C, the stimulus signal (136220, shown in Figure 35) can be used as a CC shift for the therapeutic signal (136210, shown in Figure 34). It should be recognized that the stimulus signal 136220 can also be altered according to any shift or scale transformation before being applied as a DC shift to the therapeutic signal 136210. It can be recognized that a DC shift based on the stimulus signal 136220 can be applied at any time to the therapeutic signal 136210 and can be applied multiple times over the course of the application of the therapeutic signal 136210. The DC offset applied to the therapeutic signal 136210 can be the same over multiple diversion application periods. Alternatively, each CC shift to the therapeutic signal 136210 may differ according to the shift and/or scale transformation of the stimulus signal.
[00325] [00325] It should be understood that the combination of a stimulus signal with a therapeutic signal is not limited to the examples presented above and shown in Figures 36A to 36C. A stimulus signal can be combined with a therapeutic signal in the same way throughout the electrosurgical procedure. Alternatively, a stimulus signal can be combined with a therapeutic signal in a variety of different ways throughout the electrosurgical procedure. In some respects, a stimulus signal may be combined with a therapeutic signal based on a choice made by a healthcare professional during the electrosurgical procedure. For example, the surgical probe may include one or more controls to allow the operator of the electrosurgical device to choose a way of combining the stimulus signal with the therapeutic signal. The surgical probe may also include one or more controls to allow the operator of the electrosurgical device to choose when the stimulus signal can be applied. In some alternative aspects, the surgical probe may include controls to allow a user to vary one or more characteristics of the therapeutic signal and/or stimulus signal. Non-limiting examples of such signal characteristics may include one or more frequencies, one or more phases, and one or more amplitudes. In some alternative aspects, the control or controls of the stimulus signal and the therapeutic signal, their respective characteristics, or their combinations may be in the control unit of the electrosurgical device, or may be incorporated into a controller operated with an electrosurgical device. the feet.
[00326] [00326] In some aspects, an intelligent electrosurgical device may include a processor, memory components, and instructions residing in the memory components to adjust a therapeutic signal output based on a distance between the active electrode and external tissues. citable. In some respects, such a processor, memory components and instructions can form controller components. In some respects, such a processor, memory components and instructions can form electrical generator components. In some respects, such a processor, memory components, and instructions may form components of a computer system separate from the intelligent electrosurgical device.
[00327] [00327] Figure 37 summarizes a non-limiting method 136300 in which such control can be performed.
[00328] [00328] In some additional aspects, an electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor, may cause the processor associated with a control unit to combine a stimulus signal with a therapeutic sign. Such instructions may include, without limitation: determining the type of stimulus signal (eg, amplitude, duration, and waveform); determine the type of signal combination (eg alternating, amplitude modulation, DC offset, or other type of combination); determining the timing of signal combination (ie, when, during a therapeutic activity, the therapeutic signal and stimulus signals are combined, for example, periodically, randomly, or once); or determining the types of signal transformations of the stimulus signal before it is combined with the therapeutic signal.
[00329] [00329] In some respects, the electrosurgical device may include processor-readable instructions stored in a memory component which, when executed by a processor, may cause the processor in the control unit to instruct an electrode monopolar active to emit a therapeutic signal, a combined therapeutic signal and a stimulus signal, or a stimulus signal upon contact with a patient's tissue. In some aspects, the electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor, may cause the processor in the control unit to combine a therapeutic signal and a stimulus signal to form - mar a signal emitted by an electrode and transmit the signal emitted from the active electrode into a patient's tissue. In some aspects, the electrosurgical device may include processor-readable instructions in a memory component which, when executed by a processor, may cause the processor in the control unit to receive one or more patient feedback signals, the feedback signals comprising electrical current returned from the current emitted by the monopolar active electrode and received by a feedback signal block. In some respects, the electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor, may cause the processor in the control unit to receive one or more output signals from one or more detection devices associated with a return block in contact with the patient. In some respects, the electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor, may cause the processor in the control unit to analyze the one or more output signals received. of one or more detection devices associated with a return block in contact with the patient.
[00330] [00330] In some aspects, the electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor, may cause the processor in the control unit to determine that an excitable tissue has been written. stimulated by the stimulus signal. In some examples, the one or more detection devices may include an accelerometer associated with the return block. In a non-limiting example, an accelerometer output may reflect the movement of a muscle in contact with it, which is activated by the stimulus signal. The amount of muscle movement may result, at least in part, from the amount of stimulus current received by muscle tissue or a nerve that transmits energy to the muscle. As the tissue can act as a resistive element to the propagation of the stimulus signal, the amount of muscle activation can indicate a distance between the active electrode and the muscle or the nerves that transmit energy to the muscle.
[00331] [00331] In some respects, the patient may lie supine on the return pad, and sensor outputs from the return pad, such as one or more accelerometers, may indicate an amount of muscle movement of the back muscles of a patient in contact with the return block. In an alternative aspect, a return block can be placed over a muscle or group of muscles proximal to the position of the surgical site where the electrosurgical device can be operated. In some instances, the return block may be placed over a portion of superficial abdominal muscles (such as the rectus abdominis muscles) for abdominal surgery. In some examples, the return block can be placed over a lateral portion of the abdomen to monitor the stimulation of the external oblique or serratus anterior muscles.
[00332] [00332] In some respects, the electrosurgical device may include processor-readable instructions stored in a memory component which, when executed by a processor, may cause the processor in the control unit to calculate or determine a distance between an excitable tissue and a distal end of the active electrode based, at least in part, on a feedback signal or one or more output signals from one or more sensing devices associated with a feedback pad in contact with the patient. In some respects, the electrosurgical device may include processor-readable instructions stored in a memory component that, when executed by a processor, may cause the processor in the control unit to adjust one or more of an amplitude, a frequency and phase of a therapeutic signal based, at least in part, on a distance between an excitable tissue and the distal end of the active electrode. In some aspects, the amplitude, frequency and/or phase of a therapeutic signal can be adjusted when the distance between an excitable tissue and the active electrode is less than a first predetermined value. In some respects, adjusting the amplitude, frequency, or phase of a therapeutic signal may result in electrosurgical systems not emitting any therapeutic signal when the distance between an excitable tissue and the active electrode is less than a second predetermined value.
[00333] [00333] In some additional aspects, the active electrode of a surgical probe of the electrosurgical device may be applied to a tissue solely to determine a distance between an excitable tissue and the active electrode. In such use, the medical professional using the device may operate in a stimulus-only mode, without applying therapeutic signals to the active electrode. In a stimulus mode, the user of the device can operate one or more controls configured to increase a characteristic of the stimulus signal to determine under what conditions an excitable tissue is stimulated through such controls. For example, a user can operate configured controls to increase a stimulus signal voltage or current amplitude from a low value to a high value. When a signal is received from a sensor (e.g., an accelerometer that detects muscle movement), the electrosurgical device can then calculate an approximate distance between the active electrode and the excitable tissue based, at least in part, on the amplitude of the stimulus signal. In another example, a user can operate configured controls to increase a stimulus signal frequency from a low value to a high value. When a signal is received from a sensor (e.g., an accelerometer that detects muscle movement), the electrosurgical device can then calculate an approximate distance between the active electrode and the excitable tissue based, at least in part, on the frequency of the electrosurgical device. stimulus signal.
[00334] [00334] In some respects, an electrosurgical device or a smart electrosurgical device may be incorporated into a central surgical controller system. The central controller system may incorporate a number of handheld medical devices, robotic medical devices, image capture devices, image display devices, communication devices, processing devices, networking devices, and other electronic devices that can operate in a joint and coordinated manner. In some aspects, the central controller may include these devices at a single surgical site, at a plurality of surgical sites, or at any number of computer server sites. The computer memory modules, instructions and processors described herein in the context of controlling a standalone intelligent electrosurgical device may be distributed among any of the components of the central surgical controller system as appropriate.
[00335] [00335] In some respects, additional information that can be captured by the components of the central surgical controller system can be used to improve the operation of an intelligent electrosurgical device. For example, cameras and imaging systems directed at a surgical site can provide imaging information that can be used to determine the location of the distal end of the active electrode in relation to tissue at the surgical site. Image-based location of the distal end of the active electrode can be used with the output of sensors from the return pad to refine the distance between the active electrode and any excitable tissue in the patient. In some alternative examples, the central controller system may include data comprising anatomical models related to the location of nerve and muscle tissue. Such model information can also be used in conjunction with image-based location of the active electrode and sensor output from the return pad to better determine the proximity of the active electrode to known excitable tissue.
[00336] [00336] While the functions and devices described herein may be uniquely related to an electrosurgical device, it can be recognized that such functions and devices may also be incorporated into multimode surgical devices that include functions associated with an electrosurgical device. For example, a multimode surgical device may incorporate features associated with an electrosurgical device along with the features associated with an ultrasonic surgical device. In addition to the functions described above regarding changing the properties of an electrosurgical therapeutic signal, a multimode device may include other functions. For example, a surgical device may use RF energy or ultrasound for a given therapeutic effect, for example, cutting tissue. In such a multimode device, RF energy may initially be applied to tissue for material cutting purposes, but the multimode device may be configured to switch to an ultrasound mode if it is determined that the end of the multimode device is too close to excite tissue.
[00337] [00337] — Now referring to Figure 38, a timeline 5200 is shown representing the situational recognition of a central controller, such as the central surgical controller 106 or 206, for example. Timeline 5200 is an illustrative surgical procedure and contextual information that the central surgical controller 106, 206 can derive from data received from data sources at each step of the surgical procedure. The 5200 timeline represents the typical steps that would be taken by nurses, surgeons, and other medical personnel during the course of a pulmonary segmentectomy procedure, starting with the operating room setup and ending with the patient transfer. to a postoperative recovery room.
[00338] [00338] Situational awareness central surgical controller 106, 206 receives data from data sources throughout the course of the surgical procedure, including data generated each time medical personnel use a modular device that is paired with the surgical controller central 106, 206. The central surgical controller 106, 206 can receive this data from the paired modular devices and other data sources and continually derive inferences (i.e., contextual information) about the procedure in progress as new data emerge. are received, such as which step of the procedure is being performed at any given time. The situational recognition system of the central surgical controller 106, 206 is capable of, for example, recording data concerning the procedure to generate reports, verifying steps being taken by medical personnel, providing data or warnings (for example, through a display screen) that may be pertinent to the specific step of the procedure, adjusting modular devices based on context (e.g. activating monitors, adjusting the field of view (FOV) of the medical imaging device, or changing the power level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other action described above.
[00339] [00339] As the first step 5202 in this illustrative procedure, hospital staff members obtain the patient's electronic medical record (EMR) from the hospital's EMR database. Based on the patient selection data in the RME, the central surgical controller 106, 206 determines that the procedure to be performed is a thoracic procedure.
[00340] [00340] In the second step 5204, team members scan the entry of medical supplies for the procedure. The central surgical controller 106, 206 cross-references the scanned supplies with a list of supplies that are used in various types of procedures and confirms that the mix of supplies corresponds to a thoracic procedure. Additionally, the central surgical controller 106, 206 is also able to determine that the procedure is not a wedge resection procedure (because the inlet supplies lack certain supplies that are required for a thoracic wedge resection procedure). or, otherwise, that the inlet supplies do not correspond to a thoracic wedge resection procedure).
[00341] [00341] In the third step 5206, medical personnel scan the patient's band with a scanner that is connected in communication with the central surgical controller 106, 206. The central surgical controller 106, 206 can then confirm the patient's identity based on the data scanned.
[00342] [00342] In the fourth step 5208, the medical personnel turn on the auxiliary equipment. The auxiliary equipment being used may vary according to the type of surgical procedure and the techniques to be used by the surgeon, but in this illustrative case they include a smoke evacuator, an insufflator and a medical imaging device. When activated, auxiliary equipment that are modular devices can automatically pair with the central surgical controller 106, 206 that is situated in a specific neighborhood of the modular devices as part of their startup process. The central surgical controller 106, 206 can then derive contextual information about the surgical procedure by detecting the types of modular devices paired with it during this preoperative or start-up phase. In this particular example, the central surgical controller 106, 206 determines that the surgical procedure is a VATS (video-assisted thoracic surgery) procedure based on this specific combination of paired modular devices. Based on the combination of the patient's electronic medical record (EMR) data, the list of medical supplies to be used in the procedure, and the type of modular devices that connect to the central controller, the central surgical controller 106, 206 can generally , infer the specific procedure that the surgical team will perform. After the central surgical controller 106, 206 recognizes which specific procedure is being performed, the central surgical controller 106, 206 can then retrieve the steps of that process from memory or from the cloud and then cross-reference the data that subsequently receives from connected data sources (e.g. modular devices and patient monitoring devices) to infer which step of the surgical procedure the surgical team is performing.
[00343] [00343] In the fifth step 5210, team members attach electrocardiogram (ECG) electrodes and other patient monitoring devices to the patient. ECG electrodes and other patient monitoring devices are able to pair with the central surgical controller 106, 206. As the central surgical controller 106, 206 begins to receive data from the patient monitoring devices , the central surgical controller 106, 206 thereby confirms that the patient is in the operating room.
[00344] [00344] In the sixth step 5212, medical personnel induce anesthesia in the patient. The central surgical controller 106, 206 can infer that the patient is under anesthesia based on data from modular devices and/or patient monitoring devices, including ECG data, blood pressure (BP) data, fan, or combinations thereof, for example. After completing the sixth stage
[00345] [00345] In the seventh step 5214, the lung of the patient being operated on is retracted (while ventilation is switched to the contralateral lung). The central surgical controller 106, 206 can infer from the ventilator data that the patient's lung has been retracted, for example. The central surgical controller 106, 206 can infer that the operative portion of the procedure has begun when it can compare the detection of the patient's lung collapse to the expected steps of the procedure (which can be accessed or retrieved earlier) and thus determine that lung retraction is the first operative step in this specific procedure.
[00346] [00346] In the eighth step 5216, the medical imaging device (eg, a display device) is inserted and video from the medical imaging device is started. The central surgical controller 106, 206 receives data from the medical imaging device (i.e., video or image data) through its connection to the medical imaging device. Upon receipt of data from the medical imaging device, the central surgical controller 106, 206 can determine which portion of the laparoscopic surgical procedure has been initiated. Additionally, the central surgical controller 106, 206 may determine that the specific procedure being performed is a segmentectomy rather than a lobectomy (note that a wedge resection procedure has already been ruled out by the central surgical controller 106, 206 based on the data received in the second step 5204 of the procedure). Data from the medical imaging device 124 (Figure 2) can be used to determine contextual information about the type of procedure being performed in a number of different ways, including by determining the angle at which the medical imaging device is oriented towards visualizing the patient's anatomy, monitoring the number or medical imaging devices being used (i.e., which are activated and paired with the OR 106, 206), and monitoring the types of visualization devices used. For example, a technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's chest cavity above the diaphragm, while a technique for performing a VATS segmentectomy places the camera in an intercostal position anterior to the segment fissure. . Using standard recognition techniques or machine learning, for example, the situational recognition system can be trained to recognize the positioning of the medical imaging device according to the visualization of the patient's anatomy. As another example, one technique for performing a VATS lobectomy uses a single medical imaging device, while another technique for performing a VATS segmentectomy uses multiple cameras. As yet another example, a technique for performing a VATS segmentectomy uses an infrared light source (which can be coupled in communication with the central surgical controller as part of the visualization system) to visualize the segment fissure, which it is not used in a VATS lobectomy. By tracking any or all of these data from the medical imaging device, the central surgical controller 106, 206 can thus determine the specific type of surgical procedure being performed and/or the technique being used. for a specific type of surgical procedure.
[00347] [00347] In the ninth step 5218 of the procedure, the surgical team starts the dissection step. The central surgical controller 106, 206 can infer that the surgeon is in the process of dissecting to mobilize the patient's lung because he receives data from the RF or ultrasonic generator that indicates that an energy instrument is being fired. The central surgical controller 106, 206 can cross-reference the received data with the steps retrieved from the surgical procedure to determine that a power instrument is being fired at that point in the process (i.e., after completion of the previously discussed steps of the procedure) corresponds to the dissection stage. In certain cases, the power instrument may be a power tool mounted on a robotic arm of a robotic surgical system.
[00348] [00348] “In the tenth step 5220 of the procedure, the surgical team proceeds to the ligation step. The central surgical controller 106, 206 can infer that the surgeon is ligating the arteries and veins because he receives data from the surgical stapling and cutting instrument indicating that the instrument is being triggered. Similar to the previous step, the central surgical controller 106, 206 can derive this inference by crossing the reception data from the surgical stapling and cutting instrument with the steps retrieved in the process. In certain cases, the surgical instrument may be a surgical tool mounted on a robotic arm of a robotic surgical system.
[00349] [00349] In the eleventh step 5222, the segmentectomy portion of the procedure is performed. The central surgical controller 106, 206 can infer that the surgeon is transecting the parenchyma based on data from the surgical stapling and cutting instrument, including data from its cartridge. Cartridge data may correspond to the size or type of staple being fired by the instrument, for example. As different types of staples are used for different types of fabrics, the cartridge data can thus indicate the type of fabric being stapled and/or transected. In this case, the type of staple that is fired is used for the parenchyma (or other similar types of tissue), which allows the central surgical controller 106, 206 to infer which segmentectomy portion of the procedure is being performed.
[00350] [00350] In the twelfth step 5224, the node dissection step is then performed. The central surgical controller 106, 206 can infer that the surgical team is dissecting the node and performing a leak test based on data received from the generator that indicates which ultrasonic or RF instrument is being triggered. For this specific procedure, an RF or ultrasonic instrument being used after the parenchyma has been transected corresponds to the node dissection step, which allows the central surgical controller 106, 206 to make this inference. It should be noted that surgeons regularly switch between surgical stapling/cutting instruments and surgical energy instruments (ie, RF or ultrasonic) depending on the specific step in the procedure because different instruments are better suited for specific tasks. Therefore, the specific sequence in which cutting/stapling instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. Furthermore, in certain cases, robotic tools may be used for one or more steps in a surgical procedure and/or hand-held surgical instruments may be used for one or more steps in the surgical procedure. The surgeon can switch between robotic tools and hand-held surgical instruments and/or can use the devices simultaneously, for example. Upon completion of the twelfth step 5224, the incisions are closed and the post-operative portion of the process begins.
[00351] [00351] In the thirteenth step 5226, the patient's anesthesia is reversed. The central surgical controller 106, 206 can infer that the patient is emerging from anesthesia based on ventilator data (i.e., the patient's respiratory rate begins to increase), for example.
[00352] [00352] Finally, in the fourteenth step 5228 the medical personnel removes the various patient monitoring devices from the patient. The central surgical controller 106, 206 can thus infer that the patient is being transferred to a recovery room when the central controller loses ECG, blood pressure and other data from patient monitoring devices. As can be seen from the description of this illustrative procedure, the central surgical controller 106, 206 can determine or infer when each step of a given surgical procedure is taking place according to data received from the various data sources that are coupled in communication with the central surgical controller 106, 206.
[00353] [00353] “Situational awareness is further described in US Provisional Patent Application Serial No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, which is incorporated herein by reference in its entirety. In certain cases, the operation of a robotic surgical system, including the various robotic surgical systems described herein, for example, may be controlled by the central controller 106, 206 based on its situational recognition and/or feedback from components thereof and /or based on information from cloud 102.
[00354] [00354] While various forms have been illustrated and described, it is not the intent of the claimant to restrict or limit the scope of the claims appended to such detail. Numerous modifications, variations, alterations, substitutions, combinations and equivalents of these forms can be implemented and will occur to those skilled in the art without departing from the scope of the present description. Furthermore, the structure of each element associated with the form can alternatively be described as a means to provide the function performed by the element. In addition, where materials are described for certain components, other materials may be used. It is to be understood, therefore, that the foregoing description and the appended claims are intended to cover all such modifications, combinations, and variations within the scope of the embodiments presented. The appended claims are intended to cover all such modifications, variations, alterations, substitutions, modifications and the like.
[00355] [00355] The preceding detailed description presented various forms of devices and/or processes through the use of block diagrams, flowcharts and/or examples. Although these block diagrams, flowcharts and/or examples contain one or more functions and/or operations, it will be understood by those skilled in the art that each function and/or operation within these block diagrams, flowcharts and/or examples may be implemented, individually and/or collectively, across a wide range of hardware, software, firmware or virtually any combination thereof. Those skilled in the art will recognize, however, that some aspects of the aspects described herein, in whole or in part, may be equivalently implemented on 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 any combination thereof, and that designing the circuitry and/or writing the code for the software and firmware would be within the scope of practice of one skilled in the art, in light of this description. Furthermore, those skilled in the art will understand that the mechanisms of the subject matter described herein may be distributed as one or more program products in a variety of ways and that a form illustrative of the subject matter described herein is applicable irrespective of the specific type of transmission medium. signals used to effectively carry out the distribution.
[00356] [00356] The instructions used to program the logic to perform various aspects described may 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 form readable by a machine (e.g., a computer), but is not limited to floppy disks, optical disks, compact memory disks, etc. read-only memory (CD-ROMs), and optical-dynamo disks, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), read-only memory programmable electrically erasable (EEPROM), magnetic or optical cards, flash memory, or a tangible machine-readable storage media used to transmit information over the Internet over electrical, optical, acoustic, or other forms of propagated (eg carrier waves, infrared signal, digital signals, etc.). Accordingly, non-transient computer-readable media includes any type of machine-readable media suitable for storing or transmitting electronic instructions or information in a machine-readable form (eg, a computer).
[00357] [00357] As used in any aspect of the present invention, the term "control circuit" may refer to, for example, a set of wired circuits, programmable circuits (e.g., a
[00358] [00358] “As used in any aspect of the present invention, the term "logic" may refer to an application, software, firmware and/or circuit configured to perform any of the aforementioned operations. The software may be embedded as a software package, code, instructions, instruction sets, and/or data recorded on computer-readable, non-transient storage media. Firmware can be embedded as code, instructions, or sets of instructions and/or data that are hard-coded (eg, non-volatile) in memory devices.
[00359] [00359] "As used in any aspect of the present invention, the terms "component", "system", "module" and the like may refer to a computer-related entity, whether hardware, a combination of hardware and software, running software or software.
[00360] [00360] As used herein in one aspect of the present invention, 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 they do not necessarily need to, take the form of electrical or magnetic signals that can be stored, transferred, combined, compared and manipulated in any other way. It is common usage to call these signs bits, values, elements, symbols, characters, terms, numbers, or the like. These terms and similar terms may be associated with appropriate physical quantities and are merely convenient identifications applied to those quantities and/or states.
[00361] [00361] A network may include a packet switched network. Communication devices may be able to communicate with each other using a selected packet-switched network communications protocol. An exemplary communications protocol may include an Ethernet communications protocol which may be capable of enabling communication using a transmission control protocol/Internet protocol (TCP/IP). The Ethernet protocol may conform 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 additionally, communication devices may be able to communicate with each other using an X.25 communications protocol. The X.25 communications protocol may conform or be compatible with a standard promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may be able to communicate with each other using a frame-relay communications protocol. The frame-relay communications protocol may conform or be compliant 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, the transceivers may be able to communicate with each other using an ATM (asynchronous transfer mode) communication protocol. The ATM communication protocol may conform or be compatible with an ATM standard published by the ATM forum titled "ATM-MPLS Network Interworking 2.0" published in August 2001, and/or later versions of that standard. Of course, different and/or post-developed connection-oriented network communication protocols are also contemplated in the present invention.
[00362] [00362] Unless expressly stated to the contrary, as is evident from the preceding description, it is understood that throughout the preceding description, discussions that use terms such as "processing", or "computation", or "calculus ", or "determination", or "display", or the like, refers to the action and processes of a computer, or similar electronic computing device, which manipulates and transforms data represented in the form of physical (electronic) quantities into the computer system memories and registers on other data similarly represented in the form of physical quantities in computer system memories or registers, or other devices for storing, transmitting, or displaying similar information.
[00363] [00363] One or more components may be referred to in the present invention as "configured for", "configurable for", "operable/operational for", "adapted/adaptable for", "capable of", "compliant mable/conformed to", etc. Those skilled in the art will recognize that "configured for" can generally encompass active-state components and/or idle-state components and/or standby-state components, unless the context dictates otherwise.
[00364] [00364] The terms "proximal" and "distal" are used here with reference to a case where a physician manipulates the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the physician, and the term "distal" refers to the portion located away from the physician. It will also be understood that, for the sake of convenience and clarity, spatial terms such as "vertical", "horizontal", "upwards" and "downwards" may be used in the present invention in connection with 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.
[00365] [00365] Persons skilled in the art will recognize that, in general, terms used herein, and particularly in the appended claims (e.g. bodies of appended claims) are generally intended as "open" terms (e.g., the term "including" shall be interpreted as "including, but not limited to", the term "having"
[00366] [00366] Furthermore, even if a specific number of an introduced claim mention is explicitly mentioned, those skilled in the art will recognize that such mention typically needs to be interpreted to mean at least the mentioned number (e.g., the mere mention of "two mentions", with no other modifiers, typically means at least two mentions, or two or more mentions). Furthermore, in cases where a convention analogous to "at least one of A, B and C, etc." is used, this construction is generally intended to have the sense in which the convention would be understood by (e.g. , "a system that has at least one of A, B, and C" would include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together , and/or A, B and C together, etc.). In cases where a convention analogous to "at least one of A, B, or C, etc." is used, this construction is generally intended to have the sense in which the convention would be understood by (e.g., "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 further be understood by those skilled in the art that typically a disjunctive word and/or phrase having two or more alternative terms, whether in the description, claims or drawings, is to be understood as contemplating the possibility of including one of the terms, any of the terms or both terms, unless the context dictates otherwise. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "AeB".
[00367] [00367] With respect to the appended claims, those skilled in the art will understand that the operations mentioned therein can generally be performed in any order. Furthermore, although various operational flow diagrams are presented in one or more sequences, it should be understood that the various operations may be performed in orders other than those illustrated, or may be performed simultaneously. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, inverse, or other variant orderings, unless the context dictates otherwise. Furthermore, terms such as "responsive to," "related to," or other adjectival participles are not generally intended to exclude these variants, unless the context dictates otherwise.
[00368] [00368] It is worth noting that any reference to "one (1) aspect", "one aspect", "one exemplification" or "one (1) exemplification", and the like means that a particular feature, structure or characteristic described in aspect connection is included in at least one aspect. Thus, the use of expressions such as "in one (1) aspect", "in one aspect", "in one exemplification", "in one (1) exemplification", in several places throughout this descriptive report is not necessarily refer to the same aspect. Furthermore, specific features, structures or features can be combined in any suitable way in one or more aspects.
[00369] [00369] Any patent application, patent, non-patent publication or other descriptive material mentioned in this specification and/or mentioned in any application data sheet is hereby incorporated by reference, to the extent that that the materials incorporated are not inconsistent with this. Accordingly, and to the extent necessary, the description as explicitly presented herein supersedes any conflicting material incorporated by the present invention by reference. Any material, or portion thereof, which is incorporated herein by reference, but which conflicts with existing definitions, statements, or other descriptive materials presented herein, is incorporated herein only to the extent that there is no conflict between the embedded material and existing description material.
[00370] [00370] In summary, numerous benefits have been described that result from employing the concepts described in this document. The aforementioned description of one or more embodiments has been presented for purposes of illustration and description. This description is not intended to be exhaustive or to limit the invention to the precise form described. Modifications or variations are possible in light of the above teachings. One or more embodiments have been chosen and described for the purpose of illustrating the principles and practical application to thereby enable one skilled in the art to use the various embodiments and with various modifications as may be convenient for the particular use contemplated. The attached claims are intended to define the global scope.
[00371] [00371] Various aspects of the matter described in this document are defined in the numbered examples below:
[00372] [00372] Example 1. Electrosurgical device comprising: a controller comprising an electrical generator; a surgical probe comprising a distal active electrode, the active electrode being in electrical communication with an electrical source terminal of the electrical generator; and a return block in electrical communication with an electrical return terminal of the electrical generator, wherein the electrical generator is configured to supply an electrical current from the electrical source terminal, and the electrical current supplied by the electrical generator combining the characteristics of a therapeutic electrical signal and the characteristics of an excitable tissue stimulus signal.
[00373] [00373] Example 2. The electrosurgical device of Example 1, wherein the therapeutic electrical signal is a radio frequency signal that has a frequency greater than 200 kHz and less than 5 MHz.
[00374] [00374] Example 3. Electrosurgical device of any one or more of Examples 1 and 2, wherein the excitable tissue stimulus signal is an AC signal that has a frequency less than 200 kHz.
[00375] [00375] Example 4. An electrosurgical device of any one or more of Examples 1 to 3, wherein the electrical current supplied by the electrical generator comprises at least one alternating therapeutic electrical signal and at least one excitable tissue stimulus signal. - tern.
[00376] [00376] Example 5. The electrosurgical device of any one or more of Examples 1 to 4, wherein the electrical current provided by the electrical generator comprises a therapeutic electrical signal amplitude modulated by the excitable tissue stimulus signal.
[00377] [00377] Example 6. The electrosurgical device of any one or more of Examples 1 to 5, wherein the electrical current supplied by the electrical generator includes a DC shift of the therapeutic electrical signal by the excitable tissue stimulus signal.
[00378] [00378] Example 7. Electrosurgical device of any one or more of Examples 1 to 6, wherein the return block additionally comprises at least one sensing device having a sensing device output, and the sensing device is configured to determine an excitable tissue stimulus by the excitable tissue stimulus signal.
[00379] [00379] “Example 8. Example 7 electrosurgical device, where the controller is configured to receive the output of the detection device.
[00380] [00380] Example 9. Electrosurgical device of Example 8, in which the controller comprises a processor and at least one memory component in data communication with the processor, and the at least one memory component stores one or more instructions which, when performed by the processor, cause the processor to determine a distance between the active electrode and an excitable tissue based, at least in part, on the sensor output received by the controller.
[00381] [00381] Example 10. Electrosurgical device of Example 9, in which the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to change a value of at least one characteristic of the therapeutic electrical signal when the distance between the active electrode and an excitable tissue is less than a predetermined value.
[00382] [00382] “Example 11. Electrosurgical system comprising: a processor; and a memory attached to the processor, the memory being configured to store instructions executable by the processor to: cause an electrical generator to combine one or more characteristics of a therapeutic signal with one or more characteristics of a stimulus signal of excitable tissue to form a combined signal; causing the electrical generator to transmit the combined signal into a patient's tissue through an active electrode in physical contact with the patient; and receiving a sensing device output signal from a sensing device disposed within a return block in physical contact with the patient.
[00383] [00383] Example 12. Electrosurgical system of Example 11, where the memory is configured to additionally store instructions executable by the processor to determine, based at least in part on the output signal of the detection device, a distance between it - active trode and an excitable tissue.
[00384] [00384] Example 13. Example 12 electrosurgical system, where the memory is configured to additionally store instructions executable by the processor to cause the controller to change one or more characteristics of the therapeutic signal when the distance between the active electrode and the excitable tissue is less than a predetermined value.
[00385] [00385] “Example 14. Electrosurgical system of one or more of Examples 11 to 13, wherein the processor-executable instructions for causing an electrical generator to combine one or more characteristics of a therapeutic signal with one or more characteristics - Cases of an excitable tissue stimulus signal to form a combined signal comprise instructions executable by the processor to cause the electrical generator to alternate between the therapeutic signal and the excitable tissue stimulus signal.
[00386] [00386] Example 15. Electrosurgical system of one or more of Examples 11 to 14, wherein the processor-executable instructions for causing an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal comprise instructions executable by the processor to cause the electrical generator to modulate an amplitude of the therapeutic signal by an amplitude of the excitable tissue stimulus signal.
[00387] [00387] Example 16. Electrosurgical system of one or more of Examples 11 to 15, wherein the processor-executable instructions for causing an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal comprise instructions executable by the processor to cause the electrical generator to shift a DC value of the therapeutic signal by an amplitude of the excitable tissue stimulus signal.
[00388] [00388] “Example 17. An electrosurgical system comprising: a control circuit configured to: control an electrical output of an electrical generator, wherein the electrical output comprises one or more characteristics of a therapeutic signal and a or more features of an excitable tissue stimulus signal; receiving a sensing device signal from at least one sensing device configured to measure a patient's excitable tissue activity; determining a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into a patient's tissue and a location of the at least one sensing device; and changing the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the active electrode site configured to transmit the electrical output of the electrical generator into the patient's tissue and the location of the at least one device detection is less than a predetermined value.
[00389] [00389] Example 18. The electrosurgical system of Example 17, where the control circuit configured to change the electrical output of the electrical generator by at least one characteristic of the therapeutic signal, when the distance between the active electrode site configured to transmit the output electrical generator into the patient's tissue and the location of the at least one detection device is less than a predetermined value, comprises a control circuit configured to minimize the at least one characteristic of the therapeutic signal.
[00390] [00390] Example 19. Computer-readable non-transient media that stores computer-readable instructions that, when executed, make a machine: controlling an electrical output of an electrical generator, where the electrical output comprises one or more features of a therapeutic signal and one or more characteristics of an excitable tissue stimulus signal; receiving a sensing device signal from at least one sensing device configured to measure an excitable tissue activity of a patient; determining a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into a patient's tissue and a location of the at least one sensing device; and changing the electrical output of the electrical generator by at least one characteristic of the therapeutic signal when the distance between the active electrode site configured to transmit the electrical output of the electrical generator into the patient's tissue and the location of the at least one device detection is less than a predetermined value.

权利要求:
Claims (19)
[1]
1. Electrosurgical device, characterized by comprising: a controller comprising an electrical generator; a surgical probe comprising a distal active electrode, the active electrode being in electrical communication with an electrical source terminal of the electrical generator; and a return block in electrical communication with an electrical return terminal of the electrical generator, wherein the electrical generator is configured to supply an electrical current from the electrical source terminal, and wherein the electrical current supplied by the electrical generator combines the characteristics of a therapeutic electrical signal and the characteristics of an excitable tissue stimulus signal.
[2]
2. Electrosurgical device, according to claim 1, characterized in that the therapeutic electrical signal is a radio frequency signal that has a frequency greater than 200 kHz and less than 5 MHz.
[3]
An electrosurgical device according to claim 1, characterized in that the excitable tissue stimulus signal is an AC signal that has a frequency of less than 200 kHz.
[4]
4. Electrosurgical device, according to claim 1, characterized in that the electrical current supplied by the electrical generator comprises at least one alternating therapeutic electrical signal and at least one alternating excitable tissue stimulus signal.
[5]
5. Electrosurgical device according to claim 1, characterized in that the electrical current supplied by the electrical generator comprises a therapeutic electrical signal amplitude modulated by the excitable tissue stimulus signal.
[6]
An electrosurgical device according to claim 1, characterized in that the electrical current supplied by the electrical generator comprises a DC shift of the therapeutic electrical signal by the excitable tissue stimulus signal.
[7]
An electrosurgical device according to claim 1, characterized in that the feedback block additionally comprises at least one detection device having a detection device output, and the detection device is configured to determine a stimulus. of an excitable tissue by the excitable tissue stimulus signal.
[8]
8. Electrosurgical device, according to claim 7, characterized in that the controller is configured to receive the output of the detection device.
[9]
9. Electrosurgical device, according to claim 8, characterized in that the controller comprises a processor and at least one memory component in data communication with the processor, and the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to determine a distance between the active electrode and an excitable tissue based, at least in part, on the sensor output received by the controller.
[10]
10. Electrosurgical device, according to claim 9, characterized in that the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to change a value of at least one characteristic. therapeutic electrical signal when the distance between the active electrode and an excitable tissue is less than a predetermined value.
[11]
11. Electrosurgical system, characterized by comprising: a processor; and a memory coupled to the processor, the memory being configured to store instructions executable by the processor to: cause an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal; causing the electrical generator to transmit the combined signal into a patient's tissue through an active electrode in physical contact with the patient; and receiving a sensing device output signal from a sensing device disposed within a return block in physical contact with the patient.
[12]
12. Electrosurgical system according to claim 11, characterized in that the memory is configured to additionally store instructions executable by the processor to: determine, based at least in part on the output signal of the detection device, a distance between the active electrode and an excitable tissue.
[13]
13. Electrosurgical system, according to claim 12, characterized in that the memory is configured to additionally store instructions executable by the processor to: make the controller change one or more characteristics of the therapeutic signal when the distance between the electrode active and the excitable tissue is less than a predetermined value.
[14]
An electrosurgical system according to claim 11, characterized in that the processor-executable instructions for causing an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal comprise instructions executable by the processor to cause the electrical generator to alternate the therapeutic signal and the excitable tissue stimulus signal.
[15]
The electrosurgical system of claim 11, characterized in that the processor-executable instructions for causing an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal comprises instructions executable by the processor to cause the electrical generator to modulate an amplitude of the therapeutic signal by an amplitude of the excitable tissue stimulus signal.
[16]
The electrosurgical system of claim 11, characterized in that the processor-executable instructions for causing an electrical generator to combine one or more features of a therapeutic signal with one or more features of an excitable tissue stimulus signal to form a combined signal comprises instructions executable by the processor to cause the electrical generator to shift a DC value of the therapeutic signal by an amplitude of the excitable tissue stimulus signal.
[17]
17. Electrosurgical system, characterized by comprising: a control circuit configured to: control an electrical output of an electrical generator, wherein the electrical output comprises one or more characteristics of a therapeutic signal and one or more characteristics of a stimulus signal of excitable tissue; receiving a sensing device signal from at least one sensing device configured to measure an excitable tissue activity of a patient; determining a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into a patient's tissue and a location of at least one detection device; and changing the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the active electrode site configured to transmit the electrical output of the electrical generator into the patient's tissue and the location of the at least one sensing device is less than a predetermined value.
[18]
18. Electrosurgical system, according to claim 17, characterized in that the control circuit configured to change the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the location of the active electrode configured to transmit the electrical output of the electrical generator into the patient's tissue and the location of the at least one detection device is less than a predetermined value comprising a control circuit configured to minimize the at least one characteristic of the therapeutic signal.
[19]
19. Computer-readable non-transient media, characterized by storing computer-readable instructions that, when executed, make a machine: control an electrical output of an electrical generator, wherein the electrical output comprises one or more characteristics of a therapeutic signal and one or more features of an excitable tissue stimulus signal; receiving a sensing device signal from at least one sensing device configured to measure an excitable tissue activity of a patient; determining a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into a patient's tissue and a location of at least one detection device; and changing the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the active electrode site configured to transmit the electrical output of the electrical generator into the patient's tissue and the location of the at least one sensing device is less than a predetermined value.

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

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