JP7391852B2 - Detecting the appearance of end effectors in liquids - Google Patents

Description

(Cross reference to related applications)
This application is filed August 23, 2018, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION," the entire disclosure of which is incorporated herein by reference under 35 U.S.C. 119(e). claims priority to U.S. Provisional Patent Application No. 62/721,995.

This application is filed under 35 U.S.C. 119(e) as a U.S. provisional patent filed August 23, 2018 entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS," the entire disclosure of which is incorporated herein by reference. Claims priority to Application No. 62/721,998.

This application is filed on August 23, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING," the entire disclosure of which is incorporated herein by reference under 35 U.S.C. Claims priority to U.S. Provisional Patent Application No. 62/721,999.

This application is filed under 35 U.S.C. 119(e) entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY," the entire disclosure of which is incorporated herein by reference. August 23, 2018 Claims priority to U.S. Provisional Patent Application No. 62/721,994, filed in Japan.

This application is filed August 23, 2018, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS," the entire disclosure of which is incorporated herein by reference under 35 U.S.C. 119(e). claims priority to U.S. Provisional Patent Application No. 62/721,996.

This application is further filed under 35 U.S.C. 119(e) entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE" filed June 30, 2018, each disclosure of which is incorporated herein by reference in its entirety. U.S. Provisional Patent Application No. 62/692,747, filed June 30, 2018, entitled “SMART ENERGY ARCHITECTURE,” and U.S. Provisional Patent Application No. 62/692,748, filed June 30, 2018, entitled “SMART ENERGY DEVICE.” Claims priority to U.S. Provisional Patent Application No. 62/692,768, filed June 30, 2018.

This application is further filed under 35 U.S.C. 119(e) entitled ``TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR,'' March 8, 2018, each disclosure of which is incorporated herein by reference in its entirety. U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, entitled “ESTIMATION STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR” No. 5 Claim the right of priority.

This application is further filed under 35 U.S.C. 119(e) entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," each disclosure of which is hereby incorporated by reference in its entirety on March 30, 2018. U.S. Provisional Patent Application No. 62/650,887, filed March 30, 2018, entitled “SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES”; ION MODULE FOR US Provisional Patent Application No. 62/650,882, filed March 30, 2018, entitled “INTERACTIVE SURGICAL PLATFORM” and March 2018, entitled “SURGICAL SMOKE EVACUATION SENSING AND CONTROLS.” U.S. provisional patent application filed on the 30th No. 62/650,877 claims priority.

This application further relates to a U.S. provisional patent filed December 28, 2017 entitled "INTERACTIVE SURGICAL PLATFORM," each disclosure of which is incorporated herein by reference in its entirety under 35 U.S.C. 119(e). U.S. Provisional Patent Application No. 62/611,341, filed December 28, 2017, entitled “CLOUD-BASED MEDICAL ANALYTICS” and 2017 entitled “ROBOT ASSISTED SURGICAL PLATFORM.” 12 Claims priority benefit from U.S. Provisional Patent Application No. 62/611,339, filed May 28, 2013.

In a surgical environment, smart energy devices within a smart energy architecture environment may be required.

In various embodiments, a surgical instrument is disclosed that includes an end effector that includes an ultrasonic blade and a clamp arm. The clamp arm is movable relative to the ultrasound blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasound blade and the clamp arm. The surgical instrument further includes an ultrasound transducer configured to generate an ultrasound energy output and a waveguide configured to transmit the ultrasound energy output to the ultrasound blade. The surgical instrument further includes a control circuit configured to detect immersion of the end effector in the liquid and compensate for heat flux lost due to immersion of the end effector in the liquid.

In various embodiments, a surgical instrument is disclosed that includes an end effector that includes an ultrasonic blade and a clamp arm. The clamp arm is movable relative to the ultrasound blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasound blade and the clamp arm. The surgical instrument includes an ultrasonic transducer configured to generate an ultrasonic energy output, a waveguide configured to transmit the ultrasonic energy output to an ultrasonic blade, and a clamp arm for moving the ultrasonic blade. , a drive member configured to transition the end effector to a closed configuration. The surgical instrument further includes a control circuit configured to monitor the position of the drive member, monitor the temperature of the ultrasonic blade, and ensure that the temperature does not exceed a predetermined threshold prior to the closed configuration.

In various embodiments, a surgical instrument is disclosed that includes an end effector that includes a first jaw and a second jaw. The second jaw is moved relative to the first jaw to transition the end effector between an open configuration and a closed configuration to grasp tissue between the first and second jaws. It is possible. The end effector includes an ultrasound component configured to deliver ultrasound energy to the grasped tissue and a radio frequency (RF) component configured to deliver RF energy to the grasped tissue. Prepare more. The surgical instrument further comprises a control circuit configured to operate the ultrasound component in a non-therapeutic diagnostic mode while operating the RF component in a therapeutic mode to treat the grasped tissue.

The features of various aspects are set forth in detail in the appended claims. However, various aspects of both the mechanism and the method of operation, together with further objects and advantages thereof, can best be understood by reference to the following description, taken in conjunction with the accompanying drawings, in which: FIG.
1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure. FIG. 1 is a surgical system used to perform a surgical procedure within an operating room in accordance with at least one aspect of the present disclosure. A surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. 1 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing, in accordance with at least one aspect of the present disclosure; FIG. 1 is a perspective view of a combination generator module with bipolar, ultrasonic, and monopolar contacts and smoke evacuation components in accordance with at least one aspect of the present disclosure; FIG. FIG. 6 illustrates individual power bus attachments of a plurality of lateral docking ports of a lateral modular housing configured to receive a plurality of modules in accordance with at least one aspect of the present disclosure. 2 illustrates a vertical modular housing configured to receive a plurality of modules in accordance with at least one aspect of the present disclosure. A modular device located in one or more operating rooms of a medical facility, or any room within a medical facility with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure, can be placed in the cloud. 1 illustrates a surgical data network with modular communication hubs configured to connect; 1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. 3 illustrates a surgical hub with multiple modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure; FIG. 1 illustrates one aspect of a Universal Serial Bus (USB) network hub device in accordance with at least one aspect of the present disclosure. 1 illustrates a logic diagram of a surgical instrument or tool control system in accordance with at least one aspect of the present disclosure. 1 illustrates a control circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 2 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 3 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of a robotic surgical instrument configured to manipulate the surgical tools described herein, according to at least one aspect of the present disclosure. FIG. 3 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure. 1 is a circuit diagram of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure. FIG. 1 is a system configured to execute an adaptive ultrasound blade control algorithm within a surgical data network that includes a modular communication hub, in accordance with at least one aspect of the present disclosure. 3 illustrates one example of a generator in accordance with at least one aspect of the present disclosure. 1 is a surgical system comprising a generator and various surgical instruments usable with the generator, according to at least one aspect of the present disclosure. 1 is an end effector according to at least one aspect of the present disclosure. 23 is an illustration of the surgical system of FIG. 22, in accordance with at least one aspect of the present disclosure. FIG. 3 is a model illustrating operational branch currents in accordance with at least one aspect of the present disclosure. FIG. 2 is a structural diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. 1 is a structural and functional aspect of a generator in accordance with at least one aspect of the present disclosure. 1 is a structural and functional aspect of a generator in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of one embodiment of an ultrasonic drive circuit. 30 is a circuit diagram of a transformer coupled to the ultrasonic drive circuit shown in FIG. 29, in accordance with at least one aspect of the present disclosure. FIG. 31 is a circuit diagram of the transformer shown in FIG. 30 coupled to a test circuit, in accordance with at least one aspect of the present disclosure. FIG. FIG. 2 is a circuit diagram of a control circuit in accordance with at least one aspect of the present disclosure. FIG. 3 shows a simplified block circuit diagram illustrating another electrical circuit contained within a modular ultrasonic surgical instrument in accordance with at least one aspect of the present disclosure. 4 illustrates a generator circuit divided into multiple stages in accordance with at least one aspect of the present disclosure. 2 illustrates a generator circuit divided into multiple stages, with a first stage circuit in common with a second stage circuit, in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of one aspect of a drive circuit configured to drive radio frequency current (RF) in accordance with at least one aspect of the present disclosure. 35 is a circuit diagram of a transformer coupled to the RF drive circuit shown in FIG. 34, in accordance with at least one aspect of the present disclosure. FIG. 1 is a circuit diagram of a circuit with separate power supplies for high power energy/drive circuits and low power circuits, in accordance with one aspect of a resent disclosure; FIG. 2 shows a control circuit that allows a dual generator system to switch between RF generator energy modalities and ultrasound generator energy modalities for a surgical instrument. FIG. 3A illustrates an illustration of an embodiment of a surgical instrument with a feedback system for use with a surgical instrument, according to an embodiment of the retransmitted disclosure. The basics of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate a plurality of waveforms for electrical signal waveforms for use in a surgical instrument, in accordance with at least one aspect of the present disclosure. 1 illustrates one aspect of the architecture. 1 illustrates one aspect of a direct digital synthesis (DDS) circuit configured to generate a plurality of electrical signal waveforms for use in a surgical instrument, in accordance with at least one aspect of the present disclosure. One cycle of a discrete-time digital electrical signal waveform (shown superimposed on a discrete-time digital electrical signal waveform for comparison purposes) according to at least one aspect of the present disclosure of an analog waveform, according to at least one aspect of the present disclosure. show. A control configured to provide progressive closure of the closure member as the closure member is advanced distally to close the clamp arm and apply a closure force load at a desired rate, according to one aspect of the present disclosure. FIG. 2 is a diagram of the system. 1 illustrates a proportional-integral-derivative (PID) controller feedback control system according to one aspect of the present disclosure. Elevated disassembly of a modular handheld ultrasonic surgical instrument with the left shell half removed from the handle assembly to expose a device identifier communicatively coupled to a multi-lead handle terminal assembly, according to an aspect of the present disclosure. It is a diagram. 47 is a detailed view of the trigger portion and switch of the ultrasonic surgical instrument shown in FIG. 46, in accordance with at least one aspect of the present disclosure; FIG. FIG. 7 is a fragmentary, close-up perspective view of the end effector from the distal end with the jaw members in an open position, in accordance with at least one aspect of the present disclosure. FIG. 2 is a system diagram of a segmented circuit comprising multiple independently operating circuit segments in accordance with at least one aspect of the present disclosure. FIG. 3 is a circuit diagram of various components of a surgical instrument with motor control functionality in accordance with at least one aspect of the present disclosure. 3 illustrates one aspect of an end effector with an RF data sensor located on a jaw member in accordance with at least one aspect of the present disclosure. 52 illustrates one embodiment of the flexible circuit shown in FIG. 51, in which a sensor may be attached to or integrally formed with the flexible circuit, in accordance with at least one embodiment of the present disclosure. 1 is an alternative system for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system in accordance with at least one aspect of the present disclosure. 2 is a spectrum of the same ultrasound device with the end effector in various different states and conditions, in which the phase and magnitude of the impedance of an ultrasound transducer is plotted as a function of frequency, in accordance with at least one aspect of the present disclosure. 2 is a graphical illustration of a plot of a set of 3D training data S in which the magnitude and phase of the impedance of an ultrasound transducer is plotted as a function of frequency, in accordance with at least one aspect of the present disclosure; FIG. FIG. 2 is a logic flow diagram illustrating a control program or logic arrangement for determining jaw conditions based on complex impedance characteristic patterns (fingerprints) in accordance with at least one aspect of the present disclosure. 3 is a circular plot of complex impedance plotted as an imaginary component versus a real component of a piezoelectric vibrator, in accordance with at least one aspect of the present disclosure; FIG. 3 is a circular plot of complex admittance plotted as imaginary versus real component of a piezoelectric vibrator, in accordance with at least one aspect of the present disclosure; FIG. Figure 2 is a circular plot of the complex admittance of a 55.5kHz ultrasonic piezoelectric transducer. 2 is a graphical representation of an impedance analyzer showing an impedance/admittance circle plot of an ultrasound device with open jaws and no load, with red indicating admittance and blue indicating impedance, in accordance with at least one aspect of the present disclosure; FIG. . 3 is a graphical representation of an impedance analyzer showing an impedance/admittance circle plot of an ultrasound device with the jaws clamped on a dry chamois, with red indicating admittance and blue indicating impedance, in accordance with at least one aspect of the present disclosure; FIG. shows. 2 is a graphical representation of an impedance analyzer showing an impedance/admittance circle plot of an ultrasound device with the jaw tips clamped on a wet chamois, with red color indicating admittance and blue color in accordance with at least one aspect of the present disclosure. indicates impedance. 2 is a graphical representation of an impedance analyzer showing an impedance/admittance circle plot of an ultrasound device with the jaws fully clamped on a wet chamois, with red color indicating admittance and blue color in accordance with at least one aspect of the present disclosure. indicates impedance. FIG. 7 is a graphical representation of an impedance analyzer showing an impedance/admittance plot where the frequency is swept from 48 kHz to 62 kHz to capture multiple resonances of an open jaw ultrasound device in accordance with at least one aspect of the present disclosure; FIG. , and the gray overlay is to make the circle easier to see. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic configured to determine jaw conditions based on predictions of impedance/admittance circle radius and offset, in accordance with at least one aspect of the present disclosure. 2 is a complex impedance spectrum of the same ultrasound device with cold (blue) and hot (red) ultrasound blades, according to at least one aspect of the present disclosure; FIG. 2 is a graphical representation of impedance phase angle as a function of resonant frequency of a sonic device; FIG. 2 is a complex impedance spectrum of the same ultrasound device with cold (blue) and hot (red) ultrasound blades, according to at least one aspect of the present disclosure; FIG. 1 is a graphical representation of the magnitude of impedance as a function of resonant frequency of a sonic device; FIG. FIG. 3 is an illustration of a Kalman filter that improves a temperature estimator and state-space model based on impedance across an ultrasound transducer measured at various frequencies, in accordance with at least one aspect of the present disclosure. 67 are three probability distributions used by the Kalman filter state estimator shown in FIG. 67 to maximize estimation, in accordance with at least one aspect of the present disclosure. FIG. 2 is a graph of temperature versus time for an ultrasound device in which the temperature control does not reach a maximum temperature of 490°C; FIG. 3 is a graphical illustration of temperature versus time for an ultrasound device with temperature control reaching a maximum temperature of 320° C., in accordance with at least one aspect of the present disclosure. FIG. 3 is a graphical illustration of a feedback control for adjusting the ultrasonic power applied to an ultrasonic transducer when a sudden temperature drop in the ultrasonic blade is detected, and is a graphical illustration of the ultrasonic power as a function of time. . 3 is a graphical illustration of a feedback control for adjusting ultrasound power applied to an ultrasound transducer when a rapid temperature drop in an ultrasound blade is detected as a function of time, according to at least one aspect of the present disclosure; FIG. is a plot of ultrasonic blade temperature. FIG. 2 is a process logic flow diagram illustrating a control program or logic arrangement for controlling the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. 3 is a timeline illustrating situational awareness of a surgical hub in accordance with at least one aspect of the present disclosure. 3 illustrates an end effector of a surgical instrument in accordance with at least one aspect of the present disclosure. 3 is an amplitude versus time graph illustrating treatment cycles generated by a transducer of an electrosurgical instrument, in accordance with at least one aspect of the present disclosure; FIG. 74 illustrates various stages of closure of the end effector of FIG. 73; 74 illustrates various stages of closure of the end effector of FIG. 73; FIG. 3 is a logic flow diagram of a process illustrating a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure. FIG. 3 is a schematic diagram of an exemplary tissue contacting circuit showing the completion of the circuit when a pair of spaced apart contact plates are contacted with tissue. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram illustrating a control circuit that includes an absolute position detection system in accordance with at least one aspect of the present disclosure. FIG. 2 is a logic flow diagram of a process illustrating a control program or logic arrangement for switching between energy operating modes of an electrosurgical instrument in accordance with at least one aspect of the present disclosure. In accordance with at least one aspect of the present disclosure, the energy delivered to the clamped tissue by the end effector of the electrosurgical instrument and the energy delivered to the motor of the electrosurgical instrument to a predetermined threshold of the monitored parameter. FIG. 2 is a logic flow diagram of a process showing a control program or logic structure for adjusting based on the control program; 2 is a logical flow diagram of a process illustrating a control program or logic configuration for adjusting different electromechanical systems of an ultrasonic surgical instrument based on predetermined thresholds of monitored parameters, in accordance with at least one aspect of the present disclosure; FIG. . 3 is a graph representing tissue impedance (Z), power (P), and force (F) at a distal portion (tip) of an end effector of an electrosurgical instrument clamping tissue, according to at least one aspect of the present disclosure; Tissue impedance (Z), power (P), and force (F) are plotted on the Y-axis against time (t) on the X-axis. Figure 3 is a graph representing power (P) as a function of time (t) in diagnostic mode (top graph) and response mode (bottom graph). FIG. 3 is a logic flow diagram of a process illustrating a control program or logic arrangement for detecting and compensating for immersion of an ultrasonic blade in a liquid, in accordance with at least one aspect of the present disclosure. FIG. 5 illustrates a graphical representation of power delivered to an end effector (p) and tissue temperature as a function of closure driver displacement, in accordance with at least one aspect of the present disclosure; FIG. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic arrangement for detecting and compensating for immersion of an ultrasonic blade in a liquid, in accordance with at least one aspect of the present disclosure. 2 is a graph including four graphs, the first graph from the top representing voltage (V) and current (I) versus time (t), and the second graph representing power (P), in accordance with at least one aspect of the present disclosure. ) vs. time (t), the third graph represents temperature (T) vs. time (t), and the fourth graph represents tissue impedance (Z) vs. time (t). Using a value of tissue impedance (Z) as a trigger condition for stepping up the voltage (V) applied to tissue by an end effector of an electrosurgical instrument at the end of a tissue treatment cycle, according to at least one aspect of the present disclosure. FIG. 3 is a logical flow diagram of the process showing the control program or logical configuration utilized. Utilizing a value of temperature (T) as a trigger condition to step up the voltage (V) applied to tissue by an end effector of an electrosurgical instrument at the end of a tissue treatment cycle, according to at least one aspect of the present disclosure. FIG. 2 is a logical flow diagram of a process showing a control program or logical structure for implementing the process. A control program or logic arrangement for adjusting power (P) to an RF component of a combination device based on a temperature (T) monitored by an ultrasound component of the combination device, according to at least one aspect of the present disclosure. FIG. 2 is a logical flow diagram of a process illustrating the process. 3 is a graph including three graphs, the first graph from the top is the power (P) delivered to tissue captured between the jaws of the bipolar RF component of the combination device, in accordance with at least one aspect of the present disclosure; , the second graph represents the tissue temperature measured by the ultrasound component of the combination device, and the third graph represents the dual non-therapeutic temperature measured by the ultrasound component to determine the tissue temperature. Represents frequency. 3 illustrates a control program or logic arrangement for actively adjusting the frequency of an RF waveform of an RF electrosurgical instrument or RF component of a combination device based on measured tissue impedance, according to at least one aspect of the present disclosure; FIG. 3 is a logical flow diagram of the process.

The applicant of this application owns the following United States patent applications filed August 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
United States Patent Application Docket No. END8536USNP2/180107-2 entitled "ESTIMATION STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";
United States Patent Application Docket No. END8560USNP2/180106-2 entitled “TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR”;
United States Patent Application Docket No. END8561USNP1/180144-1 entitled “RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS”;
United States Patent Application Docket No. END8563USNP1/180139-1 entitled “CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION”;
United States Patent Application Docket No. END8563USNP2/1801 entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE" No. 39-2,
United States Patent Application Docket No. END8563USNP3/180139-3 entitled "DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM";
U.S. Patent Application Docket No. END8563USNP4/180139 entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT" No. 4,
United States Patent Application Docket No. END8563USNP5/180139-5 entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR";
United States Patent Application Docket No. END8564USNP1/180140-1 entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS";
US Patent Application Docket No. END8564USNP2/1801 entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT" No. 40-2,
United States Patent Application Docket No. END8565USNP1/180142-1 entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING";
United States Patent Application Docket No. END8565USNP2/180142-2 entitled “INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP”;
U.S. Patent Application Docket No. END8566USNP1/180143-1 entitled ``BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY,'' and `` US Patent Application Docket No. END8573USNP1/180145-1 entitled ``ACTIVATION OF ENERGY DEVICES''.

The applicant of this application owns the following United States patent applications filed August 23, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Provisional Patent Application No. 62/721,995 entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION,"
U.S. Provisional Patent Application No. 62/721,998 entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS";
U.S. Provisional Patent Application No. 62/721,999 entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING";
U.S. Provisional Patent Application No. 62/721,994 entitled “BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY” and “RADIO FREQU U.S. Provisional Patent Application No. 62/721 entitled “ENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS,” No. 996.

The applicant of this application owns the following United States patent applications filed June 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Provisional Patent Application No. 62/692,747 entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE";
U.S. Provisional Patent Application No. 62/692,748, entitled "SMART ENERGY ARCHITECTURE," and U.S. Provisional Patent Application No. 62/692,768, entitled "SMART ENERGY DEVICES."

The applicant of this application owns the following United States patent applications filed June 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Patent Application No. 16/024,090 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS";
U.S. Patent Application No. 16/024,057 entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";
U.S. Patent Application No. 16/024,067 entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION,"
U.S. Patent Application No. 16/024,075 entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING,"
U.S. Patent Application No. 16/024,083 entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING,"
U.S. Patent Application No. 16/024,094 entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES";
U.S. Patent Application No. 16/024,138 entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE,"
U.S. Patent Application No. 16/024,150 entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES";
U.S. Patent Application No. 16/024,160 entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY";
U.S. Patent Application No. 16/024,124 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
U.S. Patent Application No. 16/024,132 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT";
U.S. Patent Application No. 16/024,141 entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY";
U.S. Patent Application No. 16/024,162 entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES";
U.S. Patent Application No. 16/024,066 entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
U.S. Patent Application No. 16/024,096 entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS";
U.S. Patent Application No. 16/024,116 entitled "SURGICAL EVACUATION FLOW PATHS";
U.S. Patent Application No. 16/024,149 entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL";
U.S. Patent Application No. 16/024,180 entitled "SURGICAL EVACUATION SENSING AND DISPLAY";
"COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL P U.S. Patent Application No. 16/024,245 entitled ``LATFORM'';
U.S. Patent Application No. 16/024,258 entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM,"
"SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE" U.S. Patent Application No. 16/024,265 entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS" No. 16/024, 273.

The applicant of this application owns the following United States Provisional Patent Applications filed June 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Provisional Patent Application No. 62/691,228 entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES,"
U.S. Provisional Patent Application No. 62/691,227 entitled “CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS”;
U.S. Provisional Patent Application No. 62/691,230 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
U.S. Provisional Patent Application No. 62/691,219 entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
"COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL P U.S. Provisional Patent Application No. 62/691,257 entitled ``LATFORM'';
"SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE" U.S. Provisional Patent Application No. 62/691,262 entitled ``DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.'' Application No. 62/691,251.

The applicant of this application owns the following United States Provisional Patent Applications filed April 19, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Provisional Patent Application No. 62/659,900 entitled "METHOD OF HUB COMMUNICATION."

The applicant of this application owns the following United States Provisional Patent Applications filed March 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Provisional Patent Application No. 62/650,898, filed March 30, 2018, entitled “CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS”;
U.S. Provisional Patent Application No. 62/650,887 entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES";
U.S. Provisional Patent Application No. 62/650,882 entitled ``SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM,'' and ``SURGICAL SMOKE EVACUATION SENSING AND CON. US Provisional Patent Application No. 62/650,877 entitled ``TROLS''.

The applicant of this application owns the following United States patent applications filed March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Patent Application No. 15/940,641 entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES,"
U.S. Patent Application No. 15/940,648 entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES,"
U.S. Patent Application No. 15/940,656 entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";
U.S. Patent Application No. 15/940,666 entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS";
U.S. Patent Application No. 15/940,670 entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS,"
U.S. Patent Application No. 15/940,677 entitled "SURGICAL HUB CONTROL ARRANGEMENTS";
U.S. Patent Application No. 15/940,632 entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD,"
``COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUDS BASED U.S. Patent Application No. 15/940,640 entitled ``ANALYTICS SYSTEMS'';
U.S. Patent Application No. 15/940,645 entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
U.S. Patent Application No. 15/940,649 entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
U.S. Patent Application No. 15/940,654 entitled "SURGICAL HUB SITUATIONAL AWARENESS";
U.S. Patent Application No. 15/940,663 entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
U.S. Patent Application No. 15/940,668 entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
U.S. Patent Application No. 15/940,671 entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
U.S. Patent Application No. 15/940,686 entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE,"
U.S. Patent Application No. 15/940,700 entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
U.S. Patent Application No. 15/940,629 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. Patent Application No. 15/940,704 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT,"
No. 15/940,722 entitled “CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY” and “DUA No. 15/940,742 entitled ``L CMOS ARRAY IMAGING''.
U.S. Patent Application No. 15/940,636 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. Patent Application No. 15/940,653 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS";
U.S. Patent Application No. 15/940,660 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER,"
"CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGE DATA SE U.S. patent application Ser. No. 15/940,679, entitled
U.S. Patent Application No. 15/940,694 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION" No.,
U.S. Patent Application No. 15/940,634 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES,"
U.S. patent application Ser. No. 15/940,675 entitled ``DEVICES''.
U.S. Patent Application No. 15/940,627 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,637 entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS,"
U.S. Patent Application No. 15/940,642 entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,676 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,680 entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,683 entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,690 entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" U.S. patent application Ser. No. 15/940,711 entitled "URGICAL PLATFORMS."

The applicant of this application owns the following United States Provisional Patent Applications filed March 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Provisional Patent Application No. 62/649,302 entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES,"
U.S. Provisional Patent Application No. 62/649,294 entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
U.S. Provisional Patent Application No. 62/649,300 entitled "SURGICAL HUB SITUATIONAL AWARENESS";
U.S. Provisional Patent Application No. 62/649,309 entitled “SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER”;
U.S. Provisional Patent Application No. 62/649,310 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. Provisional Patent Application No. 62/649,291 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT,"
U.S. Provisional Patent Application No. 62/649,296 entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”;
U.S. Provisional Patent Application No. 62/649,333 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER,"
U.S. Provisional Patent Application No. 62/649,327 entitled “CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES,”
U.S. Provisional Patent Application No. 62/649,315 entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK";
U.S. Provisional Patent Application No. 62/649,313 entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES,"
U.S. Provisional Patent Application No. 62/649,320 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Provisional Patent Application No. 62/649,307 entitled “AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS” and “SENSING ARRANGEMENTS FOR ROBOT-ASS US Provisional Patent Application No. 62/649,323 entitled "ISTED SURGICAL PLATFORMS."

The applicant of this application owns the following United States Provisional Patent Applications filed March 8, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Provisional Patent Application No. 62/640,417 entitled “TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR” and “ESTIMATION STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR” U.S. Provisional Patent Application No. 62/640,415 issue.

The applicant of this application owns the following United States Provisional Patent Applications filed December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety.
U.S. Provisional Patent Application No. 62/611,341 entitled "INTERACTIVE SURGICAL PLATFORM";
U.S. Provisional Patent Application No. 62/611,340 entitled "CLOUD-BASED MEDICAL ANALYTICS" and U.S. Provisional Patent Application No. 62/611,339 entitled "ROBOT ASSISTED SURGICAL PLATFORM."

Before describing various aspects of the surgical device and generator in detail, it should be noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. It should be kept in mind. The example embodiments may be implemented or incorporated into other aspects, variations, and modifications and may be practiced or carried out in various ways. Furthermore, unless otherwise stated, the terms and expressions used herein have been selected for the convenience of the reader to describe exemplary embodiments and are not intended to be limiting. . Furthermore, one or more of the aspects, implementations of the aspects, and/or examples described below may be combined with any other aspects, implementations of the aspects, and/or examples described below. It is to be understood that one or more can be combined.

Various aspects are directed to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical device may be configured, for example, to transect and/or coagulate tissue during a surgical procedure. Aspects of the electrosurgical device may be configured, for example, to transect, coagulate, scale, weld, and/or dry tissue during a surgical procedure.

Referring to FIG. 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 coupled to a storage device 105). ,including. Each surgical system 102 includes at least one surgical hub 106 that communicates with a cloud 104 that may include remote servers 113. In one example, as shown in FIG. 1, surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112 configured to communicate with each other and/or with hub 106. and, including. In some aspects, the surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112. , where M, N, O, and P are integers of 1 or more.

FIG. 3 shows an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 within a surgical operating room 116. Robotic system 110 is used as part of surgical system 102 in a surgical procedure. Robotic system 110 includes a surgeon's console 118, a patient cart 120 (surgical robot), and a surgical robot hub 122. The patient-side cart 120 is capable of manipulating at least one removably coupled surgical tool 117 while the surgeon views the surgical site via the surgeon's console 118 during a minimally invasive dissection of the patient's body. . Images of the surgical site may be obtained by medical imaging device 124, which may be manipulated by patient cart 120 to orient imaging device 124. Robotic hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via surgeon's console 118.

Other types of robotic systems can be easily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are disclosed in the application entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. No. 62/611,339.

Various examples of cloud-based analytics performed by cloud 104 and suitable for use with this disclosure are described in “CLOUD-BASED MEDICAL,” filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. US Provisional Patent Application No. 62/611,340 entitled ``ANALYTICS''.

In various aspects, imaging device 124 includes at least one 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.

Optical components of imager 124 may include one or more illumination sources and/or one or more lenses. One or more illumination sources may be directed to illuminate a portion of the surgical field. The one or more image sensors can receive reflected or refracted light from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to emit electromagnetic energy within the visible and invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or emission spectrum, is the portion of the electromagnetic spectrum that is visible to the human eye (i.e., detectable by the human eye) and is sometimes referred to as visible light, or simply light. The typical human eye is sensitive to wavelengths from about 380 nm to about 750 nm in air.

The invisible spectrum (ie, the non-emissive spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (ie, wavelengths less than about 380 nm and greater than about 750 nm). Invisible spectrum is not detectable by the human eye. Wavelengths above about 750 nm are longer than the red visible spectrum, and these become invisible infrared (IR), microwave, and wireless electromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, and these constitute invisible ultraviolet, X-ray, and gamma electromagnetic radiation.

In various aspects, imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use with the present disclosure include arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes). , endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlying structure. Multispectral images capture image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to light from specific wavelengths, including frequencies beyond the visible light range, such as IR and ultraviolet light. Spectral imaging can enable the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging techniques is described in "Advanced Imaging" in U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. Acquisition Module” section. Multispectral monitoring can be a useful tool to reposition the surgical field to perform one or more of the above-described tests on the treated tissue after one surgical task is completed.

It is self-evident that any surgical procedure requires rigorous sterilization of the operating room and surgical instruments. The stringent hygiene and sterilization conditions required in a "surgical theater", ie, operating room or treatment room, require maximum sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize anything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. A sterile field may be considered a specific area that is considered free of microorganisms, such as in a tray or on a sterile towel, or a sterile field may be considered the area immediately surrounding a patient prepared for a surgical procedure. It will be understood that what can be done. A sterile field may include cleaned team members wearing appropriate clothing and all equipment and fixtures within the area.

In various aspects, visualization system 108 includes one or more imaging sensors strategically positioned relative to the sterile field and one or more image processing units, as shown in FIG. one or more storage arrays; and one or more displays. In one aspect, visualization system 108 includes HL7, PACS, and EMR interfaces. Various components of visualization system 108 are described in U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is explained in the section "Advanced Imaging Acquisition Module".

As shown in FIG. 2, primary display 119 is positioned within the sterile field so that it is visible to an operator positioned at operating table 114. Additionally, visualization tower 111 is located outside the sterile field. Visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. A visualization system 108 guided by the hub 106 is configured to use displays 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, hub 106 may cause visualization system 108 to display a snapshot of the surgical site recorded by imaging device 124 on non-sterile display 107 or 109 while maintaining live video of the surgical site on primary display 119. I can do it. Snapshots on non-sterile display 107 or 109 may, for example, allow a non-sterile operator to perform diagnostic steps associated with a surgical procedure.

In one aspect, the hub 106 transmits diagnostic input or feedback entered by a non-sterile operator located at the visualization tower 111 within the sterile field to a primary display 119 within the sterile field and transmits this to a sterile operator located at the operating table. It is also configured so that people can view it. In one example, the input may be in the form of a modification to a snapshot displayed on non-sterile display 107 or 109 that may be sent by hub 106 to primary display 119.

Referring to FIG. 2, surgical instrument 112 is used as part of surgical system 102 in a surgical procedure. Hub 106 is also configured to coordinate the flow of information to the display of surgical instrument 112. For example, in U.S. Provisional Patent Application No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 location may be sent by the hub 106 within the sterile field to the surgical instrument display 115, where the diagnostic input or feedback is input to the surgical instrument 112. May be viewed by the operator. For exemplary surgical instruments suitable for use with surgical system 102, see, for example, the section entitled "Surgical Instrument Hardware" and the 2017 publication entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference. It is described in US Provisional Patent Application No. 62/611,341, filed December 28th.

Referring now to FIG. 3, hub 106 is shown in communication with visualization system 108, robotic system 110, and handheld intelligent surgical instrument 112. Hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communications module 130, a processor module 132, and a storage array 134. In certain aspects, as shown in FIG. 3, hub 106 further includes a smoke evacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, applying energy to tissue for sealing and/or cutting typically involves evacuation of smoke, suction of excess fluid, and/or irrigation of the tissue. Fluid, power, and/or data lines from different sources often become intertwined during surgical procedures. Valuable time may be lost addressing this problem during the surgical procedure. Disentangling the lines may require removing the lines from their corresponding modules, which may require resetting the modules. The hub's modular enclosure 136 provides a unified environment for managing power, data, and fluid lines and reduces the frequency of tangling between such lines.

Aspects of the present disclosure present a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably receivable within a docking station of the hub housing. The docking station includes data and power contacts. A combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combination generator module further includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, and application of therapeutic energy to tissue. at least one smoke evacuation component configured to expel smoke, fluid, and/or particulates; and a fluid line extending from the remote surgical site to the smoke evacuation component.

In one aspect, the fluid line is a first fluid line and the second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received within the hub housing. In one aspect, the hub housing includes a fluidic interface.

Certain surgical procedures may require the application of more than one energy type to tissue. One energy type may be more beneficial for cutting tissue, while another different energy type may be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue, while an ultrasound generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the hub's modular enclosure 136 is configured to house various generators and facilitate bi-directional communication therebetween. One of the advantages of the hub's modular housing 136 is that it allows for quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical housing for use in surgical procedures involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue and a first docking port including first data and power contacts. a first docking station comprising: a first energy generator module slidably movable into electrical engagement with the power and data contacts; and a first energy generator module comprising: The first power and data contact is slidably movable out of electrical engagement with the first power and data contact.

In addition to the above, the modular surgical housing includes a second energy generator module configured to generate a second energy for applying to tissue that is different than the first energy; a second docking station with a second docking port including data and power contacts of the second energy generator module, the second energy generator module being slidably moved into electrical engagement with the power and data contacts. and the second energy generator module is slidably movable out of electrical engagement with the second power and data contacts.

Additionally, the modular surgical housing includes a first docking port and a second docking port configured to facilitate communication between the first energy generator module and the second energy generator module. It further includes a communication bus to and from the port.

3-7, aspects of the present disclosure are presented relating to a modular housing 136 of a hub that allows for modular integration of a generator module 140, a smoke evacuation module 126, and a suction/irrigation module 128. be done. The hub's modular housing 136 further facilitates bi-directional communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 is an integrated monopolar, bipolar, and super It may also be a generator module comprising a sonic component. As shown in FIG. 5, generator module 140 may be configured to connect to monopolar device 146, bipolar device 147, and ultrasound device 148. Alternatively, the generator module 140 may include a series of monopolar, bipolar, and/or ultrasonic generator modules that interact through the hub's modular housing 136. The hub's modular housing 136 allows for the insertion of multiple generators and bi-directional communication between generators docked in the hub's modular housing 136 so that the multiple generators function as a single generator. The communication may be configured to facilitate communication.

In one aspect, the hub modular housing 136 includes a modular power and A communication backplane 149 is provided.

In one aspect, the hub modular housing 136 includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140, 126, 128. FIG. 4 shows a partial perspective view of surgical hub housing 136 and combination generator module 145 slidably receivable in docking station 151 of surgical hub housing 136. FIG. A docking port 152 with power and data contacts on the rear side of the combination generator module 145 allows the combination generator module 145 to be slid into position within the corresponding docking station 151 of the hub's modular housing 136. A corresponding docking port 150 is configured to engage power and data contacts of a corresponding docking station 151 of the hub's modular housing 136. In one aspect, the combination generator module 145 includes bipolar, ultrasonic, and monopolar modules and a smoke evacuation module integrated with a single housing unit 139, as shown in FIG.

In various aspects, the smoke evacuation module 126 includes a fluid line 154 that conveys captured/recovered smoke and/or fluid away from the surgical site, eg, to the smoke evacuation module 126. The vacuum suction generated from the smoke evacuation module 126 can draw smoke into the utility conduit opening at the surgical site. The utility conduit connected to the fluid line may be in the form of a flexible tube that terminates in the smoke evacuation module 126. Utility conduits and fluid lines define a fluid path extending toward the smoke evacuation module 126 received within the hub housing 136.

In various aspects, the aspiration/irrigation module 128 is coupled to a surgical tool that includes an aspiration fluid line and a suction fluid line. In one example, the suction and aspiration fluid lines are in the form of flexible tubing that extends from the surgical site toward the suction/irrigation module 128. The one or more drive systems may be configured to cause irrigation and suction of fluid to and from the surgical site.

In one aspect, a surgical tool includes a shaft having an end effector at a distal end thereof, at least one energy treatment portion associated with the end effector, a suction tube, and an irrigation tube. The suction tube can have an inlet port at its distal end, and the suction tube extends through the shaft. Similarly, an irrigation tube can extend through the shaft and have an entry port proximate to the energy delivery device. The energy delivery instrument is configured to deliver ultrasound and/or RF energy to the surgical site and is initially coupled to the generator module 140 by a cable extending through the shaft.

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. A fluid source and/or a vacuum source may be housed within the aspiration/irrigation module 128. In one example, the fluid source and/or vacuum source may be housed within the hub housing 136 separate from the aspiration/irrigation module 128. In such embodiments, the fluidic interface may be configured to connect the suction/irrigation module 128 to a fluid source and/or a vacuum source.

In one aspect, the modules 140, 126, 128 and/or their corresponding docking stations on the hub's modular housing 136 align the docking ports of the modules with the docking stations of the hub's modular housing 136. The device may include an alignment mechanism configured to engage the corresponding components within the device. For example, as shown in FIG. 4, the combination generator module 145 includes a side bracket configured to slidably engage a corresponding bracket 156 of a corresponding docking station 151 of the hub's modular housing 136. Contains 155. The brackets cooperate to direct the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub's modular housing 136.

In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the modules are sized to be received within the drawers 151. For example, side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are of different sizes, each designed to accommodate a particular module.

Additionally, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting the module into a drawer with incompatible contacts.

As shown in FIG. 4, the docking port 150 of one drawer 151 is coupled to the docking port 150 of another drawer 151 via a communication link 157 to accommodate modules housed within the modular housing 136 of the hub. Two-way communication between the two can be facilitated. Alternatively or additionally, the docking port 150 of the hub modular housing 136 may facilitate wireless two-way communication between modules housed within the hub modular housing 136. Any suitable wireless communication may be used, such as Air Titan-Bluetooth.

FIG. 6 illustrates individual power bus attachments of a plurality of lateral docking ports of a lateral modular housing 160 configured to receive a plurality of modules of a surgical hub 206. Lateral modular housing 160 is configured to laterally receive and interconnect modules 161. The modules 161 are slidably inserted into a docking station 162 of a lateral modular housing 160 that includes a backplane for interconnecting the modules 161. As shown in FIG. 6, the modules 161 are laterally arranged within the laterally modular housing 160. Alternatively, modules 161 may be arranged vertically within a laterally modular housing.

7 shows a vertical modular housing 164 configured to receive multiple modules 165 of surgical hub 106. FIG. The modules 165 are slidably inserted into a docking station or drawer 167 of a vertical modular housing 164 that includes a backplane for interconnecting the modules 165. Although the drawer 167 of the vertical modular housing 164 is vertically oriented, in certain cases the vertical modular housing 164 may include a laterally oriented drawer. Additionally, modules 165 may interact with each other through docking ports in vertical modular housing 164. In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of module 165. In addition, vertical modular housing 164 includes a master module 178 that houses a plurality of submodules that are slidably received within master module 178.

In various aspects, the imaging module 138 includes a built-in video processor and a modular light source, and is adapted for use with a variety of imaging devices. In one aspect, the imaging device is constructed with a modular housing that can be assembled with a light source module and a camera module. The housing may be a disposable housing. In at least one embodiment, the disposable housing is removably coupled to a reusable controller, light source module, and camera module. The light source module and/or camera module can be selectively selected depending on the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for scanned beam imaging. Similarly, the light source module can be configured to deliver white light or different lights depending on the surgical procedure.

During a surgical procedure, it can be inefficient to remove a surgical device from the surgical field and replace it with another surgical device that includes a different camera or a different light source. Temporary loss of vision of the surgical field can have undesirable consequences. The modular imaging device of the present disclosure is configured to allow replacement of the light source module or camera module midstream during a surgical procedure without the need to remove the imaging device from the surgical field.

In one aspect, an imaging device includes a tubular housing that includes a plurality of channels. The first channel is configured to slidably receive a camera module that can be configured for snap-fit engagement with the first channel. The second channel is configured to slidably receive a light source module that can be configured to snap-fit into engagement with the second channel. In another example, the camera module and/or the light source module can be rotated to a final position within their corresponding channels. A threaded engagement may be employed instead of a snap-fit engagement.

In various embodiments, multiple imaging devices are positioned at various locations within the surgical field to provide multiple views. Imaging module 138 can be configured to switch between imaging devices to provide optimal viewing. In various aspects, imaging module 138 can be configured to integrate images from different imaging devices.

Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Pat. No. 7,995,045. Additionally, U.S. Patent No. 7,982,776, issued July 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is incorporated herein by reference in its entirety, provides a method for removing motion artifacts from image data. It describes various systems for doing so. Such a system may be integrated with imaging module 138. Additionally, U.S. Patent Application Publication No. 2011/0306840, published December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS" and "SYSTEM FOR PERFO August 28, 2014 titled “RMING A MINIMALLY INVASIVE SURGICAL PROCEDURE” Published US Patent Application Publication No. 2014/0243597 is each incorporated herein by reference in its entirety.

FIG. 8 shows how a cloud-based system (e.g. storage A surgical data network 201 is shown comprising a modular communication hub 203 configured to connect to a cloud 204 ), which may include a remote server 213 coupled to a device 205 . In one aspect, modular communications hub 203 includes a network hub 207 and/or a network switch 209 that communicates with a network router. Modular communication hub 203 may further be coupled to local computer system 210 to provide local computer processing and data manipulation. Surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to go from one device (or segment) to another device (or segment) and to cloud computing resources. The intelligent surgical data network includes additional mechanisms that allow traffic to pass through the monitored surgical data network and configure each port within the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

Modular devices 1a-1n located in the operating room may be coupled to a modular communication hub 203. Network hub 207 and/or network switch 209 can be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with devices 1a-1n may be transferred via a router to a cloud-based computer for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 can be coupled to network hub 207 and/or network router 211 to connect devices 2 a - 2 m to cloud 204 . Data associated with devices 2a-2n may be transferred via network router 211 to cloud 204 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to local computer system 210 for local data processing and manipulation.

It will be appreciated that surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and/or multiple network switches 209 with multiple network routers 211. Modular communications hub 203 may be housed within a modular control tower configured to receive a plurality of devices 1a-1n/2a-2m. Local computer system 210 may also be housed in the modular control tower. The modular communication hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n/2a-2m, eg, during a surgical procedure. In various aspects, the devices 1a-1n/2a-2m include, for example, an imaging module 138 coupled to an endoscope, among other modular devices that may be connected to the modular communications hub 203 of the surgical data network 201. , a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, an aspiration/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and/or Alternatively, various modules such as a non-contact sensor module may be mentioned.

In one aspect, surgical data network 201 includes a combination of network hub(s), network switch(es), and network router(s) that connect devices 1a-1n/2a-2m to the cloud. May include. Any one or all of the devices 1a-1n/2a-2m coupled to a network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. . It will be appreciated that cloud computing relies on shared computing resources to handle software applications, rather than having a local server or personal device. Although the term "cloud" may be used as a metaphor for "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which various services such as servers, storage, and applications are provided at the surgical site. (e.g., a fixed, mobile, temporary, or on-site operating room or space) and via the Internet to a modular communication hub 203 and/or computer system 210 located in a fixed, mobile, temporary, or on-site operating room or space. and delivered to devices connected to system 210. Cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices 1a-1n/2a-2m located within one or more operating rooms. Cloud computing services can perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located within the operating room. Hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

By applying cloud computer data processing techniques to the data collected by the devices 1a-1n/2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. After the tissue sealing and cutting procedure, at least some of the devices 1a-1n/2a-2m can be used to observe the state of the tissue and assess leakage or perfusion of the sealed tissue. . At least one of the devices 1a-1n/2a-2m is configured to use cloud-based computing to examine data including images of samples of body tissue for diagnostic purposes to identify medical conditions such as disease effects. Several can be used. This includes tissue and phenotypic localization and margin confirmation. Devices 1a-1n/2a for identifying body anatomy using various sensors integrated with the imaging device and techniques such as overlaying images captured by multiple imaging devices. ~2m can be used. Data collected by devices 1a-1n/2a-2m, including image data, may be transferred to cloud 204 or local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. . Data can be used to improve surgical procedures by determining whether further treatments can be performed, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics to tissue-specific sites and conditions. Results can be analyzed to improve. Such data analysis may further employ prognostic analysis processing, using a standardized approach to confirm surgical treatment and surgeon behavior or suggest modifications to surgical treatment and surgeon behavior. You can provide helpful feedback for any of them.

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n to the network hub. Network hub 207, in one aspect, may be implemented as a local network broadcast device that functions on the physical layer of the Open Systems Interconnection (OSI) model. A network hub provides connectivity to devices 1a-1n located within the same operating room network. Network hub 207 collects data in the form of packets and sends them in half-duplex mode to the router. Network hub 207 does not store any Media Access Control/Internet Protocol (MAC/IP) for transferring device data. Only one of the devices 1a-1n can transmit data via network hub 207 at a time. Network hub 207 has no routing table or intelligence as to where to send the information and broadcasts all network data across each connection and to remote server 213 (FIG. 9) on cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can be a security risk and cause bottlenecks.

In another implementation, operating room devices 2a-2m may be connected to network switch 209 via wired or wireless channels. Network switch 209 functions within the data link layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a to 2m located in the same operating room to a network. Network switch 209 sends data in the form of frames to network router 211 and functions in full duplex mode. Multiple devices 2a-2m can transmit data simultaneously via network switch 209. Network switch 209 stores and uses the MAC addresses of devices 2a-2m to transfer data.

Network hub 207 and/or network switch 209 are coupled to network router 211 to connect to cloud 204. Network router 211 functions within the network layer of the OSI model. The network router 211 sends data packets received from the network hub 207 and/or network switch 211 to the cloud for further processing and manipulation of the data collected by any one or all of the devices 1a-1n/2a-2m. Create a route to send to a base computer resource. Network router 211 is used to connect two or more different networks located at different locations, such as, for example, different networks located in different operating rooms of the same medical facility or different operating rooms of different medical facilities. Good too. Network router 211 sends data in the form of packets to cloud 204 and functions in full duplex mode. Multiple devices can transmit data at the same time. Network router 211 uses IP addresses to transfer data.

In one embodiment, network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. A USB hub can extend a single USB port into several tiers so that more ports are available for connecting the device to a host system computer. Network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short range high bandwidth wireless communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located within the operating room.

In other embodiments, the operating room devices 1a-1n/2a-2m exchange data over short distances from fixed and mobile devices (using short wavelength UHF radio waves in the ISM band of 2.4-2.485 GHz). ), and can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard to create a personal area network (PAN). In other aspects, the operating room equipment 1a-1n/2a-2m supports Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long Term Evolution (LTE), and Ev - DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any other wireless and Communication with modular communication hub 203 may be via a number of wireless or wired communications standards or protocols, including but not limited to wired protocols. A computing module may include multiple communication modules. For example, the first communication module may be dedicated to short-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to short-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to short-range wireless communications such as may be used exclusively for long-distance wireless communications.

The modular communication hub 203 can serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handles a data type known as a frame. The frames carry data generated by devices 1a-1n/2a-2m. Once the frame is received by modular communication hub 203, the frame is amplified and sent to network router 211, which can transmit the frame to network router 211 using any of the numerous wireless or wired communication standards or protocols described herein. Transfer this data to cloud computing resources.

Modular communication hub 203 may be used as a standalone device or may be connected to compatible network hubs and network switches to form a larger network. Modular communication hub 203 is generally easy to install, configure, and maintain, making it a good choice for networking operating room equipment 1a-1n/2a-2m.

FIG. 9 shows a computer-implemented interactive surgical system 200. Computer-implemented interactive surgical system 200 is similar to computer-implemented interactive surgical system 100 in many respects. For example, computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar to surgical system 102 in many respects. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204 that may include remote servers 213. In one aspect, computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to a plurality of operating room equipment, such as, for example, intelligent surgical instruments, robots, and other computerized equipment located within the operating room. . As shown in FIG. 10, modular control tower 236 includes modular communication hub 203 coupled to computer system 210. As shown in FIG. As illustrated in the embodiment of FIG. 9, the modular control tower 236 includes an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke evacuator module 226, a suction/ Coupled to irrigation module 228 , communication module 230 , processor module 232 , storage array 234 , smart device/appliance 235 optionally coupled to display 237 , and non-contact sensor module 242 . Operating room equipment is coupled to cloud computing resources and data storage via a modular control tower 236. Robot hub 222 may also be connected to a modular control tower 236 and cloud computing resources. Among others, devices/appliances 235, visualization system 208 may be coupled to modular control tower 236 via wired or wireless communication standards or protocols described herein. Modular control tower 236 may be coupled to hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from imaging modules, device/instrument displays, and/or other visualization systems 208. . The hub display may also display data received from devices connected to the modular control tower along with images and overlay images.

FIG. 10 shows surgical hub 206 with multiple modules coupled to modular control tower 236. FIG. Modular control tower 236 includes a modular communication hub 203, such as a network connection device, and a computer system 210, for example, to provide local processing, visualization, and imaging. As shown in FIG. 10, the modular communications hubs 203 are connected in a layered configuration to expand the number of modules (e.g., devices) that can be connected to the modular communications hubs 203 to transmit data associated with the modules. The information may be transferred to computer system 210, a cloud computing resource, or both. As shown in FIG. 10, each of the network hubs/switches within modular communication hub 203 includes three downstream ports and one upstream port. An upstream network hub/switch is connected to the processor to provide communication connectivity to cloud computing resources and local display 217. Communication to cloud 204 can occur via either wired or wireless communication channels.

Surgical hub 206 uses non-contact sensor modules 242 to measure dimensions of the operating room and generates a map of the surgical site using either ultrasound or laser-type non-contact measurement devices. “Surgical Hub Spatial Awareness Within an Operator” in U.S. Provisional Patent Application No. 62/611,341, filed December 28, 2017, entitled “INTERACTIVE SURGICAL PLATFORM,” which is incorporated herein by reference in its entirety. 'ating Room' The ultrasound-based non-contact sensor module scans the operating room by transmitting bursts of ultrasound waves and receiving echoes when the bursts of ultrasound reflect off the exterior walls of the operating room, as described in section where the sensor module is configured to determine the size of the operating room and adjust the distance limit for Bluetooth pairing. A laser-based non-contact sensor module, for example, transmits laser light pulses, receives laser light pulses that reflect off the exterior walls of an operating room, and compares the phase of the transmitted pulses with the received pulses to determine the location of the operating room. Scan the operating room by determining size and adjusting Bluetooth pairing distance limits.

Computer system 210 includes a processor 244 and a network interface 245. Processor 244 is coupled to communication module 247, storage 248, memory 249, non-volatile memory 250, and input/output interface 251 via a system bus. The system bus is a 9-bit bus, Industry Standard Architecture (ISA), Micro Channel Architecture (MSA), Enhanced ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Device Interconnect (PCI), Any bus including, but not limited to, USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association Bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus. It may be any of several types of bus structures, including a memory bus or memory controller, a peripheral or external bus, and/or a local bus, using a variety of bus architectures.

Processor 244 may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex from Texas Instruments. In one aspect, the processor includes on-chip memory, e.g., 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, details of which are available in the product data sheet, to improve performance above 40 MHz. a prefetch buffer, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), and/or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital with 12 analog input channels LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including a converter (ADC).

In one aspect, the processor 244 may include a safety controller that includes two controller family families, such as the TMS570 and RM4x, also known by the Hercules ARM Cortex R4 trade names from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety limit applications, among other things, to provide advanced integrated safety features while offering scalable performance, connectivity, and memory options. good.

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 a 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 functions as external cache memory. Furthermore, RAM includes SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sink link DRAM (SLDRAM), and direct RAM bus RAM (DRRAM). is available in many forms.

Computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage can be defined as a storage medium, independently or in the form of a compact disk ROM device (CD-ROM), a compact disk recordable drive (CD-R drive), a compact disk rewritable drive (CD-RW drive), or in combination with other storage media, including, but not limited to, optical disk drives such as digital versatile disk ROM drives (DVD-ROMs). A removable or non-removable interface may be used to facilitate connection of the disk storage device to the system bus.

It should be understood that computer system 210 includes software that acts as an intermediary between users and underlying computer resources as described in the preferred operating environment. Such software includes an operating system. An operating system, which may be stored on disk storage, functions to control and allocate the resources of a computer system. System applications take advantage of resource management by the operating system through program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein can be implemented with various operating systems or combinations of operating systems.

A user enters commands or information into computer system 210 through input device(s) coupled to I/O interface 251 . Input devices include pointing devices such as mice, trackballs, styluses, and touch pads, keyboards, microphones, joysticks, game pads, satellite dishes, scanners, TV tuner cards, digital cameras, digital video cameras, and web cameras. but not limited to. These and other input devices connect to the processor through the system bus through interface port(s). Interface port(s) include, for example, serial ports, parallel ports, game ports, and USB. The output device(s) use some of the same types of ports as the input device(s). Thus, for example, a USB port may be used to provide input to a computer system and output information from the computer system to an output device. Output adapters are provided to indicate that there are several output devices such as monitors, displays, speakers, and printers, among other output devices, that require special adapters. Output adapters include, by way of example and not limitation, video and sound cards that provide a connection between an output device and a system bus. Note that other devices and/or systems of devices, such as remote computer(s), provide both input and output functionality.

Computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) may be a personal computer, server, router, network PC, workstation, microprocessor-based device, peer device, or other common network node, and typically includes a computer Contains many or all of the elements described with respect to the system. For simplicity, only the memory storage device is shown along with the remote computer(s). The remote computer(s) are logically connected to the computer system via a network interface and then physically connected via a communication connection. Network interfaces encompass communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber optic distributed data interface (FDDI), copper wire distributed data interface (CDDI), Ethernet/IEEE802.3, Token Ring/IEEE802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Network (ISDN) and its variants, packet-switched networks, and digital subscriber lines (DSL).

In various aspects, computer system 210 of FIG. 10, imaging module 238 of FIGS. 9-10, and/or visualization system 208, and/or processor module 232 are image processors, image processing engines, media processors, or digital image processors. may include any dedicated digital signal processor (DSP) used for processing. Image processors can use parallel computing using single instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) techniques to increase speed and efficiency. Digital image processing engines can perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

Communication connection(s) refers to the hardware/software used to connect the network interface to the bus. Although the communication connections are shown internal to the computer system for clarity of illustration, the communication connections may be external to the computer system 210. For illustrative purposes only, the hardware/software required to connect to a network interface includes internal and external technologies such as modems, including regular telephone grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards. Can be mentioned.

FIG. 11 illustrates a functional block diagram of one aspect of a USB network hub 300 device, in accordance with at least one aspect of the present disclosure. In the illustrated embodiment, USB network hub device 300 employs a Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308, compliant with the USB 2.0 standard. The upstream USB transmit/receive port 302 is a differential root data port that includes a differential data minus (DM0) input paired with a differential data plus (DP0) input. The three downstream USB transmit and receive ports 304, 306, 308 are differential data ports, each port including a differential data plus (DP1-DP3) output paired with a differential data minus (DM1-DM3) output.

The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller and does not require firmware programming. A fully compliant USB transceiver is integrated into the circuitry of the upstream USB transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transmit and receive ports 304, 306, 308 support both the highest speed and lower speed devices by automatically setting the slew rate depending on the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered or self-powered mode and includes hub power logic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310 (SIE). SIE 310 is the front end for the USB network hub 300 hardware and handles most of the protocols described in Chapter 8 of the USB specification. SIE 310 typically understands signaling down to the transaction level. The functions it handles include packet recognition, transaction reordering, SOP, EOP, RESET, and RESUME signal detection/generation, clock/data separation, non-return-to-zero inversion (NRZI) data encoding/decoding and bit stuffing, CRC Generation and checking (tokens and data), packet ID (PID) generation and checking/decoding, and/or serial-to-parallel/parallel-to-serial conversion may be mentioned. 310 receives a clock input 314 and includes suspend/resume logic as well as to control communication between the upstream USB transceiver port 302 and the downstream USB transceiver port 304, 306, 308 via port logic 320, 322, 324. It is coupled to a frame timer 316 circuit and a hub repeater circuit 318. SIE 310 is coupled to command decoder 326 via interface logic for controlling commands from the serial EEPROM via serial EEPROM interface 330.

In various aspects, USB network hub 300 can connect up to 127 functions organized in six logical layers to a single computer. Additionally, the USB network hub 300 can be connected to all peripherals using a standardized four wire cable that provides both communication and power distribution. The power configurations are bus power mode and self power mode. The USB network hub 300 has four types of power management: bus-powered hubs with either individual port power management or ganged port power management, and self-powered hubs with either individual port power management or ganged port power management. may be configured to support two modes. In one aspect, using a USB cable, a USB network hub 300, the upstream USB transceiver port 302 is plugged into a USB host controller, and the downstream USB transceiver ports 304, 306, 308 connect USB compatible devices. In other words, they are exposed for the sake of others.

Surgical Instrument Hardware FIG. 12 depicts a logic diagram of a surgical instrument or tool control system 470 in accordance with one or more aspects of the present disclosure. System 470 includes control circuitry. The control circuit includes a microcontroller 461 with a processor 462 and a memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to processor 462. A motor 482 driven by a motor driver 492 operably couples the longitudinally movable displacement member to drive the clamp arm closure member. Tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to a processor 462 that is programmable or configurable to determine the position of the longitudinally movable drive member and the position of the closure member. Additional motors may be provided at the tool driver interface to control movement of the closure tube, rotation of the shaft, articulation, or closure of the clamp arm, or a combination of the above. Display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on display 473 may be overlaid with images acquired via the endoscopic imaging module.

In one aspect, microcontroller 461 may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex from Texas Instruments. In one aspect, the main microcontroller 461 has on-chip memory, e.g., 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, the details of which are available in the product data sheet, improving performance above 40 MHz. 32 KB single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/or or an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments that includes one or more 12-bit ADCs with 12 analog input channels.

In one aspect, the microcontroller 461 may include a safety controller that includes two controller family families, such as the TMS570 and RM4x, also known by the Hercules ARM Cortex R4 trade names from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety limit applications, among other things, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

Microcontroller 461 may be programmed to perform various functions, such as precise control of the speed and position of the knife, articulation system, clamp arm, or combinations of the above. In one aspect, microcontroller 461 includes a processor 462 and memory 468. Electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical connection to an articulation or knife system. In one aspect, motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute position sensing system. A detailed description of the absolute position detection system is provided in the United States patent application published October 19, 2017 entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety. 2017th /0296213.

Microcontroller 461 may be programmed to provide precise control over the speed and position of the displacement member and articulation system. Microcontroller 461 may be configured to calculate the response within microcontroller 461 software. The calculated response is compared to the measured response of the actual system to obtain the "observed" response, which is used to determine the actual feedback. The observed response is a suitable calibrated value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.

In one aspect, motor 482 may be controlled by motor driver 492 and may be used by a surgical instrument or tool firing system. In various forms, motor 482 may be a brushed DC drive motor having a maximum rotational speed of approximately 25,000 RPM, for example. In other configurations, motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. Motor driver 492 may include, for example, an H-bridge driver including a field effect transistor (FET). Motor 482 may be powered by a power supply assembly releasably mounted to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery that may include a number of battery cells connected in series that may be used as a power source to power a surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and/or rechargeable battery cells. In at least one example, the battery cell may be a lithium ion battery that may be connectable to and separable from the power supply assembly.

Motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full-bridge controller for use with external N-channel power metal oxide semiconductor field effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. Driver 492 includes an inherent charge pump regulator that provides full (>10V) gate drive to battery voltages up to 7V and allows the A3941 to operate with reduced gate drive down to 5.5V. do. A bootstrap capacitor may be used to provide the battery supply voltage required for the N-channel MOSFET. An internal charge pump for high-side drive allows DC (100% duty cycle) operation. A full bridge can be driven in fast or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation is possible through both the high-side FET and the low-side FET. The power FET is protected from shoot-through by a register-adjustable dead time. Integrated diagnostics indicate low voltage, overtemperature, and power bridge abnormalities and can be configured to protect the power MOSFET under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute position sensing system.

Tracking system 480 includes controlled motor drive circuitry that includes a position sensor 472 according to one aspect of the present disclosure. A position sensor 472 for the absolute position detection system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for mating engagement with a corresponding drive gear of a gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamp arm, which may be adapted and configured to include a rack of drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to open and close a clamp arm of a stapler, ultrasonic, or electrosurgical device, or a combination of the foregoing. Accordingly, as used herein, the term displacement member is used generally to refer to any movable member of a surgical instrument or tool, such as a drive member, a clamp arm, or any element that can be displaced. be done. Therefore, the absolute position detection system can actually track the displacement of the clamp arm by tracking the linear displacement of the longitudinally movable drive member.

In other aspects, the absolute position detection system may be configured to track the position of the clamp arm during the opening and closing process. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member or the clamp arm, or a combination thereof, may be coupled to any suitable linear displacement sensor. Linear displacement sensors may include contact or non-contact displacement sensors. Linear displacement sensors include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), sliding potentiometers, movable magnets, and a series of linear displacement sensors. a magnetic sensing system comprising a Hall effect sensor disposed, a magnetic sensing system comprising a fixed magnet and a Hall effect sensor disposed on a series of movable straight lines, a movable light source and a Hall effect sensor disposed on a series of movable straight lines; It may include an optical detection system comprising a photodiode or photodetector, an optical detection system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof. .

Electric motor 482 may include a rotary shaft that operably interfaces with a gear assembly mounted in mating engagement with a set or rack of drive teeth on the displacement member. The sensor element may be operably coupled to the gear assembly such that one revolution of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gearing and sensor mechanism can be connected to a linear actuator by a rack and pinion mechanism or to a rotary actuator by a spur gear or other connection. A power supply can power the absolute position sensing system and an output indicator can display an output of the absolute position sensing system. The displacement member represents a longitudinally movable drive member with a rack of drive teeth formed thereon for mating engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents a longitudinally movable firing member that opens and closes the clamp arm.

One rotation of the sensor element associated with the position sensor 472 corresponds to a longitudinal linear displacement d ₁ of the displacement member, _which means that after one rotation of the sensor element coupled to the displacement member, the displacement member reaches point "a". " is the longitudinal straight line distance traveled from point "b" to point "b". The sensor mechanism may be connected via a gear reduction that results in the position sensor 472 completing one or more revolutions for a full stroke of the displacement member. The position sensor 472 can complete multiple rotations for a full stroke of the displacement member.

A series of switches (where n is an integer greater than 1), either used alone or in combination with a gear reduction, provide unique position signals for more than one rotation of the position sensor 472. May be used in The state of the switch is fed back to the microcontroller 461, which applies logic to determine the longitudinal linear displacement of the displacement member d ₁ +d ₂ + . ．． ．． Determine a unique position signal corresponding to d _n . The output of position sensor 472 is provided to microcontroller 461. The position sensor 472 of the sensor mechanism may comprise a magnetic sensor, an analog rotation sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.

Position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified based on whether they measure the total field or vector components of a magnetic field. The technology used to produce both types of magnetic sensors involves many aspects of physics and electronics. Techniques used to sense magnetic fields include, inter alia, search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance. , magnetostrictive/piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magneto-optics, and microelectromechanical systems-based magnetic sensors.

In one aspect, the position sensor 472 of the tracking system 480 that includes an absolute position sensing system comprises a magnetic rotation absolute position sensing system. Position sensor 472 may be implemented as an AS5055EQFT single chip magnetic rotary position sensor available from Austria Microsystems, AG. Position sensor 472 works with microcontroller 461 to provide an absolute position sensing system. Position sensor 472 is a low voltage, low power component and includes four Hall effect elements in the area of position sensor 472 located above the magnet. Additionally, a high resolution ADC and smart power management controller are provided on-chip. The digit-by-digit method and Boulder method are used to implement concise and efficient algorithms for computing hyperbolic and trigonometric functions that require only addition, subtraction, bit-shifting, and table lookup operations. A Coordinate Rotation Digital Computer (CORDIC) processor, also known as Volder's algorithm, is provided. Angular position, alarm bits, and magnetic field information are transmitted to microcontroller 461 via a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. Position sensor 472 provides 12-bit or 14-bit resolution. Position sensor 472 may be an AS5055 chip provided in a small QFN 16 pin 4x4x0.85mm package.

A tracking system 480 that includes an absolute position detection system may include and/or be programmed to implement a PID, state feedback, and feedback controller, such as an adaptive controller. A power supply converts the signal from the feedback controller into a physical input to the system, in this case voltage. Other examples include voltage, current, and force PWM. In addition to the position measured by position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, the other sensor(s) include U.S. Pat. , 345,481, and U.S. Patent Application Publication No. 2014/0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety. TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed June 20, 2017, incorporated herein by reference. As described in U.S. Patent Application No. 15/628,175 Examples include sensor mechanisms such as objects. In a digital signal processing system, an absolute position detection system is coupled to a digital data acquisition system, where the output of the absolute position detection system has a finite resolution and sampling frequency. Absolute position detection systems use comparison and combination techniques to combine the calculated response with the measured response using algorithms such as weighted averaging and theoretical control loops that drive the calculated response toward the measured response. A circuit may be provided. The calculated response of a physical system takes into account properties such as mass, inertia, viscous friction, induced drag, etc. in order to predict what the state and output of the physical system will be by knowing the inputs.

The absolute position detection system resets the displacement member, as may be required with conventional rotary encoders, where the motor 482 simply counts the number of steps forward or backward that it has taken to estimate the position of a device actuator, drive bar, knife, etc. Provides the absolute position of the displacement member upon power-up of the instrument without retracting or advancing to a (zero or home) position.

A sensor 474, such as a strain gauge or microstrain gauge, may be indicative of one or more of the end effectors, such as the amplitude of strain exerted on the anvil during a clamping operation, which may, for example, indicate the closing force applied to the anvil. configured to measure parameters of. The measured distortion is converted to a digital signal and provided to processor 462. In place of or in addition to sensor 474, a sensor 476, such as a load sensor, measures the closure force that the closure drive system applies to the anvil in a stapler or clamp arm in an ultrasonic or electrosurgical instrument. I can do it. For example, the sensor 476, such as a load sensor, may detect a firing force applied to a closure member coupled to a clamp arm of a surgical instrument or tool, or applied to tissue positioned within the jaws of an ultrasonic or electrosurgical instrument by the clamp arm. The force applied can be measured. Alternatively, current sensor 478 can be used to measure the current draw by motor 482. The displacement member may also be configured to engage the clamp arm to open and close the clamp arm. The force sensor may be configured to measure clamping force on tissue. The force required to advance the displacement member may correspond to an electrical current drawn by motor 482, for example. The measured force is converted to a digital signal and provided to processor 462.

In one form, strain gauge sensor 474 can be used to measure the force applied to tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force exerted by the end effector on the tissue being treated. A system for measuring force applied to tissue grasped by an end effector includes, for example, a strain gauge sensor 474, such as a microstrain gauge configured to measure one or more parameters of the end effector. Equipped with. In one aspect, strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the end effector jaw members during a grasping operation, which can be indicative of tissue compression. The measured distortion is converted to a digital signal and provided to the processor 462 of the microcontroller 461. Load sensor 476 can measure the force used to manipulate the knife element, for example, to cut tissue captured between the anvil and the staple cartridge. Load sensor 476 operates the clamp arm element, for example, to capture tissue between the clamp arm and an ultrasonic blade, or to capture tissue between the clamp arm and the jaws of an electrosurgical instrument. The force used to do this can be measured. A magnetic field sensor can be used to measure the thickness of captured tissue. Magnetic field sensor measurements may also be converted to digital signals and provided to processor 462.

Measurements of tissue compression, tissue thickness, and/or the force required to close the end effector on the tissue, as measured by sensors 474, 476, respectively, are determined based on the selected position of the firing member, and/or or can be used by the microcontroller 461 to characterize the corresponding value of the velocity of the firing member. In one example, memory 468 can store techniques, equations, and/or lookup tables that can be used by microcontroller 461 during evaluation.

The surgical instrument or tool control system 470 may also include wired or wireless communication circuitry for communicating with the modular communication hub as shown in FIGS. 8-11.

FIG. 13 illustrates a control circuit 500 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. Control circuit 500 may be configured to implement various processes described herein. Control circuit 500 can include a microcontroller that includes one or more processors 502 (eg, microprocessors, microcontrollers) coupled to at least one memory circuit 504. Memory circuit 504 stores machine-executable instructions that, when executed by processor 502, cause processor 502 to execute machine instructions to implement the various processes described herein. Processor 502 may be any one of a number of single or multi-core processors known in the art. Memory circuit 504 may include volatile and non-volatile storage media. Processor 502 may include an instruction processing unit 506 and a computing unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

FIG. 14 illustrates combinatorial logic 510 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. Combinatorial logic circuit 510 can be configured to implement various processes described herein. Combinatorial logic circuit 510 is a finite state machine that includes combinational logic 512 configured to receive data associated with a surgical instrument or tool at input 514, process the data through combinational logic 512, and provide output 516. may include.

FIG. 15 illustrates a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. Sequential logic circuit 520 or combinatorial logic 522 may be configured to implement various processes described herein. Sequential logic circuit 520 may include a finite state machine. Sequential logic circuit 520 may include, for example, combinational logic 522, at least one memory circuit 524, and a clock 529. At least one memory circuit 524 can store the current state of the finite state machine. In particular examples, sequential logic circuit 520 may be synchronous or asynchronous. Combinational logic 522 is configured to receive data associated with a surgical instrument or tool from input 526, process the data through combinational logic 522, and provide output 528. In other aspects, a circuit may include a combination of a processor (eg, processor 502 of FIG. 13) and a finite state machine that implements various processes herein. In other aspects, the finite state machine may include a combination of combinational logic circuits (eg, combinational logic circuit 510 of FIG. 14) and sequential logic circuit 520.

FIG. 16 shows a surgical instrument or tool with multiple motors that can be activated to perform various functions. In particular examples, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, and a third motor can be activated to perform a second function. A fourth motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain examples, multiple motors of robotic surgical instrument 600 can be individually activated to produce firing, closing, and/or articulating motions at the end effector. The firing motion, closing motion, and/or articulation motion can be transmitted to the end effector via the shaft assembly, for example.

In certain examples, a surgical instrument system or tool may include a firing motor 602. Firing motor 602 is operably coupled to firing motor drive assembly 604, which can be configured to transmit firing motion generated by motor 602 to an end effector, specifically to displace the clamp arm closure member. May be connected. The closure member may be retracted by reversing the direction of motor 602, thereby further opening the clamp arm.

In certain examples, the surgical instrument or tool may include a closure motor 603. Closure motor 603 is configured to specifically displace the closure tube to close the anvil and transmit the closure motion generated by motor 603 to the end effector to compress tissue between the anvil and the staple cartridge. may be operably coupled with a closure motor drive assembly 605, which may be configured. Closing motor 603 specifically displaces the closing tube to close the clamp arm and compress tissue between the clamp arm and either the ultrasonic blade or jaw member of the electrosurgical device. The closure motor drive assembly 605 may be operably coupled to the closure motor drive assembly 605, which may be configured to transmit the closure motion generated by 603 to the end effector. The closing motion may, for example, transition the end effector from an open configuration to an approximation configuration to capture tissue. The end effector may be moved to the open position by reversing the direction of motor 603.

In certain examples, a surgical instrument or tool may include one or more articulation motors 606a, 606b, for example. The motors 606a, 606b may be operably coupled to corresponding articulation motor drive assemblies 608a, 608b that may be configured to transmit the articulation motion generated by the motors 606a, 606b to the end effector. In certain examples, the articulation may, for example, cause the end effector to articulate relative to the shaft.

As mentioned above, a surgical instrument or tool may include multiple motors that may be configured to perform a variety of independent functions. In certain instances, multiple motors of a surgical instrument or tool may be activated independently or separately to perform one or more functions while other motors remain stopped. It can be implemented. For example, articulation motors 606a, 606b can be activated to articulate the end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 can be activated to fire multiple staples and/or advance the cutting edge while articulation motor 606 is stopped. Additionally, closure motor 603 may be activated simultaneously with firing motor 602 to advance the closure tube or member distally, as described in more detail herein below.

In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, the common control module 610 can serve one of multiple motors at a time. For example, a common control module 610 may be individually connectable and disconnectable to multiple motors of a robotic surgical instrument. In certain examples, multiple motors of a surgical instrument or tool may share one or more common control modules, such as common control module 610. In certain examples, multiple motors of a surgical instrument or tool can independently and selectively engage a common control module 610. In certain examples, the common control module 610 selectively switches from cooperating with one of the plurality of motors of the surgical instrument or tool to cooperating with another of the plurality of motors of the surgical instrument or tool. Can be switched.

In at least one example, common control module 610 selects between operative engagement with articulation motors 606a, 606b and operative engagement with either firing motor 602 or closure motor 603. can be switched. In at least one embodiment, as shown in FIG. 16, switch 614 can be moved or transitioned between multiple positions and/or states. For example, in a first position 616, the switch 614 may electrically couple the common control module 610 with the firing motor 602, and in a second position 617, the switch 614 may close the common control module 610. The switch 614 may electrically couple the common control module 610 with the first articulation motor 606a, and in the third position 618a, the switch 614 may electrically couple the common control module 610 with the first articulation motor 606a, and in the fourth position 618a. At 618b, switch 614 may electrically couple common control module 610 with second articulation motor 606b. In certain examples, a separate and common control module 610 may be electrically coupled to firing motor 602, closure motor 603, and articulation motors 606a, 606b at the same time. In particular examples, switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.

Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the motor's shaft. The force on the end effector may be sensed in any conventional manner, such as by a force sensor on the outside of the jaw or by a torque sensor on the motor actuating the jaw.

In various examples, as shown in FIG. 16, the common control module 610 may include a motor driver 626 that may include one or more H-bridge FETs. Motor driver 626 may modulate the power transferred from power supply 628 to motors coupled to common control module 610, for example, based on input from microcontroller 620 (“controller”). In certain examples, the microcontroller 620 can be used to determine the current drawn by the motors, for example, while the motors are coupled to a common control module 610, as described above.

In certain examples, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In particular examples, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform multiple functions and/or calculations described herein. good. In certain examples, one or more of memory units 624 may be coupled to processor 622, for example. In various aspects, microcontroller 620 may communicate via wired or wireless channels, or a combination thereof.

In certain examples, power supply 628 may be used to power microcontroller 620, for example. In certain examples, power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power the surgical instrument 600. A number of battery cells connected in series may be used as the power source 628. In certain examples, power source 628 may be replaceable and/or rechargeable, for example.

In various examples, processor 622 can control motor driver 626 to control the position, direction of rotation, and/or speed of motors coupled to common control module 610. In certain examples, processor 622 can signal motor driver 626 to stop and/or disable motors coupled to common control module 610. The term "processor" as used herein refers to any suitable microprocessor, microcontroller, or computer central processing unit (CPU) that combines the functionality of one or up to several integrated circuits. It should be understood to include other basic computing devices integrated above. Processor 622 is a general purpose programmable device that accepts digital data as input, processes that data according to instructions stored in memory, and provides results as output. This is an example of sequential digital logic since it has internal memory. Processors operate with numbers and symbols that are represented in a binary system.

In one example, processor 622 may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex from Texas Instruments. In a particular example, microcontroller 620 may be a LM 4F230H5QR available from Texas Instruments, for example. In at least one embodiment, the Texas Instruments LM4F230H5QR has on-chip memory, performance of up to 40 MHz of 256 KB of single-cycle flash memory or other non-volatile memory, among other characteristics readily available in the product data sheet. Prefetch buffer for super-improvement, 32KB single-cycle SRAM, internal ROM with StellarisWare® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs , an ARM Cortex-M4F processor core that includes one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be easily substituted for use with module 4410. Therefore, the present disclosure should not be limited to this context.

In certain examples, memory 624 may include program instructions for controlling each motor of surgical instrument 600 that is connectable to common control module 610. For example, memory 624 may include program instructions for controlling firing motor 602, closure motor 603, and articulation motors 606a, 606b. Such program instructions may cause processor 622 to control firing, closure, and articulation functions in accordance with input from a surgical instrument or tool algorithm or control program.

In certain examples, one or more mechanisms and/or sensors, such as sensor 630, may be used to alert processor 622 of program instructions to use in a particular configuration. For example, sensor 630 can alert processor 622 to use program instructions related to firing, closing, and articulating the end effector. In certain examples, sensor 630 may include a position sensor that can be used to sense the position of switch 614, for example. Accordingly, processor 622 uses program instructions associated with firing a closure member coupled to a clamp arm of an end effector upon detecting, for example, via sensor 630 that switch 614 is in first position 616. and the processor 622 can use program instructions associated with closing the anvil, for example, upon detecting that the switch 614 is in the second position 617 via the sensor 630, the processor 622 can: For example, upon detecting via sensor 630 that switch 614 is in third position 618a or fourth position 618b, program instructions associated with articulation of the end effector may be used.

FIG. 17 is a circuit diagram of a robotic surgical instrument 700 configured to manipulate the surgical tools described herein, according to one aspect of the present disclosure. Robotic surgical instrument 700 uses either single or multiple articulation drive connections to perform distal/proximal translation of the displacement member, distal/proximal displacement of the obturator canal, rotation of the shaft, and articulation. It may be programmed or configured to control movement. In one aspect, surgical instrument 700 may be programmed or configured to individually control the firing member, closure member, shaft member, or one or more articulation members, or combinations thereof. Surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, a closure member, a shaft member, or one or more articulating members, or a combination thereof.

In one aspect, the robotic surgical instrument 700 is coupled via a plurality of motors 704a-704e to a clamp arm 716 and closure member 714 portion of an end effector 702 and an ultrasound transducer 719 excited by an ultrasound generator 721. A control circuit 710 is configured to control the ultrasonic blade 718, the shaft 740, and one or more articulating members 742a, 742b. Position sensor 734 may be configured to provide position feedback of closure member 714 to control circuit 710. Other sensors 738 may be configured to provide feedback to control circuit 710. Timer/counter 731 provides timing and counting information to control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. Motors 704a-704e can be individually operated by control circuit 710 in open-loop or closed-loop feedback control.

In one aspect, control circuit 710 includes one or more microcontrollers, microprocessors, or other suitable devices for executing instructions that cause the processor or processors to perform one or more tasks. It may also include a processor. In one aspect, the timer/counter 731 provides an output signal, such as an elapsed time or a digital count, to the control circuit 710 to correlate the position of the closure member 714 as determined by the position sensor 734 with the output of the timer/counter 731; As a result, the control circuit 710 can determine the position of the closure member 714 at a particular time (t) relative to the starting position or time (t) when the closure member 714 is at a particular position relative to the starting position. can. Timer/counter 731 may be configured to measure elapsed time, count external events, or time external events.

In one aspect, control circuit 710 may be programmed to control the functionality of end effector 702 based on one or more tissue conditions. Control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. Control circuit 710 may be programmed to select a firing control program or a closure control program based on tissue conditions. The firing control program can describe distal movement of the displacement member. Different fire control programs can be selected to better handle different tissue conditions. For example, if thicker tissue is present, control circuit 710 may be programmed to translate the displacement member at a slower speed and/or with less power. If thinner tissue is present, control circuit 710 may be programmed to translate the displacement member at higher speeds and/or with higher power. A closure control program may control the closure force applied to tissue by clamp arm 716. Other control programs control the rotation of shaft 740 and articulating members 742a, 742b.

In one aspect, control circuit 710 may generate a motor set point signal. Motor setpoint signals may be provided to various motor controllers 708a-708e. Motor controllers 708a-708e include one or more circuits configured to provide motor drive signals to motors 704a-704e to drive motors 704a-704e, as described herein. It's okay. In some embodiments, motors 704a-704e may be brushed DC electric motors. For example, the speed of motors 704a-704e may be proportional to their respective motor drive signals. In some embodiments, the motors 704a-704e may be brushless DC electric motors, and each motor drive signal is a PWM signal provided to one or more stator windings of the motors 704a-704e. It may also include a signal. Also, in some embodiments, motor controllers 708a-708e may be omitted and control circuit 710 may directly generate the motor drive signals.

In one aspect, the control circuit 710 may initially operate each of the motors 704a-704e in an open-loop configuration during a first open-loop portion of the displacement member stroke. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a closed-loop configuration firing control program. The response of the instrument includes the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to one of the motors 704a-704e during the open loop portion, the motor Examples include the sum of pulse widths of drive signals. After the open loop portion, control circuit 710 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during a closed-loop portion of a stroke, control circuit 710 modulates one of motors 704a-704e in a closed-loop manner based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. You may let them.

In one aspect, motors 704a-704e can receive power from energy source 712. Energy source 712 may be a DC power source powered by a mains AC power source, a battery, a supercapacitor, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to individual movable mechanical elements such as closure member 714, clamp arm 716, shaft 740, joint 742a, and joint 742b via respective transmissions 706a-706e. good. Transmission devices 706a-706e may include one or more gears or other coupling components for coupling motors 704a-704e to a movable mechanical element. Position sensor 734 may sense the position of closure member 714. Position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of closure member 714. In some examples, position sensor 734 may include an encoder configured to provide a series of pulses to control circuit 710 as closure member 714 is translated distally and proximally. Control circuit 710 may track the pulses to determine the position of closure member 714. Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors can provide other signals indicative of movement of closure member 714. Also, in some embodiments, position sensor 734 may be omitted. If any of the motors 704a-704e are stepper motors, the control circuit 710 may track the position of the closure member 714 by summing the number and direction of steps that the motors 704 are instructed to perform. can. Position sensor 734 may be located within end effector 702 or any other portion of the instrument. The output of each motor 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.

In one aspect, control circuit 710 is configured to drive a firing member, such as the closure member 714 portion of end effector 702. Control circuit 710 provides motor settings to motor controller 708a, and motor controller 708a provides drive signals to motor 704a. The output shaft of motor 704a is coupled to torque sensor 744a. Torque sensor 744a is coupled to transmission device 706a coupled to closure member 714. Transmission device 706a includes movable mechanical elements such as a rotational element and a firing member to control movement of closure member 714 distally and proximally along the longitudinal axis of end effector 702. In one aspect, motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. Torque sensor 744a provides a firing force feedback signal to control circuit 710. The firing force signal represents the force required to fire or displace closure member 714. The position sensor 734 may be configured to provide the position of the closure member 714 or the position of the firing member along the firing stroke as a feedback signal to the control circuit 710. End effector 702 may include an additional sensor 738 configured to provide a feedback signal to control circuit 710. When ready for use, control circuit 710 can provide a firing signal to motor control 708a. In response to the firing signal, motor 704a drives the firing member distally along the longitudinal axis of end effector 702 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. be able to. As closure member 714 is translated distally, clamp arm 716 closes toward ultrasonic blade 718 .

In one aspect, control circuit 710 is configured to drive a closure member, such as clamp arm 716 of end effector 702. Control circuit 710 provides motor set points to motor control 708b, which provides drive signals to motor 704b. The output shaft of motor 704b is coupled to torque sensor 744b. Torque sensor 744b is coupled to transmission device 706b that is coupled to clamp arm 716. Transmission device 706b includes movable mechanical elements such as a rotating element and a closing member to control movement of clamp arm 716 from open and closed positions. In one aspect, motor 704b is coupled to a closure gear assembly that includes a closure reduction gear set supported in meshing engagement with a closure spur gear. Torque sensor 744b provides a closing force feedback signal to control circuit 710. The closing force feedback signal represents the closing force applied to clamp arm 716. Position sensor 734 may be configured to provide the position of the closure member as a feedback signal to control circuit 710. An additional sensor 738 within end effector 702 can provide a closure force feedback signal to control circuit 710. A pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718. When ready for use, control circuit 710 may provide a close signal to motor control 708b. In response to the closure signal, motor 704b advances the closure member to grasp tissue between clamp arm 716 and ultrasonic blade 718.

In one aspect, control circuit 710 is configured to rotate a shaft member, such as shaft 740, to rotate end effector 702. Control circuit 710 provides motor set points to motor control 708c, which provides drive signals to motor 704c. The output shaft of motor 704c is coupled to torque sensor 744c. Torque sensor 744c is coupled to transmission device 706c coupled to shaft 740. Transmission mechanism 706c includes a movable mechanical element, such as a rotating element, to control clockwise or counterclockwise rotation of shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is formed on (or attached to) the proximal end of the proximal closure tube such that it is operably engaged by a rotating gear assembly operably supported on the tool mounting plate. attached) to a rotational transmission assembly including a tubular gear segment. Torque sensor 744c provides a torque feedback signal to control circuit 710. The rotational force feedback signal represents the rotational force applied to shaft 740. Position sensor 734 may be configured to provide the position of the closure member as a feedback signal to control circuit 710. Additional sensors 738, such as shaft encoders, may provide the rotational position of shaft 740 to control circuitry 710.

In one aspect, control circuit 710 is configured to articulate end effector 702. Control circuit 710 provides motor set points to motor control 708d, which provides drive signals to motor 704d. The output shaft of motor 704d is coupled to torque sensor 744d. Torque sensor 744d is coupled to transmission device 706d coupled to articulation member 742a. Transmission mechanism 706d includes a movable mechanical element such as an articulation element for controlling the ±65° articulation of end effector 702. In one aspect, the motor 704d is coupled to an articulation nut rotatably pivoted on a proximal end portion of the distal spine portion and articulated on a proximal end portion of the distal spine portion. Rotatably driven by a motion gear assembly. Torque sensor 744d provides a joint force feedback signal to control circuit 710. The joint force feedback signal represents the joint force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.

In another aspect, the articulation feature of the robotic surgical system 700 may include two articulation members or connections 742a, 742b. These articulating members 742a, 742b are driven by separate disks on a robot interface (rack) driven by two motors 708d, 708e. A separate firing motor 704a is provided to provide resistive holding motion and load to the head when the head is not in motion, and to provide articulation motion when the head is articulating. Each of the articulation connections 742a, 742b may be driven competitively with respect to the other connection. Articulating members 742a, 742b are attached to the head at a fixed radius as the head rotates. Therefore, as the head rotates, the mechanical efficiency of the push-pull connection changes. This change in mechanical efficiency may be more pronounced with other articulating joint drive systems.

In one aspect, the one or more motors 704a-704e may include a brushed DC motor with a gearbox and a mechanical connection to a firing member, closure member, or articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation connections, closure tubes, and shafts. External influences are unmeasured and unpredictable influences such as friction on tissues, surrounding bodies, and physical systems. Such an external influence may be referred to as a drag acting against one of the electric motors 704a-704e. External influences, such as disturbances, can cause the behavior of a physical system to deviate from its desired behavior.

In one aspect, position sensor 734 may be implemented as an absolute position sensing system. In one aspect, position sensor 734 may comprise a magnetic rotation absolute position sensing system implemented as an AS5055EQFT single chip magnetic rotation position sensor available from Austria Microsystems, AG. Position sensor 734 may cooperate with control circuitry 710 to provide an absolute position sensing system. The position is located above the magnet and is provided to implement a concise and efficient algorithm for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. It may include a plurality of Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and Boulder algorithm.

In one aspect, control circuit 710 may communicate with one or more sensors 738. Sensor 738 is positioned on end effector 702 and is adapted to operate with robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. You can. Sensor 738 may be one of a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or the end effector 702 or any other suitable sensor for measuring more than one parameter. Sensor 738 may include one or more sensors. A sensor 738 may be placed on the clamp arm 716 to determine tissue location using segmented electrodes. Torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and/or articulation forces, among others. Thus, the control circuit 710 determines (1) the occlusion load experienced by the distal occlusion tube and its location, (2) the firing member in the rack and its location, (3) which portion of the ultrasonic blade 718 is placed on it. (4) can sense the load and position on both articulating rods.

In one aspect, the one or more sensors 738 may include strain gauges, such as microstrain gauges, configured to measure the magnitude of strain in the clamp arm 716 during clamp conditions. Strain gauges provide electrical signals whose amplitude varies with the magnitude of strain. Sensor 738 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between clamp arm 716 and ultrasonic blade 718. Sensor 738 may be configured to detect the impedance of a portion of tissue located between clamp arm 716 and ultrasonic blade 718, which impedance may be determined by the thickness and/or the tissue located therebetween. Indicates the degree of filling.

In one aspect, sensor 738 is implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, among others. may be done. In other implementations, sensor 738 may be implemented as a solid state switch that operates under the influence of light, such as a light sensor, IR sensor, UV sensor, among others. Additionally, the switch may be a solid state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, sensors 738 may include conductor-free switches, ultrasonic switches, accelerometers, and inertial sensors, among others.

In one aspect, sensor 738 may be configured to measure the force exerted on clamp arm 716 by the closure drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the clamp arm 716 to detect the closure force applied to the clamp arm 716 by the closure tube. . The force exerted on clamp arm 716 may be representative of tissue compression experienced by a tissue section captured between clamp arm 716 and ultrasound blade 718. One or more sensors 738 may be placed at various interaction points along the closure drive system to detect the closure force applied to the clamp arm 716 by the closure drive system. One or more sensors 738 may be sampled in real time during clamping operations by a processor of control circuit 710. Control circuit 710 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to clamp arm 716 in real-time.

In one aspect, current sensor 736 can be used to measure the current drawn by each of motors 704a-704e. The force required to advance any of the movable mechanical elements, such as closure member 714, corresponds to the current drawn by one of motors 704a-704e. The force is converted to a digital signal and provided to control circuit 710. Control circuit 710 may be configured to simulate the instrument's actual system response in the controller's software. The displacement member can be actuated to move the closure member 714 within the end effector 702 at or near a target speed. Robotic surgical instrument 700 may include a feedback controller, which may include any feedback controller, including, but not limited to, PID, state feedback, linear quadratic (LQR), and/or adaptive controllers. It may be any one of the following. Robotic surgical instrument 700 can include a power source for converting signals from a feedback controller into physical inputs such as, for example, case voltages, PWM voltages, frequency modulated voltages, currents, torques, and/or forces. . Further details may be found in U.S. patent application Ser. disclosure has been done.

FIG. 18 illustrates a circuit diagram of a surgical instrument 750 configured to control distal translation of a displacement member, according to one aspect of the present disclosure. In one aspect, surgical instrument 750 is programmed to control distal translation of a displacement member, such as closure member 764. Surgical instrument 750 includes an end effector 752 that may include a clamp arm 766 , a closure member 764 , and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771 .

The position, movement, displacement, and/or translation of a linear displacement member, such as closure member 764, may be measured by an absolute position sensing system, sensor mechanism, and position sensor 784. Because closure member 764 is coupled to a longitudinally movable drive member, the position of closure member 764 may be determined by measuring the position of the longitudinally movable drive member using position sensor 784. I can do it. Accordingly, in the following discussion, the position, displacement, and/or translation of closure member 764 may be accomplished by position sensor 784 as described herein. Control circuit 760 may be programmed to control translation of a displacement member, such as closure member 764. In some embodiments, the control circuit 760 provides instructions for one or more microcontrollers, microprocessors, or processors to control the displacement member, e.g., the closure member 764, in the manner described. Other suitable processors may be included for execution. In one aspect, timer/counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate the position of closure member 764 as determined by position sensor 784 with the output of timer/counter 781. , so that the control circuit 760 can determine the position of the closure member 764 at a particular time (t) relative to the starting position. Timer/counter 781 may be configured to measure elapsed time, count external events, or time external events.

Control circuit 760 may generate motor setpoint signal 772. Motor set point signal 772 may be provided to motor controller 758. Motor controller 758 may include one or more circuits configured to provide motor drive signals 774 to motor 754 to drive motor 754, as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774. In some examples, motor 754 may be a brushless DC electric motor and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754. Also, in some embodiments, motor controller 758 may be omitted and control circuit 760 may directly generate motor drive signal 774.

Motor 754 may receive power from energy source 762. Energy source 762 may be or include a battery, supercapacitor, or any other suitable energy source. Motor 754 may be mechanically coupled to closure member 764 via transmission 756. Transmission device 756 may include one or more gears or other coupling components to couple motor 754 to closure member 764. Position sensor 784 may sense the position of closure member 764. Position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of closure member 764. In some examples, position sensor 784 may include an encoder configured to provide a series of pulses to control circuit 760 as closure member 764 is translated distally and proximally. Control circuit 760 may track the pulses to determine the position of closure member 764. Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of movement of closure member 764. Also, in some examples, position sensor 784 may be omitted. If motor 754 is a stepper motor, control circuit 760 may track the position of closure member 764 by summing the number and direction of steps that motor 754 is instructed to perform. Position sensor 784 may be located within end effector 752 or any other portion of the instrument.

Control circuit 760 may communicate with one or more sensors 788. Sensor 788 may be positioned on end effector 752 and adapted to operate with surgical instrument 750 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. . Sensor 788 may be a magnetic sensor, a magnetic field sensor, an inductive sensor such as a strain gauge, a pressure sensor, a force sensor, an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or one or more of end effector 752. Any other suitable sensor for measuring the parameter may also be provided. Sensor 788 may include one or more sensors.

The one or more sensors 788 may include strain gauges, such as microstrain gauges, configured to measure the magnitude of strain in the clamp arm 766 during the clamp condition. Strain gauges provide electrical signals whose amplitude varies with the magnitude of strain. Sensor 788 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between clamp arm 766 and ultrasonic blade 768. Sensor 788 may be configured to detect the impedance of a portion of tissue located between clamp arm 766 and ultrasonic blade 768, which impedance may be determined by the thickness and/or of the tissue located therebetween. Indicates the degree of filling.

Sensor 788 may be configured to measure the force exerted on clamp arm 766 by the closure drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the clamp arm 766 to detect the closure force applied to the clamp arm 766 by the closure tube. . The force exerted on clamp arm 766 may be representative of tissue compression experienced by a tissue section captured between clamp arm 766 and ultrasound blade 768. One or more sensors 788 may be placed at various interaction points along the closure drive system to detect the closure force applied to the clamp arm 766 by the closure drive system. One or more sensors 788 may be sampled in real time during clamping operations by the processor of control circuit 760. Control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to clamp arm 766 in real-time.

A current sensor 786 can be used to measure the current drawn by motor 754. The force required to advance closure member 764 corresponds to the current drawn by motor 754. The force is converted to a digital signal and provided to control circuit 760.

Control circuit 760 may be configured to simulate the instrument's actual system response in the controller's software. The displacement member can be actuated to move the closure member 764 within the end effector 752 at or near the target speed. Surgical instrument 750 can include a feedback controller, for example, any one of any feedback controllers including, but not limited to, PID, status feedback, LQR, and/or adaptive controllers. It may be one. Surgical instrument 750 can include a power source for converting signals from the feedback controller into physical inputs such as, for example, case voltages, PWM voltages, frequency modulated voltages, currents, torques, and/or forces.

The actual drive system of the surgical instrument 750 is a brushed DC motor with a gearbox and a mechanical connection to the articulation and/or knife system to drive the displacement, cutting, or closure member 764. It is composed of Another example is an electric motor 754 that operates an exchangeable shaft assembly, such as a displacement member and an articulation driver. External influences are unmeasured and unpredictable influences such as friction on tissues, surrounding bodies, and physical systems. Such external influences may be referred to as disturbances acting against the electric motor 754. External influences, such as disturbances, can cause the behavior of a physical system to deviate from its desired behavior.

Various exemplary aspects relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical sealing and cutting instrument. For example, motor 754 may drive the displacement member distally and proximally along the longitudinal axis of end effector 752. End effector 752 may include a pivotable clamp arm 766 and an ultrasonic blade 768 positioned on the opposite side of clamp arm 766 when configured for use. A clinician may grasp tissue between clamp arm 766 and ultrasound blade 768, as described herein. When instrument 750 is ready for use, the clinician may provide a firing signal, such as by pressing a trigger on instrument 750. In response to the firing signal, motor 754 drives the displacement member distally along the longitudinal axis of end effector 752 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. You can. As the displacement member is translated distally, closure member 764 with a cutting element positioned at the distal end can cut tissue between ultrasonic blade 768 and clamp arm 766.

In various embodiments, surgical instrument 750 includes a control circuit 760 programmed to control distal translation of a displacement member, such as closure member 764, based on one or more tissue conditions. You can. Control circuit 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. Control circuit 760 may be programmed to select a control program based on tissue condition. The control program can describe distal movement of the displacement member. Different control programs can be selected to better handle different tissue conditions. For example, if thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a slower speed and/or with less power. If thinner tissue is present, control circuit 760 may be programmed to translate the displacement member at higher speeds and/or with higher power.

In some embodiments, control circuit 760 may initially operate motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's stroke. Based on the response of instrument 750 during the open loop portion of the stroke, control circuit 760 may select a firing control program. The response of the instrument includes the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, and the sum of the pulse widths of the motor drive signals. etc. may be mentioned. After the open loop portion, control circuit 760 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 760 may modulate the motor 754 in a closed-loop manner based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. Further details may be found in U.S. Patent Application No. 15/720,852, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," filed September 29, 2017, which is incorporated herein by reference in its entirety. has been disclosed.

FIG. 19 is a schematic illustration of a surgical instrument 790 configured to control various functions, according to one aspect of the present disclosure. In one aspect, surgical instrument 790 is programmed to control distal translation of a displacement member, such as closure member 764. The surgical instrument 790 includes a clamp arm 766, a closure member 764, and an ultrasonic blade 768 that may be replaced with or operate in conjunction with one or more RF electrodes 796 (shown in phantom). and an end effector 792 that may include. Ultrasonic blade 768 is coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.

In one aspect, sensor 788 may be implemented as a limit switch, electromechanical device, solid state switch, Hall effect device, MR device, GMR device, magnetometer, among others. In other implementations, the sensor 638 may be a solid state switch that operates under the influence of light, such as a light sensor, an IR sensor, an ultraviolet sensor, among others. Additionally, the switch may be a solid state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, sensors 788 may include conductor-free switches, ultrasonic switches, accelerometers, and inertial sensors, among others.

In one aspect, position sensor 784 may be implemented as an absolute position sensing system comprising a magnetic rotary absolute position sensing system implemented as an AS5055EQFT single chip magnetic rotary position sensor available from Austria Microsystems, AG. Position sensor 784 may cooperate with control circuitry 760 to provide an absolute position sensing system. The position is located above the magnet and is provided to implement a concise and efficient algorithm for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. It may include a plurality of Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and Boulder algorithm.

In some embodiments, position sensor 784 may be omitted. If motor 754 is a step motor, control circuit 760 can track the position of closure member 764 by summing the number and direction of steps the motor is instructed to perform. Position sensor 784 may be located within end effector 792 or any other portion of the instrument.

Control circuit 760 may communicate with one or more sensors 788. Sensor 788 may be positioned on end effector 792 and adapted to operate with surgical instrument 790 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. . Sensors 788 may include one or more of the following: magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or end effectors 792. Any other suitable sensor for measuring the parameter may also be provided. Sensor 788 may include one or more sensors.

An RF energy source 794 is coupled to the end effector 792 and is provided for operation when an RF electrode 796 is provided within the end effector 792 in place of or in conjunction with the ultrasonic blade 768. is applied to the RF electrode 796. For example, an ultrasonic blade may be made of conductive metal and used as a return path for electrosurgical RF current. Control circuit 760 controls the delivery of RF energy to RF electrode 796.

Further details may be found in SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF, filed June 28, 2017, which is incorporated herein by reference in its entirety. US Patent Application No. 15 entitled “USING SAME” No./636,096.

Adaptive Ultrasonic Blade Control Algorithm In various aspects, a smart ultrasonic energy device may include an adaptive algorithm to control operation of the ultrasonic blade. In one aspect, the ultrasound blade adaptive control algorithm is configured to identify tissue type and adjust device parameters. In one aspect, the ultrasound blade control algorithm is configured to parameterize tissue type. An algorithm for detecting tissue collagen/elasticity ratio to adjust the amplitude of the distal tip of the ultrasound blade is described in the following sections of this disclosure. Various aspects of smart ultrasound energy devices are described herein with respect to, for example, FIGS. 1-94. Accordingly, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with FIGS. 1-94 and their associated descriptions.

Tissue Type Identification and Device Parameter Adjustment For certain surgical procedures, it is desirable to use an adaptive ultrasound blade control algorithm. In one aspect, an adaptive ultrasound blade control algorithm may be used to adjust parameters of the ultrasound device based on the type of tissue in contact with the ultrasound blade. In one aspect, parameters of the ultrasound device may be adjusted based on the position of tissue within the jaws of the ultrasound end effector, e.g., between the clamp arm and the ultrasound blade. The impedance of the ultrasound transducer may be used to identify what percentage of tissue is located at the distal or proximal end of the end effector. The response of the ultrasound device may be based on tissue type or tissue compressibility. In another aspect, ultrasound device parameters may be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasound blade may be adjusted based on the ration of collagen to elastin tissue detected during a tissue identification procedure. The ratio of collagen to elastin tissue can be detected using a variety of techniques including infrared (IR) surface reflectance and emissivity. Forces applied to tissue by the clamp arm and/or the stroke of the clamp arm to create gaps and compression. Electrical continuity across the jaw with electrodes can be used to determine what percentage of the jaw is covered with tissue.

FIG. 20 is a system 800 configured to execute an adaptive ultrasound blade control algorithm within a surgical data network with a modular communication hub in accordance with at least one aspect of the present disclosure. In one aspect, generator module 240 is configured to execute adaptive ultrasonic blade control algorithm(s) 802 described herein with reference to FIGS. 53-94. In another aspect, the device/instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm(s) 804 described herein with reference to FIGS. 53-94. In another aspect, both device/instrument 235 and device/instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 described herein with reference to FIGS. 53-94. be done.

Generator module 240 may include a patient isolation stage in communication with the non-isolated stage via a power transformer. The secondary winding of the power transformer is housed within an insulating stage and is used for multifunctional surgical applications including, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and ultrasonic and RF energy modes that can be delivered alone or simultaneously. A tap configuration (eg, a center-tap or non-center-tap configuration) may be included to define a drive signal output for delivering drive signals to various surgical instruments, such as surgical instruments. Specifically, the drive signal output can output an ultrasonic drive signal (e.g., a 420V root mean square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output can output an RF An electrosurgical drive signal (eg, a 100V RMS drive signal) can be output to the RF electrosurgical instrument 241. Aspects of generator module 240 are described herein with reference to FIGS. 21-28B.

Generator module 240 or device/instrument 235, or both, may include, for example, intelligent surgical instruments, robots, and other computers located within the operating room, such as those described with reference to FIGS. 8-11. The control tower 236 is connected to a modular control tower 236 that is connected to a plurality of operating room equipment, such as a computer.

FIG. 21 shows an generator configured to couple with an ultrasound instrument and further configured to execute an adaptive ultrasound blade control algorithm within a surgical data network comprising the modular communication hub shown in FIG. 9 shows an example of a generator 900, which is one form of a generator. Generator 900 is configured to deliver multiple energy modalities to a surgical instrument. Generator 900 provides RF and ultrasound signals, either alone or simultaneously, for delivering energy to a surgical instrument. The RF signal and ultrasound signal may be provided alone, in combination, or simultaneously. As mentioned above, at least one generator output can transmit multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave, among others) through a single port. These signals can be delivered individually or simultaneously to the end effector to treat tissue. Generator 900 includes 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 (not shown for clarity of disclosure) stored in a memory coupled to processor 902. Digital information related to the waveform is provided to a waveform generator 904 that includes one or more DAC circuits to convert digital inputs to analog outputs. The analog output is provided to amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of amplifier 906 is coupled to power transformer 908. The signal is coupled across power transformer 908 to the secondary side on the patient isolation side. A first signal of a first energy modality is provided between terminals labeled ENERGY ₁ and RETURN of the surgical instrument. A second signal of a second energy modality is coupled across capacitor 910 and provided between terminals labeled ENERGY ₂ and RETURN of the surgical instrument. More than two energy modalities may be output, so the subscript "n" may be used to indicate that up to n ENERGY _n terminals may be provided, where n is greater than one. It will be understood that it is a positive integer of . It will also be appreciated that up to "n" return paths (RETURN _n ) may be provided without departing from the scope of this disclosure.

A first voltage sensing circuit 912 is coupled across the terminals labeled ENERGY ₁ and RETURN path to measure the output voltage therebetween. A second voltage sensing circuit 924 is coupled across the terminals labeled ENERGY ₂ and RETURN path to measure the output voltage therebetween. A current sensing circuit 914 is placed in series with the RETURN section of the secondary of the illustrated power transformer 908 to measure the output current of either energy modality. If different return paths are provided for each energy modality, separate current sensing circuits must be provided for each return leg. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to corresponding isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The outputs of isolation transformers 916 , 928 , 922 on the primary side (non-patient isolated side) of power transformer 908 are provided to one or more ADC circuits 926 . The digitized output of ADC circuit 926 is provided to processor 902 for further processing and calculations. The output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument and to calculate the output impedance, among other parameters. Input/output communication between processor 902 and patient isolation circuitry is provided through interface circuitry 920. Sensors may also be in electrical communication with processor 902 via interface circuitry 920.

In one aspect, the impedance is connected to either the first voltage sensing circuit 912 coupled across the terminal labeled ENERGY ₁ /RETURN or the second voltage sensing circuit 924 coupled across the terminal labeled ENERGY ₂ /RETURN. may be determined by processor 902 by dividing the output of current sensing circuit 914 placed in series with the RETURN section of the secondary side of power transformer 908 . The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 916. Digitized voltage and current sensing measurements from ADC circuit 926 are provided to processor 902 to calculate impedance. As an example, the first energy modality ENERGY ₁ may be ultrasound energy and the second energy modality ENERGY ₂ may be RF energy. Nevertheless, in addition to ultrasound energy modalities and bipolar or unipolar RF energy modalities, other energy modalities include irreversible and/or reversible electroporation and/or microwave energy, among others. Also, while the example illustrated in FIG. 21 shows that a single return path (RETURN) may be provided to more than one energy modality, in other aspects multiple return paths (RETURN ₎ may be provided to more than one energy modality. Each energy modality ENERGY _n may be provided. Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914, and the impedance of the tissue is determined by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914. may be measured by dividing the output of the voltage sensing circuit 924 by the current sensing circuit 914.

As shown in FIG. 21, the generator 900, which includes at least one output port, can provide power depending on the type of tissue treatment to be performed, such as ultrasound, bipolar or monopolar RF, irreversible and/or or a power transformer having a single output and having multiple taps for providing to an end effector in the form of one or more energy modalities such as reversible electroporation and/or microwave energy. 908 can be included. For example, the generator 900 can be used to drive RF electrodes for tissue sealing at high voltage and low current to drive ultrasound transducers using either monopolar or bipolar RF electrosurgical electrodes. Energy can be delivered at low voltages and high currents or in coagulation waveforms for spot coagulation. The output waveform from generator 900 may be guided, switched, or filtered to provide a frequency to an end effector of a surgical instrument. The connection of the ultrasound transducer to the generator 900 output will preferably be located between the output labeled ENERGY ₁ and RETURN as shown in FIG. In one embodiment, the connection of the RF bipolar electrode to the output of generator 900 would preferably be located between the output labeled ENERGY ₂ and RETURN. For unipolar outputs, the preferred connection would be an active electrode (eg, a pencil or other probe) to a suitable return pad connected to the ENERGY ₂ output and the RETURN output.

Further details may be found in TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL IN, which is incorporated herein by reference in its entirety. U.S. Patent Application Publication No. 2017/0086914 published March 30, 2017 entitled “STRUMENTS” Disclosed in the issue.

As used throughout this description, the term "wireless" and its derivatives describe any circuit, device, system, method, technique, communication channel, etc. that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. may be used for This term does not imply that the associated equipment does not include any wires, although in some aspects they may not be present. Communication modules include Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS , CDMA, TDMA, DECT, Bluetooth, their Ethernet derivatives, as well as any other wireless and wired protocols designated as 3G, 4G, 5G, and beyond. or may implement any of the wired communication standards or protocols. A computing module may include multiple communication modules. For example, the first communication module may be dedicated to short-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to short-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to short-range wireless communications such as It may also be used exclusively for long-distance wireless communications.

As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, usually memory or some other data stream. This term is used herein to refer to a central processor (central processing unit) within a system or computer system (particularly a system-on-chip (SoC)) that combines a number of dedicated "processors".

As used herein, a system on a chip or system on a chip (SoC or SOC) refers to an integrated circuit (also known as an "IC" or "chip") that integrates all the components of a computer or other electronic system. ). This can include digital, analog, mixed signal, and often high frequency functionality, all on a single substrate. SoCs integrate microcontrollers (or microprocessors) with modern peripherals such as graphics processing units (GPUs), Wi-Fi modules, or coprocessors. The SoC may or may not include built-in memory.

As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuitry and memory. A microcontroller (or microcontroller unit MCU) may be implemented as a miniature computer on a single integrated circuit. This may be similar to an SoC, which may include a microcontroller as one of its components. A microcontroller can house one or more core processing units (CPUs) as well as memory and programmable input/output peripherals. Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM, and small amounts of RAM are also often included on the chip. Microcontrollers may be employed for embedded applications, as opposed to microprocessors used in personal computers or other general purpose applications made up of various individual chips.

As used herein, the term controller or microcontroller may be a standalone IC or chip device that interfaces with peripheral devices. This may be a link between the two parts of a computer or controller on an external device that manages the operation of (and the connection to) the device.

Any processor or microcontroller described herein may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex from Texas Instruments. In one aspect, the processor includes on-chip memory, e.g., 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, details of which are available in the product data sheet, to improve performance above 40 MHz. One or two prefetch buffers, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM) one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels. ), the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.

In one aspect, the processor may include a safety controller that includes two controller family families, such as TMS570 and RM4x, also known by the Hercules ARM Cortex R4 trade names from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety limit applications, among other things, to provide advanced integrated safety features while offering scalable performance, connectivity, and memory options. good.

The modular device includes modules receivable within a surgical hub (e.g., as described in connection with FIGS. 3 and 9) and connected to various modules for connection or pairing with a corresponding surgical hub. and a surgical device or instrument for obtaining. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, energy generators, ventilators, inhalers, and displays. The modular devices described herein can be controlled by a control algorithm. Control algorithms may be implemented on the modular device itself, on the surgical hub to which a particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). ), can be executed. In some examples, a control algorithm for a modular device relies on data sensed by the modular device itself (i.e., by sensors within, on, or connected to the modular device). control the device based on This data may be related to the patient during surgery (eg, tissue properties or injection pressure) or to the modular device itself (eg, advancing knife speed, motor current, or energy level). For example, a control algorithm for a surgical stapling and cutting instrument can control the speed at which the instrument's motor drives the knife through tissue based on the resistance the knife encounters as it advances.

FIG. 22 shows one form of a surgical system 1000 that includes a generator 1100 and various surgical instruments 1104, 1106, 1108 that can be used therewith, where surgical instrument 1104 is an ultrasonic surgical instrument; Surgical instrument 1106 is an RF electrosurgical instrument and multifunctional surgical instrument 1108 is a combination ultrasound/RF electrosurgical instrument. Generator 1100 is configurable for use with a variety of surgical instruments. According to various embodiments, the generator 1100 is a multifunctional surgical instrument that integrates, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and RF and ultrasound energy simultaneously delivered from the generator 1100. The surgical instrument 1108 may be configurable for use with a variety of surgical devices of a variety of types. Although in the form of FIG. 22, generator 1100 is shown separately from surgical instruments 1104, 1106, 1108, in one form, generator 1100 may be attached to any of surgical instruments 1104, 1106, 1108. and may be integrally formed to form an integrated surgical system. Generator 1100 includes an input device 1110 located on the front panel of the console of generator 1100. Input device 1110 may comprise any suitable device that generates signals suitable for programming the operation of generator 1100. Generator 1100 may be configured for wired or wireless communication.

Generator 1100 is configured to drive a plurality of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 that includes a hand piece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. End effector 1122 includes an ultrasound blade 1128 acoustically coupled to ultrasound transducer 1120 and a clamp arm 1140. The handpiece 1105 includes a trigger 1143 for actuating the clamp arm 1140 and a combination of toggle buttons 1134a, 1134b, 1134c for energizing and activating the ultrasonic blade 1128 or other functions. Toggle buttons 1134a, 1134b, 1134c can be configured to energize ultrasound transducer 1120 using generator 1100.

Generator 1100 is also configured to drive second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. End effector 1124 includes electrodes in clamp arms 1142a, 1142b and returns through a conductive portion of shaft 1127. The electrodes are coupled to and energized by a bipolar energy source within generator 1100. Handpiece 1107 includes a trigger 1145 for operating clamp arms 1142a, 1142b and an energy button 1135 for operating an energy switch for energizing electrodes within end effector 1124.

Generator 1100 is also configured to drive multi-function surgical instrument 1108. Multifunctional surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. End effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. Ultrasonic blade 1149 is acoustically coupled to ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 for actuating the clamp arm 1146 and a combination of toggle buttons 1137a, 1137b, 1137c for energizing and activating the ultrasonic blade 1149 or other functions. Toggle buttons 1137a, 1137b, 1137c are configured to energize ultrasonic transducer 1120 using generator 1100 and similarly energize ultrasonic blade 1149 using a bipolar energy source contained within generator 1100. can do.

Generator 1100 is configurable for use with a variety of surgical instruments. According to various embodiments, generator 1100 is a multifunctional surgical instrument that integrates, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and RF and ultrasound energy simultaneously delivered from generator 1100. The surgical instrument 1108 may be configurable for use with a variety of surgical devices of a variety of types. Although in the form of FIG. 22, the generator 1100 is shown separately from the surgical instruments 1104, 1106, 1108, in another form, the generator 1100 is shown as one of the surgical instruments 1104, 1106, 1108. It may be integrally formed with either one to form an integrated surgical system. As mentioned above, generator 1100 includes an input device 1110 located on the front panel of the console of generator 1100. Input device 1110 may comprise any suitable device that generates signals suitable for programming the operation of generator 1100. Generator 1100 may also include one or more output devices 1112. Further aspects of generators and surgical instruments for digitally generating electrical signal waveforms are described in U.S. Patent Application Publication No. 2017-0086914-A1, which is incorporated herein by reference in its entirety. There is.

FIG. 23 is an end effector 1122 of an example ultrasound device 1104 in accordance with at least one aspect of the present disclosure. End effector 1122 may include a blade 1128 that may be coupled to ultrasound transducer 1120 via a waveguide. As described herein, when driven by the ultrasound transducer 1120, the blade 1128 can vibrate and, upon contact with tissue, can cut and/or coagulate the tissue. According to various aspects, and as illustrated in FIG. 23, end effector 1122 may further include a clamp arm 1140 that may be configured to cooperate with blade 1128 of end effector 1122. Along with blade 1128, clamp arm 1140 may include a series of jaws. Clamp arm 1140 may be pivotally connected to the distal end of shaft 1126 of instrument portion 1104. Clamp arm 1140 may include a clamp arm tissue pad 1163 that may be formed from TEFLON® or other suitable low friction material. Pad 1163 is mounted to cooperate with blade 1128 such that pivoting movement of clamp arm 1140 positions clamp pad 1163 in a substantially parallel relationship with and in contact with blade 1128. I can do it. With this configuration, a piece of tissue to be clamped may be grasped between tissue pad 1163 and blade 1128. Tissue pad 1163 may include a serration-like configuration including a plurality of axially spaced proximally extending gripping teeth 1161 to cooperate with blade 1128 to improve tissue gripping. Clamp arm 1140 may transition from the open position shown in FIG. 23 to a closed position (clamp arm 1140 in contact with or proximate blade 1128) in any suitable manner. For example, handpiece 1105 may include a jaw closure trigger. When actuated by a clinician, the jaw closure trigger may pivot clamp arm 1140 in any suitable manner.

Generator 1100 may be activated to provide a drive signal to ultrasound transducer 1120 in any suitable manner. For example, generator 1100 may include a footswitch 1430 (FIG. 24) coupled to generator 1100 via footswitch cable 1432. The clinician may activate ultrasound transducer 1120 by depressing footswitch 1430, which in turn activates ultrasound transducer 1120 and blade 1128. In addition to or in place of foot switch 1430, some embodiments of device 1104 may employ one or more switches positioned on handpiece 1105 that, when activated, , an ultrasound transducer 1120 can be activated in the generator 1100. In one aspect, for example, one or more switches may include a pair of toggle buttons 1134a, 1134b, 1134c, for example, to determine a mode of operation of the device 1104 (FIG. 22). For example, when toggle button 1134a is depressed, ultrasound generator 1100 may provide a maximum drive signal to ultrasound transducer 1120 to cause ultrasound transducer 1120 to generate maximum ultrasound energy output. By pressing toggle button 1134b, ultrasound generator 1100 can provide a user-selectable drive signal to ultrasound transducer 1120 to cause ultrasound transducer 1120 to produce a submaximal ultrasound energy output. Apparatus 1104 may additionally or alternatively include a second switch for indicating the position of a jaw closure trigger, for example, to manipulate the jaw via clamp arm 1140 of end effector 1122. Additionally, in some aspects, the ultrasound generator 1100 can be activated based on the position of the jaw closure trigger (e.g., when a clinician depresses the jaw closure trigger to close the jaw via the clamp arm 1140). , ultrasonic energy can be applied).

Additionally or alternatively, one or more switches can include a toggle button 1134c that, when depressed, causes the generator 1100 to provide a pulse output (FIG. 22). Pulses may be provided, for example, at any suitable frequency and classification. In certain aspects, the power level of the pulse may be, for example, the power level (maximum, less than maximum) associated with toggle buttons 1134a, 1134b.

It will be appreciated that the device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134c (FIG. 22). For example, the device 1104 has only two toggle buttons: a toggle button 1134a for producing maximum ultrasound energy output, and a toggle button 1134c for producing pulse output at either the maximum or less than maximum power level at a time. It can be configured to have. Thus, the drive signal output configuration of generator 1100 may be five continuous signals or any discrete number of individual pulse signals (1, 2, 3, 4, or 5 times). In certain aspects, the particular drive signal configuration may be controlled based on, for example, the EEPROM settings of the generator 1100 and/or the user's power level selection(s).

In certain aspects, a two-position switch may be provided as an alternative to toggle button 1134c (FIG. 22). For example, device 1104 may include a toggle button 1134a for generating continuous output at a maximum power level and a two-position toggle button 1134b. In the first detent position, the toggle button 1134b may generate continuous output at less than the maximum power level, and in the second detent position, the toggle button 1134b may generate a continuous output at less than the maximum power level (e.g., depending on the EEPROM settings) The pulsed output may be generated at any output level less than or equal to the output level.

In some aspects, the RF electrosurgical end effector 1124, 1125 (FIG. 22) may also include a pair of electrodes. The electrodes may communicate with the generator 1100, for example via a cable. Electrodes may be used, for example, to measure the impedance of a piece of tissue present between the clamp arms 1142a, 1146 and the blades 1142b, 1149. Generator 1100 may provide a signal (eg, a non-therapeutic signal) to the electrode. The impedance of a tissue piece can be found, for example, by monitoring the signal current, voltage, etc.

In various aspects, generator 1100 may include several separate functional elements, such as the modules and/or blocks shown in FIG. 24, which is a schematic diagram of surgical system 1000 in FIG. 22. Various functional elements or modules may be configured to drive various types of surgical devices 1104, 1106, 1108. For example, the ultrasound generator module may drive an ultrasound device, such as ultrasound device 1104. An electrosurgical/RF generator module may drive electrosurgical device 1106. The modules can generate corresponding drive signals to drive the surgical devices 1104, 1106, 1108. In various aspects, an ultrasound generator module and/or an electrosurgical/RF generator module may each be integrally formed with generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to generator 1100. (Modules are shown in phantom to illustrate this option). Also, in some aspects, the electrosurgical/RF generator module may be integrally formed with the ultrasound generator module, or vice versa.

According to the described aspects, the ultrasound generator module may generate a drive signal or signals of a particular voltage, current, and frequency (eg, 55,500 cycles/second, or Hz). The drive signal or signals may be provided to the ultrasound device 1104, particularly the transducer 1120, which may operate as described above, for example. In one aspect, generator 1100 can be configured to generate a drive signal of a particular voltage, current, and/or frequency output signal that can be stepped with high resolution, accuracy, and repeatability.

According to described aspects, an electrosurgical/RF generator module uses radio frequency (RF) energy to generate a drive signal or signals with an output power sufficient to perform a bipolar electrosurgical procedure. can be generated. In bipolar electrosurgical applications, for example, drive signals may be provided to the electrodes of, for example, electrosurgical device 1106, as described above. Thus, generator 1100 may be configured for therapeutic purposes by applying sufficient electrical energy to tissue to treat the tissue (eg, coagulation, ablation, tissue welding, etc.).

Generator 1100 can include, for example, an input device 2150 (FIG. 27B) located on the front panel of the console of generator 1100. Input device 2150 may comprise any suitable device that generates signals suitable for programming the operation of generator 1100. During operation, a user may program or otherwise control the operation of generator 1100 using input device 2150. Input device 2150 may be included by (e.g., housed within) the generator to control operation of generator 1100 (e.g., operation of an ultrasound generator module and/or an electrosurgical/RF generator module). The processor may include any suitable device that generates a signal that can be used (by one or more processors). In various aspects, input device 2150 includes one or more of buttons, switches, thumbwheels, keyboards, keypads, touch screen monitors, pointing devices, and remote connections to general purpose or special purpose computers. In other aspects, input device 2150 may include a suitable user interface, such as, for example, one or more user interface screens displayed on a touch screen monitor. Thus, the input device 2150 allows the user to determine, for example, the current (I), voltage (V), Various operating parameters of the generator can be set or programmed, such as frequency (f) and/or period (T).

Generator 1100 may also include an output device 2140 (FIG. 27B) located, for example, on the front panel of the generator 1100 console. Output device 2140 includes one or more devices for providing sensory feedback to the user. Such devices may include, for example, visual feedback devices (eg, LCD display screens, LED indicators), audible feedback devices (eg, speakers, buzzers), or tactile feedback devices (eg, tactile activation devices).

Although particular modules and/or blocks of generator 1100 may be described as examples, a greater or lesser number of modules and/or blocks may be used and this still remains within the scope of embodiments. I can understand. Further, while various aspects may be described in terms of modules and/or blocks for ease of explanation, such modules and/or blocks may include one or more hardware components, e.g. , digital signal processors (DSPs), programmable logic devices (PLDs), application specific integrated circuits (ASICs), circuits, registers and/or software components, such as programs, subroutines, logic and/or hardware components. It may be implemented by a combination of software components.

In one aspect, the ultrasound generator drive module and the electrosurgical/RF drive module 1110 (FIG. 22) are integrated into one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. May include. A module may comprise various executable modules such as software, programs, data, drivers, application program interfaces (APIs), and the like. Firmware may be stored in bit-masked read-only memory (ROM) or non-volatile memory (NVM), such as flash memory. In various implementations, flash memory may be saved by storing firmware in ROM. The NVM may be, for example, a programmable ROM (PROM), an erasable programmable ROM (EPROM), an electrically erasable programmable ROM (EEPROM), or a dynamic RAM (DRAM), a double data rate DRAM (DDRAM), and/or a synchronous DRAM ( Other types of memory may also be included, including battery-backed random access memory (RAM) such as SDRAM.

In one aspect, the module executes program instructions for monitoring various measurable characteristics of the device 1104, 1106, 1108 and generates a corresponding output drive signal or signals for operating the device 1104, 1106, 1108. It includes a hardware component implemented as a processor for generating an output drive signal. In embodiments in which generator 1100 is used with device 1104, the drive signal may drive ultrasound transducer 1120 in cutting and/or coagulation modes of operation. The electrical properties of the device 1104 and/or the tissue may be measured and used to control the operational aspects of the generator 1100 and/or provided as feedback to the user. In embodiments where generator 1100 is used with device 1106, the drive signal may provide electrical energy (eg, RF energy) to end effector 1124 in cutting, coagulation, and/or drying modes. The electrical properties of the device 1106 and/or the tissue may be measured and used to control the operational aspects of the generator 1100 and/or provided as feedback to the user. In various aspects, the hardware components may be implemented as DSPs, PLDs, ASICs, circuits, and/or registers, as described above. In one aspect, the processor stores and executes computer software program instructions to perform step functions for driving various components of the devices 1104, 1106, 1108, such as the ultrasound transducer 1120 and the end effectors 1122, 1124, 1125. It may be configured to generate an output signal.

Electromechanical ultrasound systems include ultrasound transducers, waveguides, and ultrasound blades. Electromechanical ultrasound systems have an initial resonant frequency defined by the physical properties of the ultrasound transducer, waveguide, and ultrasound blade. The ultrasound transducer is excited by an alternating voltage V _g (t) and current I _g (t) signal equal to the resonant frequency of the electromechanical ultrasound system. When the electromechanical ultrasound system resonates, the phase difference between the voltage V _g (t) and current I _g (t) signals is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. As the ultrasonic blade heats up, the compliance of the ultrasonic blade (modeled as an equivalent capacitance) changes the resonant frequency of the electromechanical ultrasonic system. Therefore, the inductive impedance is no longer equal to the capacitive impedance, which causes a mismatch between the driving frequency and the resonant frequency of the electromechanical ultrasound system. Here the system operates "off-resonance". The mismatch between the drive frequency and the resonant frequency is manifested as a phase difference between the voltage V _g (t) and current I _g (t) signals applied to the ultrasound transducer. The generator electronics can easily monitor the phase difference between the voltage V _g (t) and current I _g (t) signals and continuously increase the driving frequency until the phase difference is zero again. Can be adjusted. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. Changes in phase and/or frequency can be used as indirect measurements of ultrasonic blade temperature.

As shown in FIG. 25, the electromechanical properties of an ultrasound transducer include a first branch with a capacitance and a second branch with a series-connected inductance, resistance, and capacitance that define the electromechanical properties of the resonator. It may be modeled as an equivalent circuit including an "operation" branch. Known ultrasound generators may include a tuning inductor to tune out the capacitance at a certain resonant frequency so that substantially all of the generator drive signal current flows into the operating branch. Therefore, by using a tuning inductor, the generator's drive signal current represents the operating branch current, and the generator can therefore control its drive signal to maintain the resonant frequency of the ultrasound transducer. The tuning inductor can also transform the phase impedance plot of the ultrasound transducer to improve the frequency fixing ability of the generator. However, the tuning inductor must match the specific capacitance of the ultrasound transducer at the operating resonant frequency. In other words, different ultrasound transducers with different capacitances require different tuning inductors.

FIG. 25 illustrates an equivalent circuit 1500 of an ultrasound transducer, such as ultrasound transducer 1120, according to one aspect. The circuit 1500 has a first "operating" branch having a series connected inductance L _s , a resistance R _s , and a capacitance C _s that define the electromechanical properties of the resonator, and a second branch having a capacitance C ₀ . and a capacitive branch of. With the operating current I _m (t) flowing through the first branch and the currents I _g (t) to I _m (t) flowing through the capacitive branches, the driving current I _g (t) is may be received at a driving voltage V _g (t) from V g (t). Control of the electromechanical properties of the ultrasound transducer may be achieved by suitably controlling I _g (t) and V _g (t). As mentioned above, known generator architectures utilize a capacitance C ₀ at the resonant frequency in a parallel resonant circuit such that substantially all of the current output I _g (t) of the generator flows through the operating branch. A tuning inductor L _t (shown in phantom in FIG. 25) may be included to tune out L t . In this method, control of the operating branch current I _m (t) is achieved by controlling the current output I _g (t) of the generator. The tuning inductor L _t is specific to the capacitance C ₀ of the ultrasound transducer, but different ultrasound transducers with different static capacitances require different tuning inductors L _t . Also, since the tuning inductor L _t matches the nominal value of the capacitance C ₀ at a single resonant frequency, accurate control of the operating branch current I _m (t) is guaranteed only at that frequency. As the frequency decreases with converter temperature, precise control of the operating branch current is compromised.

Various aspects of the generator 1100 can monitor the operating branch current I _m (t) without relying on the tuning inductor L _t . Rather, the generator 1100 determines the value of the operating branch current I _m (t) on a dynamic and ongoing basis (e.g., in real time) by applying power for a particular ultrasonic surgical device 1104. (along with drive signal voltage and _current feedback data) may be used. Accordingly, such aspects of the generator 1100 may be tuned with any value of capacitance C ₀ at any frequency and not only at a single resonant frequency determined by the nominal value of capacitance C ₀ or Virtual tuning can be provided to simulate a resonant system.

FIG. 26 is a simplified block diagram of one embodiment of a generator 1100 to provide the inductorless regulation described above, among other advantages. 27A-27C illustrate the architecture of generator 1100 of FIG. 26 according to one aspect. Referring to FIG. 26, generator 1100 may include a patient isolation stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560. The secondary winding 1580 of the power transformer 1560 is included in the isolation stage 1520 and may include a tapped configuration (e.g., center-tapped or non-center-tapped configuration), e.g., for ultrasonic surgical device 1104 and electrosurgical Drive signal outputs 1600a, 1600b, 1600c are defined for outputting drive signals to various surgical devices, such as device 1106. In particular, the drive signal outputs 1600a, 1600b, 1600c may output a drive signal (eg, a 420V RMS drive signal) to the ultrasonic surgical device 1104, and the drive signal outputs 1600a, 1600b, 1600c may output an electrical A drive signal (eg, a 100V RMS drive signal) may be output to surgical device 1106, where output 1600b corresponds to a center tap of power transformer 1560. Non-isolated stage 1540 may include a power amplifier 1620 having an output connected to a primary winding 1640 of power transformer 1560. In certain aspects, power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may further include programmable logic 1660 for providing digital output to a digital-to-analog converter (DAC) 1680, which in turn provides a corresponding An analog signal is provided to an input of a power amplifier 1620. In certain aspects, programmable logic 1660 can include, for example, a field programmable gate array (FPGA). Programmable logic 1660 controls the input of power amplifier 1620 via DAC 1680, thereby controlling numerous parameters (e.g., frequency, waveform shape, , waveform amplitude). In certain aspects, and as described below, programmable logic 1660, a processor (e.g., processor 1740, described below), as well as a number of digital signal processing (DSP)-based and/or other control algorithms can be performed to control the parameters of the drive signal output by the generator 1100.

Power can be provided to the power amplifier 1620 bus by a switch mode regulator 1700. In certain aspects, switch mode regulator 1700 can include, for example, an adjustable buck regulator. As discussed above, the non-isolated stage 1540 can further include a processor 1740, which in one aspect includes a DSP processor, such as, for example, an ADSP-21469 SHARC DSP available from Analog Devices (Norwood, Mass.). can be included. In certain aspects, processor 1740 may control operation of switch-mode power converter 1700 in response to voltage feedback data that processor 1740 receives from power amplifier 1620 via an analog-to-digital converter (ADC) 1760. can. For example, in one aspect, processor 1740 can receive as input a waveform envelope of a signal (eg, an RF signal) that is amplified by power amplifier 1620 via ADC 1760. Processor 1740 then controls switch-mode regulator 1700 (e.g., via a pulse width modulation (PWM) output) such that the rail voltage provided to power amplifier 1620 tracks the waveform envelope of the amplified signal. I can do it. By dynamically modulating the rail voltage of power amplifier 1620 based on the waveform envelope, the efficiency of power amplifier 1620 may be significantly improved compared to fixed rail voltage amplifier schemes. Processor 1740 may be configured for wired or wireless communications.

In certain aspects, and as described in further detail in connection with FIGS. 28A-28B, programmable logic 1660, in conjunction with processor 1740, executes a direct digital synthesizer (DDS) control scheme to generate The waveform shape, frequency, and/or amplitude of the drive signal output by the device 1100 may be controlled. In one aspect, for example, programmable logic 1660 implements DDS control by recalling waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT, that may be embedded in an FPGA. Algorithm 2680 (FIG. 28A) may be executed. This control algorithm is particularly useful in ultrasound applications where an ultrasound transducer, such as ultrasound transducer 1120, may be driven by a well-defined sinusoidal current at its resonant frequency. Since other frequencies may excite parasitic resonances, minimizing or reducing the total distortion of the operational branch currents may correspondingly minimize or reduce undesirable resonance effects. The waveform shape of the drive signal output by the generator 1100 may be affected by various distortion sources present within the output drive circuit (e.g., power transformer 1560, power amplifier 1620), so that the voltage and current based on the drive signal may vary. The feedback data can be input to an algorithm, such as an error control algorithm executed by processor 1740, that dynamically, on an ongoing basis (e.g., in real time), analyzes the waveform samples stored in the LUT. Distortion is compensated for by appropriate predistortion or modification. In one aspect, the amount or degree of predistortion applied to the LUT samples may be based on the error between the calculated operating branch current and the desired current waveform shape, where the error is determined on a sample-by-sample basis. In this way, the pre-distorted LUT sample, when processed by the drive circuit, yields a working branch drive signal with the desired waveform shape (e.g. a sine wave) in order to optimally drive the ultrasound transducer. obtain. Therefore, in such aspects, the LUT waveform samples are not the desired waveform shape of the drive signal, but rather the desired waveform required to ultimately produce the operational branch drive signal, taking into account distortion effects. Represents the waveform shape.

The non-isolated stage 1540 includes an ADC 1780 and an ADC coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 to sample the voltage and current of the drive signal output by the generator 1100, respectively. An ADC 1800 can also be included. In certain aspects, the ADC 1780, 1800 can be configured to sample at a high rate (eg, 80Msps) to enable oversampling of the drive signal. In one aspect, for example, the sampling rate of the ADC 1780, 1800 may allow oversampling of the drive signal by approximately 200 times (depending on the drive frequency). In certain aspects, the sampling operation of the ADCs 1780, 1800 may be performed by a single ADC receiving input voltage and current signals through a bidirectional multiplexer. The use of high-speed sampling in aspects of the generator 1100 is useful for, among other things, calculating the complex current flowing through the operating branch (which may be used in certain aspects to implement the DDS-based waveform shape control described above), This makes it possible to perform accurate digital filtering of the signal and calculate the actual power consumption with high accuracy. Voltage and current feedback data output by ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering, multiplexing) by programmable logic 1660, e.g., for subsequent reading by processor 1740. may also be stored in a data memory. As described above, voltage and current feedback data may be used as input to an algorithm to predistort or modify LUT waveform samples on a dynamic and progressive basis. In certain aspects, this means that each stored voltage and current feedback data pair is associated with a corresponding LUT sample output by programmable logic 1660 when the voltage and current feedback data pair is acquired. may need to be indexed based on or otherwise associated with. Synchronization of LUT samples with voltage and current feedback data in this manner contributes to accurate timing and stability of the predistortion algorithm.

In certain aspects, voltage and current feedback data can be used to control the frequency and/or amplitude (eg, current amplitude) of the drive signal. In one aspect, for example, voltage and current feedback data can be used to determine an impedance phase, eg, a phase difference between a voltage drive signal and a current drive signal. Subsequently, the frequency of the drive signal is controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase setpoint (e.g., 0°), thereby minimizing the effects of harmonic distortion. or reduced, and the accuracy of the impedance phase measurement can be correspondingly improved. Determination of the phase impedance and frequency control signal may be performed, for example, in processor 1740, with the frequency control signal being provided as an input to a DDS control algorithm executed by programmable logic 1660.

Impedance phase can be determined by Fourier analysis. In one aspect, the phase difference between the generator voltage V _g (t) drive signal and the generator current I _g (t) drive signal is calculated using a fast Fourier transform (FFT) or a discrete Fourier transform (DFT) as follows: can be determined using

By evaluating the Fourier transform at the frequency of the sine wave, we obtain:

Other approaches include weighted least squares estimation, Kalman filtering, and space vector-based techniques. Substantially all of the processing in FFT or DFT techniques may be performed in the digital domain using, for example, a two-channel high speed ADC 1780, 1800. In one technique, digital signal samples of voltage and current signals are Fourier transformed with an FFT or DFT. The phase angle φ at any time can be calculated by the following formula:

式中、φは位相角であり、ｆは周波数であり、ｔは時間であり、φ_０は、ｔ＝０における位相である。

where φ is the phase angle, f is the frequency, t is the time, and φ ₀ is the phase at t=0.

Another technique for determining the phase difference between the voltage V _g (t) and current I _g (t) signals is the zero-crossing method, which produces highly accurate results. For voltage V _g (t) and current I _g (t) signals with the same frequency, each negative to positive zero crossing of the voltage signal V _g (t) triggers the start of a pulse, while the current signal Each negative to positive zero crossing of I _g (t) triggers the termination of the pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage and current signals. In one aspect, the pulse train can be passed through an averaging filter to obtain a phase difference measurement. Additionally, positive to negative zero crossings can be used in a similar manner to reduce any effects of DC and harmonic components when the results are averaged. In one implementation, the analog voltage V _g (t) and current I _g (t) signals are converted to digital signals that are high when the analog signal is positive and low when the analog signal is negative. . Accurate phase estimation requires abrupt transitions between high and low. In one aspect, a Schmitt trigger can be used with an RC stabilization network to convert an analog signal to a digital signal. In other aspects, edge-triggered RS flip-flops and auxiliary circuits may be used. In yet another aspect, the zero crossing technique may use an eXclusive OR (XOR) gate.

Other techniques for determining the phase difference between voltage and current signals include Lissajous diagrams, and image monitoring; methods such as the three-voltmeter method, the crossed coil method, the vector voltmeter, and the vector impedance method. ; and Phase Standard Instruments, Phase-Locked Loops, and Phase Measurement, Peter O'Shea, 2000 CRC Press LLC, <http://www. engnetbase. com>.

In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude setting may be specified directly or determined indirectly based on the specified voltage amplitude and power setting. In certain aspects, control of current amplitude may be performed by a control algorithm, such as a proportional-integral-derivative (PID) control algorithm within processor 1740, for example. Variables controlled by the control algorithm to properly control the current amplitude of the drive signal include, for example, scaling of LUT waveform samples stored in programmable logic 1660 and/or scaling of the LUT waveform samples via DAC 1860 (this provides the input to power amplifier 1620).

Non-isolated stage 1540 may further include a processor 1900 to provide user interface (UI) functionality, among other things. In one aspect, processor 1900 can include, for example, an Atmel AT91 SAM9263 processor with an ARM926EJ-S core available from Atmel Corporation (San Jose, Calif.). Examples of UI functions supported by processor 1900 include audible and visual user feedback, communication with peripheral devices (e.g., via a universal serial bus (USB) interface), communication with footswitch 1430, input Communication with device 2150 (eg, a touch screen display) as well as communication with output device 2140 (eg, a speaker) may be included. Processor 1900 may communicate with processor 1740 and programmable logic (eg, via a serial peripheral interface (SPI) bus). Although processor 1900 may primarily support UI functionality, it may also cooperate with processor 1740 in certain aspects to provide risk mitigation. For example, processor 1900 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen input 2150, foot switch 1430 input, temperature sensor input 2160) and If a condition is detected, the drive output of generator 1100 may be disabled.

In certain aspects, both processor 1740 (FIGS. 26, 27A) and processor 1900 (FIGS. 26, 27B) can determine and monitor the operational status of generator 1100. In the case of processor 1740, the operating state of generator 1100 can, for example, determine which control and/or diagnostic processes are performed by processor 1740. In the case of processor 1900, the operational state of generator 1100 can, for example, determine which elements of the user interface (eg, display screen, sounds) are provided to the user. The processors 1740, 1900 may separately maintain the current operating state of the generator 1100 and recognize and evaluate possible transitions from the current operating state. Processor 1740 acts as the master in this relationship and can determine when transitions between operating states occur. Processor 1900 can recognize valid transitions between operating states and can confirm whether a particular transition is appropriate. For example, when processor 1740 instructs processor 1900 to transition to a particular state, processor 1900 may verify that the requested transition is valid. If the transition between states required by processor 1900 is determined to be invalid, processor 1900 may place generator 1100 into a failure mode.

The non-isolated stage 1540 includes a controller 1960 (FIG. 26, 27B). In certain aspects, controller 1960 can include at least one processor and/or other controller device in communication with processor 1900. In one aspect, for example, controller 1960 includes a processor (e.g., a Mega168 8 available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. bit controller). In one aspect, controller 1960 can include a touch screen controller (eg, a QT5480 touch screen controller available from Atmel) for controlling and managing the acquisition of touch data from a capacitive touch screen.

In certain aspects, when the generator 1100 is in a "power off" state, the controller 1960 provides operating power (e.g., via a line from a power source of the generator 1100, such as power source 2110 (FIG. 26), described below). You can continue receiving. In this manner, controller 1960 may continue to monitor input device 2150 (eg, a capacitive touch sensor located on the front panel of generator 1100) for turning generator 1100 on and off. When the generator 1100 is in a "power off" state, the controller 1960 may activate the power supply (e.g., one of the power supplies 2110 enabling operation of one or more DC/DC voltage converters 2130 (FIG. 26)). As a result, controller 1960 may initiate a sequence to transition generator 1100 to a "power on" state. Conversely, if activation of the "on/off" input device 2150 is detected while the generator 1100 is in the "power on" state, the controller 1960 will sequence the generator 1100 to transition to the "power off" state. can be started. In certain aspects, for example, controller 1960 can report activation of "on/off" input device 2150 to processor 1900, which in turn causes generator 1100 to transition to a "power off" state. Execute the necessary processing sequence. In such aspects, the controller 1960 may not have an independent ability to cause the removal of power from the generator 1100 after its "power on" state is established.

In certain aspects, the controller 1960 can cause the generator 1100 to provide auditory or other sensory feedback to alert the user that a "power on" or "power off" sequence has been initiated. Such warnings may be provided at the beginning of a "power on" or "power off" sequence and before the start of other processes associated with the sequence.

In certain aspects, the isolation stage 1520 includes, for example, control circuitry of the surgical device (e.g., control circuitry with a handpiece switch) and components of the non-isolation stage 1540 (e.g., programmable logic 1660, processor 1740). , and/or the processor 1900). Instrument interface circuit 1980 communicates information with components of non-isolated stage 1540 via a communication link that maintains a suitable degree of electrical isolation between stages 1520, 1540, such as an infrared (IR) based communication link. Can be exchanged. For example, a low dropout voltage regulator powered by an isolation transformer driven from the non-isolated stage 1540 can be used to power the instrument interface circuit 1980.

In one aspect, instrument interface circuit 1980 can include programmable logic 2000 (eg, an FPGA) that communicates with signal conditioning circuit 2020 (FIGS. 26 and 27C). Signal conditioning circuit 2020 can be configured to receive a periodic signal (eg, a 2 kHz square wave) from programmable logic 2000 and generate a bipolar interrogation signal having the same frequency. The interrogation signal may be generated using, for example, a bipolar current source provided by a differential amplifier. The interrogation signal is communicated to the surgical device control circuit (e.g., by using a conductive pair in a cable connecting the generator 1100 to the surgical device) and determines the state or configuration of the control circuit. can be monitored to determine the For example, the control circuit may detect one or more characteristics of the interrogation signal (e.g., amplitude, A number of switches, resistors, and/or diodes may be included to modify the rectification. For example, in one aspect, the signal conditioning circuit 2020 can include an ADC to generate samples of the voltage signal appearing across the inputs of the control circuit caused by the passage of the interrogation signal. Programmable logic 2000 (or a component of non-isolated stage 1540) can then determine the state or configuration of the control circuit based on the ADC samples.

In one aspect, the instrument interface circuit 1980 has programmable logic 2000 (or other elements of the instrument interface circuit 1980) disposed within or otherwise associated with the surgical device. A first data circuit interface 2040 may be included to enable information exchange with a first data circuit. In certain embodiments, for example, the first data circuit 2060 is located within a cable integrally attached to the handpiece of the surgical device, or in an adapter for interfacing a particular surgical device type or model with the generator 1100. may be placed within. 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 aspects, and referring again to FIG. 26, the first data circuit interface 2040 can be implemented separately from the programmable logic 2000, and the first data circuit interface 2040 can be implemented separately from the programmable logic 2000 and the first data circuit. Suitable circuitry (e.g., separate logic, processors) may be included to enable communication between the devices. In other aspects, first data circuit interface 2040 may be integral to programmable logic 2000.

In certain aspects, first data circuit 2060 can store information regarding a particular surgical device with which first data circuit 2060 is associated. Such information may include, for example, a model number, a serial number, the number of operations in which the surgical device was used, and/or other types of information. This information is read by instrument interface circuit 1980 (e.g., by programmable logic 2000) for presentation to the user via output device 2140 and/or to control functionality or operation of generator 1100. may be transferred to components of non-isolated stage 1540 (eg, programmable logic 1660, processor 1740, and/or processor 1900) for purposes of processing. Additionally, any type of information can be communicated to the first data circuit 2060 via the first data circuit interface 2040 for storage within the first data circuit 2060 (e.g., programmable using logic mechanism 2000). Such information may include, for example, the most recent number of operations in which the surgical device was used, and/or the date and/or time of its use.

As noted above, surgical instruments may be removable from the handpiece (e.g., instrument 1106 may be removable from handpiece 1107 to facilitate interchangeability and/or disposability of the instrument). ). In such cases, known generators may be limited in their ability to recognize the particular instrument configuration being used and optimize control and diagnostic processes accordingly. However, adding readable data circuitry to surgical device instruments to address this issue is problematic from a compatibility standpoint. For example, it may be impractical to design a surgical device to be backward compatible with a generator that lacks the necessary data reading capabilities, e.g. due to different signaling schemes, design complexity, and expense. There are cases. Other aspects of the instrument economically use data circuitry that can be implemented on existing surgical instruments, minimizing design changes to maintain compatibility of the surgical device with modern generator platforms. Address these concerns by:

Additionally, aspects of generator 1100 may enable communication with instrument-based data circuitry. For example, generator 1100 may be configured to communicate with a second data circuit (eg, a data circuit) housed within an instrument (eg, instrument 1104, 1106, or 1108) of a surgical device. Instrument interface circuit 1980 can include a second data circuit interface 2100 to enable this communication. In one aspect, second data circuit interface 2100 may include a tri-state digital interface, although other interfaces may be used. In certain aspects, the second data circuit can generally be any circuit for transmitting and/or receiving data. In one aspect, for example, the second data circuit may store information regarding the particular surgical instrument with which it is associated. Such information may include, for example, a model number, serial number, number of operations in which the surgical instrument was used, and/or any other type of information. Additionally or alternatively, any type of information may be communicated to the second data circuit via the second data circuit interface 2100 for storage within the second data circuit (e.g., programmable using logic mechanism 2000). Such information may include, for example, the most recent number of operations in which the instrument was used, and/or the date and/or time of its use. In certain aspects, the second data circuit can transmit data acquired by one or more sensors (eg, an instrument-based temperature sensor). In certain aspects, the second data circuit can receive data from the generator 1100 and provide an indication (eg, an LED display or other visual indication) to a user based on the received data.

In certain aspects, the second data circuit and the second data circuit interface 2100 can be configured for this purpose without the need to provide additional conductors (e.g., dedicated conductors of the cable connecting the handpiece to the generator 1100). Communication between the programmable logic 2000 and the second data circuit can be accomplished. In one aspect, a one-wire bus communication scheme implemented over existing cabling, e.g., one of the conductors used transmits an interrogation signal from a signal conditioning circuit 2020 to a control circuit within the handpiece. can be used to communicate information to and from a second data circuit. In this way, design changes or modifications to the surgical device that may otherwise be required are minimized or reduced. Furthermore, since various types of communication can be carried out over a common physical channel (with or without frequency band separation), the presence of a second data circuit is essential for the necessary data reading. It is "invisible" to non-functional generators and can therefore enable backward compatibility of surgical device instruments.

In certain aspects, isolation stage 1520 can include at least one blocking capacitor 2960-1 (FIG. 27C) connected to drive signal output 1600b to prevent DC current from passing through the patient. A single blocking capacitor may be required, for example, to comply with medical regulations or standards. Although failures in single capacitor designs are relatively rare, such failures can still have negative consequences. In one aspect, a second blocking capacitor 2960-2 is provided in series with blocking capacitor 2960-1 to prevent current leakage from a point between blocking capacitors 2960-1, 2960-2, e.g. can be monitored by an ADC 2980 to sample the voltage. Samples may be received by programmable logic 2000, for example. Based on changes in leakage current (as indicated by the voltage samples in the manner of FIG. 26), generator 1100 can determine when at least one of blocking capacitors 2960-1, 2960-2 has failed. Accordingly, the embodiment of FIG. 26 may provide benefits for single capacitor designs with a single point of failure.

In certain aspects, non-isolated stage 1540 can include a power source 2110 for outputting DC power at a suitable voltage and current. The power supply may include, for example, a 400W power supply for outputting a 48VDC system voltage. As mentioned above, the power supply 2110 includes one or more DC outputs for receiving the output of the power supply and producing a DC output at the voltages and currents required by the various components of the generator 1100. /DC voltage converter 2130 may further be included. As described above in connection with controller 1960, one or more of DC/DC voltage converters 2130 are activated when activation of "on/off" input device 2150 by a user is detected by controller 1960. Input may be received from controller 1960 to enable operation or activation of DC/DC voltage converter 2130.

28A-28B illustrate certain functional and structural aspects of one embodiment of generator 1100. Feedback indicating the current and voltage output from the secondary winding 1580 of the power transformer 1560 is received by the ADCs 1780, 1800, respectively. As shown, the ADCs 1780, 1800 can be implemented as two-channel ADCs and can also be implemented at high speeds (e.g., 80Msps) to allow oversampling of the drive signals (e.g., approximately 200x oversampling). The feedback signal can be sampled. The current and voltage feedback signals may be suitably conditioned (eg, amplified, filtered) in the analog domain prior to processing by the ADCs 1780, 1800. Current and voltage feedback samples from ADCs 1780, 1800 may be individually buffered and then multiplexed or interleaved into a single data stream within block 2120 of programmable logic 1660. In the embodiment of FIGS. 28A-28B, programmable logic 1660 comprises an FPGA.

Multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented within block 2144 of processor 1740. A PDAP may include a packing unit for implementing any of a number of methods for correlating multiplexed feedback samples and memory addresses. In one aspect, for example, the feedback sample corresponding to a particular LUT sample output by programmable logic 1660 may be one or more memory addresses that are associated with or indexed to the LUT address of the LUT sample. can be stored in In another aspect, feedback samples corresponding to a particular LUT sample output by programmable logic 1660 may be stored in a common storage location along with the LUT address of the LUT sample. In any case, the feedback samples may be stored so that the address of the LUT sample from which a particular set of feedback samples comes can be subsequently ascertained. As mentioned above, synchronization of the LUT sample addresses and feedback samples thus contributes to accurate timing and stability of the predistortion algorithm. A direct memory access (DMA) controller implemented in block 2166 of processor 1740 provides feedback samples (and any LUT sample address data, if applicable) at a designated memory location 2180 (e.g., internal RAM) of processor 1740. can be memorized.

Block 2200 of processor 1740 may implement a pre-distortion algorithm to pre-distort or modify LUT samples stored in programmable logic 1660 on a dynamic, ongoing basis. As mentioned above, pre-distortion of the LUT samples can compensate for various sources of distortion present in the output drive circuitry of generator 1100. The pre-distorted LUT sample, when processed by the drive circuitry, therefore produces a drive signal with a desired waveform shape (eg, a sine wave) to optimally drive the ultrasound transducer.

At block 2220 of the predistortion algorithm, the current flowing through the working branch of the ultrasound transducer is determined. The operating branch currents are, for example, current and voltage feedback samples stored in memory location 2180 (which, when suitably scaled, may represent the I _g and V _g of the model of FIG. 25 above), the ultrasonic transducer Based on the value of capacitance C ₀ (measured or known a priori) and the known value of the driving frequency, it can be determined using Kirchhoff's current law. Operating branch current samples in each set of stored current and voltage feedback samples associated with a LUT sample may be determined.

At block 2240 of the predistortion algorithm, each operational branch current sample determined at block 2220 is compared to a sample of the desired current waveform shape to determine the difference or sample amplitude error between the compared samples. For this determination, samples of the current waveform shape may be provided, for example, from a waveform shape LUT 2260 that includes amplitude samples for one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT 2260 used for comparison may be determined by the LUT sample address associated with the operational branch current sample used for comparison. Accordingly, the input to block 2240 of the operational branch current may be synchronized with the input to block 2240 of its associated LUT sample address. Therefore, the LUT samples stored in programmable logic 1660 and waveform shape LUT 2260 can be of comparable numerical value. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT 2260 can be a fundamental sine wave. Other waveform shapes may be desirable. For example, superimposed with one or more other drive signals at other wavelengths, such as third harmonics, to drive at least two mechanical resonances for lateral or other modalities of beneficial vibrations. It is envisioned that an elementary sinusoidal wave can be used to drive the main longitudinal motion of the ultrasound transducer.

Each value of sample amplitude error determined at block 2240 may be communicated to a LUT (shown in block 2280 of FIG. 28A) of programmable logic 1660, along with an indication of its associated LUT address. Based on the sample amplitude error value and its associated address (and optionally the sample amplitude error value for the same LUT address received earlier), the LUT 2280 (or other control block of the programmable logic 1660 ) can predistort or modify the values of LUT samples stored at LUT addresses, thereby reducing or minimizing sample amplitude errors. Such predistortion or modification of each LUT sample in an iterative manner over the entire range of LUT addresses causes the generator output current waveform shape to match the desired current waveform shape represented by the samples of waveform shape LUT 2260. It will be understood to match or adapt.

Current and voltage amplitude measurements, power measurements, and impedance measurements may be determined at block 2300 of processor 1740 based on current and voltage feedback samples stored in memory location 2180. Prior to determination of these numbers, the feedback samples are appropriately scaled and, in certain aspects, processed through a suitable filter 2320 to remove, for example, noise and induced harmonic components caused by the data acquisition process. be able to. The filtered voltage and current samples may therefore substantially represent the fundamental frequency of the generator's drive output signal. In certain aspects, filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain. Such aspects may use fast Fourier transforms (FFT) of the output drive signal current and voltage signals. In certain aspects, the resulting frequency spectrum can be used to provide additional generator functionality. In one aspect, for example, the ratio of second and/or third harmonic components to the fundamental frequency component can be used as a diagnostic indicator.

At block 2340 (FIG. 28B), a root mean square (RMS) calculation is applied to a sample size of current feedback samples representing an integer number of cycles of the drive signal to generate a measurement I _rms representing the drive signal output current. obtain.

At block 2360, a root mean square (RMS) calculation may be applied to a sample size of voltage feedback samples representing an integer number of cycles of the drive signal to determine a measurement V _rms representing the drive signal output voltage.

At block 2380, the current and voltage feedback samples may be multiplied point by point, and an averaging calculation is applied to the samples representing an integer number of cycles of the drive signal to determine a measurement of the actual output power of the generator, P _r .

At block 2400, the measured value of the generator's apparent output power, P _a , may be determined as the product V _rms· I _rms .

At block 2420, the load impedance magnitude measurement Z _m may be determined as the quotient V _rms /I _rms .

In certain aspects, the values I _rms , V _rms , P _r , P _a , and Z _m determined in blocks 2340, 2360, 2380, 2400, and 2420 may be any one of a number of control and/or diagnostic processes. can be used by generator 1100 to implement the following. In certain embodiments, any of these numbers may be transmitted to a suitable communication interface (e.g., a USB interface), e.g., via an output device 2140 that is integral with or connected to the generator 1100 can be communicated to the user through. Various diagnostic processes include, for example, handpiece integrity, instrument integrity, instrument mounting integrity, instrument overload, approaching instrument overload, frequency lock failure, overvoltage condition, overcurrent condition, overpower condition, and voltage sensing failure. , a current sensing failure, an audible indicator failure, a visual indicator failure, a short circuit condition, a power delivery failure, or a blocking capacitor failure.

Block 2440 of processor 1740 may implement a phase control algorithm to determine and control the impedance phase of an electrical load (eg, an ultrasound transducer) driven by generator 1100. As mentioned above, the effects of harmonic distortion are addressed by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and the impedance phase setpoint (e.g., 0°). can be minimized or reduced to improve the accuracy of phase measurements.

The phase control algorithm receives current and voltage feedback samples stored in memory location 2180 as input. Before using them in the phase control algorithm, the feedback samples are scaled appropriately and, in certain aspects, are filtered with a suitable filter 2460 (e.g., to remove noise arising from the data acquisition process and induced harmonic components). (which may be the same as filter 2320). The filtered voltage and current samples may therefore substantially represent the fundamental frequency of the generator's drive output signal.

At block 2480 of the phase control algorithm, the current flowing through the operational branch of the ultrasound transducer is determined. This determination may be the same as that described above in connection with block 2220 of the predistortion algorithm. Accordingly, the output of block 2480 may be an operating branch current sample for each set of stored current and voltage feedback samples associated with a LUT sample.

At block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized inputs of the operating branch current samples and corresponding voltage feedback samples determined at block 2480. In certain aspects, the impedance phase is determined as the average of the impedance phase measured at the rising edge of the waveform and the impedance phase measured at the falling edge of the waveform.

At block 2520 of the phase control algorithm, the impedance phase value determined at block 2220 is compared to a phase set point 2540 to determine the difference or phase error between the compared values.

At block 2560 (FIG. 28A) of the phase control algorithm, a frequency output for controlling the frequency of the drive signal is determined based on the phase error value determined at block 2520 and the impedance magnitude determined at block 2420. be done. To maintain the impedance phase determined at block 2500 at a phase setting (eg, zero phase error), the frequency output value may be continuously adjusted by block 2560 and transferred to DDS control block 2680 (described below). In certain aspects, the impedance phase may be adjusted to a 0° phase setting. In this way, any amount of harmonic distortion is centered around the top of the voltage waveform, improving the accuracy of phase impedance determination.

Block 2580 of processor 1740 provides drive signals to control drive signal current, voltage, and power according to user-specified settings or according to requirements specified by other processes or algorithms implemented by generator 1100. An algorithm can be implemented to modulate the current amplitude of the signal. Control of these numbers may be achieved, for example, by scaling the LUT samples of LUT 2280 and/or by adjusting the full-scale output voltage of DAC 1680 (which provides input to power amplifier 1620) via DAC 1860. can. Block 2600 (which may be implemented as a PID controller in certain aspects) may receive current feedback samples (which may be appropriately scaled and filtered) as input from memory location 2180. The current feedback sample is compared to a "current demand" I _{d value} determined by a controlled variable (e.g., current, voltage, or power) to determine whether the drive signal is supplying the required current. can be done. In embodiments where the drive signal current is a controlled variable, the current demand I _d may be specified directly by the current set point 2620A (I _sp ). For example, the RMS value of the current feedback data (determined at block 2340) may be compared to a user-specified RMS current setpoint I _sp to determine appropriate controller action. For example, if the current feedback data indicates an RMS value lower than the current set point I _sp , the LUT scaling and/or the full scale output voltage of the DAC 1680 may be adjusted by block 2600 such that the drive signal current is increased. Conversely, if the current feedback data indicates an RMS value higher than the current set point _Isp , block 2600 may adjust the LUT scaling and/or the full-scale output voltage of DAC 1680 to reduce the drive signal current. good.

In embodiments where the drive signal voltage is a controlled variable, the current demand I _d maintains the desired voltage set point 2620B (V _sp ) given the load impedance magnitude Z _m measured at block 2420, for example. (eg, I _d =V _sp /Z _m ). Similarly, in embodiments where the drive signal power is a controlled _variable , the current demand I _d is, _e.g. (e.g., I _d =P _sp /V _rms ).

Block 2680 (FIG. 28A) may implement a DDS control algorithm to control drive signals by recalling LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm may be a numerically controlled oscillator (NCO) algorithm to generate samples of the waveform at a fixed clock rate using point-skipping techniques. The NCO algorithm may implement a phase accumulator or frequency/phase converter that acts as an address pointer to recall LUT samples from LUT 2280. In one aspect, the phase accumulator can be a D step size, modulo N phase accumulator, where D is a positive integer representing a frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D=1 may, for example, cause the phase accumulator to sequentially address all of LUT 2280 and produce a waveform output that replicates the waveform stored in LUT 2280. If D>1, the phase accumulator can skip addresses in LUT 2280 to produce a waveform output with a higher frequency. Thereby, the frequency of the waveform generated by the DDS control algorithm can thus be controlled by appropriately varying the frequency control value. In certain aspects, the frequency control value may be determined based on the output of the phase control algorithm implemented at block 2440. The output of block 2680 may provide the input of DAC 1680, which in turn provides a corresponding analog signal to the input of power amplifier 1620.

Block 2700 of processor 1740 provides a switch mode converter control algorithm for dynamically modulating the rail voltage of power amplifier 1620 based on the waveform envelope of the signal being amplified, thereby improving the efficiency of power amplifier 1620. can be carried out. In certain aspects, characteristics of the waveform envelope can be determined by monitoring one or more signals included in power amplifier 1620. In one aspect, for example, the characteristics of the waveform envelope can be determined by monitoring the minimum value of a drain voltage (eg, a MOSFET drain voltage) that is modulated according to the envelope of the amplified signal. The minimum voltage signal may be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal may be sampled by ADC 1760, and the output minimum voltage sample may be received at block 2720 of the switch mode converter control algorithm. Based on the value of the minimum voltage sample, block 2740 may control the PWM signal output by PWM generator 2760, which in turn controls the rail voltage provided to power amplifier 1620 by switch mode regulator 1700. . In certain aspects, as long as the value of the minimum voltage sample is less than the minimum target 2780 input to block 2720, the rail voltage may be modulated according to the waveform envelope characterized by the minimum voltage sample. For example, block 2740 provides a low rail voltage to power amplifier 1620 when the minimum voltage sample indicates a low envelope power level, and full rail voltage is provided only when the minimum voltage sample indicates a maximum envelope power level. It's okay. When the minimum voltage sample is below the minimum target 2780, block 2740 may maintain the rail voltage at a suitable minimum value to ensure proper operation of the power amplifier 1620.

FIG. 29 is a circuit diagram of one aspect of an electrical circuit 2900 suitable for driving an ultrasound transducer, such as ultrasound transducer 1120, in accordance with at least one aspect of the present disclosure. Electrical circuit 2900 includes an analog multiplexer 2980. Analog multiplexer 2980 multiplexes various signals from upstream channels SCL-A, SDA-A, such as ultrasound, battery, and power control circuits. A current sensor 2982 is coupled in series with the return or ground terminal of the power supply circuit and measures the current provided by the power supply. A field effect transistor (FET) temperature sensor 2984 provides ambient temperature. A pulse width modulation (PWM) watchdog timer 2988 automatically generates a system reset if the main program fails to provide a periodic system reset. This is provided to automatically reset the electrical circuit 2900 if it hangs up or freezes due to a software or hardware failure. It will be appreciated that electrical circuit 2900 may be configured as an RF driver circuit for driving an ultrasound transducer or for driving an RF electrode, such as electrical circuit 3600 shown in FIG. 36, for example. Thus, referring now again to FIG. 29, electrical circuit 2900 can be used to alternately drive both the ultrasound transducer and the RF electrode. In the case of simultaneous driving, a filter circuit may be provided in the corresponding first stage circuit 3404 (FIG. 34) to select either the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned United States Patent Publication No. US-2017-0086910-A1, entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated herein by reference in its entirety.

Drive circuit 2986 provides left and right ultrasound energy outputs. Digital signals representing signal waveforms are provided to the SCL-A and SDA-A inputs of analog multiplexer 2980 from a control circuit such as control circuit 3200 (FIG. 32). A digital-to-analog converter 2990 (DAC) converts the digital input to an analog output to drive a PWM circuit 2992 coupled to an oscillator 2994. PWM circuit 2992 provides a first signal to a first gate drive circuit 2996a coupled to first transistor output stage 2998a to drive a first ultrasonic (left side) energy output. PWM circuit 2992 also provides a second signal to a second gate drive circuit 2996b coupled to second transistor output stage 2998b to drive a second ultrasonic (right side) energy output. A voltage sensor 2999 is coupled between the ultrasonic left/right output terminals to measure the output voltage. Drive circuit 2986, first drive circuit 2996a and second drive circuit 2996b, and first transistor output stage 2998a and second transistor output stage 2998b define a first stage amplifier circuit. In operation, the control circuit 3200 (FIG. 32) generates a digital waveform 4300 (FIG. 43) using circuits such as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 41 and 42). DAC 2990 receives digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

FIG. 30 is a circuit diagram of a transformer 3000 coupled to electrical circuit 2900 shown in FIG. 29, in accordance with at least one aspect of the present disclosure. The ultrasonic left/right input terminals (primary windings) of transformer 3000 are electrically coupled to the ultrasonic left/right output terminals of electrical circuit 2900 . The secondary winding of transformer 3000 is coupled to a positive electrode 3074a and a negative electrode 3074b. The positive and negative electrodes 3074a, 3074b of the transformer 3000 are coupled to the positive terminal (stack 1) and negative terminal (stack 2) of the ultrasound transducer. In one aspect, transformer 3000 has a turns ratio of n ₁ :n ₂ of 1:50.

FIG. 31 is a circuit diagram of the transformer 3000 shown in FIG. 30 coupled to a test circuit 3165 in accordance with at least one aspect of the present disclosure. Test circuit 3165 is coupled to positive and negative electrodes 3074a, 3074b. Switch 3167 is placed in series with an inductor/capacitor/resistor (LCR) load device that simulates the loading of the ultrasound transducer.

FIG. 32 is a circuit diagram of a control circuit 3200, such as control circuit 3212, in accordance with at least one aspect of the present disclosure. Control circuit 3200 is located within the housing of the battery assembly. The battery assembly is the energy source for various local power sources 3215. The control circuitry connects the main processor 3214 to various downstream circuits via an interface master 3218, e.g., by outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. Be prepared. In one aspect, interface master 3218 is a general purpose serial interface, such as an I ² C serial interface. Main processor 3214 is also configured to drive a switch 3224 via general purpose input/output (GPIO) 3220 , a display 3226 (eg, and an LCD display), and various indicators 3228 via GPIO 3222 . A watchdog processor 3216 is provided to control main processor 3214. A switch 3230 is provided in series with the battery 3211 to activate the control circuit 3212 when the battery assembly is inserted into the handle assembly of the surgical instrument.

In one aspect, main processor 3214 is coupled to electrical circuitry 2900 (FIG. 29) by output terminals SCL-A, SDA-A. Main processor 3214 includes, for example, memory for storing a table of digitized drive signals or waveforms that are transmitted to electrical circuitry 2900 to drive ultrasound transducer 1120. 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. The main processor 3214 also provides RF drive through output terminals SCL-B, SDA-B, and various sensors (e.g., Hall effect sensors, magnetorheological fluid (MRF) sensors, etc.) through output terminals SCL-C, SDA-C. may be provided. In one aspect, main processor 3214 is configured to sense the presence of ultrasound drive circuitry and/or RF drive circuitry to enable appropriate software and user interface functionality.

In one aspect, main processor 3214 may be, for example, a LM 4F230H5QR available from Texas Instruments. In at least one example, Texas Instruments' LM4F230H5QR has on-chip memory up to 40 MHz of 256 KB of single-cycle flash memory or other non-volatile memory, improving performance above 40 MHz, among other features readily available from the product data sheet. 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2 KB electrically erasable programmable read-only memory (EEPROM), 1 one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QED) analog, one or more 12-bit analog-to-digital conversion with 12 analog input channels This is an ARM Cortex-M4F processor core that includes an ADC. Other processors may be easily substituted, so the present disclosure should not be limited to this context.

FIG. 33 depicts a simplified block circuit diagram illustrating another electrical circuit 3300 housed within a modular ultrasonic surgical instrument 3334 in accordance with at least one aspect of the present disclosure. The electrical circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power source 3304 (e.g., a battery), a switch 3306 such as a metal oxide semiconductor field effect transistor (MOSFET) power switch, a drive circuit 3308 (PLL), a transformer 3310, a signal A smoothing circuit 3312 (also referred to as a matching circuit, which may be, for example, a tank circuit), a sensing circuit 3314, a transducer 1120, and an ultrasonic blade (for example, an ultrasonic blade), which may also be referred to herein simply as a waveguide. 1128, 1149) including a shaft assembly (e.g., shaft assembly 1126, 1129) with an ultrasound transmission waveguide terminating in an ultrasound transmission waveguide.

One feature of the present disclosure that eliminates dependence on high voltage (120 VAC) input power, a characteristic of typical ultrasonic cutting equipment, is the use of low voltage switching throughout the waveforming process and just before the transformer stage. The amplification of the drive signal is limited to . For this reason, in one aspect of the present disclosure, power is derived only from a battery or battery group that is small enough to fit one within the handle assembly. State-of-the-art battery technology provides powerful cells that are a few centimeters high and wide and a few millimeters deep. By combining the features of the present disclosure to provide a self-contained and self-powered ultrasound device, reduced manufacturing costs can be achieved.

The output of power supply 3304 is provided to processor 3302 to provide power. Processor 3302 receives and outputs signals and functions according to custom logic executed by processor 3302 or according to a computer program, as described below. As mentioned above, electrical circuit 3300 can also include memory 3326, preferably random access memory (RAM), for storing computer readable instructions and data.

The output of power supply 3304 is also directed to switch 3306, which has a duty cycle controlled by processor 3302. By controlling the on-time of switch 3306, processor 3302 can determine the total amount of power ultimately delivered to transducer 1120. In one aspect, switch 3306 is a MOSFET, but other switches and switching configurations are equally applicable. The output of switch 3306 is provided to a drive circuit 3308 that includes, for example, a phase detection phase locked loop (PLL) and/or a low pass filter and/or a voltage controlled oscillator. The output of switch 3306 is sampled by processor 3302 to determine the voltage and current of the output signal (V _IN and I _IN , respectively). These values are used in the feedback architecture to adjust the pulse width modulation of switch 3306. For example, the duty cycle of switch 3306 can vary from about 20% to about 80% depending on the actual output desired from switch 3306.

Drive circuit 3308, which receives the signal from switch 3306, includes an oscillator circuit that converts the output of switch 3306 into an electrical signal at an ultrasonic frequency, eg, 55 kHz (VCO). As discussed above, a smoothed version of this ultrasound waveform is ultimately provided to the ultrasound transducer 1120 to generate a resonant sine wave along the ultrasound transmission waveguide.

At the output of the drive circuit 3308 is a transformer 3310 that can step up the low voltage signal(s) to a higher voltage. Note that upstream switching is performed at low (eg, battery powered) voltages before transformer 3310, something that has not been possible with ultrasonic cutting and ablation devices to date. This is due, at least in part, to the fact that the device advantageously uses low on-resistance MOSFET switching devices. Low on-resistance MOSFET switches are advantageous because they produce lower switching losses and less heat than conventional MOSFET devices, and can pass higher currents. Therefore, the switching stage (pre-transformer) can be characterized as low voltage/high current. To ensure a lower on-resistance of the amplifier MOSFET(s), the MOSFET(s) are operated at 10V, for example. In such a case, a separate 10VDC power supply can be used to supply the MOSFET gate, ensuring that the MOSFET is fully on and a reasonably low on-resistance is achieved. In one aspect of the disclosure, transformer 3310 boosts the battery voltage to 120V root mean square (RMS). Transformers are known in the art and are therefore not described in detail here.

In the described circuit configurations, degradation of the circuit components can negatively impact the circuit performance of the circuit. One factor that directly affects component performance is heat. Known circuits commonly monitor switching temperatures (eg, MOSFET temperatures). However, with technological advances in MOSFET design and corresponding size reductions, MOSFET temperature is no longer a valid indicator of circuit loading and heat. Thus, in accordance with at least one aspect of the present disclosure, sensing circuit 3314 senses the temperature of transformer 3310. This temperature sensing is advantageous because the transformer 3310 is operated at or near its maximum temperature during use of the device. Additional temperatures will destroy the core material, such as ferrite, and permanent damage may occur. The present disclosure provides a method for controlling transformer 3310 by, for example, reducing drive power within transformer 3310, signaling a user, turning off power, pulsing power, or other suitable responses. Capable of responding to maximum temperatures.

In one aspect of the disclosure, the processor 3302 is communicatively coupled to an end effector (e.g., 1122, 1125) that positions the material in physical contact with an ultrasonic blade (e.g., 1128, 1149). used for A sensor is provided at the end effector to measure a clamp force value (within a known range), and based on the received clamp force value, the processor 3302 changes the operating voltage V _M . Temperature sensor 3332 may be communicatively coupled to processor 3302, where processor 3302 receives information from temperature sensor 3336 on the blade, as high force values combined with a set operating speed may result in high blade temperatures. The device is operable to receive and interpret a signal indicative of a current temperature and to determine a target frequency of blade motion based on the received temperature. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the trigger (eg, 1143, 1147) to measure the force applied to the trigger by the user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch button such that the displacement strength corresponds to a force applied to the switch button by a user.

According to at least one aspect of the present disclosure, a PLL portion of drive circuit 3308 coupled to processor 3302 can determine the frequency of waveguide motion and communicate the frequency to processor 3302. Processor 3302 stores this frequency value in memory 3326 when the device is turned off. By reading the clock 3330, the processor 3302 can determine the elapsed time since the device was shut off and, if the elapsed time is less than a predetermined value, read the last frequency of waveguide motion. . The device can then be started at a final frequency that is, estimably, the optimal frequency for the current load.

Modular Battery-Powered Handheld Surgical Instrument with Multi-Stage Generator Circuit In another aspect, the present disclosure provides a modular battery-powered handheld surgical instrument with a multi-stage generator circuit. A surgical instrument is disclosed that includes a battery assembly, a handle assembly, and a shaft assembly, the battery assembly and shaft assembly being configured to mechanically and electrically connect with the handle assembly. The battery assembly includes a control circuit configured to generate a digital waveform. The handle assembly includes a first stage circuit configured to receive a digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform. The shaft assembly includes a second stage circuit coupled to the first stage circuit for receiving, amplifying and applying the analog waveform to the load device.

In one aspect, the present disclosure provides a battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, the processor configured to generate a digital waveform; a first stage circuit coupled to the processor, the first stage circuit including a digital-to-analog (DAC) converter and a first stage amplifier circuit, the DAC configured to receive a digital waveform and convert the digital waveform to an analog waveform. a handle assembly configured to receive and amplify the analog waveform; and a first stage amplifier circuit configured to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to the load device. , a surgical instrument comprising a shaft assembly including a second stage circuit coupled to a first stage amplifier circuit, the battery assembly and the shaft assembly being configured to mechanically and electrically connect with the handle assembly. do.

The load device may include any one of an ultrasound transducer, an electrode, or a sensor, or any combination thereof. The first stage circuit may include a first stage ultrasonic drive circuit and a first stage high frequency current drive circuit. The control circuit may be configured to drive the first stage ultrasonic drive circuit and the first stage high frequency current drive circuit individually or simultaneously. The first stage ultrasound drive circuit may be configured to couple to the second stage ultrasound drive circuit. A second stage ultrasound drive circuit may be configured to interface with the ultrasound transducer. The first stage high frequency current drive circuit may be configured to couple to the second stage high frequency drive circuit. A second stage high frequency drive circuit may be configured to couple to the electrode.

The first stage circuit may include a first stage sensor drive circuit. The first stage sensor drive circuit may be configured relative to the second stage sensor drive circuit. A second stage sensor drive circuit may be configured to couple to the sensor.

In another aspect, the present disclosure provides a battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, the processor configured to generate a digital waveform. a common first stage circuit coupled to a processor, the common first stage circuit including a digital-to-analog (DAC) converter and a common first stage amplifier circuit, the DAC receiving a digital waveform and converting the digital waveform; a handle assembly configured to receive and amplify the analog waveform; and a common first stage amplifier circuit configured to receive and amplify the analog waveform; a shaft assembly including a second stage circuit coupled to a common first stage amplifier circuit for applying the waveform to the load device, the battery assembly and the shaft assembly being in mechanical and electrical connection with the handle assembly; A surgical instrument is provided.

The load device may include any one of an ultrasound transducer, an electrode, or a sensor, or any combination thereof. The common first stage circuit may be configured to drive ultrasound, radio frequency current, or sensor circuitry. The common first stage drive circuit may be configured to couple with the second stage ultrasonic drive circuit, the second stage high frequency drive circuit, or the second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to couple with the ultrasonic transducer, the second stage radio frequency drive circuit may be configured to couple with the electrode, and the second stage sensor drive circuit may be configured to couple with the sensor. It is composed of

In another aspect, the present disclosure provides a control circuit including a memory coupled to a processor, the processor configured to generate a digital waveform; a common first stage circuit coupled to the processor; and a common first stage circuit configured to receive a digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform; and a handle assembly configured to receive and amplify the analog waveform. , a surgical instrument comprising a shaft assembly including a second stage circuit coupled to a common first stage circuit, the shaft assembly being configured to mechanically and electrically connect with the handle assembly.

The common first stage circuit may be configured to drive ultrasound, radio frequency current, or sensor circuitry. The common first stage drive circuit may be configured to couple with the second stage ultrasonic drive circuit, the second stage high frequency drive circuit, or the second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to couple with the ultrasonic transducer, the second stage radio frequency drive circuit may be configured to couple with the electrode, and the second stage sensor drive circuit may be configured to couple with the sensor. It is composed of

FIG. 34 illustrates a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406 in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of surgical system 1000 described herein may include a generator circuit 3400 that is divided into multiple stages. For example, the surgical instrument of surgical system 1000 includes a first stage circuit of amplification that enables operation of at least two circuits: RF energy only, ultrasound energy only, and/or a combination of RF energy and ultrasound energy. 3404 and a second stage circuit 3406. The combination modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within the handle assembly 3412 and a modular second stage circuit 3406 that is integral with the modular shaft assembly 3414. As discussed above throughout this description in connection with the surgical instruments of surgical system 1000, battery assembly 3410 and shaft assembly 3414 are configured to mechanically and electrically connect with handle assembly 3412. The end effector assembly is configured to mechanically and electrically connect with shaft assembly 3414.

Referring now to FIG. 34, generator circuit 3400 is divided into multiple stages located within multiple modular assemblies of surgical instruments, such as the surgical instruments of surgical system 1000 described herein. . In one aspect, the control stage circuit 3402 may be located within a surgical instrument battery assembly 3410. Control stage circuit 3402 is control circuit 3200 described in connection with FIG. Control circuit 3200 includes a processor 3214 that includes internal memory 3217 (FIG. 34) (eg, volatile and non-volatile memory) and is electrically coupled to battery 3211. Battery 3211 supplies power to first stage circuit 3404, second stage circuit 3406, and third stage circuit 3408, respectively. As mentioned above, control circuit 3200 generates digital waveform 4300 (FIG. 43) using the circuitry and techniques described in connection with FIGS. 41 and 42. Referring again to FIG. 34, digital waveform 4300 may be configured to drive ultrasound transducers, radio frequency (eg, RF) electrodes, or a combination thereof either individually or simultaneously. In the case of simultaneous driving, a filter circuit may be provided in the corresponding first stage circuit 3404 to select either the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned United States Patent Publication No. US-2017-0086910-A1, entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated herein by reference in its entirety.

A first stage circuit 3404 (eg, a first stage ultrasonic drive circuit 3420, a first stage RF drive circuit 3422, and a first stage sensor drive circuit 3424) is located within the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides an ultrasonic driving signal to the first stage ultrasonic driving circuit 3420 through outputs SCL-A and SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 will be described in detail with respect to FIG. The control circuit 3200 provides an RF drive signal to the first stage RF drive circuit 3422 via the outputs SCL-B and SDA-B of the control circuit 3200. The first stage RF drive circuit 3422 will be described in detail in connection with FIG. The control circuit 3200 provides a sensor drive signal to the first stage sensor drive circuit 3424 via the outputs SCL-C and SDA-C of the control circuit 3200. Generally, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section to drive the second stage circuit 3406. The output of first stage circuit 3404 is provided to the input of second stage circuit 3406.

Control circuit 3200 is configured to detect which modules are plugged into control circuit 3200. For example, the control circuit 3200 may determine whether a first stage ultrasonic drive circuit 3420, a first stage RF drive circuit 3422, or a first stage sensor drive circuit 3424 located within the handle assembly 3412 is connected to the battery assembly 3410. Configured to detect. Similarly, each of the first stage circuits 3404 can detect which second stage circuits 3406 are connected to it, and that information is used by the control circuit 3200 to determine the type of signal waveform to generate. will be returned to. Similarly, each of the second stage circuits 3406 can detect which third stage circuits 3408 or components are connected to it, and that information is used to determine the type of signal waveform to generate. It is returned to control circuit 3200.

In one aspect, second stage circuitry 3406 (e.g., ultrasound driven second stage circuit 3430, RF driven second stage circuit 3432, and sensor driven second stage circuit 3434) is located within shaft assembly 3414 of the surgical instrument. do. The first stage ultrasound drive circuit 3420 provides a signal to the second stage ultrasound drive circuit 3430 via outputs US Left/US Right. The second stage ultrasonic drive circuit 3430 will be described in detail with respect to FIGS. 30 and 31. In addition to the transformer (FIGS. 30 and 31), the second stage ultrasound drive circuit 3430 may further include filters, amplifiers, and signal conditioning circuits. A first stage radio frequency (RF) current drive circuit 3422 provides a signal to a second stage RF drive circuit 3432 via outputs RF Left/RF Right. In addition to the transformer and blocking capacitor, the second stage RF drive circuit 3432 may further include filters, amplifiers, and signal conditioning circuits. The first stage sensor drive circuit 3424 provides a signal to the second stage sensor drive circuit 3434 via output sensor 1/sensor 2. The second stage sensor drive circuit 3434 may include filters, amplifiers, and signal conditioning circuits depending on the type of sensor. The output of second stage circuit 3406 is provided to the input of third stage circuit 3408.

In one aspect, third stage circuitry 3408 (eg, ultrasound transducer 1120, RF electrodes 3074a, 3074b, and sensor 3440) may be located within various assemblies 3416 of surgical instruments. In one aspect, the second stage ultrasound drive circuit 3430 provides a drive signal to the piezoelectric stack of the ultrasound transducer 1120. In one aspect, ultrasound transducer 1120 is located within an ultrasound transducer assembly of a surgical instrument. However, in other aspects, the ultrasound transducer 1120 may be located within the handle assembly 3412, shaft assembly 3414, or end effector. In one aspect, the second stage RF drive circuit 3432 provides drive signals to RF electrodes 3074a, 3074b located generally within the end effector portion of the surgical instrument. In one aspect, the second stage sensor drive circuit 3434 provides drive signals to various sensors 3440 located throughout the surgical instrument.

FIG. 35 illustrates a generator circuit 3500 divided into multiple stages, with a first stage circuit 3504 in common with a second stage circuit 3506, in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of surgical system 1000 described herein may include a generator circuit 3500 that is divided into multiple stages. For example, the surgical instruments of surgical system 1000 may include an amplifying circuit that enables operation of at least two circuits: radio frequency (RF) energy only, ultrasound energy only, and/or a combination of RF energy and ultrasound energy. A generator circuit 3500 may be provided that is divided into a first stage circuit 3504 and a second stage circuit 3506. The combination modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 that is integral with the modular shaft assembly 3514. As discussed above throughout this description in connection with the surgical instruments of surgical system 1000, battery assembly 3510 and shaft assembly 3514 are configured to mechanically and electrically connect with handle assembly 3512. The end effector assembly is configured to mechanically and electrically connect with shaft assembly 3514.

As shown in the embodiment of FIG. 35, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes control circuit 3200 previously described. The handle assembly 3512 that connects to the battery assembly 3510 includes a common first stage drive circuit 3420. As previously discussed, the first stage drive circuit 3420 is configured to drive ultrasound, radio frequency (RF) current, and sensor loads. The output of the common first stage drive circuit 3420 is connected to a second stage circuit 3506 such as a second stage ultrasonic drive circuit 3430, a second stage radio frequency (RF) current drive circuit 3432, and/or a second stage sensor drive circuit 3434. Any one of them can be driven. Common first stage drive circuit 3420 detects which second stage circuit 3506 is located within shaft assembly 3514 when shaft assembly 3514 is connected to handle assembly 3512. When shaft assembly 3514 is connected to handle assembly 3512, common first stage drive circuit 3420 connects second stage circuit 3506 (e.g., second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and/or or second stage sensor drive circuit 3434 ) is located within shaft assembly 3514 . This information is located within the handle assembly 3512 in order to provide the appropriate digital waveform 4300 (FIG. 43) to the second stage circuit 3506 to drive the appropriate load (e.g. ultrasound, RF, or sensor). Control circuit 3200 is provided. It will be appreciated that identification circuitry may be included in various assemblies 3516 within third stage circuitry 3508, such as ultrasound transducer 1120, electrodes 3074a, 3074b, or sensor 3440. Thus, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

FIG. 36 is a circuit diagram of one aspect of an electrical circuit 3600 configured to drive radio frequency current (RF) in accordance with at least one aspect of the present disclosure. Electrical circuit 3600 includes an analog multiplexer 3680. Analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A, such as RF, battery, and power control circuits. A current sensor 3682 is coupled in series with the return or ground terminal of the power supply circuit and measures the current provided by the power supply. A field effect transistor (FET) temperature sensor 3684 provides ambient temperature. A pulse width modulated (PWM) watchdog timer 3688 automatically generates a system reset if the main program fails to provide a periodic system reset. This is provided to automatically reset the electrical circuit 3600 if it hangs up or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 3600 may be configured to drive an RF electrode or to drive an ultrasound transducer 1120, for example, as described with respect to FIG. 29. Thus, referring now again to FIG. 36, electrical circuit 3600 can be used to alternately drive both the ultrasound and RF electrodes.

Drive circuit 3686 provides left and right RF energy outputs. Digital signals representing signal waveforms are provided to the SCL-A and SDA-A inputs of analog multiplexer 3680 from a control circuit such as control circuit 3200 (FIG. 32). A digital-to-analog converter 3690 (DAC) converts the digital input to an analog output to drive a PWM circuit 3692 coupled to an oscillator 3694. PWM circuit 3692 provides a first signal to a first gate drive circuit 3696a coupled to first transistor output stage 3698a to drive a first RF+ (left side) energy output. PWM circuit 3692 also provides a second signal to a second gate drive circuit 3696b coupled to second transistor output stage 3698b to drive a second RF (right side) energy output. A voltage sensor 3699 is coupled between the RF left/RF output terminals to measure the output voltage. Drive circuit 3686, first drive circuit 3696a and second drive circuit 3696b, and first transistor output stage 3698a and second transistor output stage 3698b define a first stage amplifier circuit. In operation, the control circuit 3200 (FIG. 32) generates a digital waveform 4300 (FIG. 43) using circuits such as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 41 and 42). DAC 3690 receives digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

FIG. 37 is a circuit diagram of a transformer 3700 coupled to the electrical circuit 3600 shown in FIG. 36, in accordance with at least one aspect of the present disclosure. The RF+/RF input terminal (primary winding) of transformer 3700 is electrically coupled to the RF left/RF output terminal of electrical circuit 3600. One side of the secondary winding is coupled in series with a first blocking capacitor 3706 and a second blocking capacitor 3708. A second blocking capacitor is coupled to the positive terminal of the second stage RF drive circuit 3774a. The other side of the secondary winding is coupled to the negative terminal of the second stage RF drive circuit 3774b. The positive output of the second stage RF drive circuit 3774a is coupled to the ultrasonic blade, and the negative ground terminal of the second stage RF drive circuit 3774b is coupled to the outer tube. In one aspect, the transformer has a turns ratio of n ₁ :n ₂ of 1:50.

FIG. 38 is a circuit diagram of a circuit 3800 that includes separate power supplies for high power energy/drive circuits and low power circuits, in accordance with at least one aspect of the present disclosure. Power supply 3812 includes a primary battery pack that includes a first primary battery 3815 and a second primary battery 3817 (e.g., Li-ion batteries) that are connected to circuit 3800 by switch 3818 when power supply 3812 is inserted into the battery assembly. and a secondary battery pack including a secondary battery 3820 connected to the circuit by a switch 3823. The secondary battery 3820 is an anti-sag battery having components that are resistant to gamma or other radiation sterilization. For example, a switched mode power supply 3827 and optional charging circuitry within the battery assembly may be incorporated to allow the secondary battery 3820 to reduce the voltage sag of the primary batteries 3815, 3817. This ensures a fully charged cell at the beginning of the surgery, which is easy to introduce into the sterile field. Primary batteries 3815, 3817 can be used to directly power motor control circuit 3826 and energy circuit 3832. Motor control circuit 3826 is configured to control a motor, such as motor 3829. Power supply/battery pack 3812 includes a primary Li-ion battery 3815 with dedicated energy cell 3820 for controlling handle electronics circuit 3830 from dedicated energy cells 3815, 3817 for operating motor control circuit 3826 and energy circuit 3832. , 3817 and a secondary NiMH battery 3820. In this case, once the primary batteries 3815, 3817 involved in driving the energy circuit 3832 and/or the motor control circuit 3826 go low, the circuit 3810 draws from the secondary battery 3820 involved in driving the handle electronics circuit 3830. In various aspects, the circuit 3810 is a unidirectional diode that does not allow current to flow in the opposite direction (e.g., from a battery involved in driving the energy and/or motor control circuit to a battery involved in driving the electronics circuit). may include.

Additionally, a gamma-friendly charging circuit can be provided, including a switch mode power supply 3827 that uses diode and vacuum tube components to minimize voltage sags at a given level. By including a minimum sag voltage that is a division of the NiMH voltage (three NiMH cells), the switch mode power supply 3827 can be eliminated. Furthermore, a modular system can be provided in which radiation-cured components are located within modules, which can be sterilized by radiation sterilization. Other non-radiation-cured components may be included in other module components and connections made between module components so that the components appear as if they were located together on the same circuit board. , the components work together. If only two NiMH cells are desired, a diode and vacuum tube based switch mode power supply 3827 allows for sterilizable electronics within the disposable primary battery pack.

Referring now to FIG. 39, a control circuit 3900 is shown for operating an RF generator circuit 3902 powered by a battery 3901 for use with a surgical instrument, in accordance with at least one aspect of the present disclosure. The surgical instrument is configured to perform a surgical coagulation/cutting procedure on biological tissue using both ultrasonic vibrations and high frequency electric current, and to perform a surgical coagulation procedure on biological tissue using high frequency electric current. .

FIG. 39 shows a control circuit that allows the dual generator system to switch between the energy modalities of RF generator circuit 3902 and ultrasound generator circuit 3920 for surgical instruments of surgical system 1000. 3900 is shown. In one aspect, a current threshold in the RF signal is detected. When tissue impedance is low, the radio frequency current through the tissue is high when RF energy is used as a tissue treatment source. According to one aspect, a visual indicator 3912 or light located on a surgical instrument of surgical system 1000 may be configured to be on during this high current period. When the current falls below the threshold, visual indicator 3912 is turned off. Accordingly, phototransistor 3914 can be configured to detect a transition from an on state to an off state and release the RF energy, as shown in control circuit 3900 shown in FIG. 39. Thus, when the energy button is released and the energy switch 3926 is opened, the control circuit 3900 is reset and both the RF generator circuit 3902 and the ultrasound generator circuit 3920 are kept off.

Referring to FIG. 39, in one aspect, a method of managing an RF generator circuit 3902 and an ultrasound generator circuit 3920 is provided. RF generator circuit 3902 and/or ultrasound generator circuit 3920 may be used, for example, in handle assembly 1109 of multifunction electrosurgical instrument 1108, ultrasound transducer/RF generator assembly 1120, battery assembly, shaft assembly 1129, and/or It may be located within the nozzle. Control circuit 3900 remains in a reset state when energy switch 3926 is off (eg, open). Thus, when energy switch 3926 is opened, control circuit 3900 is reset and both RF generator circuit 3902 and ultrasound generator circuit 3920 are turned off. When the energy switch 3926 is pressed and the energy switch 3926 is engaged (e.g., closed), RF energy is delivered to the tissue and a visual indicator 3912 operated by the current sensing step-up transformer 3904 indicates that the tissue impedance is Lights up while low. Light from visual indicator 3912 provides a logic signal to keep ultrasound generator circuit 3920 off. Once the tissue impedance increases above the threshold and the radio frequency current through the tissue decreases below the threshold, the visual indicator 3912 turns off and the light transitions to the off state. The logic signal generated by this transition turns off relay 3908, which turns off RF generator circuit 3902 and turns on ultrasonic generator circuit 3920 to complete the coagulation and cutting cycle.

Still referring to FIG. 39, in one aspect, a dual generator circuit configuration includes an onboard RF generator circuit 3902 powered by a battery 3901 for one modality, and an onboard RF generator circuit 3902 powered by a battery 3901 for one modality, e.g. a second onboard ultrasound generator circuit 3920 that may be onboard within the handle assembly 1109, battery assembly, shaft assembly 1129, nozzle, and/or ultrasound transducer/RF generator assembly 1120 of the instrument 1108; , is used. Ultrasonic generator circuit 3920 is also powered by battery 3901. In various aspects, RF generator circuit 3902 and ultrasound generator circuit 3920 can be integral or separable components of handle assembly 1109. According to various aspects, having dual RF/ultrasonic generator circuits 3902, 3920 as part of handle assembly 1109 may eliminate the need for complex wiring. The RF/ultrasonic generator circuits 3902, 3920 may be configured to provide the full capabilities of an existing generator while simultaneously utilizing the capabilities of a cordless generator system.

Either type of system may have separate control over modalities that are not in communication with each other. The surgeon separately and optionally activates RF and ultrasound. Another approach is to provide a fully integrated communication scheme that shares buttons, tissue status, instrument actuation parameters (e.g. jaw closure, force, etc.) and algorithms for managing tissue treatment. . Various combinations of this integration may be implemented to provide appropriate levels of functionality and performance.

As mentioned above, in one aspect, the control circuit 3900 includes an RF generator circuit 3902 powered by a battery 3901, which includes a battery as an energy source. As shown, the RF generator circuit 3902 is coupled to two conductive surfaces, referred to herein as electrodes 3906a, 3906b (i.e., active electrode 3906a and return electrode 3906b), to direct the electrodes 3906a, 3906b to RF energy ( For example, it is configured to be driven by a high frequency current). A first winding 3910a of step-up transformer 3904 is connected in series with a bipolar RF generator circuit 3902 and one pole of a return electrode 3906b. In one aspect, first winding 3910a and return electrode 3906b are connected to the negative pole of bipolar RF generator circuit 3902. The other pole of the bipolar RF generator circuit 3902 is connected to the active electrode 3906a through a switch contact 3909 of a relay 3908, or by any suitable method including a movable piece of iron moved by an electromagnet 3936 to operate a switch contact 3909. Connected to an electromagnetic switching device. When electromagnet 3936 is energized, switch contact 3909 is closed, and when electromagnet 3936 is de-energized, switch contact 3909 is open. When the switch contacts close, RF current flows through conductive tissue (not shown) located between electrodes 3906a and 3906b. It will be appreciated that in one aspect, active electrode 3906a is connected to the positive pole of bipolar RF generator circuit 3902.

Visual indicator circuit 3905 includes step-up transformer 3904, series resistor R2, and visual indicator 3912. Visual indicator 3912 may be adapted for use with surgical instrument 1108 as well as other electrosurgical systems and tools such as those described herein. A first winding 3910a of the step-up transformer 3904 is connected in series with a return electrode 3906b, and a second winding 3910b of the step-up transformer 3904 is connected to a resistor R2 and a visual indicator including, for example, an NE-2 type neon bulb. 3912 in series.

In operation, when switch contact 3909 of relay 3908 opens, active electrode 3906a is separated from the positive pole of bipolar RF generator circuit 3902 and is passed through tissue, return electrode 3906b, and first winding 3910a of step-up transformer 3904. Current stops flowing. Therefore, visual indicator 3912 is not energized and does not emit light. When the switch contact 3909 of the relay 3908 is closed, the active electrode 3906a is connected to the positive pole of the bipolar RF generator circuit 3902, thereby allowing the voltage to flow through the tissue, through the return electrode 3906b, and through the first winding 3910a of the step-up transformer 3904. A current is passed and allowed to operate on the tissue, for example to cut and cauterize the tissue.

A first current flows through the first winding 3910a as a function of the impedance of the tissue located between the active electrode 3906a and the return electrode 3906b, and flows across the first winding 3910a of the step-up transformer 3904. 1 voltage. A boosted second voltage is induced across the second winding 3910b of the step-up transformer 3904. A secondary voltage appears across resistor R2 and energizes visual indicator 3912 to illuminate a neon bulb when the current through the tissue is greater than a predetermined threshold. It will be understood that circuit and component values are exemplary and not limiting. When switch contact 3909 of relay 3908 closes, current flows through the tissue and visual indicator 3912 is turned on.

Referring now to the energy switch 3926 portion of the control circuit 3900, when the energy switch 3926 is in the open position, a logic high is applied to the input of the first inverter 3928 and a logic low is applied to one of the two inputs of the AND gate 3932. Applies to one of the following. Therefore, the output of AND gate 3932 is low and transistor 3934 is off, preventing current from flowing through the windings of electromagnet 3936. When electromagnet 3936 is de-energized, switch contacts 3909 of relay 3908 remain open, preventing current from flowing through electrodes 3906a, 3906b. The logic low output of the first inverter 3928 is also applied to the second inverter 3930, driving the output high and resetting the flip-flop 3918 (eg, a D-type flip-flop). At this time, the Q output goes low, turning off the circuit of the ultrasonic generator circuit 3920,

出力はハイになり、ＡＮＤゲート３９３２の他の入力に適用される。

The output goes high and is applied to the other input of AND gate 3932.

When the user presses the energy switch 3926 on the instrument handle to apply energy to the tissue between electrodes 3906a and 3906b, the energy switch 3926 closes and applies a logic low to the input of the first inverter 3928, which Applying a logic high to the other input of AND gate 3932 causes the output of AND gate 3932 to be high, turning on transistor 3934. In the on state, transistor 3934 conducts and sinks current through the winding of electromagnet 3936 to energize electromagnet 3936 and close switch contact 3909 of relay 3908. As described above, when switch contact 3909 closes, current flows through electrodes 3906a, 3906b and first winding 3910a of step-up transformer 3904 when tissue is located between electrodes 3906a and 3906b. can flow.

As mentioned above, the magnitude of the current flowing through electrodes 3906a, 3906b depends on the impedance of the tissue located between electrodes 3906a and 3906b. Initially, the tissue impedance is low and the magnitude of the current through the tissue and first winding 3910a is high. Therefore, the voltage applied to the second winding 3910b is high enough to turn on the visual indicator 3912. The light emitted by visual indicator 3912 turns on phototransistor 3914, which pulls the input of inverter 3916 low and causes the output of inverter 3916 to go high. A high input applied to the CLK of flip-flop 3918 is applied to the Q or

出力に影響を与えず、Ｑ出力はローのままであり、

does not affect the output, the Q output remains low,

出力はハイのままである。したがって、視覚インジケータ３９１２は通電されたままであり、超音波発生器回路３９２０はオフとなり、多機能型電気外科用器具の超音波トランスデューサ３９２２及び超音波ブレード３９２４は起動しなくなる。

The output remains high. Accordingly, the visual indicator 3912 remains energized, the ultrasound generator circuit 3920 is turned off, and the multifunction electrosurgical instrument's ultrasound transducer 3922 and ultrasound blade 3924 are deactivated.

As the tissue between electrodes 3906a and 3906b dries due to the heat generated by the electrical current flowing through the tissue, the impedance of the tissue increases and the electrical current passing therethrough decreases. As the current through the first winding 3910a decreases, the voltage across the second winding 3910b also decreases, and when the voltage falls below the minimum threshold required to operate the visual indicator 3912 and the phototransistor 3914 is turned off. When phototransistor 3914 is turned off, a logic high is applied to the input of inverter 3916 and a logic low is applied to the CLK input of flip-flop 3918 to provide a logic high to the Q output and a logic low to the Q output.

出力にクロックする。Ｑ出力における論理ハイによって、超音波発生器回路３９２０がオンになり、超音波トランスデューサ３９２２及び超音波ブレード３９２４を起動させて電極３９０６ａと電極３９０６ａとの間に位置する組織の切断を開始させる。超音波発生器回路３９２０がオンになるのと同時に又はほぼ同時に、フリップフロップ３９１８の

Clock to output. A logic high at the Q output turns on ultrasound generator circuit 3920, activating ultrasound transducer 3922 and ultrasound blade 3924 to begin cutting tissue located between electrodes 3906a. At or about the same time as ultrasonic generator circuit 3920 turns on, flip-flop 3918 turns on.

出力はローになり、ＡＮＤゲート３９３２の出力をローにして、トランジスタ３９３４をオフにし、それにより、電磁石３９３６を非通電にして、リレー３９０８のスイッチ接点３９０９を開いて電極３９０６ａ、３９０６ｂを通る電流の流れを遮断する。

The output goes low, causing the output of AND gate 3932 to go low, turning off transistor 3934, thereby de-energizing electromagnet 3936, and opening switch contact 3909 of relay 3908, allowing the current to flow through electrodes 3906a, 3906b. cut off the flow.

While switch contact 3909 of relay 3908 is open, no current flows through electrodes 3906a, 3906b, tissue, and first winding 3910a of step-up transformer 3904. Therefore, no voltage is developed across the second winding 3910b and no current flows through the visual indicator 3912.

While the user squeezes the energy switch 3926 on the instrument handle to maintain the energy switch 3926 closed, the Q and Flip-flops 3918

出力の状態は同じままである。したがって、双極ＲＦ発生器回路３９０２から電極３９０６ａ、３９０６ｂを通って電流が流れていない間は、超音波ブレード３９２４は起動した状態を維持してエンドエフェクタのジョーの間の組織を切断し続ける。ユーザが器具ハンドルのエネルギースイッチ３９２６を解放すると、エネルギースイッチ３９２６が開いて、第１のインバータ３９２８の出力はローになり、第２のインバータ３９３０の出力はハイになってフリップフロップ３９１８をリセットし、Ｑ出力をローにして超音波発生器回路３９２０をオフにする。同時に、

The state of the output remains the same. Thus, while no current is flowing through the electrodes 3906a, 3906b from the bipolar RF generator circuit 3902, the ultrasonic blade 3924 remains activated and continues to cut tissue between the jaws of the end effector. When the user releases the energy switch 3926 on the instrument handle, the energy switch 3926 opens, the output of the first inverter 3928 goes low and the output of the second inverter 3930 goes high, resetting the flip-flop 3918; The Q output is brought low to turn off the ultrasound generator circuit 3920. at the same time,

出力はハイになり、ここで回路はオフ状態になって、ユーザが器具ハンドル上のエネルギースイッチ３９２６を作動させて、エネルギースイッチ３９２６を閉じ、電極３９０６ａと電極３９０６ｂとの間に位置する組織に電流を印加し、上述のように組織にＲＦエネルギーを印加し、組織に超音波エネルギーを印加するサイクルを繰り返す準備が整う。

The output goes high, where the circuit is in an off state and the user activates the energy switch 3926 on the instrument handle, closing the energy switch 3926 and applying electrical current to the tissue located between electrodes 3906a and 3906b. , and is ready to repeat the cycle of applying RF energy to the tissue and applying ultrasound energy to the tissue as described above.

FIG. 40 shows a surgical system 1000 including a feedback system for use with any one of the surgical instruments of surgical system 1000, which may include or implement many of the features described herein. FIG. 4 is a diagram of a surgical system 4000 representing one aspect of the invention. Surgical system 4000 may include a generator 4002 coupled to a surgical instrument that includes an end effector 4006 that can be activated when a clinician manipulates a trigger 4010. In various aspects, the end effector 4006 can include an ultrasonic blade for delivering ultrasonic vibrations to perform surgical coagulation/cutting procedures on biological tissue. In other aspects, the end effector 4006 includes a conductive element coupled to an electrosurgical high frequency current energy source to perform a surgical coagulation or ablation procedure on biological tissue and a cutting procedure on biological tissue. and either a mechanical knife or an ultrasonic blade with a sharp edge for the purpose. When trigger 4010 is actuated, force sensor 4012 can generate a signal indicative of the amount of force being applied to trigger 4010. In addition to or in place of the force sensor 4012, the surgical instrument may generate a signal indicating the position of the trigger 4010 (e.g., how deeply the trigger is depressed or otherwise actuated). A position sensor 4013 may be included. In one aspect, the position sensor 4013 may be a sensor positioned with the outer tubular sheath or a reciprocating tubular actuating member located within the outer tubular sheath of a surgical instrument. In one aspect, the sensor may be a Hall effect sensor or any suitable transducer that changes its output voltage in response to a magnetic field. Hall effect sensors can be used in proximity switching, positioning, speed sensing and current sensing applications. In one aspect, the Hall effect sensor operates as an analog converter and returns voltage directly. The known magnetic field allows the distance from the Hall plate to be determined.

Control circuit 4008 can receive signals from sensors 4012 and/or 4013. Control circuit 4008 may include any suitable analog or digital circuitry. Control circuit 4008 further communicates with generator 4002 and/or transducer 4004 to determine the force applied to trigger 4010 and/or the position of trigger 4010 and/or reciprocating tubular actuation located within the outer tubular sheath. The power delivered to the end effector 4006 and/or the generator level or excess of the end effector 4006 is determined based on the position of the outer tubular sheath relative to the member (e.g., as measured by a Hall effect sensor and magnet combination). The sonic blade amplitude can be modulated. For example, when more force is applied to trigger 4010, more power and/or higher ultrasonic blade amplitude may be delivered to end effector 4006. According to various aspects, force sensor 4012 may be replaced by a multi-position switch.

According to various aspects, end effector 4006 may include a clamp or clamping mechanism. When trigger 4010 is first actuated, the clamp mechanism can close and clamp tissue between the clamp arm and end effector 4006. As the force applied to the trigger increases (e.g., as sensed by force sensor 4012), control circuitry 4008 causes power to be delivered to end effector 4006 by transducer 4004 and/or around end effector 4006. The generator level or ultrasonic blade amplitude can be increased. In one aspect, the trigger position sensed by position sensor 4013 or the clamp or clamp arm position sensed by position sensor 4013 (e.g., using a Hall effect sensor) sets the power and/or amplitude of end effector 4006. may be used by control circuit 4008 to do so. For example, as the trigger is moved further toward the fully actuated position or the clamp or clamp arm is moved further toward the ultrasonic blade (or end effector 4006), the power and/or amplitude of the end effector 4006 is increased. obtain.

According to various aspects, the surgical instruments of surgical system 4000 can also include one or more feedback devices to indicate the amount of power delivered to end effector 4006. For example, speaker 4014 can emit a signal indicating the power of the end effector. According to various aspects, speaker 4014 can emit a series of pulsed tones, the frequency of which is indicative of power. In addition to or in place of speaker 4014, the surgical instrument can include a visual display 4016. Visual display 4016 may indicate end effector power according to any suitable method. For example, visual display 4016 may include a series of LEDs, where the power of the end effector is indicated by the number of illuminated LEDs. Speaker 4014 and/or visual display 4016 may be driven by control circuit 4008. According to various aspects, the surgical instrument can include a ratchet device connected to trigger 4010. When more force is applied to trigger 4010, the ratchet device can generate an audible sound to provide an indirect indication of end effector power. Surgical instruments can include other features that can increase safety. For example, control circuit 4008 may be configured to prevent power from being delivered to end effector 4006 above a predetermined threshold. The control circuit 4008 may also provide a delay between the time a change in end effector power is indicated (e.g., by speaker 4014 or visual display 4016) and the time the change in end effector power is delivered. I can do it. In this way, the clinician can be alerted well in advance that the level of ultrasound power delivered to the end effector 4006 is about to change.

In one aspect, the ultrasound or high frequency current generator of surgical system 1000 digitally converts an electrical signal waveform into a digital waveform, preferably using a predetermined number of phase points stored in a look-up table. may be configured to generate. The phase points may be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 41 illustrates one aspect of a basic architecture for a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit 4100, configured to generate multiple waveforms for an electrical signal waveform. The generator software and digital control can instruct the FPGA to scan addresses in lookup table 4104, which in turn provides various digital input values to DAC circuit 4108 that powers the power amplifier. Addresses may be scanned according to the target frequency. Use of such a lookup table 4104 can be provided within a tissue, or within a transducer, an RF electrode, multiple transducers simultaneously, multiple RF electrodes simultaneously, or a combination of RF and ultrasound instruments. , which makes it possible to generate various types of waveforms. Additionally, multiple lookup tables 4104 representing multiple waveforms can be created, stored, and applied from the generator to the tissue.

The waveform signal is an output current, an output voltage, or an output power of an ultrasound transducer and/or an RF electrode, or a plurality thereof (e.g., two or more ultrasound transducers and/or two or more RF electrodes). It may be configured to control at least one of the power. Additionally, if the surgical instrument includes an ultrasound component, the waveform signal may be configured to drive at least two modes of vibration of the ultrasound transducer of the at least one surgical instrument. Accordingly, the generator may be configured to provide a waveform signal to the at least one surgical instrument, the waveform signal being responsive to at least one of the plurality of waveforms in the table. Note that the waveform signals provided to the two surgical instruments may include two or more waveforms. The table may include information related to multiple waveforms, and the table may be stored within the generator. In one aspect or example, the table may be a direct digital synthesis table and may be stored within the FPGA of the generator. The table may be addressed by any method convenient for categorizing waveforms. According to one aspect, the table, which may be a direct digital synthesis table, is addressed according to the frequency of the waveform signal. Additionally, information related to multiple waveforms may be stored in the table as digital information.

The analog electrical signal waveform includes the output current, output voltage, Alternatively, the output power may be configured to control at least one of the output power. Additionally, if the surgical instrument includes an ultrasound component, the analog electrical signal waveform may be configured to drive at least two modes of vibration of the ultrasound transducer of the at least one surgical instrument. Accordingly, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, the analog electrical signal waveform being at least one of the plurality of waveforms stored in lookup table 4104. corresponds to two waveforms. Note that the analog electrical signal waveforms provided to the two surgical instruments may include two or more waveforms. Lookup table 4104 may include information related to multiple waveforms, and lookup table 4104 may be stored in either the generator circuit or the surgical instrument. In one aspect or example, lookup table 4104 may be a direct digital synthesis table, which may be stored in a generator circuit or FPGA of a surgical instrument. Lookup table 4104 may be addressed by any method convenient for categorizing waveforms. According to one aspect, lookup table 4104, which can be a direct digital synthesis table, is addressed according to the frequency of the desired analog electrical signal waveform. Additionally, information related to multiple waveforms may be stored as digital information in lookup table 4104.

With the widespread use of digital technology in instrumentation and communication systems, digital control methods have been developed to generate multiple frequencies from a reference frequency, referred to as direct digital synthesis. The basic architecture is shown in FIG. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic of the generator circuit and a memory circuit located within the generator circuit of surgical system 1000. DDS circuit 4100 includes 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 an address counter 4102 and a register 4106 is a programmable read-only register that stores one or more integer numbers of cycles of a sine wave (or any other waveform) in a lookup table 4104. Drives memory (PROM). As address counter 4102 steps through the memory locations, the values stored in lookup table 4104 are written to register 4106 coupled to DAC circuit 4108. The corresponding digital amplitude of the signal in the lookup table 4104 storage location in turn drives a DAC circuit 4108 that causes an analog output signal 4110 to be generated. The spectral purity of analog output signal 4110 is primarily determined by DAC circuit 4108. The phase noise is essentially that of the reference clock f _c . A first analog output signal 4110 output from the DAC circuit 4108 is filtered by a filter 4112, and a second analog output signal 4114 output by the filter 4112 is filtered by an amplifier having an output coupled to the output of the generator circuit. provided to. The second analog output signal has a frequency f _out .

Since the DDS circuit 4100 is a sampled data system, issues associated with sampling such as quantization noise, aliasing, filtering, etc. must be considered. For example, higher harmonics of the output of a phase-locked loop (PLL)-based synthesizer may be filtered, whereas higher harmonics of the DAC circuit 4108 output frequency fold back into the Nyquist bandwidth, making them unfilterable. do. Lookup table 4104 contains signal data for an integer number of cycles. The final output frequency f _out can be changed by changing the reference clock frequency f _c or by reprogramming the PROM.

DDS circuit 4100 may include a plurality of lookup tables 4104 that store waveforms represented by a predetermined number of samples, the samples defining a predetermined waveform shape. Accordingly, multiple waveforms with unique shapes can be stored within multiple look-up tables 4104 to provide various 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 electrical signal waveforms that promote effective modified coagulation. Can be mentioned. In one aspect, the DDS circuit 4100 can create a plurality of waveform lookup tables 4104 to determine the desired Switching can occur between various waveforms stored in separate lookup tables 4104 based on tissue effects and/or tissue feedback.

Thus, switching between waveforms can be based on tissue impedance and other factors, for example. In other aspects, the lookup table 4104 can store an electrical signal waveform (ie, a trapezoidal wave or a square wave) that is shaped to maximize the power delivered into the tissue each cycle. In other aspects, the lookup table 4104 can store synchronized waveforms such that the waveforms are used to deliver RF and ultrasound drive signals to the multifunction surgical instrument of the surgical system 1000. Maximize power delivery by In yet other aspects, lookup table 4104 can store electrical signal waveforms that simultaneously drive ultrasound and RF therapeutic and/or subtherapeutic energy while maintaining lock on ultrasound frequency. Custom waveforms specific to various instruments and their tissue effects may be stored within the non-volatile memory of the generator circuit or within the non-volatile memory (e.g., EEPROM) of the surgical system 1000 and may also be used for multifunction surgical instruments. is fetched when connecting to the generator circuit. An example of an exponentially decaying sinusoid used in many high crest factor "coagulation" waveforms is shown in FIG.

A more flexible and effective implementation of DDS circuit 4100 uses a digital circuit called a numerically controlled oscillator (NCO). A block diagram of a more flexible and effective digital synthesis circuit, such as DDS circuit 4200, is shown in FIG. In this simplified block diagram, the DDS circuit 4200 is coupled to a processor, controller, or logic of the generator and to memory circuitry located in either the generator or the surgical instrument of the surgical system 1000. ing. DDS circuit 4200 includes a load register 4202, a parallel delta phase register 4204, an adder circuit 4216, a phase register 4208, a look-up table 4210 (phase-to-amplitude converter), a DAC circuit 4212, and a filter 4214. Adder circuit 4216 and phase register 4208 form part of phase accumulator 4206. Clock frequency f _c is applied to phase register 4208 and DAC circuit 4212 . Load register 4202 receives an adjustment word that specifies the output frequency as a fraction of reference clock frequency signal _fc . The output of load register 4202 is provided to parallel delta phase register 4204 along with adjustment word M.

DDS circuit 4200 includes a sample clock to generate a clock frequency f _c , a phase accumulator 4206, and a look-up table 4210 (eg, a phase-to-amplitude converter). The contents of phase accumulator 4206 are updated once every clock cycle _fc . When phase accumulator 4206 is updated, the digital number M stored in parallel delta phase register 4204 is added to the number in phase register 4208 by adder circuit 4216. The number in parallel delta phase register 4204 is 00. ．． ．． 01, and the initial contents of phase accumulator 4206 are 00. ．． ．． Assume that it is 00. The phase accumulator 4206 registers 00 . ．． ．． It is updated to 01. If phase accumulator 4206 is 32-bits wide, then phase accumulator 4206 is 00. ．． ．． 232 clock cycles (over 4 billion) are required to return to 00 and the cycle repeats.

The truncated output 4218 of the phase accumulator 4206 is provided to a phase-to-amplitude converter lookup table 4210, and the output of the lookup table 4210 is coupled to a DAC circuit 4212. The truncated output 4218 of the phase accumulator 4206 serves as an address to a sine (or cosine) lookup table. The addresses in the lookup table correspond to phase points from 0° to 360° in the sine wave. Lookup table 4210 contains the corresponding digital amplitude information of one complete cycle of the sine wave. Accordingly, lookup table 4210 maps phase information from phase accumulator 4206 to a digital amplitude word, which in turn drives DAC circuit 4212. The output of the DAC circuit is a first analog signal 4220, which is filtered by filter 4214. The output of filter 4214 is a second analog signal 4222 that is provided to a power amplifier coupled to the output of the generator circuit.

In one aspect, the waveform that may be digitized can be any suitable waveform in the range 256 (28) to 281, 474, 976, 710, 656 (248), where n is a positive integer, as shown in Table 1. Although the number of phase points is 2n, the electrical signal waveform may be digitized into 1024 (210) phase points. The electrical signal waveform may be represented as A _n (θ _n ), where the normalized amplitude A _n at point n is represented by the phase angle θ _n and is referred to as the phase point at point n. The number of distinct phase points n determines the adjustment resolution of DDS circuit 4200 (and DDS circuit 4100 shown in FIG. 41).

Table 1 specifies an electrical signal waveform that is digitized into multiple phase points.

The generator circuit algorithm and digital control circuit scan the addresses in the lookup table 4210, which in turn provides various digital input values to the DAC circuit 4212 that powers the filter 4214 and power amplifier. Addresses may be scanned according to the target frequency. Using a look-up table, it is converted to an analog output signal by a DAC circuit 4212, filtered by a filter 4214, amplified by a power amplifier coupled to the output of the generator circuit, and delivered to the tissue in the form of RF energy. It is possible to generate various types of shapes that can be applied to the tissue in the form of ultrasonic vibrations that are supplied to the ultrasonic transducer and deliver energy to the tissue in the form of heat. The output of the amplifier can be applied to, for example, a single RF electrode, multiple RF electrodes simultaneously, a single ultrasound transducer, multiple ultrasound transducers simultaneously, or a combination of RF transducers and ultrasound transducers. Additionally, multiple waveform tables can be created, stored, and applied to tissue from the generator circuit.

Referring again to FIG. 41, for n=32 and M=1, phase accumulator 4206 steps through 232 possible outputs before overflowing and restarting. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M=2, the phase register 1708 will "roll over" twice as fast and the output frequency will double. This can be generalized as follows.

For a phase accumulator 4206 configured to accumulate n-bits (n typically ranges from 24 to 32 in most DDS systems, but as previously discussed, n may be selected from a wide range of choices). ), there are 2 ⁿ possible phase points. The digital word M in the delta phase register represents the amount by which the phase accumulator is incremented each clock cycle. If f _c is the clock frequency, the frequency of the output sine wave is equal to:

The above equation is known as the DDS "adjustment equation". The frequency resolution of the system is

と等しいことに留意されたい。ｎ＝３２では、分解能は４０億における一部よりも高い。ＤＤＳ回路４２００の一態様では、位相アキュムレータ４２０６外の全てのビットがルックアップテーブル４２１０に伝えられるわけではなく、切り捨てられて、例えば、最初の１３～１５個の最上位ビット（ＭＳＢ）のみが残される。これはルックアップテーブル４２１０のサイズを低減し、かつ周波数分解能に影響を及ぼさない。位相の切り捨ては、少量だが許容できる位相雑音の量のみを最終出力に追加する。

Note that it is equal to At n=32, the resolution is higher than some at 4 billion. In one aspect of the DDS circuit 4200, not all bits outside the phase accumulator 4206 are passed to the lookup table 4210, but are truncated, leaving only the first 13 to 15 most significant bits (MSBs), for example. It will be done. This reduces the size of lookup table 4210 and does not affect frequency resolution. Phase truncation adds only a small but acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by current, voltage, or power at a predetermined frequency. Additionally, if any one of the surgical instruments of surgical system 1000 includes an ultrasound component, the electrical signal waveform is configured to drive at least two modes of vibration of the ultrasound transducer of the at least one surgical instrument. It's okay to be. Accordingly, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, the electrical signal waveform being stored in lookup table 4210 (or lookup table 4104 in FIG. 41). characterized by a predetermined waveform. Note that the electrical signal waveform may be a combination of two or more waveforms. Lookup table 4210 may include information related to multiple waveforms. In one aspect or embodiment, lookup table 4210 may be generated by DDS circuit 4200 and may also be referred to as a direct digital synthesis table. DDS operates by first storing large repetitive waveforms in on-board memory. A cycle of a waveform (sine, triangular, square, arbitrary) can be represented by a predetermined number of phase points and stored in memory, as shown in Table 1. Once the waveform is stored within memory, it can be generated at very precise frequencies. The direct digital synthesis table may be stored in non-volatile memory of the generator circuit and/or may be implemented with FPGA circuitry within the generator circuit. Lookup table 4210 may be addressed by any suitable technique useful for categorizing waveforms. According to one aspect, lookup table 4210 is addressed according to the frequency of the electrical signal waveform. Additionally, information related to the plurality of waveforms may be stored as digital information in memory or as part of lookup table 4210.

In one aspect, the generator circuit may be configured to simultaneously provide electrical signal waveforms to at least two surgical instruments. The generator circuit is also configured to simultaneously provide electrical signal waveforms (which may be characterized by two or more waveforms) to two surgical instruments via a single output channel of the generator circuit. may be done. For example, in one aspect, the electrical signal waveform includes a first electrical signal (eg, an ultrasound drive signal) that drives an ultrasound transducer, a second RF drive signal, and/or a combination thereof. Additionally, the electrical signal waveform may include multiple ultrasonic drive signals, multiple RF drive signals, and/or a combination of multiple ultrasonic drive signals and RF drive signals.

Further, a method of operating a generator circuit according to the present disclosure includes generating an electrical signal waveform and providing the generated electrical signal waveform to any one of the surgical instruments of surgical system 1000. Including, generating the electrical signal waveform includes receiving information related to the electrical signal waveform from the memory. The generated electrical signal waveform includes at least one waveform. Additionally, providing the generated electrical signal waveform to at least one surgical instrument includes simultaneously providing the electrical signal waveform to at least two surgical instruments.

The generator circuits described herein may enable generation of various types of direct digital synthesis tables. Examples of RF/electrosurgical signal waveforms produced by the generator circuit that are suitable for the treatment of various tissues include RF signals with high crest factors (which may be used for surface coagulation in RF mode), low crest factors, RF signals with high speed (which can be used for deeper tissue penetration) and waveforms that promote efficient modified coagulation. The generator circuit can also generate multiple waveforms using the direct digital synthesis lookup table 4210 and can switch between specific waveforms based on desired tissue effects on the fly. Switching may be based on tissue impedance and/or other factors.

In addition to conventional sine/cosine waveforms, the generator circuit may be configured to generate waveform(s) (i.e., trapezoidal or square waves) that maximize power to tissue per cycle. If the generator circuit includes a circuit topology that allows simultaneous driving of an RF signal and an ultrasonic signal, the generator circuit has a Waveform(s) can be provided that are synchronized to maximize delivered power and maintain ultrasound frequency lock. Additionally, custom waveforms specific to the instrument and its tissue effects may be stored in non-volatile memory (NVM) or in the instrument's EEPROM and may be used to connect any one of the surgical instruments of surgical system 1000 to a generator circuit. can be fetched when connecting to.

DDS circuit 4200 may include a plurality of lookup tables 4104 that store waveforms represented by a predetermined number of phase points (sometimes referred to as samples), where phase points are associated with a predetermined waveform. Define the shape of. Accordingly, multiple waveforms with unique shapes can be stored in multiple lookup tables 4210 to provide various 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 electrical signal waveforms that promote effective modified coagulation. Can be mentioned. In one aspect, the DDS circuit 4200 can create a plurality of waveform lookup tables 4210 and perform the desired Switching can occur between different waveforms stored in different lookup tables 4210 based on tissue effects and/or tissue feedback.

Thus, switching between waveforms can be based on tissue impedance and other factors, for example. In other aspects, the look-up table 4210 can store an electrical signal waveform (ie, a trapezoidal wave or a square wave) that is shaped to maximize the power delivered into the tissue on a cycle-by-cycle basis. In other aspects, the lookup table 4210 can store synchronized waveforms such that when the waveforms deliver the RF and ultrasound drive signals, the Maximize power delivery by any one. In yet other aspects, lookup table 4210 can store electrical signal waveforms that simultaneously drive ultrasound and RF therapeutic and/or subtherapeutic energy while maintaining lock on ultrasound frequency. Generally, the output waveform may be in the form of a sine wave, cosine wave, pulse wave, square wave, etc. Nevertheless, more complex custom waveforms specific to different instruments and their tissue effects can be stored within the non-volatile memory of the generator circuit or within the non-volatile memory (e.g., EEPROM) of the surgical instrument. and can be fetched when connecting the surgical instrument to the generator circuit. An example of a custom waveform is the exponentially decaying sinusoidal waveform used in many high crest factor "coagulation" waveforms, as shown in FIG.

FIG. 43 illustrates one cycle of a discrete-time digital electrical signal waveform 4300 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison purposes) in accordance with at least one aspect of the present disclosure of an analog waveform 4304. The horizontal axis represents time (t) and the vertical axis represents digital phase points. Digital electrical signal waveform 4300 is, for example, a digital discrete time version of desired analog waveform 4304. Digital electrical signal waveform 4300 is generated by storing amplitude phase points 4302 representing the amplitude every clock cycle T _clk over one cycle or period T _o . Digital electrical signal waveform 4300 is generated by any suitable digital processing circuitry over a period of time T _o . Amplitude phase points are digital words stored in memory circuitry. In the embodiment shown in FIGS. 41 and 42, the digital word is a 6-bit word capable of storing amplitude phase points with a resolution of 26 or 64 bits. It will be appreciated that the embodiments shown in FIGS. 41 and 42 are for illustrative purposes and that in actual implementations the resolution may be much higher. Digital amplitude phase points 4302 over one cycle T _o are stored in memory as strings of string words in look-up tables 4104, 4210, eg, as described with respect to FIGS. 41 and 42. To generate an analog version of the analog waveform 4304, the amplitude phase points 4302 are sequentially read from memory from 0 to T _o every clock cycle T _clk , as also described with respect to FIGS. and is converted by DAC circuits 4108 and 4212. Additional cycles can be generated by repeatedly reading the amplitude phase points 4302 of the digital electrical signal waveform 4300 from 0 to T _o for as many cycles or periods as may be desired. A smooth analog version of the analog waveform 4304 is achieved by filtering the output of the DAC circuits 4108, 4212 by filters 4112, 4214 (FIGS. 41 and 42). The filtered analog output signals 4114, 4222 (FIGS. 41 and 42) are applied to the input of a power amplifier.

FIG. 44 depicts providing gradual closure of a closure member (e.g., closure tube) when the displacement member is distally advanced and coupled with a clamp arm (e.g., an anvil), according to one aspect of the present disclosure; FIG. 12 is a diagram of a control system 12950 configured to reduce the closure force load on the closure member at a desired rate and reduce the firing force load on the firing member. In one aspect, control system 12950 may be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) for continuously calculating an error value as the difference between a desired set point and a measured process variable, with proportional, integral, and derivative terms (respectively P , I, and D). Nested PID controller feedback control system 12950 includes a primary controller 12952 in a primary (outer) feedback loop 12954 and a secondary controller 12955 in a secondary (inner) feedback loop 12956. The primary controller 12952 may be a PID controller 12972 as shown in FIG. 45, and the secondary controller 12955 may also be a PID controller 12972 as shown in FIG. Primary controller 12952 controls primary process 12958 and secondary controller 12955 controls secondary process 12960. The output 12966 of the primary process 12958 is subtracted from the primary set point SP ₁ by a first adder 12962. First adder 12962 produces a single sum output signal that is applied to primary controller 12952. The output of primary controller 12952 is secondary set point _SP2 . The output 12968 of the secondary process 12960 is subtracted from the secondary set point SP ₂ by a second adder 12964.

In the situation of controlling the displacement of a closure tube, the control system 12950 determines that the primary setpoint SP ₁ is the desired closure force value and the primary controller 12952 receives the closure force from a torque sensor coupled to the output of the closure motor. may be configured to determine the motor speed of the closing motor set point _SP2 . In other aspects, the closing force may be measured with a strain gauge, load cell, or other suitable force sensor. The closure motor speed set point SP ₂ is compared to the actual speed of the closure tube as determined by the secondary controller 12955. The actual velocity of the obturator tube may be determined by comparing the measurement of the obturator tube displacement using a position sensor and the elapsed time measurement using a timer/counter. Other techniques such as linear or rotary encoders can be used to measure the displacement of the closed tube. The output 12968 of secondary process 12960 is the actual velocity of the closed tube. This closure tube velocity output 12968 is provided to a primary process 12958 that determines the force acting on the closure tube and is fed back to a summer 12962 that subtracts the measured closure force from the primary set point _SP1 . The primary setting value _SP1 may be an upper threshold value or a lower threshold value. Based on the output of summer 12962, primary controller 12952 controls the speed and direction of the closure motor. The secondary controller 12955 closes the tube based on the actual speed of the closure tube measured by the secondary process 12960 and a secondary set point SP ₂ that is based on a comparison of the actual firing force and the firing force upper and lower thresholds. Control the speed of the motor.

FIG. 45 illustrates a PID feedback control system 12970, according to one aspect of the present disclosure. The primary controller 12952 or the secondary controller 12955, or both, may be implemented as a PID controller 12972. In one aspect, PID controller 12972 may include a proportional element 12974 (P), an integral element 12976 (I), and a differential element 12978 (D). The outputs of P element 12974, I element 12976, and D element 12978 are summed by adder 12986, which provides a control variable μ(t) to process 12980. The output of process 12980 is the process variable y(t). Adder 12984 calculates the difference between the desired setpoint r(t) and the measured process variable y(t). The PID controller 12972 determines the error value e( t) (e.g., the difference between the closing force threshold and the measured closing force), calculated by proportional element 12974 (P), integral element 12976 (I), and differential element 12978 (D), respectively. Apply corrections based on proportional, integral, and derivative terms. PID controller 12972 attempts to minimize error e(t) over time by adjusting control variables μ(t) (eg, velocity and direction of the closed tube).

According to the PID algorithm, the "P" element 12974 accounts for the current value of error. For example, if the error is large and positive, the control output will also be large and positive. According to the present disclosure, the error term e(t) differs between the desired closure force and the measured closure force of the closure tube. The "I" element 12976 accounts for past values of error. For example, if the current output is not strong enough, the error integral will accumulate over time and the controller will respond by applying stronger action. The "D" element 12978 accounts for possible future trends in error based on its current rate of change. For example, returning to the P example above, if a large positive control output succeeds in bringing the error close to zero, it also puts the process on a path to a large negative error in the near future. In this case, the derivative becomes negative and the D module reduces the strength of the operation to prevent this overshoot.

It will be appreciated that other variables and set points may be monitored and controlled according to the feedback control system 12950, 12970. For example, the adaptive closure member speed control algorithms described herein control the parameters of firing member stroke position, firing member load, cutting element displacement, cutting element velocity, closure tube stroke position, closure tube load, among others. At least two of them can be measured.

Ultrasonic surgical devices, such as ultrasonic scalpels, are finding increasingly widespread use in surgical procedures due to their unique performance characteristics. Depending on the particular device configuration and operating parameters, the ultrasonic surgical device can provide homeostasis through substantially simultaneous transsection and coagulation of tissue, desirably minimizing trauma to the patient. The ultrasonic surgical device has a handpiece that includes an ultrasonic transducer, and a distally mounted end effector (e.g., a blade tip) coupled to the ultrasonic transducer for cutting and sealing tissue. May include equipment. In some cases, the instrument can be permanently attached to the handpiece. In other cases, the instrument may be removable from the handpiece, such as in the case of disposable or replaceable instruments. The end effector transmits ultrasonic energy to tissue in contact with the end effector to achieve the cutting and sealing action. Such ultrasonic surgical devices can be configured for open surgical applications, laparoscopic or endoscopic surgery, including robot-assisted surgery.

Ultrasonic energy cuts and coagulates tissue using lower temperatures than those used in electrosurgery and may be transmitted to the end effector by an ultrasound generator in communication with the handpiece. The ultrasonic blade vibrates at high frequencies (eg, 55,500 cycles per second) to denature proteins in the tissue and form sticky clots. Pressure applied against the tissue by the blade surface collapses the blood vessel, allowing the clot to form a hemostatic seal. The surgeon can control the rate of cutting and coagulation due to the force applied to the tissue by the end effector, the time the force is applied, and the level of performance of the end effector selected.

The ultrasound transducer is modeled as an equivalent circuit including a first branch with a capacitance and a second "working" branch with a series connected inductance, resistance, and capacitance, defining the electromechanical properties of the resonator. can be done. Known ultrasound generators may include a tuning inductor to tune out the capacitance at a resonant frequency so that substantially all of the generator drive signal current flows into the operating branch. Thus, by using a tuning inductor, the generator's drive signal current represents the operating branch current, and the generator can therefore control its drive signal to maintain the resonant frequency of the ultrasound transducer. The tuning inductor can also transform the phase impedance plot of the ultrasound transducer to improve the frequency fixing ability of the generator. However, the tuning inductor must match the specific capacitance of the ultrasound transducer at the operating resonant frequency. In other words, different ultrasound transducers with different capacitances require different tuning inductors.

Additionally, in some ultrasound generator structures, the generator drive signal exhibits asymmetric harmonic distortion that complicates impedance magnitude and phase measurements. For example, the accuracy of impedance phase measurements may be reduced by harmonic distortion of the current and voltage signals.

Furthermore, electromagnetic interference in a noisy environment reduces the generator's ability to keep the ultrasound transducer's resonant frequency fixed, increasing the likelihood of invalid control algorithm inputs.

Electrosurgical devices for applying electrical energy to tissue to treat and/or destroy tissue are also finding increasingly widespread use in surgical procedures. An electrosurgical device may include an instrument having a handpiece and a distally attached end effector (eg, one or more electrodes). The end effector can be positioned relative to tissue such that 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 by the end effector's working electrode and returned from the tissue by the end effector's return electrode, respectively. During monopolar operation, electrical current is introduced into the tissue by the active electrode of the end effector and returned through a return electrode (eg, a ground pad) located separately on the patient's body. The heat generated by the electrical current flowing through the tissue may form a hemostatic seal within and/or between tissues, and thus may be particularly useful, for example, for sealing blood vessels. The end effector of the electrosurgical device may also include a cutting member movable relative to the tissue and an electrode for transecting the tissue.

Electrical energy applied by an electrosurgical device may be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy may be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that can be within the frequency range of 300kHz to 1MHz, as described in EN60601-2-2:2009+A11:2011, Definition 201.3.218-HIGH FREQUENCY. For example, frequencies in unipolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF applications, the frequency can be almost any value. Frequencies above 200 kHz are typically used for monopolar applications to avoid unnecessary stimulation of nerves and muscles resulting from the use of low frequency currents. Lower frequencies may be used for bipolar techniques if the risk analysis indicates that the potential for neuromuscular stimulation has been mitigated to an acceptable level. To minimize problems associated with high frequency leakage currents, frequencies above 5 MHz are typically not used. It is generally recognized that 10 mA is the lower threshold for thermal effects on tissue.

During its operation, the electrosurgical device can transmit low frequency RF energy through tissue, which causes ionic agitation or friction, or resistive heating, to increase the temperature of the tissue. A sharp border can be formed between the treated tissue and its surrounding tissue, allowing the surgeon to operate with a high level of precision and control without sacrificing adjacent non-target tissue. The low operating temperature of RF energy can be useful in removing, shrinking, or sculpting soft tissue while simultaneously sealing blood vessels. RF energy can work particularly well on connective tissue, which is primarily composed of collagen and contracts when it comes in contact with heat.

Because of their unique drive signal, sensing and feedback needs, ultrasound and electrosurgical devices generally require different generators. In addition, if the instrument is disposable or compatible with the handpiece, ultrasound and electrosurgical generators are aware of the specific instrument configuration used, thus optimizing the control and diagnostic process. ability is limited. Additionally, capacitive coupling between the generator's non-isolated circuits and the patient-isolated circuits can result in exposing the patient to unacceptable levels of leakage current, especially when higher voltages and frequencies are used.

Furthermore, due to their unique drive signal, sensing and feedback needs, ultrasound and electrosurgical devices have generally required different user interfaces for different generators. In these conventional ultrasound and electrosurgical devices, one user interface may be configured for use with an ultrasound instrument while another user interface is configured for use with an electrosurgical instrument. be. Such user interfaces include hand- and/or foot-activated user interfaces, such as hand-activated switches and/or foot-activated switches. Various embodiments of a combined generator for use with both ultrasonic and electrosurgical instruments are contemplated in subsequent disclosures to operate with both ultrasonic and/or electrosurgical instrument generators. Additional user interfaces configured as such are also contemplated.

Additional user interfaces for providing feedback to either the user or other machines to provide feedback indicating the operating mode or status of any of the ultrasonic and/or electrosurgical instruments are provided within subsequent disclosures. Will be considered. Providing user and/or machine feedback for operating a combination of ultrasound and/or electrosurgical instruments includes providing sensory feedback to the user and providing electrical/mechanical/electromechanical feedback to the machine. need to do. For use with combined ultrasound and/or electrosurgical instruments, visual feedback devices (e.g., LCD display screens, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., Feedback devices incorporating tactile actuators) are discussed within subsequent disclosures.

Other electrosurgical instruments include, but are not limited to, irreversible and/or reversible electroporation, and/or microwave techniques, among others. Accordingly, the techniques disclosed herein apply to ultrasound, bipolar or monopolar RF (electrosurgical), irreversible and/or reversible electroporation, and/or microwave based surgical instruments, among others. It is possible.

Various aspects are directed to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical device may be configured, for example, to transect and/or coagulate tissue during a surgical procedure. Aspects of the electrosurgical device may be configured, for example, to transect, coagulate, scale, weld, and/or dry tissue during a surgical procedure.

Generator aspects use high-speed analog-to-digital sampling (e.g., approximately 200x oversampling depending on frequency) of the generator drive signal currents and voltages, along with digital signal processing, and offer many advantages over known generator architectures. provides benefits and benefits. In one aspect, the generator may determine the operating branch current of the ultrasound transducer based on, for example, current and voltage feedback data, capacitance values of the ultrasound transducer, and drive signal frequency values. This simulates the existence of a system that is tuned or resonant with any value of capacitance (e.g., C ₀ in Figure 25) at any frequency, providing the benefit of a substantially tuned system. do. Therefore, control of the operating branch current can be achieved by tuning out the capacitance effect without the need for regulating inductors. Additionally, elimination of the tuning inductor may not degrade the frequency fixing capability of the generator, since frequency fixing may be achieved by suitably processing current and voltage feedback data.

High speed analog-to-digital sampling of generator drive signal currents and voltages with digital signal processing may also enable precise digital filtering of the samples. For example, embodiments of the generator use a low-pass digital filter (e.g., a finite impulse response (FIR) filter) that rolls off between the fundamental drive signal frequency and a second harmonic to control current and voltage feedback samples. Asymmetric harmonic distortion and EMI induced noise may be reduced. The filtered current and voltage feedback samples substantially represent the fundamental drive signal frequency, thus allowing for more accurate impedance phase measurements with respect to the fundamental drive signal frequency and improving the generator's ability to maintain a fixed resonant frequency. Make it. The accuracy of the impedance phase measurement can be further improved by averaging the falling edge and rising edge phase measurements and adjusting the measured impedance phase to 0°.

Various aspects of the generator can also use high speed analog-to-digital sampling of generator drive signal currents and voltages, along with digital signal processing, to determine actual power consumption and other quantities with high accuracy. This allows the generator to perform many useful functions, such as controlling the amount of power delivered to tissue as the tissue impedance changes, and controlling the power delivery to maintain a constant rate of increase in tissue impedance. It may be possible to perform various algorithms. Some of these algorithms are used to determine the phase difference between the generator drive signal current and voltage signal. At resonance, the phase difference between the current and voltage signals is zero. When the ultrasound system goes off-resonance, the phase changes. Various algorithms may be used to detect the phase difference and adjust the drive frequency until the ultrasound system returns to resonance, ie, the phase difference between the current and voltage signals is zero. Phase information may also be used to estimate the state of the ultrasonic blade. As explained in detail below, the phase changes as a function of the temperature of the ultrasonic blade. Therefore, phase information may be used to control the temperature of the ultrasonic blade. This, for example, reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at too high a temperature, and reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at too low a temperature. This can be done by increasing the power applied.

Various embodiments of the generator may have a wide frequency range and increased output power necessary to drive both ultrasonic and electrosurgical devices. The lower voltage, higher current demands of electrosurgical devices may be met by dedicated taps on broadband power transformers, thus eliminating the need for separate power amplifiers and output converters. Additionally, the generator's sensing and feedback circuitry can support a large dynamic range, meeting the needs of both ultrasonic and electrosurgical applications with minimal distortion.

Various embodiments provide that the generator uses existing multi-conductor generator/handpiece cables to connect data circuits (e.g., known under the trade name "1-Wire") located within the instrument attached to the handpiece. The present invention provides a simple and economical means for reading from, and optionally writing to, a single-wire bus device (such as a single-wire protocol EEPROM). In this way, the generator can read and process instrument-specific data from the instrument attached to the handpiece. This may allow the generator to provide better control and improved diagnostics and error detection. Additionally, the ability of the generator to write data to the instrument creates possible new functionality, for example in tracking instrument usage and capturing operational data. In addition, the use of frequency bands allows backward compatibility of equipment including existing generator bus devices.

The disclosed embodiments of the generator provide active removal of leakage currents caused by unintentional capacitive coupling between the generator's non-isolated circuits and the patient-isolated circuits. In addition to reducing patient risk, reducing leakage current may also reduce electromagnetic emissions.

These and other benefits of aspects of the present disclosure will be apparent from the description below.

It will be understood that the terms "proximal" and "distal" are used herein with reference to the clinician grasping the handpiece. The end effector is therefore distal to the more proximal handpiece. Furthermore, it is understood that for convenience and clarity, spatial terms such as "upper" and "lower" may also be used herein with reference to the clinician grasping the handpiece. However, surgical devices are used in many orientations and positions, and these terms are not intended to be limiting or absolute.

FIG. 46 illustrates a modular handheld ultrasonic surgical device with the left shell half removed from handle assembly 6482 to expose a device identifier communicatively coupled to a multi-lead handle terminal assembly, according to one aspect of the present disclosure. 6480 is an elevated exploded view of instrument 6480. FIG. In an additional aspect of the present disclosure, an intelligent or smart battery is used to power the modular handheld ultrasonic surgical instrument 6480. However, smart batteries are not limited to modular handheld ultrasonic surgical instrument 6480 and may or may not have different power requirements (e.g., current and voltage) from each other, as described below. Can be used in a variety of devices. A smart battery assembly 6486 according to an aspect of the present disclosure can advantageously identify a particular device with which it is electrically coupled. This is done through encrypted or non-encrypted identification methods. For example, smart battery assembly 6486 can have a connecting portion, such as connecting portion 6488. Handle assembly 6482 may also be communicatively coupled to multi-lead handle terminal assembly 6491 and provided with a device identifier operable to communicate at least one piece of information regarding handle assembly 6482. This information includes the number of times handle assembly 6482 has been used, the number of times ultrasound transducer/generator assembly 6484 (currently disconnected from handle assembly 6482) has been used, waveguide shaft assembly 6490 (currently disconnected from handle assembly 6482) has been used, the type of waveguide shaft assembly 6490 currently connected to handle assembly 6482, and the type of ultrasound transducer/generator assembly 6484 currently connected to handle assembly 6482. or identification information, and/or many other characteristics. When smart battery assembly 6486 is inserted into handle assembly 6482, a connecting portion 6488 within smart battery assembly 6486 makes communicative contact with a device identifier on handle assembly 6482. Handle assembly 6482 may transmit information to smart battery assembly 6486 (either self-activated or in response to a request from smart battery assembly 6486) via hardware, software, or a combination thereof. This communicated identifier is received by connection portion 6488 of smart battery assembly 6486. In one aspect, once the smart battery assembly 6486 receives the information, the communication portion is operable to control the output of the smart battery assembly 6486 to comply with the particular power requirements of the device.

In one aspect, the communication portion includes a processor 6493 and memory 6497, which may be separate or a single component. Processor 6493, in combination with memory, can provide intelligent power management for modular handheld ultrasonic surgical instrument 6480. This aspect is particularly advantageous because ultrasonic devices such as modular handheld ultrasonic surgical instrument 6480 have power requirements (frequency, current and voltage) that may be unique to modular handheld ultrasonic surgical instrument 6480. . In effect, the modular handheld ultrasonic surgical instrument 6480 has specific power requirements or limitations for one size or type of outer tube 6494 and a second type of waveguide having a different size, shape, and/or configuration. may have a second different power requirement for.

Thus, smart battery assembly 6486 according to at least one aspect of the present disclosure allows the battery assembly to be used among several surgical instruments. Because the smart battery assembly 6486 can identify the device to which it is attached and change its output accordingly, operators of a variety of different surgical instruments utilizing the smart battery assembly 6486 can You no longer have to worry about which power supply you are attempting to install within the electronics equipment being used. This is particularly advantageous in operating environments where the battery assembly needs to be replaced or replaced with another surgical instrument during a complex surgical procedure.

In a further aspect of the present disclosure, smart battery assembly 6486 stores a record in memory 6497 each time a particular device is used. This record may be useful for evaluating the end of the useful or acceptable life of the device. For example, if a device has been used 20 times, this device is defined as a "no longer reliable" surgical instrument, so those batteries in the smart battery assembly 6486 connected to this device Refuse to supply power to. Reliability is determined based on many factors. One factor can be wear, which can be estimated in many ways, including the number of times the device is used or activated. After a certain number of uses, the parts of the device may wear out and tolerances between the parts may be exceeded. For example, smart battery assembly 6486 can sense the number of button presses received by handle assembly 6482 and can determine when a maximum number of button presses has been reached or exceeded. The smart battery assembly 6486 can also monitor the impedance of the button mechanism, which may change if the handle becomes contaminated with salt water, for example.

This wear can lead to unacceptable failure during the procedure. In some aspects, the smart battery assembly 6486 can recognize which parts have been assembled together within the device, as well as how many uses the parts have experienced. For example, if smart battery assembly 6486 is a smart battery according to the present disclosure, handle assembly 6482, waveguide shaft assembly 6490, and ultrasound transducer/generator assembly 6484 are identified well before the user attempts to use the combined device. can do. Memory 6497 within smart battery assembly 6486 may, for example, record the time that ultrasound transducer/generator assembly 6484 is operating, as well as how, when, and for how long it has been operating. can. If the ultrasound transducer/generator assembly 6484 has an individual identifier, the smart battery assembly 6486 will track the use of the ultrasound transducer/generator assembly 6484 once the handle assembly 6482 or the ultrasound transducer/generator assembly 6484 Power can be denied to the ultrasound transducer/generator assembly 6484 once its maximum number of uses has been exceeded. Ultrasonic transducer/generator assembly 6484, handle assembly 6482, waveguide shaft assembly 6490, or other components can include memory chips that also record this information. In this way, any number of smart batteries in the smart battery assembly 6486 can be used with any number of ultrasound transducer/generator assemblies 6484, staplers, vascular sealers, etc., and still The total number of uses or hours of use (through the use of a clock), or the total number of actuations, etc., or charge or discharge cycles of the device assembly 6484, stapler, vessel sealer, etc. can be determined. Smart functionality may be external to battery assembly 6486, such as within handle assembly 6482, ultrasound transducer/generator assembly 6484, and/or shaft assembly 6490.

When counting the uses of the ultrasound transducer/generator assembly 6484 to intelligently end the life of the ultrasound transducer/generator assembly 6484, the surgical instrument is configured to monitor the actual use of the ultrasound transducer/generator assembly 6484 in the surgical procedure. and momentary loss of operation of the ultrasound transducer/generator assembly 6484 due to, for example, battery replacement or a temporary delay in a surgical procedure. Therefore, as an alternative to easily count the number of activations of the ultrasound transducer/generator assembly 6484, a real-time clock (RTC) circuit can be implemented to keep track of the times when the ultrasound transducer/generator assembly 6484 is actually shut down. The quantity can be tracked. Whether the shutdown was significant enough to be considered the actual end of a single use due to the length of time measured, or whether the shutdown was too short to be considered the end of a single use. can be determined by appropriate theory. Thus, in some applications, this method may be used, for example, if 10 "activations" occur during a surgical procedure, 10 activations should indicate that the counter is incremented by 1. The useful life of the ultrasound transducer/generator assembly 6484 can be determined more accurately than a simple "activation-based" algorithm. In general, this internal clocking type and system prevents misuse of devices designed to fool simple "activation-based" algorithms, and also prevents the use of ultrasonic transducer/generator assemblies 6484 or 6484 that are needed for legitimate reasons. Prevents false logging as a completed use when there is only a simple disconnection of the smart battery assembly 6486.

Although the ultrasonic transducer/generator assembly 6484 of the surgical instrument 6480 is reusable, in one aspect, a finite number of uses is established because the surgical instrument 6480 is exposed to harsh conditions during cleaning and sterilization. may be done. More specifically, the battery pack is configured to be sterilized. Regardless of the material used for the outer surface, there is a limited expected lifespan for the actual material used. This lifespan is determined by a variety of characteristics, which may include, for example, the amount of time the pack has been actually sterilized, the amount of time since the pack was manufactured, and the number of times the pack has been refilled, to name just a few. Ru. Furthermore, the lifespan of the battery cell itself is limited. The software of the present disclosure verifies the number of uses of the ultrasound transducer/generator assembly 6484 and the smart battery assembly 6486 and disables the device when this number of uses is reached or exceeded. It incorporates. Analysis of the battery pack exterior for each possible sterilization method can be performed. Based on the most severe sterilization technique, a maximum number of sterilizations allowed can be defined, and that number can be stored in the memory of the smart battery assembly 6486. If the charger is non-sterile and the smart battery assembly 6486 is assumed to be used after its charging, the charge count can be defined to be equal to the number of sterilizations that a particular pack encounters.

In one aspect, hardware within the battery pack can be disabled to minimize or eliminate safety concerns due to continuous draining from the battery cells after the pack is disabled by software. There may be situations in which the battery's internal hardware is unable to disable the battery under certain low voltage conditions. In such situations, in one aspect, the charger can be used to "shut down" the battery. Due to the fact that the battery microcontroller is off while the battery is in its charger, it uses non-volatile System Management Bus (SMB)-based electrically erasable programmable read-only memory (EEPROM). information can be exchanged between the battery microcontroller and the charger. Therefore, a series of EEPROMs can be used to store information that can be written and read even when the battery microcontroller is off, which is very important when trying to exchange information with a charger or other peripherals. It is beneficial for The EEPROM in this example has at least (a) a usage count limit at which the battery should be disabled (battery usage count), (b) the number of procedures the battery will experience (battery usage count), just to name a few. and/or (c) may be configured to include memory registers sufficient to store the number of charges that the battery experiences (a charge count). Some of the information stored in the EEPROM, such as the usage count register and the charge count register, is stored in a write-protected portion of the EEPROM to prevent the user from changing the information. In one aspect, usage and counters are stored with corresponding bit-flipping small registers to detect data corruption.

Any residual voltage in the SMBus line can damage the microcontroller and corrupt the SMBus signal. Therefore, a relay is provided between the external SMBus line and the battery microcontroller board to ensure that the battery controller's SMBus line does not carry voltage while the microcontroller is off.

During charging of the smart battery assembly 6486, for example, when using a constant current/constant voltage charging scheme, when the current inflow into the battery tapers below a given threshold, the "charging" of the battery in the smart battery assembly 6486 stops. Terminate" status is determined. To accurately detect this "end of charge" condition, the battery microcontroller and back board are powered down and turned off while the battery is charging, and any reduce current drain. Additionally, the microcontroller and back board are powered down during charging to prevent any resulting SMBus signal corruption.

Regarding the charger, in one aspect, the smart battery assembly 6486 is prevented from being inserted into the charger in any manner other than the correct insertion position. Therefore, the exterior of smart battery assembly 6486 is provided with a mechanism to retain the charger. The cup for securely retaining the smart battery assembly 6486 within the charger conforms to the contours to prevent the smart battery assembly 6486 from being accidentally inserted in any manner other than the correct (intended) manner. Consists of a tapered shape. It is further anticipated that the presence of smart battery assembly 6486 may be detectable by the charger itself. For example, the charger may be configured to detect the presence of an SMBus transmission from the battery protection circuit as well as a resistor located within the protection board. In such a case, the charger will be able to control the voltage exposed at the charger pins until the smart battery assembly 6486 is properly seated or placed in place on the charger. This is because exposed voltages at the pins of the charger present a danger and risk that an electrical short will occur across the pins and the charger will start charging unintentionally.

In some aspects, smart battery assembly 6486 can communicate to the user through audio and/or visual feedback. For example, smart battery assembly 6486 can cause LEDs to light up in a preset manner. In such a case, even though the microcontroller within the ultrasound transducer/generator assembly 6484 controlled the LEDs, the microcontroller receives instructions to be executed directly from the smart battery assembly 6486.

In yet a further aspect of the present disclosure, the microcontroller within the ultrasound transducer/generator assembly 6484 enters a sleep mode when not used for a predetermined period of time. Advantageously, when in sleep mode, the microcontroller's clock speed is reduced, significantly reducing current drain. Some current continues to be consumed as the processor continues to ping and wait to sense input. Advantageously, when the microcontroller is in this power-saving sleep mode, the microcontroller and battery controller can directly control the LEDs. For example, the decoder circuitry may be integrated into the ultrasound transducer/generator assembly 6484 and connected to the communication line, such that while the microcontroller of the ultrasound transducer/generator assembly 6484 is in "off" or "sleep mode" , LEDs may be independently controlled by processor 6493. This is a power saving mechanism that eliminates the need to activate the microcontroller within the ultrasound transducer/generator assembly 6484. Power is conserved by turning off the generator while still allowing user interface indicators to be actively controlled.

Another aspect slows down one or more of the microcontrollers when not in use to conserve power. For example, the clock frequency of both microcontrollers can be reduced to save power. To maintain synchronized operation, the microcontroller coordinates each clock frequency change to occur at approximately the same time, and a reduction followed by a subsequent increase in frequency when full speed operation is required. For example, when entering idle mode, the clock frequency decreases, and when exiting idle mode, the frequency increases.

In an additional aspect, the smart battery assembly 6486 can determine the amount of usable power remaining within its cells, such that there is sufficient battery power remaining to operate the device predictably throughout the anticipated procedure. It is programmed to operate the attached surgical instruments only if it determines that there are remaining. For example, the smart battery assembly 6486 can remain inactive if there is not enough power in the cell to operate the surgical instrument for 20 seconds. According to one aspect, smart battery assembly 6486 determines the amount of power remaining in the cell at the end of its most recent preceding function, such as a surgical cut. In this manner, the smart battery assembly 6486 will therefore not allow subsequent functions to be performed if, for example, the cell is determined to be underpowered during the procedure. Alternatively, if the smart battery assembly 6486 determines that there is sufficient power for a subsequent procedure during a procedure and is below that threshold, it completes the procedure in progress without interrupting it. , preventing additional procedures from occurring subsequently.

The following describes the benefits of maximizing the use of devices comprising the smart battery assembly 6486 of the present disclosure. In this example, different sets of devices have different ultrasound transmission waveguides. By definition, waveguides may have their own maximum allowable power limits, beyond which power limits will overstress the waveguide and eventually cause it to break. One waveguide from a set of waveguides inherently has the smallest maximum power tolerance. Because prior art batteries lack intelligent battery power management, the output of prior art batteries is limited to the smallest/thinnest/most fragile waveguide in the set that is intended to be used with the device/battery. Must be limited by the minimum maximum allowable power input to the tube. This is true even though a larger, thicker waveguide is later attached to its handle, which by definition allows more force to be applied. This limit is also true for maximum battery power. For example, if one battery is designed to be used in multiple devices, its maximum output power is limited to the lowest maximum power rating of any of the devices in which it is used. Such configurations may prevent one or more devices or device configurations from maximizing the use of the battery because the battery is unaware of the particular limitations of the particular device.

In one aspect, the smart battery assembly 6486 can be used to intelligently circumvent the limitations of ultrasound devices described above. A smart battery assembly 6486 can produce one output for one device or a particular device configuration, and the same smart battery assembly 6486 can later produce a different output for a second device or device configuration. be able to. This universal smart battery surgical system is suitable for modern operating rooms where space and time are at a premium. By operating many different devices on smart battery packs, nurses can easily manage the storage, retrieval, and inventory of these packs. Advantageously, in one aspect, smart batteries according to the present disclosure can utilize one type of charging station, thus increasing ease and efficiency of use and reducing cost of operating room charging equipment.

Additionally, other surgical instruments, such as an electric stapler, may have power requirements that are different from those of the modular handheld ultrasonic surgical instrument 6480. According to various aspects of the present disclosure, the smart battery assembly 6486 can be used with any one of a series of surgical instruments and has its own power supply tailored to the particular device in which it is installed. It can be manufactured to adjust the output. In one aspect, this power regulation is a switch, such as a buck, buck-boost, boost, or other configuration, that is integral to or otherwise coupled to the smart battery assembly 6486 and controlled by the smart battery assembly 6486. This is implemented by controlling the duty cycle of the mode power supply. In other aspects, smart battery assembly 6486 can dynamically change its power output during device operation. For example, in blood vessel sealing devices, power management provides improved tissue sealing. These devices require large constant current values. As tissue is sealed, its impedance changes, requiring dynamic adjustment of the total power output. Aspects of the present disclosure provide a variable maximum current limit for smart battery assembly 6486. Current limits may vary from application (or device) to application (or device) based on the requirements of the application or device.

FIG. 47 is a detailed view of the trigger 6483 portion and switch of the ultrasonic surgical instrument 6480 shown in FIG. 46 in accordance with at least one aspect of the present disclosure. Trigger 6483 is operably coupled to jaw member 6495 of end effector 6492. Ultrasonic blade 6496 is energized by ultrasonic transducer/generator assembly 6484 upon actuation of activation switch 6485. With continued reference to FIG. 46 and also to FIG. 47, a trigger 6483 and activation switch 6485 are shown as components of the handle assembly 6482. Trigger 6483 actuates an end effector 6492 in cooperative relationship with ultrasonic blade 6496 of waveguide shaft assembly 6490 to interact with end effector jaw member 6495 and ultrasonic blade 6496 with various types of tissue and/or other materials. contact. Jaw members 6495 of end effector 6492 are typically pivoting jaws that act to grasp or clamp tissue disposed between the jaws and ultrasonic blade 6496. In one aspect, audible feedback is provided within the trigger that clicks when the trigger is fully depressed. Noise can be generated by thin metal parts snapping while the trigger is closing. This feature uses an audible component to notify the user that the jaws are fully compressed against the waveguide and that sufficient clamping pressure has been applied to achieve a vessel seal. Add to user feedback. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to trigger 6483 to measure the force applied to trigger 6483 by a user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch 6485 button such that the displacement strength corresponds to the force applied to the switch 6485 button by the user.

Activation switch 6485, when depressed, places modular handheld ultrasonic surgical instrument 6480 into an ultrasonic operating mode, causing ultrasonic motion in waveguide shaft assembly 6490. In one aspect, pressing the activation switch 6485 closes electrical contacts within the switch, thereby completing the circuit between the smart battery assembly 6486 and the ultrasound transducer/generator assembly 6484 and transmitting the ultrasound waves as described above. Power is applied to the transducer. In another aspect, pressing activation switch 6485 closes the electrical contact to smart battery assembly 6486. It will be appreciated that the description of closing electrical contacts in a circuit is merely an exemplary general description of switch operation here. There are many alternative embodiments that can include open contacts or processor-controlled power delivery that receives information from the switch and directs a corresponding circuit response based on that information.

FIG. 48 is a fragmentary, close-up perspective view of end effector 6492 from the distal end with jaw member 6495 in an open position, in accordance with at least one aspect of the present disclosure. Referring to FIG. 48, a perspective partial view of a distal end 6498 of waveguide shaft assembly 6490 is shown. Waveguide shaft assembly 6490 includes an outer tube 6494 surrounding a portion of the waveguide. The ultrasonic blade 6496 portion of the waveguide 6499 projects from the distal end 6498 of the outer tube 6494. This is the portion of the ultrasound blade 6496 that contacts tissue and transfers its ultrasound energy to the tissue during a medical procedure. Waveguide shaft assembly 6490 also includes a jaw member 6495 coupled to an outer tube 6494 and an inner tube (not visible in this view). The jaw member 6495, along with the inner and outer tubes and the ultrasonic blade 6496 portion of the waveguide 6499, may be referred to as an end effector 6492. As explained below, the outer tube 6494 and the inner tube (not shown) slide longitudinally relative to each other. When relative movement between outer tube 6494 and an inner tube (not shown) occurs, jaw member 6495 pivots on a pivot point, thereby opening and closing jaw member 6495. When closed, the jaw members 6495 apply a clamping force to tissue located between the jaw members 6495 and the ultrasonic blade 6496 to ensure positive and efficient blade-tissue contact.

FIG. 49 is a system diagram 7400 of a segmentation circuit 7401 comprising a plurality of independently operating circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440, in accordance with at least one aspect of the present disclosure. A circuit segment of the plurality of circuit segments of segmented circuit 7401 includes one or more circuits and a set of one or more machine-executable instructions stored in one or more memory devices. and, including. One or more circuits of a circuit segment are coupled for telecommunication through one or more wired or wireless connection media. The plurality of circuit segments are configured to transition between three modes, including a sleep mode, a standby mode, and an operating mode.

In one aspect shown, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 first begin in a standby mode, secondly enter a sleep mode, and thirdly enter an operational mode. Move to. However, in other aspects, the plurality of circuit segments can transition from any one of the three modes to any other one of the three modes. For example, multiple circuit segments can be transitioned directly from standby mode to operational mode. Individual circuit segments may be placed in particular states by voltage control circuit 7408 based on execution by the processor of machine-executable instructions. These states include a de-energized state, a low energy state, and a energized state. The de-energized state corresponds to a sleep mode, the low energy state corresponds to a standby mode, and the energized state corresponds to an operating mode. The transition to a lower energy state can be achieved, for example, by the use of a potentiometer.

In one aspect, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 can transition from a sleep mode or standby mode to an operational mode according to an energization sequence. The plurality of circuit segments may also be transitioned from an operational mode to a standby or sleep mode according to a de-energized sequence. The energization sequence and de-energization sequence may be different. In some aspects, the energization sequence includes energizing only a subset of the circuit segments of the plurality of circuit segments. In some aspects, the de-energizing sequence includes de-energizing only a subset of the circuit segments of the plurality of circuit segments.

Referring again to system diagram 7400 of FIG. 49, segmentation circuitry 7401 includes transition circuitry segment 7402, processor circuitry segment 7414, handle circuitry segment 7416, communication circuitry segment 7420, display circuitry segment 7424, motor control circuitry segment 7428, and energy treatment circuitry. A plurality of circuit segments are provided, including circuit segment 7434 and shaft circuit segment 7440. The transition circuit segment includes a wake-up circuit 7404, a boost current circuit 7406, a voltage control circuit 7408, a safety controller 7410, and a POST controller 7412. Transition circuit segment 7402 is configured to implement de-energizing and energizing sequences, safety detection protocols, and POST.

In some aspects, wake-up circuit 7404 includes an accelerometer button sensor 7405. In aspects, transition circuit segment 7402 is configured to be in a energized state, while other circuit segments of the plurality of circuit segments of segmented circuit 7401 are configured to be in a low energy state, a de-energized state, or a energized state. It is composed of Accelerometer button sensor 7405 may monitor movement or acceleration of surgical instrument 6480 described herein. For example, the movement may be a change in orientation or rotation of the surgical instrument. A surgical instrument can be moved in any direction relative to three-dimensional Euclidean space, for example by a user of the surgical instrument. When the accelerometer button sensor 7405 senses movement or acceleration, the accelerometer button sensor 7405 sends a signal to the voltage control circuit 7408 causing the voltage control circuit 7408 to apply voltage to the processor circuit segment 7414 to remove the processor and volatile memory. Shifts to energized state. In aspects, the processor and volatile memory are in a powered state before voltage control circuit 7409 applies voltage to the processor and volatile memory. In the operational mode, the processor can initiate a energizing or de-energizing sequence. In various aspects, the accelerometer button sensor 7405 can also send a signal to the processor to cause the processor to initiate a energization or de-energization sequence. In some aspects, the processor initiates the energization sequence when a majority of the individual circuit segments are in a low energy or de-energized state. In other aspects, the processor initiates the de-energizing sequence when a majority of the individual circuit segments are in the energized state.

Additionally or alternatively, accelerometer button sensor 7405 can sense external movement of the surgical instrument within a predetermined vicinity. For example, accelerometer button sensor 7405 can sense a user of a surgical instrument 6480 described herein moving the user's hand within a predetermined vicinity. When accelerometer button sensor 7405 senses this external movement, accelerometer button sensor 7405 can signal voltage control circuit 7408 and signal the processor, as described above. After receiving the transmitted signal, the processor can initiate a energization or de-energization sequence to transition one or more circuit segments between the three modes. In an aspect, a signal sent to voltage control circuit 7408 is sent to verify that the processor is in an operational mode. In some aspects, the accelerometer button sensor 7405 can sense when the surgical instrument is dropped and send a signal to the processor based on the sensed drop. For example, the signal may indicate an error in the operation of an individual circuit segment. One or more sensors can sense damage or malfunction of individual affected circuit segments. Based on the sensed damage or malfunction, POST controller 7412 can perform POST of the corresponding individual circuit segment.

An energizing or de-energizing sequence may be defined based on the accelerometer button sensor 7405. For example, accelerometer button sensor 7405 can sense a particular movement or sequence of movements indicative of selection of a particular circuit segment of the plurality of circuit segments. Based on the sensed motion or series of sensed motions, accelerometer button sensor 7405 directs one or more of the plurality of circuit segments when the processor is in the energized state. A signal containing the information may be sent to the processor. Based on this signal, the processor determines an energization sequence that includes the selected one or more circuit segments. Additionally or alternatively, a user of a surgical instrument 6480 described herein can select the number and order of circuit segments to create an energization sequence or sequence based on interaction with a graphical user interface (GUI) of the surgical instrument. De-energizing sequences can be defined.

In various aspects, the accelerometer button sensor 7405 detects when the accelerometer button sensor 7405 detects movement of the surgical instrument 6480 described herein, or external movement within a predetermined neighborhood that exceeds a predetermined threshold. can only send a signal to the voltage control circuit 7408 and send a signal to the processor. For example, a signal may be sent only if movement is sensed for more than 5 seconds or if the surgical instrument is moved more than 5 inches. In other aspects, the accelerometer button sensor 7405 can signal the voltage control circuit 7408 and signal the processor only when the accelerometer button sensor 7405 detects vibrational movement of the surgical instrument. . The predetermined threshold reduces inadvertent migration of circuit segments of the surgical instrument. As described above, the transition may include transitioning to an operating mode following an energizing sequence, transitioning to a low energy mode following a de-energizing sequence, or transitioning to a sleep mode following a de-energizing sequence. In some aspects, the surgical instrument includes an actuator that can be actuated by a user of the surgical instrument. This actuation is sensed by accelerometer button sensor 7405. The actuator may be a slider, toggle switch, or momentary contact switch. Based on the sensed actuation, accelerometer button sensor 7405 can signal voltage control circuit 7408 and signal the processor.

A boost current circuit 7406 is coupled to the battery. Boost current circuit 7406 is a current amplifier, such as a relay or transistor, configured to amplify the magnitude of the current in the individual circuit segment. The initial magnitude of the current corresponds to the power supply voltage provided to the segmentation circuit 7401 by the battery. Suitable relays include solenoids. Suitable transistors include field effect transistors (FETs), MOSFETs, and bipolar junction transistors (BJTs). Boost current circuit 7406 can amplify the magnitude of current corresponding to individual circuit segments or circuits that require more current draw during operation of surgical instrument 6480 described herein. For example, an increase in current to motor control circuit segment 7428 may be provided when a surgical instrument motor requires more input power. An increase in current provided to an individual circuit segment can cause a corresponding decrease in current in another circuit segment or circuit segments. Additionally or alternatively, the increase in current may correspond to a voltage provided by an additional voltage source operating in conjunction with the battery.

Voltage control circuit 7408 is coupled to the battery. Voltage control circuit 7408 is configured to provide voltage to or remove voltage from multiple circuit segments. Voltage control circuit 7408 is also configured to increase or decrease the voltage provided to multiple circuit segments of segmentation circuit 7401. In various aspects, voltage control circuit 7408 comprises combinatorial logic circuits such as multiplexers (MUXs) that select inputs, electronic switches, and voltage converters. The electronic switches of the plurality of electronic switches may be configured to switch between open and closed configurations to disconnect or connect individual circuit segments from the battery. The plurality of electronic switches may be solid state devices such as transistors, or other types of switches such as wireless switches, ultrasonic switches, accelerometers, inertial sensors, among others. The combinational logic circuit is configured to select individual electronic switches to switch to an open configuration to enable application of voltage to the corresponding circuit segment. The combinational logic circuit is also configured to select individual electronic switches to switch to a closed configuration to enable removal of voltage from the corresponding circuit segment. By selecting a plurality of individual electronic switches, the combinational logic circuit can implement de-energizing or energizing sequences. The plurality of voltage converters can provide step-up or step-down voltages to the plurality of circuit segments. Voltage control circuit 7408 may also include a microprocessor and memory device.

Safety controller 7410 is configured to perform safety checks on circuit segments. In some aspects, safety controller 7410 performs safety checks when one or more individual circuit segments are in an operational mode. A safety check may be performed to determine if there are any errors or defects in the function or operation of the circuit segment. Safety controller 7410 can monitor one or more parameters of multiple circuit segments. Safety controller 7410 can verify the identity and operation of multiple circuit segments by comparing one or more parameters to predefined parameters. For example, when an RF energy modality is selected, the safety controller 7410 verifies that the shaft articulation parameters match the predefined articulation parameters for the surgical instrument 6480 described herein. The operation of the RF energy modality can be verified. In some aspects, the safety controller 7410 may monitor, through sensors, a predetermined relationship between one or more characteristics of the surgical instrument to detect a fault. A failure may occur when one or more characteristics are inconsistent with a predetermined relationship. If safety controller 7410 determines that a fault exists, an error exists, or operation of a portion of a plurality of circuit segments was not verified, safety controller 7410 determines that the fault, error, or verification failure is Preventing or disabling the operation of the particular circuit segment that occurred.

POST controller 7412 performs POST to verify proper operation of multiple circuit segments. In some aspects, POST applies voltages to individual circuit segments of the plurality of circuit segments before voltage control circuit 7408 applies voltages to the individual circuit segments to transition the individual circuit segments from standby or sleep mode to operational mode. Performed on segments. If an individual circuit segment does not pass POST, the particular circuit segment will not transition from standby or sleep mode to operational mode. POST of handle circuit segment 7416 may include, for example, testing whether handle control sensor 7418 senses actuation of a handle control of surgical instrument 6480 described herein. In some aspects, POST controller 7412 can send signals to accelerometer button sensor 7405 to verify operation of individual circuit segments as part of POST. For example, after receiving a signal, the accelerometer button sensor 7405 can prompt a user of the surgical instrument to move the surgical instrument to a plurality of different positions to confirm operation of the surgical instrument. . The accelerometer button sensor 7405 may also monitor the output of the circuit segment or the circuit of the circuit segment as part of POST. For example, accelerometer button sensor 7405 can sense incremental motor pulses generated by motor 7432 to verify operation. A motor controller in motor control circuit 7430 can be used to control motor 7432 to generate incremental motor pulses.

In various aspects, the surgical instruments 6480 described herein may include additional accelerometer button sensors. POST controller 7412 may also execute a control program stored in a memory device of voltage control circuit 7408. The control program can cause the POST controller 7412 to send signals requesting matching encryption parameters from multiple circuit segments. Failure to receive matching encryption parameters from an individual circuit segment indicates to the POST controller 7412 that the corresponding circuit segment is corrupted or malfunctioning. In some aspects, if the POST controller 7412 determines that a processor is corrupted or malfunctioning based on the POST, the POST controller 7412 sends a signal to one or more secondary processors to Or, two or more secondary processors can perform marginal functions that a processor cannot perform. In some aspects, if POST controller 7412 determines that one or more circuit segments are not operating properly based on POST, POST controller 7412 determines that POST has failed or A lower performance mode can be initiated for properly operating circuit segments while locking out non-operating circuit segments. A locked out circuit segment may function similar to a circuit segment in standby or sleep mode.

Processor circuit segment 7414 includes a processor and volatile memory. The processor is configured to initiate a energization or de-energization sequence. To initiate the energization sequence, the processor sends an energization signal to voltage control circuit 7408 to cause voltage control circuit 7408 to apply voltage to the plurality of circuit segments or a subset of the plurality of circuit segments according to the energization sequence. To initiate a de-energizing sequence, the processor sends a de-energizing signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to remove voltage from the plurality of circuit segments or a subset of the plurality of circuit segments according to the de-energizing sequence. let

Handle circuit segment 7416 includes a handle control sensor 7418. Handle control sensor 7418 may sense actuation of one or more handle controls of surgical instrument 6480 described herein. In various aspects, the one or more handle controls include a clamp control, a release button, an articulation switch, an energy activation button, and/or any other suitable handle control. The user can activate the energy activation button to select RF energy mode, ultrasound energy mode, or a combination of RF energy mode and ultrasound energy mode. Handle control sensor 7418 can also facilitate attachment of the modular handle to a surgical instrument. For example, the handle control sensor 7418 can sense proper attachment of the modular handle to the surgical instrument and indicate the sensed attachment to a user of the surgical instrument. LCD display 7426 can provide a graphical display of sensed attachment. In some aspects, handle control sensor 7418 senses actuation of one or more handle controls. Based on the sensed actuation, the processor can initiate either an energization sequence or a de-energization sequence.

Communication circuit segment 7420 includes communication circuit 7422 . Communication circuit 7422 includes a communication interface to facilitate signal communication between individual circuit segments of the plurality of circuit segments. In some aspects, communication circuitry 7422 provides a path for modular components of surgical instrument 6480 described herein to communicate electrically. For example, when the module shaft and module transducer are mounted together to a handle of a surgical instrument, a control program can be uploaded to the handle via the communication circuit 7422.

Display circuit segment 7424 includes an LCD display 7426. LCD display 7426 can include a liquid crystal display screen, LED indicators, or the like. In some aspects, LCD display 7426 is an organic light emitting diode (OLED) screen. The display may be located on the surgical instrument 6480 described herein, embedded, or remotely located. For example, the display may be placed on the handle of a surgical instrument. The display is configured to provide sensory feedback to the user. In various aspects, LCD display 7426 further includes a backlight. In some aspects, the surgical instrument can also include an audible feedback device, such as a speaker or buzzer, and a tactile feedback device, such as a tactile actuator.

Motor control circuit segment 7428 includes a motor control circuit 7430 coupled to motor 7432. Motor 7432 is coupled to the processor by a driver and a transistor such as a FET. In various aspects, motor control circuit 7430 includes a motor current sensor in signal communication with the processor to provide a signal to the processor indicative of a measurement of the motor's current draw. The processor sends a signal to the display. The display receives this signal and displays a measurement of the motor 7432 current draw. The processor uses the signals to, for example, monitor that the current draw of the motor 7432 is within an acceptable range, compare the current draw to one or more parameters of the plurality of circuit segments, and One or more parameters of the treatment site can be determined. In various aspects, motor control circuit 7430 includes a motor controller that controls operation of the motor. For example, motor control circuit 7430 controls various motor parameters, such as by adjusting the speed, torque, and acceleration of motor 7432. This section is performed based on the current through the motor 7432 as measured by the motor current sensor.

In various aspects, motor control circuit 7430 includes force sensors that measure force and torque generated by motor 7432. Motor 7432 is configured to operate the mechanisms of surgical instrument 6480 described herein. For example, motor 7432 is configured to control actuation of a shaft of a surgical instrument to provide clamping, rotation, and articulation functions. For example, motor 7432 can actuate the shaft to effect clamping motion with the jaws of a surgical instrument. The motor controller can determine whether the material clamped by the jaws is tissue or metal. The motor controller may also determine the degree to which the jaws clamp the material. For example, the motor controller can determine the extent to which the jaws open or close based on sensed motor current or motor voltage derivatives. In some aspects, the motor 7432 is configured to actuate the transducer to cause the transducer to apply torque to the handle or control articulation of the surgical instrument. A motor current sensor can interact with a motor controller to set a motor current limit. If the current meets a predetermined threshold limit, the motor controller initiates a corresponding change in motor control behavior. For example, exceeding a motor current limit causes the motor controller to reduce the current draw of the motor.

Energy treatment circuit segment 7434 includes RF amplifier and safety circuitry 7436 and ultrasound signal generator circuitry 7438 to implement energy module functionality of surgical instrument 6480 as described herein. In various aspects, the RF amplifier and safety circuit 7436 is configured to control the RF modality of the surgical instrument by generating an RF signal. Ultrasonic signal generator circuit 7438 is configured to control the ultrasound energy modality by generating ultrasound signals. The RF amplifier and safety circuit 7436 and the ultrasound signal generator circuit 7438 can jointly operate to control the combined RF and ultrasound energy modality.

Shaft circuit segment 7440 includes a shaft module controller 7442 , a module control actuator 7444 , one or more end effector sensors 7446 , and non-volatile memory 7448 . Shaft module controller 7442 is configured to control a plurality of shaft modules including a control program executed by a processor. Multiple shaft modules implement shaft modalities such as ultrasound, combined ultrasound and RF, RF I-blades, and RF-opposable jaws. Shaft module controller 7442 can select a shaft modality by selecting the corresponding shaft module that the processor executes. Module control actuator 7444 is configured to actuate the shaft according to the selected shaft modality. After actuation is initiated, the shaft articulates the end effector according to one or more parameters, routines, or programs specific to the selected shaft modality and the selected end effector modality. The one or more end effector sensors 7446 located on the end effector can include force sensors, temperature sensors, current sensors, or motion sensors. One or more end effector sensors 7446 transmit data regarding one or more operations of the end effector based on the energy modality performed by the end effector. In various aspects, the energy model includes an ultrasound energy modality, an RF energy modality, or a combination of ultrasound energy modalities and RF energy modalities. Non-volatile memory 7448 stores shaft control programs. The control program includes one or more parameters, routines or programs specific to the shaft. In various aspects, non-volatile memory 7448 may be ROM, EPROM, EEPROM, or flash memory. Non-volatile memory 7448 stores the shaft module corresponding to the selected shaft of surgical instrument 6480 described herein. Shaft modules may be modified or upgraded in non-volatile memory 7448 by shaft module controller 7442 depending on the surgical instrument shaft used during operation.

FIG. 50 is a circuit diagram of a circuit 7925 of various components of a surgical instrument with motor control functionality in accordance with at least one aspect of the present disclosure. In various aspects, the surgical instruments 6480 described herein are configured to drive shafts and/or gear components to perform various operations associated with the surgical instruments 6480. A drive mechanism 7930 may also be included. In one aspect, the drive mechanism 7930 includes a rotational drive train 7932 configured to rotate the end effector, for example, about a longitudinal axis relative to the handle housing. Drive mechanism 7930 further includes a closing drive train 7934 configured to close the jaw members and grasp tissue with the end effector. Further, the drive mechanism 7930 includes a firing drive train 7936 configured to open and close a clamp arm portion of the end effector to grasp tissue with the end effector.

Drive mechanism 7930 includes a selector gearbox assembly 7938 that can be located within a handle assembly of a surgical instrument. Proximal to selector gearbox assembly 7938, one of drive trains 7932, 7934, 7936 is selectively positioned to connect optional second motor 7944 and motor drive circuit 7946 (second motor 7944 and motor Drive circuit 7946 is operative to selectively move a gear element within selector gearbox assembly 7938 to engage an input drive component (shown in dashed lines to indicate that it is an optional component). , a function selection module including a first motor 7942 .

Still referring to FIG. 50, the motors 7942, 7944 are coupled to motor control circuits 7946, 7948, respectively, which include the flow of electrical energy from a power source 7950 to the motors 7942, 7944. 7944. Power source 7950 may be a DC battery (e.g., a rechargeable lead-based, nickel-based, lithium ion-based battery, etc.) or any other power source suitable for providing electrical energy to a surgical instrument. .

The surgical instrument further includes a microcontroller 7952 ("controller"). In certain examples, controller 7952 may include a microprocessor 7954 ("processor") and one or more computer readable media or memory units 7956 ("memory"). In particular examples, memory 7956 can store various program instructions that, when executed, can cause processor 7954 to perform the functions and/or calculations described herein. can. Power supply 7950 can be configured to provide power to controller 7952, for example.

Processor 7954 may communicate with motor control circuit 7946. Additionally, memory 7956 , when executed by processor 7954 in response to user input 7958 or feedback element 7960 , causes motor control circuit 7946 to stimulate motor 7942 to produce at least one rotational movement and selector gearbox assembly 7938 . can selectively move a gear element within to selectively position one of the drive trains 7932, 7934, 7936 to engage an input drive component of the second motor 7944; Program instructions can be stored. Further, processor 7954 may communicate with motor control circuit 7948. Memory 7956 also causes motor control circuit 7948 to stimulate motor 7944 to produce at least one rotational motion when executed by processor 7954 in response to user input 7958, such as input drive of second motor 7948. Program instructions can be stored that can drive the drive train associated with the components.

Controller 7952 and/or other controllers of this disclosure may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both. Examples of integrated hardware elements include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor devices, chips, microchips, chipsets, microcontrollers, system chip (SoC), and/or single in-line package (SIP). Examples of discrete hardware elements may include circuits and/or circuit elements such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and/or relays. In certain examples, controller 7952 may include a hybrid circuit that includes, for example, discrete and integrated circuit elements or components on one or more substrates.

In a particular example, controller 7952 and/or other controllers of this disclosure may be, for example, a LM 4F230H5QR available from Texas Instruments. In a particular example, Texas Instruments' LM4F230H5QR improves performance beyond 40 MHz, up to 256 KB of single-cycle flash memory or other non-volatile memory on-chip memory, among other readily available features. prefetch buffer, 32 KB single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, 12 An ARM Cortex-M4F processor core that includes one or more 12-bit ADCs with analog input channels. Other microcontrollers may be easily substituted for use with this disclosure. Therefore, the present disclosure should not be limited to this context.

In various examples, one or more of the various steps described herein can be performed by a finite state machine that includes either combinational logic circuits or sequential logic circuits; or sequential logic circuits are coupled to at least one memory circuit. At least one memory circuit stores a current state of the finite state machine. Combinatorial or sequential logic circuits are configured to provide finite state machines for these steps. Sequential logic circuits may be synchronous or asynchronous. In other examples, one or more of the various steps described herein may be performed by circuitry including, for example, a combination of processor 7958 and a finite state machine.

In various instances, it may be advantageous to be able to assess the functional status of a surgical instrument to ensure proper functioning. For example, drive mechanisms configured to include various motors, drive trains, and/or gear components to perform various operations of surgical instruments, such as those described above, wear out over time. It is possible that Although this may occur through normal use, in some instances the drive mechanism may wear out faster due to abuse conditions. In certain examples, a surgical instrument can be configured to perform a self-assessment to determine the condition, e.g., health, of the drive mechanism and its various components.

For example, using self-diagnosis to determine when a surgical instrument is capable of performing its function prior to resterilization, or when some of its components should be replaced and/or repaired. I can do it. Evaluation of drive mechanisms and their components, including but not limited to rotating drive train 7932, closed drive train 7934, and/or firing drive train 7936, can be accomplished in a variety of ways. The magnitude of deviation from predicted performance can be used to determine the probability of a sensed failure and the severity of such failure. Several metrics may be used, including periodic analysis of repeatably predictable events, peaks or drops above expected thresholds, and width of failures.

In various examples, characteristic waveforms of one or more of the properly functioning drive mechanism or its components are used to determine the state of the drive mechanism or one or more of its components. can be evaluated. The one or more vibration sensors are positioned relative to one or more of the properly functioning drive mechanism or its components to ensure that the properly functioning drive mechanism or its components Various vibrations occurring during one or more operations can be recorded. The recorded vibrations can be used to generate characteristic waveforms. Future waveforms can be compared to characteristic waveforms to assess the condition of the drive mechanism and its components.

With continued reference to FIG. 50, surgical instrument 7930 is configured to record and analyze one or more audible outputs of one or more of drive trains 7932, 7934, 7936. Includes drivetrain failure detection module 7962. Processor 7954 may communicate with or otherwise control module 7962. As described in more detail below, module 7962 comprises a computer readable medium (e.g., memory 7956) that stores computer readable program instructions executable by circuitry, hardware, processing equipment (e.g., processor 7954). It may be embodied in various means, such as a computer program product, or some combination thereof. In some aspects, processor 36 may include or otherwise control module 7962.

Referring now to FIG. 51, end effector 8400 includes RF data sensors 8406, 8408a, 8408b located on jaw member 8402. End effector 8400 includes a jaw member 8402 and an ultrasonic blade 8404. Jaw member 8402 is shown clamping tissue 8410 located between jaw member 8402 and ultrasonic blade 8404. A first sensor 8406 is located in the center of the jaw member 8402. A second sensor 8408a and a third sensor 8408b are located on the outer portion of jaw member 8402. Sensors 8406, 8408a, 8408b are attached to or integrally formed with a flexible circuit 8412 (more specifically shown in FIG. 52) that is configured to be fixedly attached to jaw member 8402.

End effector 8400 is an exemplary end effector for a surgical instrument. Sensors 8406, 8408a, 8408b are electrically connected to a control circuit, such as control circuit 7400 (FIG. 63), via an interface circuit. The sensors 8406, 8408a, 8408b are powered by batteries, and the signals generated by the sensors 8406, 8408a, 8408b are provided to analog and/or digital processing circuitry of the control circuit.

In one aspect, first sensor 8406 is a force sensor for measuring normal force F3 applied by jaw member 8402 to tissue 8410. A second sensor 8408a and a third sensor 8408b are one or more for applying RF energy to tissue 8410 and measuring tissue impedance, downward force F1, lateral force F2, and temperature, among other parameters. Contains two or more elements. Electrodes 8409a, 8409b are electrically coupled to an energy source and apply RF energy to tissue 8410. In one aspect, first sensor 8406 and second sensor 8408a and third sensor 8408b are strain gauges for measuring force or force per unit area. It will be appreciated that the measurements of downward force F1, lateral force F2, and normal force F3 can be easily converted to pressure by determining the surface area on which force sensors 8406, 8408a, 8408b act. Further, as described in detail herein, flexible circuit 8412 may include a temperature sensor embedded within one or more layers of flexible circuit 8412. One or more temperature sensors may be arranged symmetrically or asymmetrically to provide tissue 8410 temperature feedback to the control circuits of the ultrasound drive circuit and the RF drive circuit.

FIG. 52 illustrates one embodiment of the flexible circuit 8412 shown in FIG. 51 in which the sensors 8406, 8408a, 8408b can be attached to or integrally formed with the flexible circuit 8412. Flexible circuit 8412 is configured to be fixedly attached to jaw member 8402. As illustrated in FIG. 52, asymmetric temperature sensors 8414a, 8414b are attached to flexible circuit 8412 and allow the temperature of tissue 8410 (FIG. 51) to be measured.

FIG. 53 is an alternative system 132000 for controlling the frequency and detecting the impedance of an ultrasound electromechanical system 132002 in accordance with at least one aspect of the present disclosure. System 132000 may be incorporated into a generator. A processor 132004 coupled to memory 132026 programs programmable counter 132006 to tune to the output frequency _fo of ultrasound electromechanical system 132002. The input frequency is generated by a crystal oscillator 132008 and input to a fixed counter 132010 to scale the frequency to a suitable value. The outputs of fixed counter 132010 and programmable counter 132006 are applied to phase/frequency detector 132012. The output of the phase/frequency detector 132012 is applied to an amplifier/active filter circuit 132014 to generate a regulated voltage V _t that is applied to a voltage controlled oscillator 132016 (VCO). VCO 132016 applies an output frequency _fo to the ultrasound transducer portion of ultrasound electromechanical system 132002, which is modeled and shown herein as an equivalent electrical circuit. The voltage and current signals applied to the ultrasound transducer are monitored by voltage sensor 132018 and current sensor 132020.

The outputs of voltage sensor 132018 and current sensor 13020 are applied to another phase/frequency detector 132022 to determine the phase angle between the voltage and current measured by voltage sensor 132018 and current sensor 13020. The output of phase/frequency detector 132022 is applied to one channel of a high speed analog-to-digital converter 132024 (ADC) and provided therethrough to processor 132004. Optionally, the outputs of voltage sensor 132018 and current sensor 132020 are applied to respective channels of two-channel ADC 132024 to determine the phase angle between the voltage and current signals applied to ultrasound electromechanical system 132002. and may be provided to processor 132004 for zero crossing, FFT, or other algorithms described herein.

Optionally, the regulated voltage V _t that is proportional to the output frequency f _o may be fed back to the processor 132004 via the ADC 132024 . This provides a feedback signal to the processor 132004 that is proportional to the output frequency _fo , which feedback can be used to adjust and control the output frequency _fo .

Prediction of jaw condition (burned pads, staples, broken blades, bone in the jaw, tissue in the jaw)
A challenge with ultrasonic energy delivery is that ultrasonic sound is applied to the wrong material or the wrong tissue, which can result in device failure, such as burnout of the clamp arm pad or breakage of the ultrasonic blade. It is also desirable to detect what is located within the jaws of an end effector of an ultrasound device and the condition of the jaws without adding additional sensors within the jaws. Positioning sensors within the jaws of ultrasonic end effectors poses reliability, cost, and complexity challenges.

Impedance of an ultrasonic transducer configured to drive an ultrasonic transducer blade in accordance with at least one aspect of the present disclosure.

に基づいて、ジョーの状態（クランプアームパッドの燃焼、ステープル、破壊されたブレード、ジョー内の骨、ジョー内の組織、ジョーが閉じた状態でのバックカット）を推定するために、超音波分光スマートブレードアルゴリズム技術を用いてもよい。インピーダンスＺ_ｇ（ｔ）、規模｜Ｚ｜、及び位相φは、周波数ｆの関数としてプロットされる。

Ultrasonic spectroscopy to estimate the condition of the jaws (burned clamp arm pads, staples, broken blades, bone in the jaws, tissue in the jaws, backcut with the jaws closed) based on Smart blade algorithm techniques may also be used. Impedance Z _g (t), magnitude |Z|, and phase φ are plotted as a function of frequency f.

Dynamic mechanical analysis (DMA), also known as dynamic mechanical spectroscopy or simply mechanical spectroscopy, is a technique used to study and characterize materials. Applying a sinusoidal stress to a material and measuring the strain in the material allows the complex modulus of the material to be determined. Spectroscopy applied to ultrasound devices involves exciting the tip of an ultrasound blade with a sweep of frequencies (compound signal or conventional frequency sweep) and measuring the resulting complex impedance at each frequency. Complex impedance measurements of an ultrasound transducer over a range of frequencies are used in a classifier or model to infer properties of the ultrasound end effector. In one aspect, the present disclosure provides adaptive algorithms for determining the state of ultrasound end effectors (clamp arms, jaws) to automate automation within an ultrasound device (e.g., disabling power to protect the device). (e.g., implementing, retrieving information, identifying organizations, etc.).

FIG. 54 is a spectrum 132030 of an ultrasound device with various different states and conditions of the end effector, where impedance Z _g (t), magnitude |Z|, and phase, according to at least one aspect of the present disclosure. φ is plotted as a function of frequency f. The spectrum 132030 is plotted in three-dimensional space, where frequency (Hz) is plotted along the x-axis, phase (rad) is plotted along the y-axis, and magnitude (ohms) is plotted along the z-axis. be done.

Spectral analysis of different jaw occlusions and device conditions produces different complex impedance characteristic patterns (fingerprints) over a range of frequencies for different situations and conditions. Each state or situation has a different characteristic pattern in 3D space when plotted. These characteristic patterns may be used to estimate the situation and state of the end effector. FIG. 54 shows spectra of air 132032, clamp arm pad 132034, chamois 132036, staple 132038, and broken blade 132040. Chamois 132036 may be used to characterize different types of tissue.

Spectrum 132030 can be evaluated by applying a low power electrical signal across the ultrasound transducer to produce non-therapeutic excitation of the ultrasound blade. Applying a low-power electrical signal in the form of a swept or compound Fourier series, we use FFT to determine the impedance across an ultrasound transducer in a range of frequencies in series (sweep) or in parallel (combined signal).

を測定することができる。

can be measured.

New data classification methods For each characteristic pattern, parametric lines are fitted to the data used for training using polynomials, Fourier series, or any other form of parametric equations, as may be determined by convenience. can be done. New data points are received and classified by using the Euclidean vertical distance from the new data points to the trajectory fitted to the characteristic pattern training data. The vertical distance to each new data point's trajectory (each trajectory representing a different state or situation) is used to assign the point to a state or situation.

The probability distribution of the distance from each point in the training data to the fitted curve can be used to estimate the probability of a new data point being correctly classified. This essentially constructs a two-dimensional probability distribution in the plane perpendicular to the fitted trajectory at each new data point of the fitted trajectory. New data points are then included in the training set based on their probability of correct classification, which easily detects high frequency changes in condition, but introduces deviations in system performance, such as dirty equipment or worn pads. An adaptive learning classifier can be created that adapts to delay the .

FIG. 55 is a graphical illustration of a plot 132042 of a 3D training data set (S), in which the impedance Z _g (t), magnitude |Z|, and phase of an ultrasound transducer, according to at least one aspect of the present disclosure. φ is plotted as a function of frequency f. The 3D training dataset (S) plot 132042 is graphically displayed in three-dimensional space, where phase (rad) is plotted along the x-axis, frequency (Hz) is plotted along the y-axis, and magnitude ( Ohms) are plotted along the z-axis and a parametric Fourier series is fitted to the 3D training data set. The method for classifying the data is based on a 3D training dataset (S0 is used to generate plot 132042).

The parametric Fourier series fitted to the 3D training dataset (S) is given by:

What's new

について、

about,

での垂直距離は、以下によって見出される。

The vertical distance at is found by:

以下の場合、

In the following cases,

すると、

Then,

Data points belonging to group S using the probability distribution of D

の確率を推定することができる。

It is possible to estimate the probability of

Control Based on the classification of the data measured before, during or after activation of the ultrasonic transducer/ultrasonic blade, various automatic tasks and safety measures can be implemented. Similarly, the state of the tissue located within the end effector and the temperature of the ultrasound blade may also be estimated to some extent and may be used to better inform the user of the state of the ultrasound device or to protect critical structures, etc. You can also do it. Temperature control of ultrasonic blades is described in commonly owned U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC," which is incorporated herein by reference in its entirety. DEVICE AND CONTROL SYSTEM THEREFOR”.

Similarly, when the ultrasonic blade is likely to contact the clamp arm pad (e.g., there is no tissue in between), or if the ultrasonic blade is broken or the ultrasonic blade touches metal (e.g., staples). If there is a possibility of touching, power delivery can be reduced. Additionally, backcutting can be disabled if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad.

Integration of other data to improve classification The system uses probability functions and Kalman filters to combine data from this process with previously described data such as sensor, user, patient metrics, environmental factors, etc. May be used in conjunction with other information provided by. A Kalman filter determines the maximum likelihood of a state or situation occurring, taking into account a variety of uncertain measurements of reliability. Since this method allows the assignment of probabilities to newly classified data points, the information in this algorithm can be implemented using other measurements or estimates within the Kalman filter.

FIG. 56 is a logic flow diagram 132044 illustrating a control program or logic configuration for determining jaw conditions based on a complex impedance characteristic pattern (fingerprint) in accordance with at least one aspect of the present disclosure. Before determining the jaw conditions based on the complex impedance characteristic pattern (fingerprint), the database is populated with air 132032, clamp arm pad 132034, chamois 132036, staple 132038, broken blade 132040, and A reference complex impedance characteristic pattern or training data set (S) is populated that characterizes a variety of jaw conditions, including, but not limited to, various tissue types and conditions. Chamois, whether dry or wet, whole bite or tip, may be used to characterize different types of tissue. The data points used to generate the reference complex impedance characteristic pattern or training data set (S) are determined by applying a subtherapeutic drive signal to the ultrasound transducer and increasing the drive frequency to a predetermined range from below resonance to above resonance. It is obtained by sweeping over a frequency range, measuring the complex impedance at each of the frequencies, and recording the data points. The data points are then fitted to a curve using various numerical methods including polynomial curve fitting, Fourier series, and/or parametric equations. A parametric Fourier series fitted to a reference complex impedance characteristic pattern or training data set (S) is described herein.

Once the reference complex impedance characteristic pattern or training data set (S) is generated, the ultrasound instrument measures new data points, classifies these new data points, and assigns the new data points to the reference complex impedance characteristic pattern. or decide whether to add it to the training dataset (S).

Referring now to the logic flow diagram of FIG. 56, in one aspect, the processor or control circuit measures the complex impedance of the ultrasound transducer (132046). Here, the complex impedance is

として定義される。プロセッサ又は制御回路は、複素インピーダンス測定データ点を受信し（１３２０４８）、複素インピーダンス測定データ点を基準複素インピーダンス特性パターン内のデータ点と比較する（１３２０５０）。プロセッサ又は制御回路は、比較分析の結果に基づいて複素インピーダンス測定データ点を分類し（１３２０５２）、比較分析の結果に基づいてエンドエフェクタの状態又は状況を割り当てる（１３２０５４）。

is defined as The processor or control circuit receives the complex impedance measurement data points (132048) and compares the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern (132050). The processor or control circuit classifies the complex impedance measurement data points based on the results of the comparative analysis (132052) and assigns a state or status of the end effector based on the results of the comparative analysis (132054).

In one aspect, a processor or control circuit receives a reference complex impedance characteristic pattern from a database or memory coupled to the processor. In one aspect, a processor or control circuit generates a reference complex impedance characteristic pattern as follows. A drive circuit coupled to the processor or control circuit applies a non-therapeutic drive signal to the ultrasound transducer starting at an initial frequency, ending at a final frequency, and occurring at multiple frequencies therebetween. A processor or control circuit measures the impedance of the ultrasound transducer at each frequency and stores data points corresponding to each impedance measurement. A processor or control circuit curve is fitted to the plurality of data points to produce a three-dimensional curve representing a reference complex impedance characteristic pattern, where magnitude |Z| and phase φ are plotted as a function of frequency f. . Curve fitting includes polynomial curve fitting, Fourier series, and/or parametric equations.

In one aspect, the processor or control circuit receives a new impedance measurement data point and uses a Euclidean vertical distance from the new impedance measurement data point to a trajectory fitted to a reference complex impedance characteristic pattern to determine the new impedance measurement data point. Classify impedance measurement data points. A processor or control circuit estimates the probability that the new impedance measurement data point will be correctly classified. A processor or control circuit adds the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point. In one aspect, the processor or control circuit classifies the data based on a training data set (S), the training data set (S) includes a plurality of complex impedance measurements, and the curve is classified using a parametric Fourier series. is fitted to a training dataset (S), S is defined herein, and a probability distribution is used to estimate the probability of a new impedance measurement data point belonging to group S.

State of the Model-Based Jaw Classifier There is existing interest in classifying materials located within the jaws of ultrasound devices, including tissue type and status. In various aspects, it may be shown that this classification is possible using advanced data sampling and sophisticated pattern recognition. This approach is based on impedance as a function of frequency, where magnitude, phase, and frequency are plotted in 3D, and the pattern is as shown in FIGS. 54 and 55 and the logic flow diagram of FIG. It looks like Ribbon-sama. The present disclosure provides an alternative smart blade algorithm approach based on the well-established model of piezoelectric transducers.

As an example, an equivalent electrical lumped constant model is known to be an accurate model of a physical piezoelectric transducer. This is based on the Mittakrefler extension of the tangent around the mechanical resonance. When the complex impedance or complex admittance is plotted as an imaginary component versus a real component, a circle is formed. FIG. 57 is a circle plot 132056 of complex impedance plotted as imaginary versus real components of a piezoelectric vibrator, in accordance with at least one aspect of the present disclosure. FIG. 58 is a circle plot 132058 of the complex admittance plotted as the imaginary component versus the real component of a piezoelectric vibrator, in accordance with at least one aspect of the present disclosure. The circles shown in Figures 57 and 58 are taken from the IEEE 177 standard, which is incorporated herein by reference in its entirety. Tables 1-4 are taken from the IEEE 177 standard and are disclosed herein for completeness.

This circle is created when the frequency is swept from below resonance to above resonance. Rather than stretching the circle in 3D, we identify the circle and estimate its radius (r) and offset (a, b). These values are then compared to the values established for the given conditions. These conditions may be 1) open and empty in the jaws, 2) tip occlusion, and 3) full occlusion and staples in the jaws. If the sweep produces multiple resonances, there will be circles with different characteristics for each resonance. Each circle will be drawn before proceeding if the resonance is isolated. Rather than fitting a 3D curve with a series of approximations, we fit a circle to the data. The radius (r) and offset (a, b) can be calculated using a processor programmed to implement various mathematical or numerical techniques described below. These values are estimated by capturing an image of the circle and using image processing techniques to estimate the radius (r) and offset (a, b) that define the circle.

FIG. 59 is a circle plot 132060 of complex admittance for a 55.5 kHz ultrasonic piezoelectric transducer for lumped constant inputs and outputs specified below. The values for the lumped constant model were used to generate the complex admittance. A moderate load was applied to the model. The resulting admittance circle generated in MathCad is shown in FIG. Circle plot 132060 is formed when the frequency is swept from 54 to 58 kHz.

The lumped constant input values are as follows.
Co=nF
Cs=8.22pF
Ls=1.0H
Rs=450Ω

The output of the model based on the input is:

The output values are used to plot the circle plot 132060 shown in FIG. Circle plot 132060 has a radius (r) and center 132062 is offset from origin 132064 (a, b).
r=1.012 ^* 10 ³
a=1.013 ^* 10 ³
b=-954.585

The summations AE specified below are necessary to estimate the example circle plot 132060 plot given in FIG. 59, according to at least one aspect of this disclosure. Several algorithms exist to calculate the fit to a circle. A circle is defined by its radius (r) and the offset of its center from the origin (a, b).
r ² = (x-a) ² + (y-b) ²

The modified least squares method (Umbach and Jones) is useful in that there are simple closed-form solutions for a, b, and r.

The caret above the variable "a" indicates the estimate of the true value. A, B, C, D, and E are the sums of various products calculated from the data. These are included herein for completeness as follows.

Ｚ１，ｉは、コンダクタンスと称される実数成分の第１のベクトルであり、
Ｚ２，ｉは、サセプタンスと称される虚数成分の第２であり、
Ｚ３，ｉは、アドミッタンスが計算される周波数を表す第３のベクトルである。

Z1,i is the first vector of real components called conductance,
Z2,i is the second imaginary component called susceptance,
Z3,i is the third vector representing the frequency at which admittance is calculated.

The present disclosure works for ultrasound systems and may be applicable to electrosurgical systems even if the electrosurgical system does not rely on resonance.

60-64 show images obtained from an impedance analyzer showing impedance/admittance circle plots of the ultrasound device with the end effector jaws in various open or closed configurations and loads. In accordance with at least one aspect of the present disclosure, a solid circle plot indicates impedance and a dashed circle plot indicates admittance. As an example, an impedance/admittance circle plot is generated by connecting an ultrasound device to an impedance analyzer. The display of the impedance analyzer is set to complex impedance and complex admittance, which may be selectable from the front panel of the impedance analyzer. The initial display may be obtained with the ultrasound end effector jaws in an open position and the ultrasound device in an unloaded state, for example, as described below in connection with FIG. 60. The autoscale display feature of the impedance analyzer may be used to generate both complex impedance circle plots and complex admittance circle plots. The same display is used for subsequent runs of the ultrasound device with different loading conditions, as shown in subsequent FIGS. 60-64. Data files may be uploaded using the LabVIEW application. In another technique, the display image may be captured with a camera, such as a smartphone camera such as an iPhone or Android. As such, the display image may contain some "keystone distortion" and may not generally appear parallel to the screen. Using this technique, the circle plot trace on the display will appear distorted in the captured image. This approach allows the material located within the jaws of an ultrasonic end effector to be classified.

Complex impedance and complex admittance are exact reciprocals of each other. No new information should be added by looking at both. Another consideration includes determining how sensitive the estimate is to noise when using complex impedance or complex admittance.

In the examples shown in Figures 60-64, the impedance analyzer is set at a range that simply captures the main resonance. By scanning over a wider range of frequencies, more resonances can be encountered and multiple circle plots can be formed. An equivalent circuit for an ultrasound transducer consists of a first "motion" branch with an inductance Ls, a resistance Rs, and a capacitance Cs connected in series, defining the electrosurgical properties of the resonator, and a capacitance C0. A second capacity branch may be modeled. In the impedance/admittance plots shown in subsequent FIGS. 60-64, the values of the components of the equivalent circuit are as follows.
Ls=L1=1.1068H
Rs=R1=311.352Ω
Cs=C1=7.43265pF
C0=C0=3.64026nF

The oscillator voltage applied to the ultrasound transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500 μS/div. Measurements of values that may characterize the impedance (Z) and admittance (Y) circular plots may be taken at locations on the circular plot indicated by the impedance cursor and admittance cursor.

Jaw Condition: Unloaded and Open FIG. 60 is a complex impedance (Z)/admittance (Y) circular plot of an ultrasound device with jaws open and no load, according to at least one aspect of the present disclosure. 132066 is a graphical representation of an impedance analyzer showing 132068, 132070, with the solid circle plot 132068 indicating complex impedance and the dashed circle plot 132070 indicating complex admittance. The oscillator voltage applied to the ultrasound transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500 μS/div. Measurements of values that may characterize the complex impedance (Z) and admittance (Y) circular plots 132068, 132070 may be taken at positions on the circular plots 132068, 132070 indicated by impedance cursors 132072 and admittance cursors 132074. Thus, impedance cursor 132072 is located on a portion of impedance circle plot 132068 that is equal to approximately 55.55 kHz, and admittance cursor 132074 is located on a portion of admittance circle plot 132070 that is equal to approximately 55.29 kHz. As shown in FIG. 60, the position of the impedance cursor 132072 corresponds to the following values.
R=1.66026Ω
X=-697.309Ω
In the formula, R is resistance (real value) and X is reactance (imaginary value). Similarly, the position of the admittance cursor 132074 corresponds to the following values.
G=64.0322μS
B=1.63007mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Jaw Condition: Clamped on a Dry Chamois FIG. 61 shows the complex impedance (Z)/ 132076 is a graphical representation of an impedance analyzer showing admittance (Y) circle plots 132078, 132080, with impedance circle plot 132078 shown as a solid line and admittance circle plot 132080 shown as a dashed line. The voltage applied to the ultrasound transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500 μS/div.

Measurements of values that may characterize the complex impedance (Z) and admittance (Y) circular pots 132078, 132080 may be taken at positions on the circular plots 132078, 132080 indicated by impedance cursors 132082 and admittance cursors 132084. Thus, impedance cursor 132082 is located on a portion of impedance circle plot 132078 that is equal to approximately 55.68 kHz, and admittance cursor 132084 is located on a portion of admittance circle plot 132080 that is equal to approximately 55.29 kHz. As shown in FIG. 61, the position of the impedance cursor 132082 corresponds to the following values.
R=434.577Ω
X=-758.772Ω
In the formula, R is resistance (real value) and X is reactance (imaginary value). Similarly, the position of the admittance cursor 132084 corresponds to the following values.
G=85.1712μS
B=1.49569mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Jaw Condition: Tip Clamped on Wet Chamois Figure 62 shows the complex impedance (Z) of an ultrasound device with jaw tips clamped on a wet chamois, according to at least one aspect of the present disclosure. is a graphical representation 132086 of an impedance analyzer showing /admittance (Y) circle plots 132098, 132090, with impedance circle plot 132088 shown as a solid line and admittance circle plot 132090 shown as a dashed line. The voltage applied to the ultrasound transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500 μS/div.

Measurements of values that may characterize the complex impedance (Z) and complex admittance (Y) circular plots 132088, 132090 may be taken at positions on the circular plots 132088, 132090 indicated by impedance cursors 132092 and admittance cursors 132094. Thus, impedance cursor 132092 is located on a portion of impedance circle plot 132088 that is equal to approximately 55.68 kHz, and admittance cursor 132094 is located on a portion of admittance circle plot 132090 that is equal to approximately 55.29 kHz. As shown in FIG. 63, the impedance cursor 132092 corresponds to the following values.
R=445.259Ω
X=-750.082Ω
In the formula, R is resistance (real value) and X is reactance (imaginary value). Similarly, admittance cursor 132094 corresponds to the following values.
G=96.2189μS
B=1.50236mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Jaw Condition: Fully Clamped on a Wet Chamois FIG. 63 shows the complex impedance (Z) of an ultrasound device with jaws fully clamped on a wet chamois, according to at least one aspect of the present disclosure. is a graphical representation 132096 of an impedance analyzer showing /admittance (Y) circle plots 132098, 132100, with impedance circle plot 132098 shown as a solid line and admittance circle plot 132100 shown as a dashed line. The voltage applied to the ultrasound transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200Ω/div and the admittance (Y) scale is 500 μS/div.

Measurements of values that may characterize the impedance and admittance circle plots 132098, 132100 may be taken at positions on the circle plots 132098, 1332100 indicated by the impedance cursor 13212 and the admittance cursor 132104. Thus, impedance cursor 132102 is located on a portion of impedance circle plot 132098 that is equal to approximately 55.63 kHz, and admittance cursor 132104 is located on a portion of admittance circle plot 132100 that is equal to approximately 55.29 kHz. As shown in FIG. 63, the impedance cursor 132102 corresponds to the values of resistance R (real value, not shown) and reactance X (imaginary value, not shown).

Similarly, admittance cursor 132104 corresponds to the following values.
G=137.272μS
B=1.48481mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Jaw Condition: Open with No Load FIG. 64 is a graphical representation 132106 of an impedance analyzer showing an impedance (Z)/admittance (Y) circular plot, in accordance with at least one aspect of the present disclosure, where the frequency is The area designated by rectangle 132108, swept from 48 kHz to 62 kHz and shown as a dashed line, to capture the multiple resonances of the ultrasound device with open jaws and no load, is shown as an impedance circle plot shown as a solid line. 132110a, 132110b, 132110c, and admittance circle plots 132112a, 132112b, 132112c are made easier to see. The voltage applied to the ultrasound transducer is 500 mV and the frequency is swept from 48 kHz to 62 kHz. The impedance (Z) scale is 500Ω/div and the admittance (Y) scale is 500 μS/div.

Measurements of values that may characterize impedance and admittance circle plots 132110a-c, 132112a-c are taken at positions on impedance and admittance circle plots 132110a-c, 132112a-c indicated by impedance cursor 132114 and admittance cursor 132116. may be done. Thus, impedance cursor 132114 is located on a portion of impedance circle plot 132110a-c equal to approximately 55.52 kHz, and admittance cursor 132116 is located on a portion of admittance circle plot 132112a-c equal to approximately 59.55 kHz. As shown in FIG. 64, the impedance cursor 132114 corresponds to the following values.
R=1.86163kΩ
X=-536.229Ω
In the formula, R is resistance (real value) and X is reactance (imaginary value). Similarly, admittance cursor 132116 corresponds to the following values.
G=649.956μS
B=2.51975mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Since there are only 400 samples across the sweep range of the impedance analyzer, there are only a few points for resonance. This causes the circle on the right to become choppy. However, this is only due to the impedance analyzer and the settings used to cover multiple resonances.

If multiple resonances are present, there is more information to improve the classifier. The fits of circle plots 132110a-c, 132112a-c may be computed for each as they are encountered to maintain fast execution of the algorithm. Therefore, if there is a intersection of complex admittances, meaning a circle, during the sweep, the fit can be calculated.

Benefits include an intra-jaw classifier based on data and well-known models for ultrasound systems. Counting and characterizing circles in visual systems is well known. Therefore, data processing is readily available. For example, to calculate the radius and axis offsets for a circle, a closed-form solution exists. This technique can be relatively fast.

Table 2 is a list of symbols used for lumped parameter models of piezoelectric transducers (from the IEEE 177 standard).

表３は伝送ネットワークの記号の一覧である（ＩＥＥＥ１７７規格から）。

Table 3 is a list of symbols for transmission networks (from the IEEE 177 standard).

^＊実数解を指し、複素根は無視する。

^* Refers to real solutions and ignores complex roots.

Table 4 is a list of solutions for various characteristic frequencies (from the IEEE 177 standard).

^＊実数解を指し、複素根は無視する
表５は、３種類の圧電材料の損失のリストである。

^* Refers to real solutions, ignoring complex roots Table 5 lists the losses of three types of piezoelectric materials.

様々な種類の圧電振動子について予想される比Ｑ^ｒ／ｒの最小値

Minimum value of ratio Q ^r /r expected for various types of piezoelectric vibrators

Table 6 is based on the real-time measurements of the complex impedance/admittance, the radius (rr) and offset (ar, br) of the reference circle represented by the reference variables Rref, Gref, Xref, Bref, as described in Figures 60-64. estimated parameters based on real-time measurements of complex impedance/admittance, radius (re) and offset (ae and be) of the circle represented by the measured variables Re, Ge, Xe, Be, and the parameters of the reference circle plot. These values are then compared to the values established for the given conditions. These conditions may be 1) empty and open in the jaws, 2) tip occlusion, and 3) full occlusion and staples in the jaws. An equivalent circuit of an ultrasonic transducer was modeled as follows, and the frequency was swept from 55 kHz to 56 kHz.
Ls=L1=1.1068H
Rs=R1=311.352Ω
Cs=C1=7.43265pF and C0=C0=3.64026nF.

In use, the ultrasound generator sweeps the frequency, records the measured variables, and determines the estimated Re, Ge, Xe, Be. These estimates are then compared to reference variables Rref, Gref, Xref, Bref stored in memory (eg, stored in a lookup table) to determine jaw conditions. The reference jaw conditions shown in Table 6 are merely examples. Additional or fewer reference jaw-like conditions may be classified and stored in memory. These variables can be used to estimate the radius and offset of the impedance/admittance circle.

FIG. 65 illustrates a control program or logic configuration configured to determine jaw conditions based on predictions of impedance/admittance circle radius (r) and offset (a, b) in accordance with at least one aspect of the present disclosure. 132120 is a logical flow diagram of a process illustrating the process. Initially, a database or lookup table is populated with reference values based on reference jaw conditions, as described in connection with FIGS. 60-64 and Table 6. A reference jaw condition is set and the frequency is swept from a value below resonance to a value above resonance. The reference values Rref, Gref, Xref, Bref that define the corresponding impedance/admittance circle plots are stored in a database or lookup table. In use, under the control of a control program or logic configuration, a processor or control circuit of the generator or instrument sweeps the frequency from below resonance to above resonance (132122). The processor or control circuit measures and records (132124) the variables Re, Ge, Xe, Be that define a corresponding impedance/admittance circle plot, and the reference values Rref, Gref, Xref, stored in a database or lookup table. Compare with Bref (132126). The processor or control circuit determines (132128), e.g., estimates, the status of the end effector jaws based on the results of the comparison.

Temperature Estimation FIGS. 66A-66B are graphical representations 133000, 133010 of composite impedance spectra of the same ultrasound device with cold (room temperature) and hot ultrasound blades in accordance with at least one aspect of the present disclosure. As used herein, a cold ultrasonic blade refers to an ultrasonic blade at room temperature, and a high temperature ultrasonic blade refers to an ultrasonic blade after it has been heated by friction during use. 66A is a graphical representation 133000 of the impedance phase angle φ as a function of resonant frequency _fo for the same ultrasonic device with cold and hot ultrasonic blades, and FIG. 66B is a graph of the same ultrasonic device with cold and hot ultrasonic blades. FIG. 133010 is a graphical representation of the impedance magnitude |Z| as a function of the resonant frequency f _o of an ultrasound device. The impedance phase angle φ and the impedance magnitude |Z| are minimum at the resonant frequency f _o .

The ultrasonic transducer impedance Z _g (t) can be measured as the ratio of the drive signal generator voltage V _g (t) and the current I _g (t) drive signal.

As shown in FIG. 66A, when the ultrasonic blade is at a low temperature, such as room temperature, and is not heated by friction, the electromechanical resonant frequency f _o of the ultrasonic device is approximately 55,500 Hz, and the ultrasonic transducer's The excitation frequency is set at 55,500Hz. Therefore, when the ultrasound transducer is excited at the electromechanical resonant frequency f _o and the ultrasound blade is cold, the phase angle φ is at a minimum or about 0 Rad, as shown by the cold blade plot 133002. As shown in FIG. 66B, when the ultrasonic blade is cold and the ultrasonic transducer is excited at the electromechanical resonant frequency _fo , the impedance magnitude |Z| is 800 Ω, for example, the impedance magnitude |Z| | is the minimum impedance and the drive signal amplitude is maximum due to the series resonant equivalent circuit of the ultrasonic electromechanical system shown in FIG.

Referring again to FIGS. 66A and 66B, an ultrasound transducer is driven at an electromechanical resonant frequency f _o of 55,500 Hz by a generator voltage V _g (t) signal and a generator current I _g (t) signal. then the phase angle φ between the generator voltage V _g (t) signal and the generator current I _g (t) signal is zero and the impedance magnitude |Z| is the minimum impedance, e.g. 800 Ω, The signal amplitude is at its peak or maximum due to the series resonant equivalent circuit of the ultrasound electromechanical system. As the temperature of the ultrasonic blade increases, the electromechanical resonant frequency _fo ' of the ultrasonic device decreases due to the frictional heat generated during use. Since the ultrasound transducer is still driven by the generator voltage V _g (t) signal and the generator current I _g (t) signal at the previous (cold blade) electromechanical resonance frequency fo of 55,500 Hz, the ultrasonic device operates off-resonance f _o ', causing a change in the phase angle φ between the generator voltage V _g (t) signal and the generator current I _g (t) signal. There is also an increase in the impedance magnitude |Z| and a decrease in the peak magnitude of the drive signal for the previous (cold blade) electromechanical resonant frequency of 55,500 Hz. Therefore, the temperature of the ultrasonic blade changes the phase angle φ between the generator voltage V _g (t) signal and the generator current I _g (t) signal to the electromechanical resonant frequency f due to the temperature change of the ultrasonic blade. It can be estimated by measuring the change in _o .

As mentioned above, an electromechanical ultrasound system includes an ultrasound transducer, a waveguide, and an ultrasound blade. As mentioned above, an ultrasound transducer has a first branch with a capacitance and a second "working" branch with a series connected inductance, resistance, and capacitance that define the electromechanical properties of the resonator. may be modeled as an equivalent series resonant circuit (see FIG. 25) including: Electromechanical ultrasound systems have an initial electromechanical resonant frequency defined by the physical properties of the ultrasound transducer, waveguide, and ultrasound blade. The ultrasound transducer is excited by an alternating voltage V _g (t) and current I _g (t) signal at an electromechanical resonant frequency, eg, a frequency equal to the resonant frequency of the electromechanical ultrasound system. When the electromechanical ultrasound system is excited at the resonant frequency, the phase angle φ between the voltage V _g (t) and current I _g (t) signals is zero.

Stated another way, at resonance, the similar inductive impedance of the electromechanical ultrasound system is equal to the similar capacitive impedance of the electromechanical ultrasound system. As the ultrasound blade heats up, for example due to frictional engagement with tissue, the compliance of the ultrasound blade (modeled as an equivalent capacitance) changes the resonant frequency of the electromechanical ultrasound system. In this example, as the temperature of the ultrasound blade increases, the resonant frequency of the electromechanical ultrasound system decreases. Therefore, the similar inductive impedance of the electromechanical ultrasound system is no longer equal to the similar capacitive impedance of the electromechanical ultrasound system, thereby changing the driving frequency and the new resonant frequency of the electromechanical ultrasound system. Inconsistency is caused between. Therefore, for hot ultrasonic blades, electromechanical ultrasonic systems operate "off-resonance." The mismatch between the drive frequency and the resonant frequency is manifested as a phase angle φ between the voltage V _g (t) and current I _g (t) signals applied to the ultrasound transducer.

As mentioned above, the generator electronics can easily monitor the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal applied to the ultrasound transducer. The phase angle φ can be calculated using Fourier analysis, weighted least squares estimation, Kalman filtering, space vector-based techniques, zero-crossing methods, Lissajous diagrams, three-voltmeter methods, crossed-coil methods, vector voltmeters, and vectors, among other techniques mentioned above. It can be determined by impedance methods, phase standard equipment, and phase locked loops. The generator can continuously monitor the phase angle φ and adjust the drive frequency until the phase angle φ is zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. Changes in phase angle φ and/or generator drive frequency can be used as indirect or inferential measurements of the temperature of the ultrasonic blade.

Various techniques are available for estimating temperature from these spectral data. Most notably, we employ a set of time-varying, nonlinear state-space equations over a range of generator drive frequencies to model the dynamic relationship between ultrasonic blade temperature and measured impedance. can,

ここで発生器駆動周波数の範囲は装置モデルに固有である。

The range of generator drive frequencies here is device model specific.

Method of Temperature Estimation One aspect of estimating or inferring the temperature of an ultrasonic blade may include three steps. First, we define a time- and energy-dependent temperature and frequency state-space model. To model temperature as a function of frequency content, a set of nonlinear state-space equations is used to model the relationship between the electromechanical resonant frequency and the temperature of the ultrasonic blade. Second, we apply a Kalman filter to improve the accuracy of the temperature estimator and state-space model over time. Third, a state estimator is provided in the feedback loop of the Kalman filter to control the power applied to the ultrasonic transducer and thus the ultrasonic blade to adjust the temperature of the ultrasonic blade. The three steps are described below.

Process 1
The first step is to define a time- and energy-dependent temperature and frequency state-space model. To model temperature as a function of frequency content, a set of nonlinear state-space equations is used to model the relationship between the electromechanical resonant frequency and the temperature of the ultrasonic blade. In one aspect, the state-space model is given by the following equation:

The state-space model describes the natural frequencies of an electromechanical ultrasound system with respect to natural frequencies F _n (t), temperature T(t), energy E(t), and time t.

の変化率及び超音波ブレードの温度

rate of change and temperature of ultrasonic blade

の変化率を表す。

represents the rate of change.

は、電気機械的超音波システムの固有周波数Ｆ_ｎ（ｔ）、超音波ブレードの温度Ｔ（ｔ）、超音波ブレードに印加されるエネルギーＥ（ｔ）、及び時間ｔなどの測定可能かつ観察可能な変数の可観測性を表す。超音波ブレードの温度Ｔ（ｔ）は、推定値として観察可能である。

are measurable and observable factors such as the natural frequency F _n (t) of the electromechanical ultrasound system, the temperature T(t) of the ultrasound blade, the energy E(t) applied to the ultrasound blade, and the time t. represents the observability of variables. The temperature T(t) of the ultrasonic blade is observable as an estimate.

Process 2
The second step is to apply a Kalman filter to improve the temperature estimator and state space model. FIG. 67 is an illustration of a Kalman filter 133020 for improving the impedance-based temperature estimator and state-space model according to Eq.

これは、本開示の少なくとも１つの態様による、様々な周波数で測定された超音波トランスデューサにわたるインピーダンスを表す。

This represents the impedance across the ultrasound transducer measured at various frequencies in accordance with at least one aspect of the present disclosure.

Kalman filter 133020 may be used to improve temperature estimation performance, allowing augmentation of external sensors, models, or prior information to improve temperature prediction in noisy data. Kalman filter 133020 includes a regulator 133022 and a plant 133024. In control theory, a plant 133024 is a combination of processes and actuators. Plant 133024 may be referred to as a transfer function that describes the relationship between the input and output signals of the system. Regulator 133022 includes a state estimator 133026 and a controller K133028. State regulator 133026 includes feedback loop 133030. State regulator 133026 receives as inputs y, the output of plant 133024, and feedback variable u. State estimator 133026 is an internal feedback system that converges to the true value of the state of the system. The output of the state estimator 133026 is

であり、完全なフィードバック制御変数は、電気機械的超音波システムのＦ_ｎ（ｔ）、超音波ブレードの温度の推定値Ｔ（ｔ）、超音波ブレードに印加されるエネルギーＥ（ｔ）、位相角φ、及び時間ｔを含む。コントローラＫ１３３０２８への入力はｘであり、コントローラＫ１３３０２８の出力ｕは、状態推定器１３３０２６及びプラント１３３０２４のｔにフィードバックされる。

, and the complete feedback control variables are F _n (t) of the electromechanical ultrasound system, an estimate of the temperature of the ultrasound blade T(t), the energy applied to the ultrasound blade E(t), and the phase It includes the angle φ and the time t. The input to controller K133028 is x, and the output u of controller K133028 is fed back to state estimator 133026 and t of plant 133024.

Kalman filtering, also known as Linear Quadratic Estimation (LQE), uses a set of measurements observed over time, including statistical noise and other inaccuracies, to create a joint probability distribution over the variables in a single time window. is an algorithm that generates estimates of unknown variables that tend to be more accurate than those based on a single measurement alone, by estimating and thus calculating the maximum likelihood estimate of the actual measurements. . The algorithm works in a two-step process. In the prediction step, Kalman filter 133020 produces estimates of the current state variables along with their uncertainties. As the results of the next measurement are observed (inevitably corrupted by some amount of error, including random noise), these estimates are updated using a weighted average, and for higher certainty estimates given higher weight. The algorithm is recursive and can be executed in real time using only the current input measurements and previously calculated states and their uncertainty matrices; no additional historical information is required.

The Kalman filter 133020 uses a dynamic model of an electromechanical ultrasound system, known control inputs to that system, and the natural frequency and phase angle of the signal applied to the ultrasound transducer (e.g., the magnitude of the electrical impedance of the ultrasound transducer). The ultrasonic blade portion of the electromechanical ultrasonic system by using multiple continuous measurements (observations) of the amplitude and phase of the electromechanical ultrasonic system to form estimates of the changing quantities (its state) of the electromechanical ultrasonic system. , which is better than the estimate obtained using only one measurement. Therefore, the Kalman filter 133020 is an algorithm that includes sensors and data fusion to provide a maximum likelihood estimate of the temperature of the ultrasonic blade.

The Kalman filter 133020 effectively handles the uncertainty due to noisy measurements of the signal applied to the ultrasound transducer to measure the natural frequency and phase shift data, and also handles the uncertainty due to random external factors. Handle sexuality effectively. Kalman filter 133020 produces an estimate of the state of the electromechanical ultrasound system as the average of the predicted state of the system and the new measurements using a weighted average. Weighted values provide a better (ie, smaller) estimated uncertainty and are more "reliable" than unweighted values. The weights may be calculated from the covariance, which is a measure of the estimated uncertainty of the prediction of the system state. The result of the weighted average is a new state estimate that lies between the predicted and measured states and has a better estimated uncertainty than either alone. This process is repeated for every time step, and the new estimates and their covariances provide the predictions used in subsequent iterations. This recursive nature of the Kalman filter 133020 requires only the last "best guess" rather than the entire history of states of the electromechanical ultrasound system to calculate new states.

The relative certainty of measurements and current state estimates is an important consideration, and it is common to discuss the response of the filter with respect to the gain K of the Kalman filter 133020. Kalman gain K is the relative weight given to measurements and current state estimates, and can be "tuned" to achieve particular performance. For a high gain K, the Kalman filter 133020 places more weight on the most recent measurements and therefore follows them more responsively. For low gain K, Kalman filter 133020 follows the model predictions more closely. At the extremes, a high gain near unity results in a more variable estimated trajectory, and a low gain near zero removes noise but reduces responsiveness.

When performing the actual calculations of the Kalman filter 133020 (as described below), the state estimates and covariances are encoded into a matrix to handle the multiple dimensions involved in a single set of calculations. This allows the expression of linear relationships between various state variables (such as position, velocity, and acceleration), either in the transition model or in covariance. The use of Kalman filter 133020 does not assume that the errors are Gaussian. However, Kalman filter 133020 yields accurate conditional probability estimates in the special case where all errors are Gaussian distributed.

Process 3
The third step uses the state estimator 133026 in the feedback loop 133032 of the Kalman filter 133020 to control the power applied to the ultrasound transducer and thus the ultrasound blade to adjust the temperature of the ultrasound blade. .

FIG. 68 is a graphical representation 133040 of three probability distributions employed by the state estimator 133026 of the Kalman filter 133020 shown in FIG. 67 to maximize estimates, in accordance with at least one aspect of the present disclosure. The probability distributions include a prior probability distribution 133042, a predicted (state) probability distribution 133044, and an observed probability distribution 133046. Three probability distributions 133042, 133044, 1330467 represent power applied to an ultrasound transducer to adjust temperature based on impedance across the ultrasound transducer measured at various frequencies, according to at least one aspect of the present disclosure. used for feedback control. The estimator used for feedback control of the power applied to the ultrasound transducer to regulate temperature based on impedance is given by the following equation:

これは、本開示の少なくとも１つの態様による、様々な周波数で測定された超音波トランスデューサにわたるインピーダンスである。

This is the impedance across the ultrasound transducer measured at various frequencies in accordance with at least one aspect of the present disclosure.

The prior probability distribution 133042 includes state fluctuations defined by the following equation.

state fluctuation

は、予測（状態）確率分布１３３０４４として表されるシステムの次の状態を予測するために使用される。観測確率分布１３３０４６は、観測分散σ_ｍが以下の式によって付与されるゲインを定義するために用いられる、システム状態の実際の観測値の確率分布である。

is used to predict the next state of the system, represented as a predicted (state) probability distribution 133044. Observation probability distribution 133046 is the probability distribution of the actual observed values of the system state, where the observation variance σ _m is used to define the gain given by the following equation.

Feedback Control Power input is reduced to ensure that the temperature (estimated by the state estimator and Kalman filter) is controlled.

In one aspect, an initial proof of concept assumed a static linear relationship between the natural frequency of the electromechanical ultrasound system and the temperature of the ultrasound blade. By reducing the power as a function of the natural frequency of the electromechanical ultrasound system (ie, adjusting the temperature with feedback control), the temperature of the ultrasound blade tip can be directly controlled. In this example, the temperature of the distal tip of the ultrasonic blade may be controlled to not exceed the melting point of the Teflon pad.

FIG. 69A is a graphical representation 133050 of temperature versus time for an ultrasound device without temperature feedback control. The temperature of the ultrasonic blade (°C) is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. The test was carried out using a chamois placed in the jaws of an ultrasound machine. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade was excited at a resonant frequency while in frictional engagement with the chamois clamped between the ultrasonic blade and the clamp arm. Over time, the temperature (°C) of the ultrasonic blade increases due to the frictional engagement with the chamois. Over time, the temperature profile 133052 of the ultrasonic blade increases until the chamois sample is cut at a temperature of 220° C. after about 19.5 seconds, as shown at point 133054. Without temperature feedback control, after the chamois sample is cut, the temperature of the ultrasonic blade increases well above the melting point of TEFLON, about 380°C, up to a temperature of about 490°C. At point 133056, the ultrasonic blade temperature reaches a maximum temperature of 490° C. until the TEFLON pad completely melts. The temperature of the ultrasonic blade decreases slightly from the peak temperature at point 133056 after the pad has completely disappeared.

FIG. 69B is a plot of temperature versus time for an ultrasound device with temperature feedback control, according to at least one aspect of the present disclosure. The temperature of the ultrasonic blade (°C) is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. The test was carried out with a chamois sample placed in the jaws of an ultrasound machine. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade was excited at a resonant frequency while in frictional engagement with the chamois clamped between the ultrasonic blade and the clamp arm pad. Over time, the temperature profile 133062 of the ultrasonic blade increases until the chamois sample is cut at a temperature of 220° C. after about 23 seconds, shown at point 133064. With temperature feedback control, the temperature of the ultrasonic blade increases to a maximum temperature of about 380° C., just below the TEFLON melting point, indicated by point 133066, and then decreases to an average of about 330° C., generally indicated by region 133068. , thereby preventing the TEFLON pad from melting.

Application of smart ultrasonic blade technology When the ultrasonic blade is immersed in a fluid-filled surgical field, the ultrasonic blade cools down during activation and becomes less effective for sealing and cutting tissue in contact with it. It will be done. Cooling the ultrasonic blade may result in longer start-up times and/or hemostasis problems because not enough heat is delivered to the tissue. To overcome cooling of the ultrasonic blade, more energy delivery may be required to reduce transverse incision time and achieve suitable hemostasis under these fluid immersion conditions. Using a frequency-temperature feedback control system, the ultrasonic blade temperature is either started below a certain temperature or remains below a certain temperature for a certain period of time. If detected, the output power of the generator may be increased to offset the cooling due to blood/saline/other fluids present in the surgical field.

Accordingly, the frequency-temperature feedback control system described herein is useful for controlling ultrasound devices, particularly when the ultrasound blade is partially or fully positioned or immersed within a fluid-filled surgical field. Performance can be improved. The frequency-temperature feedback control system described herein minimizes potential problems with long start-up times and/or ultrasound device performance in fluid-filled surgical fields.

As mentioned earlier, the temperature of the ultrasonic blade can be determined by detecting the impedance of the ultrasonic transducer, which is given by the following equation:

あるいは同等に、超音波トランスデューサに印加される電圧Ｖ_ｇ（ｔ）信号と電流Ｉ_ｇ（ｔ）信号との間の位相角φを検出することによって推定することができる。位相角φの情報はまた、超音波ブレードの状態を推定するために使用されてもよい。本明細書で詳細に論じられるように、位相角φは、超音波ブレードの温度の関数として変化する。したがって、位相角φ情報は、超音波ブレードの温度を制御するために用いられてもよい。これは、例えば、超音波ブレードが過度に高温で動作しているときは超音波ブレードに送達される電力を低減し、超音波ブレードが過度に低温で動作しているときは超音波ブレードに送達される電力を増加させることによって行われ得る。図７０Ａ～図７０Ｂは、超音波ブレードの急激な温度低下が検出されたときに超音波トランスデューサに印加される超音波出力を調節するための温度フィードバック制御のグラフ図である。

Or equivalently, it can be estimated by detecting the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal applied to the ultrasound transducer. Phase angle φ information may also be used to estimate the state of the ultrasonic blade. As discussed in detail herein, the phase angle φ changes as a function of the temperature of the ultrasonic blade. Therefore, the phase angle φ information may be used to control the temperature of the ultrasonic blade. This, for example, reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at excessively high temperatures, and reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at excessively low temperatures. This can be done by increasing the power applied. 70A-70B are graphical illustrations of temperature feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a sudden temperature drop in the ultrasonic blade is detected.

FIG. 70A is a graphical illustration of ultrasound power 133070 as a function of time, in accordance with at least one aspect of the present disclosure. The power output of the ultrasound generator is shown along the vertical axis and time (in seconds) is shown along the horizontal axis. FIG. 70B is a graphical illustration of ultrasonic blade temperature 133080 as a function of time, in accordance with at least one aspect of the present disclosure. Ultrasonic blade temperature is shown along the vertical axis and time (in seconds) is shown along the horizontal axis. The temperature of the ultrasonic blade is increased by applying constant power 133072, as shown in FIG. 70A. During use, the temperature of the ultrasonic blade drops rapidly. This can be due to a variety of conditions, but during use, the temperature of the ultrasound blade when it is immersed in a fluid-filled surgical field (e.g. blood, saline, water, etc.) can be estimated to decrease. At time t ₀ , the temperature of the ultrasonic blade decreases below the desired minimum temperature 133082, and the frequency-temperature feedback control algorithm detects the decrease in temperature and increases the power ramp delivered to the ultrasonic blade. A power increase or "ramp up" indicated by 133074 is initiated to begin raising the temperature of the ultrasonic blade above the desired minimum temperature 133082.

Referring to FIGS. 70A and 70B, the ultrasonic generator outputs a substantially constant power 133072 as long as the ultrasonic blade temperature remains above the desired minimum temperature 133082. At t ₀ , the processor and/or control circuit of the generator or instrument detects that the temperature of the ultrasonic blade drops below the desired minimum temperature 133072 and initiates a frequency-temperature feedback control algorithm to Raise the temperature of the sonic blade above the lowest desired temperature 133082. Therefore, the power of the generator starts increasing at t ₁ (133074), which corresponds to the detection of a sudden drop in the temperature of the ultrasonic blade at t ₀ . Under the frequency-temperature feedback control algorithm, the power continues to increase (133074) until the ultrasonic blade temperature exceeds the desired minimum temperature 133082.

FIG. 71 is a process logic flow diagram 133090 illustrating a control program or logic configuration for controlling the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. According to this process, the processor and/or control circuit of the generator or instrument executes one aspect of the frequency-temperature feedback control algorithm described in connection with FIGS. 70A and 70B to control the ultrasonic transducer. A power level is applied (133092) to achieve the desired temperature in the ultrasonic blade. The generator monitors the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal applied to drive the ultrasound transducer (133094). Based on the phase angle φ, the generator estimates the temperature of the ultrasonic blade using the techniques described herein in connection with FIGS. 66A-68 (133096). The generator determines whether the temperature of the ultrasonic blade is less than a desired minimum temperature by comparing the estimated temperature of the ultrasonic blade to a predetermined desired temperature (133098). The generator then adjusts the power level applied to the ultrasound transducer based on the comparison. For example, when the ultrasonic blade temperature is above the desired minimum temperature, the process proceeds along the "no" branch, and when the ultrasonic blade temperature is below the desired minimum temperature, the process proceeds along the "yes" branch. Proceed. When the temperature of the ultrasonic blade is below a desired minimum temperature, the generator increases the power to the ultrasonic transducer, e.g. by increasing the voltage V _g (t) signal and/or the current I _g (t) signal. Increase the level (133100) to increase the temperature of the ultrasonic blade and continue to increase the power level applied to the ultrasonic transducer until the temperature of the ultrasonic blade increases and exceeds the lowest desired temperature.

Situational Awareness Referring now to FIG. 72, a timeline 5200 is shown illustrating situational awareness of a hub, such as surgical hub 106 or 206, for example. Timeline 5200 is an exemplary surgical procedure and the context information that the surgical hub 106, 206 may derive from the data it receives from the data sources at each step of the surgical procedure. Time line 5200 is taken by nurses, surgeons, and other medical personnel during the course of a segmental lung resection surgery, starting with setting up the operating room and ending with transferring the patient to the post-operative recovery room. A typical process is shown below.

The situational awareness surgical hub 106, 206 sources data including data generated each time a medical personnel uses a modular device paired with the surgical hub 106, 206 throughout the course of a surgical procedure. Receive from. The surgical hub 106, 206 receives this data from paired modular devices and other data sources and receives new data such as which steps of the procedure are being performed at any given time. Once performed, inferences (i.e., contextual information) regarding the ongoing procedure can be continuously derived. The situational awareness system of the surgical hub 106, 206 may, for example, record data regarding a procedure to generate a report, verify steps being taken by medical personnel, collect data that may be related to a particular procedure step, or providing prompts (e.g., via a display screen), adjusting the modular device based on context (e.g., activating a monitor, adjusting the field of view (FOV) of a medical imaging device, or ultrasonic surgical (such as changing the energy level of the instrument or the RF electrosurgical instrument), and any other such operations described above.

As a first step 5202 in this exemplary procedure, hospital personnel retrieve the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.

In the second step 5204, personnel scan incoming medical supplies for treatment. The surgical hub 106, 206 cross-references the scanned supplies with a list of supplies utilized in various types of procedures to ensure that the mix of supplies corresponds to the thoracic procedure. Additionally, the surgical hub 106, 206 may also determine that the procedure is not a wedge procedure (incoming supplies do not include certain supplies required for a thoracic wedge procedure, or otherwise (because they are either not compatible with cuneiform procedures).

In a third step 5206, the medical personnel scans the patient's band via a scanner communicatively connected to the surgical hub 106, 206. The surgical hub 106, 206 can then verify the patient's identity based on the scanned data.

In the fourth step 5208, medical staff turns on the auxiliary device. The auxiliary equipment utilized may vary according to the type of surgical procedure and the technique used by the surgeon, but in this illustrative case these include a smoke evacuation device, an inhaler, and a medical imaging device. Once activated, an auxiliary device that is a modular device may automatically pair with a surgical hub 106, 206 located within a particular proximity of the modular device as part of its initialization process. . The surgical hub 106, 206 can then derive contextual information regarding the surgical procedure by detecting the type of modular device with which it is paired during this pre-operative or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on a combination of data from the patient's EMR, the list of medical supplies used in the procedure, and the type of modular equipment that connects to the hub, the surgical hub 106, 206 generally determines the specific procedure that the surgical team will perform. It can be estimated. Once the surgical hub 106, 206 knows what particular procedure is being performed, the surgical hub 106, 206 can then read the steps for that procedure from memory or from the cloud and then connect to the surgical hub 106, 206. Data subsequently received from data sources (e.g., modular devices and patient monitoring devices) can be cross-referenced to infer which steps of the surgical procedure the surgical team is performing.

In a fifth step 5210, personnel attach EKG electrodes and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with the surgical hub 106, 206. When the surgical hub 106, 206 begins receiving data from the patient monitoring device, the surgical hub 106, 206 confirms that the patient is in the operating room.

In the sixth step 5212, the medical personnel induces anesthesia in the patient. The surgical hub 106, 206 may determine that the patient is under anesthesia based on data from the modular device and/or patient monitoring equipment, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. It can be estimated. Upon completion of the sixth step 5212, the preoperative portion of the lung segmentectomy surgery is complete and the surgical portion begins.

In the seventh step 5214, the patient's lung being manipulated is collapsed (while ventilation is switched to the contralateral lung). The surgical hub 106, 206 may, for example, infer from the ventilator data that the patient's lung has collapsed. The surgical hub 106, 206 can compare the detected collapse of the patient's lungs to the expected steps of the procedure (which can be accessed or read out in advance) so that the surgical portion of the procedure is It can be estimated that this has started, thereby determining that collapsing the lung is the first surgical step in this particular procedure.

In an eighth step 5216, a medical imaging device (eg, a scope) is inserted and video footage from the medical imaging device is initiated. The surgical hub 106, 206 receives medical imaging device data (ie, video or image data) through a connection to the medical imaging device. Upon receiving the medical imager data, the surgical hub 106, 206 may determine that the laparoscopic portion of the surgical procedure has begun. Further, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (based on data received in the second step 5204 of the procedure). Note that the wedge-shaped procedure is already discounted by the surgical hub 106, 206). Data from the medical imaging device 124 (FIG. 2) is used (i.e., activated and among many different methods, including by monitoring the number (or medical imaging devices) that are paired with the surgical hub 106, 206; and by monitoring the type of visualization device being used. can be used to determine contextual information regarding the type of procedure being performed. For example, one technique for performing a VATS lobectomy places the camera above the diaphragm in the anteroinferior corner of the patient's thoracic cavity, whereas one technique for performing a VATS segmentectomy places the camera is placed in the anterior intercostal position relative to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situational awareness system can be trained to recognize the location of a medical imaging device based on visualization of the patient's anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmentectomy utilizes multiple cameras. As yet another example, one technique for performing a VATS segmentectomy uses an infrared light source (which may be communicatively coupled to the surgical hub as part of the visualization system) to visualize the segmental cleft. , which is not used in VATS lobectomy. By tracking any or all of this data from medical imaging devices, the surgical hub 106, 206 can determine whether the surgical hub 106, 206 is performing a particular type of surgical procedure and/or is being used for a particular type of surgical procedure. technology can be determined.

In a ninth step 5218, the surgical team begins the incision step of the procedure. The surgical hub 106, 206 receives data from the RF or ultrasound generator indicating that the energy instrument is being fired, and therefore infers that the surgeon is in the process of dissecting and separating the patient's lungs. I can do it. The surgical hub 106, 206 cross-references the received data with the readout steps of the surgical procedure to determine the energy being delivered at this point in the process (i.e., after the steps of the procedure described above are completed). It can be determined that the instrument is compatible with the cutting process. In certain examples, the energy instrument may be an energy tool attached to a robotic arm of a robotic surgical system.

In a tenth step 5220, the surgical team proceeds to the ligation step of the procedure. The surgical hub 106, 206 receives data from the surgical stapling and cutting instruments indicating that the instruments are being fired, so it can assume that the surgeon is ligating the artery and vein. Similar to the previous step, the surgical hub 106, 206 can derive this estimate by cross-referencing the receipt of data from the surgical stapling and cutting instruments with steps in the process that have been read out. . In certain examples, the surgical instrument may be a surgical tool attached to a robotic arm of a robotic surgical system.

In the eleventh step 5222, the segmental excision portion of the procedure is performed. The surgical hub 106, 206 can estimate that the surgeon is transecting parenchymal tissue based on data from the surgical stapling and cutting instruments, including data from the cartridge. Cartridge data can correspond, for example, to the size or type of staples fired by the instrument. Because different types of staples are utilized on different types of tissue, the cartridge data can indicate the type of tissue being stapled and/or transected. In this case, the type of staple fired is used in the parenchymal tissue (or other similar tissue type) so that the surgical hub 106, 206 can assume that the segmental resection portion of the procedure is being performed. I can do it.

Subsequently, in a twelfth step 5224, a nodule dissection step is performed. The surgical hub 106, 206 may infer that the surgical team is dissecting the nodule and performing a leak test based on data received from the generator indicating that the RF or ultrasound instrument is being fired. I can do it. For this particular procedure, the RF or ultrasound instruments used after the parenchymal tissue is transected are compatible with a nodule dissection step that allows the surgical hub 106, 206 to make this estimate. It becomes possible. Because different instruments are better suited to specific tasks, surgeons routinely use surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic ) Please note the alternating between the instruments. Thus, the particular sequence in which the stapling/cutting instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. Additionally, in certain instances, a robotic tool may be used for one or more steps during a surgical procedure and/or a handheld surgical instrument may be used for one or more steps during a surgical procedure. can be used. The surgeon(s) may, for example, alternate between robotic tools and handheld surgical instruments, and/or may use the devices simultaneously, for example. Upon completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.

In a thirteenth step 5226, the patient's anesthesia is reversed. The surgical hub 106, 206 may estimate that the patient is emerging from anesthesia based on, for example, ventilator data (ie, the patient's breathing rate begins to increase).

Finally, the fourteenth step 5228 is for the medical personnel to remove the various patient monitoring devices from the patient. Therefore, the surgical hub 106, 206 can assume that the patient is being transferred to the recovery room when the hub loses the EKG, BP, and other data from the patient monitoring device. As can be seen from this exemplary procedure description, based on data received from various data sources communicatively coupled to the surgical hub 106, 206, the surgical hub 106, 206 performs a given surgical procedure. It is possible to determine or estimate when each step is occurring.

Situational awareness is further described in U.S. Provisional Patent Application No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety. In certain examples, the operation of a robotic surgical system, including, for example, the various robotic surgical systems disclosed herein, is based on its situational awareness and/or feedback from its components and/or from the cloud 102. may be controlled by the hub 106, 206 based on the information of the hub 106, 206.

Situational Awareness of Electrosurgical Systems Electrosurgical instruments are utilized to treat various types of tissue by applying energy to the tissue. As described in connection with FIGS. 22-24, electrosurgical instruments (e.g., surgical instruments 1104, 1106, 1108) may be connected to generator 1100 to grasp tissue and apply treatment to tissue. End effectors (eg, end effectors 1122, 1124, 1125) configured to transfer energy may also be included.

In various aspects, the end effector may be used to seal, weld, or coagulate tissue, such as a blood vessel, by applying energy to the blood vessel while being grasped by the end effector. Because blood vessels are generally surrounded by protective tissue, it is necessary to separate the tissue in order to expose the blood vessels to achieve an effective seal. However, tissue separation requires less energy than tissue sealing or coagulation. Additionally, the amount of tissue separated will vary depending on, for example, the anatomical location of the blood vessel, the condition of the tissue, and the type of surgery being performed.

One technique for treating tissue containing blood vessels involves separating and moving the inner muscular layer of the blood vessel away from the adventitial layer before sealing and/or cutting the blood vessel. To more effectively separate the tissue layers of a blood vessel, a low level of energy can be generated and delivered to the tissue that is sufficient to separate the tissue, but does not coagulate or seal. Subsequently, high level energy is used to seal or coagulate the tissue.

Successful energy treatment of tissue grasped by the end effector depends on selecting a suitable operating energy mode for each end effector closure phase. Additionally, the end effector closure stage may be determined by various situational parameters, such as, for example, tissue type, anatomical location, and/or composition. Various suitable situational parameters are described under the heading "Situational Awareness" in connection with FIG.

Aspects of the present disclosure present various processes for selecting different energy modes for different closure stages of an end effector of an electrosurgical instrument. The selection can be based, at least in part, on one or more situational parameters.

In various embodiments, the interaction of the tissue with the end effector during closure provides one or more situational parameters that may be useful in selecting or adjusting the energy mode for treating the tissue. . FIG. 73 shows end effector 131000 extending from shaft 131001 and undergoing a closing motion to grasp tissue "T". End effector 131000 includes a first jaw 131002 and a second jaw 131004. At least one of the first jaw 131002 and the second jaw 131004 is movable relative to the other to grasp tissue therebetween. In various aspects, the closing step includes one or more angular positions of the first jaw 131002 relative to the second jaw 131004, or one or more angular positions between the first jaw 131002 and the second jaw 131004. It may be defined by two or more angular distances.

In the example of FIG. 73, the first jaw 131002 connects the second jaw to clamp tissue between the jaws 131002, 131004, transitioning the end effector through different stages of closure between open and closed configurations. It is movable relative to 131004. Figure 73 shows two stages of closure. In the first closing phase, the first jaw 131002 is moved an angular distance θ1 from the open configuration.

The first closure stage is immediately followed by a second closure stage extending an angular distance θ2 from the open configuration of end effector 131000. Although only two closure stages are shown in the example of FIG. 73, end effectors according to the present disclosure may transition through more or less than two closure stages.

75A and 75B are schematic illustrations of end effector 131000 undergoing a closing motion to separate, seal, and cut tissue "T." In FIG. 75A, end effector 131000 is in a first phase of closure and initial contact with tissue "T" has been established. In FIG. 75B, the first jaw 131002 has completed the first closing phase and is about to begin the second closing phase.

Referring to FIG. 74, graph 131010 depicts a first treatment cycle 131012 applied to tissue "T" of FIGS. 75A and 75B. Time is represented on the x-axis and amplitude on the y-axis. The first treatment cycle 131012 includes an initial tissue separation energy mode that achieves tissue separation in a first closure phase by applying a first energy to tissue "T." The first treatment cycle 131012 further includes a tissue sealing energy mode that achieves tissue sealing by applying a second energy greater than the first energy to the tissue "T" in a second closure phase.

A second treatment cycle 131014 is also shown in graph 131010 of FIG. The second treatment cycle 131014 includes only tissue sealing energy modes. In other words, in the second treatment cycle 131014, the tissue sealing energy mode does not follow the initial tissue separation energy mode. The second treatment cycle 131014 is suitable for use in certain situations where tissue separation is not required.

FIG. 76 is a logic flow diagram of a process 131020 illustrating a control program or logic configuration for selecting an energy operating mode of an electrosurgical device in accordance with one aspect of the present disclosure. Process 131020 detects the closing phase of end effector 131000 (131022). Process 131020 further selects between energy modes that deliver different energy outputs based on the detected closure phase of end effector 131000 (131024). In one example, a first energy mode that delivers a first energy output is selected in the first closure phase, and a second energy mode that delivers a second energy output that is greater than the first energy output. selected in the second closure stage. The first energy output is sufficient to separate, but not seal, tissue "T", while the second energy output is sufficient to seal tissue "T".

In certain aspects, one or more of the processes of the present disclosure may be applied to, for example, control circuitry 710 of surgical instrument 700, control circuitry 760 of surgical instrument 750, and/or control circuitry of surgical instrument 790. 760 may be performed by an electrosurgical instrument's control circuitry. In certain aspects, as shown in FIG. , a microcontroller), the processor 502 may include at least one memory circuit 504 that stores program instructions that, when executed by the processor 502, cause the processor 502 to perform one or more of the processes. connected. Alternatively, one or more of the processes of this disclosure may be performed by one or more of the control circuits shown in FIGS. 14 and 15. In certain aspects, an electrosurgical instrument may include a non-transitory storage medium that stores one or more algorithms for performing one or more of the processes of this disclosure.

FIG. 77 is another logic flow diagram of process 131030 illustrating a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument. Process 131030 selects an operating mode from multiple operating modes that deliver different energy outputs based on sensor signals indicative of the closure phase of end effector 131000. In one example, the process of FIG. 77 is performed by a control circuit connected to one or more sensors configured to generate a sensor signal indicative of the closing phase of the end effector 131000. The sensor signal is received by a control circuit that selects an energy operating mode from operating modes that deliver different energy outputs based on the received sensor signal (131032). The control circuit, for example, determines whether the received sensor signal indicates that the end effector 131000 is in a first closure phase (131034). If so, the control circuit selects a first mode of operation to deliver a first energy output to tissue "T" (131036). If the received sensor signal does not indicate that the end effector is in the first closure stage, the control circuitry further determines whether the received sensor signal indicates that the end effector 131000 is in the second closure stage. Determine (131038). If so, the control circuit selects a second mode of operation to deliver a second energy output to tissue "T" that is greater than the first energy output (131039).

In various examples, the control circuit of the ultrasonic surgical instrument is configured to vary the magnitude of the ultrasonic energy output to the transducer in response to transition of the clamp member from the first closure phase to the second closure phase. configured.

In various examples, the control circuit is configured to correlate a change in magnitude of energy output to a transition from a first closure phase to a second closure phase. In various examples, the second energy output is sufficient to seal and coagulate the tissue, while the first energy output is sufficient to separate the tissue, but does not seal the tissue. Not enough to solidify. Although only two modes of energy operation are shown in the example of FIG. 77, electrosurgical instruments according to the present disclosure may include more or less than two modes of energy operation, each of which 131,000 corresponds to a predetermined closure stage. In various examples, the tissue separation mode is defined by an amplitude and/or frequency that is lower than the amplitude and/or frequency of the tissue coagulation and sealing mode.

FIG. 78 is another logic flow diagram of process 131040 illustrating a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument. Process 131040 is similar in many respects to the process of FIG. Additionally, the process 131040 determines when initial contact with tissue "T" is achieved while the first jaw 131002 moves through the closure phase between the open and closed configurations (see FIG. 75A). Decide (131042). More specifically, the selection between energy operating modes of the electrosurgical instrument is based on the closure phase at which initial contact with tissue "T" is detected.

In various aspects, initial tissue contact may be detected by a tissue contact circuit that includes a first jaw electrode and a second jaw electrode. A first jaw electrode is connected to one pole of the electrosurgical energy source and a second jaw electrode is connected to an opposite pole of the electrosurgical energy source. When tissue contacts the first and second jaw electrodes simultaneously, the tissue contacting circuit is in a closed configuration allowing non-therapeutic signals to pass between the jaws 131002, 131004. Thus, electrical continuity is established between the jaws 131002, 131004 with tissue located therebetween, and no electrical continuity is established between the jaws 131002, 131004 without tissue located therebetween.

In various aspects, initial tissue contact is achieved when the jaws 131002, 131004 exert sufficient compression on the tissue "T" captured between them to cause the sensing circuit "SC" to close.

FIG. 78A is a schematic diagram of an exemplary tissue contacting circuit showing the completion of the circuit when a pair of spaced apart contact plates are contacted with tissue. Contact of the jaws 131002, 131004 with tissue "T" is achieved by establishing contact with a pair of opposing plates "P1, P2" provided on the jaws 131002, 131004, which would otherwise be open sensing Close the circuit "SC". Closure of the sensing circuit "SC" sends a sensor signal to the control circuit (eg, FIGS. 13-14, 17-19). The sensor signal indicates that initial tissue contact has been established. FIG. 78A and additional illustrations are further described in U.S. Pat. , the entire disclosure of which is incorporated herein by reference.

FIG. 79 is another logical flow of process 131050 showing a control program or logic configuration for selecting an energy operating mode of an electrosurgical instrument based on the closure phase at which initial contact with tissue "T" is detected. It is a diagram. Process 131050 includes receiving (131052) first and second sensor signals. In one example, the process 131050 is performed by a control circuit connected to at least one first sensor configured to generate a sensor signal indicative of the closing phase of the end effector 131000 (e.g., FIGS. 13-14 , 17-19). The control circuit is also connected to at least one second sensor configured to generate a sensor signal indicative of detecting initial contact with tissue "T." Sensor signals from the first and second sensors are sent to a control circuit.

Process 131050 further determines whether the first sensor signal indicates that end effector 131000 is in a first closure phase (131054). If so, the process 131050 further determines whether the second sensor signal indicates that initial tissue contact has been established (131056).

If the first sensor signal indicates that the end effector 131000 is in the first closure phase and the second sensor signal indicates that initial tissue contact has been established, the first energy output is (131058). In one example, the control circuit selects a first mode of operation that causes a first energy output to be delivered to tissue "T" (131058).

Conversely, if the end effector 131000 is not in the first closure stage, the process 131050 further determines whether the end effector 131000 is in the second closure stage (131060). If so, process 131050 further determines whether the second sensor signal indicates that initial tissue contact has been established in the second closure phase (131062).

If the first sensor signal indicates that the end effector 131000 is in the second closure phase and the second sensor signal indicates that initial tissue contact has been established in the second closure phase, then the first A second energy output that is greater than the energy output is delivered to tissue "T" (131064). In one example, the control circuit selects a second mode of operation that causes a second energy output to be delivered to tissue "T" (131064).

In other words, detection of initial contact with tissue during the first closure phase causes the control circuit to deliver a first energy output to tissue "T" while detecting initial contact with tissue during the second closure phase. The detection causes the control circuit to deliver a second energy output to tissue "T". As described above, in various aspects, the second energy output is sufficient to seal and coagulate the tissue, while the first energy output is sufficient to separate the tissue, Not sufficient for tissue sealing and coagulation.

In various aspects, the closing phase may be defined by the angular position or range of angular positions of the first jaw 131002 relative to the second jaw 131004, as described in more detail above. In certain examples, the first and second closure stages may span a predetermined portion of the maximum angular distance between the jaws 131002, 131004 in the open configuration. End effector 131000 completes a complete closure cycle by moving first jaw 131002 a maximum angular distance relative to second jaw 131004.

In one example, the first closure stage extends a first angular distance and the second closure stage extends a second angular distance. In one example, the first and second angular distances are equal or at least substantially equal. In one example, the second angular distance immediately follows the first angular distance. Alternatively, in another example, the first angular distance is spaced apart from the second angular distance. In one example, the ratio of the first angular distance to the second angular distance is selected from a range of about 0.5 to about 2, for example.

In one example, the first closure phase spans a first half of the maximum angular distance and the second closure phase spans a second half of the maximum angular distance. Thus, detection of initial tissue contact at any point up to 50% of the complete closure cycle of end effector 131000 results in a first energy output, according to process 131050, and initial tissue contact at a point above the 50% mark. Detection of results in a second energy output.

Angular position is not the only distinguishing characteristic of the closure phase of end effector 131000. As described below in connection with FIG. 80, the closing movement of end effector 131000 is driven by longitudinally movable drive member 131110. The longitudinal position of the longitudinally movable drive member 131110 is another distinguishing characteristic of the closing phase. The longitudinal movement of the longitudinally movable drive member 131110 corresponds to the angular movement of the first jaw 131002 relative to the second jaw 131004 and is monitored by the absolute position sensing system 7000.

In various examples, the control circuitry of the electrosurgical instrument (e.g., FIGS. 13-14, 17-19) provides, among other things, information characteristics of the closure phase of the end effector 131000, e.g., the start point of the closure phase, the end point of the closure phase. , the angular position(s) of the first jaw 131002 associated with the closing phase, and/or the longitudinal position(s) of the longitudinally movable drive member 131110 associated with the closing phase, etc. including.

As shown in FIG. 80, absolute position detection system 7000 is configured to track closure of end effector 131000. Depending on the stored information and the output of the absolute position detection system 7000, the control circuitry of the electrosurgical instrument (e.g., FIGS. 13-14, 17-19) transitions between the open and closed configurations. , the closure stage of the end effector 131000 can be determined.

In certain aspects, the drive system is configured to apply a drive motion to guide the end effector 131000 through the closure phase. The drive system may use an electric motor 131102. In various forms, motor 131102 may be a brushed DC drive motor having a maximum rotational speed of approximately 25,000 RPM, for example. In other configurations, motor 131102 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. A battery 1104 (or "power source" or "power pack"), such as a lithium ion battery, may power the control circuitry and ultimately the motor 131102.

The electric motor 131102 may include a rotary shaft 7016 that is a gear reducer mounted in meshing engagement with a set or rack of drive teeth on the longitudinally movable drive member 131110. In operative communication with assembly 7014. In use, the voltage polarity provided by battery 1104 allows electric motor 131102 to operate in a clockwise direction, whereas the voltage polarity applied to electric motor 131102 by battery 1104 allows electric motor 131102 to operate in a counterclockwise direction. It can be reversed to operate in the same direction. When electric motor 131102 is rotated in one direction, longitudinally movable drive member 131110 is driven axially in a distal direction "D" to close first jaw 131002 from an open configuration to a closed configuration. Move through the stages. When the motor 131102 is driven in the opposite rotational direction, the drive member 131110 is driven axially in the proximal direction "P" to transition the first jaw 131002 back to the open configuration.

FIG. 80 is a schematic diagram of an absolute position sensing system 7000 comprising a motor drive circuit arrangement controlled by a microcontroller 7004 with a sensor arrangement 7002, according to one embodiment. Electrical and electronic circuitry associated with absolute position sensing system 7000 and/or sensor device 7002 is supported by a control circuit board assembly. Microcontroller 7004 generally includes a memory 7006 and a microprocessor 7008 (“processor”) operably coupled thereto. Processor 7008 controls the circuitry of motor driver 7010 to control the position and speed of motor 131102. The motor 131102 is operably coupled to a sensor device 7002 and an absolute position sensor device 7012 that control the respective possible positions of the longitudinally movable drive member 131110; and subsequently provides a unique position signal to the microcontroller 7004 for each possible position of the first jaw 131002.

The unique position signal is provided to microcontroller 7004 via feedback element 7024. It should be understood that the unique position signal may be an analog signal or a digital value depending on the interface between the position sensor 7012 and the microcontroller 7004. In one aspect, the interface between position sensor 7012 and microcontroller 7004 is a standard serial peripheral interface (SPI) and the unique position signal is a digital value representing the position of sensor element 7026 over one revolution. be. Values representing the absolute position of sensor element 7026 over one revolution may be stored in memory 7006. The absolute position feedback value of sensor element 7026 corresponds to the position of first jaw 131002.

Additionally, other sensor(s) 7018 may be provided to measure other parameters associated with the absolute position detection system 7000. One or more display indicators 7020 may also be provided, and the display indicators 7020 may include an acoustic component.

Sensor device 7002 provides a unique position signal corresponding to the position of longitudinally movable drive member 131110. The electric motor 131102 may include a rotary shaft 7016 that is mounted in meshing engagement with a set or rack of drive teeth on the longitudinally movable drive member 131110. operably linked with. Sensor element 7026 may be operably coupled to gear assembly 7014 such that one rotation of sensor element 7026 corresponds to some linear longitudinal movement of longitudinally movable drive member 131110. good.

The sensor device 7002 of the absolute position detection system 7000 uses a position sensor 7012 that causes one revolution of a sensor element associated with the position sensor 7012 to generate a unique position signal for each rotational position. Therefore, one revolution of the sensor element associated with position sensor 7012 is equivalent to a longitudinal linear displacement d1 of longitudinally movable drive member 131110. In other words, d1 is the length of the longitudinal movement of the longitudinally movable drive member 131110 from point a to point b after one rotation of the sensor element coupled to the longitudinally movable drive member 131110. It is a straight line distance. To provide a unique position signal for one or two revolutions of the position sensor 7012, a series of switches 7022a-7022n (where n is an integer greater than 1) can be used alone or in conjunction with a reduction gear. may be used. The states of the switches 7022a-7022n are fed back to the microcontroller 7004, which applies logic to determine the longitudinal linear displacement d1+d2+. ．． ．． A unique position signal corresponding to dn is determined, which corresponds to a unique position of the first jaw 131002 between the open and closed configurations.

In various embodiments, the position sensor 7012 of the sensor device 7002 may include, for example, one or more magnetic sensors, an analog rotational sensor such as a potentiometer, an array of analog Hall effect elements, an analog Hall effect element, etc., among others. The elements are those that output position signals or unique combinations of values.

In various embodiments, motor 131102 is replaced with a hand trigger that manually drives longitudinally movable drive member 131110. The hand trigger may be part of the handle of the ultrasonic surgical instrument. In such aspects, absolute position sensing system 7000 is configured to track manual advancement and retraction of longitudinally movable drive member 131110.

In various aspects, the microcontroller 7004 may be programmed to perform various functions, such as precise control over the speed and position of the first jaw 131002. Using known physical characteristics, the microcontroller 7004 can be designed to determine the position of the first jaw 131002 and/or the rate of movement of the first jaw 131002 over its range of motion, and It can also be used to determine the current stage of closure of the first jaw 131002. Further details regarding absolute position sensing systems can be found in U.S. patent application Ser. FOR SURGICAL INSTRUMENTS”.

In certain aspects, the closure phase is defined or characterized by a predetermined location that may be stored in the storage medium of the control circuit (eg, FIGS. 13-15, 17-19). Position sensor 7012 sends a sensor signal to the control circuit indicative of the position of longitudinally movable drive member 131110 along its range of motion. Since the position of the longitudinally movable drive member 131110 corresponds to the position of the first jaw 131002, the control circuit controls the closing phase of the end effector 131000 according to the received sensor signal and the predetermined position stored in the storage medium. Can be evaluated based on data.

For example, the first closure stage may extend over a first position range and the second closure stage may extend over a second position range beyond the first position range. Accordingly, a sensor signal from position sensor 7012 indicating that the position of longitudinally movable drive member 131110 is within a first position range causes processor 7008 to indicate that end effector 131000 is in a first closing phase. is determined, resulting in the selection of the first energy mode of operation. Meanwhile, a sensor signal from position sensor 7012 indicating that the position of longitudinally movable drive member 131110 is within a second position range causes processor 7008 to determine that end effector 131000 is in a second closing phase. is determined, resulting in a second energy mode of operation selection that is different from the first energy mode of operation. As discussed above, the second energy mode of operation may produce a second energy output sufficient to seal and coagulate the tissue, while the first mode of energy operation separates the tissue. A first energy output may be generated that is sufficient to seal and coagulate the tissue.

Another distinguishing characteristic of the closure phase of end effector 131000 includes closure speed. Motor 131102 (FIG. 80) may be configured to guide a longitudinally movable drive member 131110 that drives first jaw 131002 at a constant speed. However, as the first jaw 131002 interacts with tissue "T", the closure rate may vary depending on the characteristics of the portion of tissue "T" with which the first jaw 131002 interacts. Thus, a change in closure speed may be a distinguishing characteristic of the closure phase of end effector 131000. The closure speed changes as the end effector 131000 transitions from one tissue section to another, such as from a tissue section suitable for tissue separation to a tissue section suitable for tissue sealing. You may. A change in the speed of movement of the first jaw 131002 may indicate completion of tissue separation prior to tissue sealing and coagulation.

In certain aspects, the closure phase is defined or characterized by a predetermined speed of movement that may be stored in the storage medium of the control circuit (eg, FIGS. 13-15, 17-19). A speed of movement of the longitudinally movable drive member 131110 that corresponds to a speed of movement of the first jaw 131002 may be determined based on the sensor signal of the position sensor 7012. In certain aspects, the change in the speed of movement of the longitudinally movable drive member 131110 can cause the control circuit to switch from the first energy operating mode to the second energy operating mode from the first closure stage to the second energy operating mode. indicates the transition to the closure phase.

Another distinguishing characteristic of the closing phase of end effector 131000 includes clamp loading. Similar to the closure speed, the load exerted by the end effector 131000 on the tissue "T" may vary depending on the characteristics of the portion of the tissue "T" that interacts with the first jaw 131002. Therefore, the change in clamp load may be a distinguishing characteristic of the closing phase of the end effector 131000. The clamp load changes as the end effector 131000 transitions from one tissue section to another, such as from a tissue section suitable for tissue separation to a tissue section suitable for tissue sealing. You may. A change in clamp load may indicate completion of tissue separation prior to tissue sealing and coagulation.

FIG. 81 is a logic flow diagram of a process 131070 illustrating a control program or logic configuration for switching between energy operating modes of an electrosurgical instrument in accordance with at least one aspect of the present disclosure. Process 131070 includes detecting (131072) the closing speed and clamp load of end effector 131000. Closing speed may be monitored via absolute position sensing system 7000. Clamp load may be determined using sensors 8406, 8408a, 8408b as described in connection with FIGS. 51, 52. Sensors 8406, 8408a, 8408b are electrically connected to a control circuit, such as control circuit 7400 (FIG. 49), via an interface circuit. Process 131070 further includes determining (131074) whether the closure rate has changed by more than a predetermined threshold. The storage medium of the control circuit that performs the process 131070 may store the predetermined threshold value. The current closing speed may be compared to a predetermined threshold to determine whether the current closing speed meets or exceeds the predetermined threshold. Process 131070 also determines whether the clamp load has changed by more than a predetermined threshold (131076). The storage medium of the control circuit that performs the process 131070 may store the predetermined threshold value. The current clamp load may be compared to a predetermined threshold to determine whether the current clamp load reaches or exceeds the predetermined threshold. The occurrence of either of two events causes the process 131070 to switch from the tissue separation energy mode to the tissue sealing energy mode (131078).

In various examples, the end effector 131000 may be an ultrasonic end effector, an RF electrosurgical device adapted for use with the ultrasonic surgical instrument 1104, as described in connection with FIGS. 17-19, 22-24. The surgical instrument 1106 may be in the form of an RF end effector adapted for use with the surgical instrument 1106 or a combination end effector adapted for use with the multifunctional surgical instrument 1108. Any of the instruments 1104, 1106, 1108 may be configured to perform one or more of the processes 131020, 131030, 131040, 131050, 131070, as described above.

In examples where end effector 131000 is in the form of an ultrasonic end effector, jaws 131002, 131004 may be in the form of a clamping member and an ultrasonic blade. The clamp members may be moved relative to the ultrasound blade to capture tissue therebetween. As described in more detail above, the ultrasound generator may be activated to apply power to an ultrasound transducer that is acoustically coupled to the ultrasound blade via the ultrasound waveguide. .

In various embodiments, a first ultrasound frequency is first set during a first closure phase before applying a second ultrasound frequency to cut and seal the blood vessel during a second closure phase. The muscular tissue layers of the blood vessel may be mechanically separated.

The ultrasonic generator module is programmed to output a first drive frequency f1 during the first closure phase, the first frequency f1 being significantly off resonance, e.g. fo/2, 2fo, or other structural resonant frequency, where fo is the resonant frequency (eg, 55.5kHz). The first frequency f1 provides a low level mechanical vibration effect on the ultrasonic blade that, when combined with the clamping force, allows the musculature of the blood vessel (below the therapeutic level) to be heated without causing significant heating that typically occurs with resonance. mechanically separate. During the second closure phase, the ultrasound generator module is programmed to automatically switch the drive frequency to the resonant frequency fo to cut and seal the blood vessel.

In various aspects, ultrasonic surgical instruments are connected to a surgical hub that interacts with a cloud-based system as described in connection with FIGS. 1-11. In such instances, the control circuitry of the electrosurgical instrument may receive input regarding various situational parameters collected by the surgical hub and/or the cloud-based system. Such input may be useful in selecting a suitable energy operating mode. Additionally, the energy level produced by the transducer can be tailored specifically to the type of tissue being treated. Contextual parameters include, but are not limited to, tissue type, tissue anatomical location, and/or tissue composition. For example, the energy required for tissue separation in the liver or other solid organs may be different than in other organs. Additionally, the energy level for tissue separation can be increased to accommodate tissue adhesions or other irregular connective tissue as reported by the surgical hub. Further details regarding situational awareness of surgical hubs, cloud-based systems, and various surgical instruments are described under the heading "Situational Awareness."

Control of Different Electromechanical Systems of Electrosurgical Instruments Various surgical instruments include clamping tissue and applying RF energy, ultrasound energy, or RF energy and ultrasound, as described in connection with FIGS. An end effector is included that applies a combination of sonic energy to the clamped tissue. Optimal tissue treatment is achieved by carefully regulating tissue energy application and tissue compression, which is accomplished by systems that are separate but influence each other's effects on the tissue. For example, energy application to tissue can be influenced by tissue water content, which is influenced by compression applied to the tissue. By increasing the compression applied to the tissue, the water content of the tissue increases the rate at which it releases the tissue clamped by the end effector, thereby affecting tissue conductivity.

Aspects of the present disclosure provide various processes for adjusting a system of electrosurgical instruments that act on tissue separately, yet have interrelated effects on the tissue. Using the same parameters to adjust separate systems of electrosurgical instruments that have interrelated effects on the tissue ensures consistency of the effects of the systems on the tissue. In other words, relying on the same parameters to adjust the operation of such a system allows for better correlated effects on the tissue.

In certain aspects, one or more of the processes of the present disclosure may be performed on an electrosurgical instrument, such as, for example, control circuit 710 of surgical instrument 700 and/or control circuit 760 of surgical instrument 750, 790. It can be performed by a control circuit. In certain aspects, as shown in FIG. 13, a control circuit for executing one or more processes comprises one or more processors 502 (e.g., microprocessors, microcontrollers). The processor 502 is often coupled to at least one memory circuit 504 that stores program instructions that, when executed by the processor 502, cause the processor 502 to perform one or more processes. Alternatively, one or more processes may be performed by one or more of the control circuits shown in FIGS. In certain aspects, an electrosurgical instrument may include a non-transitory storage medium that stores one or more algorithms for performing one or more processes.

FIG. 82 shows a process 131100 that illustrates a control program or logical arrangement for regulating a system of surgical instruments (e.g., surgical instruments 700, 750, 790, 1104, 1106, 1108) in accordance with at least one aspect of the present disclosure. FIG. Process 131100 monitors parameters of the surgical instrument (131101). In various examples, the electrosurgical instrument includes an end effector 131000. In a particular example, the parameter is the impedance of the tissue grasped by end effector 131000. In another example, the parameter is the temperature of the grasped tissue.

The process 131100 further causes a change 131104 in the energy delivered to the tissue in response to reaching or exceeding (131106) a predetermined upper threshold of the parameter. The process 131100 generates a change 131108 in the energy delivered to the motor (e.g., motor 603, 704a, 754) of the surgical instrument in response to reaching or exceeding (131109) a predetermined lower threshold of the parameter. cause more. The motor is operably coupled to the end effector 131000 such that energy delivered to the motor transitions the end effector 131000 toward the closed configuration. Thus, process 131100 results in a change in end effector closure in response to reaching or exceeding (131109) a predetermined lower threshold of the parameter.

In the example of FIG. 82, changing the end effector closure is accomplished by changing the energy delivered to the motor. In other examples, variations in end effector closure may be accomplished differently, for example via a gearbox assembly. The clutch mechanism may be configured to engage or disengage the gearbox assembly to increase or decrease the speed of the drive shaft coupled to the motor, thereby causing a desired change in end effector closure. .

In situations where tissue impedance (Z) is a monitored parameter, tissue impedance (Z) is monitored by one or more sensors, as described in connection with FIGS. 18, 19, 21, 78A. can be done. For example, end effector 131000 can include the tissue contacting circuit of FIG. 78A in which tissue "T" is grasped between plates P1, P2. Tissue impedance (Z _tissue ) can be calculated based on the following formula:

式中、Ｖは電圧であり、Ｉは電流であり、Ｚ_感知回路は、感知回路「ＳＣ」の所定のインピーダンスであり、これは図７８Ａに例示されるとおりである。様々な例では、図２１に関連して例示されるように、組織インピーダンス（Ｚ）は、第２の電圧感知回路９２４の出力を電流感知回路９１４で割ることによって測定されてもよい。

where V is the voltage, I is the current, and the Z _{sensing circuit} is the predetermined impedance of the sensing circuit "SC", as illustrated in FIG. 78A. In various examples, tissue impedance (Z) may be measured by dividing the output of the second voltage sensing circuit 924 by the current sensing circuit 914, as illustrated in connection with FIG.

In situations where tissue impedance (Z) is a monitored parameter, tissue impedance (Z) may be monitored by one or more temperature sensors. Alternatively, tissue temperature can be determined as described above in connection with FIGS. 51-53, where flexible circuit 8412 includes a temperature sensor embedded in one or more layers of flexible circuit 8412. You may prepare. One or more temperature sensors may be arranged symmetrically or asymmetrically and may provide tissue 8410 temperature feedback to the control circuitry of the ultrasound drive circuit and/or the RF drive circuit. In other examples, changes in phase angle φ and/or generator drive frequency may be used as an indirect or inferred measurement of ultrasonic blade temperature, as shown in connection with FIGS. 66A-66B. , the temperature of tissue being clamped between the ultrasound blade and the clamping member of the ultrasound end effector can be predicted or estimated.

FIG. 83 illustrates a process 131120 that illustrates a control program or logic configuration for regulating a system of electrosurgical instruments (e.g., surgical instruments 700, 750, 790, 1104, 1108) in accordance with at least one aspect of the present disclosure. FIG. 2 is a logical flow diagram. Process 131120 monitors parameters associated with the electrosurgical instrument (131121). As described above in connection with process 131120, the parameter may be impedance or temperature associated with the electrosurgical instrument. The process 131120 further causes a change 131124 in the first electromechanical system of the electrosurgical instrument in response to reaching or exceeding (131126) a predetermined upper threshold of the parameter. The process 131120 includes a change 131128 in a second electromechanical system of the electrosurgical instrument that is different from the first electromechanical system in response to reaching or exceeding a predetermined upper threshold (131129) of the parameter. cause more.

FIG. 84 is a graph 131130 illustrating an implementation of process 131120 in connection with an ultrasonic surgical instrument, including, for example, ultrasonic end effector 1122 of FIG. 23. The first electromechanical system is represented by a transducer 1120 and an ultrasound blade 1128, the ultrasound blade 1128 being acoustically coupled to the ultrasound transducer 1120 via a waveguide. Ultrasonic transducer 1120 may be energized by generator 1100. As described herein, when driven by ultrasound transducer 1120, ultrasound blade 1128 can vibrate and, upon contact with tissue, can cut and/or coagulate tissue.

A second electromechanical system is represented by a motor-driven clamp arm 1140 of end effector 1122. The motorized movement of the clamp arm of an ultrasonic surgical instrument is described in more detail in connection with FIGS. 46-50. The clamp arm 1140 is operated with a motor that can drive the clamp arm 1140 to transition the end effector 1122 between an open configuration and a closed configuration to grasp tissue between the clamp arm 1122 and the ultrasonic blade 1128. can be linked together.

Referring to FIG. 84, graph 131130 includes three graphs 131132 illustrating tissue impedance (Z), power (P), and force (F) plotted on the Y-axis against time (t) on the X-axis. , 131134, 131136 are included. Force (F) is determined at the distal portion (tip) of end effector 1122. Upper and lower thresholds are defined within the impedance graph 131132. At t ₁ and t ₄ , power (P) is adjusted in power graph 131 134 when impedance (Z) reaches or exceeds an upper threshold defined in impedance graph 131 132 . Therefore, the energy delivered to the first electrosurgical system transducer 1120 is governed by the upper threshold of the impedance (Z) parameter. At t ₂ and t ₃ , the tip force (F) is adjusted in force graph 131136 when the impedance value reaches or exceeds a lower threshold defined in impedance graph 131132. Therefore, the force exerted on the tissue by clamping member 1122 is governed by the lower threshold of the impedance (Z) parameter.

In various examples, the current delivered to the motor (I) is varied when the tissue impedance (Z) reaches or exceeds a lower threshold to effect a change in the force exerted on the cell by the clamping member 1122. can be done. In at least one example, as illustrated in FIG. 84, a motor current ( I) can be increased.

Due to the pivoting movement of the clamp arm of the ultrasonic surgical instrument, greater tissue compression is applied to tissue positioned proximally between the jaws than tissue positioned distally between the jaws. . Reduced tissue compression in the distal portion of the jaws may reduce heat flux to the tissue in the distal portions of the jaws below a threshold level necessary for effective treatment of the tissue.

In various aspects, the clamp arm can include tissue sensing circuitry configured to determine the position of tissue clamped between the jaws of the end effector. Examples of suitable tissue sensing circuits are described in U.S. Pat. , the entire disclosure of which is incorporated herein by reference. Various tissue sensing techniques are also described in U.S. Provisional Application No. 62/650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," filed March 30, 2018, and incorporated herein by reference in its entirety. incorporated herein by. In at least one example, the tissue sensing circuit includes two spaced apart electrodes. When tissue is in contact with the two electrodes, the tissue sensing circuit is closed, thereby producing a sensor signal indicating the presence of tissue that is transmitted to the control circuit (eg, FIGS. 13-14, 17-19).

Clamp arm load can be adjusted based on detected tissue location. For example, higher loads can be applied in situations where tissue is concentrated in the distal portion of the jaw. The higher clamp arm load may be sustained until the tissue clamped in the distal portion of the jaws is nearly completely coagulated. The clamp arm load is then reduced to avoid driving the ultrasonic blade into the pad of the clamp arm. In one example, the higher clamp arm load can be sustained up to a predetermined angular distance between the clamp arm and the ultrasonic blade. When the clamp arm reaches or exceeds a predetermined angular distance, the clamp arm load is reduced.

In certain embodiments, in conjunction with a combination device, RF energy may be blended with modulation of the clamp arm load to provide sufficient heat flux to coagulate tissue concentrated in a distal end portion of the jaw. can.

Detection of Appearance of an End Effector in a Liquid The frequency response associated with immersion of an ultrasonic blade in a liquid is similar to that associated with thick tissue clamped between the clamping member and the ultrasonic blade. It is desirable to detect when the ultrasonic blade is immersed in liquid to avoid falsely triggering tissue treatment by generators dedicated to thick tissues.

As described above in connection with FIGS. 70A-71, an ultrasonic surgical instrument, or a combination electrosurgical instrument that includes an ultrasonic component, may reduce the temperature of an ultrasonic blade significantly below a predetermined threshold. The ultrasonic blade is configured to detect immersion of the ultrasonic blade in a liquid (eg, blood, saline, water, etc.) by sensing the temperature of the blade.

As mentioned earlier, the temperature of the ultrasonic blade can be determined by detecting the impedance of the ultrasonic transducer, which is given by the following equation:

Or equivalently, it can be estimated by detecting the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal applied to the ultrasound transducer. The phase angle φ information may also be used to estimate the state of the ultrasonic blade. As discussed in detail herein, the phase angle φ changes as a function of the temperature of the ultrasonic blade. Therefore, the phase angle φ information may be used to control the temperature of the ultrasonic blade.

70A-70B are graphical illustrations of temperature feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a sudden temperature drop in the ultrasonic blade is detected. The temperature of the ultrasonic blade is increased by applying power 133072, as shown in FIG. 70A. During use, the temperature of the ultrasonic blade drops rapidly. It can be assumed that the temperature of the ultrasonic blade decreases when the ultrasonic blade is immersed in a fluid-filled surgical field (eg, blood, saline, water, etc.).

When an ultrasonic blade is immersed in a liquid, a proportion of the heat generated by the ultrasonic blade is lost to the liquid. Thus, immersion increases the heat flux necessary to effect effective treatments such as tissue coagulation. The generator adjusts the power delivered to the ultrasound transducer to adjust the heat flux to a level sufficient to provide effective treatment.

In certain instances, a blend of RF and ultrasound energy may be used to adjust the heat flux to a level sufficient to provide effective treatment. In certain instances, the compressive force applied to the tissue between the ultrasound blade and the clamp arm of the surgical instrument may be adjusted to adjust the heat flux to a level sufficient to provide effective treatment.

In another aspect, as shown in FIG. 85, detection of immersion of the ultrasonic blade in liquid can be deduced from the frequency response of the waveguide/transducer.

Referring to FIG. 85, power (P) is plotted as a function of time in diagnostic mode, as shown in graph 131140, and response mode, as shown in graph 131142. Power (P) is plotted on the vertical axis and time (t) on the horizontal axis. The frequency response of a waveguide/transducer in liquid is different from the ideal frequency response of a waveguide/transducer in air and is below a predetermined threshold curve 131141. The frequency response curve 131143 of the waveguide/transducer shows that when the ultrasonic blade is immersed in a liquid, rather than the expected increase in characteristics and plateau region in the ideal frequency response curve 131145 that delivers effective tissue treatment. flattened to

FIG. 86 is a logic flow diagram of a process 131150 illustrating a control program or logic configuration for detecting and compensating for immersion of an ultrasonic blade in a liquid, in accordance with at least one aspect of the present disclosure. Process 131150 monitors (131152) the power delivered to the tissue over time and compares it to a predetermined threshold. As shown in FIG. 85, process 131150 may sample the change in power over a predetermined time period (δP/δt) and compare it to a predetermined threshold slope. If the determined slope (δp/δt) is below a threshold slope, the ultrasonic blade is immersed in a liquid that moistens/cools the blade, increasing the head flux necessary for the blade to provide effective treatment. It is estimated that (curve 131145). To compensate (131156) more power (curve 131147) is delivered to the transducer. The added power is selected to be sufficient to provide the ideal frequency response (curve 131145) when modulated by the dampening effect of the liquid. However, if the determined slope (δp/δt) is greater than the threshold slope, power delivery to the ultrasound transducer continues as planned.

As shown in graph 131142 of FIG. 85, in response to detecting that the ultrasound end effector is immersed in fluid, a modified power curve 131147 is delivered to the tissue. Modified power curve 131147 compensates for liquid immersion. In the example of graph 131142, the modified power (P) curve 131147 increases the power delivered to the transducer by a predetermined factor/percentage to achieve the desired power curve 131145.

In another aspect, detection of immersion of the end effector in liquid may be determined by a liquid sensing circuit within the end effector. The liquid sensing circuit may include two electrodes on the end effector, which may be placed on separate jaws. Alternatively, the electrodes may be placed on the same jaw. The presence of liquid between the electrodes completes a circuit that transmits a signal that can be used to detect immersion of the end effector in liquid. As described above, in response to detection, the power delivered to the ultrasound transducer may be adjusted to compensate for the wetting/cooling effects of immersing the end effector in the liquid.

Depending on the extent to which the end effector is immersed in the liquid and/or the temperature of the liquid, an algorithm can be selected to compensate for heat lost to the liquid to provide effective treatment of the tissue. In at least one example, the power (P) delivered to the ultrasound transducer may be adjusted as described above to counteract the effects of immersion. Alternatively, a compressive force may be applied to the tissue between the clamp arm and the ultrasonic blade to counteract the effects of immersion. In various embodiments, both power (P) and tissue compression may be adjusted to counteract the effects of liquid immersion. Blended RF and ultrasound energy modes can be used to minimize the effects of immersion, which can be used in combination with increasing ultrasound power, RF power, or clamp arm pressure to Effective treatment of the tissue can be achieved.

Referring to FIG. 87, a graph 131160 shows the power (P) delivered to tissue by the end effector 131000 (FIG. 73) of the electrosurgical instrument and the temperature (T) of the tissue grasped by the end effector 131000. 131000 as a function of displacement of a closure driver (eg, closure member 764 of FIGS. 18 and 19) controlling the transition of 131000 to a closed configuration. As described herein, end effector 131000 treats tissue by grasping tissue and applying RF energy and/or ultrasound energy to the grasped tissue.

In addition to the above, a closure driver is operably coupled to at least one of the jaws 131002, 131004 and moves the end effector 131000 between an open configuration and a closed configuration to clamp tissue between the jaws 131002, 131004. It is movable so as to migrate. Accordingly, the movement of the closure driver may represent or be correlated with the closure movement of the end effector 131000. Therefore, a correlation exists between the compressive force applied by the end effector 131000 to the tissue captured between the jaws 131002, 131004 and the closure driver displacement.

Graph 131160 represents the tissue treatment cycle of end effector 131000. Power (P) is represented on the left vertical axis, temperature (T) is represented on the right vertical axis, and closure driver displacement or translation (δ) is represented on the horizontal axis. Each δ in graph 131160 on the horizontal axis represents the distance the closure driver has moved from its starting position.

The stages of the tissue treatment cycle are defined by the closed driver position. In various embodiments, it is desirable to maintain tissue at a desired temperature or desired temperature range during one or more of the stages of a tissue treatment cycle. The power (P) delivered to the tissue can be adjusted to maintain tight control over tissue temperature.

In the example of FIG. 87, initial stage 131162 shows a gradual increase in power (P) toward power level (P1) as the closure driver translates toward δ1. The power (P) is then maintained at the power level (P1) in the first stage 131164, which corresponds to a temperature of approximately 60°C. At such temperatures, tissues undergo collagen denaturation. At the end of the first stage 131164, the power level increases again to the power level (P2) corresponding to a temperature of 60°C to 100°C at the beginning of the second stage 131166. At the end of the second phase 131166, the power level increases again toward a power level (P4) configured to cause the tissue to reach and/or exceed a temperature of 100°C.

On the horizontal axis, a first stage 131164 is defined between a first position at δ1 and a second position at δ2. Power (P) is maintained at power level (P1) as the closure driver translates toward the second position at δ2. Tissue temperature is maintained at 60°C to promote collagen denaturation.

A second stage 131166 is defined between a second position at δ2 and a third position at δ3. Power (P) is maintained at power level (P2) as the closure driver translates toward the third position at δ3. During the second stage 131166, it is desirable to maintain a tissue temperature of 60°C to 100°C to avoid collateral damage to surrounding tissue that may be caused by the resulting 100°C steam. However, in a particular example, as illustrated by curved portion 131168 of graph 131160, the tissue temperature may rise to 100° C. prematurely before the closure driver reaches δ _max . In various aspects, as shown in FIG. 87, a predetermined power threshold (P3) is set to prevent the tissue from prematurely reaching a boiling temperature of 100°C.

FIG. 88 is a logic flow diagram of a process 131170 illustrating a control program or logic configuration for maintaining tissue temperature below 100° C. as the clamp arm transitions to the closed configuration at δ _max . Process 131170 monitors closure driver position and/or displacement (131172). In one example, closed tube position and/or displacement may be monitored through an absolute position detection system 7000, as described in more detail in connection with FIG. 80.

Process 131170 also monitors (131172) tissue temperature, which may be estimated based on the temperature of the ultrasound blade, for example. If the end effector 131000 is in the form of an ultrasonic end effector or a combination end effector, the ultrasonic blade temperature can be determined by sensing the impedance of the ultrasonic transducer given by the following equation:

or equivalently, determined by detecting the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal applied to the ultrasound transducer, as described herein. be able to. Alternatively, end effector 131000 may be equipped with one or more temperature sensors to measure tissue temperature.

Based on the monitored temperature and position information, the process 131170 determines that the temperature of the tissue prematurely increases before the closure driver reaches or passes δ _max , as shown by the curved portion 131168 of the graph 131160. Determine whether 100°C is reached or exceeded (131174). If so, process 131170 ensures that the tissue temperature (T) does not reach 100°C before the closure driver reaches or passes δ _max , as shown in curve portion 131169. Then, the power (P) is adjusted to a level below a predetermined power threshold (P3) (131176).

In certain aspects, process 131170 may be implemented at least in part by control circuitry (FIG. 13) that stores program instructions that, when executed by processor 502, cause processor 502 to execute process 131170. It includes one or more processors 502 (eg, microprocessors, microcontrollers) coupled to a memory circuit 504. The control circuit may receive closure driver position information from the absolute position detection system 7000, for example. Tissue temperature can be ascertained by processor 502 from temperature sensor readings or determined ultrasound blade temperature, as described herein.

In addition to the above, determining 131174 whether the temperature of the tissue reaches 100° C. prematurely before the closure driver reaches or passes δ _max can be performed, for example, in the second stage 131166. Upon completion, this may be accomplished by calculating a temperature trajectory from position, power, and/or temperature data. In one example, processor 502 can be used to calculate a temperature trajectory from, for example, one or more tables and/or equations stored in memory circuit 504.

In various aspects, process 131170 may be performed by one or more of the control circuits shown in FIGS. In certain aspects, an electrosurgical instrument may include a non-transitory storage medium that stores one or more algorithms for performing process 131170.

In at least one example, as shown in FIG. 87, reaching or exceeding a predetermined threshold temperature T ₁ that is between 60° C. and 100° C. at a predetermined threshold position δ3 that is less than δ _max , It may be shown that the tissue temperature reaches or exceeds 100° C. prematurely before the closure driver reaches or passes δ _max . Therefore, if the determined temperature is greater than or equal to the predetermined threshold temperature _T1 at the predetermined position threshold δ3, the process 131170 determines that the temperature of the tissue is prematurely increased before the closure driver reaches or passes _δmax . (131174).

Referring to FIG. 89, graph 131180 includes four graphs 131182, 131184, 131186, and 131188. Graph 131182 represents voltage (V) and current (I) vs. time (t), graph 131184 represents power (P) vs. time (t), graph 131186 represents temperature (T) vs. time (t), Graph 131188 represents tissue impedance (Z) versus time (t). In graph 131188, an impedance bathtub (eg, tissue impedance versus time first decreases, stabilizes, and finally increases, the curve resembling a bathtub shape) is shown.

Here, time zero represents the first point at which electrosurgical energy is applied to tissue at the surgical site. The Y-axis represents the level of tissue impedance (Z) that exists when a substantially constant level of power (P) is applied to the tissue, as shown in the corresponding portion of graph 131184. At time zero, the tissue exhibits an initial level of impedance (Zinit). The initial level of impedance (Zinit) may be based on natural physiological properties of the tissue, such as its density, water content, and tissue type. Over a short period of time, the level of impedance actually decreases slightly as power is continuously applied to the tissue. Eventually, a minimum level of impedance (Zmin) is reached. From here, the overall level of impedance increases.

As tissue impedance (Z) decreases toward minimum tissue impedance (Zmin) at time (t1), current (I) increases and voltage (V) decreases. The current curve shown in graph 131182 corresponds to voltage curve L1. For clarity, the current curves corresponding to voltage curves L2 and L3 have been omitted. During the initial period (t1), the temperature of the tissue gradually increases towards 100°C. As water within the tissue begins to evaporate, the tissue impedance (Z) increases significantly, causing an attenuation of the electrical current (I) passing through the tissue. As tissue impedance (Z) increases toward 100 Ω, tissue temperature also increases toward 110° C., which constitutes the boiling point of certain tissue oils.

To achieve effective tissue treatment, it is desirable to maintain tissue below a predetermined maximum temperature. In order to prevent the temperature of the tissue from exceeding a predetermined maximum threshold temperature, the voltage (V) is stepped as shown in voltage (V) curves L2 and L3. The increase in voltage (V) prevents the temperature of the tissue from exceeding a predetermined threshold temperature, as shown in temperature curve L3'', which corresponds to voltage curve L3, or at least corresponds to voltage curve L2. As shown in temperature curve L2'', the temperature of the tissue quickly returns below the predetermined threshold temperature. In comparison, if the voltage (V) is not increased, as shown in the voltage curve L1, the tissue temperature of the tissue increases significantly above a predetermined threshold temperature, as shown in the corresponding temperature curve L1''.

In at least one example, as shown in FIG. 89, the predetermined maximum temperature is about 130°C. To maintain the tissue below a predetermined maximum temperature, the voltage (V) is increased stepwise to slow further increase in temperature and eventually reverse the increase in temperature.

In the example of FIG. 89, when the tissue impedance (Z) reaches 100Ω, the tissue temperature reaches about 110°C, and when the tissue impedance (Z) reaches 450Ω, the tissue temperature (T) reaches about 130°C. .

Processes 131190 (FIG. 90) and 131200 (FIG. 91) provide trigger conditions for stepping up the voltage (V) applied by end effector 131000 toward the end of the tissue treatment cycle, as shown in FIG. shows a control program or logic arrangement using such values of tissue impedance (Z) and temperature (T). Other values of tissue impedance (Z) and tissue temperature (T) that can be used as trigger conditions to step up the voltage (V) are contemplated by this disclosure. In various examples, the threshold tissue impedance (Z) can be about 100Ω, as shown in graph 131188 of FIG. 89. In other examples, the threshold tissue impedance (Z) may be about 450Ω. In various examples, the threshold temperature (T) can be about 110° C., as shown in graph 131186 of FIG. 89. In other examples, the threshold temperature (T) may be about 130°C.

In one example, as shown in process 131190 of FIG. 90, tissue impedance (Z) is monitored (131192) and used to determine (131194) when to trigger (131196) an increase in voltage (V). obtain. A sensing circuit can be utilized to determine tissue impedance (Z), as described herein in connection with FIG. 78A. Ultrasonic drive circuitry and/or RF drive circuitry control circuitry (eg, FIGS. 13-15) may be utilized to perform process 131190 based on inputs received from the sensing circuitry.

In another example, as shown in process 131200 of FIG. 91, tissue temperature (T) is monitored (131202) to determine (131204) when to trigger (131206) an increase in voltage (V). can be used. As described herein in connection with FIGS. 66A-68, the generator generates a signal between a voltage Vg(t) signal and a current Ig(t) signal applied to drive the ultrasound transducer. Estimate the temperature of the ultrasonic blade based on the phase angle φ. Alternatively, tissue temperature can be determined as described above in connection with FIGS. 51-53, where flexible circuit 8412 includes a temperature sensor embedded in one or more layers of flexible circuit 8412. You may prepare. The one or more temperature sensors, which may be symmetrically or asymmetrically arranged, are connected to the control circuits of the ultrasound drive circuit and/or the RF drive circuit (e.g., FIGS. 13-15) to determine the temperature of the tissue 8410. You may also provide feedback. Control circuitry may be utilized to perform process 131200 based on temperature feedback.

In various examples, the voltage (V) increases in steps, as shown in voltage curves L2, L3. In other examples, the voltage (V) may be increased gradually.

In at least one example, two different upper boundary temperatures are set to achieve the power level. In addition to maximum temperature thresholds, primary and secondary minimum cut-off temperature thresholds may be used.

Combination of Ultrasonic and Radiofrequency Surgical Instruments As described above, the end effector 131000 (FIG. 73) provides tissue treatment through the application of radiofrequency (RF) energy, either alone or in combination with ultrasonic vibrations. , may be adapted for use with combination electrosurgical instruments. Examples of generators configured to drive ultrasonic transducers and RF electrodes of end effectors are described in "Modular Battery Powered Hand-Held Surgical Instrument With Curved End Effectors Havin," which is incorporated by reference in its entirety. g Asymmetric Engagement Between Jaw and Blade ”, US Patent Publication No. 2017/0202609.

In various aspects, an end effector 131000 that includes an ultrasound component and an RF component is configured to adjust one or more parameters of the RF component based on tissue temperature measurements performed by the ultrasound component. It is composed of Thus, while the RF component is utilized in a therapeutic mode, the ultrasound component may be utilized in a non-therapeutic diagnostic mode to adjust one or more parameters of the RF component in real time. can.

FIG. 92 is a process 131210 that illustrates a control program or logic arrangement for utilizing ultrasound components in a non-therapeutic diagnostic mode while RF components are utilized in a therapeutic mode.

Process 131210 monitors the temperature of the ultrasonic blade (131212). The process 131210 further determines whether the temperature of the ultrasonic blade is greater than or equal to a predetermined threshold temperature (131214). If so, process 131210 adjusts the power (P) of the RF components to reduce the energy delivered to the tissue.

As described in connection with FIGS. 66A-68, the generator adjusts the phase angle φ between the voltage Vg(t) signal and the current Ig(t) signal applied to drive the ultrasound transducer. Estimate the temperature of the ultrasonic blade based on. Because the temperature of the ultrasound blade corresponds to the temperature of the tissue captured by the end effector 131000 of the combination device, the ultrasound component is utilized in a diagnostic non-therapeutic mode to monitor tissue temperature and the RF component. Feedback can be provided to adjust the power level.

FIG. 93 is a graph 131220 illustrating an implementation of process 131210 in accordance with at least one aspect of the present disclosure. Graph 131220 includes three graphs 131222, 131224, 131226 showing power (P), temperature (T), and phase, respectively, on the vertical axis. Graph 131222 represents power (P) versus time (t) delivered to tissue captured between jaws 131002, 131004 of end effector 131000 of the combination device. Graph 131224 represents temperature (T) versus time (t) of the ultrasonic blade of end effector 131000. Graph 131226 illustrates the dual non-therapeutic frequencies used by the ultrasound component to determine the temperature of the ultrasound blade and thus the temperature of the tissue, as described in more detail in connection with FIGS. 66A-68. represents. The ultrasound component may be configured to detect transitions in tissue temperature up to or across a predetermined threshold temperature (T- _Threshold ), as shown in graph 131224. The power (P) level of the RF components may then be adjusted (from P1 to P2) to prevent excessive temperatures, as shown in graph 131222.

In at least one example, the power (P) level of the RF component maintains the tissue temperature below 100° C. to prevent vapors from causing collateral damage to surrounding tissue, while still maintaining the end of the combination device. The effector 131000 is adjusted to locally coagulate collagen within the grasped tissue. In at least one example, the power (P) level of the RF component is adjusted to maintain tissue temperature below 130° C. to prevent tissue charring that can occur at such temperatures. In at least one example, temperature feedback provided by the ultrasound component allows the RF component to adjust the power ramp rate according to tissue phase transitions during a tissue treatment cycle.

In various embodiments, the process includes a control program or logic to differentiate segments of the ultrasonic blade based on temperature. This process separates the extremely hot subsections from the moderately hot larger sections of the ultrasonic blade. In at least one aspect, the process applies multiple frequencies through the standard frequency of 55.5Khz, followed by alternatively using a triple frequency, e.g. It involves determining two different resonant frequencies that may allow determination of a small section or a larger section of the ultrasonic blade that is of moderate temperature.

FIG. 94 illustrates a control program or logic arrangement for adjusting the frequency of an RF waveform of an RF electrosurgical instrument or RF component of a combination device based on measured tissue impedance, according to at least one aspect of the present disclosure. , a logical flow diagram of process 131230. In at least one example, tissue impedance is measured 131232 before or during the first portion of a tissue treatment cycle, and this measurement is used to determine a predetermined high frequency 131234 of an RF waveform applied to the tissue. A selection is made between the low frequency 131236 (131231).

Process 131230 addresses low power transmission conditions. If the measured tissue impedance is determined to be less than or equal to a predetermined threshold, a high frequency RF waveform is selected for the treatment cycle. High frequency RF waveforms are configured to drive tissue impedance higher to accommodate low power transmission. However, if the measured tissue impedance is determined to be greater than or equal to a predetermined threshold, a low frequency RF waveform is selected for the treatment cycle. In various aspects, tissue impedance may be measured by one or more sensors, as described in connection with FIGS. 18, 21, 78A.

In various aspects, one or more of the processes of the present disclosure may be applied to, for example, control circuitry 710 of surgical instrument 700, control circuitry 760 of surgical instrument 750, and/or control circuitry of surgical instrument 790. 760 may be performed by an electrosurgical instrument's control circuitry. In certain aspects, as shown in FIG. 13, control circuitry for performing one or more of the processes of the present disclosure includes one or more processors 502 (e.g., microprocessors, The processor 502 may include a microcontroller (microcontroller) coupled to at least one memory circuit 504 that stores program instructions that, when executed by the processor 502, cause the processor 502 to perform one or more of the processes. has been done. Alternatively, one or more of the processes of this disclosure may be performed by one or more of the control circuits shown in FIGS. 14, 15. In certain aspects, an electrosurgical instrument may include a non-transitory storage medium that stores one or more algorithms for performing one or more of the processes of this disclosure.

Various aspects of the subject matter described herein are illustrated in the numbered examples below.

Example 1 - Surgical instrument with an end effector comprising an ultrasonic blade and a clamp arm. The clamp arm is movable relative to the ultrasound blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasound blade and the clamp arm. The surgical instrument further includes an ultrasound transducer configured to generate an ultrasound energy output and a waveguide configured to transmit the ultrasound energy output to the ultrasound blade. The surgical instrument further includes a control circuit configured to detect immersion of the end effector in the liquid and compensate for lost heat flux due to immersion of the end effector in the liquid.

Example 2 - Detecting immersion comprises monitoring the phase angle Φ between the voltage Vg(t) signal applied to the ultrasound transducer and the current Ig(t) signal applied to the ultrasound transducer; estimating the temperature of the ultrasonic blade based on the phase angle Φ between the voltage Vg(t) signal and the current Ig(t) signal; and comparing the estimated temperature of the ultrasonic blade with a predetermined temperature. The surgical instrument of Example 1, comprising:

Example 3 - The surgical instrument of Example 1 or 2, further comprising a liquid sensing circuit, and wherein detecting immersion includes receiving a signal from the liquid sensing circuit.

Example 4 - The surgical instrument of any of Examples 1-3, wherein compensating for heat flux is achieved by adjusting the power to the ultrasound transducer.

Example 5 - Any of Examples 1-4, wherein compensating the heat flux is achieved by adjusting the compressive load applied to the clamped tissue between the clamp arm and the ultrasonic blade. Surgical instruments listed.

Example 6 - Surgical instrument with an end effector comprising an ultrasonic blade and a clamp arm. The clamp arm is movable relative to the ultrasound blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasound blade and the clamp arm. The surgical instrument includes an ultrasonic transducer configured to generate an ultrasonic energy output, a waveguide configured to transmit the ultrasonic energy output to an ultrasonic blade, and a clamp arm for moving the ultrasonic blade. , a drive member configured to transition the end effector to a closed configuration. The surgical instrument further comprises a control circuit configured to monitor the position of the drive member, monitor the temperature of the ultrasonic blade, and ensure that the temperature does not exceed a predetermined threshold prior to the closed configuration. .

Example 7 - The surgical instrument of Example 6, wherein the temperature is estimated from the phase angle φ between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasound transducer.

Example 8 - The surgical instrument of Example 6 or 7, wherein the position of the drive member is determined by an absolute positioning system.

Example 9 - The surgical instrument according to any one of Examples 6-8, wherein the predetermined threshold is 100°C.

Example 10 - The surgical method according to any one of Examples 6 to 9, wherein preventing the temperature from exceeding a predetermined threshold is achieved by adjusting the power delivered to the ultrasound transducer. utensils.

Example 11 - The surgical instrument of any one of Examples 6-10, wherein the closed configuration corresponds to a predetermined distance that the drive member has moved from the starting position.

Example 12 - The surgical instrument of any one of Examples 6-10, wherein the closed configuration corresponds to the maximum compression applied to the tissue by the clamp arm.

Example 13 - Surgical instrument comprising an end effector comprising a first jaw and a second jaw. The second jaw is moved relative to the first jaw to transition the end effector between an open configuration and a closed configuration to grasp tissue between the first and second jaws. It is possible. The end effector includes an ultrasound component configured to deliver ultrasound energy to the grasped tissue and a radio frequency (RF) component configured to deliver RF energy to the grasped tissue. Prepare more. The surgical instrument further comprises a control circuit configured to operate the ultrasound component in a non-therapeutic diagnostic mode while operating the RF component in a therapeutic mode to treat the grasped tissue.

Example 14 - The surgical instrument of Example 13, wherein the non-therapeutic diagnostic mode includes determining a temperature of at least one of the grasped tissue.

Example 15 - The surgical instrument of Example 13 or 14, wherein the ultrasound component comprises an ultrasound transducer.

Example 16 - The surgical instrument of Example 15, wherein the temperature is estimated from the phase angle φ between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasound transducer.

Example 17 - The surgical instrument of any one of Examples 13-16, wherein the treatment mode includes applying RF energy to seal the grasped tissue.

Example 18 - The surgical instrument of any one of Examples 13-17, wherein the ultrasound component includes an ultrasound transducer and the RF component includes an RF electrode.

Example 19 - The surgical instrument of Example 18, further comprising a generator configured to drive the ultrasound transducer and the RF electrode.

While several embodiments have been illustrated and described, it is not the intention of the applicant to limit or limit the scope of the appended claims to such details. Numerous modifications, variations, changes, permutations, combinations and equivalents of these forms may be implemented and will occur to those skilled in the art without departing from the scope of this disclosure. Furthermore, the structure of each element in connection with the described form may alternatively be described as a means for providing the functionality performed by that element. Also, although materials are disclosed for particular components, other materials may be used. It is therefore intended that the foregoing description and appended claims cover all such modifications, combinations, and variations as falling within the scope of the disclosed forms. I want you to understand. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

The detailed description above has described various forms of apparatus and/or processes using block diagrams, flowcharts, and/or example embodiments. To the extent that such block diagrams, flowcharts, and/or implementations include one or more features and/or operations, those skilled in the art will appreciate that such block diagrams, flowcharts, and/or implementations include one or more features and/or operations. Each feature and/or operation included in an embodiment may be implemented individually and/or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will appreciate that all or a portion of some aspects of the forms disclosed herein can be implemented as one or more computer programs running on one or more computers (e.g., one as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g. (as one or more programs running on a microprocessor), as firmware, or on an integrated circuit as virtually any combination thereof; , and/or software and/or firmware code is within the skill of those skilled in the art in light of this disclosure. Additionally, those skilled in the art will appreciate that the features of the subject matter described herein can be distributed as one or more program products in a variety of formats; The specific forms of the subject matter described are employed without regard to the particular type of signal-bearing medium used to actually effectuate the distribution.

The instructions used to program the logic to perform the various disclosed aspects may be stored in memory within the system, such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Additionally, the instructions may be distributed over a network or by other computer-readable media. Thus, a machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including floppy diskettes, optical disks, compact disks, read-only memory (CDs), etc. - ROM), as well as magneto-optical disks, read only memory (ROM), random access memory (RAM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), magnetic or optical cards, Flash memory or any tangible machine-readable device used to transmit information over the Internet via electrical, optical, acoustic, or other forms of propagating signals (e.g., carrier waves, infrared signals, digital signals, etc.) Not limited to storage. Thus, non-transitory computer-readable media includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).

As used in any aspect herein, the term "control circuit" refers to, for example, hard-wired circuits, programmable circuits (e.g., computer processors containing one or more individual instruction processing cores, processing units, , processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuit, programmable circuit Can refer to firmware that stores instructions to be executed, and any combination thereof. Control circuits may be used, collectively or individually, in, for example, integrated circuits (ICs), application specific integrated circuits (ASICs), systems on chips (SoCs), desktop computers, laptop computers, tablet computers, servers, smartphones, etc. , may be implemented as a circuit that forms part of a larger system. Accordingly, as used herein, "control circuit" refers to an electrical circuit having at least one individual electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application specific integrated circuit. a circuit, a general-purpose computing device configured with a computer program (e.g., a general-purpose computer configured with a computer program that at least partially executes a process and/or device described herein, or a process described herein) and/or electrical circuits forming memory devices (e.g. in the form of random access memory), and/or communication devices (e.g. Examples include, but are not limited to, electrical circuits forming a modem, communications switch, or optical-electrical equipment. Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form or some combination thereof.

As used in any aspect herein, the term "logic" may refer to applications, software, firmware, and/or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions, or a set of instructions in a memory device, and/or hard-coded (eg, non-volatile) data.

As used in any aspect herein, the terms "component," "system," "module," etc. refer to either hardware, a combination of hardware and software, software, or running software. Can refer to some computer-related entity.

As used in any aspect herein, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result; a "step" may include, but does not require, storage, transfer, combination, Refers to the manipulation of physical quantities and/or logical states, which can take the form of electrical or magnetic signals, which can be compared and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities or are simply convenient labels applied to these quantities and/or conditions.

The network may include a packet switched network. The communication devices can communicate with each other using a selected packet-switched network communication protocol. One example communication protocol may include the Ethernet communication protocol, which may enable communication using Transmission Control Protocol/Internet Protocol (TCP/IP). The Ethernet protocol shall conform to or be compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) under the title "IEEE 802.3 Standard" published December 2008, and/or any later version of this standard. is possible. Alternatively or additionally, the communication device is configured to support X. can communicate with each other using the X.25 communication protocol. X. The T.25 communication protocols may conform to or be compatible with standards promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may communicate with each other using a frame relay communication protocol. The Frame Relay communication protocol is a protocol developed by the Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute ( may conform to or be compatible with standards promulgated by ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published by the ATM Forum in August 2001 under the title "ATM-MPLS Network Interworking 2.0" and/or with later versions of this standard. . Of course, different and/or later developed connection-oriented network communication protocols are equally contemplated herein.

Unless explicitly stated otherwise, it is clear from the foregoing disclosure that throughout the foregoing disclosure, terms such as "process", "calculate", "calculate", "determine", "display", etc. Discussion of the use of the term refers to data that is represented as a physical (electronic) quantity in the registers and memory of a computer system, and It will be understood to refer to the operations and processes of a computer system or similar electronic computing device that manipulate and convert other data into similarly represented data.

One or more components are herein defined as "configured to," "configurable to," "operable/as such." "operable/operative to", "adapted/adaptable", "able to", "conformable/conformed" may be referred to as "to)". Those skilled in the art will understand that "configured to" generally refers to components in an active state and/or components in an inactive state and/or components in a standby state, unless the context requires otherwise. It will be understood that elements can be included.

The terms "proximal" and "distal" are used herein with reference to the clinician manipulating the handle portion of the surgical instrument. The term "proximal" refers to the part closest to the clinician, and the term "distal" refers to the part located away from the clinician. It will be further understood that for convenience and clarity, spatial terms such as "vertical," "horizontal," "above," and "below" may be used herein with respect to the drawings. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Those skilled in the art will generally understand that the terms used herein, and particularly in the appended claims (e.g., the text of the appended claims), are generally intended as "open" terms. (For example, the term "including" should be interpreted as "including but not limited to," and the term "having" should be interpreted as "including but not limited to.") should be interpreted as “having at least” and the term “includes” should be interpreted as “includes but is not limited to.” should be done, etc.). Further, if a specific number is intended in an introduced claim recitation, such intent will be clearly stated in the claim, and if no such statement is present, no such intent exists. will be understood by those skilled in the art. For example, as an aid to understanding, the following appended claims contain the introductory phrases "at least one" and "one or more" in the claims. May be included to introduce the description. However, the use of such a phrase does not apply when a claim is introduced by the indefinite article "a" or "an," even if "one or more" or "at least one" are included in the same claim. Even if the introductory phrase and the indefinite article "a" or "an" are included, any particular claim containing such an introduced claim statement will be treated as a claim containing only one such statement. shall not be construed as suggesting limitation (e.g., "a" and/or "an" generally mean "at least one" or "one or more"). should be interpreted). The same applies when introducing claim statements using definite articles.

Furthermore, even if a particular number is specified in an introduced claim statement, such statement is typically to be construed to mean at least the recited number. , as will be recognized by those skilled in the art (e.g., a mere statement of "two entries" without any other modifiers generally means at least two entries, or two or more entries). (meaning a matter). Further, when a notation similar to "at least one of A, B, and C, etc." is used, such construction is generally intended in the sense that a person skilled in the art would understand the notation (e.g. , "a system having at least one of A, B, and C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and and/or all of A, B, and C, etc.). When a notation similar to "at least one of A, B, or C, etc." is used, such construction is generally intended in the sense that a person skilled in the art would understand the notation (e.g., " A system having at least one of A, B, or C includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C. (including systems having both, and/or all of A, B, and C, etc.). Further, typically any disjunctive words and/or phrases representing two or more alternative terms are used in the specification unless the context requires otherwise. It is understood that the possibility is intended to include one, either, or both of these terms, whether in the claims or in the drawings. Those skilled in the art will understand that this should be the case. For example, the phrase "A or B" will typically be understood to include the possibilities "A" or "B" or "A and B."

With reference to the appended claims, those skilled in the art will appreciate that the acts recited herein may generally be performed in any order. Additionally, while flow diagrams of various operations are shown in sequence(s), it is understood that the various operations may be performed in an order other than that illustrated, or may be performed simultaneously. It should be. Examples of such alternative orderings include overlapping, interleaving, interpolating, reordering, incremental, preliminary, additional, simultaneous, reverse, or other different orderings, unless the context requires otherwise. May include. Additionally, terms such as "responsive to," "relating to," or other past tense adjectives generally exclude such variations unless the context requires otherwise. It's not intended.

Any reference to "an aspect," "an aspect," "an example," "an example," etc. refers to the fact that the particular feature, structure, or characteristic described in connection with that aspect is included in at least one aspect. The meaning of this is worth noting. Thus, the phrases "in one aspect," "in an aspect," "in an example," and "in one example" appearing in various places throughout this specification do not necessarily all refer to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or other disclosure material referenced herein and/or listed in any application data sheet is incorporated by reference herein to the extent that the incorporated material is not inconsistent with this specification. , incorporated herein by reference. As such, and to the extent necessary, disclosure expressly set forth herein shall supersede any conflicting disclosure herein incorporated by reference. Any content, or portion thereof, that is inconsistent with current definitions, views, or other disclosures set forth herein shall be incorporated herein by reference, but the references and current disclosures shall be incorporated herein by reference. shall be referred to only to the extent that there is no conflict between them.

In summary, many benefits have been described that result from using the concepts described herein. The above description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or limited to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The form or forms are illustrative of the principles and practical application, thereby enabling those skilled in the art to utilize the various forms, with various modifications, as appropriate for the particular application contemplated. It has been selected and described for this reason. It is intended that the claims presented herewith define the overall scope.

[Mode of implementation]
(1) A surgical instrument,
An end effector,
ultrasonic blade,
a clamp arm moved relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamp arm; an end effector comprising a clamp arm;
an ultrasonic transducer configured to generate an ultrasonic energy output;
a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade;
A control circuit,
detecting immersion of the end effector in a liquid;
a control circuit configured to compensate for lost heat flux due to the immersion of the end effector in the liquid.
(2) detecting the immersion,
monitoring a phase angle φ between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasound transducer;
estimating the temperature of the ultrasonic blade based on the phase angle φ between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasonic transducer;
and comparing the estimated temperature of the ultrasonic blade to a predetermined temperature.
(3) The surgical instrument of embodiment 1, further comprising a liquid sensing circuit, and wherein detecting the immersion includes receiving a signal from the liquid sensing circuit.
4. The surgical instrument of embodiment 1, wherein compensating for heat flux is accomplished by adjusting power to the ultrasound transducer.
5. The surgical method of claim 1, wherein compensating for heat flux is accomplished by adjusting a compressive load applied to the tissue clamped between the clamp arm and the ultrasonic blade. utensils.

(6) A surgical instrument,
An end effector,
ultrasonic blade,
a clamp arm moved relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamp arm; an end effector comprising a clamp arm;
an ultrasonic transducer configured to generate an ultrasonic energy output;
a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade;
a drive member configured to guide and move the clamp arm to transition the end effector to the closed configuration;
A control circuit,
monitoring the position of the drive member;
monitoring the temperature of the ultrasonic blade;
a control circuit configured to prevent the temperature from exceeding a predetermined threshold prior to the closed configuration.
7. The surgical instrument of claim 6, wherein the temperature is estimated from a phase angle φ between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasound transducer.
8. The surgical instrument of embodiment 6, wherein the position of the drive member is determined by an absolute position detection system.
(9) The surgical instrument according to embodiment 6, wherein the predetermined threshold value is 100°C.
10. The surgical instrument of claim 6, wherein preventing the temperature from exceeding the predetermined threshold is accomplished by adjusting power delivered to the ultrasound transducer.

11. The surgical instrument of claim 6, wherein the closed configuration corresponds to a predetermined distance that the drive member has moved from a starting position.
12. The surgical instrument of claim 6, wherein the closed configuration corresponds to a maximum compression applied to the tissue by the clamp arm.
(13) A surgical instrument,
An end effector,
With the first Joe,
a second jaw for transitioning the end effector between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw; a second jaw movable relative to the jaw of the
an ultrasound component configured to deliver ultrasound energy to the grasped tissue;
an end effector comprising a radio frequency (RF) component configured to deliver RF energy to the grasped tissue;
a control circuit configured to operate the ultrasound component in a non-therapeutic diagnostic mode while operating the RF component in a therapeutic mode to treat the grasped tissue. utensils.
14. The surgical instrument of claim 13, wherein the non-therapeutic diagnostic mode includes determining a temperature of at least one of the grasped tissue.
15. The surgical instrument of embodiment 14, wherein the ultrasound component comprises an ultrasound transducer.

16. The surgical instrument of embodiment 15, wherein the temperature is estimated from a phase angle φ between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasound transducer.
17. The surgical instrument of claim 13, wherein the treatment mode includes applying RF energy to seal the grasped tissue.
18. The surgical instrument of embodiment 13, wherein the ultrasound component comprises an ultrasound transducer and the RF component comprises an RF electrode.
19. The surgical instrument of embodiment 18, further comprising a generator configured to drive the ultrasound transducer and the RF electrode.

Claims (14)

A surgical instrument,
An end effector,
ultrasonic blade,
a clamp arm moved relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamp arm; an end effector comprising a clamp arm;
an ultrasonic transducer configured to generate an ultrasonic energy output;
a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade;
A control circuit,
detecting immersion of the end effector in a liquid;
a control circuit configured to compensate for lost heat flux due to the immersion of the end effector in the liquid. detecting the immersion,
monitoring a phase angle φ between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasound transducer;
estimating the temperature of the ultrasonic blade based on the phase angle φ between the voltage Vg(t) signal and the current Ig(t) signal applied to the ultrasonic transducer;
and comparing the estimated temperature of the ultrasonic blade to a predetermined temperature. The surgical instrument of claim 1, further comprising a liquid sensing circuit, and wherein detecting the immersion includes receiving a signal from the liquid sensing circuit. The surgical instrument of claim 1, wherein compensating for the heat flux is accomplished by adjusting power to the ultrasound transducer. The surgical instrument of claim 1, wherein compensating the heat flux is accomplished by adjusting a compressive load applied to the tissue clamped between the clamp arm and the ultrasonic blade. . further comprising a drive member configured to guide and move the clamp arm to transition the end effector to the closed configuration;
The control circuit includes:
monitoring the position of the drive member;
monitoring the temperature of the ultrasonic blade;
The surgical instrument of claim 1, wherein the temperature is configured to prevent the temperature from exceeding a predetermined threshold before the closed configuration. The surgical instrument of claim 6, wherein the temperature is estimated from a phase angle φ between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasound transducer. The surgical instrument of claim 6, wherein the predetermined threshold is 100<0>C. 7. The surgical instrument of claim 6, wherein preventing the temperature from exceeding the predetermined threshold is accomplished by adjusting power delivered to the ultrasound transducer. The surgical instrument of claim 6, wherein the closed configuration corresponds to a maximum compression applied to the tissue by the clamp arm. further comprising a radio frequency (RF) component configured to deliver RF energy to the clamped tissue;
The control circuit is configured to operate the ultrasound transducer in a diagnostic mode while operating the radio frequency (RF) component in a therapeutic mode to treat the clamped tissue ;
the diagnostic mode includes determining a temperature of the clamped tissue;
the temperature is estimated from the phase angle φ between a voltage Vg(t) signal and a current Ig(t) signal applied to the ultrasound transducer;
The surgical instrument of claim 1 , wherein a power level of the radio frequency (RF) component is adjusted based on the temperature of the tissue determined in the diagnostic mode . The surgical instrument of claim 11 , wherein the treatment mode includes applying RF energy to seal the clamped tissue. The surgical instrument of claim 11 , wherein the radio frequency (RF) component comprises an RF electrode. The surgical instrument of claim 13 , further comprising a generator configured to drive the ultrasound transducer and the RF electrode.

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