CN111565658A

CN111565658A - Determining the state of an ultrasound electromechanical system from a frequency shift

Info

Publication number: CN111565658A
Application number: CN201880084557.4A
Authority: CN
Inventors: C·R·诺特; F·P·奎格利; F·E·谢尔顿四世; K·L·豪泽; D·C·耶茨; C·N·法勒; M·C·杰梅; P·J·斯科金斯
Original assignee: Ethicon LLC
Current assignee: Ethicon LLC
Priority date: 2017-12-28
Filing date: 2018-10-12
Publication date: 2020-08-21
Also published as: JP7383615B2; BR112020013070A2; JP2021509601A; MX2020006845A; WO2019130106A1

Abstract

Various systems and methods for determining the state of an ultrasound electromechanical system are disclosed. The control circuit may be configured to monitor changes in the resonant frequency of the ultrasonic electromechanical system of the ultrasonic surgical instrument as the ultrasonic blade vibrates and to determine the state or change in state of the ultrasonic electromechanical system accordingly. The change in state of the ultrasound electromechanical system may include, for example, a change in temperature of the system. In some aspects, the control circuit may be configured to modify the operation of the ultrasonic electromechanical system or other operating parameters of the ultrasonic surgical instrument in accordance with the state or state change of the system.

Description

Determining the state of an ultrasound electromechanical system from a frequency shift

Cross Reference to Related Applications

This patent application claims priority from U.S. provisional patent application 62/721,995 entitled control of ULTRASONIC surgical instruments (control AN ULTRASONIC surgical instrument TO TISSUE LOCATION) filed on 23.8.8.2018 under the provisions of section 119 (volume 35 of the U.S. code), the disclosure of which is incorporated herein by reference in its entirety.

This patent application claims the priority OF a situation AWARENESS for ELECTROSURGICAL SYSTEMS (patent architecture OF ELECTROSURGICAL SYSTEMS) U.S. provisional patent application 62/721,998 filed on 2018, 8, 23, in accordance with the provisions OF clause 119 (e) OF U.S. code 35, volume 35, the priority being incorporated herein by reference in its entirety.

This patent application claims priority from us provisional patent application 62/721,999 entitled ENERGY INTERRUPTION DUE to unintentional CAPACITIVE COUPLING (interim OF ENERGY DUE to ENERGY INTERRUPTION with access control coating) filed on 23.8.2018 under the provisions OF clause 119 (e) OF volume 35 OF the united states code, the disclosure OF which is incorporated herein by reference in its entirety.

This patent application claims priority from U.S. provisional patent application 62/721,994 entitled BIPOLAR COMBINATION device for AUTOMATICALLY adjusting PRESSURE BASED ON ENERGY modalities (BIPOLAR COMBINATION device for use in conjunction with PRESSURE regulation) filed ON 23.8.8.2018 in accordance with the provisions of section 119 (volume 35 of the united states code), the disclosure of which is incorporated herein by reference in its entirety.

This patent application claims priority from us provisional patent application 62/721,996 entitled RADIO FREQUENCY energy device (RADIO FREQUENCY resonance ENERGY DEVICE for RADIO FREQUENCY communication COMBINED ELECTRICAL SIGNALS) filed on 23.8.8.2018, the disclosure of which is incorporated herein by reference in its entirety, in accordance with the provisions of clause 119 (e) of the united states code, volume 35.

This patent application also claims the priority OF U.S. provisional patent application 62/692,747 entitled intelligent ACTIVATION OF an energy DEVICE by another DEVICE (SMART activity OF AN ENERGY DEVICE bypass DEVICE) filed on 30.6.2018, U.S. provisional patent application 62/692,748 entitled intelligent energy ARCHITECTURE (SMART ENERGY ARCHITECTURE) filed on 30.6.2018, and U.S. provisional patent application 62/692,768 entitled intelligent energy DEVICE (SMART ENERGY DEVICES) filed on 30.6.2018, the disclosures OF each OF which are incorporated herein by reference in their entirety, as specified in clause 119 (e) OF U.S. code 35.

This patent application also claims the benefit OF priority from U.S. provisional patent application serial No. 62/640,417 entitled "temparature CONTROL IN ultra sound DEVICE AND CONTROL SYSTEM for" filed on 3, 8.2018 AND U.S. provisional patent application serial No. 62/640,415 entitled "ESTIMATING STATE OF ultra sound END effect AND CONTROL SYSTEM for" filed on 3, 8.2018, the disclosure OF each OF which is incorporated herein by reference IN its entirety, as specified IN clause 119 (e) OF the U.S. code, volume 35.

This patent application also claims the benefit of priority of U.S. provisional patent application serial No. 62/650,898 entitled capacitively coupled return path pad with separable array elements (CAPACITIVE COUPLED RETURNPATH PAD WITH SEPARABLE ARRAY ELEMENTS) filed on 3/20.2018, U.S. provisional patent application serial No. 62/650,887 entitled SURGICAL system with optimized sensing capability (SURGICAL system with optimized sensing capability) filed on 3/30.2018, U.S. provisional patent application serial No. 62/650,882 entitled SMOKE EVACUATION module or interactive SURGICAL SMOKE EVACUATION system PLATFORM filed on 3/30.2018, and U.S. provisional patent application serial No. 62/650,877 entitled SURGICAL SMOKE EVACUATION sensing and control (SURGICAL SMOKE EVACUATION module SENSING AND) filed on 3/30.2018, the disclosure of each of these provisional patent applications is incorporated herein by reference in its entirety.

The present patent application further claims the benefit of priority from U.S. provisional patent application serial No. 62/611,341 entitled interactive SURGICAL PLATFORM (INTERACTIVE SURGICAL PLATFORM) filed on 2017, 12, 28, date 35, the U.S. provisional patent application serial No. 62/611,340 entitled CLOUD-BASED medical analysis (CLOUD-BASED medical analysis) filed on 2017, 12, 28,

date

12, 28, and U.S. provisional patent application serial No. 62/611,339 entitled robotically ASSISTED SURGICAL PLATFORM (ROBOT ASSISTED SURGICAL PLATFORM) filed on 2017, 12, 28, date, the disclosure of each of these provisional patent applications being incorporated herein by reference in its entirety.

Background

In a surgical environment, the smart energy device may be required in a smart energy architecture environment.

Disclosure of Invention

In one general aspect, the present disclosure is directed to an ultrasonic electromechanical system for an ultrasonic surgical instrument. The ultrasound electromechanical system includes: the ultrasonic blade includes an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, and a control circuit coupled to the ultrasonic transducer. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. The control circuit is configured to: a first resonant frequency of the ultrasonic electromechanical system is determined, a second resonant frequency of the ultrasonic electromechanical system is determined while the ultrasonic blade is vibrated against tissue, and a condition of the ultrasonic surgical instrument is determined based on a comparison between the first resonant frequency and the second resonant frequency.

In another general aspect, the present disclosure is directed to an ultrasonic generator connectable to an ultrasonic electromechanical system for an ultrasonic surgical instrument. The ultrasonic electromechanical system includes an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade. The ultrasound generator includes a control circuit capable of being coupled to the ultrasound transducer. The control circuit is configured to: applying a drive signal to the ultrasonic transducer to vibrate the ultrasonic blade, determining a first resonant frequency of the ultrasonic electromechanical system, determining a second resonant frequency of the ultrasonic electromechanical system while the ultrasonic blade is vibrating against tissue, and determining a status of the ultrasonic surgical instrument based on a comparison between the first resonant frequency and the second resonant frequency.

In another general aspect, the present disclosure is directed to a method of controlling an ultrasonic electromechanical system for an ultrasonic surgical instrument. The ultrasonic electromechanical system includes an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade. The method comprises the following steps: determining, by a control circuit coupled to the ultrasound electromechanical system, a natural resonant frequency of the ultrasound electromechanical system; monitoring, by the control circuit, a resonant frequency of the ultrasonic electromechanical system while the ultrasonic blade is vibrating; and determining, by the control circuit, whether a change in state of the ultrasound electromechanical system has occurred as a function of whether a resonant frequency of the ultrasound electromechanical system has deviated from the natural resonant frequency.

Drawings

The features of the various aspects are set out with particularity in the appended claims. The various aspects, however, both as to organization and method of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings.

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. 2 is a surgical system for performing a surgical procedure in an operating room in accordance with at least one aspect of the present disclosure.

Fig. 3 is a surgical hub paired with a visualization system, a robotic system, and a smart instrument according to at least one aspect of the present disclosure.

Fig. 4 is a partial perspective view of a surgical hub housing and a composite generator module slidably received in a drawer of the surgical hub housing according to at least one aspect of the present disclosure.

Fig. 5 is a perspective view of a combined generator module having bipolar, ultrasonic and monopolar contacts and a smoke evacuation component according to at least one aspect of the present disclosure.

Fig. 6 illustrates a single power bus attachment for a plurality of lateral docking ports of a lateral modular housing configured to house a plurality of modules in accordance with at least one aspect of the present disclosure.

Fig. 7 illustrates a vertical modular housing configured to receive a plurality of modules according to at least one aspect of the present disclosure.

Fig. 8 illustrates a surgical data network including a modular communication hub configured to connect modular devices located in one or more operating rooms of a medical facility or any room in a medical facility dedicated to surgical operations to a cloud in accordance with at least one aspect of the present disclosure.

Fig. 9 is a computer-implemented interactive surgical system according to at least one aspect of the present disclosure.

Fig. 10 illustrates a surgical hub including a plurality of modules coupled to a modular control tower according to at least one aspect of the present disclosure.

Fig. 11 illustrates one aspect of a Universal Serial Bus (USB) hub device in accordance with at least one aspect of the present disclosure.

Fig. 12 illustrates a logic diagram of a control system of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 13 illustrates a control circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 14 illustrates a combinational logic circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 15 illustrates sequential logic circuitry configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 16 illustrates a surgical instrument or tool including multiple motors that can be activated to perform various functions in accordance with at least one aspect of the present disclosure.

Fig. 17 is a schematic view of a robotic surgical instrument configured to operate a surgical tool described herein, according to at least one aspect of the present disclosure.

Fig. 18 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.

Fig. 19 is a schematic view of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure.

Fig. 20 is a system configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, according to at least one aspect of the present disclosure.

Fig. 21 illustrates an example of a generator in accordance with at least one aspect of the present disclosure.

Fig. 22 is a surgical system including a generator and various surgical instruments that may be used therewith according to at least one aspect of the present disclosure.

Fig. 23 is an end effector according to at least one aspect of the present disclosure.

Fig. 24 is an illustration of the surgical system of fig. 22 in accordance with at least one aspect of the present disclosure.

Fig. 25 is a model illustrating dynamic branch current in accordance with at least one aspect of the present disclosure.

Fig. 26 is a structural view of a generator architecture according to at least one aspect of the present disclosure.

Fig. 27A-27C are functional views of a generator architecture according to at least one aspect of the present disclosure.

Fig. 28A-28B are structural and functional aspects of a generator according to at least one aspect of the present disclosure.

FIG. 29 is a schematic diagram of one aspect of an ultrasonic drive circuit.

Fig. 30 is a schematic diagram of a control circuit according to at least one aspect of the present disclosure.

Fig. 31 illustrates a simplified circuit block diagram showing another circuit included within a modular ultrasonic surgical instrument, in accordance with at least one aspect of the present disclosure.

Fig. 32 illustrates a generator circuit divided into a plurality of stages according to at least one aspect of the present disclosure.

Fig. 33 illustrates a generator circuit divided into a plurality of stages, wherein a first stage circuit is common to a second stage circuit, in accordance with at least one aspect of the present disclosure.

Fig. 34 is a schematic diagram of one aspect of a drive circuit configured to drive high frequency current (RF) in accordance with at least one aspect of the present disclosure.

Fig. 35 illustrates one aspect of a basic architecture of a digital synthesis circuit, such as a Direct Digital Synthesis (DDS) circuit, configured to generate a plurality of wave shapes for electrical signal waveforms in a surgical instrument, in accordance with at least one aspect of the present disclosure.

Fig. 36 illustrates one aspect of a Direct Digital Synthesis (DDS) circuit configured to generate a plurality of wave shapes for an electrical signal waveform in a surgical instrument, in accordance with at least one aspect of the present disclosure.

Fig. 37 illustrates one cycle of a discrete-time digital electrical signal according to at least one aspect of the present disclosure in terms of an analog waveform (shown superimposed over a discrete-time digital electrical signal waveform for comparison purposes), in accordance with at least one aspect of the present disclosure.

Fig. 38 is an illustration of a control system configured to provide gradual closure of the closure member as the closure member is advanced distally to close the clamp arms to apply a closing force load at a desired rate according to one aspect of the present disclosure.

FIG. 39 illustrates a proportional-integral-derivative (PID) controller feedback control system according to an aspect of the present disclosure.

Fig. 40 is a system diagram of a segmented circuit including a plurality of independently operating circuit segments, according to at least one aspect of the present disclosure.

Fig. 41 is a circuit diagram of various components of a surgical instrument having motor control functionality in accordance with at least one aspect of the present disclosure.

FIG. 42 is an alternative system for controlling the frequency and detecting the impedance of an ultrasound electromechanical system according to at least one aspect of the present disclosure.

FIG. 43A is a graphical representation of impedance phase angle as a function of resonant frequency for the same ultrasonic device having cold (blue) and warm (red) ultrasonic blades; and is

FIG. 43B is a graphical representation of impedance magnitude as a function of resonant frequency for the same ultrasonic device with a cool (blue) and warm (red) ultrasonic blade.

Fig. 44 is a schematic diagram of a kalman filter to improve a temperature estimator and a state space model based on impedances on an ultrasound transducer measured at multiple frequencies, according to at least one aspect of the present disclosure.

FIG. 45 is a block diagram of three probability distributions that the state estimator of the Kalman filter shown in FIG. 44 uses to maximize the estimation, in accordance with at least one aspect of the present disclosure.

Figure 46A is a graphical representation of the temperature of an ultrasound device reaching a maximum temperature of 490 c without temperature control versus time.

Figure 46B is a graphical representation of the temperature of an ultrasound device reaching a maximum temperature of 320 ℃ with temperature control over time, according to at least one aspect of the present disclosure.

47A-47B are illustrations of adjusting ultrasonic power applied to an ultrasonic transducer upon detection of a sudden drop in temperature of the ultrasonic blade with feedback control, wherein

FIG. 47A is a graphical representation of ultrasound power as a function of time; and is

Fig. 47B is a graph of ultrasonic blade temperature as a function of time in accordance with at least one aspect of the present disclosure.

Fig. 48 is a logic flow diagram depicting a process of controlling a control program or logic configuration of the temperature of the ultrasonic blade in accordance with at least one aspect of the present disclosure.

Fig. 49 is a graphical representation of ultrasonic blade temperature as a function of time during vessel firing according to at least one aspect of the present disclosure.

Fig. 50 is a logic flow diagram depicting a process of controlling a control program or logic configuration that controls the temperature of an ultrasonic blade between two temperature set points in accordance with at least one aspect of the present disclosure.

Fig. 51 is a logic flow diagram depicting a process of determining a control program or logic configuration for an initial temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure.

Fig. 52 is a logic flow diagram depicting a process of a control program or logic configuration that determines when an ultrasonic blade is approaching instability and then adjusts the power to the ultrasonic transducer to prevent instability of the ultrasonic transducer, in accordance with at least one aspect of the present disclosure.

Fig. 53 is a logic flow diagram depicting a process of providing a control program or logic configuration for ultrasonic sealing with temperature control in accordance with at least one aspect of the present disclosure.

Fig. 54 is a graphical representation of ultrasonic transducer current and ultrasonic blade temperature as a function of time in accordance with at least one aspect of the present disclosure.

Fig. 55 is a bottom view of an ultrasonic end effector showing a clamp arm and an ultrasonic blade and depicting tissue positioned within the ultrasonic end effector in accordance with at least one aspect of the present disclosure.

Fig. 56 is a graphical representation depicting the change in impedance of an ultrasound transducer as a function of the position of tissue within an ultrasonic end effector over a range of predetermined ultrasonic generator power level increases in accordance with at least one aspect of the present disclosure.

Fig. 57 is a graphical representation depicting changes in impedance of an ultrasound transducer as a function of time relative to the position of tissue within an ultrasonic end effector in accordance with at least one aspect of the present disclosure.

Fig. 58 is a logic flow diagram depicting a process of identifying a control program or logic configuration for operation within a non-therapeutic power range applied to an ultrasound transducer to determine tissue localization in accordance with at least one aspect of the present disclosure.

FIG. 59 illustrates one aspect of an end effector of an ultrasonic surgical instrument including an Infrared (IR) sensor on a jaw member according to at least one aspect of the present disclosure.

FIG. 60 illustrates one aspect of a flexible circuit on which the IR sensor shown in FIG. 59 may be mounted or integrally formed, according to one aspect of the present disclosure.

Fig. 61 is a cross-sectional view of an ultrasonic end effector including a clamp arm and an ultrasonic blade according to at least one aspect of the present disclosure.

Fig. 62 illustrates an IR refractive index detection sensor circuit mounted on a flexible circuit substrate, shown in plan view, in accordance with at least one aspect of the present disclosure.

Fig. 63 is a logic flow diagram depicting a process of a control program or logic configuration that measures IR reflectance to determine tissue composition to tune the amplitude of an ultrasound transducer in accordance with at least one aspect of the present disclosure.

Fig. 64A is a graphical representation of the closing rate of a gripping arm identifying collagen transition points versus time, with time shown along the horizontal axis and gripping arm position changes shown along the vertical axis, in accordance with at least one aspect of the present disclosure, in accordance with various aspects of the present disclosure.

Fig. 64B is an enlarged portion of the graphical representation shown in fig. 64A.

Fig. 65 is a logic flow diagram depicting a process of a control program or logic configuration that detects a collagen transition point to control a closing rate of a clamp arm or an amplitude of an ultrasound transducer in accordance with at least one aspect of the present disclosure.

Fig. 66 is a graphical representation of identifying collagen transition temperature points to identify collagen/elastin ratios according to various aspects of the present disclosure, wherein tissue temperature is shown along the horizontal axis and ultrasound transducer impedance is shown along the vertical axis, according to at least one aspect of the present disclosure.

Fig. 67 is a logic flow diagram depicting a process of identifying a collagen transition temperature to identify a control program or logic configuration of a collagen/elastin ratio, according to at least one aspect of the present disclosure.

Fig. 68 is a graphical representation of a distribution of compressive load on an ultrasonic blade in accordance with at least one aspect of the present disclosure.

Fig. 69 is a graphical representation of pressure applied to tissue versus time in accordance with at least one aspect of the present disclosure.

FIG. 70 illustrates an end effector including a single jaw electrode array for detecting tissue location according to at least one aspect of the present disclosure.

Fig. 71 is an activation matrix of the single-jaw electrode array of fig. 70 in accordance with at least one aspect of the present disclosure.

Fig. 72 illustrates an end effector including a dual jaw electrode array for detecting tissue location according to at least one aspect of the present disclosure.

Fig. 73 is an activation matrix of the dual-jaw electrode array of fig. 72, according to at least one aspect of the present disclosure.

Fig. 74 illustrates opposing sets of electrodes covering tissue grasped by an end effector corresponding to the activation matrix on fig. 73 in accordance with at least one aspect of the present disclosure.

Fig. 75 illustrates an end effector including a dual-jaw segmented electrode array in accordance with at least one aspect of the present disclosure.

Fig. 76 illustrates tissue covering a jaw including a segmented electrode array in accordance with at least one aspect of the present disclosure.

Fig. 77 is a schematic diagram of a segmented electrode array circuit including a band pass filter according to at least one aspect of the present disclosure.

Fig. 78 is a graphical representation of a frequency response corresponding to the tissue grasped in fig. 76, in accordance with at least one aspect of the present disclosure.

FIG. 79 is a graphical representation of frequency of an ultrasonic transducer system as a function of drive frequency and ultrasonic blade temperature drift according to at least one aspect of the present disclosure.

Fig. 80 is a graphical representation of temperature of an ultrasound transducer as a function of time in accordance with at least one aspect of the present disclosure.

FIG. 81 is a graphical representation of modal shift of resonant frequency based on temperature of an ultrasonic blade moving resonant frequency as a function of temperature of the ultrasonic blade in accordance with at least one aspect of the present disclosure.

Fig. 82 is a spectrum of an ultrasonic surgical instrument having a plurality of different states and conditions of an end effector, wherein the phase and magnitude of the impedance of the ultrasonic transducer is plotted as a function of frequency, according to at least one aspect of the present disclosure.

Fig. 83 is a method of classifying data based on a set of training data S, where ultrasound transducer impedance magnitude and phase are plotted as a function of frequency, according to at least one aspect of the present disclosure.

Fig. 84 is a logic flow diagram depicting a control program or logic configuration for determining jaw condition based on a complex impedance signature pattern (fingerprint) in accordance with at least one aspect of the present disclosure.

Fig. 85 is a timeline depicting situational awareness for a surgical hub, according to at least one aspect of the present disclosure.

Detailed Description

The applicant of the present patent application owns the following U.S. patent applications filed on 28/8/2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. patent application Ser. No. END8536USNP2/180107-2 entitled estimated State OF an ULTRASONIC END EFFECTOR AND its control System (ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR);

U.S. patent application Ser. No. END8560USNP2/180106-2 entitled ULTRASONIC END EFFECTOR TEMPERATURE CONTROL AND CONTROL System thereof (TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR);

U.S. patent application Ser. No. END8561USNP1/180144-1 entitled RADIO FREQUENCY energy device FOR DELIVERING combined electrical SIGNALS (RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMMUNICATIONS SIGNALS);

U.S. patent application Ser. No. END8563USNP1/180139-1 entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT (control AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUELOCATION) depending on tissue location;

U.S. patent application Ser. No. END8563USNP2/180139-2 entitled CONTROLLING the ACTIVATION OF AN ULTRASONIC surgical instrument based on the presence OF TISSUE (relating activity OF AN ULTRASONIC surgical instrument TO THE PRESENCE OF TISSUE);

U.S. patent application publication No. END8563USNP3/180139-3, entitled determining tissue composition via ultrasound system (DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM);

U.S. patent application Ser. No. END8563USNP5/180139-5, entitled determining ULTRASONIC END EFFECTOR status (DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR);

U.S. patent application Ser. No. END8564USNP1/180140-1 entitled SITUATIONAL AWARENESS for ELECTROSURGICAL SYSTEMS (SITUATIONAL AWARENESS OF ELECTROTROSURGICAL SYSTEMS);

U.S. patent application publication number END8564USNP2/180140-2 entitled mechanism for controlling different electromechanical systems of an electrosurgical instrument (MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICALSYSTEMS OF AN ELECTROSURGICAL INSTRUMENT);

U.S. patent application Ser. No. END8564USNP3/180140-3 entitled detecting END EFFECTOR IMMERSION IN LIQUID (DETECTION OF END EFFECTOR IMMERSION IN LIQUID);

U.S. patent application publication No. END8565USNP1/180142-1 entitled ENERGY INTERRUPTION DUE TO improper capacitive coupling (INTERRUPTION OF ENERGY DUE TO insulation Capacitvenent Capacitveceoupling);

U.S. patent application publication number END8565USNP2/180142-2 entitled increasing radio frequency to create a padless unipolar LOOP (INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP);

U.S. patent application publication No. END8566USNP1/180143-1 entitled BIPOLAR COMBINATION device for automatic pressure adjustment BASED ON ENERGY MODALITY (BIPOLAR COMBINATION DEVICE THAT automatic adjustment using pressure BASED ON ENERGY mode); and

U.S. patent application publication number END8573USNP1/180145-1 entitled ACTIVATION OF energy device (activity OF ENERGY DEVICES).

The applicant of the present patent application owns the following U.S. patent applications filed on 23.8.2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application 62/721,995 entitled CONTROLLING ULTRASONIC SURGICAL INSTRUMENTs (CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT) based on TISSUE LOCATION;

U.S. provisional patent application 62/721,998 entitled situational awareness for ELECTROSURGICAL SYSTEMS (SITUATIONALAWARENESS OF ELECTROROSURGICAL SYSTEMS);

us provisional patent application 62/721,999 entitled ENERGY INTERRUPTION DUE TO improper capacitive COUPLING (INTERRUPTION OF ENERGY TO INADVERTENT CAPACITIVE COUPLING);

U.S. provisional patent application 62/721,994 entitled BIPOLAR COMBINATION device for automatic PRESSURE adjustment based on ENERGY MODALITY (BIPOLAR COMBINATION DEVICE THAT automatic adjustment system for PRESSURE adjustment in a BIPOLAR system); and

us provisional patent application 62/721,996 entitled RADIO FREQUENCY energy device (RADIO FREQUENCY resonance ENERGY DEVICE FOR delayed combination ELECTRICAL SIGNALS) FOR DELIVERING a COMBINED electrical signal.

The applicant of the present patent application owns the following U.S. patent applications filed on 30.6.2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application 62/692,747 entitled Smart ACTIVATION OF energy DEVICE BY ANOTHER DEVICE (SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE);

U.S. provisional patent application 62/692,748 entitled SMART energy architecture (SMART energy architecture); and

us provisional patent application 62/692,768 entitled smart energy device (SMART ENERGYDEVICES).

The applicant of the present patent application owns the following U.S. patent applications filed on 29.6.2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. patent application serial No. 16/024,090, entitled capacitively coupled return path pad with SEPARABLE array elements (CAPACITIVE COUPLED RETURN PATH PAD WITH seperable ARRAY ELEMENTS);

U.S. patent application Ser. No. 16/024,057, entitled CONTROLLING SURGICAL INSTRUMENTs (control A SURGICAL INSTRUMENT) based on SENSED CLOSURE PARAMETERS;

U.S. patent application Ser. No. 16/024,067, entitled System FOR ADJUSTING END EFFECTOR PARAMETERS BASED on perioperative INFORMATION (SYSTEM FOR ADJUSE END EFFECTOR PARAMETERS BASED ONPERIORATIVE INFORMATION);

U.S. patent application serial No. 16/024,075, entitled safety system FOR intelligently POWERED SURGICAL suturing (SAFETY SYSTEMS FOR SMART POWERED SURGICAL suturing);

U.S. patent application serial No. 16/024,083, entitled safety system FOR intelligently POWERED SURGICAL suturing (SAFETY SYSTEMS FOR SMART POWERED SURGICAL suturing);

U.S. patent application Ser. No. 16/024,094, entitled SURGICAL System FOR detecting end EFFECTOR TISSUE irregularities (SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGORATITIES);

U.S. patent application Ser. No. 16/024,138, entitled System FOR DETECTING PROXIMITY OF a SURGICAL END EFFECTOR to cancerous TISSUE (SYSTEM FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE);

U.S. patent application Ser. No. 16/024,150, entitled SURGICAL INSTRUMENT CARTRIDGE SENSOR Assembly (SURGICAL Instrument Cartridge SENSOR Assembly);

U.S. patent application serial No. 16/024,160, entitled VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY (VARIABLE OUTPUT SENSOR ASSEMBLY);

U.S. patent application Ser. No. 16/024,124, entitled SURGICAL Instrument with Flexible ELECTRODEs (SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE);

U.S. patent application Ser. No. 16/024,132, entitled SURGICAL Instrument with Flexible Circuit (SURGICAL INSTRUMENT HAVING A FLEXIBLE CICUIT);

U.S. patent application Ser. No. 16/024,141, entitled SURGICAL Instrument WITH TISSUE MARKING Assembly (SURGICAL Instrument WITH A TISSUE MARKING Assembly);

U.S. patent application serial No. 16/024,162, entitled SURGICAL system with PRIORITIZED DATA TRANSMISSION CAPABILITIES (SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES);

U.S. patent application Ser. No. 16/024,066 entitled SURGICAL EVACUATION sensing and Motor CONTROL (SURGICAL EVACUTION SENSING AND MOTOR CONTROL);

U.S. patent application Ser. No. 16/024,096, entitled SURGICAL EVACUATION SENSOR arrangement (SURGICAL EVACUTION SENSOR ARRANGEMENTS);

U.S. patent application Ser. No. 16/024,116, entitled surgical evacuation FLOW Path (SURGICALEVACUATION FLOW PATHS);

U.S. patent application Ser. No. 16/024,149, entitled SURGICAL EVACUATION sensing and Generator CONTROL (SURGICAL EVACUTION SENSING AND GENERATOR CONTROL);

U.S. patent application Ser. No. 16/024,180, entitled surgical evacuation sensing and display (SURGICALEVACUATION SENSING AND DISPLAY);

U.S. patent application Ser. No. 16/024,245, entitled System FOR conveying Smoke EVACUATION System parameters TO a HUB OR CLOUD IN a Smoke EVACUATION Module FOR an Interactive surgical PLATFORM (COMMUNICATION OF SMOKE EVACUATION SYSTEMPARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATYING);

U.S. patent application serial No. 16/024,258, entitled SMOKE EVACUATION SYSTEM INCLUDING segmented control circuits FOR an INTERACTIVE SURGICAL PLATFORM (SMOKE evacution SYSTEM in recording A SEGMENTED control computer program FOR INTERACTIVE SURGICAL PLATFORM);

U.S. patent application Ser. No. 16/024,265, entitled SURGICAL EVACUATION System with COMMUNICATION circuitry FOR COMMUNICATION BETWEEN Filter and fume extractor (SURGICAL EVACUTION SYSTEM WITH A COMMUNICATIONCIRCUIT FOR COMMUNICATIONBETWEEN A FILTER AND A SMOKE EVACUTION DEVICE); and

U.S. patent application Ser. No. 16/024,273, entitled Dual IN-line Large and Small DROPLET FILTERS (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 2018, 6/28, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. provisional patent application serial No. 62/691,228, entitled a Method of using an enhanced flex circuit having multiple sensors with electrosurgical devices (a Method of using a re-formed flex circuit with multiple sensors with electronic devices);

U.S. provisional patent application serial No. 62/691,227, entitled controlling surgical instruments (controlled a surgical instrument) based on sensed closure parameters;

U.S. provisional patent application serial No. 62/691,230, entitled SURGICAL INSTRUMENT with FLEXIBLE ELECTRODEs (SURGICAL INSTRUMENT);

U.S. provisional patent application serial No. 62/691,219, entitled SURGICAL EVACUATION sensing and MOTOR CONTROL (SURGICAL EVACUTION SENSING AND MOTOR CONTROL);

U.S. provisional patent application serial No. 62/691,257, entitled system FOR delivering SMOKE EVACUATION system parameters TO a HUB OR CLOUD IN a SMOKE EVACUATION MODULE FOR an interactive surgical PLATFORM (composite of SMOKE EVACUATION system TO HUB OR CLOUD IN SMOKE EVACUATION MODULE);

U.S. provisional patent application serial No. 62/691,262, entitled SURGICAL extraction system with COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN filter and smoke exhaust (SURGICAL extraction system SYSTEM WITH optical extraction CIRCUIT FOR COMMUNICATION BETWEEN filter and smoke exhaust A FILTER AND A microwave extraction DEVICE); and

U.S. provisional patent application serial No. 62/691,251, entitled DUAL tandem macroand minidroplet FILTERS (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 2018, 4/19, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. provisional patent application serial No. 62/659,900, entitled hub COMMUNICATION METHOD (METHOD office COMMUNICATION).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 30/3/2018, the disclosures of each of which are incorporated herein by reference in their entirety:

us provisional patent application 62/650,898 filed 3, 30, 2018, entitled capacitively coupled return path pad (CAPACITIVE COUPLED RETURN PATH PAD WITHSEPARABLE ARRAY ELEMENTS) with separable array elements;

U.S. provisional patent application serial No. 62/650,887, entitled SURGICAL system with OPTIMIZED SENSING CAPABILITIES (SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES);

U.S. patent application Ser. No. 62/650,882, entitled Smoke EVACUATION Module FOR Interactive SURGICAL PLATFORM (SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATTOM); and

U.S. patent application serial No. 62/650,877, entitled surgical smoke sensing and control (SURGICALSMOKE evacution SENSING AND CONTROLS).

The applicant of the present patent application owns the following U.S. patent applications filed on 29/3/2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. patent application serial No. 15/940,641, entitled interactive surgical system with encrypted COMMUNICATION capability (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES);

U.S. patent application serial No. 15/940,648, entitled interactive surgical system with CONDITION processing device and data capability (INTERACTIVE SURGICAL SYSTEMS WITH CONDITION manual OF DEVICESAND DATA CAPABILITIES);

U.S. patent application Ser. No. 15/940,656, entitled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION for operating room DEVICES (SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING DEVICES);

U.S. patent application serial No. 15/940,666, entitled spatial perception OF a SURGICAL hub IN an OPERATING room (SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS);

U.S. patent application Ser. No. 15/940,670, entitled COOPERATIVE UTILIZATION OF data derived FROM secondary sources BY an Intelligent SURGICAL hub (COOPERATIVE diagnosis OF DATA DERIVED FROM SECONDARY OURCES BY INTELLIGENT SURGICAL HUBS);

U.S. patent application Ser. No. 15/940,677, entitled SURGICAL HUB CONTROL arrangement (SURGICAL HUB CONTROL ARRANGEMENTS);

U.S. patent application Ser. No. 15/940,632, entitled data stripping METHOD for data interrogation of PATIENT RECORDS and creation of anonymous RECORDS (DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORD and ANDCREATE ANONYMIZED RECORD);

U.S. patent application Ser. No. 15/940,640, entitled COMMUNICATION HUB AND storage DEVICE FOR STORING parameters AND conditions OF a SURGICAL DEVICE TO BE shared with a CLOUD-BASED analysis system (COMMUNICATION HUB AND STORAGE EVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS);

U.S. patent application Ser. No. 15/940,645, entitled SELF DESCRIBING data packet generated at ISSUING INSTRUMENT (SELF description DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT);

U.S. patent application Ser. No. 15/940,649, entitled data pairing for interconnecting DEVICE measurement parameters with results (DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH ANOUTCOME);

U.S. patent application Ser. No. 15/940,654, entitled surgical hub SITUATIONAL AWARENESS (SURGICALHUB SITUATIONAL AWARENESS);

U.S. patent application Ser. No. 15/940,663, entitled surgical System DISTRIBUTED PROCESSING (SURGICAL SYSTEMS DISTRIBUTED PROCESSING);

U.S. patent application Ser. No. 15/940,668, entitled AGGREGATION AND REPORTING OF SURGICAL HUB DATA (AGGREGATION AND REPORTING OF SURGICAL HUB DATA);

U.S. patent application serial No. 15/940,671, entitled SURGICAL HUB spatial perception for determining devices in an operating room (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN operatingtheother);

U.S. patent application Ser. No. 15/940,686, entitled showing ALIGNMENT OF staple cartridges with a previously linear staple line (DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE);

U.S. patent application Ser. No. 15/940,700, entitled sterile field Interactive CONTROLs display (STERILEFIELD INTERACTIVE CONTROL DISPLAY);

U.S. patent application Ser. No. 15/940,629, entitled COMPUTER-implemented Interactive SURGICAL System (COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS);

U.S. patent application Ser. No. 15/940,704, entitled "determining characteristics OF backscattered light Using laser light and Red-Green-BLUE COLORATION" (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINONEPIERTIES OF BACK SCATTERED LIGHT);

U.S. patent application Ser. No. 15/940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES by USE OF monochromatic light refractive index" (CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY); and

U.S. patent application serial No. 15/940,742 entitled DUAL CMOS array imaging (DUAL CMOS imaging).

U.S. patent application Ser. No. 15/940,636, entitled ADAPTIVE CONTROL PROGRAM update FOR SURGICAL DEVICES (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);

U.S. patent application Ser. No. 15/940,653, entitled ADAPTIVE CONTROL PROGRAM update FOR SURGICAL hub (ADAPTIVE CONTROL PROGRAM update FOR SURGICAL hub);

U.S. patent application Ser. No. 15/940,660, entitled CLOUD-BASED medical analysis FOR CUSTOMIZATION AND recommendation to USERs (CLOOUD-BASED MEDICAL ANALYTICS FOR CURSTOMIZATION AND RECOMMENDITIONSTO A USER);

U.S. patent application Ser. No. 15/940,679, entitled CLOUD-BASED medical analysis for linking LOCAL USAGE trends with RESOURCE ACQUISITION behavior for larger DATA SETs (CLOOUD-BASED MEDICAL ANALYTICS FORLINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEOL RS OFLARGER DATA SET);

U.S. patent application serial No. 15/940,694, entitled CLOUD-BASED medical analysis OF medical facilities FOR personalizing INSTRUMENT FUNCTION segments (CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITYSEGMENTED differentiation OF inertial FUNCTIONs);

U.S. patent application Ser. No. 15/940,634, entitled CLOUD-BASED medical analysis FOR Security and certification trends and reactivity measurements (CLOOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTATION TRENDS AND REACTIVE MEASURES);

U.S. patent application serial No. 15/940,706 entitled data processing and priority IN CLOUD analysis NETWORKs (DATA HANDLING AND priority IN a CLOUD analysis NETWORK); and

U.S. patent application serial No. 15/940,675, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES (CLOUD INTERFACE FOR coated led DEVICES).

U.S. patent application Ser. No. 15/940,627, entitled drive arrangement FOR a robotic-ASSISTED SURGICAL platform (DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLANTSS);

U.S. patent application Ser. No. 15/940,637, entitled COMMUNICATION arrangement FOR a robotic ASSISTED surgery platform (COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,642, entitled control FOR a robotically-ASSISTED SURGICAL platform (controlfor ROBOT-ASSISTED surgery PLATS);

U.S. patent application Ser. No. 15/940,676, entitled AUTOMATIC TOOL adjustment FOR robotically-ASSISTED SURGICAL PLATFORMS (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,680, entitled controller FOR a robotic-ASSISTED SURGICAL platform (controlers FOR ROBOT-ASSISTED SURGICAL platform);

U.S. patent application Ser. No. 15/940,683, entitled collaborative SURGICAL action FOR a robotically ASSISTED SURGICAL platform (collaborative SURGICAL action FOR Robot-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,690, entitled display arrangement FOR a robotic-ASSISTED SURGICAL platform (DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLANTSM); and

U.S. patent application serial No. 15/940,711, entitled sensing arrangement FOR a robotic-ASSISTED SURGICAL platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED surgery platformes).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 2018, 3, 28, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. provisional patent application serial No. 62/649,302, entitled interactive surgical system with encrypted communication capability (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED communicative capabilities);

U.S. provisional patent application serial No. 62/649,294, entitled data stripping METHOD for interrogating PATIENT RECORDS and creating anonymous RECORDS (DATA STRIPPING METHOD TO interface PATIENT RECORDS and anonymous RECORDS);

U.S. patent application Ser. No. 62/649,300, entitled surgical hub SITUATIONAL AWARENESS (SURGICALHUB SITUATIONAL AWARENESS);

U.S. provisional patent application serial No. 62/649,309, entitled SURGICAL HUB spatial perception for determining devices in an operating room (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER);

U.S. patent application Ser. No. 62/649,310, entitled COMPUTER-implemented Interactive SURGICAL System (COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS);

U.S. provisional patent application serial No. 62/649,291, entitled "USE OF laser and red, GREEN, BLUE COLORATION TO determine the characteristics OF backscattered light" (USE OF LASER LIGHT AND RED-GREEN-BLUE color TO detection OF particles OF BACK SCATTERED LIGHT);

U.S. patent application Ser. No. 62/649,296, entitled ADAPTIVE CONTROL PROGRAM update FOR SURGICAL DEVICES (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);

U.S. provisional patent application serial No. 62/649,333, entitled CLOUD-BASED medical analysis FOR CUSTOMIZATION and recommendation TO USERs (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION and computing services TO a USER);

U.S. provisional patent application serial No. 62/649,327, entitled CLOUD-BASED medical analysis FOR SECURITY and certification trends and reactivity measurements (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY and identification TRENDS AND REACTIVE MEASURES);

U.S. provisional patent application serial No. 62/649,315 entitled data processing and priority IN CLOUD analysis NETWORKs (DATA HANDLING AND priority IN a CLOUD analysis NETWORK);

U.S. patent application serial No. 62/649,313, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES (CLOUD INTERFACE FOR coated led DEVICES);

U.S. patent application Ser. No. 62/649,320, entitled drive arrangement FOR a robotic-ASSISTED SURGICAL platform (DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLANTSS);

U.S. provisional patent application serial No. 62/649,307, entitled AUTOMATIC TOOL adjustment FOR robotic ASSISTED SURGICAL platform (AUTOMATIC TOOL adjustment FOR ROBOT ASSISTED SURGICAL platform); and

U.S. provisional patent application serial No. 62/649,323, entitled sensing arrangement FOR a robotic-ASSISTED SURGICAL platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL platform).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 8/3/2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application serial No. 62/640,417 entitled TEMPERATURE CONTROL IN an ultrasound device and CONTROL system therefor (temparature CONTROL IN ULTRASONIC DEVICE AND CONTROL system for); and

U.S. provisional patent application serial No. 62/640,415, entitled estimating the state OF an ULTRASONIC END EFFECTOR AND a control system THEREFOR (ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM tool thermally).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 2017, 12, 28, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. provisional patent application serial No. 62/611,341, entitled interactive surgical PLATFORM (interactive surgical PLATFORM);

U.S. provisional patent application serial No. 62/611,340, entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS); and

U.S. patent application serial No. 62/611,339, entitled robot-assisted SURGICAL PLATFORM (robot assisted surgery).

Before explaining various aspects of the surgical device and generator in detail, it should be noted that the example illustrated application or use is not limited to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative examples may be implemented alone or in combination with other aspects, variations and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments for the convenience of the reader and are not for the purpose of limiting the invention. Moreover, it is to be understood that expressions of one or more of the following described aspects, and/or examples may be combined with any one or more of the other below described aspects, and/or examples.

Various aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of an ultrasonic surgical device may be configured for transecting and/or coagulating tissue, for example, during a surgical procedure. Aspects of the electrosurgical device may be configured for transecting, coagulating, targeting, welding, and/or drying tissue, for example, 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., cloud 104, which may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with cloud 104, which may include a remote server 113. In one example, as shown in fig. 1, the surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld smart surgical instrument 112 configured to communicate with each other and/or with the hub 106. In some aspects, surgical system 102 may include M number of hubs 106, N number of visualization systems 108, O number of robotic systems 110, and P number of handheld intelligent surgical instruments 112, where M, N, O and P are integers greater than or equal to one.

Fig. 3 depicts an example of a surgical system 102 for performing a surgical procedure on a patient lying on a surgical table 114 in a surgical suite 116. The robotic system 110 is used as part of the surgical system 102 in a surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 117 can manipulate at least one removably coupled surgical tool 118 through a minimally invasive incision in the patient's body as the surgeon views the surgical site through the surgeon's console 120. An image of the surgical site may be obtained by the medical imaging device 124, which may be manipulated by the patient side cart 120 to orient the imaging device 124. The robot hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.

Other types of robotic systems may be readily adapted for use with the surgical system 102. Various examples of robotic systems and SURGICAL tools suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,339 entitled ROBOT ASSISTED SURGICAL PLATFORM (ROBOT ASSISTED SURGICAL PLATFORM), filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.

Various examples of CLOUD-BASED analyses performed by the CLOUD 104 and suitable for use with the present disclosure are described in U.S. provisional patent application serial No. 62/611,340 entitled "CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS)" filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.

In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, Charge Coupled Device (CCD) sensors and Complementary Metal Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or more illumination sources and/or one or more lenses. One or more illumination sources may be directed to illuminate portions of the surgical field. The one or more image sensors may receive light reflected or refracted 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 radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum (sometimes referred to as the optical spectrum or the luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye, and may be referred to as visible light or simple light. A typical human eye will respond to wavelengths in air from about 380nm to about 750 nm.

The invisible spectrum (i.e., the non-luminescent spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380nm and above about 750 nm). The human eye cannot detect the invisible spectrum. Wavelengths greater than about 750nm are longer than the red visible spectrum and they become invisible Infrared (IR), microwave and radio electromagnetic radiation. Wavelengths less than about 380nm are shorter than the violet spectrum and they become invisible ultraviolet, x-ray and gamma-ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophago-duodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-nephroscopes, sigmoidoscopes, thoracoscopes, and intrauterine scopes.

In one aspect, the imaging device employs multispectral monitoring to distinguish topography from underlying structures. A multispectral image is an image that captures image data across a particular range of wavelengths of the electromagnetic spectrum. The wavelengths may be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible range, such as IR and ultraviolet. Spectral imaging may allow extraction of additional information that the human eye fails to capture with its red, green, and blue receptors. Use of multispectral imaging is described in more detail under the heading "advanced imaging Acquisition Module" of U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICALPLATFORM)", filed 2017, 12, 28, the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring may be a useful tool for repositioning the surgical site after completion of a surgical task to perform one or more of the previously described tests on the treated tissue.

It is self-evident that strict disinfection of the operating room and surgical equipment is required during any surgery. The stringent hygiene and disinfection conditions required in a "surgical room" (i.e., an operating room or a treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is any substance that needs to be sterilized, including the imaging device 124 and its attachments and components, in contact with the patient or penetrating the sterile field. It should be understood that a sterile field may be considered a designated area that is considered free of microorganisms, such as within a tray or within a sterile towel, or a sterile field may be considered an area around a patient that has been prepared for a surgical procedure. The sterile field may include a properly worn swabbed team member, as well as all furniture and fixtures in the area.

In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays that are strategically arranged relative to the sterile field, as shown in fig. 2. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the heading "advanced imaging Acquisition Module" of U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICALPLATFORM)", filed 2017, 12, 28, the disclosure of which is incorporated herein by reference in its entirety.

As shown in fig. 2, a main display 119 is positioned in the sterile field to be visible to the operator at the surgical table 114. Further, the visualization tower 111 is positioned 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. Visualization system 108, guided by hub 106, is configured to utilize

displays

107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, the hub 106 may cause the imaging system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the

non-sterile display

107 or 109 while maintaining a real-time feed of the surgical site on the main display 119. A snapshot on

non-sterile display

107 or 109 may allow a non-sterile operator to, for example, perform diagnostic steps related to a surgical procedure.

In one aspect, hub 106 is further configured to route diagnostic inputs or feedback entered by non-sterile operators at visualization tower 111 to main display 119 within the sterile field, where it can be viewed by sterile operators on the operating floor. In one example, the input may be a modified form of a snapshot displayed on

non-sterile display

107 or 109, which may be routed through hub 106 to main display 119.

Referring to fig. 2, a surgical instrument 112 is used in a surgical procedure as part of the surgical system 102. Hub 106 is further configured to coordinate the flow of information to the display of surgical instrument 112. For example, U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic inputs or feedback entered by non-sterile operators at visualization tower 111 may be routed by hub 106 to surgical instrument display 115 within the sterile field, where the inputs or feedback may be viewed by the operator of surgical instrument 112. For example, an exemplary SURGICAL INSTRUMENT suitable for use with the SURGICAL system 102 is described under the heading "SURGICAL INSTRUMENT HARDWARE (SURGICAL INSTRUMENT HARDWARE)" of U.S. provisional patent application serial No. 62/611,341, entitled "interactive SURGICAL platform (INTERACTIVE SURGICAL PLATFORM)", the disclosure of which is incorporated herein by reference in its entirety, filed 2017, 12, month 28.

Referring now to fig. 3, hub 106 is depicted 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 communication 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, energy applied to tissue for sealing and/or cutting is typically associated with smoke evacuation, aspiration of excess fluid, and/or irrigation of the tissue. Fluid lines, power lines, and/or data lines from different sources are often tangled during a surgical procedure. Valuable time may be lost in addressing the problem during a surgical procedure. Disconnecting the lines may require disconnecting the lines from their respective modules, which may require resetting the modules. The hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of entanglement between such lines.

Aspects of the present disclosure provide a surgical hub for a surgical procedure involving application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a composite generator module slidably received in a docking station of the hub housing. The docking station includes data contacts and power contacts. The combined 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 seated in a single cell. In one aspect, the combined generator module further includes a smoke evacuation component for connecting the combined generator module to at least one energy delivery cable of the surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluids, and/or particles generated by application of the therapeutic energy to the tissue, 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 a suction and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.

Certain surgical procedures may require more than one energy type to be applied to the tissue. One energy type may be more advantageous for cutting tissue, while a different energy type may be more advantageous for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication therebetween. One of the advantages of the hub modular housing 136 is the ability to quickly remove and/or replace various modules.

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

as further described above, the modular surgical housing further includes a second energy generator module configured to generate a second energy different from the first energy for application to tissue, and a second docking station including a second docking port including a second data and power contact, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contact, and wherein the second energy generator is slidably movable out of electrical contact with the second power and data contact.

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

Referring to fig. 3-7, aspects of the present disclosure are presented as a hub modular housing 136 that allows for modular integration of the generator module 140, smoke evacuation module 126, and suction/irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the

modules

140, 126, 128. As shown in fig. 5, the generator module 140 may be a generator module with integrated monopolar, bipolar, and ultrasound components supported in a single housing unit 139 that is slidably inserted into the hub modular housing 136. As shown in fig. 5, the generator module 140 may be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasound device 148. Alternatively, the generator modules 140 may include a series of monopole generator modules, bipolar generator modules, and/or ultrasonic generator modules that interact through the hub modular housing 136. The hub modular housing 136 may be configured to facilitate the insertion of multiple generators and the interactive communication between generators docked into the hub modular housing 136 such that the generators will act as a single generator.

In one aspect, the hub modular housing 136 includes a modular power and communications backplane 149 having external and wireless communications connections to enable removable attachment of the

modules

140, 126, 128 and interactive communications therebetween.

In one aspect, the hub modular housing 136 includes a docking cradle or drawer 151 (also referred to herein as a drawer) configured to slidably receive the

modules

140, 126, 128. Fig. 4 illustrates a partial perspective view of the surgical hub housing 136 and the composite generator module 145 that can be slidably received in the docking station 151 of the surgical hub housing 136. The docking port 152 having power and data contacts on the back of the combined generator module 145 is configured to engage the corresponding docking port 150 with the power and data contacts of the corresponding docking station 151 of the hub module housing 136 when the combined generator module 145 is slid into place within the corresponding docking station 151 of the hub module housing 136. In one aspect, the combined generator module 145 includes bipolar, ultrasonic, and monopolar modules integrated together into a single housing unit 139, as shown in fig. 5.

In various aspects, the smoke evacuation module 126 includes a fluid line 154 that transports captured/collected smoke and/or fluid from the surgical site to, for example, the smoke evacuation module 126. Vacuum suction from smoke evacuation module 126 may draw smoke into the opening of the common conduit at the surgical site. The common conduit coupled to the fluid lines may be in the form of a flexible tube terminating at the smoke evacuation module 126. The common conduit and fluid lines define a fluid path that extends toward the smoke evacuation module 126 received in the hub housing 136.

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

In one aspect, a surgical tool includes a shaft having an end effector at a distal end thereof and at least one energy treatment associated with the end effector, a suction tube, and an irrigation tube. The draft tube may have an inlet at a distal end thereof, and the draft tube extends through the shaft. Similarly, a draft tube may extend through the shaft and may have an inlet adjacent the energy delivery tool. The energy delivery tool is configured to deliver ultrasonic and/or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the shaft.

The irrigation tube may be in fluid communication with a fluid source, and the aspiration tube may be in fluid communication with a vacuum source. The fluid source and/or vacuum source may be seated in the suction/irrigation module 128. In one example, the fluid source and/or vacuum source may be seated in the hub housing 136 independently of the suction/irrigation module 128. In such examples, the fluid interface can connect the suction/irrigation module 128 to a fluid source and/or a vacuum source.

In one aspect, the

modules

140, 126, 128 on the hub modular housing 136 and/or their corresponding docking stations may include alignment features configured to align the docking ports of the modules into engagement with their corresponding ports in the docking stations of the hub modular housing 136. For example, as shown in fig. 4, the combined generator module 145 includes side brackets 155, the side brackets 155 configured to slidably engage with corresponding brackets 156 of corresponding docking mounts 151 of the hub modular housing 136. The brackets cooperate to guide the docking port contacts of the combined generator module 145 into electrical engagement with the docking port contacts of the hub 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 in the drawers 151. For example, the 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 sized differently and are each designed to accommodate a particular module.

In addition, 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 having unmatched contacts.

As shown in fig. 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 by a communication link 157 to facilitate interactive communication between modules seated in the hub modular housing 136. Alternatively or additionally, the docking port 150 of the hub modular housing 136 can facilitate wireless interactive communication between modules seated in the hub modular housing 136. Any suitable wireless communication may be employed, such as, for example, Air Titan-Bluetooth.

Fig. 6 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular housing 160, the lateral modular housing 160 configured to house multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally receive and interconnect the modules 161. The modules 161 are slidably inserted into docking feet 162 of a lateral modular housing 160, which lateral modular housing 160 includes a floor for interconnecting the modules 161. As shown in fig. 6, the modules 161 are arranged laterally in a lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically in a lateral modular housing.

Fig. 7 illustrates a vertical modular housing 164 configured to house a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into docking feet or drawers 167 of a vertical modular housing 164, which vertical modular housing 164 includes a floor for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are arranged vertically, in some cases, the vertical modular housing 164 may include laterally arranged drawers. Further, the modules 165 may interact with each other through docking ports of the vertical modular housing 164. In the example of FIG. 7, a display 177 is provided for displaying data related to the operation of module 165. In addition, the vertical modular housing 164 includes a main module 178 that seats a plurality of sub-modules slidably received in the main module 178.

In various aspects, the imaging module 138 includes an integrated video processor and modular light source, and is adapted for use with a variety of imaging devices. In one aspect, the imaging device is constructed of a modular housing that can be fitted with a light source module and a camera module. The housing may be a disposable housing. In at least one example, the disposable housing is removably coupled to the reusable controller, the light source module, and the camera module. The light source module and/or the camera module may be selectively selected according to 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 scanning beam imaging. Also, the light source module may be configured to deliver white light or different light, depending on the surgical procedure.

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

In one aspect, an imaging device includes a tubular housing including a plurality of channels. The first channel is configured to slidably receive a camera module, which may be configured to snap-fit engage with the first channel. The second channel is configured to slidably receive a light source module, which may be configured to snap-fit engage with the second channel. In another example, the camera module and/or the light source module may be rotated within their respective channels to a final position. Threaded engagement may be used instead of snap-fit engagement.

In various examples, multiple imaging devices are placed at different locations in a surgical field to provide multiple views. The imaging module 138 may be configured to switch between imaging devices to provide an optimal view. In various aspects, the imaging module 138 may be configured to integrate images from different imaging devices.

Various IMAGE PROCESSORs AND imaging devices suitable for use in the present disclosure are described in united states patent 7,995,045 entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR (COMBINED SBI AND associated IMAGE PROCESSOR) published on 9/8/2011, which is incorporated by reference herein in its entirety. Further, U.S. patent 7,982,776 entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD (SBI MOTION ARTIFACT REMOVAL MOTION ARTIFACT AND METHOD), published 7/19/2011, which is incorporated herein by reference in its entirety, describes various systems for removing MOTION ARTIFACTs from image data. Such a system may be integrated with the imaging module 138. Further, U.S. patent application publication 2011/0306840 entitled CONTROLLABLE MAGNETIC SOURCE TO fixture in-vivo device (CONTROLLABLE MAGNETIC SOURCE TO fix tissue APPARATUS application), published 2011, and U.S. patent application publication 2014/0243597 entitled SYSTEM FOR PERFORMING minimally invasive surgical PROCEDUREs (SYSTEM FOR patient protocol A MINIMALLY invasivisable protocol) published 2014, 15/12, each of which is incorporated herein by reference in its entirety.

Fig. 8 illustrates a surgical data network 201 including a modular communication hub 203, the modular communication hub 203 configured to connect modular devices located in one or more operating rooms of a medical facility or any room in the medical facility specifically equipped for surgical operations to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, modular communication hub 203 includes a network hub 207 and/or a network switch 209 that communicate with network routers. Modular communication hub 203 may also be coupled to local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured to be passive, intelligent, or switched. The passive surgical data network acts as a conduit for data, enabling it to be transferred from one device (or segment) to another device (or segment) as well as cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuring each port in the hub 207 or network switch 209. The 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.

The 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 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with the devices 1a-1n may be transmitted via the router to the cloud-based computer for remote data processing and manipulation. Data associated with the devices 1a-1n may also be transmitted to the 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 the network switch 209. Network switch 209 may be coupled to network hub 207 and/or network router 211 to connect devices 2a-2m to cloud 204. Data associated with the devices 2a-2n may be transmitted via the network router 211 to the cloud 204 for data processing and manipulation. Data associated with the devices 2a-2m may also be transmitted to the local computer system 210 for local data processing and manipulation.

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

In one aspect, the surgical data network 201 may include a combination of one or more network hubs, one or more network switches, and one or more network routers that connect the devices 1a-1n/2a-2m to the cloud. Any or all of the devices 1a-1n/2a-2m coupled to the network hub or network switch may collect data in real time and transmit the data into the cloud computer for data processing and manipulation. It should be appreciated that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term "cloud" may be used as a metaphor for "internet," although 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 different services (such as servers, memory, and applications) are delivered to modular communication hub 203 and/or computer system 210 located in a surgical room (e.g., a fixed, mobile, temporary, or live operating room or space) and devices connected to modular communication hub 203 and/or computer system 210 over the internet. The cloud infrastructure may be maintained by a cloud service provider. In this case, the cloud service provider may be an entity that coordinates the use and control of the devices 1a-1n/2a-2m located in one or more operating rooms. Cloud computing services can perform a large amount of computing based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware enables multiple devices or connections to connect to a computer in communication with the cloud computing resources and memory.

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. At least some of the devices 1a-1n/2a-2m may be employed to observe tissue conditions to assess leakage or perfusion of sealed tissue following a tissue sealing and cutting procedure. At least some of the devices 1a-1n/2a-2m may be employed to identify pathologies, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes localization and edge confirmation of tissues and phenotypes. At least some of the devices 1a-1n/2a-2m may be employed to identify anatomical structures of the body using a variety of sensors integrated with the imaging devices and techniques, such as overlaying images captured by multiple imaging devices. The data (including image data) collected by the devices 1a-1n/2a-2m may be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve the surgical procedure outcome by determining whether further treatment can be continued, such as endoscopic intervention, emerging technologies, targeted radiation, targeted intervention, and the application of precision robotics to tissue-specific sites and conditions. Such data analysis may further employ result analysis processing, and using standardized methods may provide beneficial feedback to confirm or suggest modifications to the behavior of the surgical treatment and surgeon.

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 through a wired channel or a wireless channel, depending on the configuration of the devices 1a-1n to the network hub. In one aspect, hub 207 may be implemented as a local network broadcaster operating at the physical layer of the Open Systems Interconnection (OSI) model. The hub provides connectivity to devices 1a-1n located in the same operating room network. The hub 207 collects the data in the form of packets and sends it to the routers in half-duplex mode. Hub 207 does not store any media access control/internet protocol (MAC/IP) used to transmit device data. Only one of the devices 1a-1n may transmit data through the hub 207 at a time. The hub 207 does not have routing tables or intelligence as to where to send information and broadcast all network data on each connection and to the remote server 213 (fig. 9) through the cloud 204. Hub 207 may detect basic network errors such as conflicts, but broadcasting all information to multiple ports may present a security risk and lead to bottlenecks.

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

Network hub 207 and/or network switch 209 are coupled to network router 211 to connect to cloud 204. Network router 211 operates in the network layer of the OSI model. Network router 211 creates a route for transmitting data packets received from network hub 207 and/or network switch 211 to the cloud-based computer resources for further processing and manipulation of data collected by any or all of devices 1a-1n/2a-2 m. Network router 211 may be employed to connect two or more different networks located at different locations, such as, for example, different operating rooms of the same medical facility or different networks located in different operating rooms of different medical facilities. Network router 211 sends data in packets to cloud 204 and operates in full duplex mode. Multiple devices may transmit data simultaneously. The network router 211 transmits data using the IP address.

In one example, hub 207 may be implemented as a USB hub, which allows multiple USB devices to be connected to a host. A USB hub may extend a single USB port to multiple tiers so that more ports are available for connecting devices to a host system computer. Hub 207 may include wired or wireless capabilities for receiving information over a wired channel or a wireless channel. In one aspect, a wireless USB short-range, high bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in an operating room.

In other examples, the operating room devices 1a-1n/2a-2m may communicate with the modular communication hub 203 via the Bluetooth wireless technology standard for exchanging data from fixed and mobile devices over short distances (using short wavelength UHF radio waves of 2.4 to 2.485GHz in the ISM band) and building Personal Area Networks (PANs). In other aspects, the operating room devices 1a-1n/2a-2m may communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE) and Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and above. The computing module may include a plurality of communication modules. For example, a first communication module may be dedicated for shorter range wireless communications such as Wi-Fi and bluetooth, and a second communication module may be dedicated for longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and the like.

The modular communication hub 203 may serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handle a data type called a frame. The frames carry data generated by the devices 1a-1n/2a-2 m. When the modular communication hub 203 receives the frame, it is amplified and transmitted to the network router 211, which network router 211 transmits the data to the cloud computing resources using a plurality of wireless or wired communication standards or protocols as described herein.

Modular communication hub 203 may be used as a stand-alone device or connected to a compatible network hub and network switch to form a larger network. The modular communication hub 203 is generally easy to install, configure and maintain, making it a good option to network the operating room devices 1a-1n/2a-2 m.

Fig. 9 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236, the modular control tower 236 being connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in an operating room. As shown in fig. 10, the modular control tower 236 includes a modular communication hub 203 coupled to the computer system 210. As shown in the example of fig. 9, the modular control tower 236 is coupled to an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke ejector module 226, a suction/irrigation module 228, a communication module 230, a processor module 232, a storage array 234, an intelligent device/instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via modular control tower 236. Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. The devices/instruments 235, visualization system 208, etc. may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 may be coupled to the hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device/instrument display, and/or other visualization system 208. The hub display may also combine the image and the overlay image to display data received from devices connected to the modular control tower.

Fig. 10 shows the surgical hub 206 including a plurality of modules coupled to a modular control tower 236. The modular control tower 236 includes a modular communication hub 203 (e.g., a network connectivity device) and a computer system 210 to provide, for example, local processing, visualization, and imaging. As shown in fig. 10, the modular communication hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communication hub 203 and transmit data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in fig. 10, each of the network hubs/switches in modular communication hub 203 includes three downstream ports and one upstream port. The upstream hub/switch is connected to the processor to provide a communication connection with the cloud computing resources and the local display 217. Communication with the cloud 204 may be through a wired or wireless communication channel.

The surgical hub 206 employs the non-contact sensor module 242 to measure dimensions of the operating room and uses ultrasound or laser type non-contact measurement devices to generate a map of the operating room. An ultrasound-based non-contact sensor module scans an Operating Room by transmitting a burst of ultrasound waves and receiving echoes as it bounces off the enclosure of the Operating Room, as described under U.S. provisional patent application serial No. 62/611,341 entitled "interactive Surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on 12/28 2017, entitled "Surgical Hub space sensing in an Operating Room," which is incorporated herein by reference in its entirety, wherein the sensor module is configured to determine the size of the Operating Room and adjust the bluetooth pairing distance limit. The laser-based contactless sensor module scans the operating room by transmitting laser pulses, receiving laser pulses bouncing off the enclosure of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the bluetooth paired distance limit.

Computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled via a system bus to a communication module 247, storage 248, memory 249, non-volatile memory 250, and an input/output interface 251. The system bus can be any of several types of bus structure(s) including the memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any variety of available bus architectures including, but not limited to, 9-bit bus, Industrial Standard Architecture (ISA), micro Charmel architecture (MSA), extended ISA (eisa), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), personal computer memory card international association bus (PCMCIA), Small Computer System Interface (SCSI), or any other peripheral bus.

The controller 244 may be any single-core or multi-core processor, such as those provided by Texas instruments under the tradename ARM Cortex. In one aspect, the processor may be a processor core available from, for example, Texas Instruments LM4F230H5QR ARM Cortex-M4F, which includes 256KB of on-chip memory of single cycle flash or other non-volatile memory (up to 40MHZ), a prefetch buffer for improved performance above 40MHz, 32KB of single cycle Sequential Random Access Memory (SRAM), loaded with a load of memory, etc

Software internal Read Only Memory (ROM), 2KB 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 converters (ADCs) with 12 analog input channels, the details of which can be seen in the product data sheet.

In one aspect, the processor 244 may comprise a safety controller comprising two series controller-based controllers (such as TMS570 and RM4x), also known under the trade name Hercules ARM Cortex R4, also manufactured by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO26262 safety critical applications, etc., to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. The basic input/output system (BIOS), containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory can include ROM, Programmable ROM (PROM), Electrically Programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes Random Access Memory (RAM), which acts as external cache memory. Further, RAM may be available in a variety of forms, such as SRAM, Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDRSDRAM), Enhanced SDRAM (ESDRAM), Synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media such as, for example, disk storage. Disk storage includes, but is not limited to, devices such as a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card, or memory stick. In addition, disk storage can include storage media separately or in combination with other storage media including, but not limited to, an optical disk drive such as a compact disk ROM device (CD-ROM), compact disk recordable drive (CD-R drive), compact disk rewritable drive (CD-RW drive) or a digital versatile disk ROM drive (DVD-ROM). To facilitate connection of the disk storage devices to the system bus, a removable or non-removable interface may be used.

It is to be appreciated that the computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in suitable operating environments. Such software includes an operating system. An operating system, which may be stored on disk storage, is used to control and allocate resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored in system memory or on disk storage. It is to be appreciated 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 the computer system 210 through one or more input devices coupled to the I/O interface 251. Input devices include, but are not limited to, a pointing device such as a mouse, trackball, stylus, touch pad, keyboard, microphone, joystick, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices are connected to the processor through the system bus via one or more interface ports. The one or more interface ports include, for example, a serial port, a parallel port, a game port, and a USB. One or more output devices use the same type of port as one or more input devices. Thus, for example, a USB port may be used to provide input to a computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (such as monitors, displays, speakers, and printers) that require special adapters among other output devices.

The computer system 210 may operate in a networked environment using logical connections to one or more remote computers, such as one or more cloud computers, or local computers. The one or more remote cloud computers can be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or other common network nodes, etc., and typically include many or all of the elements described relative to the computer system. For purposes of clarity, only a memory storage device having one or more remote computers is illustrated. One or more remote computers are logically connected to the computer system through a network interface and then physically connected via a communications connection. Network interfaces encompass communication networks such as Local Area Networks (LANs) and Wide Area Networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, token Ring/IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks like Integrated Services Digital Networks (ISDN) and variations thereon, packet switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210, imaging module 238, and/or visualization system 208 of fig. 10, and/or the processor module 232 of fig. 9-10 may include an image processor, an image processing engine, a media processor, or any dedicated Digital Signal Processor (DSP) for processing digital images. The image processor may employ parallel computing with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a series of tasks. The image processor may be a system on a chip having a multi-core processor architecture.

One or more communication connections refer to the hardware/software employed to connect the network interface to the bus. While a communication connection is shown for exemplary clarification inside the computer system, it may also be located outside of computer system 210. The hardware/software necessary for connection to the network interface includes, for exemplary purposes only, internal and external technologies such as, modems including regular telephone grade modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards.

Fig. 11 illustrates a functional block diagram of one aspect of a USB hub 300 device in accordance with at least one aspect of the present disclosure. In the illustrated aspect, the USB hub device 300 employs a TUSB2036 integrated circuit hub from texas instruments. The USB 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 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP0) input paired with a differential data positive (DM0) input. The three downstream

USB transceiver ports

304, 306, 308 are differential data ports, where each port includes a differential data positive (DP1-DP3) output paired with a differential data negative (DM1-DM3) output.

The USB hub 300 device is implemented with a digital state machine rather than a microcontroller and does not require firmware programming. Fully compatible USB transceivers are integrated into the circuitry for the upstream USB transceiver port 302 and all downstream

USB transceiver ports

304, 306, 308. The downstream

USB transceiver ports

304, 306, 308 support both full-speed devices and low-speed devices by automatically setting the slew rate according to the speed of the device attached to the port. The USB hub 300 device may be configured in a bus-powered mode or a self-powered mode and includes hub power logic 312 for managing power.

The USB hub 300 device includes a serial interface engine 310 (SIE). SIE 310 is the front end of the USB hub 300 hardware and handles most of the protocols described in section 8 of the USB specification. The SIE 310 typically includes signaling up to the transaction level. The processing functions thereof may include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, no return to zero inversion (NRZI) data encoding/decoding and digit stuffing, CRC generation and checking (token and data), packet id (pid) generation and checking/decoding, and/or serial-parallel/parallel-serial conversion. 310 receives a clock input 314 and is coupled to pause/resume logic and frame timer 316 circuitry and hub repeater circuitry 318 to control communications between the upstream USB transceiver port 302 and the downstream

USB transceiver ports

304, 306, 308 through

port logic circuitry

320, 322, 324. The SIE 310 is coupled to a command decoder 326 via interface logic to control commands from the serial EEPROM via a serial EEPROM interface 330.

In various aspects, the USB hub 300 may connect 127 functions configured in up to six logical layers (tiers) to a single computer. Further, the USB hub 300 may be connected to all external devices using a standardized four-wire cable that provides both communication and power distribution. The power configuration is a bus powered mode and a self-powered mode. The USB hub 300 may be configured to support four power management modes: bus-powered hubs with individual port power management or package port power management, and self-powered hubs with individual port power management or package port power management. In one aspect, the USB hub 300, upstream USB transceiver port 302, are plugged into the USB host controller using a USB cable, and downstream

USB transceiver ports

304, 306, 308 are exposed for connection of USB compatible devices, or the like.

Surgical instrument hardware

Fig. 12 illustrates a logic diagram for a control system 470 for a surgical instrument or tool according to one or more aspects of the present disclosure. The system 470 includes control circuitry. The control circuit includes a microcontroller 461 that includes a processor 462 and a memory 468. For example, one or more of the

sensors

472, 474, 476 provide real-time feedback to the processor 462. A motor 482 driven by a motor driver 492 is operably coupled to the longitudinally movable displacement member to drive the clamp arm closure member. The tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to a processor 462, which processor 462 may be programmed or configured 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 closure tube travel, shaft rotation, articulation, or gripper arm closure, or combinations thereof. The display 473 displays a variety of operating conditions of the instrument and may include touch screen functionality for data entry. The information displayed on the display 473 may be overlaid with the image acquired via the endoscopic imaging module.

In one aspect, microprocessor 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In one aspect, microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, Inc. (Texas Instruments), for example, that includes on-chip memory of 256KB of single-cycle flash memory or other non-volatile memory (up to 40MHZ), a prefetch buffer for improving performance above 40MHz, a 32KB single-cycle bufferSRAM equipped with

Internal ROM of software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADCs with 12 analog input channels, the details of which can be seen in the product data sheet.

In one aspect, microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, also manufactured by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO26262 safety critical applications, etc., to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functions such as precisely controlling the speed and position of the knife, the articulation system, the clamp arm, or a combination of the above. In one aspect, microcontroller 461 includes processor 462 and memory 468. The electric motor 482 may be a brushed Direct Current (DC) motor having a gear box and a mechanical link to an articulation or knife system. In one aspect, the motor driver 492 may be a3941 available from Allegro Microsystems, Inc. Other motor drives can be readily substituted for use in tracking system 480, including an absolute positioning system. Detailed description of absolute positioning system U.S. patent application publication 2017/0296213 entitled system and method FOR CONTROLLING a SURGICAL stapling and severing instrument (SYSTEMS AND METHODS FOR CONTROLLING a SURGICAL stapling a SURGICAL STAPLING AND cutting system), which is published on 19/10/2017, is incorporated herein by reference in its entirety.

The microcontroller 461 may be programmed to provide precise control of the speed and position of the displacement member and the articulation system. The microcontroller 461 may be configured to calculate a response in the software of the microcontroller 461. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used for the actual feedback decision. The observed response is a favorable tuning value that balances the smooth continuous nature of the simulated response with the measured response, which can detect external effects on the system.

In one aspect, the motor 482 can be controlled by a motor driver 492 and can be employed by a firing system of a surgical instrument or tool. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of about 25,000 RPM. In other arrangements, the motor 482 may comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may comprise, for example, an H-bridge driver including a Field Effect Transistor (FET). The motor 482 may be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool. The power assembly may include a battery that may include a plurality of battery cells connected in series that may be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and/or rechargeable battery cells. In at least one example, the battery cell may be a lithium ion battery that is capable of being coupled to and separable from the power component.

The driver 492 may be a3941 available from Allegro Microsystems, Inc. A 3941492 is a full-bridge controller for use with an external N-channel power Metal Oxide Semiconductor Field Effect Transistor (MOSFET) specifically designed for inductive loads, such as brushed DC motors. Driver 492 includes a unique charge pump regulator that provides full (>10V) gate drive for battery voltages as low as 7V and allows a3941 to operate with reduced gate drive as low as 5.5V. A bootstrap capacitor may be employed to provide the aforementioned battery supply voltage required for the N-channel MOSFET. The internal charge pump of the high-side drive allows for direct current (100% duty cycle) operation. The full bridge may be driven in fast decay mode or slow decay mode using diodes or synchronous rectification. In the slow decay mode, current recirculation may pass through either the high-side FET or the low-side FET. The power FET is protected from breakdown by a resistor adjustable dead time. The integral diagnostics provide an indication of undervoltage, overheating, and power bridge faults, and may be configured to protect the power MOSFETs under most short circuit conditions. Other motor drives can be readily substituted for use in tracking system 480, including an absolute positioning system.

The tracking system 480 includes a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for the absolute positioning 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 including a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured as a rack including drive teeth. In a further aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamp arm, which may be adapted and configured as a rack comprising drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to close and open a clamp arm of a stapler, a clamp arm of an ultrasonic or electrosurgical device, or a combination thereof. Accordingly, as used herein, the term displacement member is used generically 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). Thus, the absolute positioning system can in fact track the displacement of the gripping arm by tracking the linear displacement of the longitudinally movable drive member.

In other aspects, the absolute positioning system can be configured to track the position of the clamp arm during closing or opening. 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. The linear displacement sensor may comprise a contact displacement sensor or a non-contact displacement sensor. The linear displacement sensor may comprise a Linear Variable Differential Transformer (LVDT), a Differential Variable Reluctance Transducer (DVRT), a sliding potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged hall effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.

The electric motor 482 may include a rotatable shaft that operably interfaces with a gear assembly mounted on the displacement member in meshing engagement with the set or rack of drive teeth. The sensor element may be operably coupled to the gear assembly such that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The arrangement of the transmission and sensor may be connected to the linear actuator via a rack and pinion arrangement, or to the rotary actuator via a spur gear or other connection. The power source powers the absolute positioning system and the output indicator may display an output of the absolute positioning system. The displacement member represents a longitudinally movable drive member including a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents a longitudinally movable firing member for opening and closing the clamp arm.

A single rotation of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement d of the displacement member₁Wherein d is₁Is the longitudinal linear distance that the displacement member moves from point "a" to point "b" after a single rotation of the sensor element coupled to the displacement member. The sensor arrangement may be connected via a gear reduction that causes the position sensor 472 to complete only one or more rotations for the full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a full stroke of the displacement member.

A series of switches (where n is an integer greater than one) may be employed alone or in conjunction with the gear reduction to provide unique position signals for more than one rotation of the position sensor 472. The state of the switch is fed back to the microcontroller 461, which microcontroller 461 applies logic to determine the pairIn response to longitudinal linear displacement d of the displacement member₁+d₂+…d_nA unique position signal of. The output of the position sensor 472 is provided to a microcontroller 461. The position sensor 472 of the sensor arrangement may include a magnetic sensor, an analog rotation sensor (e.g., a potentiometer), 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 that are classified according to whether they measure the total or vector component of the magnetic field. The techniques for producing the two types of magnetic sensors described above encompass a number of aspects of physics and electronics. Technologies for magnetic field sensing include search coils, flux gates, optical pumps, nuclear spins, superconducting quantum interferometers (SQUIDs), hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedances, magnetostrictive/piezoelectric composites, magnetodiodes, magnetotransistors, optical fibers, magneto-optical, and magnetic sensors based on micro-electromechanical systems, among others.

In one aspect, the position sensor 472 for the tracking system 480 including an absolute positioning system comprises a magnetic rotary absolute positioning system. The position sensor 472 may be implemented AS an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria microelectronics, AG, australia. The position sensor 472 interfaces with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage and low power component and includes four hall effect elements located in the area of the position sensor 472 above the magnet. A high resolution ADC and an intelligent power management controller are also provided on the chip. Coordinate rotation digital computer (CORDIC) processors (also known as bitwise and Volder algorithms) are provided to perform simple and efficient algorithms to compute hyperbolic and trigonometric functions, which require only addition, subtraction, digital displacement and table lookup operations. The angular position, alarm bits and magnetic field information are transmitted to the microcontroller 461 via a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. The position sensor 472 provides 12 or 14 bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16 pin 4 × 4 × 0.85mm package.

The tracking system 480, including an absolute positioning system, may include and/or may be programmed to implement feedback controllers such as PID, state feedback, and adaptive controllers. The power source converts the signal from the feedback controller into a physical input to the system: in this case a voltage. Other examples include PWM of voltage, current and force. In addition to the location measured by the location sensor 472, one or more other sensors may be provided to measure physical parameters of the physical system. In some aspects, the one or more other sensors may include a sensor arrangement, such as those described in U.S. patent 9,345,481 entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE TISSUE thicknes) issued at 24.5.2016, which is incorporated herein by reference in its entirety; U.S. patent application publication 2014/0263552 entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE TISSUE thicknes) published 9, 18, 2014, which is incorporated herein by reference in its entirety; and us patent application serial No. 15/628,175 entitled technique FOR ADAPTIVE CONTROL OF motor speed FOR SURGICAL stapling and CUTTING INSTRUMENTs (TECHNIQUES FOR ADAPTIVE CONTROL OF MOTORVELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT) filed 2017, 8, month 20, which is incorporated herein by reference in its entirety. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, wherein the output of the absolute positioning system will have a limited resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using an algorithm (such as a weighted average and a theoretical control loop) that drives the calculated response toward the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, inductive resistance to predict the state and output of the physical system by knowing the inputs.

Thus, the absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument, and does not retract or advance the displacement member to a reset (clear or home) position as may be required by conventional rotary encoders, which simply count the number of forward or backward steps taken by the motor 482 to infer the position of the device actuator, drive rod, knife, etc.

The sensor 474 (such as, for example, a strain gauge or a micro-strain gauge) is configured to measure one or more parameters of the end effector, such as, for example, the amplitude of the strain exerted on the anvil during a clamping operation, which may be indicative of the closing force applied to the anvil. The measured strain is converted to a digital signal and provided to the processor 462. Alternatively or in addition to sensor 474, sensor 476 (such as, for example, a load sensor) may measure the closing force applied by the closure drive system to an anvil in a stapler or clamping arm in an ultrasonic or electrosurgical instrument. The sensor 476 (such as, for example, a load sensor) may measure a firing force applied to a closure member coupled to a clamp arm of a surgical instrument or tool or a force applied by the clamp arm to tissue located in a jaw of an ultrasonic or electrosurgical instrument. Alternatively, a current sensor 478 may be employed to measure the current drawn by the motor 482. The displacement member may also be configured to engage the clamp arm to open or close the clamp arm. The force sensor may be configured to measure a clamping force on the tissue. The force required to advance the displacement member may correspond to, for example, the current consumed by the motor 482. The measured force is converted to a digital signal and provided to the processor 462.

In one form, the strain gauge sensor 474 may be used to measure the force applied to tissue by the end effector. A strain gauge may be coupled to the end effector to measure the force on the tissue being treated by the end effector. The system for measuring the force applied to tissue grasped by the end effector includes a strain gauge sensor 474, such as, for example, a micro-strain gauge, configured to measure one or more parameters of, for example, the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain applied to the jaw members of the end effector during a clamping operation, which can indicate tissue compression. The measured strain is converted to a digital signal and provided to the processor 462 of the microcontroller 461. Load sensor 476 may measure a force used to operate the knife member, for example, to cut tissue captured between the anvil and the staple cartridge. The load cell 476 may measure a force used to operate the clamp arm member, for example, to capture tissue between the clamp arm and the ultrasonic blade or to capture tissue between the clamp arm and the jaws of the electrosurgical instrument. A magnetic field sensor may be employed to measure the thickness of the trapped tissue. The measurements of the magnetic field sensors may also be converted to digital signals and provided to the processor 462.

The microcontroller 461 can use measurements of tissue compression, tissue thickness, and/or force required to close the end effector, as measured by the

sensors

474, 476, respectively, to characterize selected positions of the firing member and/or corresponding values of the velocity of the firing member. In one case, the memory 468 can store techniques, formulas, and/or look-up tables that can be employed by the microcontroller 461 in the evaluation.

The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with the modular communication hub, as shown in fig. 8-11.

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

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

Fig. 15 illustrates a sequential logic circuit 520 configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. Sequential logic circuitry 520 or combinational logic 522 may be configured to implement the various processes described herein. Sequential logic circuit 520 may comprise a finite state machine. Sequential logic circuitry 520 may include, for example, combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store the current state of the finite state machine. In some cases, the sequential logic circuit 520 may be synchronous or asynchronous. The combinational logic 522 is configured to receive data associated with a surgical instrument or tool from inputs 526, process the data through the combinational logic 522, and provide outputs 528. In other aspects, a circuit may comprise a combination of a processor (e.g., processor 502, fig. 13) and a finite state machine to implement the various processes herein. In other aspects, the finite state machine may comprise a combination of combinational logic circuitry (e.g., combinational logic circuitry 510, fig. 14) and sequential logic circuitry 520.

Fig. 16 illustrates a surgical instrument or tool including multiple motors that can be activated to perform various functions. In some cases, the first motor may be activated to perform a first function, the second motor may be activated to perform a second function, and the third motor may be activated to perform a third function. In some instances, multiple motors of the robotic surgical instrument 600 may be individually activated to cause firing, closing, and/or articulation motions in the end effector. Firing motions, closing motions, and/or articulation motions can be transmitted to the end effector, for example, by a shaft assembly.

In certain instances, a surgical instrument system or tool may include a firing motor 602. The firing motor 602 is operably coupled to a firing motor drive assembly 604, which firing motor drive assembly 604 may be configured to transmit a firing motion generated by the motor 602 to the end effector, in particular for displacing the clamp arm closure member. The closure member may be retracted by reversing the direction of the motor 602, which also causes the gripper arms to open.

In some cases, the surgical instrument or tool may include a closure motor 603. The closure motor 603 can be operably coupled to a closure motor drive assembly 605, the closure motor drive assembly 605 being configured to transmit the closure motions generated by the motor 603 to the end effector, in particular for displacing a closure tube to close the anvil and compress tissue between the anvil and staple cartridge. The closure motor 603 can be operably coupled to a closure motor drive assembly 605 configured to transmit the closure motions generated by the motor 603 to the end effector, in particular for displacing the closure tube to close the clamp arm and compress tissue between the clamp arm and the ultrasonic blade or jaw member of the electrosurgical device. The closing motion can transition, for example, the end effector from an open configuration to an approximated configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.

In some cases, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606 b. The motors 606a, 606b can be operably coupled to respective articulation motor drive assemblies 608a, 608b, which can be configured to transmit articulation motions generated by the motors 606a, 606b to the end effector. In some cases, the articulation can articulate the end effector relative to the shaft, for example.

As described above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of a surgical instrument or tool may be activated individually or independently to perform one or more functions while other motors remain inactive. For example, the articulation motors 606a, 606b may be activated to articulate the end effector while the firing motor 602 remains inactive. Alternatively, the firing motor 602 may be activated to fire a plurality of staples and/or advance the cutting edge while the articulation motor 606 remains inactive. Further, the closure motor 603 may be activated simultaneously with the firing motor 602 to advance the closure tube or closure member distally, as described in more detail below.

In some instances, a surgical instrument or tool may include a common control module 610, which common control module 610 may be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 may regulate one of the plurality of motors at a time. For example, the common control module 610 can be individually coupled to and separable from multiple motors of the surgical instrument. In some cases, multiple motors of a surgical instrument or tool may share one or more common control modules, such as common control module 610. In some instances, multiple motors of a surgical instrument or tool may independently and selectively engage a common control module 610. In some cases, the common control module 610 may switch from interfacing with one of the plurality of motors of the surgical instrument or tool to interfacing with another of the plurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can be selectively switched between operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or the closure motor 603. In at least one example, as shown in fig. 16, the switch 614 may move or transition between a plurality of positions and/or states. In the first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602; in a second position 617, the switch 614 may electrically couple the common control module 610 to the close motor 603; in the third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606 a; and in the fourth position 618b, the switch 614 may electrically couple the common control module 610 to, for example, the second articulation motor 606 b. In some instances, a single common control module 610 may be electrically coupled to the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b simultaneously. In some cases, the 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 shaft of the motor. The force on the end effector can be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of a motor used to actuate the jaws.

In various instances, as shown in fig. 16, the common control module 610 may include a motor driver 626, which motor driver 626 may include one or more H-bridge FETs. The motor driver 626 may modulate power transmitted from a power source 628 to the motors coupled to the common control module 610, for example, based on input from a microcontroller 620 ("controller"). In some cases, when the motors are coupled to the common control module 610, the microcontroller 620 may be employed, for example, to determine the current consumed by the motors, as described above.

In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform various functions and/or computations as described herein. In some cases, one or more of the memory units 624 may be coupled to the processor 622, for example. In various aspects, microcontroller 620 can communicate over a wired or wireless channel, or a combination thereof.

In some cases, power source 628 may be used, for example, to power microcontroller 620. In some cases, the power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery, for example. In some cases, the battery pack may be configured to be releasably mounted to the handle for powering the surgical instrument 600. A plurality of series-connected battery cells may be used as the power source 628. In some cases, the power source 628 may be replaceable and/or rechargeable, for example.

In various instances, the processor 622 may control a motor driver 626 to control the position, rotational direction, and/or speed of motors coupled to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and/or disable the motors coupled to the common controller 610. It is to be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that combines the functions of a computer's Central Processing Unit (CPU) on one integrated circuit or at most several integrated circuits. Processor 622 is a multipurpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides the result as output. Because the processor has internal memory, it is an example of sequential digital logic. The operands of the processor are numbers and symbols represented in a binary numerical system.

In one case, the processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In some cases, microcontroller 620 may be, for example, LM4F230H5QR, available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of on-chip memory of single cycle flash or other non-volatile memory (up to 40MHz), prefetch buffer for improved performance above 40MHz, 32KB of single cycle SRAM, load with

Internal ROM of software, EEPROM of 2KB, one or more PWM modules, one or more QEI analog, one or more 12-bit ADC with 12 analog input channels, and other features readily available. Other microcontrollers could be readily substituted for use with module 4410. Accordingly, the present disclosure should not be limited to this context.

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

In some cases, one or more mechanisms and/or sensors, such as sensor 630, may be used to alert processor 622 of program instructions that should be used in a particular setting. For example, the sensor 630 may alert the processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In some cases, sensor 630 may include, for example, a position sensor that may be used to sense the position of switch 614. Thus, the processor 622 can use program instructions associated with firing a closure member coupled to a clamp arm of the end effector when the switch 614 is detected in the first position 616, such as by the sensor 630; the processor 622 can use the program instructions associated with closing the anvil when the switch 614 is detected in the second position 617, for example, by the sensor 630; and the processor 622 may use the program instructions associated with articulating the end effector when the switch 614 is detected to be in the third position 618a or the fourth position 618b, for example, by the sensor 630.

Fig. 17 is a schematic illustration of a robotic surgical instrument 700 configured to operate a surgical tool described herein, according to one aspect of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of the displacement member, distal/proximal displacement of the closure tube, shaft rotation, and articulation with single or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to control the firing member, the closure member, the shaft member, or one or more articulation members individually, or in combinations thereof. The surgical instrument 700 includes a control circuit 710, the control circuit 710 configured to control a motor driven firing member, a closure member, a shaft member, or one or more articulation members, or a combination thereof.

In one aspect, the robotic surgical instrument 700 includes a control circuit 710, the control circuit 710 configured to control the clamp arm 716 and closure member 714 portions of the end effector 702, an ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721, a shaft 740, and one or

more articulation members

742a, 742b via a plurality of motors 704a-704 e. The position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710. Other sensors 738 may be configured to provide feedback to the control circuit 710. The timer/counter 731 provides timing and count information to the 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. The motors 704a-704e may be operated individually by the control circuit 710 in open loop or closed loop feedback control.

In one aspect, control circuit 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to perform one or more tasks. In one aspect, the timer/counter 731 provides an output signal, such as a 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 so that the control circuit 710 can determine the position of the closure member 714 at a particular time (t) relative to a starting position or at a time (t) when the closure member 714 is at a particular position relative to a starting position. The timer/counter 731 may be configured to measure elapsed time, count external events, or time external events.

In one aspect, the control circuit 710 can be programmed to control the function of the end effector 702 based on one or more tissue conditions. Control circuit 710 may be programmed to sense a tissue condition, such as thickness, directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or a closing control program based on tissue conditions. The firing control routine may describe distal movement of the displacement member. Different firing control programs may be selected to better address different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a lower speed and/or at a lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher speed and/or at a higher power. The closure control program can control the closure force applied to the tissue by the clamp arms 716. Other control programs control the rotation of the shaft 740 and the

articulation members

742a, 742 b.

In one aspect, the control circuit 710 may generate a motor set point signal. The motor set point signals may be provided to various motor controllers 708a-708 e. The motor controllers 708a-708e may include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e, as described herein. In some examples, the motors 704a-704e may be brushed DC electric motors. For example, the speeds of the motors 704a-704e may be proportional to the respective motor drive signals. In some examples, the motors 704a-704e can be brushless DC motors, and the respective motor drive signals can include PWM signals provided to one or more stator windings of the motors 704a-704 e. Also, in some examples, the motor controllers 708a-708e may be omitted and the control circuit 710 may generate the motor drive signals directly.

In some examples, the control circuit 710 may initially operate each of the motors 704a-704e in an open loop configuration for a first open loop portion of the stroke of the displacement member. 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 firing control program in a closed-loop configuration. The response of the instrument may include the translation 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 sum of the pulse widths of the motor drive signals, and so forth. After the open loop portion, the control circuit 710 may implement the selected firing control routine for a second portion of the displacement member travel. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e based on translation data that describes the position of the displacement member in a closed-loop manner to translate the displacement member at a constant speed.

In one aspect, the motors 704a-704e may receive power from an energy source 712. The energy source 712 may be a DC power source driven by a main ac power source, a battery, a super capacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to separate movable mechanical elements, such as the closure member 714, the clamp arm 716, the shaft 740, the articulation 742a, and the articulation 742b, via respective transmissions 706a-706 e. The actuators 706a-706e may include one or more gears or other linkage members to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the closure member 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the closure member 714 is translated distally and proximally. The control circuit 710 may track the pulses to determine the position of the closure member 714. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the closure member 714. Also, in some examples, position sensor 734 may be omitted. Where the motors 704a-704e are stepper motors, the control circuit 710 may track the position of the closure member 714 by aggregating the number and direction of steps that the motor 704 has been instructed to perform. The position sensor 734 may be located in the end effector 702 or at any other portion of the instrument. The output of each of the motors 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, the control circuit 710 is configured to drive a closure member 714 portion of a firing member, such as the end effector 702. The control circuit 710 provides a motor set point to the motor control 708a, which provides a drive signal to the motor 704 a. The output shaft of motor 704a is coupled to a torque sensor 744 a. The torque sensor 744a is coupled to the transmission 706a, which transmission 706a is coupled to the closure member 714. The transmission 706a includes movable mechanical elements, such as rotating elements and firing members, to control the distal and proximal movement of the closure member 714 along the longitudinal axis of the end effector 702. In one aspect, the 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. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to fire or displace the closure member 714. The position sensor 734 may be configured to provide the position of the closure member 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 may provide a firing signal to the motor control 708 a. In response to the firing signal, the motor 704a can drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal stroke start position to an end of stroke position distal of the stroke start position. As the closure member 714 translates distally, the clamp arm 716 closes toward the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to drive a closure member, such as a clamp arm 716 portion of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708b, which motor control 708b provides a drive signal to the motor 704 b. The output shaft of motor 704b is coupled to a torque sensor 744 b. The torque sensor 744b is coupled to the transmission 706b coupled to the clamp arm 716. The actuator 706b includes movable mechanical elements, such as rotating elements and closing members, to control the movement of the clamp arms 716 from the open and closed positions. In one aspect, the 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. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal is representative of the closing force applied to the clamp arm 716. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 may provide a closing force feedback signal to the control circuit 710. Pivotable clamp arm 716 is positioned opposite ultrasonic blade 718. When ready for use, the control circuit 710 may provide a close signal to the motor control 708 b. In response to the closure signal, the motor 704b advances the closure member to grasp tissue between the clamp arm 716 and the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to rotate a shaft member, such as the shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor set point to the motor control 708c, which motor control 708c provides a drive signal to the motor 704 c. The output shaft of motor 704c is coupled to a torque sensor 744 c. Torque sensor 744c is coupled to transmission 706c, which is coupled to shaft 740. Actuator 706c includes a movable mechanical element, such as a rotating element, to control rotation of shaft 740 up to 360 ° and beyond 360 ° clockwise or counterclockwise. In one aspect, the motor 704c is coupled to a rotary transmission assembly that includes a tube gear section formed on (or attached to) the proximal end of the proximal closure tube for operable engagement by a rotary gear assembly operably supported on the tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the control circuit 710 with the rotational position of the shaft 740.

In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor set point to the motor control 708d, which motor control 708d provides a drive signal to the motor 704 d. The output of the motor 704d is coupled to a torque sensor 744 d. The torque sensor 744d is coupled to the transmission 706d that is coupled to the articulation member 742 a. The transmission 706d includes mechanical elements, such as articulation elements, that are movable to control the + -65 deg. articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut that is rotatably journaled on the proximal end portion of the distal spine and rotatably driven thereon by an articulation gear assembly. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the control circuit 710 with the articulated position of the end effector 702.

In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members or

links

742a, 742 b. These

articulation members

742a, 742b are driven by separate disks on the robotic interface (rack) that are driven by the two motors 708d, 708 e. When a separate firing motor 704a is provided, each of the

articulation links

742a, 742b can be driven antagonistic to the other link to provide resistance holding motion and load to the head when the head is not moving and to provide articulation when the head is articulating. When the head is rotated, the

articulation members

742a, 742b are attached to the head at a fixed radius. Thus, the mechanical advantage of the push-pull link changes as the head rotates. This variation in mechanical advantage may be more apparent for other articulation link drive systems.

In one aspect, one or more of the motors 704a-704e can include a brushed DC motor having a gearbox and a mechanical link to a firing member, a closure member, or an articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on the physical system. Such external influences may be referred to as drag forces, which act against one of the electric motors 704a-704 e. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.

In one aspect, position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a magnetic rotary absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria microelectronics, australia, AG. Position sensor 734 interfaces with controller 710 to provide an absolute positioning system. The location may include a hall effect element located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and a Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only an addition operation, a subtraction operation, a digit shift operation, and a table lookup operation.

In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 can be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derivative parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 738 may include magnetic sensors, magnetic field sensors, strain gauges, load sensors, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors for measuring one or more parameters of the end effector 702. The sensors 738 may include one or more sensors. A sensor 738 may be located on the clamp arm 716 to determine tissue location using segmented electrodes. The 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 may sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) the portion of the ultrasonic blade 718 having tissue thereon, and (4) the load and position on the two articulation bars.

In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro-strain gauge, configured to measure a magnitude of strain in the clamp arm 716 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the 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 an impedance of a tissue section located between clamp arm 716 and ultrasonic blade 718, which impedance is indicative of the thickness and/or degree of filling of tissue located therebetween.

In one aspect, the sensors 738 may be implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, Magnetoresistive (MR) devices, Giant Magnetoresistive (GMR) devices, magnetometers, and the like. In other implementations, the sensor 738 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and so forth. Also, the switch may be a solid state device, such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensors 738 may include a non-conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and so forth.

In one aspect, the sensor 738 may be configured to measure the force exerted on the 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 closing force applied to the clamp arm 716 by the closure tube. The force exerted on clamp arm 716 may be indicative of tissue compression experienced by a section of tissue captured between clamp arm 716 and ultrasonic blade 718. One or more sensors 738 may be positioned 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. The one or more sensors 738 may be sampled in real time by a processor of the control circuit 710 during a clamping operation. The control circuit 710 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to the gripping arm 716 in real-time.

In one aspect, the current sensor 736 can be used to measure the current consumed by each of the motors 704a-704 e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current consumed by one of the motors 704a-704 e. The force is converted to a digital signal and provided to the processor 710. The control circuit 710 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the closure member 714 in the end effector 702 at or near a target speed. The robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, PID, state feedback, linear square (LQR), and/or adaptive controllers. The robotic surgical instrument 700 may include a power source to, for example, convert signals from a feedback controller into physical inputs, such as housing voltages, PWM voltages, frequency modulated voltages, currents, torques, and/or forces. Additional details are disclosed in U.S. patent application serial No. 15/636,829 entitled CLOSED LOOP VELOCITY CONTROL technology FOR ROBOTIC SURGICAL INSTRUMENTs (CLOSED LOOP VELOCITY CONTROL FOR ROBOTIC SURGICAL INSTRUMENTs) filed on 29.6.2017, which is incorporated herein by reference in its entirety.

Fig. 18 illustrates a schematic view 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, the surgical instrument 750 is programmed to control distal translation of a displacement member, such as the closure member 764. The surgical instrument 750 includes an end effector 752, which end effector 752 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 the closure member 764, may be measured by an absolute positioning system, sensor arrangement, and position sensor 784. Since the closure member 764 is coupled to the longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member with the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the closure member 764 may be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control the translation of a displacement member, such as the closure member 764. In some examples, the control circuitry 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the closure member 764) in the manner described. In one aspect, the timer/counter 781 provides an output signal, such as a elapsed time or a digital count, to the control circuit 760 to correlate the position of the closure member 764, as determined by the position sensor 784, with the output of the 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. The timer/counter 781 may be configured to measure elapsed time, count external events or time external events.

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

The motor 754 may receive power from an energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the closure member 764 via a transmission 756. The transmission 756 can include one or more gears or other linkage components to couple the motor 754 to the closure member 764. The position sensor 784 may sense the position of the closure member 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the closure member 764 is translated distally and proximally. The control circuit 760 may track the pulses to determine the position of the 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 the motion of the closure member 764. Also, in some examples, position sensor 784 may be omitted. Where the motor 754 is a stepper motor, the control circuit 760 may track the position of the closure member 764 by aggregating the number and direction of steps the motor 754 has been instructed to perform. The position sensor 784 may be located in the end effector 752 or at any other portion of the instrument.

The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derivative parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensors 788 may include, for example, 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 any other suitable sensors for measuring one or more parameters of the end effector 752. The sensor 788 may include one or more sensors.

In certain instances, the one or more sensors 788 may include a strain gauge, such as a micro-strain gauge, configured to measure a magnitude of strain in the clamp arm 766 during a clamp condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect an impedance of a section of tissue located between the clamp arm 766 and the ultrasonic blade 768, which impedance is indicative of a thickness and/or degree of filling of the tissue located therebetween.

The sensor 788 may be configured to measure the force exerted by the closure drive system on the clamp arm 766. 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 closing force applied by the closure tube to the clamp arm 766. The force exerted on the clamp arm 766 may be representative of the tissue compression experienced by a section of tissue captured between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force applied by the closure drive system to the clamp arm 766. The one or more sensors 788 may be sampled in real time by the processor of the control circuitry 760 during the clamping operation. The control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to the gripping arm 766 in real-time.

A current sensor 786 may be used to measure the current drawn by the motor 754. The force required to advance the closure member 764 may correspond to, for example, the current consumed by the motor 754. The force is converted to a digital signal and provided to the control circuit 760.

The control circuit 760 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the closure member 764 in the end effector 752 at or near a target speed. The surgical instrument 750 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, a PID, status feedback, LQR, and/or adaptive controller. The surgical instrument 750 may include a power source to, for example, convert signals from the feedback controller into physical inputs such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force.

The actual drive system of the surgical instrument 750 is configured to drive the displacement, cutting or closure member 764 through a brushed DC motor having a gearbox and mechanical link to the articulation and/or knife system. Another example is an electric motor 754 that operates a displacement member and articulation driver, such as an interchangeable shaft assembly. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on the physical system. Such external influences may be referred to as drag forces acting opposite the electric motor 754. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.

Various example aspects relate to a surgical instrument 750 including an end effector 752 having a motorized surgical sealing and cutting implementation. For example, the motor 754 can drive the displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766, and when configured for use, the ultrasonic blade 768 is positioned opposite the clamp arm 766. The clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768, as described herein. When the instrument 750 is ready for use, the clinician may provide a firing signal, for example, by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke start position to an end of stroke position distal to the stroke start position. The closure member 764, having a cutting element positioned at the distal end, may cut tissue between the ultrasonic blade 768 and the clamp arm 766 as the displacement member is translated distally.

In various examples, the surgical instrument 750 can include a control circuit 760, the control circuit 760 programmed to control distal translation of a displacement member (such as the closure member 764) based on one or more tissue conditions. Control circuit 760 may be programmed to sense a tissue condition, such as thickness, directly or indirectly, as described herein. The control circuit 760 may be programmed to select a control program based on tissue conditions. The control program may describe distal movement of the displacement member. Different control programs may be selected to better address different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower speed and/or at a lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and/or at a higher power.

In some examples, the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of the stroke of the displacement member. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control routine. The response of the instrument may include the translation 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, the sum of the pulse widths of the motor drive signals, and the like. After the open loop portion, the control circuit 760 may implement the selected firing control routine for a second portion of the displacement member travel. For example, during the closed-loop portion of the stroke, the control circuit 760 may modulate the motor 754 based on translation data that describes the position of the displacement member in a closed-loop manner to translate the displacement member at a constant speed. Additional details are disclosed in U.S. patent application serial No. 15/720,852 entitled system and method FOR CONTROLLING a display OF a SURGICAL INSTRUMENT (SYSTEM AND METHODS FOR CONTROLLING an input device OF a SURGICAL INSTRUMENT), filed on 29.9.2017, which is incorporated herein by reference in its entirety.

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

In one aspect, the sensor 788 can be implemented as a limit switch, an electromechanical device, a solid state switch, a hall effect device, an MR device, a GMR device, a magnetometer, or the like. In other implementations, the sensor 638 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and so forth. Also, the switch may be a solid state device, such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensors 788 may include a non-conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and so forth.

In one aspect, the position sensor 784 may be implemented AS an absolute positioning system including a monolithic magnetic rotary position sensor implemented AS5055EQFT, available from austria microelectronics, AG, australia. Position sensor 784 may interface with controller 760 to provide an absolute positioning system. The location may include a hall effect element located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and a Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only an addition operation, a subtraction operation, a digit shift operation, and a table lookup operation.

In some examples, the position sensor 784 may be omitted. Where the motor 754 is a stepper motor, the control circuit 760 may track the position of the closure member 764 by aggregating the number and direction of steps the motor has been instructed to perform. The position sensor 784 may be located in the end effector 792 or at any other portion of the instrument.

The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derivative parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensor 788 may include, for example, a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 792. The sensor 788 may include one or more sensors.

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

Additional details are disclosed in U.S. patent application serial No. 15/636,096 filed on 28.6.2017, entitled SURGICAL SYSTEM coupleable with a staple cartridge and a RADIO FREQUENCY cartridge and METHOD OF use thereof (SURGICAL SYSTEM on shelf WITHSTAPLE CARTRIDGE AND RADIO FREQUENCY resonance CARTRIDGE, AND METHOD OF USING SAME), which is incorporated herein by reference in its entirety.

Generator hardware

Self-adaptive ultrasonic knife control algorithm

In various aspects, the smart ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to identify a tissue type and adjust a device parameter. In one aspect, the ultrasonic blade control algorithm is configured to parameterize tissue type. The following sections of the present disclosure describe an algorithm for detecting the collagen/elasticity ratio of tissue to tune the amplitude of the distal tip of an ultrasonic blade. Aspects of a smart ultrasonic energy device are described herein in connection with, for example, fig. 1-85. Accordingly, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with fig. 1-85 and the description associated therewith.

Tissue type identification and device parameter adjustment

In certain surgical procedures, it is desirable to employ an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be employed to adjust parameters of an ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, parameters of the ultrasonic device can be adjusted based on the position of tissue within the jaws of the ultrasonic end effector (e.g., the position of tissue between the clamp arm and the ultrasonic blade). The impedance of the ultrasound transducer can be used to distinguish the percentage of tissue in the distal or proximal end of the end effector. The response of the ultrasound device may be based on the tissue type or compressibility of the tissue. In another aspect, parameters of the ultrasound device may be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be tuned based on the ratio of collagen to elastin tissue detected during the tissue identification process. The ratio of collagen to elastin tissue can be detected using a variety of techniques, including Infrared (IR) surface reflectance and specific radiance. The force applied to the tissue by the clamp arm and/or the stroke of the clamp arm creates the gap and compression. Electrical continuity across the electrode-equipped jaws may be employed to determine the percentage of jaw coverage by tissue.

Fig. 20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, according to at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute one or more adaptive ultrasonic blade control algorithms 802 as described herein with reference to fig. 43A-54. In another aspect, the device/instrument 235 is configured to execute one or more adaptive ultrasonic blade control algorithms 804 as described herein with reference to fig. 43A-54. In another aspect, both the device/instrument 235 and the device/instrument 235 are configured to execute the adaptive ultrasonic

blade control algorithms

802, 804 as described herein with reference to fig. 43A-54.

The generator module 240 may include a patient isolation stage in communication with a non-isolation stage via a power transformer. The secondary winding of the power transformer is contained in an isolation stage and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define a drive signal output for delivering drive signals to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-functional surgical instruments including ultrasonic energy modes and RF energy modes that can be delivered separately or simultaneously. In particular, the drive signal output may 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 may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to fig. 21-28B.

The generator module 240 or the device/instrument 235, or both, are coupled to a modular control tower 236, which modular control tower 236 is connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room, as described with reference to fig. 8-11, for example.

Fig. 21 shows an example of a generator 900, which is one form of a generator configured to be coupled to an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, as shown in fig. 20. The generator 900 is configured to deliver a plurality of energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals for delivering energy to the surgical instrument independently or simultaneously. The RF signal and the ultrasound signal may be provided separately or in combination, and may be provided simultaneously. As described above, at least one generator output may deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.) through a single port, and these signals may be delivered separately or simultaneously to the end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to generate a variety of signal waveforms based on information stored in a memory coupled to the processor 902, which memory is not shown for clarity of the present disclosure. Digital information associated with the waveform is provided to a waveform generator 904, which provides the waveformGenerator 904 includes one or more DAC circuits to convert a digital input to an analog output. The analog output is fed to an amplifier 1106 for signal conditioning and amplification. The regulated and amplified output of amplifier 906 is coupled to power transformer 908. The signal is coupled to the secondary side of the patient isolation side through a power transformer 908. A first signal of a first ENERGY mode is provided to a first ENERGY mode labeled ENERGY₁And a terminal of the RETURN. A second signal of a second ENERGY mode is coupled across capacitor 910 and provided to a second terminal labeled ENERGY₂And a terminal of the RETURN. It will be appreciated that more than two ENERGY modes may be output, and thus the subscript "n" may be used to specify that up to n ENERGY may be provided_nA terminal, wherein n is a positive integer greater than 1. It should also be understood that up to n RETURN paths RETURN may be provided without departing from the scope of this disclosure_n。

First voltage sensing circuit 912 is coupled to a first voltage sense circuit labeled ENERGY₁And across the terminals of the RETURN path to measure the output voltage therebetween. A second voltage sense circuit 924 is coupled to the output terminal labeled ENERGY₂And across the terminals of the RETURN path to measure the output voltage therebetween. As shown, a current sensing circuit 914 is placed in series with the RETURN leg on the secondary side of the power transformer 908 to measure the output current of either energy mode. If a different return path is provided for each energy modality, a separate current sensing circuit should be provided in each return branch. The outputs of the first 912 and second 924 voltage sensing circuits are provided to

respective isolation transformers

916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The output of the

isolation transformers

916, 928, 922 on the primary side of the power transformer 908 (not the patient isolation side) is provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and computation. Output voltage and output current feedback information may be employed to adjust the output voltage and current provided to the surgical instrument and calculate parameters such as output impedance. Input/output communication between the processor 902 and the patient isolation circuitry is through an interfaceAnd provided by way 920. The sensors may also be in electrical communication with the processor 902 through an interface 920.

In one aspect, the impedance may be determined by the processor 902 by coupling at a coupling labeled ENERGY₁First voltage sense circuit 912 coupled across terminals of/RETURN or otherwise labeled ENERGY₂The output of the second voltage sense circuit 924 across the terminals of the/RETURN is divided by the output of the current sense circuit 914 arranged in series with the RETURN leg on the secondary side of the power transformer 908. The outputs of the first 912 and second 924 voltage sensing circuits are provided to separate

isolation transformers

916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 for use in calculating the impedance. For example, the first ENERGY modality ENERGY₁May be ultrasonic ENERGY and the second ENERGY modality ENERGY₂May be RF energy. However, in addition to ultrasound and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and/or reversible electroporation and/or microwave energy, among others. Also, while the example shown in fig. 21 shows that a single RETURN path RETURN may be provided for two or more ENERGY modalities, in other aspects, a single RETURN path RETURN may be provided for each ENERGY modality ENERGY_nProviding multiple RETURN paths RETURN_n. Thus, as described herein, the ultrasound transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914, and the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.

As shown in fig. 21, the generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to the end effector in the form of one or more energy modalities (such as ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, generator 900 may deliver energy with higher voltage and lower current to drive an ultrasound transducer, and lower voltage and higher current to drive an RF electrodeFor sealing tissue or delivering energy with a coagulating waveform for use with monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of the generator 900 will preferably be at what is labelled ENERGY₁And the output of RETURN, as shown in fig. 21. In one example, the connection of the RF bipolar electrode to the output of generator 900 will preferably be at what is labeled ENERGY₂And the output of RETURN. In the case of a unipolar output, the preferred connection would be an active electrode (e.g. a light cone (pencil) or other probe) to ENERGY₂The sum of the outputs is connected to a suitable RETURN pad of the RETURN output.

Additional details are disclosed in U.S. patent application publication 2017/0086914 entitled technique FOR OPERATING a GENERATOR AND housing instrument FOR digitally generating electrical signal WAVEFORMS (TECHNIQUES FOR OPERATING GENERATITOR FOR DIGITALLYGENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS), published 3, 30, 2017, which is incorporated herein by reference in its entirety.

As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some aspects they may not. The communication module may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, and Ethernet derivatives thereof, as well as any other wireless and wired protocols designated as 3G, 4G, 5G, and above. The computing module may include a plurality of communication modules. For example, a first communication module may be dedicated for shorter range wireless communications such as Wi-Fi and bluetooth, and a second communication module may be dedicated for longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and the like.

As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, typically a memory or some other data stream. The term is used herein to refer to a central processing unit (cpu) in one or more systems, especially systems on a chip (SoC), that combine multiple specialized "processors".

As used herein, a system-on-chip or system-on-chip (SoC or SoC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all of the components of a computer or other electronic system. It may contain digital, analog, mixed signal, and often radio frequency functions-all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a Graphics Processing Unit (GPU), 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. The microcontroller (or MCU of the microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; the SoC may include a microcontroller as one of its components. Microcontrollers may include 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 memory or OTP ROM as well as a small amount of RAM are often included on the chip. In contrast to microprocessors used in personal computers or other general-purpose applications composed of various discrete chips, microcontrollers may be used in embedded applications.

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

Any of the processors or microcontrollers as described herein may be any single-core or multi-core processor, such as those provided by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be available, for example, from GermanyThe LM4F230H5QR ARMCortex-M4F processor core of the Kax Instruments (Texas Instruments) which includes: 256KB of on-chip memory of single cycle flash or other non-volatile memory (up to 40MHz), prefetch buffer for performance improvement above 40MHz, 32KB of single cycle Serial Random Access Memory (SRAM), load with

Internal Read Only Memory (ROM) in software, Electrically Erasable Programmable Read Only Memory (EEPROM) in 2KB, 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 (ADCs) with 12 analog input channels, and other features readily available.

In one example, the processor may include a safety controller that includes two series based controllers, such as TMS570 and RM4x, also available from Texas Instruments under the trade name Hercules ARMCortex R4. The safety controller may be configured specifically for IEC 61508 and ISO26262 safety critical applications, etc., to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

The modular device includes modules receivable within a surgical hub (as described in connection with fig. 3 and 9) and surgical devices or instruments connectable to the various modules for connection or mating with a corresponding surgical hub. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction/irrigation devices, smoke ejectors, energy generators, respirators, insufflators, and displays. The modular devices described herein may be controlled by a control algorithm. The control algorithms may be executed on the modular devices themselves, on a surgical hub paired with a particular modular device, or on both the modular devices and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data may be related to the patient being operated on (e.g., tissue characteristics or insufflation pressure) or the modular device itself (e.g., rate at which the knife is advanced, motor current, or energy level). For example, the control algorithm of a surgical stapling and severing instrument may control the rate at which the motor of the instrument drives its knife through tissue based on the resistance encountered by the knife as it advances.

Fig. 22 illustrates one form of a surgical system 1000 including a generator 1100 and various

surgical instruments

1104, 1106, 1108 that may be used therewith, wherein the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunctional surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument. The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates both RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 22, the generator 1100 is shown separate from the

surgical instruments

1104, 1106, 1108, in one form, the generator 1100 may be integrally formed with any of the

surgical instruments

1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may be configured for wired or wireless communication.

The generator 1100 is configured to drive a plurality of

surgical instruments

1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and includes a handpiece 1105(HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 acoustically coupled to an ultrasonic transducer 1120. The handpiece 1105 includes a combination of a trigger 1143 for operating the clamp arm 1140 and toggle

buttons

1134a, 1134b, 1134c for energizing the ultrasonic blade 1128 and driving the ultrasonic blade 1128 or other functions.

Toggle buttons

1134a, 1134b, 1134c may be configured to energize ultrasound transducer 1120 with generator 1100.

The generator 1100 is further configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a hand piece 1107(HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the

clamp arms

1142a, 1142b and returns through the electrical conductor portion of the shaft 1127. These electrodes are coupled to and powered by a bipolar energy source within the generator 1100. The handpiece 1107 includes a trigger 1145 for operating the

clamp arms

1142a, 1142b and an energy button 1135 for actuating an energy switch to energize the electrodes in the end effector 1124.

The generator 1100 is further configured to drive a multi-function surgical instrument 1108. The multifunctional surgical instrument 1108 includes a hand piece 1109(HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a combination of a trigger 1147 for operating the clamp arm 1146 and

switch buttons

1137a, 1137b, 1137c for energizing the ultrasonic blade 1149 and driving the ultrasonic blade 1149 or other functions. The

toggle buttons

1137a, 1137b, 1137c may be configured to energize the ultrasonic transducer 1120 with the generator 1100, and to energize the ultrasonic blade 1149 with a bipolar energy source also contained within the generator 1100.

The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 22, the generator 1100 is shown separate from the

surgical instruments

1104, 1106, 1108, in another form, the generator 1100 may be integrally formed with any of the

surgical instruments

1104, 1106, 1108 to form an integrated surgical system. As discussed above, the generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may also include one or more output devices 1112. Additional aspects of generators and surgical instruments for digitally generating electrical signal waveforms are described in U.S. patent publication US-2017-0086914-A1, which is incorporated herein by reference in its entirety.

Fig. 23 is an end effector 1122 of an example ultrasonic device 1104 in accordance with at least one aspect of the present disclosure. The end effector 1122 may include a blade 1128, and the blade 1128 may be coupled to an ultrasonic transducer 1120 via a waveguide. When driven by the ultrasonic transducer 1120, the blade 1128 may vibrate and, when in contact with tissue, may cut and/or coagulate the tissue, as described herein. In accordance with various aspects, and as shown in fig. 23, the end effector 1122 may further comprise a clamp arm 1140, which clamp arm 1140 may be configured to act in cooperation with a knife 1128 of the end effector 1122. With knife 1128, clamp arm 1140 can comprise a set of jaws. The clamp arm 1140 may be pivotally connected at a distal end of the shaft 1126 of the instrument portion 1104. Clamp arm 1140 can comprise a clamp arm tissue pad 1163, and clamp arm tissue pad 1163 can be formed from

Or other suitable low friction material. A pad 1163 may be mounted for cooperation with the knife 1128, wherein pivotal movement of the clamp arm 1140 positions the clamp pad 1163 generally parallel to and in contact with the knife 1128. With this configuration, the bite of tissue to be clamped can be grasped between the tissue pad 1163 and the knife 1128. The tissue pad 1163 may have a serrated configuration including a plurality of axially spaced proximally extending gripping teeth 1161 to cooperate with the knife 1128 to enhance the grip of tissue. The clamp arm 1140 may be transitioned from the open position shown in fig. 23 to the closed position (where the clamp arm 1140 is in contact with or proximate to the knife 1128) in any suitable manner. For example, the handpiece 1105 can include a jaw closure trigger. When actuated by the clinician, the jaw closure trigger may pivot the clamp arm 1140 in any suitable manner.

The generator 1100 may be activated to provide a drive signal to the transducer 1120 in any suitable manner. For example, the generator 1100 can include a foot switch 1430 (fig. 24), the foot switch 1430 being coupled to the generator 1100 via a foot switch cable 1432. The clinician may activate the ultrasonic transducer 1120, and thereby the ultrasonic transducer 1120 and the knife 1128, by depressing the foot switch 1430. In addition, or in lieu of the foot switch 1430, some aspects of the apparatus 1104 may utilize one or more switches positioned on the handpiece 1105 that, when activated, may cause the generator 1100 to activate the transducer 1120. In one aspect, for example, the one or more switches can include a pair of

toggle buttons

1134a, 1134b, 1134c (fig. 22), e.g., to determine the operating mode of device 1104. When the toggle button 1134a is depressed, for example, the ultrasonic generator 1100 may provide a maximum drive signal to the transducer 1120, causing it to produce a maximum ultrasonic energy output. Depressing the toggle button 1134b may cause the ultrasound generator 1100 to provide a user selectable drive signal to the ultrasound transducer 1120, causing it to produce an ultrasound energy output that is less than a maximum value. Additionally or alternatively, the device 1104 may include a second switch to, for example, indicate the position of a jaw closure trigger for operating the jaws via the clamp arm 1140 of the end effector 1122. Further, in some aspects, the sonicator 1100 may be activated based on the position of the jaw closure trigger (e.g., ultrasonic energy may be applied when the clinician depresses the jaw closure trigger to close the jaws via the clamp arm 1140).

Additionally or alternatively, the one or more switches can include a toggle button 1134c, which toggle button 1134c, when depressed, causes generator 1100 to provide a pulsed output (fig. 22). The pulses may be provided, for example, at any suitable frequency and grouping. In certain aspects, for example, the power level of the pulse may be the power level associated with the

toggle buttons

1134a, 1134b (maximum, less than maximum).

It should be appreciated that the device 1104 may include any combination of

toggle buttons

1134a, 1134b, 1134c (FIG. 22). For example, the device 1104 may be configured with only two toggle buttons: a toggle button 1134a for producing a maximum ultrasonic energy output and a toggle button 1134c for producing a pulsed output at or below a maximum power level. Thus, the drive signal output configuration of generator 1100 may be five continuous signals, or any discrete number of single pulse signals (1, 2, 3, 4, or 5). In certain aspects, a particular drive signal configuration may be controlled, for example, based on an EEPROM setting and/or one or more user power level selections in generator 1100.

In some aspects, an on/off switch may be provided in place of toggle button 1134c (FIG. 22). For example, the device 1104 may include a toggle button 1134a and a dual toggle button 1134b for producing a continuous output at a maximum power level. In the first detent position, the switch button 1134b may produce a continuous output at less than the maximum power level, and in the second detent position, the switch button 1134b may produce a pulsed output (e.g., at or less than the maximum power level, depending on the EEPROM setting).

In some aspects, the RF electrosurgical end effector 1124, 1125 (fig. 22) can also include a pair of electrodes. The electrodes may be in communication with the generator 1100, for example, via a cable. The electrodes may be used, for example, to measure the impedance of a tissue bite existing between the grasping

arms

1142a, 1146 and the

blades

1142b, 1149. Generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes. For example, the impedance of tissue occlusion can be found by monitoring the current, voltage, etc. of the signal.

In various aspects, the generator 1100 may include several separate functional elements, such as modules and/or blocks, as shown in the illustrations of the surgical system 1000 of fig. 24, 22. Different functional elements or modules may be configured to drive different kinds of

surgical devices

1104, 1106, 1108. For example, the ultrasonic generator module may drive an ultrasonic device, such as ultrasonic surgical device 1104. The electrosurgical/RF generator module may drive an electrosurgical device 1106. For example, the modules may generate respective drive signals for driving the

surgical devices

1104, 1106, 1108. In various aspects, the ultrasonic generator module and/or the electrosurgical/RF generator module can each be integrally formed with the generator 1100. Alternatively, one or more of the modules may be provided as a separate circuit module electrically coupled to the generator 1100. (the module is shown in phantom to illustrate this portion.) furthermore, in some aspects, the electrosurgical/RF generator module may be integrally formed with the ultrasonic generator module, or vice versa.

According to the aspects, the ultrasonic generator module may generate one or more drive signals of a particular voltage, current, and frequency (e.g., 55,500 cycles per second or Hz). The one or more drive signals may be provided to ultrasound device 1104, in particular transducer 1120, which may operate, for example, as described above. In one aspect, the generator 1100 may be configured to generate drive signals for specific voltage, current, and/or frequency output signals that may be modified in terms of high resolution, accuracy, and reproducibility.

According to the aspects, the electrosurgical/RF generator module may generate one or more drive signals having an output power sufficient to perform bipolar electrosurgery using Radio Frequency (RF) energy. In a bipolar electrosurgical application, the drive signal may be provided to, for example, an electrode of the electrosurgical device 1106, as described above. Accordingly, the generator 1100 may be configured for therapeutic purposes by applying electrical energy to tissue sufficient to treat the tissue (e.g., coagulate, cauterize, tissue weld, etc.).

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

The generator 1100 may also include an input device 2140 located, for example, on the front panel of the generator 1100 console (fig. 27B). Output devices 2140 include one or more devices for providing sensory feedback to a user. Such devices may include, for example, visual feedback devices (e.g., LCD display screens, LED indicators), audio feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., haptic actuators).

Although certain modules and/or blocks of generator 1100 may be described by way of example, it may be appreciated that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the described aspects. Furthermore, although various aspects may be described in terms of modules and/or blocks for ease of illustration, such modules and/or blocks may be implemented by one or more hardware components (e.g., processors, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Application Specific Integrated Circuits (ASICs), circuits, registers) and/or software components (e.g., programs, subroutines, logic), and/or a combination of hardware and software components.

In one aspect, the ultrasonic generator driver module and the electrosurgical/RF driver module 1110 (fig. 22) can include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may include various executable modules such as software, programs, data, drivers, Application Program Interfaces (APIs), and so forth. The firmware may be stored in a non-volatile memory (NVM), such as a bit-mask read-only memory (ROM) or flash memory. In various implementations, storing firmware in ROM may protect flash memory. NVM may include other types of memory including, for example, programmable rom (prom), erasable programmable rom (eprom), electrically erasable programmable rom (eeprom), or battery backed Random Access Memory (RAM) (such as dynamic RAM (dram), double data rate dram (ddram), and/or synchronous dram (sdram)).

In one aspect, the modules include hardware components implemented as processors for executing program instructions for monitoring various measurable characteristics of the

devices

1104, 1106, 1108 and generating corresponding output drive signals for operating the

devices

1104, 1106, 1108. In aspects in which the generator 1100 is used in conjunction with the device 1104, the drive signal may drive the ultrasonic transducer 1120 in a cutting and/or coagulation mode of operation. Electrical characteristics of the device 1104 and/or tissue can be measured and used to control aspects of the operation of the generator 1100 and/or can be provided as feedback to a user. In aspects in which the generator 1100 is used in conjunction with the device 1106, the drive signal can supply electrical energy (e.g., RF energy) to the end effector 1124 in a cutting, coagulation, and/or dehydration mode. Electrical characteristics of the device 1106 and/or tissue can be measured and used to control operational aspects of the generator 1100 and/or can be provided as feedback to a user. In various aspects, as described previously, the hardware components may be implemented as DSPs, PLDs, ASICs, circuits and/or registers. In one aspect, the processor may be configured to store and execute computer software program instructions to generate step function output signals for driving various components of the

apparatus

1104, 1106, 1108 (e.g., the ultrasonic transducer 1120 and the

end effectors

1122, 1124, 1125).

An electromechanical ultrasound system includes an ultrasound transducer, a waveguide, and an ultrasonic blade. The electromechanical ultrasound system has an initial resonant frequency defined by the physical characteristics of the ultrasound transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer being excited by an alternating voltage V_g(t) Signal and Current I_g(t) the resonant frequency of the signal is equal to the electromechanical ultrasound system. When the ultrasonic electromechanical system is at resonance, the voltage V_g(t) Signal and Current I_g(t) the phase difference between the 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) causes the resonant frequency of the electromechanical ultrasonic system to shift. As a result, the inductive impedance is no longer equal to the capacitive impedance, resulting in a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasound system. The system now operates "off-resonance". The mismatch between the drive frequency and the resonant frequency being manifested as a mismatch applied to the ultrasonic transducerVoltage V of energy device_g(t) Signal and Current I_g(t) phase difference between the signals. The generator electronics can easily monitor the voltage V_g(t) and current I_g(t) the phase difference between the signals and the drive frequency can be continuously adjusted until the phase difference is again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. The change in phase and/or frequency can be used as an indirect measure of the temperature of the ultrasonic blade.

As shown in fig. 25, the electromechanical properties of the ultrasound transducer can be modeled as an equivalent circuit comprising a first branch with a static capacitance and a second "dynamic" branch with series-connected inductance, resistance and capacitance defining the electromechanical properties of the resonator. The known ultrasonic generator may comprise a tuning inductor for detuning the static capacitance at the resonance frequency, such that substantially all of the driving signal current of the generator flows into the dynamic branch. Thus, by using a tuning inductor, the generator's drive signal current is representative of the dynamic branch current, and thus the generator is able to control its drive signal to maintain the resonant frequency of the ultrasound transducer. The tuning inductor may also transform the phase impedance profile of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the particular static capacitance of the ultrasound transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different static capacitances require different tuning inductors.

Fig. 25 illustrates an equivalent circuit 1500 of an ultrasound transducer, such as ultrasound transducer 1120, according to an aspect. The circuit 1500 includes a series-connected inductor L having electromechanical properties defining a resonator_sResistance R_sAnd a capacitor C_sAnd a first "dynamic" branch C having a static capacitance₀. Can be driven at a voltage V_g(t) receiving a drive current I from a generator_g(t) wherein the dynamic current I_m(t) flows through the first branch and a current I_g(t)-I_m(t) flows through the capacitive branch. Can be controlled by properly controlling I_g(t) and V_g(t) to realize the electromechanics of the ultrasonic transducerAnd (4) controlling the characteristics. As mentioned above, known generator architectures may include a tuned inductor L in a parallel resonant circuit_t(shown in dashed lines in fig. 25), the tuning inductor is used to couple the static capacitance C₀Tuned to the resonance frequency so that substantially the current output I of the generator_gAll of (t) flow through the dynamic leg. In this way, by controlling the generator current output I_g(t) to realize the dynamic branch current I_m(t) control. However, the tuning inductor L_tStatic capacitance C to ultrasonic transducer₀Are specific and different ultrasonic transducers with different static capacitances require different tuning inductors L_t. Furthermore, because the inductor L is tuned_tAt a single resonant frequency with a static capacitance C₀So that the dynamic branch current I is only guaranteed at this frequency_m(t) precise control. As the frequency shifts downward with transducer temperature, precise control of the dynamic branch current is compromised.

Various aspects of the generator 1100 may not rely on tuning the inductor L_tTo monitor the dynamic branch current I_m(t) of (d). Rather, the generator 1100 may use a static capacitance C between applications of power for a particular ultrasonic surgical device 1104₀Along with drive signal voltage and current feedback data to determine dynamic branch current I on a dynamic travel basis (e.g., in real time)_mThe value of (t). Thus, such aspects of the generator 1100 can provide virtual tuning to simulate a tuned system or static capacitance C at any frequency₀Is resonant, rather than only at the static capacitance C₀Is resonant at a single resonant frequency as indicated by the nominal value of (a).

Fig. 26 is a simplified block diagram of an aspect of a generator 1100 that provides inductorless tuning, as described above, among other benefits. Fig. 27A-27C illustrate an architecture of the 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-isolation stage 1540 via a power transformer 1560. Secondary winding 1580 of power transformer 1560 is included in isolation stage 1520 and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define

drive signal outputs

1600a, 1600b, 1600c for outputting drive signals to different surgical devices, such as, for example, ultrasonic surgical device 1104 and electrosurgical device 1106. Specifically, drive

signal outputs

1600a, 1600b, 1600c may output a drive signal (e.g., a 420V RMS drive signal) to ultrasonic surgical device 1104, and drive

signal outputs

1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to electrosurgical device 1106, with output 1600b corresponding to the 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 a power transformer 1560. In certain aspects, the power amplifier 1620 may comprise a push-pull amplifier, for example. The non-isolation stage 1540 may also include a programmable logic device 1660, the programmable logic device 1660 being configured to supply a digital output to a digital-to-analog converter (DAC)1680, which digital-to-analog converter 1680 in turn supplies a corresponding analog signal to the input of the power amplifier 1620. In certain aspects, programmable logic device 1660 may comprise a Field Programmable Gate Array (FPGA), for example. As a result of controlling the input of power amplifier 1620 via DAC 1680, programmable logic device 1660 may thus control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signals present at

drive signal outputs

1600a, 1600b, 1600 c. In certain aspects and as described below, programmable logic device 1660 in conjunction with a processor (e.g., processor 1740 described below) can implement a plurality of Digital Signal Processing (DSP) based algorithms and/or other control algorithms to control parameters of the drive signals output by generator 1100.

Power may be supplied to the power rails of power amplifier 1620 by switch-mode regulator 1700. In certain aspects, the switch mode regulator 1700 may comprise, for example, an adjustable buck regulator. As described above, non-isolation stage 1540 may further include a processor 1740, which processor 1740 in one aspect may include a DSP processor such as ADSP-21469 arc DSP, available from Analog Devices, Norwood, Mass, for example. In certain aspects, processor 1740 may control the operation of switch-mode power converter 1700 in response to voltage feedback data received by processor 1740 from power amplifier 1620 via analog-to-digital converter (ADC) 1760. In one aspect, for example, processor 1740 can receive as input via ADC 1760 a waveform envelope of a signal (e.g., an RF signal) being amplified by power amplifier 1620. Processor 1740 may then control switch-mode regulator 1700 (e.g., via a Pulse Width Modulation (PWM) output) so that the rail voltage supplied to power amplifier 1620 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 may be significantly increased relative to a fixed rail voltage amplifier scheme. The processor 1740 may be configured for wired or wireless communication.

In certain aspects and as discussed in more detail in connection with fig. 28A-28B, programmable logic device 1660 in conjunction with processor 1740 can implement a Direct Digital Synthesizer (DDS) control scheme to control the waveform shape, frequency, and/or amplitude of the drive signals output by generator 1100. In one aspect, for example, the programmable logic device 1660 may implement the DDS control algorithm 2680 (fig. 28A) by retrieving (recall) waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT that may be embedded in an FPGA. The control algorithm is particularly useful for ultrasound applications where an ultrasound transducer, such as ultrasound transducer 1120, may be driven by a purely sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the total distortion of the dynamic branch current may correspondingly minimize or reduce adverse resonance effects. Because the waveform shape of the drive signal output by the generator 1100 is affected by various sources of distortion present in the output drive circuitry (e.g., power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal may be input into an algorithm, such as an error control algorithm implemented by processor 1740, that compensates for the distortion by pre-distorting or modifying the waveform samples stored in the LUT, as appropriate, on a dynamic ongoing basis (e.g., in real time). In one form, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated dynamic branch current and the desired current waveform shape, where the error may be determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed by the drive circuit, can cause the dynamic branch drive signal to have a desired waveform shape (e.g., sinusoidal shape) to optimally drive the ultrasound transducer. Thus, in such aspects, when distortion effects are taken into account, the LUT waveform samples will therefore not represent the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately produce the desired waveform shape of the dynamic branch drive signal.

Non-isolation stage 1540 may further include

ADCs

1780 and 1800 coupled to the output of power transformer 1560 via

respective isolation transformers

1820, 1840 for sampling the voltage and current, respectively, of the drive signal output by generator 1100. In certain aspects, the

ADCs

1780, 1800 may be configured to sample at high speed (e.g., 80Msps) to enable oversampling of the drive signal. In one aspect, for example, the sampling speed of the

ADCs

1780, 1800 may enable approximately 200X (as a function of frequency) oversampling of the drive signal. In certain aspects, the sampling operations of the

ADCs

1780, 1800 may be performed by a single ADC that receives the input voltage signal and the current signal via a two-way multiplexer. By using high speed sampling in aspects of the generator 1100, among other things, computation of complex currents flowing through the dynamic branch (which in some aspects can be used to implement the above-described DDS based waveform shape control), accurate digital filtering of the sampled signal, and computation of actual power consumption with high accuracy can be achieved. The voltage and current feedback data output by the

ADCs

1780, 1800 may be received and processed (e.g., FIFO buffered, multiplexed) by the programmable logic device 1660 and stored in data memory for subsequent retrieval by, for example, the DSP processor 1740. As described above, the voltage and current feedback data may be used as inputs to an algorithm for pre-distorting or modifying LUT waveform samples in a dynamic marching manner. In certain aspects, when voltage and current feedback data pairs are collected, this may entail indexing each stored voltage and current feedback data pair based on or otherwise associated with a corresponding LUT sample output by programmable logic device 1660. Synchronizing the LUT samples with the voltage and current feedback data in this manner facilitates accurate timing and stability of the predistortion algorithm.

In certain aspects, voltage and current feedback data may be used to control the frequency and/or amplitude (e.g., current amplitude) of the drive signal. In one aspect, for example, voltage and current feedback data may be used to determine an impedance phase, such as a phase difference between voltage and current drive signals. The frequency of the drive signal may then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0 °), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving impedance phase measurement accuracy. The determination of the phase impedance and frequency control signals may be implemented in processor 1740, for example, where the frequency control signals are supplied as inputs to a DDS control algorithm implemented by programmable logic device 1660.

The impedance phase may be determined by fourier analysis. In one aspect, the generator voltage V may be determined using a Fast Fourier Transform (FFT) or a Discrete Fourier Transform (DFT) as follows_g(t) drive signal and generator current I_g(t) phase difference between drive signals:

evaluating the fourier transform at sinusoidal frequencies yields:

other methods include weighted least squares estimation, kalman filtering, and space vector based techniques. For example, almost all processing in the FFT or DFT techniques may be performed in the digital domain with the aid of, for example, a 2-channel high-

speed ADC

1780, 1800. In one technique, digital signal samples of the voltage signal and the current signal are fourier transformed with an FFT or DFT. The phase angle at any point in time can be calculated by the following formula

Wherein

Is a phase angle, f is a frequency, t is a time, and

is the phase at t-0.

For determining the voltage V_g(t) Signal and Current I_g(t) another technique for phase difference between signals is the zero crossing method and produces very accurate results. For voltages V having the same frequency_g(t) Signal and Current I_g(t) signal, voltage signal V_g(t) the start of each negative-to-positive zero crossing trigger pulse, and the current signal I_gEach negative to positive zero crossing of (t) triggers the end of a pulse. The result is a pulse train having a pulse width proportional to the phase angle between the voltage signal and the current signal. In one aspect, the pulse train may be passed through an averaging filter to obtain a measure of the phase difference. Furthermore, if positive to negativeZero crossings are also used in a similar manner and the results averaged, then any effects of DC and harmonic components can be reduced. In one implementation, the analog voltage V_g(t) Signal and Current I_g(t) the signal is converted to a digital signal which is high if the analog signal is positive and low if the analog signal is negative. High precision phase estimation requires sharp transitions between high and low values. In one aspect, Schmitt triggers and RC stabilization networks may be employed to convert analog signals to digital signals. In other aspects, edge-triggered RS flip-flops (flip-flops) and ancillary circuits may be employed. In yet another aspect, the zero crossing technique may employ exclusive or (XOR) gates.

Other techniques for determining the phase difference between the voltage and current signals include Lissajous diagrams and monitoring of images; methods such as the three volt method, the cross-coil method, the vector voltmeter, and the vector impedance method; and the use of phase-standard instruments, phase-locked loops, and "phase measurements" (Peter O 'Shea, 2000CRC Press LLC, < http:// www.engnetbase.com >) as by Peter O' Shea,2000 CRC Press, Inc. < http:// www.engnetbase.com >, which are incorporated herein by reference.

In another aspect, for example, current feedback data can be monitored in order to maintain the current amplitude of the drive signal at a current amplitude setpoint. The current amplitude set point may be specified directly or determined indirectly based on a particular voltage amplitude and power set point. In certain aspects, control of the current amplitude may be achieved by a control algorithm in processor 1740, such as, for example, a proportional-integral-derivative (PID) control algorithm. Variables controlled by the control algorithm for appropriately controlling the current amplitude of the drive signal may include, for example, scaling of LUT waveform samples stored in programmable logic device 1660 and/or full-scale output voltage via DAC1680 of DAC 1860 (which supplies an input to power amplifier 1620).

Non-isolated stage 1540 may further include a processor 1900 for providing User Interface (UI) functionality, among other things. In one aspect, processor 1900 may include, for example, an Atmel AT91 SAM9263 processor with an ARM 926EJ-S core available from Atmel Corporation, San Jose, Calif., of San Jose, Calif. Examples of UI functions supported by the processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with the foot switch 1430, communication with an input device 2150 (e.g., a touch screen display), and communication with an output device 2140 (e.g., a speaker). Processor 1900 may communicate with processor 1740 and a programmable logic device (e.g., via a Serial Peripheral Interface (SPI) bus). Although the processor 1900 may primarily support UI functions, in some aspects it may also cooperate with the processor 1740 to achieve risk mitigation. For example, processor 1900 may be programmed to monitor various aspects of user input and/or other input (e.g., touch screen input 2150, foot pedal 1430 input, temperature sensor input 2160) and disable the drive output of generator 1100 when an error condition is detected.

In certain aspects, processor 1740 (fig. 26, 27A) and processor 1900 (fig. 26, 27B) may determine and monitor an operating state of generator 1100. With respect to processor 1740, the operational state of generator 1100 may, for example, indicate to processor 1740 which control and/or diagnostic processes are being implemented. For processor 1900, the operational state of generator 1100 may, for example, indicate which elements of a user interface (e.g., display screen, sound) are presented to the user.

Processors

1740, 1900 may independently maintain the current operating state of generator 1100 and identify and evaluate possible transitions of the current operating state. Processor 1740 may serve as a master in this relationship and determine when transitions between operating states may occur. The processor 1900 may note valid transitions between operating states and may verify that 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. In the event that processor 1900 determines that the requested inter-state transition is invalid, processor 1900 may cause generator 1100 to enter a failure mode.

Non-isolated stage 1540 may further include a controller 1960 (fig. 26, 27B) for monitoring input device 2150 (e.g., capacitive touch sensor, capacitive touch screen for turning generator 1100 on and off). In certain aspects, the controller 1960 can include at least one processor and/or other controller device that communicates with the processor 1900. In one aspect, for example, the controller 1960 can include a processor (e.g., a Mega 1688 bit controller available from Atmel corporation) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, the controller 1960 can include a touchscreen controller (e.g., a QT5480 touchscreen controller available from Atmel corporation (Atemel)) to control and manage the acquisition of touch data from a capacitive touchscreen.

In certain aspects, the controller 1960 may continue to receive operating power (e.g., via a line from a power source of the generator 1100, such as the power source 2110 (fig. 26) discussed below) when the generator 1100 is in a "power off state. In this way, controller 1960 may continue to monitor input device 2150 (e.g., 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 the "power off" state, if activation of the user "on/off input device 2150 is detected, the controller 1960 can wake up the power source (e.g., enable operation of one or more DC/DC voltage converters 2130 (fig. 26) of the power source 2110). Controller 1960 can begin a sequence that transitions generator 1100 to a "power on" state. Conversely, when generator 1100 is in a "power on" state, if activation of "on/off input device 2150 is detected, controller 1960 may begin a sequence that transitions generator 1100 to a" power off "state. In certain aspects, for example, controller 1960 may report activation of "on/off input device 2150 to processor 1900, which in turn implements the desired sequence of processes to transition generator 1100 to a" power off "state. In such aspects, the controller 1960 may not have the independent ability to remove power from the generator 1100 after the "power off" state has been established.

In certain aspects, the controller 1960 can cause the generator 1100 to provide audible or other sensory feedback for alerting a user that a "power on" or "power off sequence has begun. This alert may be provided at the beginning of a "power on" or "power off" sequence and before the beginning of other processes associated with that sequence.

In certain aspects, the isolation stage 1520 may include instrument interface circuitry 1980 to provide a communication interface, for example, between control circuitry of the surgical device (e.g., control circuitry including a handpiece switch) and components of the non-isolation stage 1540 (such as, for example, programmable logic device 1660, processor 1740, and/or processor 1900). The instrument interface circuit 1980 may exchange information with components of the non-isolated stage 1540 via a communication link that maintains a suitable degree of electrical isolation between the

stages

1520, 1540, such as, for example, an Infrared (IR) based communication link. For example, instrument interface circuit 1980 may be supplied with power using a low drop-out voltage regulator powered by an isolation transformer, which is driven from non-isolated stage 1540.

In one aspect, the instrument interface circuit 1980 may include a programmable logic device 2000 (e.g., an FPGA) in communication with the signal conditioning circuit 2020 (fig. 26 and 27C). The signal conditioning circuit 2020 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the programmable logic device 2000 to generate a bipolar interrogation signal having the same frequency. For example, the interrogation signal may be generated using a bipolar current source fed by a differential amplifier. The interrogation signal may be sent 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 monitored to determine the state or configuration of the control circuit. For example, the control circuit may include a plurality of switches, resistors, and/or diodes to modify one or more characteristics (e.g., amplitude, correction) of the interrogation signal such that the state or configuration of the control circuit may be uniquely discerned based on the one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may include an ADC for generating samples of a voltage signal in an input of the control circuit derived from the interrogation signal by the control circuit. Programmable logic device 2000 (or a component of non-isolation stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.

In one aspect, the instrument interface circuit 1980 may include a first data circuit interface 2040 to enable the exchange of information between the programmable logic device 2000 (or other elements of the instrument interface circuit 1980) and a first data circuit disposed in or otherwise associated with the surgical device. In certain aspects, for example, the first data circuit 2060 may be provided in a cable integrally attached to the surgical device handpiece or provided in an adapter for interfacing a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit may include 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 may be implemented separately from the programmable logic device 2000 and include suitable circuitry (e.g., discrete logic devices, processors) to enable communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 may be integral to the logic device 2000.

In certain aspects, the first data circuit 2060 may store information associated with the particular surgical device associated. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical device has been used, and/or any other type of information. This information may be read by instrument interface circuitry 1980 (e.g., by programmable logic device 2000), transmitted to components of non-isolation stage 1540 (e.g., to programmable logic device 1660, processor 1740, and/or processor 1900), presented to a user via output device 2140, and/or to control functions or operations of generator 1100. Additionally, any type of information may be sent to the first data circuit 2060 via the first data circuit interface 2040 (e.g., using the programmable logic device 2000) for storage therein. Such information may include, for example, the updated number of operations in which the surgical device is used and/or the date and/or time of its use.

As previously discussed, the surgical instrument is detachable from the handpiece (e.g., the instrument 1106 is detachable from the handpiece 1107) to facilitate instrument interchangeability and/or disposability. In such cases, the ability of the known generator to identify the particular instrument configuration used and to optimize the control and diagnostic procedures accordingly may be limited. However, from a compatibility perspective, solving this problem by adding readable data circuitry to the surgical device instrument is problematic. For example, designing a surgical device to remain backward compatible with a generator lacking the requisite data reading functionality may be impractical due to, for example, different signal schemes, design complexity, and cost. Other aspects of the instrument address these issues by using a data circuit that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical device with current generator platforms.

In addition, aspects of the generator 1100 may enable communication with instrument-based data circuitry. For example, the generator 1100 may be configured to communicate with a second data circuit included in an instrument (e.g.,

instruments

1104, 1106, or 1108) of the surgical device. The instrument interface circuit 1980 may include a second data circuit interface 2100 for enabling this communication. In one aspect, second data circuit interface 2100 may comprise a tri-state digital interface, although other interfaces may also be used. In certain aspects, the second data circuit may generally be any circuit for transmitting and/or receiving data. In one aspect, the second data circuit may store information associated with the associated particular surgical instrument. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and/or any other type of information. Additionally or alternatively, any type of information may be sent to the second data circuit via the second data circuit interface 2100 (e.g., using the programmable logic device 2000) for storage therein. Such information may include, for example, the number of updates to the operation in which the surgical instrument is used and/or the date and/or time of its use. In certain aspects, the second data circuit may transmit data collected by one or more sensors (e.g., instrument-based temperature sensors). In certain aspects, the second data circuit may receive data from the generator 1100 and provide an indication (e.g., an LED indication 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 may be configured such that communication between the programmable logic device 2000 and the second data circuit may be achieved without providing additional conductors for this (e.g., dedicated conductors of a cable connecting the handpiece to the generator 1100). In one aspect, information may be transmitted to and from the second data circuit using a single bus communication scheme implemented on an existing cable, such as one of the conductors used to transmit interrogation signals from signal conditioning circuit 2020 to control circuitry in the handpiece, for example. In this way, design changes or modifications to the surgical device that may otherwise be necessary may be minimized or reduced. Furthermore, because different types of communication may be implemented on a common physical channel (with or without band splitting), the presence of the second data circuit may be "invisible" to generators that do not have the requisite data reading functionality, thus enabling backwards compatibility of surgical device instruments.

In certain aspects, the isolation stage 1520 may include at least one blocking capacitor 2960-1 (fig. 27C) that is connected to the drive signal output 1600b to prevent DC current from flowing to the patient. For example, the signal blocking capacitor may be required to comply with medical regulations or standards. While failures occur relatively rarely in single capacitor designs, such failures can have negative consequences. In one aspect, a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1, wherein current leakage from a point between the blocking capacitors 2960-1, 2960-2 is detected by, for example, the ADC 2980 for sampling the voltage induced by the leakage current. The sample may be received by programmable logic device 2000, for example. Based on the change in leakage current (as indicated by the voltage samples in the aspect of FIG. 26), the generator 1100 may determine when at least one of the blocking capacitors 2960-1, 2960-2 fails. Thus, the aspect of fig. 26 has benefits over a single capacitor design with a single point of failure.

In certain aspects, the non-isolated stage 1540 may include a power source 2110 for outputting DC power at appropriate voltages and currents. The power source may comprise, for example, a 400W power source for outputting a system voltage of 48 VDC. As described above, the power source 2110 may further include one or more DC/DC voltage converters 2130 for receiving the output of the power source to produce a DC output at the voltage and current required by the various components of the generator 1100. As described above in connection with controller 1960, one or more of DC/DC voltage converters 2130 may receive input from controller 1960 when controller 1960 detects a user activation of "on/off input device 2150 to enable operation of DC/DC voltage converter 2130 or to wake up DC/DC voltage converter 2130.

Fig. 28A-28B illustrate certain functional and structural aspects of an aspect of the generator 1100. Feedback indicative of 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,

ADCs

1780, 1800 may be implemented as 2-channel ADCs, and the feedback signal may be sampled at high speed (e.g., 80Msps) to allow oversampling (e.g., approximately 200x oversampling) of the drive signal. The current feedback signal and the voltage feedback signal may be appropriately conditioned (e.g., amplified, filtered) in the analog domain prior to processing by the

ADC

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 device 1660. In the aspect of fig. 28A-28B, programmable logic device 1660 comprises an FPGA.

The multiplexed current and voltage feedback samples may be received by a Parallel Data Acquisition Port (PDAP) implemented within block 2144 of the processor 1740. The PDAP may comprise an encapsulation unit for implementing any of a variety of methods for associating multiplexed feedback samples with memory addresses. In one aspect, for example, feedback samples corresponding to particular LUT samples output by programmable logic device 1660 can be stored at one or more memory addresses that correlate to or index LUT addresses of the LUT samples. In another aspect, feedback samples corresponding to particular LUT samples output by programmable logic device 1660 can be stored at a common memory location along with LUT addresses for the LUT samples. In any case, the feedback samples may be stored such that the address of the LUT sample from which the particular set of feedback samples originated may be subsequently determined. As described above, synchronizing the LUT sample addresses and the feedback samples in this manner facilitates correct timing and stability of the predistortion algorithm. A Direct Memory Access (DMA) controller implemented at block 2166 of processor 1740 may store the feedback samples (and any LUT sample address data, if applicable) at a designated memory location 2180 (e.g., internal RAM) of processor 1740.

Block 2200 of processor 1740 may implement a predistortion algorithm for predistorting or modifying LUT samples stored in programmable logic device 1660 on a dynamic marching basis. As described above, predistortion of the LUT samples may compensate for various distortion sources present in the output drive circuit of generator 1100. The pre-distorted LUT samples, when processed by the drive circuit, will thus cause the drive signal to have a desired waveform shape (e.g., sinusoidal shape) to optimally drive the ultrasound transducer.

At block 2220 of the predistortion algorithm, the current through the dynamic branch of the ultrasound transducer is determined. May be based on, for example, current and voltage feedback samples stored at memory location 2180 (which, when properly calibrated, may represent I in the model of FIG. 25 discussed above_gAnd V_g) Static capacitance C of ultrasonic transducer₀And a known value of the drive frequency, using kirchhoff's current law to determine the dynamic branch current. Dynamic branch current samples for each set of stored current and voltage feedback samples associated with LUT samples may be determined.

At block 2240 of the predistortion algorithm, each dynamic leg current sample determined at block 2220 is compared to a sample of the desired current waveform shape to determine a difference or sample amplitude error between the compared samples. For this determination, samples of the desired current waveform shape may be supplied, for example, from waveform shape LUT2260, which waveform shape LUT2260 contains amplitude samples for one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT2260 used for comparison may be determined by the LUT sample address associated with the dynamic branch current sample used for comparison. Thus, the input of the motion leg current to block 2240 may be synchronized to the input of its associated LUT sample address to block 2240. Thus, the number of LUT samples stored in programmable logic device 1660 and LUT samples stored in waveform shape LUT2260 may be equal. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT2260 may be a basic sine wave. Other waveform shapes may be desired. For example, it is contemplated that a basic sine wave for driving the main longitudinal motion of the ultrasound transducer superimposed with one or more other drive signals at other frequencies may be used, such as a third harmonic for driving at least two mechanical resonances for advantageous vibrations in the transverse or other modes.

Each value of the sample amplitude error determined at block 2240 is transmitted to the LUT of the programmable logic device 1660 (shown at block 2280 in fig. 28A) along with an indication of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and optionally, the previously received value of the sample amplitude error for the same LUT address), the LUT2280 (or other control block of the programmable logic device 1660) can predistort or modify the value of the LUT sample stored at the LUT address such that the sample amplitude error is reduced or minimized. It will be appreciated that such predistortion or modification of each LUT sample in an iterative manner over the entire LUT address range will result in the waveform shape of the generator's output current matching or conforming to the desired current waveform shape represented by the samples of waveform shape LUT 2260.

The 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 at memory location 2180. Prior to determining these quantities, the feedback samples may be appropriately scaled and, in some aspects, processed through a suitable filter 2320 to remove noise resulting from, for example, the data acquisition process and induced harmonic components. Thus, the filtered voltage and current samples may substantially represent the fundamental frequency of the generator's drive output signal. In certain aspects, the filter 2320 may be a Finite Impulse Response (FIR) filter applied to the frequency domain. Such aspects may use a Fast Fourier Transform (FFT) of the output drive signal current and voltage signals. In some aspects, the resulting frequency spectrum may be used to provide additional generator functionality. In one aspect, for example, the ratio of the second order harmonic component and/or the third order harmonic component relative to the fundamental frequency component may be used as a diagnostic indicator.

At block 2340 (fig. 28B), a Root Mean Square (RMS) calculation may be applied to current feedback samples representing a sample size of the drive signal for an integer cycle to generate a measurement I representing the drive signal output current_rms。

At block 2360, a Root Mean Square (RMS) calculation may be applied to the voltage feedback samples representing a sample size of the drive signal for an integer cycle to determine a measurement V representing the output voltage of the drive signal_rms。

At block 2380, the current and voltage feedback samples may be multiplied point-by-point and the samples representing the integer-cycle drive signal may be averaged to determine a measure P of the true output power of the generator_r。

At block 2400, a measure P of the apparent output power of the generator_aCan be determined as the product V_rms·I_rms。

At block 2420, the measured value of the load resistance value Z_mCan be determined as a quotient V_rms/I_rms。

In certain aspects, the amount I determined at

blocks

2340, 2360, 2380, 2400, and 2420_rms、V_rms、P_r、P_aAnd Z_mCan be used by the generator 1100 to implement any of a number of control and/or diagnostic processes. In certain aspects, any of these quantities may be communicated to a user via, for example, output device 2140 integral to generator 1100 or output device 2140 connected to generator 1100 through a suitable communication interface (e.g., a USB interface). For example, various diagnostic procedures may include, but are not limited to, handpiece integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock failure, over current condition, over power condition, voltage sensing failure, current sensing failure, audio indication failure, visual indication failure, short circuit condition, power delivery failure, or blocking capacitor failure.

Block 2440 of processor 1740 may implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (e.g., an ultrasound transducer) driven by generator 1100. As described above, by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0 °), the effects of harmonic distortion may be minimized or reduced and the accuracy of the phase measurement increased.

The phase control algorithm receives as inputs the current and voltage feedback samples stored in memory location 2180. The feedback samples may be appropriately scaled and processed in some respects by a suitable filter 2460 (which may be the same as filter 2320) to remove noise resulting from, for example, the data acquisition process and induced harmonic components, before being used in the phase control algorithm. Thus, the filtered voltage and current samples may substantially represent the fundamental frequency of the generator's drive output signal.

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

At block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronous input of the dynamic branch current samples and the corresponding voltage feedback samples determined at block 2480. In certain aspects, the impedance phase is determined as an 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 the phase set point 2540 to determine a 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 value of the phase error determined at block 2520 and the impedance magnitude determined at block 2420. The value of the frequency output may be continuously adjusted by the block 2560 and transmitted to the DDS control block 2680 (discussed below) in order to maintain the impedance phase determined at block 2500 at a phase set point (e.g., zero phase error). In certain aspects, the impedance phase may be adjusted to a 0 ° phase setpoint. In this way, any harmonic distortion will be centered around the peak of the voltage waveform, thereby enhancing the accuracy of the phase impedance determination.

Block 2580 of processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal to control the drive signal current, voltage, and power according to user-specified set points or according to requirements specified by other processes or algorithms implemented by generator 1100. Control of these amounts may be achieved, for example, by scaling LUT samples in LUT2280 and/or by adjusting the full-scale output voltage of DAC1680 (which supplies input to power amplifier 1620) via DAC 1860. Block 2600 (which in some aspects may be implemented as a PID controller) may receive as input current feedback samples (which may be appropriately scaled and filtered) from memory location 2180. The current feedback samples may be compared to a "current demand" I specified by a controlled variable (e.g., current, voltage, or power)_dThe values are compared to determine whether the drive signal supplies the necessary current. In terms of driving signal current as a control variable, current demand I_dCan be controlled by current set point 2620A (I)_sp) And directly specifying. For example, the RMS value of the current feedback data (as determined in block 2340) may be compared to a user-specified RMS current set point I_spA comparison is made to determine the appropriate controller action. For example, if the current feedback data indicates that the RMS value is less than the current set point I_spThe LUT scaled and/or full-scaled output voltage of DAC1680 may be adjusted by block 2600 such that the drive signal current is increased. Conversely, when the current feedback data indicates that the RMS value is greater than the current set point I_spWhen desired, block 2600 may adjust LUT scaling and/or full scale output voltages of DAC1680 to reduce drive signal current.

In terms of driving signal voltage as a control variable, current demand I_dMay be based, for example, on maintaining the load impedance magnitude Z measured at block 2420_mGiven a desired voltage set point 2620B (V)_sp) Required current ofIndirect assignment (e.g. I)_d＝V_sp/Z_m). Similarly, in terms of driving signal power as a control variable, current demand I_dMay be based, for example, on the voltage V measured at block 2360_rmsGiven a desired setpoint 2620C (P)_sp) The required current is indirectly specified (e.g. I)_d＝P_sp/V_rms)。

Block 2680 (fig. 28A) may implement a DDS control algorithm for controlling the drive signal by retrieving LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm may be a digitally controlled oscillator (NCO) algorithm for generating samples of a waveform at a fixed clock rate using a point (memory location) -skip technique. The NCO algorithm may implement a phase accumulator or frequency-to-phase converter that is used as an address pointer for retrieving LUT samples from the LUT 2280. In one aspect, the phase accumulator may be a D step, modulus N phase accumulator, where D is a positive integer representing the frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D ═ 1 may cause the phase accumulator to sequentially point to each address of LUT2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. When D >1, the phase accumulator may skip addresses in LUT2280, resulting in a waveform output with a higher frequency. Accordingly, the frequency of the waveform generated by the DDS control algorithm can thus be controlled by appropriately changing 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 supply an input of DAC1680, which DAC1680 in turn supplies a corresponding analog signal to an input of power amplifier 1620.

Block 2700 of processor 1740 may implement a switch-mode converter control algorithm for dynamically modulating a rail voltage of power amplifier 1620 based on a waveform envelope of an amplified signal to improve efficiency of power amplifier 1620. In certain aspects, characteristics of the waveform envelope may be determined by monitoring one or more signals contained in the power amplifier 1620. In one aspect, for example, the characteristics of the waveform envelope may be determined by monitoring a minimum value of a drain voltage (e.g., a MOSFET drain voltage) 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 the ADC 1760 with the output minimum voltage sample being 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 PWM generator 2760 in turn controls the rail voltage supplied to power amplifier 1620 by switch-mode regulator 1700. In certain aspects, the mains voltage may be modulated according to the waveform envelope characterized by the minimum voltage samples, as long as the value of the minimum voltage samples is less than the minimum target 2780 input into block 2720. For example, block 2740 may result in supplying a low rail voltage to power amplifier 1620 when the minimum voltage samples indicate a low envelope power level, with the full rail voltage being supplied only when the minimum voltage samples indicate a maximum envelope power level. When the minimum voltage sample falls below the minimum target 2780, block 2740 may keep the rail voltage at a minimum value suitable to ensure proper operation of power amplifier 1620.

Fig. 29 is a schematic diagram of one aspect of a circuit 2900 suitable for driving an ultrasonic transducer, such as ultrasonic transducer 1120, in accordance with at least one aspect of the present disclosure. Circuit 2900 includes an analog multiplexer 2980. The analog multiplexer 2980 multiplexes various signals from the upstream channel SCL-A, SDA-A such as ultrasound, battery, and power control circuitry. A current sensor 2982 is coupled in series with the return or ground branch of the power source circuit to measure the current provided by the power source. A Field Effect Transistor (FET) temperature sensor 2984 provides ambient temperature. If the main program ignores maintenance on it periodically, a Pulse Width Modulation (PWM) watchdog timer 2988 automatically generates a system reset. Which is set to auto-reset circuit 2900 when it stalls or freezes due to a software or hardware failure. It should be understood that circuit 2900 may be configured as an RF driver circuit for driving an ultrasonic transducer or for driving an RF electrode such as circuit 3600 shown in fig. 34, for example. Thus, referring now back to fig. 29, circuit 2900 may be used to interchangeably drive both the ultrasound transducer and the RF electrode. If driven simultaneously, filter circuits can be provided in the corresponding first stage circuit 3404 (FIG. 32) to select the ultrasonic or RF waveform. Such filtering TECHNIQUES are described in commonly owned U.S. patent publication US-2017-0086910-A1, entitled technique FOR circuit topology FOR a combinational GENERATOR (TECHNIQUES FOR COMMUNICED GENERATOR), which is incorporated herein by reference in its entirety.

The drive circuit 2986 provides a left ultrasonic energy output and a right ultrasonic energy output. Digital signals representing the signal waveforms are provided from a control circuit, such as control circuit 3200 (fig. 30), to SCL-A, SDA-a inputs of analog multiplexer 2980. A digital-to-analog converter 2990(DAC) converts a digital input to an analog output to drive a Pulse Width Modulation (PWM) circuit 2992 coupled to an oscillator 2994. The PWM circuit 2992 provides a first signal to a first gate drive circuit 2996a coupled to a first transistor output stage 2998a to drive a first ultrasonic (LEFT) energy output. The PWM circuit 2992 also provides a second signal to a second gate drive circuit 2996b coupled to a second transistor output stage 2998b to drive a second ultrasonic (RIGHT) energy output. A voltage sensor 2999 is coupled between the ultrasonic LEFT/RIGHT output terminals to measure the output voltage. The driver circuit 2986, the first and second driver circuits 2996a and 2996b, and the first and second transistor output stages 2998a and 2998b define a first stage amplifier circuit. In operation, the control circuit 3200 (fig. 30) generates the digital waveform 4300 (fig. 37) using a circuit such as a Direct Digital Synthesis (DDS) circuit 4100, 4200 (fig. 35 and 36). The DAC 2990 receives the digital waveform 4300 and converts it to an analog waveform that is received and amplified by the first stage amplifier circuit.

Fig. 30 is a schematic diagram of a control circuit 3200, such as control circuit 3212, according to at least one aspect of the present disclosure. The control circuit 3200 is located within the housing of the battery assembly. The battery assembly is an energy source for the various local power sources 3215. The control circuitry includes a main processor 3214, the main processor 3214 being coupled to various downstream circuits via an interface host (interface master)3218 by, for example, the outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. In one aspect, the interface host 3218 is a universal serial interface, such as I²And C, serial interface. The main processor 3214 is further configured to drive switches 3224 through general purpose input/output (GPIO)3220, a display 3226 (e.g., and LCD display) and various indicators 3228 through GPIO 3222. The watchdog processor 3216 is arranged to control the 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, the main processor 3214 is coupled to the circuit 2900 (FIG. 29) through the output terminals SCL-A, SDA-A. The main processor 3214 includes a memory for storing, for example, a table of digitized drive signals or waveforms transmitted to the circuit 2900 to drive the ultrasonic transducer 1120. In other aspects, the main processor 3214 may generate and transmit digital waveforms to the circuit 2900, or may store digital waveforms for later transmission to the circuit 2900. The main processor 3214 may also provide RF drive through the output terminals SCL-B, SDA-B, and may provide various sensors (e.g., Hall effect sensors, magneto-rheological fluid (MRF) sensors, etc.) through the output terminals SCL-C, SDA-C. In one aspect, the main processor 3214 is configured to sense the presence of the ultrasound drive circuitry and/or RF drive circuitry to enable appropriate software and user interface functionality.

In one aspect, primary processor 3214 may be, for example, LM4F230H5QR, available from texas instruments (texas instruments). In at least one example, LM4F230H5QR, Texas instruments (Texas instruments), is an ARM Cortex-M4F processor core that includes: 256KB of on-chip memory of single cycle flash or other non-volatile memory (up to 40MHz), prefetch buffer for performance improvement above 40MHz, 32KB of single cycle Serial Random Access Memory (SRAM), load with

Internal Read Only Memory (ROM) for software, Electrically Erasable Programmable Read Only Memory (EEPROM) for 2KB, one or more Pulse Width Modulation (PWM) modules, one or more quadrature encoder inputs (QED analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, and other features readily availableAnd (5) characterizing the parts. Other processors may be readily substituted, and the disclosure should not be limited in this context.

Fig. 31 illustrates a simplified circuit block diagram showing another circuit 3300 included within a modular ultrasonic surgical instrument 3334, in accordance with at least one aspect of the present disclosure. The 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 smoothing circuit 3312 (also referred to as a matching circuit and may be, for example, a tank circuit), a sense circuit 3314, a transducer 1120, and a shaft assembly (e.g., shaft assemblies 1126, 1129) that includes an ultrasonic transmission waveguide terminated at an ultrasonic blade (e.g., ultrasonic blade 1128, 1149), which may be referred to herein simply as a waveguide.

One feature of the present disclosure that cuts off the dependence on high voltage (120 volts ac) input power (a feature of typical ultrasonic cutting devices) is the utilization of low voltage switches during the entire wave forming process, and the amplification of the drive signal only immediately prior to the transformer stage. Thus, in one aspect of the present disclosure, power is sourced from only one battery or a group of batteries that are small enough to fit within the handle assembly. The battery technology in the art provides high power batteries with a height and width of a few centimeters and a depth of a few millimeters. By combining features of the present disclosure to provide self-contained and self-powered ultrasound devices, a reduction in manufacturing costs can be achieved.

The output of power source 3304 is fed to and powers processor 3302. The processor 3302 receives and outputs signals, and as will be described below, the processor 3302 operates according to custom logic or according to a computer program executed by the processor 3302. As described above, circuit 3300 can also include memory 3326, preferably Random Access Memory (RAM), which stores computer-readable instructions and data.

The output of power source 3304 is also directed to switch 3306, which has a duty cycle controlled by processor 3302. By controlling the on-time of the switch 3306, the processor 3302 can specify the total amount of power that is ultimately delivered to the transducer 1120. In one aspectSwitch 3306 is a MOSFET, but other switches and switch configurations are also adaptable. The output of the switch 3306 is fed to a drive circuit 3308, which drive circuit 3308 comprises, 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 (V) of the output signal, respectively_INAnd I_IN). These values are used in a feedback architecture to adjust the pulse width modulation of the switch 3306. For example, the duty cycle of the switch 3306 may vary in a range of about 20% to about 80%, depending on the desired and actual outputs from the switch 3306.

The drive circuit 3308, which receives signals from the switch 3306, includes an oscillating circuit (VCO) that converts the output of the switch 3306 into an electrical signal having an ultrasonic frequency (e.g., 55 kHz). As described above, this smoothed version of the ultrasonic waveform is ultimately fed to the ultrasonic transducer 1120 to produce a resonant sine wave along the ultrasonic transmission waveguide.

The output of the driver circuit 3308 is a transformer 3310 capable of boosting one or more low voltage signals to a higher voltage. It should be noted that the upstream switching before the transformer 3310 is performed at a low (e.g., battery-driven) voltage, which has heretofore not been possible with ultrasonic cutting and cauterization devices. 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 allow higher currents to pass. Thus, the switching stage (pre-transformer) can be characterized as low voltage/high current. To ensure a low on-resistance of the one or more amplifier MOSFETs, the one or more MOSFETs are operated at e.g. 10V. In this case, a separate 10VDC power source may be used to power the MOSFET gate, which ensures that the MOSFET is fully on and a relatively low on-resistance is achieved. In one aspect of the present disclosure, the transformer 3310 boosts the battery voltage to 120 volts Root Mean Square (RMS). Transformers are known in the art and are therefore not described in detail herein.

In such circuit configurations, circuit component degradation can negatively impact circuit performance of the circuit. One factor that directly affects the performance of a component is heat. Known circuits typically monitor switch temperature (e.g., MOSFET temperature). However, as MOSFET design technology advances and the corresponding size decreases, MOSFET temperature is no longer a valid indicator of circuit loading and heat. Thus, according to at least one aspect of the present disclosure, the sensing circuit 3314 senses the temperature of the transformer 3310. This temperature sensing is advantageous because transformer 3310 operates at or very near its maximum temperature during device use. The additional temperature will cause the core material (e.g., ferrite) to crack and permanent damage may occur. The present disclosure may respond to the maximum temperature of transformer 3310 by, for example, reducing the drive power in transformer 3310, signaling a user, shutting down power, pulsing power, or other suitable response.

In one aspect of the present disclosure, the processor 3302 is communicatively coupled to an end effector (e.g., 1122, 1125) for placing material in physical contact with an ultrasonic blade (e.g., 1128, 1149). A sensor is provided that measures a clamping force value (existing within a known range) at the end effector, and based on the clamping force value received, the processor 3302 changes the dynamic voltage V_M. Since high force values in combination with set rates of motion may result in high blade temperatures, the temperature sensor 3332 may be communicatively coupled to the processor 3302, wherein the processor 3302 may be operated to receive and interpret signals indicative of the current temperature of the blade from the temperature sensor 3336 and determine a target frequency of blade movement based on the received temperature. In another aspect, a force sensor, such as a strain sensor or a pressure sensor, may be coupled to the trigger (e.g., 1143, 1147) to measure the force applied to the trigger by the user. In another aspect, a force sensor, such as a strain sensor or a 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 the drive circuit 3308 coupled to the processor 3302 can determine the frequency of the waveguide movement and communicate the frequency to the processor 3302. When the device is turned off, the processor 3302 stores the frequency value in the memory 3326. By reading the clock 3330, the processor 3302 can determine the elapsed time after the device is turned off and retrieve the last waveguide movement frequency if the elapsed time is less than a predetermined value. The device can then be started at more than one frequency, which is probably the optimum frequency for the current load.

Modular battery-powered hand-held surgical instrument with multi-stage generator circuit

In another aspect, the present disclosure provides a modular battery-powered hand-held surgical instrument having a multi-stage generator circuit. A surgical instrument includes a battery assembly, a handle assembly, and a shaft assembly, wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to 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 to receive, amplify, and apply the analog waveform to the load.

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

The load may include any of the ultrasound transducer, the electrode, or the 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 independently or simultaneously. The first stage ultrasonic drive circuit may be configured to be coupled to the second stage ultrasonic drive circuit. The second stage ultrasonic drive circuit may be configured to be coupled to an ultrasonic transducer. The first stage high frequency current drive circuit may be configured to be coupled to the second stage high frequency drive circuit. The second stage high frequency drive circuit may be configured to be coupled to the electrode.

The first stage circuitry may include first stage sensor drive circuitry. The first stage sensor drive circuit may be configured as a second stage sensor drive circuit. The second stage sensor drive circuit may be configured to be coupled to the sensor.

In another aspect, the present disclosure provides a surgical instrument comprising: a battery assembly comprising control circuitry including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, wherein the processor is configured to generate a digital waveform; a handle assembly comprising a common first stage circuit coupled to the processor, the common first stage circuit comprising a digital-to-analog (DAC) converter and a common first stage amplifier circuit, wherein the DAC is configured to receive a digital waveform and convert the digital waveform to an analog waveform, wherein the common first stage amplifier circuit is configured to receive and amplify the analog waveform; and a shaft assembly comprising a second stage circuit coupled to the common first stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to the load; wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to the handle assembly.

The load may include any of the ultrasound transducer, the electrode, or the sensor, or any combination thereof. The common first stage circuit may be configured to drive ultrasonic, high frequency current, or sensor circuits. The common first stage drive circuit may be configured to be coupled to a second stage ultrasonic drive circuit, a second stage high frequency drive circuit, or a second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to be coupled to an ultrasonic transducer, the second stage high frequency drive circuit configured to be coupled to an electrode, and the second stage sensor drive circuit configured to be coupled to a sensor.

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

The common first stage circuit may be configured to drive ultrasonic, high frequency current, or sensor circuits. The common first stage drive circuit may be configured to be coupled to a second stage ultrasonic drive circuit, a second stage high frequency drive circuit, or a second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to be coupled to an ultrasonic transducer, the second stage high frequency drive circuit configured to be coupled to an electrode, and the second stage sensor drive circuit configured to be coupled to a sensor.

Fig. 32 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 the surgical system 1000 described herein can include a generator circuit 3400 divided into a plurality of stages. For example, the surgical instrument of the surgical system 1000 can include a generator circuit 3400 divided into at least two circuits: first and

second stage circuits

3404, 3406 that enable RF energy operation only, ultrasonic energy operation only, and/or a combination of RF energy and ultrasonic energy operation. Modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within handle assembly 3412 and a modular second stage circuit 3406 integrally formed with modular shaft assembly 3414. As previously discussed throughout this specification in connection with the surgical instruments of the surgical system 1000, the battery assembly 3410 and the shaft assembly 3414 are configured to be mechanically and electrically connected to the handle assembly 3412. The end effector assembly is configured to mechanically and electrically connect shaft assembly 3414.

Turning now to fig. 32, the generator circuit 3400 is divided into a plurality of stages that are located in a plurality of modular assemblies of a surgical instrument, such as the surgical instrument of the surgical system 1000 described herein. In one aspect, the control stage circuitry 3402 may be located in the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is a control circuit 3200 as described in connection with fig. 30. The control circuit 3200 includes a processor 3214 that includes internal memory 3217 (fig. 32) (e.g., volatile and non-volatile memory) and is electrically coupled to a battery 3211. The battery 3211 supplies power to the first, second, and

third stage circuits

3404, 3406, and 3408, respectively. As previously described, the control circuit 3200 uses the circuits and techniques described in connection with fig. 35 and 36 to generate the digital waveform 4300 (fig. 37). Returning to fig. 32, the digital waveform 4300 may be configured to drive an ultrasound transducer, a high frequency (e.g., RF) electrode, or a combination thereof, independently or simultaneously. If driven simultaneously, filter circuits may be provided in the corresponding first stage circuit 3404 to select the ultrasonic or RF waveform. Such filtering TECHNIQUES are described in commonly owned U.S. patent publication US-2017-0086910-a1, entitled CIRCUIT topology FOR a combined generator (TECHNIQUES FOR COMMUNICATION), the entire contents of which are incorporated herein by reference.

The first stage circuitry 3404 (e.g., first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, and first stage transducer drive circuit 3424) is located in the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides an ultrasonic drive signal to the first stage ultrasonic drive circuit 3420 via the output SCL-A, SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 is described in detail in connection with fig. 29. Control circuit 3200 provides the RF drive signal to first stage RF drive circuit 3422 via output SCL-B, SDA-B of control circuit 3200. The first stage RF driver circuit 3422 is described in detail in connection with fig. 34. The control circuit 3200 provides sensor drive signals to the first level sensor drive circuit 3424 via the output SCL-C, 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 the first stage 3404 is provided to the input 3406 of the second stage.

The control circuit 3200 is configured to detect which modules are inserted into the control circuit 3200. For example, control circuit 3200 is configured to detect whether first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, or first stage sensor drive circuit 3424 located in handle assembly 3412 is connected to battery assembly 3410. Likewise, each of the first stage circuits 3404 may detect which of the second stage circuits 3406 are connected to, and this information is provided back to the control circuit 3200 to determine the type of signal waveform to be generated. Similarly, each of the second stage circuits 3406 may detect which third stage circuit 3408 or which components are connected thereto, and this information is provided back to the control circuit 3200 to determine the type of signal waveform to generate.

In one aspect, the second stage circuitry 3406 (e.g., ultrasonic drive second stage circuitry 3430, RF drive second stage circuitry 3432, and sensor drive second stage circuitry 3434) is located in the shaft assembly 3414 of the surgical instrument. The first stage ultrasonic drive circuit 3420 provides a signal to the second stage ultrasonic drive circuit 3430 via the output US-Left/US-Right. The second stage ultrasonic drive circuit 3430 may include, for example, a transformer, a filter, an amplifier, and/or a signal conditioning circuit. The first stage high frequency (RF) current drive circuit 3422 provides signals to the second stage RF drive circuit 3432 via output RF-Left/RF-Right. In addition to the transformer and blocking capacitor, the second stage RF driver circuit 3432 may also include filters, amplifiers, and signal conditioning circuits. First stage Sensor drive circuit 3424 provides signals to second stage Sensor drive circuit 3434 via outputs Sensor-1/Sensor-2. Depending on the type of sensor, the second stage sensor drive circuit 3434 may include filters, amplifiers, and signal conditioning circuits. The output of the second stage circuit 3406 is provided to the input of the third stage circuit 3408.

In one aspect, the third stage circuit 3408 (e.g., the ultrasound transducer 1120, the

RF electrodes

3074a, 3074b, and the sensor 3440) may be located in various components 3416 of the surgical instrument. In one aspect, the second stage ultrasonic drive circuit 3430 provides a drive signal to the ultrasonic transducer 1120 piezoelectric stack. In one aspect, the ultrasonic transducer 1120 is located in an ultrasonic transducer assembly of a surgical instrument. However, in other aspects, the ultrasonic transducer 1120 may be located in the handle assembly 3412, the shaft assembly 3414, or the end effector. In one aspect, second stage RF drive circuit 3432 provides drive signals to

RF electrodes

3074a, 3074b, which are typically located in 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. 33 illustrates a generator circuit 3500 divided into a plurality of stages, wherein a first stage circuit 3504 is common to a second stage circuit 3506, in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3500 divided into a plurality of stages. For example, the surgical instrument of the surgical system 1000 may include a generator circuit 3500 divided into at least two circuits: a first stage amplifier circuit 3504 and a second stage amplifier circuit 3506 that enable high frequency (RF) energy operation only, ultrasonic energy operation only, and/or a combination of RF energy and ultrasonic energy operation. The 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 integrally formed with the modular shaft assembly 3514. As previously discussed throughout this specification in connection with the surgical instruments of the surgical system 1000, the battery assembly 3510 and the shaft assembly 3514 are configured to be mechanically and electrically connected to the handle assembly 3512. The end effector assembly is configured to mechanically and electrically connect the shaft assembly 3514.

As shown in the example of fig. 33, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes the previously described control circuit 3200. A handle assembly 3512 connected to a battery assembly 3510 includes a common first stage drive circuit 3420. As previously described, the first stage drive circuit 3420 is configured to drive ultrasound, high frequency (RF) current, and sensor loads. The output of common first stage drive circuit 3420 may drive any of second stage circuits 3506, such as second stage ultrasonic drive circuit 3430, second stage high frequency (RF) current drive circuit 3432, and/or second stage sensor drive circuit 3434. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 detects which second stage circuit 3506 is located in the shaft assembly 3514. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 determines which of the second stage circuits 3506 (e.g., the second stage ultrasonic drive circuit 3430, the second stage RF drive circuit 3432, and/or the second stage sensor drive circuit 3434) is located in the shaft assembly 3514. This information is provided to the control circuit 3200 located in the handle assembly 3512 to provide the appropriate digital waveform 4300 (fig. 37) to the second stage circuit 3506 to drive an appropriate load, such as an ultrasonic, RF or sensor. It is to be understood that the identification circuit can be included in various components 3516 in the third stage circuit 3508, such as the ultrasonic transducer 1120, the

electrodes

3074a, 3074b, or the sensor 3440. Therefore, 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. 34 is a schematic diagram of one aspect of a circuit 3600 configured to drive high frequency current (RF) in accordance with at least one aspect of the present disclosure. Circuit 3600 includes analog multiplexer 3680. Analog multiplexer 3680 multiplexes the various signals from upstream channels SCL-A, SDA-A such as RF, battery, and power control circuitry. A current sensor 3682 is coupled in series with the return or ground leg of the power source circuit to measure the current provided by the power source. A Field Effect Transistor (FET) temperature sensor 3684 provides ambient temperature. Pulse Width Modulation (PWM) watchdog timer 3688 automatically generates a system reset if the main program ignores maintenance on it periodically. Which is set to auto-reset circuit 3600 when it stalls or freezes due to a software or hardware failure. It should be understood that circuit 3600 may be configured for driving RF electrodes or for driving ultrasound transducer 1120, for example, as described in connection with fig. 29. Thus, referring now back to fig. 34, circuit 3600 may be used to interchangeably drive both ultrasound and RF electrodes.

Drive circuit 3686 provides a Left RF energy output and a Right RF energy output. Digital signals representing signal waveforms are provided from a control circuit, such as control circuit 3200 (fig. 30), to SCL-A, SDA-a inputs of analog multiplexer 3680. A digital-to-analog converter 3690(DAC) converts a digital input to an analog output to drive a Pulse Width Modulation (PWM) circuit 3692 coupled to an oscillator 3694. PWM circuit 3692 provides a first gate drive circuit 3696a coupled to a first transistor output stage 3698a to drive a first RF + (Left) energy output. The PWM circuit 3692 also provides a second gate drive circuit 3696b coupled to the second transistor output stage 3698b to drive a second RF- (Right) energy output. A voltage sensor 3699 is coupled between the RFLEft/RF output terminals to measure the output voltage. The driver circuit 3686, the first and second driver circuits 3696a, 3696b, and the first and second

transistor output stages

3698a, 3698b define a first stage amplifier circuit. In operation, the control circuit 3200 (fig. 30) generates the digital waveform 4300 (fig. 37) using a circuit such as a Direct Digital Synthesis (DDS) circuit 4100, 4200 (fig. 35 and 36). DAC 3690 receives the digital waveform 4300 and converts it to an analog waveform that is received and amplified by the first stage amplifier circuit.

In one aspect, the ultrasonic or high frequency current generator of the surgical system 1000 may be configured to digitally generate the electrical signal waveform such that it is desirable to digitize the waveform using a predetermined number of phase points stored in a look-up table. The phase points may be stored in tables defined in memory, a Field Programmable Gate Array (FPGA), or any suitable non-volatile memory. Fig. 35 illustrates one aspect of the basic architecture of a digital synthesis circuit, such as a Direct Digital Synthesis (DDS) circuit 4100, configured to generate multiple wave shapes of electrical signal waveforms. The generator software and digital controls may command the FPGA to scan for addresses in a lookup table 4104, which lookup table 4104 in turn provides varying digital input values to the DAC circuit 4108 feeding the power amplifier. The addresses may be scanned according to the frequency of interest. Various types of waveforms can be generated using this lookup table 4104, which can be fed simultaneously into tissue or transducers, RF electrodes, multiple transducers, multiple RF electrodes, or a combination of RF and ultrasonic instruments. Further, multiple lookup tables 4104 representing multiple wave shapes can be created, stored, and applied to the tissue from the generator.

The waveform signal may be configured to control at least one of an output current, an output voltage, or an output power of the ultrasound transducer and/or the RF electrode or multiples thereof (e.g., two or more ultrasound transducers and/or two or more RF electrodes). Additionally, where the surgical instrument includes an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of an ultrasonic 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, wherein the waveform signal corresponds to at least one wave shape of the plurality of wave shapes in the table. In addition, the waveform signals provided to the two surgical instruments may include two or more wave shapes. The table may include information associated with a plurality of waveform shapes, and the table may be stored within the generator. In one aspect or example, the table may be a direct digital synthesis table that may be stored in the FPGA of the generator. The table may be addressed in any manner that facilitates classification of waveform shapes. 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 associated with the plurality of waveform shapes may be stored as digital information in a table.

The analog electrical signal waveform can be configured to control at least one of an output current, an output voltage, or an output power of the ultrasound transducer and/or the RF electrode or multiples thereof (e.g., two or more ultrasound transducers and/or two or more RF electrodes). Additionally, where the surgical instrument includes an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of an ultrasonic transducer of the at least one surgical instrument. Accordingly, the generator circuit may be configured to provide an analog electrical signal waveform to the at least one surgical instrument, wherein the analog electrical signal waveform corresponds to at least one wave shape of the plurality of wave shapes stored in the lookup table 4104. In addition, the analog electrical signal waveforms provided to the two surgical instruments may include two or more wave shapes. The lookup table 4104 may include information associated with a plurality of waveform shapes, and the lookup table 4104 may be stored within the generator circuit or the surgical instrument. In one aspect or example, the lookup table 4104 can be a direct digital synthesis table that can be stored in the generator circuit or FPGA of the surgical instrument. The lookup table 4104 may be addressed in any manner that facilitates classification of waveform shapes. According to one aspect, the lookup table 4104 (which may be a direct digital synthesis table) is addressed according to the frequency of the desired analog electrical signal waveform. In addition, information associated with the plurality of waveform shapes may be stored as digital information in the lookup table 4104.

As digital technology is widely used in instruments and communication systems, digital control methods for generating multiple frequencies from a reference frequency source have evolved and are referred to as direct digital synthesis. The infrastructure is shown in fig. 35. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic device of the generator circuit and to a memory circuit located in the generator circuit of the surgical system 1000. The DDS circuit 4100 includes an address counter 4102, a lookup table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. Stable clock f_cIs received by an address counter 4102, and register 4106 drives a Programmable Read Only Memory (PROM) that stores one or more integer cycles of a sine wave (or other arbitrary waveform) in a lookup table 4104. As the address counter 4102 steps through memory locations, the values stored in the lookup table 4104 are written to a register 4106, which register 4106 is coupled to a DAC circuit 4108. The corresponding digital amplitude of the signal at the memory location of the lookup table 4104 drives the DAC circuit 4108, which DAC circuit 4108 in turn generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The phase noise being substantially the reference clock f_cPhase noise of (2). The first analog output signal 4110 output from the DAC circuit 4108 is filtered by a filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal having a frequency f_{Output of}。

Because the DDS circuit 4100 is a sampled data system, the problems involved in sampling must be considered: quantization noise, aliasing, filtering, etc. For example, higher order harmonics of the DAC circuit 4108 output frequency are folded back into the Nyquist bandwidth so that they are not filterable, while higher order harmonics of the output of a Phase Locked Loop (PLL) based synthesizer may be filtered. The lookup table 4104 contains an integer number of cycles of signal data. By varying the frequency f of the reference clock_cOr by reprogramming the PROM to change the final output frequency f_{Output of}。

The DDS circuit 4100 may include a plurality of lookup tables 4104, wherein the lookup tables 4104 store waveforms represented by a predetermined number of samples, wherein the samples define a predetermined shape of the waveform. Accordingly, multiple waveforms having unique shapes may be stored in multiple lookup tables 4104 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4100 may create multiple waveform-shaped look-up tables 4104 and switch between different wave shapes stored in the individual look-up tables 4104 based on desired tissue effects and/or tissue feedback during the tissue treatment process (e.g., based on "on-the-fly" or virtual real-time of user or sensor input).

Thus, switching between waveforms may be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4104 can store electrical signal waveforms shaped to maximize the power delivered into the tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the lookup table 4104 can store waveforms synchronized in a manner that maximizes power delivery for the multi-function surgical instrument of the surgical system 1000 when delivering the RF drive signal and the ultrasonic drive signal. In other aspects, the lookup table 4104 can store electrical signal waveforms to drive ultrasound energy and RF therapy energy, and/or sub-therapy energy, simultaneously while maintaining ultrasound lock. The customized waveforms and their tissue effects specific to the different instruments may be stored in non-volatile memory of the generator circuit or in non-volatile memory (e.g., EEPROM) of the surgical system 1000 and extracted when the multifunctional surgical instrument is connected to the generator circuit. An example of an exponentially decaying sinusoid as used in many high crest factor "coag" waveforms is shown in fig. 37.

A more flexible and efficient implementation of the DDS circuit 4100 employs a digital circuit known as a digitally controlled oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit, such as DDS circuit 4200, is shown in fig. 36. In this simplified block diagram, the DDS circuit 4200 is coupled to a processor, controller, or logic device of the generator and connected to a memory circuit located in the generator or in any of the surgical instruments of the surgical system 1000. The 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. The adder circuit 4216 and phase register 4208 form part of the phase accumulator 4206. Clock frequency f_cIs applied to the phase register 4208 and the DAC circuit 4212. The load register 4202 receives the signal f designating the output frequency as the reference clock frequency_cFractional tuning words of (a). The output of load register 4202 is provided to parallel delta phase register 4204 as a tuning word M.

DDS circuit 4200 includes generating a clock frequency f_cThe sampling clock, the phase accumulator 4206, and the look-up table 4210 (e.g., phase-to-amplitude converter). Each clock cycle f_cThe contents of phase accumulator 4206 are updated once. When the time of the phase accumulator 4206 is updated, the number M stored in the parallel delta phase register 4204 is added to the number in the phase register 4208 by the adder circuit 4216. Assume that the number in the parallel delta phase register 4204 is 00 … 01 and the initial content of the phase accumulator 4206 is 00 … 00. Phase accumulator 4206 updates 00 … 01 every clock cycle. If the phase accumulator 4206 is 232 bits wide, 232 clock cycles (over 40 hundred million) are required before the phase accumulator 4206 returns to 00 … 00 and the cycle is repeated.

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

In one aspect, the electrical signal waveform may be digitized as 1024(210) phase points, but the wave shape may be digitized as any suitable number of 2n phase points in the range 256(28) to 281,474,976,710,656(248), where n is a positive integer, as shown in table 1. The waveform of the electrical signal can be represented as A_n(θ_n) With normalized amplitude A at point n_nBy the phase angle theta of a phase point called point n_nAnd (4) showing. The number of discrete phase points, n, determines the tuning resolution of the DDS circuit 4200 (as well as the DDS circuit 4100 shown in fig. 35).

Table 1 specifies the electrical signal waveforms digitized into a plurality of phase points.

N	Number of phase points 2ⁿ
		8	256
10	1,024
		12	4,096
14	16,384
		16	65,536
18	262,144
		20	1,048,576
22	4,194,304
		24	16,777,216
26	67,108,864
		28	268,435,456
…	…
		32	4,294,967,296
…	…
		48	281,474,976,710,656
…	…

TABLE 1

The generator circuit algorithm and digital control circuit scan for addresses in a look-up table 4210, which look-up table 4210 in turn provides varying digital input values to a DAC circuit 4212 feeding a filter 4214 and a power amplifier. The addresses may be scanned according to the frequency of interest. Using a look-up table, various types of shapes can be generated that can be converted to analog output signals by the DAC circuit 4212, filtered by a filter 4214, amplified by a power amplifier coupled to the output of the generator circuit, or fed to the tissue in the form of RF energy, or fed to the tissue in the form of ultrasonic vibrations that deliver energy to the tissue in the form of heat. The output of the amplifier may be applied to, for example, an RF electrode, to multiple RF electrodes simultaneously, to an ultrasound transducer, to multiple ultrasound transducers simultaneously, or to a combination of RF and ultrasound transducers. In addition, multiple waveform tables may be created, stored, and applied to tissue from the generator circuit.

Referring back to fig. 35, for n-32 and M-1, the phase accumulator 4206 steps through 232 possible outputs before it overflows and restarts. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M is 2, the phase register 1708 "rolls over" twice as fast and the output frequency is doubled. This can be summarized as follows.

For a phase accumulator 4206 configured to accumulate n bits (n is typically in the range of 24 to 32 in most DDS systems, but as previously mentioned n can be selected from a wide range of options), there is 2ⁿA possible phase point. The digital word M in the increment phase register represents the amount by which the phase accumulator increments per clock cycle. If f is_cAt the clock frequency, the frequency of the output sinusoid is equal to:

the above formula is referred to as the DDS "tuning formula". Note that the frequency resolution of the system is equal to

For n-32, the resolution is greater than forty parts per billion. In one aspect of the DDS circuit 4200, not all bits from 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. This reduces the size of the look-up table 4210 and does not affect the 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, where any of the surgical instruments of the surgical system 1000 includes an ultrasonic component, the electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one of the surgical instruments. Accordingly, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, wherein the electrical signal waveform is characterized by a predetermined waveform shape stored in the look-up table 4210 (or look-up table 4104 of fig. 35). Further, the electrical signal waveform may be a combination of two or more wave shapes. The lookup table 4210 may include information associated with a plurality of waveform shapes. In one aspect or example, the look-up table 4210 may be generated by the DDS circuit 4200 and may be referred to as a direct digital synthesis table. The DDS works by first storing a large number of repeating waveforms in on-board memory. The cycles of the waveform (sine, triangle, square, arbitrary) may be represented by a predetermined number of phase points as shown in table 1 and stored into memory. Once the waveform is stored in memory, it can be generated at a very precise frequency. The direct digital synthesis table may be stored in a non-volatile memory of the generator circuit and/or may be implemented with FPGA circuitry in the generator circuit. The lookup table 4210 may be addressed by any suitable technique that facilitates classification of waveform shapes. According to one aspect, the look-up table 4210 is addressed according to the frequency of the electrical signal waveform. Additionally, information associated with the plurality of waveform shapes may be stored in memory as digital information or as part of the lookup table 4210.

In one aspect, the generator circuit can be configured to provide electrical signal waveforms to at least two surgical instruments simultaneously. The generator circuit may also be configured to simultaneously provide electrical signal waveforms, which may be characterized by two or more waveforms, to two surgical instruments via output channels of the generator circuit. For example, in one aspect, the electrical signal waveform includes a first electrical signal (e.g., an ultrasonic drive signal) for driving the ultrasonic transducer, a second RF drive signal, and/or combinations thereof. Further, the electrical signal waveform may include a plurality of ultrasonic drive signals, a plurality of RF drive signals, and/or a combination of a plurality of 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 of the surgical instruments of the surgical system 1000, wherein generating the electrical signal waveform includes receiving information associated with the electrical signal waveform from a memory. The generated electrical signal waveform includes at least one wave shape. Further, providing the generated electrical signal waveform to at least one surgical instrument includes providing the electrical signal waveform to at least two surgical instruments simultaneously.

A generator circuit as described herein may allow for the generation of various types of direct digital synthesis tables. Examples of wave shapes of RF/electrosurgical signals generated by the generator circuit suitable for treating a variety of tissues include RF signals with high crest factors (which can be used for surface coagulation in RF mode), low crest factor RF signals (which can be used for deeper tissue penetration), and waveforms that promote effective touch coagulation. The generator circuit may also employ a direct digital synthesis look-up table 4210 to generate a plurality of wave shapes, and may rapidly switch between particular wave shapes based on desired tissue effects. Switching may be based on tissue impedance and/or other factors.

In addition to the traditional sine/cosine wave shapes, the generator circuit may also be configured to generate one or more wave shapes (i.e., trapezoidal or square waves) that maximize the power into the tissue in each cycle. The generator circuit may provide one or more wave shapes that are synchronized to maximize power delivered to the load and maintain ultrasonic lock when the RF signal and the ultrasonic signal are driven simultaneously, provided that the generator circuit includes a circuit topology that is capable of driving the RF signal and the ultrasonic signal simultaneously. Additionally, customized waveform shapes specific to the instrument and its tissue effects may be stored in non-volatile memory (NVM) or instrument EEPROM and may be extracted when any of the surgical instruments of surgical system 1000 are connected to the generator circuit.

The DDS circuit 4200 may include a plurality of lookup tables 4104, where the lookup tables 4210 store waveforms represented by a predetermined number of phase points (which may also be referred to as samples), where the phase points define a predetermined shape of the waveform. Accordingly, multiple waveforms having unique shapes may be stored in multiple look-up tables 4210 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4200 may create multiple waveform-shaped look-up tables 4210 and switch between different wave shapes stored in different look-up tables 4210 based on desired tissue effects and/or tissue feedback during a tissue treatment process (e.g., "on-the-fly" or virtual real-time based on user or sensor input).

Thus, switching between waveforms may be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4210 may store electrical signal waveforms shaped to maximize the power delivered into the tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the look-up table 4210 may store waveform shapes that are synchronized in such a way that they maximize power delivery by any of the surgical instruments of the surgical system 1000 when delivering the RF signal and the ultrasonic drive signal. In other aspects, the lookup table 4210 may store electrical signal waveforms to drive the ultrasound energy and the RF therapy energy, and/or sub-therapy energy simultaneously, while maintaining ultrasound lock. Generally, the output wave shape may be in the form of a sine wave, cosine wave, pulse wave, square wave, or the like. However, more complex and customized waveforms specific to different instruments and their tissue effects may be stored in non-volatile memory of the generator circuit or non-volatile memory (e.g., EEPROM) of the surgical instrument and extracted upon connecting the surgical instrument to the generator circuit. One example of a custom wave shape is an exponentially decaying sinusoid as used in many high crest factor "coag" waveforms, as shown in fig. 37.

Fig. 37 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) of an analog waveform 4304, in accordance with at least one aspect of the present disclosure. The horizontal axis represents time (t), while the vertical axis represents digital phase points. The digital electrical signal waveform 4300 is a digital discrete-time version of, for example, a desired analog waveform 4304. A digital electrical signal waveform 4300 is generated by storing an amplitude phase point 4302, the amplitude phase point 4302 representing one cycle or period T_oPer clock cycle T_clkThe amplitude of (d). Digital electrical signal waveform 4300 is passed through any suitable digital processing circuitry for one period T_oThe above is generated. The amplitude phase points are digital words stored in a memory circuit. In the examples shown in fig. 35 and 36, the digital word is a six-bit word capable of storing amplitude phase points at a resolution of 26 bits or 64 bits. It should be understood that the examples shown in fig. 35 and 36 are for illustrative purposes, and that in actual implementations, the resolution may be higher. For example, one period T_oThe digital amplitude phase points 4302 within are stored in memory as a string in look-up tables 4104, 4210, as described in connection with fig. 35 and 36. To generate an analog version of analog waveform 4304, clock period T is provided from memory_clkFrom 0 to T_oThe amplitude phase points 4302 are read in turn and converted by

DAC circuits

4108, 4212, also described in connection with fig. 35 and 36. The amplitude phase point 4302 of the digital electrical signal waveform 4300 may be adjusted from 0 to T_oReading as many cycles or periods as possible is repeated to generate additional cycles.A smooth analog version of the analog waveform 4304 is achieved by filtering the output of the

DAC circuits

4108, 4212 with filters 4112, 4214 (fig. 35 and 36). The filtered analog output signals 4114, 4222 (fig. 35 and 36) are applied to the input of the power amplifier.

Fig. 38 is a schematic view of a control system 12950 configured to provide gradual closure of a closure member (e.g., a closure tube) as a displacement member advances distally and couples to a clamp arm (e.g., an anvil) to reduce a closure force load on the closure member and reduce a firing force load on the firing member at a desired rate according to one aspect of the present disclosure. In one aspect, the control system 12950 can be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) that is used to continuously calculate an error value as the difference between a desired set point and a measured process variable and apply corrections based on proportional, integral, and derivative terms (sometimes denoted P, I and D, respectively). The 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 can be a PID controller 12972 as shown in fig. 39 and the secondary controller 12955 can also be a PID controller 12972 as shown in fig. 39. The main controller 12952 controls the primary process 12958 and the secondary controller 12955 controls the secondary process 12960. Output 12966 of preliminary process 12958 is a slave master set point SP₁The first summer 12962 is subtracted. First summer 12962 generates a single sum output signal that is applied to main controller 12952. The output of the main controller 12952 is the secondary setpoint SP₂. The output 12968 of the secondary process 12960 is a slave secondary set point SP₂The second summer 12964 is subtracted.

In the case of controlling the displacement of the closure tube, the control system 12950 may be configured such that the main set point SP is₁Is a desired closing force value, and the main controller 12952 is configured to receive the closing force from a torque sensor coupled to the output of the closing motor and determine a set point SP for the closing motor₂The motor speed. In other aspects, the closing force may be provided by a strain gauge, load cell, or other suitable forceA sensor to measure. Will close the motor speed set point SP₂Compared to the actual speed of the closure tube, as determined by the secondary controller 12955. The actual velocity of the closure tube may be measured by comparing the measured closure tube displacement with a position sensor and measuring the elapsed time with a timer/counter. Other techniques such as linear encoders or rotary encoders may be used to measure the displacement of the closure tube. The output 12968 of the secondary process 12960 is the actual speed of the closed tube. The closure tube velocity output 12968 is provided to a preliminary process 12958, which preliminary process 12958 determines the force acting on the closure tube and feeds back to an adder 12962, which adder 12962 derives from a main set point SP₁The measured closing force is subtracted. Main set point SP₁May be an upper threshold or a lower threshold. Based on the output of adder 12962, main controller 12952 controls the speed and direction of the closing motor. The secondary controller 12955 bases the actual speed of the closed tube as measured by the secondary process 12960 and the secondary set point SP₂To control the speed of the closure motor based on a comparison of the actual firing force to upper and lower firing force thresholds.

Fig. 39 illustrates a PID feedback control system 12970 in accordance with an aspect of the present disclosure. Either the primary controller 12952 or the secondary controller 12955, or both, can be implemented as a PID controller 12972. In one aspect, the PID controller 12972 may include a proportional element 12974(P), an integral element 12976(I), and a derivative element 12978 (D). The outputs of the P element 12974, I element 12976, and D element 12978 are summed by a summer 12986, which summer 12986 provides a control variable μ (t) to the process 12980. The output of process 12980 is a process variable y (t). Summer 12984 calculates the difference between the desired set point r (t) and the measured process variable y (t). The PID controller 12972 continuously calculates an error value e (t) (e.g., the difference between the closing force threshold and the measured closing force) as the difference between the desired set point r (t) (e.g., the closing force threshold) and the measured process variable y (t) (e.g., the speed and direction of the closed tube), and applies corrections based on the proportional, integral, and derivative terms calculated by the proportional element 12974(P), the integral element 12976(I), and the derivative element 12978(D), respectively. The PID controller 12972 attempts to minimize the error e (t) over time by adjusting the control variable μ (t) (e.g., the speed and direction of the closed tube).

The "P" element 12974 calculates the current value of the error according to a PID algorithm. For example, if the error is large and positive, then the control output will also be large and positive. According to the present disclosure, the error term e (t) is different between the desired closing force and the measured closing force of the closure tube. The "I" element 12976 calculates a past value of the error. For example, if the current output is not strong enough, the integral of the error will accumulate over time and the controller will respond by applying a stronger action. The "D" element 12978 calculates the future probable trend for this error based on its current rate of change. For example, continuing the above P example, when a large positive control output successfully brings the error closer to zero, it also places the process in the path of the most recent future large negative error. In this case, the derivative becomes negative and the D module reduces the strength of the action to prevent this overshoot.

It should be understood that other variables and set points may be monitored and controlled according to the

feedback control systems

12950, 12970. For example, the adaptive closing member speed control algorithm described herein may measure at least two of the following parameters: firing member travel position, firing member load, cutting element displacement, cutting element velocity, closure tube travel position, closure tube load, and the like.

Ultrasonic surgical devices, such as ultrasonic scalpels, are used in a variety of applications for surgical procedures due to their unique performance characteristics. Depending on the particular device configuration and operating parameters, the ultrasonic surgical device may provide transection of tissue and hemostasis by coagulation substantially simultaneously, thereby advantageously minimizing patient trauma. An ultrasonic surgical device may include a handpiece containing an ultrasonic transducer having a distally mounted end effector (e.g., a blade tip) to cut and seal tissue, and an instrument coupled to the ultrasonic transducer. In some cases, the instrument may be permanently attached to the handpiece. In other cases, the instrument may be detachable from the handpiece, as in the case of disposable instruments or interchangeable instruments. The end effector transmits ultrasonic energy to tissue in contact with the end effector to effect the cutting and sealing action. Ultrasonic surgical devices of this nature may be configured for open surgical use, laparoscopic or endoscopic surgical procedures, including robotically-assisted procedures.

Ultrasonic energy is used to cut and coagulate tissue using temperatures lower than those used in electrosurgical procedures, and ultrasonic energy may be transmitted to the end effector by an ultrasonic generator in communication with the handpiece. With high frequency vibration (e.g., 55,500 cycles per second), the ultrasonic blade denatures proteins in the tissue to form a viscous coagulum. The pressure exerted by the knife surface on the tissue collapses the vessel and causes the clot to form a hemostatic seal. The surgeon may control the cutting speed and coagulation by the force applied to the tissue by the end effector, the time that the force is applied, and the selected deflection level of the end effector.

The ultrasonic transducer can be modeled as an equivalent circuit comprising a first branch with a static capacitance and a second "dynamic" branch with an inductance, a resistance and a capacitance connected in series, which define the electromechanical properties of the resonator. The known ultrasonic generator may comprise a tuning inductor for detuning the static capacitance at the resonance frequency, so that substantially all of the generator's drive signal current flows into the dynamic branch. Thus, by using a tuning inductor, the generator's drive signal current is representative of the dynamic branch current, and thus the generator is able to control its drive signal to maintain the resonant frequency of the ultrasound transducer. The tuning inductor may also transform the phase impedance profile of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the particular static capacitance of the ultrasound transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different static capacitances require different tuning inductors.

In addition, in some ultrasound generator architectures, the drive signal of the generator exhibits asymmetric harmonic distortion, which complicates impedance magnitude and phase measurements. For example, the accuracy of impedance phase measurements may be reduced due to harmonic distortion in the current and voltage signals.

Furthermore, electromagnetic interference in a noisy environment can reduce the generator's ability to maintain a lock on the resonant frequency of the ultrasonic transducer, thereby 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. Electrosurgical devices include a handpiece and an instrument having a distally mounted end effector (e.g., one or more electrodes). The end effector is positionable against tissue such that an electrical current is introduced into the tissue. The electrosurgical device may be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into and returned from the tissue through the active and return electrodes, respectively, of the end effector. During monopolar operation, current is introduced into tissue through the active electrode of the end effector and returned through a return electrode (e.g., a ground pad) separately positioned on the patient's body. The heat generated by the current flowing through the tissue may form a hemostatic seal within and/or between the tissues, and thus may be particularly useful, for example, in 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.

The electrical energy applied by the 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. The RF energy is in the form of electrical energy that can be in 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 monopolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF applications, the frequency can be almost any value. Monopolar applications typically use frequencies above 200kHz in order to avoid unwanted stimulation of nerves and muscles due to the use of low frequency currents. Bipolar techniques may use lower frequencies if the risk analysis shows that the likelihood of neuromuscular stimulation has been mitigated to an acceptable level. Typically, frequencies above 5MHz are not used to minimize the problems associated with high frequency leakage currents. It is generally considered that 10mA is the lower threshold for tissue thermal effects.

During its operation, the electrosurgical device may transmit low frequency RF energy through tissue, which may cause ionic oscillations or friction, and in effect resistive heating, thereby increasing the temperature of the tissue. Because a sharp boundary may be formed between the affected tissue and the surrounding tissue, the surgeon is able to operate at a high level of accuracy and control without damaging adjacent non-target tissue. The low operating temperature of the RF energy may be suitable for removing soft tissue, contracting soft tissue, or sculpting soft tissue while sealing the vessel. RF energy may be particularly well suited for connective tissue, which is composed primarily of collagen and contracts when exposed to heat.

Ultrasonic and electrosurgical devices typically require different generators due to their unique drive signal, sensing and feedback requirements. In addition, in situations where the instrument is disposable or interchangeable with the handpiece, the ability of the ultrasound and electrosurgical generators to identify the particular instrument configuration used and to optimize the control and diagnostic procedures accordingly is limited. Furthermore, capacitive coupling between the non-isolated circuitry of the generator and the patient isolated circuitry, especially where higher voltages and frequencies are used, can result in exposure of the patient to unacceptable levels of leakage current.

Furthermore, ultrasonic and electrosurgical devices often require different user interfaces for different generators due to their unique drive signal, sensing and feedback requirements. In such conventional ultrasonic and electrosurgical devices, one user interface is configured for use with an ultrasonic instrument, while the other user interface may be configured for use with an electrosurgical instrument. Such user interfaces include hand and/or foot activated user interfaces, such as hand activated switches and/or foot activated switches. Since various aspects of a combined generator for use with ultrasonic and electrosurgical instruments are contemplated in the ensuing disclosure, additional user interfaces configured to operate with ultrasonic and/or electrosurgical instrument generators are also contemplated.

Additional user interfaces for providing feedback to a user or other machine are contemplated in subsequent disclosures to provide feedback indicative of the mode or state of operation of the ultrasonic and/or electrosurgical instrument. Providing user and/or machine feedback for operating a combination of ultrasonic and/or electrosurgical instruments would require providing sensory feedback to the user as well as providing electrical/mechanical/electromechanical feedback to the machine. Feedback devices incorporating visual feedback devices (e.g., LCD display screens, LED indicators), audio feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., tactile actuators) for combining ultrasonic and/or electrosurgical instruments are contemplated in the subsequent disclosure.

Other electrosurgical instruments include, but are not limited to, irreversible and/or reversible electroporation, and/or microwave technology, among others. Accordingly, the techniques disclosed herein may be applicable to ultrasound, bipolar or monopolar RF (electrosurgical), irreversible and/or reversible electroporation, and/or microwave-based surgical instruments, among others.

Aspects of the generator utilize high-speed analog-to-digital sampling (e.g., approximately 200 oversampling, depending on frequency) of the generator drive signal current and voltage, as well as digital signal processing, to provide a number of advantages and benefits over known generator architectures. In one aspect, for example, the generator may determine a dynamic branch current of the ultrasonic transducer based on current and voltage feedback data, a value of a static capacitance of the ultrasonic transducer, and a value of a drive signal frequency. This provides the benefits of a substantially tuned system and simulates any value of static capacitance at any frequency (e.g., C in fig. 25)₀) The presence of a system that performs tuning or resonance. Thus, control of the dynamic branch current may be achieved by tuning the effect of the static capacitance without the need to tune the inductor. Additionally, eliminating the tuning inductor may not degrade the frequency locking capability of the generator, as frequency locking may be achieved by properly processing current and voltage feedback data.

High-speed analog-to-digital sampling of the generator drive signal current and voltage, and digital signal processing may also enable accurate digital filtering of the samples. For example, aspects of the generator may utilize a low-pass digital filter (e.g., a Finite Impulse Response (FIR) filter) that attenuates between the fundamental drive signal frequency and the second order harmonics to reduce asymmetric harmonic distortion and EMI induced noise in the current and voltage feedback samples. The filtered current and voltage feedback samples are substantially representative of the fundamental drive signal frequency, thus enabling more accurate impedance phase measurements relative to the fundamental drive signal frequency and improving the generator's ability to maintain resonant frequency lock. The accuracy of the impedance phase measurement can be further enhanced by averaging the falling edge measurement and the rising edge phase measurement, and by adjusting the measured impedance phase to 0 °.

Aspects of the generator may also utilize high-speed analog-to-digital sampling of the generator drive signal current and voltage, as well as digital signal processing, to determine the actual power consumption and other quantities with high accuracy. This may allow the generator to implement a variety of available algorithms, such as, for example, controlling the amount of power delivered to the tissue as the impedance of the tissue changes and controlling the power delivery to maintain a constant rate of increase of the tissue impedance. Some of these algorithms are used to determine the phase difference between the generator drive signal current signal and the voltage signal. At resonance, the phase difference between the current signal and the voltage signal is zero. When the ultrasound system comes out of resonance, the phase changes. Various algorithms may be employed to detect the phase difference and adjust the drive frequency until the ultrasound system returns to resonance, i.e., the phase difference between the current signal and the voltage signal is zero. The phase information may also be used to infer the condition of the ultrasonic blade. As discussed in detail below, the phase changes as a function of the temperature of the ultrasonic blade. Thus, the phase information may be employed to control the temperature of the ultrasonic blade. This may be accomplished, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade is running too hot, and increasing the power delivered to the ultrasonic blade when the ultrasonic blade is running too cold.

Various aspects of the generator may have a wide frequency range and increased output power necessary to drive both the ultrasonic and electrosurgical devices. The lower voltage, higher current requirements of electrosurgical devices can be met by dedicated taps on broadband power transformers, eliminating the need for separate power amplifiers and output transformers. In addition, the sensing and feedback circuitry of the generator can support a large dynamic range that meets the needs of both ultrasonic and electrosurgical applications with minimal distortion.

The various aspects may provide a simple, economical means for the generator to read and optionally write to a data circuit (e.g., a single Wire bus device, such as a single Wire protocol EEPROM known under the trade name "1-Wire") disposed in an instrument attached to the handpiece using existing multi-conductor generator/handpiece cables. In this way, the generator is able to retrieve and process instrument specific data from the instrument attached to the handpiece. This may enable the generator to provide better control and improved diagnostics and error detection. In addition, the ability of the generator to write data to the instrument provides potentially new functionality in, for example, tracking instrument usage and capturing operational data. Furthermore, the use of frequency bands allows the appliance containing the bus device to be backward compatible with existing generators.

The disclosed aspects of the generator provide for active cancellation of leakage currents caused by unintended capacitive coupling between the generator's non-isolated circuitry and the patient isolated circuitry. In addition to reducing patient risk, the reduction in leakage current may also reduce electromagnetic radiation.

Fig. 40 is a system diagram 7400 of a segmented 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 section of the plurality of circuit sections of the segmented circuit 7401 comprises one or more circuits and one or more sets of machine executable instructions stored in one or more memory devices. One or more circuits of the circuit section are coupled to communicate electrically over one or more wired or wireless connection mediums. The plurality of circuit sections are configured to transition between three modes, including a sleep mode, a standby mode, and an operational mode.

In one aspect shown, the plurality of

circuit segments

7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 are first activated in a standby mode, second transitioned to a sleep mode, and again transitioned to an operational mode. However, in other aspects, the plurality of circuit sections may transition from any of the three modes to any other of the three modes. For example, the plurality of circuit sections may transition directly from the standby mode to the operating mode. Based on the execution of the machine-executable instructions by the processor, the voltage control circuitry 7408 may place individual circuit segments into particular states. The states include a power-off state, a low energy state, and a power-on state. The power-off state corresponds to a sleep mode, the low energy state corresponds to a standby mode, and the power-on state corresponds to an operational mode. The transition to the low energy state may be achieved by, for example, using a potentiometer.

In one aspect, the plurality of

circuit segments

7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 may transition from a sleep mode or a standby mode to an operational mode according to a power-on sequence. The plurality of circuit segments may also transition from an operational mode to a standby mode or a sleep mode according to a power-down sequence. The power-up sequence and the power-down sequence may be different. In some aspects, the power-up sequence includes powering up only a subset of the circuit segments of the plurality of circuit segments. In some aspects, the power down sequence includes powering down only a subset of the circuit segments of the plurality of circuit segments.

Referring back to the system diagram 7400 in fig. 40, the segmented circuit 7401 includes a plurality of circuit segments including a transition circuit segment 7402, a processor circuit segment 7414, a handle circuit segment 7416, a communication circuit segment 7420, a display circuit segment 7424, a motor control circuit segment 7428, an energy processing circuit segment 7434, and a shaft circuit segment 7440. The transition circuit section 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 section 7402 is configured to implement power down and power up sequences, safety detection protocol, and POST.

In some aspects, the wake-up circuit 7404 includes an accelerometer button sensor 7405. In various aspects, the transition circuit segment 7402 is configured to be in a powered on state, while other circuit segments of the plurality of circuit segments of the segmented circuit 7401 are configured to be in a low energy state, a powered off state, or a powered on state. The accelerometer button sensor 7405 can monitor the movement or acceleration of the surgical instrument 6480 described herein. For example, the movement may be a change in orientation or rotation of the surgical instrument. The surgical instrument can be moved in any direction relative to the three-dimensional Euclidean space by, for example, 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 to cause the voltage control circuit 7408 to apply a voltage to the processor circuit section 7414 to transition the processor and volatile memory to a powered-on state. In aspects, the processor and volatile memory are in a powered-on state before the voltage control circuit 7409 applies a voltage to the processor and volatile memory. In the operating mode, the processor may begin a power-on sequence or a power-off sequence. In various aspects, the accelerometer button sensor 7405 can also send a signal to the processor to cause the processor to begin a power-up sequence or a power-down sequence. In some aspects, the processor begins a power-up sequence when most of the individual circuit sections are in a low-energy state or a power-down state. In other aspects, the processor begins a power-down sequence when a majority of the individual circuit segments are in a power-on state.

Additionally or alternatively, the accelerometer button sensor 7405 can sense external movement within a predetermined proximity of the surgical instrument. For example, the accelerometer button sensor 7405 may sense that a user of the surgical instrument 6480 described herein is moving the user's hand in a predetermined proximity. When the accelerometer button sensor 7405 senses this external movement, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and a signal to the processor, as previously described. After receiving the transmitted signal, the processor may begin a power-on sequence or a power-off sequence to transition one or more circuit segments between the three modes. In aspects, a signal sent to the voltage control circuit 7408 is sent to verify that the processor is in an operating mode. In some aspects, the accelerometer button sensor 7405 can sense when the surgical instrument has been 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 the individual circuit segments. One or more sensors may sense damage or failure of the affected individual circuit segments. Based on the sensed damage or failure, POST controller 7412 may perform POST on the corresponding individual circuit segment.

The power-up sequence or power-down sequence may be defined based on the accelerometer button sensor 7405. For example, the accelerometer button sensor 7405 may sense a particular motion or sequence of motions indicative of selection of a particular circuit segment of the plurality of circuit segments. Based on the sensed motion or series of sensed motions, the accelerometer button sensor 7405 can transmit a signal to the processor including an indication of one or more of the plurality of circuit segments when the processor is in a powered state. Based on the signal, the processor determines a power-on sequence that includes the selected one or more circuit segments. Additionally or alternatively, a user of the surgical instrument 6480 described herein may select the number and order of circuit segments to define a power-up sequence or a power-down sequence based on interaction with a Graphical User Interface (GUI) of the surgical instrument.

In various aspects, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and a signal to the processor only when the accelerometer button sensor 7405 detects movement of the surgical instrument 6480 described herein or an external motion within a predetermined proximity above a predetermined threshold. For example, a signal may be sent only if movement is sensed for 5 or more seconds or if the surgical instrument is moved 5 or more inches. In other aspects, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and a signal to the processor only when the accelerometer button sensor 7405 detects an oscillating motion of the surgical instrument. The predetermined threshold reduces accidental transitioning of the circuit section of the surgical instrument. As previously described, the transition may include transitioning to an operational mode according to a power-up sequence, transitioning to a low energy mode according to a power-down sequence, or transitioning to a sleep mode according to a power-down sequence. In some aspects, a surgical instrument includes an actuator actuatable by a user of the surgical instrument. The actuation is sensed by accelerometer button sensor 7405. The actuator may be a slider, a toggle switch, or a momentary contact switch. Based on the sensed actuation, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and a signal to the processor.

A boost current circuit 7406 is coupled to the battery. The boost current circuit 7406 is a current amplifier (such as a relay or a transistor) and is configured to amplify the magnitude of the current of the individual circuit section. The initial magnitude of the current corresponds to the source voltage provided by the battery to the segmented circuit 7401. Suitable relay systems include solenoids. Suitable transistors include Field Effect Transistors (FETs), MOSFETs and Bipolar Junction Transistors (BJTs). The boost current circuit 7406 may amplify a magnitude of current corresponding to an independent circuit segment or circuit that requires more current consumption during operation of the surgical instrument 6480 described herein. For example, when the motor of the surgical instrument requires more input power, an increase in current to the motor control circuit section 7428 may be provided. An increase in the current provided to an individual circuit segment may result in a corresponding decrease in the current of 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. The voltage control circuit 7408 is configured to provide voltages to or remove voltages from a plurality of circuit segments. The voltage control circuit 7408 is further configured to increase or decrease the voltage provided to the plurality of circuit segments of the segmented circuit 7401. In various aspects, the voltage control circuit 7408 includes combinational logic circuitry, such as a Multiplexer (MUX) for selecting the input, the plurality of electronic switches, and the plurality of voltage converters. An electronic switch of the plurality of electronic switches may be configured to switch between an open and a closed configuration to disconnect the individual circuit segment from the battery or to connect the individual circuit segment to 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, and the like. The combinational logic circuit is configured to select individual electronic switches for switching to an open configuration to enable application of a voltage to the corresponding circuit segment. The combinational logic circuit is further configured to select individual electronic switches for switching to a closed configuration to enable voltage removal from the corresponding circuit segment. By selecting a plurality of individual electronic switches, the combinational logic circuit can implement a power-down sequence or a power-up sequence. The plurality of voltage converters may provide a boosted voltage or a reduced voltage to the plurality of circuit sections. The voltage control circuit 7408 may also include a microprocessor and a memory device.

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

POST controller 7412 executes POST to verify proper operation of the various circuit segments. In some aspects, POST is performed on individual ones of the plurality of circuit segments before the voltage control circuit 7408 applies a voltage to the individual circuit segments to transition the individual circuit segments from a standby mode or a sleep mode to an operational mode. If a single circuit segment fails POST, the particular circuit segment does not transition from a standby mode or a sleep mode to an operational mode. The POST of the handle circuit segment 7416 may include, for example, testing whether the handle control sensor 7418 senses actuation of a handle control of the surgical instrument 6480 described herein. In some aspects, the POST controller 7412 may transmit signals to the accelerometer button sensor 7405 to verify the operation of the individual circuit segments that are part of the POST. For example, after receiving the signal, the accelerometer button sensor 7405 can prompt a user of the surgical instrument to move the surgical instrument to a plurality of varying positions to ensure operation of the surgical instrument. The accelerometer button sensor 7405 may also monitor the output of a circuit segment or a circuit of a circuit segment that is part of the POST. For example, the accelerometer button sensor 7405 may sense incremental motor pulses generated by the motor 7432 to verify operation. A motor controller of the motor control circuit 7430 may be used to control the motor 7432 to generate incremental motor pulses.

In various aspects, the surgical instrument 6480 described herein may include additional accelerometer button sensors. POST controller 7412 may also execute control programs stored in a memory device of voltage control circuit 7408. The control program may cause POST controller 7412 to transmit signals requesting matching encryption parameters from multiple circuit segments. Failure to receive a matching encryption parameter from an individual circuit segment indicates to POST controller 7412 that the corresponding circuit segment has been damaged or failed. In some aspects, if POST controller 7412 determines based on POST that a processor has been damaged or has failed, POST controller 7412 may send a signal to one or more secondary processors to cause the one or more secondary processors to perform a critical function that the processor is unable to perform. In some aspects, if the POST controller 7412 determines based on POST that one or more circuit segments are not functioning properly, the POST controller 7412 may begin a reduced performance mode for those circuit segments that are operating properly while locking those circuit segments that are not passing POST or are not operating properly. The locked circuit section may function similar to a circuit section in a standby mode or a sleep mode.

The processor circuit section 7414 includes a processor and volatile memory. The processor is configured to initiate a power-up sequence or a power-down sequence. To begin the power-on sequence, the processor transmits a power-on signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to apply voltages to multiple or a subset of the multiple circuit segments according to the power-on sequence. To begin a power down sequence, the processor transmits a power down signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to remove voltage from multiple or a subset of the multiple circuit segments according to the power down sequence.

The handle circuit section 7416 includes a handle control sensor 7418. The handle control sensor 7418 may sense actuation of one or more handle controls of the 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 activated button, and/or any other suitable handle control. The user may activate an energy activation button to select between an RF energy mode, an ultrasonic energy mode, or a combination of an RF energy mode and an ultrasonic energy mode. The handle control sensor 7418 may also facilitate attachment of the modular handle to a surgical instrument. For example, the handle control sensor 7418 may sense the proper attachment of the modular handle to the surgical instrument and indicate the sensed attachment to a user of the surgical instrument. The LCD display 7426 may provide a graphical indication of the sensed attachment. In some aspects, the handle control sensor 7418 senses actuation of one or more handle controls. Based on the sensed actuation, the processor may begin a power-on sequence or a power-off sequence.

The communication circuit section 7420 includes a communication circuit 7422. The communication circuitry 7422 includes a communication interface to facilitate communication of signals between individual ones of the plurality of circuit segments. In some aspects, the communication circuitry 7422 provides a path for electrical communication for the modular components of the surgical instrument 6480 described herein. For example, when the modular shaft and modular transducer are attached together to the handle of a surgical instrument, the control program may be uploaded to the handle through the communication circuitry 7422.

The display circuit section 7424 includes an LCD display 7426. The LCD display 7426 may include a liquid crystal display, LED indicators, or the like. In some aspects, the LCD display 7426 is an Organic Light Emitting Diode (OLED) screen. The display may be placed on, embedded in, or located remotely from the surgical instrument 6480 described herein. For example, the display may be placed on a handle of the surgical instrument. The display is configured to provide sensory feedback to the user. In various aspects, the LCD display 7426 also includes a backlight. In some aspects, the surgical instrument may further comprise an audio feedback device such as a speaker or buzzer and a haptic feedback device such as a haptic actuator.

The motor control circuit section 7428 includes a motor control circuit 7430 coupled to a motor 7432. The motor 7432 is coupled to the processor through a driver and a transistor, such as a FET. In various aspects, the motor control circuitry 7430 includes a motor current sensor in signal communication with the processor to provide a signal indicative of a measure of current consumption of the motor to the processor. The processor transmits the signal to the display. The display receives the signal and displays a measurement of the current draw of the motor 7432. The processor may, for example, use the signal to monitor that the current draw of the motor 7432 is within an acceptable range, to compare the current draw to one or more parameters of the plurality of circuit segments, and to determine one or more parameters of the patient treatment site. In various aspects, the motor control circuitry 7430 includes a motor controller for controlling the operation of the motor. For example, the motor control circuitry 7430 controls various motor parameters, such as by adjusting the speed, torque, and acceleration of the motor 7432. This adjustment is done based on measuring the current through the motor 7432 by a motor current sensor.

In various aspects, the motor control circuitry 7430 includes force sensors to measure the force and torque generated by the motor 7432. The motor 7432 is configured to actuate the mechanism of the surgical instrument 6480 described herein. For example, the motor 7432 is configured to control actuation of the shaft of the surgical instrument to perform clamping, rotation, and articulation functions. For example, the motor 7432 may actuate the shaft to effect a clamping motion with the jaws of the surgical instrument. The motor controller can determine whether the material gripped by the jaws is tissue or metal. The motor controller may also determine the degree to which the jaws grip the material. For example, the motor controller may determine how the jaws are opened or closed based on a derivative of the sensed motor current or motor voltage. In some aspects, the motor 7432 is configured to actuate the transducer to cause the transducer to apply torque to the handle or to control articulation of the surgical instrument. The motor current sensor may interact with the motor controller to set the motor current limit. When the current meets a predefined threshold limit, the motor controller initiates a corresponding change in motor control operation. For example, exceeding the motor current limit causes the motor controller to reduce the current consumption of the motor.

The energy processing circuit section 7434 includes RF amplifier and safety circuits 7436 and ultrasonic signal generator circuits 7438 to enable energy modular functionality of the surgical instrument 6480 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. The ultrasonic signal generator circuit 7438 is configured to control the ultrasonic energy modality by generating an ultrasonic signal. The RF amplifier and safety circuitry 7436 and the ultrasonic signal generator circuitry 7438 may operate in conjunction to control the combination of RF energy mode and ultrasonic energy mode.

The shaft circuit section 7440 includes a shaft module controller 7442, a modular control actuator 7444, one or more end effector sensors 7446, and a non-volatile memory 7448. The axle module controller 7442 is configured to control a plurality of axle modules including a control program to be executed by the processor. The plurality of shaft modules implement shaft modalities such as ultrasound, a combination of ultrasound and RF, RF I-blade, and RF-opposable jaws. The axis module controller 7442 may select an axis modality for execution by the processor by selecting a corresponding axis module. The modular control actuators 7444 are configured to actuate the shafts according to the selected shaft mode. 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 at the end effector may include a force sensor, a temperature sensor, a current sensor, or a motion sensor. The one or more end effector sensors 7446 transmit data regarding one or more operations of the end effector based on the energy modality achieved by the end effector. In various aspects, the energy modality includes an ultrasonic energy modality, an RF energy modality, or a combination of an ultrasonic energy modality and an RF energy modality. The nonvolatile memory 7448 stores a spindle control program. The control program includes one or more parameters, routines or programs that are specific to the shaft. In various aspects, the non-volatile memory 7448 may be a ROM, EPROM, EEPROM, or flash memory. The non-volatile memory 7448 stores a shaft module corresponding to a selected shaft of the surgical instrument 6480 described herein. The shaft module may be changed or upgraded in the non-volatile memory 7448 by the shaft module controller 7442 depending on the surgical instrument shaft to be used in operation.

FIG. 41 is a schematic diagram of a circuit 7925 for various components of a surgical instrument having motor control functionality in accordance with at least one aspect of the present disclosure. In various aspects, the surgical instrument 6480 described herein includes a drive mechanism 7930, the drive mechanism 7930 being configured to drive a shaft and/or a gear component in order to perform various operations associated with the surgical instrument 6480. In one aspect, the drive mechanism 7930 includes a rotary drive train (drivetrain)7932 configured to rotate the end effector relative to the handle housing, e.g., about a longitudinal axis. Drive mechanism 7930 also includes a closure drivetrain 7934 configured to close the jaw members to grasp tissue with the end effector. In addition, the drive mechanism 7930 includes a firing power transmission 7936 configured to open and close the clamp arm portions of the end effector to grasp tissue with the end effector.

The drive mechanism 7930 includes a selector gearbox assembly 7938 that may be located in a handle assembly of the surgical instrument. Adjacent the selector gearbox assembly 7938 is a function selection module that includes a first motor 7942 for selectively moving a gear element within the selector gearbox assembly 7938 to selectively position one of the drivelines 7932, 7934, 7936 into engagement with an input drive component of an optional second motor 7944 and motor drive circuit 7946 (shown in dotted lines to indicate that the second motor 7944 and motor drive circuit 7946 are optional components).

Still referring to fig. 41, the

motors

7942, 7944 are coupled to

motor control circuits

7946, 7948, respectively, which are configured to control the operation of the

motors

7942, 7944, including the flow of electrical energy from the power source 7950 to the

motors

7942, 7944. The 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 also includes a microcontroller 7952 ("controller"). In some cases, the controller 7952 can include a microprocessor 7954 ("processor") and one or more computer-readable media or memory units 7956 ("memory"). In some cases, memory 7956 may store various program instructions that, when executed, may cause processor 7954 to perform various functions and/or computations described herein. The power source 7950 may be configured to provide power to the controller 7952, for example.

The processor 7954 may be in communication with a motor control circuit 7946. Additionally, the memory 7956 may store program instructions that, when executed by the processor 7954 in response to the user input 7958 or the feedback element 7960, may cause the motor control circuit 7946 to actuate the motor 7942 to generate at least one rotational motion to selectively move a gear element within the selector gearbox assembly 7938 to selectively position one of the drivelines 7932, 7934, and 7936 and move it into engagement with an input drive member of the second motor 7944. Further, the processor 7954 may be in communication with the motor control circuitry 7948. The memory 7956 may also store program instructions that, when executed by the processor 7954 in response to the user input 7958, may cause the motor control circuit 7948 to actuate the motor 7944 to generate at least one rotational motion to drive, for example, a drivetrain engaged with an input drive component of the second motor 7948.

The controller 7952 and/or other controllers of the present disclosure may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor devices, chips, microchips, chipsets, microcontrollers, systems on a chip (SoC), and/or single in-line packages (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 some cases, for example, the controller 7952 may include a hybrid circuit that includes discrete and integrated circuit elements or components on one or more substrates.

In some cases, controller 7952 and/or other controllers of the present disclosure may be, for example, LM4F230H5QR, available from Texas Instruments, Inc. (Texas Instruments). In some cases, the Texas instruments LM4F230H5QR is an ARM Cortex-M4F processor core, which includes: 256KB of on-chip memory of single cycle flash or other non-volatile memory (up to 40MHz), prefetch buffer for improved performance above 40MHz, 32KB of single cycle SRAM, load with

Internal ROM of software, EEPROM of 2KB, one or more PWM modules, one or more QEI analog, one or more 12-bit ADC with 12 analog input channels, and other features readily available. Other microcontrollers may be readily substituted for use in conjunction with the present disclosure. Accordingly, the present disclosure should not be limited to this context.

In various instances, one or more of the various steps described herein may be performed by a finite state machine that includes combinational or sequential logic circuitry coupled to at least one storage circuit. At least one memory circuit stores a current state of the finite state machine. Combinational or sequential logic circuitry is configured to cause the finite state machine to reach these steps. Sequential logic circuits may be synchronous or asynchronous. In other cases, one or more of the various steps described herein may be performed by circuitry that includes a combination of the processor 7958 and a finite state machine, for example.

In various circumstances, it may be advantageous to be able to assess the functional status of a surgical instrument to ensure that it is functioning properly. For example, the drive mechanisms (configured to include various motors, power trains, and/or gear components to perform various operations of the surgical instrument) as described above may wear out over time. This can occur during normal use and in some cases the drive mechanism may wear out faster due to abuse conditions. In some instances, the surgical instrument may be configured to perform a self-assessment to determine the status (e.g., health) of the drive mechanism and its various components.

For example, self-evaluation may be used to determine when a surgical instrument is able to perform its function or when some of the components should be replaced and/or repaired before being re-sterilized. Evaluation of the drive mechanism and its components (including, but not limited to, the rotary power transmission system 7932, the closure power transmission system 7934, and/or the firing power transmission system 7936) may be accomplished in a variety of ways. The magnitude of the deviation from the predicted performance may be used to determine the likelihood of a sensed fault and the severity of such failure. A number of metrics may be used, including: periodic analysis of predicted events, peaks or dips above expected thresholds, and the width of the failure may be repeated.

In various instances, the condition of the drive mechanism or one or more components thereof may be evaluated using a signature of a properly functioning drive mechanism or one or more components thereof. One or more vibration sensors may be arranged relative to the normally operating drive mechanism or one or more components thereof to record various vibrations occurring during operation of the normally operating drive mechanism or one or more components thereof. The recorded vibrations may be used to create a signature. The future waveform may be compared to the signature waveform to assess the state of the drive mechanism and its components.

Still referring to fig. 41, the surgical instrument 7930 includes a driveline failure detection module 7962 configured to record and analyze one or more acoustic outputs of one or more of the drivelines 7932, 7934, 7936. The processor 7954 may communicate with or otherwise control the module 7962. As described in more detail below, the module 7962 may be embodied as various means, such as circuitry, hardware, a computer program product including a computer-readable medium (e.g., the memory 7956) storing computer-readable program instructions that are executable by a processing device (e.g., the processor 7954), or some combination thereof. In some aspects, processor 36 may include or otherwise control module 7962.

Fig. 42 is an alternative system 132000 for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system 132002 in accordance with at least one aspect of the present disclosure. The system 132000 can be incorporated into a generator. The processor 132004 coupled to the memory 132026 programs the programmable counter 132006 to tune to the output frequency f of the ultrasound electromechanical system 132002_o. The input frequency is generated by a crystal oscillator 132008 and input into a fixed counter 132010 to scale the frequency to an appropriate value. The outputs of the fixed counter 132010 and the programmable counter 132006 are applied to a phase/frequency detector 132012. The output of the phase/frequency detector 132012 is applied to an amplifier/active filter circuit 132014 to generate a tuning voltage V applied to a voltage controlled oscillator 132016(VCO)_t. VCO 132016 outputs frequency f_oApplied to the ultrasound transducer portion of the ultrasound electromechanical system 132002, which is modeled as an equivalent circuit as shown herein. The voltage and current signals applied to the ultrasonic transducer are monitored by a voltage sensor 132018 and a current sensor 132020.

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

Optionally tuning the voltage V_t(the voltage and the output frequency f_oProportional) may be fed back to the processor 132004 via the ADC 132024. This will provide the output frequency f to the processor 132004_oProportional feedbackA signal, and the feedback can be used to adjust and control the output frequency f_o。

Temperature inference

43A-43B are

graphical representations

133000, 133010 of complex impedance spectra of the same ultrasound device with a cold (room temperature) ultrasonic blade and a hot ultrasonic blade according to at least one aspect of the present disclosure. As used herein, a cold ultrasonic blade refers to an ultrasonic blade at room temperature, while a hot ultrasonic blade refers to an ultrasonic blade after frictional heating in use. FIG. 43A is a graph of resonant frequency f as the same ultrasonic device with a cold ultrasonic blade and a hot ultrasonic blade_oImpedance phase angle of function of

Is 133000 and fig. 43B is a resonant frequency f as the same ultrasonic device with a cold ultrasonic blade and a hot ultrasonic blade_oA graphical representation 133010 of the impedance magnitude | Z | of the function of (c). Impedance phase angle

And the impedance magnitude | Z | is at the resonant frequency f_oEverywhere is at a minimum.

Impedance Z of ultrasonic transducer_g(t) may be measured as the drive signal generator voltage V_g(t) drive signal and Current I_g(t) ratio of drive signals:

as shown in FIG. 43A, when the ultrasonic blade is cold (e.g., at room temperature) and not frictionally heated, the electromechanical resonant frequency f of the ultrasonic device_oIs about 55,500Hz and the excitation frequency of the ultrasonic transducer is set to 55,500 Hz. Thus, when the ultrasonic transducer is at the electromechanical resonant frequency f_oPhase angle when the lower part is excited and the ultrasonic blade is cold

At a minimum or about 0Rad, as indicated by the cold knife plot 133002. As shown in FIG. 43BWhen the ultrasonic blade is cold and the ultrasonic transducer is at the electromechanical resonant frequency f_oWhen excited down, the impedance magnitude | Z | is 800 Ω, e.g., the impedance magnitude | Z | is at a minimum impedance and the drive signal amplitude is at a maximum due to the series resonance equivalent circuit of the ultrasound electromechanical system, as depicted in fig. 25.

Referring now back to FIGS. 43A and 43B, when the ultrasonic transducer is at an electromechanical resonant frequency f of 55,500Hz_oLower free generator voltage V_g(t) Signal and Generator Current I_g(t) generator voltage V when driven by signal_g(t) Signal and Generator Current I_g(t) phase angle between signals

At zero, the impedance magnitude, IZ, is at a minimum impedance (e.g., 800 Ω), and the signal amplitude is at a peak or maximum due to the series resonant equivalent circuit of the ultrasound electromechanical system. When the temperature of the ultrasonic blade increases, the electromechanical resonance frequency f of the ultrasonic device due to frictional heat generated in use_o' decrease. Since the ultrasonic transducer is still at the previous (cold blade) electromechanical resonance frequency f of 55,500Hz_oLower free generator voltage V_g(t) Signal and Generator Current I_g(t) signal drive, so that the ultrasonic device is not resonant f_o' operate to cause the generator voltage V_g(t) Signal and Generator Current I_g(t) phase angle between signals

And (4) offsetting. There is also an increase in the impedance magnitude, IZ, and a decrease in the peak magnitude of the drive signal relative to the previous (cold blade) electromechanical resonant frequency of 55,500 Hz. Thus, the frequency can be adjusted by the electromechanical resonance frequency f_oMeasuring the generator voltage V as a function of the temperature of the ultrasonic blade_g(t) Signal and Generator Current I_g(t) phase angle between signals

To infer the temperature of the ultrasonic blade.

As has been described in the foregoing, the present invention,an electromechanical ultrasound system includes an ultrasound transducer, a waveguide, and an ultrasonic blade. The ultrasonic transducer can be modeled as an equivalent series resonant circuit (see fig. 25) comprising a first branch with a static capacitance and a second "dynamic" branch with series connected inductance, resistance and capacitance defining the electromechanical properties of the resonator. The electromechanical ultrasound system has an initial electromechanical resonant frequency defined by the physical characteristics of the ultrasound transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer is powered by an alternating voltage V at a frequency equal to the electromechanical resonant frequency (e.g., the resonant frequency of the electromechanical ultrasound system)_g(t) Signal and Current I_g(t) signal excitation. When the electromechanical ultrasonic system is excited at the resonant frequency, the voltage V_g(t) Signal and Current I_g(t) phase angle between signals

Is zero.

In other words, at resonance, the analog inductive impedance of the electromechanical ultrasound system is equal to the analog capacitive impedance of the electromechanical ultrasound system. When the ultrasonic blade heats up, for example, due to frictional engagement with tissue, the compliance of the ultrasonic blade (modeled as an analog capacitance) causes the resonant frequency of the electro-mechanical ultrasound system to shift. In this example, as the temperature of the ultrasonic blade increases, the resonant frequency of the electromechanical ultrasound system decreases. As a result, the analog inductive impedance of the electromechanical ultrasound system is no longer equal to the analog capacitive impedance of the electromechanical ultrasound system, resulting in a mismatch between the drive frequency and the new resonant frequency of the electromechanical ultrasound system. Thus, with a thermal ultrasonic blade, the electromechanical ultrasound system operates "off-resonance". The mismatch between the drive frequency and the resonant frequency is manifested as a voltage V applied to the ultrasonic transducer_g(t) Signal and Current I_g(t) phase angle between signals

As previously discussed, the generator electronics can easily monitor the voltage V applied to the ultrasonic transducer_g(t) Signal and Current I_g(t) phase angle between signals

Phase angle

Can be determined by fourier analysis, weighted least squares estimation, kalman filtering, space vector based techniques, zero crossing methods, Lissajous figures, three volt methods, cross coil methods, vector voltmeters and vector impedance methods, phase calibration instruments, phase locked loops, and the like. The generator may continuously monitor the phase angle

And adjusting the drive frequency to a phase angle

Becomes zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. Phase angle

And/or the change in generator drive frequency may be used as an indirect or inferred measure of the temperature of the ultrasonic blade.

A variety of techniques can be used to estimate the temperature from the data in these spectra. Most notably, a time-varying nonlinear state space equation set may be employed to model the dynamic relationship between the temperature of the ultrasonic blade and the measured impedance

Within a generator drive frequency range, wherein the range of generator drive frequencies is specific to the device model.

Temperature estimation method

One aspect of estimating or inferring the temperature of the ultrasonic blade may include three steps. First, a state space model of temperature and frequency dependent on time and energy is defined. To model temperature as a function of frequency content, a set of nonlinear state space equations are used to model the relationship between the electromechanical resonant frequency and the temperature of the ultrasonic blade. Second, a kalman filter is applied to improve the accuracy of the temperature estimator and the state space model over time. Again, 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. These three steps are described below.

Step 1

The first step is to define a state space model that depends on temperature and frequency of time and energy. To model temperature as a function of frequency content, a set of nonlinear state space equations are used to model the relationship between the electromechanical resonant frequency and the temperature of the ultrasonic blade. In one aspect, the state space model is given by:

state space model representation with respect to natural frequency F_n(t), temperature T (t), energy E (t), and time t

Rate of change and temperature of the ultrasonic blade

The rate of change of (c).

Representing a measurable and observable variable (such as the natural frequency F of an electromechanical ultrasound system)_n(t), temperature of the ultrasonic blade T (t), energy applied to the ultrasonic blade E (t), and observability of time t). The temperature t (t) of the ultrasonic blade can be observed as an estimate.

Step 2

The second step is to apply a kalman filter to improve the temperature estimator and the state space model. FIG. 44 is an illustration of a Kalman filter 133020 for improving a temperature estimator and a state space model based on impedance according to the following equation:

representing the impedance measured across the ultrasound transducer at a plurality of frequencies according to at least one aspect of the present disclosure.

The kalman filter 133020 may be employed to improve the performance of the temperature estimation and allow for the addition of external sensors, models or previous information to improve the temperature prediction in noisy data. The kalman filter 133020 includes a regulator 133022 and a plant 133024. In a comparative theory, the device 133024 is a combination of a process and an actuator. Device 133024 is said to have a transfer function that indicates the relationship between the input signal and the output signal of the system. The regulator 133022 includes a state estimator 133026 and a controller K133028. The state adjuster 133026 includes a feedback loop 133030. The state adjuster 133026 receives y, the output of the device 133024 as inputs and feeds back a variable u. The state estimator 133026 is an internal feedback system that converges with the true values of the system state. The output of the state estimator 133026 is a full feedback control variable

Including the natural frequency F of the electromechanical ultrasound system_n(t), temperature of the ultrasonic blade T (t), energy applied to the ultrasonic blade E (t), phase angle

And a time t. Inputs to controller K133028 are

And the output u of the controller K133028 is fed back to the state estimator 133026 and t of the device 133024.

Kalman filtering, also known as Linear Quadratic Estimation (LQE), is an algorithm that uses a series of measurements (including statistical noise and other inaccuracies) observed over time and produces estimates of unknown variables by estimating the joint probability distribution of the variables for each time frame and thus computing the maximum likelihood estimate of the actual measurement. The algorithm works in a two-step process. In the prediction step, the kalman filter 133020 generates estimates of the current state variables and their uncertainties. Once the results of the next measurement are observed, which must be corrupted by a certain amount of error, including random noise, these estimates are updated using a weighted average, giving a higher weight, with a higher certainty. The algorithm is recursive and can run in real-time, using only current input measurements and previously computed states and their uncertainty matrices; no additional past information is required.

The kalman filter 133020 uses a kinetic model of the electromechanical ultrasound system, a control input known to the system, and a plurality of time-series measurements (observations) of the natural frequency and phase angle of the signal applied to the ultrasound transducer (e.g., the magnitude and phase of the electrical impedance of the ultrasound transducer) to form an estimate of the amount of change (its state) of the electromechanical ultrasound system to predict the temperature of the ultrasonic blade portion of the electromechanical ultrasound system better than an estimate obtained using only one single measurement. Thus, the kalman filter 133020 is an algorithm that includes sensor 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 ultrasonic transducer to measure the natural frequency and phase shift data, and also effectively handles the uncertainty due to random external factors. The kalman filter 133020 produces an estimate of the state of the electromechanical ultrasound system with the predicted state of the system and the newly measured average using the weighted average. The weighted values provide a better (i.e., less) estimate of uncertainty and are more "trustworthy" than the unweighted values. The weights may be calculated from the covariance, a measure of the uncertainty of the estimation of the system state prediction. The result of the weighted average is a new state estimate that lies between the predicted state and the measured state and has a better estimate uncertainty than the one alone. This process is repeated at each step, with the new estimate and its covariance telling the prediction used in the following iteration. This recursive nature of the kalman filter 133020 requires only the last "best guess" of the state of the electro-mechanical ultrasound system to compute the new state, rather than the entire history.

The relative certainty of the measurement and current state estimation is an important consideration, and it is common to discuss the response of the filter in terms of the gain K of the kalman filter 133020. The kalman gain, K, is a relative weight given to the measurement and current state estimate, and may be "tuned" to achieve a particular performance. With a high gain K, the kalman filter 133020 applies more weight to the most recent measurements and therefore follows them more responsively. Using a low gain K, the kalman filter 133020 follows the model prediction more closely. In the extreme case, a high gain near one will result in estimated trajectories that are more jerky, while a low gain near zero will smooth out noise but reduce responsiveness.

When performing the actual calculations of the kalman filter 133020 (described below), the state estimates and covariance are encoded as matrices to handle the multiple dimensions involved in a single set of calculations. This allows for representing a linear relationship between different state variables, such as position, velocity and acceleration, in either the transition model or covariance. The use of the kalman filter 133020 does not assume that the error is gaussian. However, in the special case where all errors are gaussian distributed, the kalman filter 133020 produces an accurate conditional probability estimate.

Step 3

The second step uses the state estimator 133026 in the feedback loop 133032 of the kalman filter 133020 to control the power applied to the ultrasonic transducer and hence to the ultrasonic blade to adjust the temperature of the ultrasonic blade.

Fig. 45 is a graphical representation 133040 of the three probability distributions used by the state estimator 133026 of the kalman filter 133020 shown in fig. 44 to maximize estimated values, in accordance with at least one aspect of the present disclosure. The probability distributions include a previous probability distribution 133042, a predicted (state) probability distribution 133044, and an observed probability distribution 133046. In accordance with at least one aspect of the present disclosure, the three

probability distributions

133042, 133044, 1330467 are used for feedback control of the power applied to the ultrasound transducer to adjust the temperature based on the impedance measured across the ultrasound transducer at various frequencies. The estimator used in the feedback control of the power applied to the ultrasonic transducer to adjust the temperature based on the impedance is given by the following expression:

which is the impedance measured across the ultrasound transducer at multiple frequencies according to at least one aspect of the present disclosure.

The previous probability distribution 133042 includes a state variance defined by the following expression:

variance of state

For predicting the next state of the system, which is represented as a predictive (state) probability distribution 133044. Observation probability distribution 133046 is the observation variance σ_mA probability distribution of actual observations of the state of the system defining a gain given by the expression:

feedback control

The power input is reduced to ensure that the temperature (as estimated by the state estimator and kalman filter) is controlled.

In one aspect, the initial proof of concept assumes that a static linear relationship exists between the natural frequency of the electromechanical ultrasound system and the temperature of the ultrasonic blade. By reducing the power as a function of the natural frequency of the electromechanical ultrasound system (i.e., adjusting the temperature with feedback control), the temperature of the ultrasonic 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. 46A is a graphical representation 133050 of temperature versus time for an ultrasound device without temperature feedback control. The temperature of the ultrasonic blade (deg.C) is shown along the vertical axis and time (seconds) is shown along the horizontal axis. The test was performed with antelope skin in the jaws of an ultrasonic device. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade is excited at a resonant frequency while frictionally engaging the chamois clamped between the ultrasonic blade and the clamping arm. Over time, the temperature of the ultrasonic blade (C.) increases due to frictional engagement with the antelope skin. Over time, the temperature profile 133052 of the ultrasonic blade increased until the antelope skin sample was cut after about 19.5 seconds at a temperature of 220 ℃, as indicated at point 133054. Without temperature feedback control, after cutting the antelope skin sample, the temperature of the ultrasonic blade increased to a temperature of 380 ℃ up to 490 ℃ well above the melting point of TEFLON. At point 133056, the temperature of the ultrasonic blade reached a maximum temperature of 490 ℃ until the TEFLON pad completely melted. After the pad completely disappears, the temperature of the ultrasonic blade drops slightly from the peak temperature at point 133056.

FIG. 46B is a graph of temperature versus time for an ultrasound device with temperature feedback control in accordance with at least one aspect of the present invention. The temperature of the ultrasonic blade (deg.C) is shown along the vertical axis and time (seconds) is shown along the horizontal axis. The test was performed with a sample of antelope skin positioned in the jaw of the ultrasound device. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade is excited at a resonant frequency while frictionally engaging the chamois clamped between the ultrasonic blade and the clamping arm pad. Over time, the temperature profile 133062 of the ultrasonic blade increased until the antelope skin sample was cut after about 23 seconds at a temperature of 220 ℃, as indicated at point 133064. With temperature feedback control, as indicated at point 133066, the temperature of the ultrasonic blade increased up to a maximum temperature of about 380 ℃, just below the melting point of TEFLON, and then decreased to an average value of about 330 ℃, as generally indicated at region 133068, thereby preventing the TEFLON pad from melting.

Application of intelligent ultrasonic knife technology

When the ultrasonic blade is immersed in a fluid-filled surgical site, the ultrasonic blade cools during activation, making sealing and cutting of tissue in contact therewith less effective. Cooling of the ultrasonic blade may result in longer activation times and/or hemostasis problems because sufficient heat is not delivered to the tissue. To overcome the cooling of the ultrasonic blade, more energy delivery may be required to shorten the transection time and achieve proper hemostasis under these fluid submersion conditions. Using a frequency temperature feedback control system, if the ultrasonic blade is detected to start at or remain below a certain temperature for a period of time, the output power of the generator may be increased to compensate for the cooling due to the blood/saline/other fluids present in the surgical site.

Thus, the frequency temperature feedback control system described herein may improve the performance of the ultrasonic device, particularly when the ultrasonic blade is partially or fully positioned or immersed in a fluid-filled surgical site. The frequency temperature feedback control system described herein minimizes long activation times and/or potential problems with the performance of an ultrasonic device in a fluid-filled surgical site.

As previously mentioned, the temperature of the ultrasonic blade may be inferred by detecting the impedance of the ultrasonic transducer given by the following expression:

or in other words by detecting the voltage V applied to the ultrasonic transducer_g(t) Signal and Current I_g(t) phase angle between signals

To infer. Phase angle

The information may also be used to infer the condition of the ultrasonic blade. Phase angle, as discussed in detail herein

As a function of the temperature of the ultrasonic blade. Thus, the phase angle

The information may be used to control the temperature of the ultrasonic blade. This may be accomplished, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade is running too hot, and increasing the power delivered to the ultrasonic blade when the ultrasonic blade is running too cold. 47A-47B are graphical representations of temperature feedback control for adjusting ultrasonic power applied to an ultrasonic transducer when a temperature dip of the ultrasonic blade is detected.

Fig. 47A is a graphical representation of ultrasonic power output 133070 as a function of time in accordance with at least one aspect of the present disclosure. The power output of the ultrasonic generator is shown along the vertical axis and time (seconds) is shown along the horizontal axis. Fig. 47B is a graphical representation of ultrasonic blade temperature 133080 as a function of time in accordance with at least one aspect of the present disclosure. The ultrasonic blade temperature is displayed along the vertical axis and time (seconds) is displayed along the horizontal axis. The temperature of the ultrasonic blade increases with the application of constant power 133072, as shown in fig. 47A. During use, the temperature of the ultrasonic blade suddenly drops. This may be caused by a variety of conditions, however, during use, it may be inferred that the temperature of the ultrasonic blade drops as it is immersed in a fluid-filled surgical site (e.g., blood, saline, water, etc.). At time t₀Here, the temperature of the ultrasonic blade drops below the desired minimum temperature 133082, and the frequency temperature feedback control algorithm detects the temperature drop and begins to increase or "ramp up" power, as shown by the power ramp 133074 delivered to the ultrasonic blade, to begin to raise the temperature of the ultrasonic blade above the desired minimum temperature 133082.

Referring to fig. 47A and 47B, the ultrasonic generator output is substantially constant power 133072 as long as the temperature of the ultrasonic blade remains above the desired minimum temperature 133082. At t₀Where a processor or control circuit in the generator or instrument or both detects that the temperature of the ultrasonic blade has fallen below a desired minimum temperature 133072 and a frequency temperature feedback control algorithm is initiated to raise the temperature of the ultrasonic blade above the minimum desired temperature 133082. Thus, the generator power is at a value corresponding to t₀T at which a sudden drop in the temperature of the ultrasonic blade is detected₁Where it begins to ramp 133074. Under the frequency temperature feedback control algorithm, the power continues to ramp 133074 until the temperature of the ultrasonic blade is above the desired minimum temperature 133082.

Fig. 48 is a logic flow diagram 133090 depicting a process of controlling a program or logic configuration of a control for controlling the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. In accordance with this process, the processor or control circuitry of the generator or instrument or both executes an aspect of the frequency-temperature feedback control algorithm discussed in connection with fig. 47A and 47B to apply 133092 a power level to the ultrasonic transducer to achieve a desired temperature at the ultrasonic blade. The generator monitors 133094 the voltage V applied to drive the ultrasonic transducer_g(t) Signal and Current I_g(t) phase angle between signals

Based on phase angle

The generator infers 133096 the temperature of the ultrasonic blade using the techniques described herein in connection with fig. 43A-45. The generator determines 133098 whether the temperature of the ultrasonic blade is below the desired minimum temperature by comparing the inferred temperature of the ultrasonic blade to a predetermined desired temperature. The generator then adjusts the power level applied to the ultrasound transducer based on the comparison. For example, when the temperature of the ultrasonic blade reaches or is above the desired minimum temperature, the method continues along the "no" branch, and when the temperature of the ultrasonic blade is below the desired minimum temperature, the process continues along the "yes" branch. When the temperature of the ultrasonic blade is below the desired minimum temperature, the generator increases the voltage V, for example_g(t) signal and/or current I_g(t) signal to increase 133100 the power level to the ultrasonic transducer 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 toAbove the minimum desired temperature.

Adaptive advanced tissue treatment pad protection mode

Fig. 49 is a graphical representation 133110 of ultrasonic blade temperature as a function of time during firing of a blood vessel in accordance with at least one aspect of the present disclosure. A plot 133112 of ultrasonic blade temperature is plotted along the vertical axis as a function of time along the horizontal axis. The frequency temperature feedback control algorithm combines the temperature of the ultrasonic blade feedback control with the jaw sensing capability. The frequency temperature feedback control algorithm provides optimal hemostasis balanced with device durability and is able to intelligently deliver energy for optimal sealing while protecting the clamp arm pads.

As shown in FIG. 49, the optimal temperature for vessel sealing 133114 is labeled as a first target temperature T₁And the optimal temperature 133116 for "infinite" clamp arm pad life is labeled as the second target temperature T₂. The frequency temperature feedback control algorithm infers the temperature of the ultrasonic blade and maintains the temperature of the ultrasonic blade at a first target temperature threshold T₁And a second target temperature threshold T₂In the meantime. Thus, the generator power output is driven to achieve an optimal ultrasonic blade temperature for sealing the blood vessel and extending the life of the clamp arm pad.

Initially, the temperature of the ultrasonic blade increases as the blade heats up and eventually exceeds a first target temperature threshold T₁. Frequency-temperature feedback control algorithm takes over to control the temperature of the knife to T₁Until at t ₀133118 transection of the blood vessel is completed and the temperature of the ultrasonic blade falls below a second target temperature threshold T₂Until now. A processor or control circuit of the generator or instrument or both detects when the ultrasonic blade contacts the clamp arm pad. Once at t₀When the blood vessel crosscutting is finished and detected, the frequency temperature feedback control algorithm is switched to control the temperature of the ultrasonic knife to be the second target threshold value T₂To prolong the life of the clamping arm pad. The optimal clamp arm pad life temperature for the TEFLON clamp arm pad is about 325 ℃. In one aspect, the user may be notified of the advanced tissue treatment at the second activation tone.

FIG. 50 is a view in accordance with the present disclosureA logic flow diagram 133120 depicting a process of control program or logic configuration that controls the temperature of the ultrasonic blade between two temperature set points as depicted in fig. 49, in at least one aspect. According to this process, the generator executes an aspect of the frequency-temperature feedback control algorithm to, for example, adjust the voltage V applied to the ultrasonic transducer_g(t) signal and/or current I_g(T) the signal to apply 133122 a first power level to the ultrasound transducer to set the ultrasound blade temperature to a first target T optimized for vessel sealing₁. As previously mentioned, the generator monitors 133124 the voltage V applied to the ultrasonic transducer_g(t) Signal and Current I_g(t) phase angle between signals

And based on the phase angle

The generator infers 133126 the temperature of the ultrasonic blade using the techniques described herein in connection with fig. 43A-45. The processor or control circuitry of the generator or instrument or both maintains the temperature of the ultrasonic blade at a first target temperature T according to a frequency temperature feedback control algorithm₁Until the crosscut is completed. A frequency temperature feedback control algorithm may be used to detect completion of the vessel transection procedure. A processor or control circuit of the generator or instrument or both determines 133128 when the vessel transection is complete. The method continues along the "no" branch when the vessel transection is not complete, and along the "yes" branch when the vessel transection is complete.

When the vessel transection is not complete, the processor or control circuitry of the generator or instrument or both determines 133130 whether the temperature of the ultrasonic blade is set to a temperature T optimized for vessel sealing and transection₁. If the temperature of the ultrasonic blade is set to T₁Then the process continues along the yes branch and the processor or control circuit of the generator or instrument or both continues to monitor 133124 the voltage V applied to the ultrasonic transducer_g(t) Signal and Current I_g(t) phase angle between signals

And based on the phase angle

If the temperature of the ultrasonic blade is not set to T₁Then the process continues along the no branch and the processor or control circuitry of the generator or instrument or both continues to apply 133122 the first power level to the ultrasonic transducer.

When the vessel transection is complete, the processor or control circuitry of the generator or instrument or both applies 133132 a second power level to the ultrasonic transducer to set the ultrasonic blade to a second target temperature T optimized for maintaining or extending the life of the clamp arm pad₂. The processor or control circuit of the generator or instrument or both determines 133134 whether the temperature of the ultrasonic blade is at the set temperature T₂. If the temperature of the ultrasonic blade is set to T2, the procedure completes 133136 the vessel transection procedure.

Starting temperature of knife

Knowing the temperature of the ultrasonic blade at the beginning of the transection may enable the generator to deliver the proper amount of power to heat the blade for quick cuts, or to add only the power needed if the blade is already hot. This technique may enable more consistent traverse times and extend the life of the clamping arm pad (e.g., TEFLON clamping arm pad). Knowing the temperature of the ultrasonic blade at the beginning of the transection may enable the generator to deliver the proper amount of power to the ultrasonic transducer to generate the desired amount of ultrasonic blade displacement.

Fig. 51 is a logic flow diagram 133140 depicting a process of determining a control program or logic configuration for an initial temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. To determine the initial temperature of the ultrasonic blade, the resonant frequency of the ultrasonic blade is measured at room temperature or a predetermined ambient temperature at the manufacturing facility. The baseline frequency values are recorded and stored in a look-up table of the generator or the instrument or both. The baseline value is used to generate the transfer function. At the beginning of the ultrasonic transducer activation cycle, the generator measures 133142 the resonant frequency of the ultrasonic blade and compares 133144 the measured resonant frequency to a baseline resonant frequency valueAnd the difference (Δ f) in frequency is determined. Δ f is compared to a look-up table or transfer function of the corrected ultrasonic blade temperature. The resonant frequency of the ultrasonic blade may be determined by sweeping the voltage V applied to the drive ultrasonic transducer_g(t) Signal and Current I_g(t) the frequency of the signal. The resonant frequency being the voltage V_g(t) Signal and Current I_g(t) phase angle between signals

A frequency at zero, as described herein.

Once the resonant frequency of the ultrasonic blade is determined, a processor or control circuit of the generator or instrument or both determines 133146 an initial temperature of the ultrasonic blade based on the difference between the measured resonant frequency and the baseline resonant frequency. The generator may be used, for example, by adjusting the voltage VgV before activating the ultrasonic transducer_g(t) drive signal or current I_g(t) the drive signal or both to set the power level delivered to the ultrasound transducer to one of the following values.

The processor or control circuit of the generator or instrument or both determines 133148 whether the initial temperature of the ultrasonic blade is low. If the initial temperature of the ultrasonic blade is low, the method continues along the "Yes" branch and the processor or control circuit of the generator or instrument or both applies 133152 the high power level to the ultrasonic transducer to increase the temperature of the ultrasonic blade and complete the 133156 vessel transection procedure.

If the initial temperature of the ultrasonic blade is not low, the method continues along the "No" branch and the processor or control circuit of the generator or instrument or both determines 133150 whether the initial temperature of the ultrasonic blade is high. If the initial temperature of the ultrasonic blade is high, the method continues along the "Yes" branch and the processor or control circuit of the generator or instrument or both applies 133154 a low power level to the ultrasonic transducer to reduce the temperature of the ultrasonic blade and complete the 133156 vessel transection procedure. If the initial temperature of the ultrasonic blade is not high, the method continues along the "No" branch and the processor or control circuitry of the generator or instrument or both completes 133156 the vessel transection.

Smart knife techniques for controlling knife instability

The temperature of the contents within the jaws of the ultrasonic blade and ultrasonic end effector may be determined using the frequency temperature feedback control algorithm described herein. The frequency/temperature relationship of the ultrasonic blade is used to control the instability of the ultrasonic blade at temperature.

As described herein, there is a well-known relationship between frequency and temperature in an ultrasonic blade. Some ultrasonic blades exhibit displacement instability or modal instability in the presence of increased temperature. This may employ the known relationship to explain when the ultrasonic blade is approaching instability and then adjust the power level at which the ultrasonic transducer is driven (e.g., by adjusting the drive voltage V applied to the ultrasonic transducer_g(t) Signal or Current I_g(t) signal, or both) to modulate the temperature of the ultrasonic blade to prevent instability of the ultrasonic blade.

Fig. 52 is a logic flow diagram 133160 depicting a process of a control program or logic configuration that determines when an ultrasonic blade is approaching instability and then adjusts the power to the ultrasonic transducer to prevent instability of the ultrasonic transducer in accordance with at least one aspect of the present disclosure. Frequency/temperature relationship of an ultrasonic blade exhibiting displacement or modal instability by sweeping the drive voltage V over the temperature of the ultrasonic blade_g(t) Signal or Current I_g(t) the frequency of the signal or both and recording the results for mapping. A function or relationship is developed that can be used/interpreted by a control algorithm executed by the generator. A trigger point may be established using this relationship to inform the generator that the ultrasonic blade is approaching a known blade instability. The generator performs a frequency-temperature feedback control algorithm processing function and a closed loop response such that the drive power level is reduced (e.g., by reducing the drive voltage V applied to the ultrasonic transducer)_g(t) or the current I_g(t) or both) to modulate the temperature of the ultrasonic blade to or below the trigger point to prevent a given blade from reaching instability.

Advantages include simplifying the ultrasonic blade configuration so that the instability characteristics of the ultrasonic blade need not be designed and can be compensated for using the instability control techniques of the present disclosure. The instability control techniques of the present disclosure also enable new ultrasonic blade geometries and may improve stress distribution in heated ultrasonic blades. Additionally, the ultrasonic blade may be configured to reduce the performance of the ultrasonic blade if used with a generator that does not employ this technique.

According to the method depicted by logic flow diagram 133160, a processor or control circuit of the generator or instrument or both monitors 133162 the voltage V applied to the ultrasound transducer_g(t) Signal and Current I_g(t) phase angle between signals

The processor or control circuit of the generator or instrument or both is based on the voltage V applied to the ultrasonic transducer_g(t) Signal and Current I_g(t) phase angle between signals

The temperature of the ultrasonic blade is inferred 133164. The processor or control circuit of the generator or instrument or both compares 133166 the inferred temperature of the ultrasonic blade to the ultrasonic blade instability trigger point threshold. The processor or control circuit of the generator or instrument or both determines 133168 whether the ultrasonic blade is approaching instability. If not, the method follows the NO branch and the phase angle is monitored 133162

The temperature of the ultrasonic blade is inferred 133164 and the inferred temperature of the ultrasonic blade is compared 133166 to an ultrasonic blade instability trigger point threshold until the ultrasonic blade is near an instability. The method then proceeds along the yes branch and the processor or control circuit of the generator or instrument or both adjusts 133170 the power level applied to the ultrasonic transducer to modulate the temperature of the ultrasonic blade.

Ultrasonic sealing algorithm with temperature control

An ultrasonic sealing algorithm with ultrasonic blade temperature control may be used to improve hemostasis using the frequency temperature feedback control algorithm described herein to take advantage of the frequency/temperature relationship of the ultrasonic blade.

In one aspect, a frequency temperature feedback control algorithm may be employed to vary the power level applied to the ultrasound transducer based on a measured temperature-dependent resonant frequency (using spectroscopy), as described in various aspects of the present disclosure. In one aspect, the frequency temperature feedback control algorithm may be activated by an energy button on the ultrasonic instrument.

It is known that optimal tissue effects can be achieved by increasing the power level at which the ultrasound transducer is driven early in the sealing cycle (e.g., by increasing the drive voltage V applied to the ultrasound transducer)_g(t) or the current I_g(t) or both) to rapidly heat and dehydrate tissue, and then reduce the power level at which the ultrasound transducer is driven (e.g., by reducing the drive voltage V applied to the ultrasound transducer_g(t) or the current I_g(t) or both) to slowly allow formation of the final seal. In one aspect, a frequency temperature feedback control algorithm according to the present disclosure sets limits on the temperature threshold achievable when tissue is heated during higher power level levels, and then reduces the power level based on the melting point of the clamping jaw pad (e.g., TEFLON) to control the temperature of the ultrasonic blade to complete the seal. The control algorithm may be implemented by activating an energy button on the instrument for a more responsive/adaptive seal to further reduce the complexity of the hemostasis algorithm.

Fig. 53 is a logic flow diagram 133180 describing a control program or logic configuration placement process for providing ultrasonic sealing with temperature control in accordance with at least one aspect of the present disclosure. According to the control algorithm, the processor or control circuitry of the generator or instrument or both activates 133182 ultrasonic blade sensing using spectroscopy (e.g., a smart blade) and measures 133184 the resonant frequency of the ultrasonic blade (e.g., the resonant frequency of the ultrasonic electromechanical system) to determine the temperature of the ultrasonic blade using a frequency temperature feedback control algorithm (spectroscopy) as described herein. As previously described, the resonant frequency of the ultrasonic electromechanical system is mapped to obtain the temperature of the ultrasonic blade as a function of the resonant frequency of the electromechanical ultrasonic system.

First desired resonance frequency f of the ultrasonic electromechanical system_xCorrespond toAt a first desired temperature Z of the ultrasonic blade. In one aspect, the first desired ultrasonic blade temperature Z is the optimal temperature for tissue coagulation (e.g., 450℃.). Second desired frequency f of the ultrasonic electromechanical system_YCorresponding to the second desired temperature ZZ ° of the ultrasonic blade. In one aspect, the second desired ultrasonic blade temperature ZZ ° is a temperature of 330 ℃ that is below the melting point of the clamp arm pad, which for TEFLON is about 380 ℃.

The processor or control circuit of the generator or instrument or both converts the measured resonant frequency of the ultrasonic electromechanical system to a first desired frequency f_xA comparison 133186 is made. In other words, the method determines whether the temperature of the ultrasonic blade is less than the temperature for optimal tissue coagulation. If the measured resonant frequency of the ultrasonic electromechanical system is less than the first desired frequency f_xThen the no branch is followed and the processor or control circuit of the generator or instrument or both increases 133188 the power level applied to the ultrasonic transducer to increase the temperature of the ultrasonic blade until the measured resonant frequency of the ultrasonic electromechanical system exceeds the first desired frequency f_xUntil now. In this case, the tissue coagulation process is complete and the method controls the temperature of the ultrasonic blade to correspond to the second desired frequency f_yThe second desired temperature of (a).

The method continues along the yes branch and the processor or control circuit of the generator or instrument or both reduces 133190 the power level applied to the ultrasonic transducer to reduce the temperature of the ultrasonic blade. The processor or control circuit of the generator or instrument or both measures 133192 the resonant frequency of the electromechanical system of the ultrasound and matches the measured resonant frequency with a second desired frequency f_YA comparison is made. If the measured resonance frequency is not less than the second desired frequency f_YThe processor or control circuit of the generator or instrument or both reduces 133190 the ultrasonic power level until the measured resonant frequency is less than the second desired frequency f_YUntil now. The frequency temperature feedback control algorithm maintains the measured resonant frequency of the ultrasonic electromechanical system below a second desired frequency f_yFor example, the temperature of the ultrasonic blade is less than the melting point of the clamp arm pad, and then the generator performs an increase application to the ultrasonic transducerTo increase the temperature of the ultrasonic blade until the tissue transection process is complete 133196.

Fig. 54 is a graphical representation 133200 of ultrasonic transducer current and ultrasonic blade temperature as a function of time in accordance with at least one aspect of the present disclosure. Fig. 54 shows the result of applying the frequency-temperature feedback control algorithm described in fig. 53. Diagram 133200 shows the ultrasonic transducer current I as a function of time_g(t) first graph 133202 of ultrasonic blade temperature as a function of time of the second graph 133204. As shown, the transducer I_g(t) held constant until the ultrasonic blade temperature reached 450 °, which is the optimum coagulation temperature. Once the temperature of the ultrasonic blade reaches 450 degrees, the frequency temperature feedback control algorithm reduces the current I of the transducer_g(t) until the temperature of the ultrasonic blade drops below 330 °, which is below the melting point of, for example, a TEFLON pad.

Tissue type identification or parameterization

In various aspects, a surgical instrument (e.g., an ultrasonic surgical instrument) is configured to identify or parameterize tissue grasped by an end effector and to adjust various operating parameters of the surgical instrument accordingly. Identification or parameterization of tissue may include tissue type (e.g., physiological tissue type), physical characteristics or properties of the tissue, composition of the tissue, location of the tissue within or relative to the end effector, and the like. In one example discussed in more detail below, an ultrasonic surgical instrument is configured to tune the displacement amplitude of the distal tip of the ultrasonic blade according to the collagen/elastin ratio of tissue detected in the jaws of the end effector. As previously discussed, the ultrasonic instrument includes an ultrasonic transducer acoustically coupled to an ultrasonic blade via an ultrasonic waveguide. The displacement of the ultrasonic blade is a function of the electrical power applied to the ultrasonic transducer, and thus the electrical power provided to the ultrasonic transducer can be modulated according to the detected collagen/elastin ratio of the tissue. In another example, discussed in more detail below, the force exerted by the clamp arm on the tissue can be modulated according to the position of the tissue relative to the end effector. Various techniques for identifying or parameterizing an organization are described herein, and more detail may be found in, for example, U.S. provisional patent application No. 62/692,768 (entitled "smart energy device (SMART ENERGY DEVICES)", the disclosure of which is incorporated herein by reference in its entirety, filed on 30/6/2018.

Determination of tissue location by impedance changes

Referring back to fig. 23, in accordance with at least one aspect of the present disclosure, an end effector 1122 is shown that includes an ultrasonic blade 1128 and a clamp arm 1140. Fig. 55 is a bottom view of the ultrasonic end effector 1122 showing the clamp arm 1140 and the ultrasonic blade 1128 and depicting tissue positioned within the ultrasonic end effector 1122 in accordance with at least one aspect of the present disclosure. The positioning of tissue between the clamp arm 1140 and the ultrasonic blade 1128 can be described in terms of the regions or zones in which the tissue is located, such as the distal region 130420 and the proximal region 130422.

Referring now to fig. 23 and 55, the ultrasonic end effector 1122 grasps tissue between the ultrasonic blade 1128 and the clamp arm 1140 as described herein. Once the tissue is grasped, an ultrasound generator (e.g., generator 1100 described in connection with fig. 22) may be activated to apply power to an ultrasound transducer acoustically coupled to the ultrasonic blade 1128 via an ultrasonic waveguide. The power applied to the ultrasound transducer may be within a therapeutic or non-therapeutic range of energy levels. The resulting displacement of the ultrasonic blade 1128 does not affect or minimally affects the grasped tissue so as not to coagulate or cut the tissue in the non-therapeutic range of applied power. Non-therapeutic excitation may be particularly useful for determining the impedance of the ultrasonic transducer, which will vary based on a variety of conditions present at the end effector 1122 including, for example, tissue type, tissue location within the end effector, ratio of different tissue types, and temperature of the ultrasonic blade, among other conditions. A variety of these conditions are described herein. The impedance of an ultrasonic transducer is given by

As described herein. Once the condition at the ultrasonic end effector 1122 is determined using the non-therapeutic ultrasonic energy level, therapeutic ultrasonic energy may be applied based on the determined end effector 1122 condition to optimize tissue treatment, effective sealing, transection and duration, and other variables associated with a particular surgical procedure. The treatment energy is sufficient to coagulate and cut tissue.

In one aspect, the present disclosure provides a control process, such as an algorithm, to determine the thickness and type of tissue located within the jaws of the ultrasonic end effector 1122 (i.e., between the clamp arm 1140 and the ultrasonic blade 1128) as shown in fig. 23 and 55. Additional details regarding detecting various states and properties of an object grasped by the end effector 1122 are discussed below in U.S. provisional patent application No. 62/692,768 (entitled "smart energy device (SMART ENERGY DEVICES)") under the heading "determine jaw state".

FIG. 56 is a graphical representation 130000 depicting the change in impedance of an ultrasound transducer as a function of the position of tissue within the ultrasonic end-effector 1122 over a range of predetermined ultrasonic generator power level increases in accordance with at least one aspect of the present disclosure. The horizontal axis 130004 represents tissue position, while the vertical axis 130002 represents transducer impedance (Ω). Various limits along the horizontal axis 130004 (such as a first limit or proximal limit 130010 and a second limit or distal limit 130012) may depict or correspond to different locations of tissue grasped within the ultrasonic end effector 1122. Depiction of the proximal and distal tissue locations is schematically shown in fig. 55 (i.e., proximal portion 130422 and distal portion 130420). FIGS. 130006, 130008 show when the power applied to the ultrasound transducer is from a minimum or first non-therapeutic power level L₁To a maximum or second non-therapeutic power level L₂The transducer impedance omega changes. The greater the change in transducer impedance Ω, the closer the resulting map will be to the distal limit 130012. Thus, the location of the tissue corresponds to the location of the resulting map relative to various limits (e.g., proximal limit 130010 and distal limit 130012). In the first of the graphs 130006, the graph,₁representing the change in transducer impedance when tissue is located at the proximal portion 130422 of the end effector 1122. This can be seen from the fact that the first plot 130006 does not exceed the proximal limit 130010. In the first placeIn the two figures 130008, there are shown,₂representing the change in transducer impedance when tissue is located at the distal end 130012 of the end effector 1122. This can be seen from the fact that the first plot 130006 exceeds the proximal limit 130010 and/or is located near the distal limit 130012. As shown by figures 130006, 130008,₂ratio of₁Much larger.

When power (voltage and current) (e.g., insufficient power to cut or coagulate tissue) is applied to the ultrasonic transducer to activate the ultrasonic blade 1128 in a non-therapeutic range, the measured transducer impedance (Ω) is a useful indicator of the location of tissue within the jaws of the end-effector 1122, whether at the distal end 130420 or the proximal end 130422 of the ultrasonic blade 1128, as shown in fig. 55. When the non-therapeutic power level applied to the ultrasound transducer is from a minimum power level (e.g., L)₁) To a maximum power level (e.g. L)₂) The position of tissue within the end effector 1122 may be determined based on changes in transducer impedance. In some aspects, one or more non-therapeutic power levels applied to the ultrasound transducer may cause the ultrasonic blade 1128 to vibrate at or below a minimum therapeutic amplitude (e.g., less than or equal to 35 μm at the distal end and/or the proximal end of the ultrasonic blade 1128). The calculation of the impedance was previously discussed in this disclosure. When the first power level L is applied₁To the first transducer impedance Z₁Taking a measurement, which provides an initial measurement value; when the applied power increases to a second power level L₂Time, same pair impedance Z₂Subsequent measurements are made. In one aspect, the first power level L₁0.2A, second power level L₂0.4A or a first power level L₁While the voltage remains constant. Based on the applied power level, the resulting longitudinal displacement amplitude of the ultrasonic blade 1128 provides an indication of the tissue location within the jaws of the end effector 1122. In one exemplary implementation, the first power level L₁A longitudinal displacement amplitude of 35 μm was produced at the distal end 130420 and a longitudinal displacement amplitude of 15 μm was produced at the proximal end 130422. Further, in this example, the second power level L₂Producing 70 μ at distal end 130420A longitudinal amplitude of m, resulting in a longitudinal amplitude of 35 μm at the proximal end 130422. An algorithm may calculate the difference in transducer impedance between the first and second measurements to find the change in impedance Δ Z_g(t) of (d). The change in impedance is plotted against tissue position and shows that a higher impedance change represents tissue position distributed at the distal end 130012 of the end effector 1122 and a lower impedance change represents tissue position distributed at the proximal end 130010. In general, if the power level is changed from L₁Increase to L₂With a large change in impedance, the tissue is only positioned distally within the end effector 1122; if total with power level from L₁Increase to L₂With only a small change in impedance, the tissue will be more distributed within the end effector 1122.

Fig. 57 is a graphical representation 130050 depicting the change in impedance of an ultrasound transducer as a function of time relative to the position of tissue within an ultrasonic end effector in accordance with at least one aspect of the present disclosure. The horizontal axis 130054 represents time (t) and the vertical axis 130052 represents the change () in transducer impedance between the first and second measurements.

Graphs

130060, 130066 depict changes () in transducer impedance versus time (t) for proximal and distal positions of tissue within the bite of the clamp arm 1140. For the proximal and distal tissue positions, the clamp arm 1140 force is applied to hold the tissue in the ultrasonic end effector 1122 and a delay period is applied before the first low power level is applied and the transducer impedance is measured. Subsequently, the system applies a second higher power level and measures the impedance again. It should be understood that the first power level and the second power level applied to the ultrasound transducer are both non-therapeutic power levels. An algorithm executed by a processor or control circuit portion of the generator or surgical instrument (e.g., processor 902 in fig. 21 or control circuit 760 in fig. 18) may calculate a difference () in transducer impedance between the first and second power levels for the proximal and distal tissue locations. As shown with respect to the first graph 130060, if the difference () in transducer impedance is below the first threshold 130056, the algorithm determines that tissue is located in the proximal portion 130422 of the end effector 1122. In the first graph 130060, the difference in transducer impedance between the measurements increases 130062 over time until it stabilizes or remains 130064 below the first threshold 130056. As shown with respect to the first graph 130066, if the difference () in transducer impedance is above the second threshold 130058, the algorithm determines that tissue is located in the distal portion 130420 of the end effector 1122. In the second graph 130066, the difference in transducer impedance between the measurements increases 130068 over time until it stabilizes or remains 130070 above the second threshold 130058. If the difference () in transducer impedance is between the first threshold 130056 and the second threshold 130058, the algorithm determines that tissue is located in the middle portion 130424 of the end effector 1122, e.g., between the proximal and distal portions of the end effector.

Fig. 58 is a logic flow diagram depicting a process 130100 of identifying a control program or logic configuration for operation within a non-therapeutic power range applied to an instrument to determine tissue location in accordance with at least one aspect of the present disclosure. The process 130100 can be performed by a processor or control circuit of a surgical instrument (such as the control circuit 760 of fig. 18) or a generator (such as the processor 902 of fig. 21). For the sake of brevity, the process 130100 will be described as being performed by a processor, but it should be understood that the following description encompasses the foregoing variations.

In accordance with one aspect of the procedure 130100, the processor applies control signals to close the clamp arm 1140, thereby capturing tissue between the clamp arm 1140 and the ultrasonic blade 1128. After the clamp arms 1140 are closed onto the tissue, the processor waits a predetermined delay period to relax the tissue and relinquish some of the moisture content. After the delay period, the processor sets 130102 the power level applied to the ultrasound transducer to a first non-therapeutic power level. Optionally, an aspect of the process 130100 includes that feedback control can be used to verify that the first power is set below the therapeutic power level. In this aspect, the processor determines 130106 whether the first power level is less than the therapeutic power level. If the first power level is not less than the therapeutic power level, the process 130100 continues along the "No" branch and the processor decreases 130108 the applied powerThe power is applied and cycled until the first power level is less than the therapeutic power level. The process 130100 then continues along the yes branch and the processor measures 130110 a first impedance Z of the ultrasonic transducer corresponding to the first power level_g1(t) of (d). The processor then sets 130112 the power level applied to the ultrasound transducer to a second non-therapeutic power level, where the second power is greater than the first power level and less than the therapeutic power level. Also, optionally, feedback control may be used to verify that the second power level is not only greater than the first power level but also lower than the therapeutic power level. In this aspect, the processor determines 130114 whether the second power level is less than the therapeutic power level. If the second power is greater than the therapeutic power level, process 130100 continues along the "no" branch and the processor reduces 130108 the second power level and loops until it is below the therapeutic power level threshold. The process 130100 then continues along the yes branch and the processor measures 130116 a second impedance, Z, of the ultrasound transducer corresponding to the second power level_g2(t) of (d). The impedance of the ultrasound transducer may be measured using a variety of techniques as discussed herein. The processor then calculates 130118 the difference in transducer impedance between the applied first power level and the second power level:

＝Z_g2(t)-Z_g1(t)。

the processor then provides 130120 an indication of the tissue location to the user. The processor may indicate the tissue location via an output device of the surgical instrument (e.g., a visual feedback device such as the display depicted in fig. 31, an audio feedback device, and/or a haptic feedback device), the display 135 (fig. 3), or other output device of the surgical hub 106 (e.g., a visual feedback device, an audio feedback device, and/or a haptic feedback device) communicatively connected to the surgical instrument and/or the output device 2140 (fig. 27B) of the generator 1100.

The processor compares the difference in transducer impedance to a first threshold and a second threshold, wherein as shown in fig. 57, the algorithm determines that tissue is located in the proximal portion 130422 of the end effector 1122 if the difference () in transducer impedance is below the first threshold 130056 and determines that tissue is located in the distal portion 130420 of the end effector 1122 if the difference () in transducer impedance is above the second threshold 130058. If the difference () in transducer impedance is between the first threshold 130056 and the second threshold 130058, the algorithm determines that tissue is located in the middle portion 130424 of the end effector 1122, e.g., between the proximal portion 130422 and the distal portion 130420 of the end effector 1122. In accordance with the described procedure, the impedance of the ultrasound transducer can be used to differentiate the percentage of tissue located in a distal, proximal, or intermediate position of the end effector 1122 before applying the appropriate therapeutic power level.

Switchless mode based on tissue localization

In various aspects, the response of the ultrasonic instrument may be based on whether tissue is present within the end effector, the type of tissue located within the end effector, or the compressibility or composition of the tissue located within the end effector. Accordingly, the generator or ultrasonic surgical instrument may include and/or execute instructions to execute an algorithm to control the time between clamping tissue in the jaws of the end effector and activating the ultrasonic transducer to treat the tissue. If tissue is not sensed, the ultrasound generator activation button or pedal may be assigned a different meaning to perform a different function. In one aspect, an advanced energy device can use the detection of the presence of tissue within the jaws of an end effector as a queue for activating an ultrasonic transducer to begin a tissue coagulation cycle. In another aspect, the compression characteristics and situational awareness may enable the device to activate automatically to adjust parameters of the algorithm also for the sensed tissue type. For example, the advanced generator may ignore activation of a button or foot pedal unless tissue contact with the jaws of the end effector is sensed. This configuration will eliminate inadvertent activation of the queue, thereby making it possible to operate the device in a simpler manner.

Accordingly, an advanced generator (such as the advanced generator described in conjunction with fig. 1-42) and/or a surgical instrument (such as an ultrasonic surgical instrument described throughout this disclosure) may be configured to operate in a switchless mode. In the switchless mode, the ultrasonic device is automatically activated in the coagulation mode upon sensing or detecting the presence of tissue in the jaws of the end effector. In one aspect, when operating in an automatic energy activation mode (or "switchless" mode), a control algorithm controlling the activation of the ultrasonic surgical instrument may be configured to initially apply less energy to the ultrasonic instrument than would be activated when not operating in the switchless mode. Further, the ultrasonic generator or instrument may be configured to determine contact with tissue located in the jaws of the end effector and the type of the tissue. Based on sensing or detecting the presence of tissue in the jaws of the end effector, a control algorithm executed by a processor or control circuit of the generator or ultrasonic instrument may cause the ultrasonic instrument to operate in a switchless mode, and the algorithm may be adjusted to achieve optimal bulk coagulation of tissue in the jaws of the end effector. In other aspects, instead of automatically activating the surgical instrument and/or generator, a control algorithm executed by a processor or control circuit of the generator or ultrasonic instrument may prevent the generator or ultrasonic instrument from activating unless the presence of tissue is detected in the end effector.

In one aspect, the present disclosure provides an algorithm that is executed by a processor or control circuit located in a generator or a handheld ultrasonic instrument to determine the presence of tissue and the type of tissue located within the jaws of the end effector. In one aspect, the control algorithm can be configured to determine that tissue is located within the end effector VIA the techniques described herein for determining tissue LOCATION, as described below under the heading "determining tissue LOCATION VIA ELECTRODE CONTINUITY (detection CONTINUITY). For example, the control algorithm may be configured to determine whether tissue is located within the end effector (as described below) based on whether there is any continuity between the electrodes, and thus automatically activate (e.g., by causing a generator coupled to) or allow activation of the surgical instrument when tissue is detected. When the surgical instrument and/or generator is operating in the switchless mode, the control algorithm may be further configured to activate the surgical instrument at a particular power level, which may or may not be different from a standard initial activation power level of the surgical instrument. In some aspects, the control algorithm may be configured TO activate or allow activation of the surgical instrument ACCORDING TO a particular type or composition of tissue, which may be detected via techniques described below under the heading "determining a tissue collagen TO ELASTIN RATIO from IR SURFACE reflectance and emissivity (DETERMINING TISSUECOLLAGEN-TO-elastic RATIO TO IR SURFACE RATIO REFLECTANCE ANDEMISSIVITY)", for example. For example, the control algorithm may be configured to activate the surgical instrument when tissue having a high collagen composition has been grasped, but not necessarily when tissue having a high elastin composition has been grasped. In some aspects, the control algorithm may be configured to activate or allow activation of the surgical instrument depending on whether the grasped tissue is located at a particular location within the end effector or whether the end effector has grasped a particular amount of tissue via techniques such as those described below under the heading "determine tissue location via electrode continuity (DETERMINING TISSUE LOCATION VIA ELECTRODE CONTINUITY)". For example, the control algorithm may be configured to activate the surgical instrument when a certain percentage of the end effector is covered by the grasped tissue. As another example, the control algorithm can be configured to activate the surgical instrument when the grasped tissue is located at the distal end of the end effector.

In other aspects, the control algorithm may be configured to determine whether the end effector has grasped tissue, tissue type or composition, and other characteristics OF the end effector or tissue via a SITUATIONAL AWARENESS system described under the heading "SITUATIONAL AWARENESS" as in U.S. provisional patent application serial No. 62/659,900 (METHOD OF HUB COMMUNICATION) filed on 19/4/2018, entitled HUB COMMUNICATION, which is hereby incorporated by reference in its entirety. In these aspects, a surgical hub 106 (fig. 1-11) coupled to the surgical instrument and/or generator may receive data from the surgical instrument, generator, and/or other medical devices used in the operating room and make inferences regarding the surgical procedure being performed or the specific steps thereof. Thus, the situational awareness system may infer whether and what type of tissue is being manipulated at any given moment or step, and the control algorithm may then control the surgical instrument accordingly, including automatically activating the surgical instrument accordingly. For example, the control algorithm may be configured to automatically activate or allow activation of the surgical instrument when the tissue grasped by the end effector corresponds to a tissue type or tissue composition expected by the situational awareness system.

With the ability to detect whether the instrument is contacting tissue and what type of tissue is at the time of contact, the ultrasonic instrument may be operated in a switchless mode of operation, with operation permitted based on the sensing capabilities of the ultrasonic instrument. In some aspects, the control algorithm may be configured to ignore actuations of the activation button, foot pedal, and other input devices coupled to the generator and/or ultrasonic surgical instrument unless tissue contact with the jaw/end effector of the surgical instrument is sensed, thereby preventing accidental activation of the instrument. In some aspects, the control algorithm may be configured to assign different meanings to the activation button, foot pedal, and other input devices coupled to the generator and/or ultrasonic surgical instrument depending on whether tissue contact with the jaw/end effector of the surgical instrument is sensed. For example, when tissue is present in the end effector, the control algorithm may be configured to activate the surgical instrument in response to actuating the activation button; however, when no tissue is present within the end effector, the control algorithm may be configured to perform some different or additional action upon actuation of the activation button.

Being able to determine that there is no tissue present in the jaws of the end effector allows the instrument to be changed to a switchless mode and then initiate an auto-coagulation cycle of operation when tissue is subsequently detected, thereby making the instrument more useful for its uptime and allowing the user to proceed based on his predictive ability. In addition to being able to detect the presence of tissue, being able to detect the type of tissue allows the algorithm to adjust and calculate the optimal clotting opportunities.

Tuning ultrasound systems according to tissue composition

In various aspects, an ultrasonic surgical instrument may include a processor or control circuit that executes an adaptive ultrasonic blade control algorithm to detect the composition of tissue grasped by or at an end effector and control the operating parameters of an ultrasonic transducer and/or ultrasonic blade accordingly. The tissue composition may include, for example, the ratio of collagen to elastin in the tissue, the stiffness of the tissue, or the thickness of the tissue. The operating parameters controlled or adjusted by the adaptive ultrasonic blade control algorithm may include, for example, the amplitude of the ultrasonic blade, the temperature or heat flux of the ultrasonic blade, or the like. The adaptive ultrasonic blade control algorithm may be executed by a control circuit or processor located in the generator or surgical instrument.

In one example described in more detail below, the adaptive ultrasonic blade control algorithm may be configured to control the amplitude of the ultrasonic blade according to the ratio of collagen to elastin of the tissue. The ratio of collagen to elastin of the tissue may be determined via a variety of techniques, such as those described below. In another example described in more detail below, the adaptive ultrasonic blade control algorithm may be configured to control the ultrasonic transducer/ultrasonic blade such that the lower the collagen content of the tissue, the longer the warming time and the lower the final temperature of the ultrasonic blade.

Determining the ratio of tissue collagen to elastin based on frequency shift

In various aspects, the control algorithm may be configured to determine the collagen to elastin ratio of the tissue by detecting the natural frequency of the ultrasonic blade and the offset of the ultrasonic blade waveform (e.g., to tune the amplitude of the distal tip of the ultrasonic blade). For example, the techniques described in connection with FIGS. 1-54 may be used to detect the ratio of collagen to elastin in tissue located in an end effector of an ultrasonic instrument. In one aspect, the present disclosure provides an adaptive ultrasonic blade control algorithm to detect shifts in the natural frequency and waveform of the ultrasonic blade to detect the composition of tissue in contact with the ultrasonic blade. In another aspect, the adaptive ultrasonic blade control algorithm may be configured to detect collagen and elastin constituent content of the tissue and adjust a treatment heat flux of the ultrasonic blade based on the detected collagen content of the tissue. Techniques for monitoring deviations in the natural frequency of an ultrasonic blade based on the type of tissue located in the jaws of an end effector of an ultrasonic instrument are described herein in connection with fig. 1-54. Accordingly, such techniques will not be repeated here for the sake of brevity and clarity of this disclosure.

The ratio of elastin to collagen may be determined by monitoring the shift in the natural frequency of the ultrasonic blade and comparing the natural frequency to a look-up table. The look-up table may be stored in a memory (e.g., memory 3326 of fig. 31) and contain the ratio of elastin to collagen and an empirically determined specific ratio of the corresponding natural frequency shift.

Determination of tissue collagen to elastin ratio based on IR surface reflectance and emissivity

In various aspects, the control algorithm may be configured to determine the collagen to elastin ratio of the tissue by determining the IR reflectance of the tissue (e.g., to tune the amplitude of the distal tip of the ultrasonic blade). For example, fig. 59 shows an ultrasound system 130164 including an ultrasound generator 130152 coupled to an ultrasonic instrument 130150. The ultrasonic instrument 130150 is coupled to the ultrasonic end effector 130400 via an ultrasonic waveguide 130154. The ultrasonic generator 130152 may be integral to the ultrasonic instrument 130150 or may be connected to the ultrasonic instrument 130150 using wire or radio/electronic coupling techniques. In accordance with at least one aspect of the present disclosure, the end effector 130400 of the ultrasonic surgical instrument 130150 includes an IR sensor located on the clamp arm 130402 (e.g., jaw member). The ultrasonic generator 130152 and/or the ultrasonic instrument 130150 may be coupled to the surgical hub 130160 and/or the cloud 130162 via a wireless or wired connection, as described in connection with fig. 1-11.

FIG. 60 illustrates an IR reflectance detection sensor circuit 130409 that can be integrally mounted or formed with a clamp arm 130402 of an ultrasonic end effector 130400 to detect tissue composition in accordance with at least one aspect of the present disclosure. The IR sensor circuit 130409 includes an IR source 130416 (e.g., an IR emitter) and an IR detector 130418 (e.g., an IR receiver). The IR source 130416 is coupled to a voltage source V. When the control circuit 130420 closes the switch SW1, a current is generated through R2. When switch SW1 is closed, IR source 130416 is directed toward tissue 130410 (e.g., clamped or positioned in a clip)Tissue between the holder arm 130402 and the ultrasonic blade 130404). Some of the emitted IR energy is absorbed by tissue 130410, some of the emitted IR energy is transmitted through tissue 130410, and some of the emitted IR energy is reflected by tissue 130410. The IR detector 130418 receives IR energy reflected by tissue 130410 and generates an output voltage V_oOr signal, which is applied to the control circuit 130420 for processing.

Referring to fig. 59 and 60, in one aspect, the ultrasonic generator 130152 includes a control circuit 130420 to drive an IR source 130416 and an IR detector 130418 located on or in the clamp arm 130402 of the ultrasonic end effector 130400. In other aspects, the ultrasonic instrument 130150 includes a control circuit 130420 to drive an IR source 130416 and an IR detector 130418 located on or in the clamp arm 130402 of the ultrasonic end effector 130400. In either aspect, the IR source 130416 is energized by the control circuit 130420, such as by illuminating the tissue with IR energy, by closing switch SW1 when tissue 130410 is grasped between the ultrasonic blade 130404 and the clamp arm 130402. In one aspect, the IR detector 130418 generates a voltage V proportional to the IR energy reflected by the tissue 130410 _o. The total IR energy emitted by IR source 130416 is equal to the sum of the IR energy reflected by tissue 130410, the IR energy absorbed by tissue 130410, and the IR energy transmitted through tissue 130410, plus any losses. Accordingly, the control circuit 130420 or processor can be configured to detect the collagen content of the tissue 130410 by the amount of IR energy detected by the IR detector 130418 relative to the total amount of IR energy emitted by the IR source 130416. The algorithm takes into account the amount of energy that tissue 130410 absorbs and/or transmits through the tissue to determine the collagen content of tissue 130410. The IR source 130416 and IR detector 130418 and the algorithm are calibrated to provide a useful measure of the collagen content of tissue 130410 using the IR reflectance principle.

The IR reflectance detection sensor circuit 130409 shown in FIG. 60 provides IR surface reflectance and emissivity to determine the ratio of elastin to collagen. The IR reflectivity can be used to determine the tissue composition used to tune the amplitude of the ultrasound transducer. The refractive index is an optical constant that controls the light dependent reflection of IR light. The refractive index can be used to distinguish tissue types. For example, refractive index contrast has been shown to distinguish between normal liver tissue and liver metastases. The refractive index may be used as an absolute or comparative measure of tissue differentiation.

One method of comparison employs an energy dissecting device such as the ultrasonic blade 130404, for example, to determine the exact ratio (as described above), and then uses this index as a baseline to predict the collagen ratio for all further actuations. In this way, the endoscope can update the dissection device (e.g., the ultrasonic blade 130404) based on the collagen ratio. The dissector device may fine-tune the prediction at each actuation to perform the actual collagen denaturation firing. An alternative approach may employ an absolute index with a look-up table that can distinguish between surface irregularities and subsurface collagen concentrations. Other information about the IR refractive index properties of tissue can be found in the following documents: visible to near infrared refractive index characteristics of freshly resected human liver tissue: marking Liver Malignancies (Visible To Near-induced reactive Properties of Freefly-excited Human-live Properties: Marking Liver Malignancies); panagiotis Gianios, Konstatinos G.Toutozas, Maria Matiatou, Konstatinos Stasinos, Manousos M.Konstadolukis, George C.Zooglafos, and Konstatinos Moutzourisa; sci.rep.2016; 27910 (which is hereby incorporated by reference).

In other aspects, the ultrasonic dissection device may be configured to vary the ideal temperature of the ultrasonic blade control algorithm in proportion to the collagen ratio. For example, the ultrasonic blade temperature control algorithm may be modified based on the collagen ratio received from the control circuit 130420. As one particular example, the ultrasonic blade temperature control algorithm can be configured to decrease the temperature set at which the ultrasonic blade 130404 is held and increase the holding time for the ultrasonic blade 130404 to contact the tissue 130410 to cause a higher concentration of collagen in the grasped tissue 130410. As another example, the latency of the algorithm cycling through full activation may be modified based on the collagen ratio. Various temperature control algorithms for the ultrasonic blade are described in connection with fig. 43-54.

Fig. 61 is a cross-sectional view of an ultrasonic end effector 130400 including a clamp arm 130402 and an ultrasonic blade 130404 according to one aspect of the present disclosure. The clamp arms 130402 include IR reflectance

detection sensor circuits

130409a, 130409b that can be integrally mounted or formed with the clamp arms 130402 of the ultrasonic end effector 130400 to detect the composition of the tissue 130410. The IR reflectance

detection sensor circuits

130409a, 130409b may be mounted on a flexible circuit substrate 130412, which is shown in plan view in fig. 62. The flexible circuit substrate 130412 includes three

elongated members

130408a, 130408b, 130408c on which the IR reflectance

detection sensor circuits

130409a, 130409b and IR sensors 130414a, 130414b are mounted. The IR sensors 130414a, 130414b can include an IR source 130416 and an IR detector 130418 as shown in fig. 60.

Fig. 63 is a logic flow diagram depicting a process 130200 of a control program or logic configuration that measures IR reflectance to determine tissue composition to tune the amplitude of an ultrasound transducer. The process 130200 can be performed by a processor or control circuit (such as the control circuit 760 of fig. 18) or a generator (such as the processor 902 of fig. 21) of the surgical instrument. For the sake of brevity, the process 130200 will be described as being performed by a control circuit, but it should be understood that the following description encompasses the foregoing variations.

1-54 and 59-63, in one aspect, the control circuitry energizes 130202 the IR source 130416 to apply IR energy to tissue 130410 clamped in the end effector 13400 of the ultrasonic instrument 130150. The control circuitry then detects 130204 the IR energy reflected by tissue 130410 via IR detector 130418. Thus, the control circuitry determines 130206 the ratio of collagen to elastin of tissue 130410 based on the detected IR energy reflected by tissue 130410. The control circuit adjusts 130208 the ultrasonic blade temperature control algorithm based on the determined collagen/elastin ratio of the tissue, as discussed in U.S. provisional patent application No. 62/692,768, entitled "smart energy device (SMART ENERGY DEVICES)". In one aspect, the collagen content of tissue 130410 can be detected from the reflectance of the IR light source 130416. In another aspect, the lower the collagen content of the tissue 130410, the longer the warming time and the lower the final temperature of the ultrasonic blade 130404. In another aspect, the tissue 130410 composition can be tissue thickness or stiffness and can be used to affect the ultrasonic blade transducer control program.

The ratio of elastin to collagen may be determined by monitoring the IR reflectance of the tissue and comparing the detected IR reflectance to a look-up table. The look-up table may be stored in a memory (e.g., memory 3326 of fig. 31) and contain the ratio of elastin to collagen and the corresponding IR reflectance at a particular ratio as determined empirically.

Determining the ratio of tissue collagen to elastin based on collagen transition point

Different types of tissue are composed of different amounts of structural proteins (such as collagen and elastin) that provide different properties to the different types of tissue. When heat is applied to tissue (e.g., by an ultrasonic blade), the structural proteins denature, which can affect tissue integrity and other tissue properties. However, structural proteins denature at different known temperatures. For example, collagen is denatured prior to elastin. Thus, by detecting at what temperature a property of the tissue changes, the tissue composition (e.g., the ratio of collagen to elastin in the tissue) can be inferred. In various aspects, the control algorithm may be configured to determine a ratio of collagen to elastin of the tissue by determining a collagen transition point of the tissue. The control algorithm may then control various operating parameters of the surgical instrument, such as the amplitude of the ultrasonic blade, in accordance with the determined tissue composition. In one aspect, the control algorithm may determine the collagen transition point of the tissue by measuring the rate of change of the position of the clamp arm actuation member and its displacement while keeping the load on the clamp arm constant. In another aspect, the control algorithm can determine the collagen transition point of the tissue by directly measuring the temperature of the tissue/blade interface to identify the collagen/elastin percentage.

Figures 16-19 schematically illustrate a motorized clamp arm closure mechanism. Fig. 40 is a system diagram 7400 of a segmented circuit 7401 including a plurality of independently

operating circuit segments

7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 according to one aspect of the present disclosure, while fig. 35 is a circuit diagram of various components of a surgical instrument having motor control functionality according to one aspect of the present disclosure. For example, fig. 35 illustrates a drive mechanism 7930 that includes a closure drivetrain 7934 configured to close the jaw members to grasp tissue with the end effector. Fig. 38-39 illustrate

control systems

12950, 12970 for controlling the rate of closure of a jaw member, such as a clamp arm portion of an ultrasonic end effector, wherein fig. 38 is a diagram of a control system 12950 configured to provide gradual closure of the closure member as it is advanced distally to close the clamp arms to apply a closing force load at a desired rate in accordance with an aspect of the present disclosure, and fig. 39 illustrates a Proportional Integral Derivative (PID) controller feedback control system 12970 in accordance with an aspect of the present disclosure. Thus, in the following description of an ultrasound system including a motorized clamp arm controller to control the closing rate and/or position of the clamp arm, reference should be made to FIGS. 16-19 and 38-41.

In one aspect, the control algorithm may be configured to detect a collagen transition point of the grasped tissue, thus controlling the delivery of ultrasound energy to the tissue by controlling the phase and/or amplitude of the ultrasound transducer drive signal or the closing rate of the grasping arms. For example, in one aspect, the control algorithm may be configured to control the force applied by the grasping arm to the tissue as a function of the collagen transition point. This may be accomplished by measuring the position of the clamp arm actuation member and its rate of change while keeping the load of the clamp arm constant over an engagement pressure within a set operating range (e.g., 130-.

Fig. 64A is a graphical representation 130250 of displacement of the gripper arms 1140 (fig. 23) versus time when closing the gripper arms 1140 to identify a collagen transition point, in accordance with at least one aspect of the present disclosure. Fig. 64B is an enlarged portion 130256 of the graphical representation 130250 shown in fig. 64A. The horizontal axis 130254 represents time (e.g., in seconds), while the vertical axis 130252 represents clamp arm displacement (e.g., in millimeters). In one aspect, the control algorithm may be configured to control the load applied to the tissue by the clamp arms 1140 (e.g., by controlling the closing rate of the clamp arms 1140) as the ultrasonic blade 1128 (fig. 23) heats the tissue according to the collagen transition point of the tissue. In one such aspect, the control algorithm is configured to close the clamp arm 1140 until the clamp arm load reaches a threshold value, which may comprise a particular value (e.g., 4.5 pounds) or range of values (e.g., in the range of 3.5 to 5 pounds). At that time, the control algorithm sets the gripper arm displacement rate of change threshold θ and monitors the displacement of the gripper arm 1140. As long as the rate of change of the gripper arm displacement remains within predetermined negative limits (i.e., below the threshold θ), the control algorithm can determine that the tissue is below the transition temperature. As shown in the graphical representations of fig. 64A and 64B, when the control algorithm determines that the rate of change of gripper arm displacement exceeds the threshold value θ, the control algorithm can determine that the melting temperature of collagen has been reached.

In one aspect, once the control algorithm determines that the transition temperature has been reached, the control algorithm may be configured to change the operation of the ultrasonic instrument accordingly. For example, the control algorithm may switch the surgical instrument from load control (of the clamp arm 1140) to temperature control. In another aspect, the control algorithm may maintain load control of the gripper arms after the collagen transition temperature has been reached and monitor when a gripper arm displacement change rate threshold has been reached. The second gripper arm rate of change of displacement threshold may correspond to, for example, a transition temperature of elastin. The location of the collagen and/or elastin transition temperature in the gripping arm displacement versus time curve 130258 may be referred to as the "knee" in curve 130258. Thus, in this aspect, the control algorithm may be configured to alter the operation of the ultrasonic instrument based on whether the second clamp arm rate of change of displacement threshold (or elastin "knee") has been reached, and alter the operation of the ultrasonic instrument accordingly. For example, when the elastin knee in curve 130258 is detected, the control algorithm may switch the surgical instrument from load control (of clamp arm 1140) to temperature control.

For collagen where the elastin has different melting temperatures, the collagen transition should be constant for a given heat flux between 45 ℃ and 50 ℃. Furthermore, as collagen absorbs heat, the temperature strain flattens. In some aspects, the control algorithm may be configured to sample the position of the clamp arm and/or clamp arm displacement member at a higher rate near a particular temperature or within a temperature range (e.g., an expected temperature range for collagen and/or elastin transitions) in order to accurately determine when a monitored event occurs.

In the aspect depicted in FIGS. 64A and 64B, when at time t_mThe control algorithm is used to change the surgical instrument from load control to temperature control when a collagen transition point is detected. As shown in projected curve 130260, the clamp arm displacement will increase geometrically without changing the surgical instrument to temperature control. In one aspect, after the threshold θ is reached, as shown by the flat portion of the curve 130258, the control algorithm operating in the temperature control mode reduces the amplitude of the ultrasonic transducer drive signal to vary the heat flux generated by the ultrasonic blade 1128. In some aspects, the control algorithm may be configured to increase the amplitude of the ultrasound transducer drive signal after a certain period of time, for example, to measure the rate of temperature increase, to determine when the elastin transition temperature is reached. Thus, as the clamp arm closing rate approaches the next knee (i.e., the elastin knee), the clamp arm closing rate decreases. Load control of the clamp arm 1140 may be beneficial because it may provide optimal sealing of the container in some cases.

Fig. 65 is a logic flow diagram of a process 130300 depicting a control program or logic configuration to detect a collagen transition point to control a closing rate of a clamp arm or an amplitude of an ultrasound transducer in accordance with at least one aspect of the present disclosure. The process 130300 may be performed by a control circuit or processor located in the surgical instrument or generator. Thus, the control circuitry performing process 130300 measures 130302 the position of the clamp arm actuation member and its rate of change while keeping the load on the clamp arm constant. As previously described, in one aspect, the load on the clamp arm is maintained within the engagement pressure set within the appropriate range (130-. Once the jaws are subjected to a particular clamp arm load (e.g., 4.5 pounds) or the clamp arm load is within a particular range (e.g., 3.5-5 pounds), the control circuit sets 130304 the clamp arm displacement rate of change and monitors the position of the clamp arm actuation member over a period of time to maintain the clamp arm displacement rate of change within a predetermined negative limit (corresponding to tissue below the collagen transition temperature). Accordingly, control determines 130306 whether the rate of change of gripper arm displacement exceeds a set threshold, or in other words, whether the tissue has reached a transition temperature. If the transition temperature has been reached, the process 130300 follows the YES branch, and the control circuit switches 130308 the surgical instrument to temperature control (e.g., controls the ultrasonic transducer to lower or maintain the temperature of the ultrasonic blade). In one aspect, the control circuit continues to monitor the collagen transition temperature. Alternatively, in the aspect depicted in fig. 65, if the transition temperature has not been reached, the process 130300 follows the "no" branch and the control circuit maintains 130310 load control of the clamp arm 1140 and monitors the clamp arm displacement rate of change to determine when the next transition point of the grasped tissue (e.g., elastin transition point) occurs. The control circuit may do so, for example, to prevent the temperature of the tissue from increasing beyond the elastin transition temperature.

It will be appreciated that for a given heat flux (45 ℃ -50 ℃), the collagen turnover should be constant. It should also be appreciated that in some cases, load control of the clamp arm 1140 may provide an optimal seal for a particular type of tissue (e.g., a blood vessel). During the time period when collagen conversion occurs, the temperature strain of the tissue flattens while the collagen absorbs heat. The control circuit may be configured to modulate the rate at which data points are collected at or near a particular temperature (e.g., a transition temperature). In addition, the control circuit may tune the amplitude of the ultrasonic transducer drive signal to control the heat flux generated by the ultrasonic blade 1128 at different points during the surgical procedure. For example, the control circuit may reduce the ultrasound transducer amplitude during collagen conversion. As another example, the control circuit may increase the ultrasound transducer amplitude to measure the rate of temperature increase as the elastin knee occurs. It will be appreciated that the rate of temperature change will decrease as the elastin knee is approached.

In another aspect, the control algorithm can be configured to detect a collagen transition temperature to identify a collagen/elastin percentage of the grasped tissue. As described above, the control algorithm may then control various operating parameters of the surgical instrument according to the identified composition of the grasped tissue.

Fig. 66 is a graphical representation 130350 of identifying a collagen transition temperature point to identify a collagen/elastin ratio, according to at least one aspect of the present disclosure. The vertical axis 130352 represents ultrasound transducer impedance, while the horizontal axis 130632 represents tissue temperature. The point at which the rate of change of the ultrasound transducer impedance shifts corresponds to the collagen/tissue composition of the tissue in an empirically determined manner. For example, if the rate of change of the ultrasound transducer impedance is shifted at the first temperature 130362, the tissue composition is 100% collagen. Accordingly, if the rate of change of the ultrasound transducer impedance is offset at the second temperature 130364, the tissue composition is 100% elastin. If the rate of change of the ultrasound transducer impedance is offset between the first temperature 130362 and the second temperature 130364, the tissue is composed of a mixture of collagen and elastin.

The collagen transition temperature may be used to directly identify the collagen/elastin percentage in the tissue, and the control algorithm may be configured to adjust the operation of the ultrasound device accordingly. As shown in fig. 66, curve 130356 represents an empirical relationship between ultrasound transducer impedance and tissue temperature. As shown by curve 130356, the impedance (Z) of the ultrasound transducer increases linearly at a first rate of change (slope) as a function of temperature (T) at the tissue contact region. At the collagen transition temperature shown at point 130358 in the curve, the rate of change of impedance (Z) as a function of temperature (T) decreases to a second rate of change. At point 130358 where the slope of curve 130356 changes, the collagen to elastin ratio may correspond to an empirically determined temperature 130360 (e.g., 85%). In one aspect, the control circuit or processor executing the aforementioned algorithm may be configured to determine the temperature at which the ultrasound transducer impedance rate changes, and then retrieve the corresponding tissue composition (e.g., collagen percentage, elastin percentage, or collagen/elastin ratio) from a memory (e.g., a look-up table).

Fig. 67 is a logic flow diagram of a process 130450 for identifying the composition of tissue from changes in ultrasound transducer impedance in accordance with at least one aspect of the present disclosure. The process 130450 can be performed by control circuitry of a processor located, for example, in a surgical instrument or generator. Thus, the control circuit monitors 130452 the impedance (Z) of the ultrasonic transducer as a function of temperature (T). As previously described, the temperature (T) at the interface of the tissue and the ultrasonic blade may be inferred by the algorithms described herein. The control circuit determines 130454 a rate of change of the impedance of the ultrasonic transducer, Δ Z/Δ T. As the temperature at the ultrasonic blade/tissue interface increases, the impedance (Z) increases linearly at a first rate, as shown in fig. 66. Thus, the control circuit determines 130456 whether the slope Δ Z/Δ T has changed (e.g., has decreased). If the slope Δ Z/Δ T has not changed, the process 130450 proceeds along the "NO" branch and continues with determining 130454 the slope Δ Z/Δ T. If the slope Δ Z/Δ T has changed, the control circuit determines 130458 that the collagen transition temperature has been reached.

The ratio of elastin to collagen may be determined by monitoring the collagen transition point of the tissue and comparing the detected collagen transition point to a look-up table. The look-up table may be stored in a memory (e.g., memory 3326 of fig. 31) and contain the ratio of elastin to collagen and an empirically determined corresponding collagen transition point for a particular ratio.

Adjusting clamping arm force based on tissue location

In various aspects, the control algorithm can be configured to determine the position of tissue within or relative to the end effector and adjust the clamp arm force accordingly. In one aspect, tissue can be identified or parameterized by measuring the compressive force load on the clamp arms and the location of the tissue within the jaws (e.g., the location where the tissue is located along the length of the ultrasonic blade). In one aspect, the time to reach an initially measured load on the clamp arm is measured, and then the compressibility on the tissue is measured to determine the relationship between the compressibility of the tissue and the amount of tissue located over the length of the jaw. In performing load control, the rate of change of position of the clamp arm actuator is monitored as a way of determining tissue compressibility and thus tissue type/disease state.

Fig. 68 is a graphical representation 130500 of the distribution of the compressive load on the ultrasonic blade 130404 in accordance with at least one aspect of the present disclosure. Vertical axis 130502 represents force applied to tissue by clamp arm 1140, while horizontal axis 130504 represents position. The ultrasonic blade 130404 is sized such that there are periodic nodes and antinodes along the length of the blade. The position of the node/antinode is determined by the wavelength of the ultrasonic displacement induced in the ultrasonic blade 130404 by the ultrasonic transducer. The ultrasonic transducer is driven by an electrical signal of suitable amplitude and frequency. As is known in the art, a node is the point of minimum or zero displacement of the ultrasonic blade 130404 and an antinode is the point of maximum displacement of the ultrasonic blade 130404.

In the graphical representation 130500, the ultrasonic blade 130404 is represented such that the nodes and antinodes are aligned with their corresponding positions along a horizontal axis 130504. The graphical representation 130500 includes a first curve 130506 and a second curve 130508. As represented by either of the

curves

130506, 130508, the compressive force applied to the ultrasonic blade 130404 decreases exponentially from the proximal end of the ultrasonic blade 130404 to the distal end of the ultrasonic blade 130404. Thus, tissue 130410 located at the distal end of the ultrasonic blade 130404 experiences a much lower compressive force than tissue 130410 located closer to the proximal end of the ultrasonic blade 130404. A first curve 130506 may represent a default closure of the clamp arm 1140, where the total force applied to the distal tissue 130410 is F₁. Generally, the amount of force applied to the tissue 130410 by the clamp arms 1140 cannot be increased widely without consideration because then too much force would be applied to the tissue 130410 located proximally along the ultrasonic blade 130404. However, by monitoring the position of the tissue 130410 along the ultrasonic blade 130404 (e.g., as discussed above under the heading "determine tissue position by impedance change" and below under the heading "determine tissue position by electrode continuity"), as in the case shown in fig. 68, the control algorithm can amplify the force applied to the tissue 130410 by the clamp arm 1140 with the tissue 130410 located only at the distal end of the ultrasonic blade 130404. For example, the second curve 130508 may represent a clamp arm1140, wherein the control algorithm determines that the tissue 130410 is located only at the distal end of the ultrasonic blade 130404 and correspondingly increases the force applied to the distal tissue 130410 by the clamp arm 1140 to F₂(F₂>F₁)。

FIG. 69 is a graphical representation 130520 of pressure applied to tissue versus time according to one aspect of the present disclosure. Vertical axis 130522 represents pressure applied to tissue (e.g., in N/mm)²In units) and the horizontal axis 130524 represents time. A first curve 130526 represents a normal or default compressive force applied to the distal tissue 130410 without magnification. During the default closure of the clamp arms 1140, the compressive force applied to the tissue 130410 is maintained at a constant value after an initial ramp-up period. A second curve 130528 represents an amplified compressive force applied to the distal tissue 130410 to compensate for the presence of only the distal tissue 130410. In the modified closure of the gripper arms 1140, the pressure is increased 130530 compared to the default closure until the final amplified compressive force returns 130532 to the normal compressive level to prevent burning/fusing through the gripper arm 1140 pads.

Tissue location determination by electrode continuity

In various aspects, the control algorithm can be configured to determine the position of tissue within or relative to the end effector from electrical continuity across an array of bipolar (i.e., positive and negative) electrodes positioned along one or more jaws of the end effector. The position of the tissue detectable by the bipolar electrode array may correspond to a particular position of the tissue relative to the one or more jaws and/or a percentage of the one or more jaws covered by the tissue. In one aspect, the positive and negative electrodes are separated by a physical gap such that electrical continuity is established between the electrodes when tissue bridges the positive and negative electrodes. The positive and negative electrodes are configured in a matrix or array such that the processor or control circuitry may be configured to detect the location of tissue between the positive and negative electrodes by monitoring or scanning the electrode array. In one aspect, the bipolar electrode array can be positioned along one jaw of the end effector. Accordingly, a control circuit or processor coupled to the bipolar electrode array may be configured to detect electrical continuity between adjacent electrodes to detect the presence of tissue thereagainst. In another aspect, the bipolar electrode array can be positioned along opposing jaws of the end effector. Accordingly, a control circuit or processor coupled to the bipolar electrode array may be configured to detect electrical continuity between the opposing jaws to detect the presence of tissue therebetween.

Determining which surface area of one or more jaws is covered with tissue allows the control algorithm to determine an appropriate engagement pressure for the amount of tissue grasped by the end effector and then calculate the corresponding clamp arm load. The clamp arm load may be expressed in terms of applied pressure (e.g., 130 psi) or applied force (e.g., 3.5-5 pounds or nominally 4.5 pounds). In some aspects, the bipolar electrode array may deliver power from a monopolar or bipolar RF electrosurgical generator to the positive and negative electrodes. The generator power output may be a function of a number of constants, variables, or minimum values (e.g., 45W, 35W, or 5W), various variables associated with the surgical instrument and/or the generator (e.g., the amplitude of the ultrasonic blade or the clamp arm force), or specified by an algorithm for controlling the generator according to its power profile (e.g., during ramping of the generator).

FIG. 70 illustrates an end effector 130400 comprising a single jaw electrode array for detecting tissue location according to at least one aspect of the present disclosure. In the depicted aspect, the end effector 130400 includes a first jaw 130430 having an electrode array 130431 disposed thereon and a second jaw 130432. Electrode array 130431 includes electrodes 130429 coupled to an energy source, such as an RF generator. The end effector 130400 can comprise an end effector for an ultrasonic surgical instrument in which the second jaw 130432 is, for example, an ultrasonic blade 1128 (fig. 23), an end effector for an electrosurgical instrument, an end effector for a surgical stapling and severing instrument, and the like. The second jaw 130432 may include, for example, an ultrasonic blade 1128 (fig. 23) or a mating jaw of an electrosurgical or surgical stapling and cutting instrument. In the depicted aspect, electrode array 130431 includes 12 electrodes 130429 arranged in a generally herringbone pattern; however, the number, shape, and arrangement of electrodes 130429 in electrode array 130431 are for illustration purposes only. Accordingly, electrode array 130431 may include various numbers, shapes, and/or arrangements of electrodes 130429. For example, the number of electrodes 130429 may be adjusted according to the desired resolution for detecting tissue location.

In one aspect, electrode array 130431 may include electrodes 130429 separated by a physical gap and alternating in polarity or coupled to opposite terminals of an energy source (i.e., a supply terminal and a return terminal). For example, in the depicted aspect, even-numbered electrodes 130429 can be of a first polarity (e.g., positive polarity or a supply terminal coupled to a power source), while odd-numbered electrodes 130429 can be of a second polarity (e.g., negative polarity or a return terminal coupled to a power source). Thus, when tissue 130410 contacts an adjacent electrode 130429, tissue 130410 physically and electrically bridges bipolar electrode 130429 and allows current to flow between them. The flow of current between bipolar electrodes 130429 may be detected by a control algorithm executed by a control circuit or processor coupled to electrode array 130431, allowing the control circuit or processor to detect the presence of tissue 130410.

The detection of tissue by electrode array 130431 may be represented graphically by an activation matrix. For example, fig. 71 shows an activation matrix 130550 indicating the location of tissue 130410 according to electrode array 130431 depicted in fig. 70. Both the vertical axis 130554 and the horizontal axis 130555 represent electrodes 130429 of the electrode array 130431, with numbers along the

axes

130554, 130555 representing correspondingly numbered electrodes 130429. Activation region 130552 indicates where continuity exists between corresponding electrodes 130429, i.e., where tissue 130410 is present. In fig. 70, tissue 130410 is present on first, second, and third electrodes 130429, and as described above, in some aspects, the polarity of electrode 130429 can be alternated. Thus, there is electrical continuity between the first and second electrodes 130429 and the second and third electrodes 130429. It should be noted that in this described aspect, there will be no continuity between the first and third electrodes 130429, as they will have the same polarity. The continuity between these electrodes 130429 is graphically represented by activation regions 130552 in activation matrix 130550. It should also be noted that region 130553, bounded by activation region 130552, is not shown as being activated because electrode 130429 cannot be contiguous with itself in this described aspect. A control algorithm executed by a control circuit or processor coupled to electrode array 130431 can be configured to infer the position of tissue 130410 within end effector 130400 (because the position of electrode 130429 is known), the proportion of

jaws

130430, 130432 of end effector 130400 that are covered by tissue 130410, and so forth, because the tissue position corresponds to the particular electrode 130429 for which electrical continuity has been established.

Fig. 72 illustrates an end effector 130400 comprising a dual jaw electrode array for detecting tissue location in accordance with at least one aspect of the present disclosure. In the depicted aspect, the end effector 130400 includes a first jaw 130430 having a first electrode array 130431 disposed thereon and a second jaw 130432 having a second electrode array 130433 disposed thereon.

Electrode arrays

130431, 130433 each include electrodes 130429 coupled to an energy source, such as an RF generator. The end effector 130400 can comprise an end effector for an electrosurgical instrument, an end effector for a surgical stapling and severing instrument, and the like. As described above, the number, shape, and/or arrangement of the electrodes 130429 may vary in various respects. For example, in fig. 75, the

electrode arrays

130431, 130433 are arranged in an overlapping tiled or rectangular pattern.

In one aspect, opposing electrodes 130429 of

electrode arrays

130431, 130433 are separated by a physical gap, and each

electrode array

130431, 130433 has opposite polarity or is coupled to opposing terminals (i.e., an electrical supply terminal and a return terminal). For example, in the depicted aspect, first electrode array 130431 can be of a first polarity (e.g., positive polarity or a power supply terminal coupled to a power source) while second electrode array 130433 can be of a second polarity (e.g., negative polarity or a return terminal coupled to a power source). Thus, when tissue 130410 contacts electrodes 130429 of each of opposing

electrode arrays

130431, 130433, tissue 130410 physically and electrically bridges bipolar electrode 130429 and allows current to flow therebetween. The flow of current between bipolar electrodes 130429 may be detected by a control algorithm executed by a control circuit or processor coupled to

electrode arrays

130431, 130433, allowing the control circuit or processor to detect the presence of tissue 130410.

As described above, the activation matrix may graphically represent the presence of tissue. For example, fig. 73 shows an activation matrix 130556 indicating the location of tissue 130410 as depicted in fig. 74. A vertical axis 130557 represents electrodes 130429 of first electrode array 130431, while a horizontal axis 130558 represents electrodes 130429 of second electrode array 130433, wherein numbers along

axes

130557, 130558 represent correspondingly numbered electrodes 130429 of each

electrode array

130431, 130433. Activation region 130552 indicates where continuity exists between corresponding electrodes 130429, i.e., where tissue 130410 is present. In fig. 74, tissue 130410 is positioned against first, second, and

third electrodes

130431a, 130431b, and 130431c of first electrode array 130431 and first, second, and

third electrodes

130433a, 130433b, and 130433c of second electrode array 130433. Thus, when current may flow between the sets of electrodes of the opposing

electrode arrays

130431, 130433, there is electrical continuity between each of the opposing sets of electrodes. The electrodes between which there is continuity due to the location of the grasped tissue 130410 are represented graphically by activation region 130552 in activation matrix 130556 of fig. 73. Furthermore, because tissue 130410 is not positioned against fourth electrode 130431d, fifth electrode 130431e, and sixth electrode 130431f of first electrode array 130431 and fourth electrode 130433d, fifth electrode 130433e, and sixth electrode 130433f of second electrode array 130433, there is no electrical continuity between these electrodes. A control algorithm executed by a control circuit or processor coupled to

electrode arrays

130431, 130433 can be configured to infer the position of tissue 130410 within end effector 130400 (as the position of electrodes 130429 is known, as shown in fig. 74), the proportion of

jaws

130430, 130432 of end effector 130400 that are covered by tissue 130410, and so forth, as the tissue position corresponds to a particular electrode 130429 for which electrical continuity has been established. In the depicted example, the active electrodes of first electrode array 130431 and second electrode array 130433 are overlapping electrodes 130429 and there is tissue 130410 between them.

In another aspect, the end effector can be configured to transmit multiple signals or acoustic pulses at varying frequencies, and the electrode array can be coupled to circuitry that includes corresponding band pass filters that can each detect signals of one or more particular frequency signals by frequency translation. Various portions of the electrode array circuit may include band pass filters tuned to different frequencies. Thus, the location of tissue grasped by the end effector corresponds to a particular detected signal. The signal may be transmitted, for example, at a non-therapeutic frequency (e.g., at a frequency higher than the therapeutic frequency range of the RF electrosurgical instrument). The electrode array circuit may comprise, for example, a flexible circuit.

Fig. 75 illustrates an end effector 130400 comprising a first jaw 130430 having a first segmented electrode array 130431 and a second jaw 130432 having a second segmented electrode array 130433 in accordance with at least one aspect of the present disclosure. Further, fig. 76 shows tissue 130410 covered by second jaw 130432 grasped by end effector 130400. In one aspect, first electrode array 130431 is configured to transmit signals at various frequencies (e.g., non-therapeutic frequencies), and second electrode array 130433 is configured to receive signals through tissue 130410 grasped by end effector 130400 (i.e., when tissue 130410 contacts both electrode arrays 130431, 130433). As shown in fig. 77, second electrode array 130433 can include segmented electrode array circuit 130600, where each circuit segment includes a band pass filter 130601 coupled to each electrode 130602 of second electrode array 130433. Each band pass filter 130601 may include one or more capacitors 130604 and one or more inductors 130606, where the number, arrangement, and values of capacitors 130604 and inductors 130606 may be selected to tune each band pass filter 130601 to a particular frequency or frequency band. Since tissue 130410 serves as a signal conducting medium between

electrode arrays

130431, 130433, and different portions of second electrode array 130433 are tuned to detect signals of varying frequencies (via differently tuned band pass filters 130601), a control algorithm executed by a control circuit or processor coupled to

electrode arrays

130431, 130433 can be configured to infer the location of tissue 130410 from the signals detected thereby. In the depicted aspect, the

electrode arrays

130431, 130433 include six electrode segments 130602 arranged in a generally tiled pattern and having semi-circular end segments; however, the number, shape, and arrangement of electrodes 130602 in

electrode arrays

130431, 130433 are for illustration purposes only. Accordingly,

electrode arrays

130431, 130433 may include various numbers, shapes, and/or arrangements of electrodes 130602. For example, the number of electrodes 130602 may be adjusted according to the desired resolution for detecting tissue location.

Fig. 78 is a graphical representation 130650 of a frequency response corresponding to the tissue 130410 grasped in fig. 76, in accordance with at least one aspect of the present disclosure. The vertical axis 130652 represents amplitude, while the horizontal axis 130654 represents RF frequency. In one aspect, second electrode array 130433 includes tuning to a first center frequency f_S1First electrode circuit section 130602a of a frequency band defined by (e.g., 5MHz), tuned to a frequency band defined by second center frequency f_S2Second electrode circuit section 130602b of a frequency band defined by (e.g., 10MHz), tuned to a frequency band defined by third center frequency f_S3(e.g., 15MHz) of a frequency band defined by third electrode circuit section 130602c and tuned to a fourth center frequency f_S4(e.g., 20MHz) of the frequency band defined by the fourth electrode circuit section 130602 d. As depicted in FIG. 78, the sensing band is defined above by f_T1(e.g., 300kHz) to f_T2A treatment frequency range 130656 defined (e.g., 500kHz) and/or a sensing frequency range 130658 of a preferred treatment frequency (e.g., 350 kHz). In one aspect, the center sensing frequency f in the sensing frequency range 130658_S1、f_S2、f_S3、f_S4Each separated by a defined frequency value (e.g., 5 MHz). Further, although the sensing frequency range 130658 is shown as including four sensing frequency bands, this is for illustration purposes only. In the depicted example, grasped tissue 130410 is contacting second electrode circuitry section 130602b, third electrode circuitry section 130602c, and fourth electrode circuitry section 130602 d. Thus, the detected frequency response includes peaks 130655b, 130655 at each corresponding frequencyc. 130655 d. Thus, the control algorithm can infer the position of tissue 130410 from the detected frequency response, i.e., the control circuitry can determine that tissue 130410 is positioned within end effector 130400 such that it is in contact with second electrode circuit section 130602b, third electrode circuit section 130602c, and fourth electrode circuit section 130602d, but not with other circuit sections. Thus, the control algorithm can infer the position of tissue 130410 relative to

jaws

130430, 130432 of end effector 130400 and/or the percentage of

jaws

130430, 130432 that are in contact with tissue 130410.

Adaptive ultrasonic blade temperature monitoring

In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust various operating parameters of the ultrasound system based on the temperature of the ultrasonic blade. The operating parameters controlled or adjusted by the adaptive ultrasonic blade control algorithm may include, for example, the amplitude of the ultrasonic blade, the control signal driving the ultrasonic transducer, the pressure applied by the clamp arm, and the like. The adaptive ultrasonic blade control algorithm may be executed by a control circuit or processor located in the generator or surgical instrument.

In one example, described in more detail below, the adaptive ultrasonic blade control algorithm dynamically monitors the temperature of the ultrasonic blade and adjusts the amplitude of the ultrasonic blade and/or the signal provided to the ultrasonic transducer accordingly. In another example, described in more detail below, the adaptive ultrasonic blade control algorithm dynamically monitors the temperature of the ultrasonic blade and adjusts the clamp arm pressure accordingly. The adaptive ultrasonic blade control algorithm may measure the temperature of the ultrasonic blade via various techniques, such as by analyzing the frequency spectrum of the ultrasonic transducer, as described above under the heading "temperature inference". Other techniques for determining the temperature of the ultrasonic blade employ non-contact imaging. These and other techniques are described in detail herein, and additional details may be found in U.S. provisional patent application No. 62/692,768, entitled "smart energy device (SMART ENERGY DEVICES)".

Adjusting ultrasound system parameters based on temperature

In one aspect, the adaptive ultrasonic blade control algorithm may be configured to adjust an operating parameter of the ultrasound system based on the temperature of the ultrasonic blade. As discussed above under the heading "temperature inference," the natural frequency of the ultrasonic blade/transducer moves with temperature, and thus the temperature of the ultrasonic blade can be inferred from the phase angle between the voltage signal and the current signal applied to drive the ultrasonic transducer. Further, the ultrasonic blade temperature corresponds to the tissue temperature. In some aspects, the adaptive ultrasonic blade control algorithm may be configured to detect an ultrasonic blade temperature and modulate an operating parameter of the surgical instrument as a function of the temperature. The operating parameters may include, for example, the frequency of the ultrasonic transducer drive signal, the amplitude of the ultrasonic blade (which may, for example, correspond to the magnitude or amplitude of the current provided to the ultrasonic transducer), the pressure applied by the clamp arm, and so forth. The adaptive ultrasonic blade control algorithm may be executed by a control circuit or processor located in the generator or surgical instrument.

Thus, in one aspect, the adaptive ultrasonic blade control algorithm detects the resonant frequency of the ultrasonic blade (as described previously under the heading "temperature inference") and then monitors the resonant frequency over time to detect modal shifts in the resonant frequency waveform. The shift in the resonant waveform may be correlated to the occurrence of a systematic change, such as an increase in the temperature of the ultrasonic blade. In some aspects, the adaptive ultrasonic blade control algorithm may be configured to adjust the amplitude of the ultrasonic drive signal, and thus the amplitude of the ultrasonic blade displacement, to measure the temperature of the tissue. In other aspects, the adaptive ultrasonic blade control algorithm may be configured to control the amplitude of the ultrasonic drive signal, and thus the amplitude of the ultrasonic blade displacement, as a function of the temperature of the ultrasonic blade and/or tissue to maintain the temperature of the ultrasonic blade and/or tissue at a predetermined temperature or within a predetermined threshold (e.g., to allow the ultrasonic blade to cool if the temperature of the ultrasonic blade becomes too high). In other aspects, the adaptive ultrasonic blade control algorithm may be configured to modulate the RF power and waveform of the electrosurgical instrument to minimize temperature overshoot or to vary the ultrasonic blade heat flux, for example, as a function of tissue impedance, tissue temperature, and/or ultrasonic blade temperature. For example, further details regarding these and other functions have been described with reference to FIGS. 95-100.

FIG. 79 is a graph of frequency as a drive and ultrasound according to at least one aspect of the present disclosureA graphical representation 130700 of the frequency of the ultrasonic transducer system as a function of blade temperature drift. The horizontal axis 130704 represents the drive frequency (e.g., in Hz) applied to the ultrasound system (e.g., ultrasound transducer and/or ultrasound blade), and the vertical axis 130702 represents the resulting impedance phase angle (e.g., in rad). A first curve 130706 represents a characteristic resonant waveform of the ultrasound system at normal or ambient temperature. As can be seen in the first curve 130706, the ultrasound system is operating at an excitation frequency f_eThe driving is in phase (because the impedance phase angle is 0rad or close to 0 rad). Thus, f_eRepresenting the resonant frequency of the ultrasound system at ambient temperature. A second curve 130708 represents a characteristic waveform of the ultrasound system when the temperature of the ultrasound system has been raised. As shown in fig. 79, as the temperature of the ultrasound system increases, the characteristic waveforms of the ultrasonic blade and the ultrasonic transducer (depicted by the first curve 130706) shift to the left, for example, to a lower frequency range. Due to the frequency waveform shift of the ultrasound system, the ultrasound system is at the excitation frequency f_eThe drive is no longer in phase. Conversely, the resonant frequency has been shifted down to f'_e. Thus, a control circuit coupled to the ultrasound system may detect or infer a change in temperature of the ultrasound system by detecting a change in the resonant frequency of the ultrasound system and/or detecting when the ultrasound system is out of phase when driven at a previously determined resonant frequency.

Thus, in some aspects, control circuitry coupled to the ultrasound system may be configured to control the drive signals applied to the ultrasound system by the generator in accordance with the inferred temperature of the ultrasound system to keep the ultrasound system in phase. Keeping the ultrasound system in phase may be used, for example, to control the temperature of the ultrasound system. As described above, as the temperature of the ultrasonic blade and/or ultrasonic transducer increases, the resonant frequency at which the voltage and current signals are in phase is shifted from f at normal temperature_e(e.g., 55.5kHz) to f'_e. Thus, as the temperature of the ultrasound system increases, the control circuitry may control the frequency at which the generator will drive the ultrasound system from f_eConversion to f'_eTo keep the ultrasound system in phase with the generator drive signal. Additional description for adaptive ultrasonic blade control algorithmSee the description above in connection with FIGS. 43A-54.

Fig. 80 is a graphical representation 130750 of the temperature of an ultrasound transducer as a function of time in accordance with at least one aspect of the present disclosure. The vertical axis 130752 represents the temperature of the ultrasound transducer, while the horizontal axis 130754 represents time. In one aspect, when the ultrasound transducer temperature (represented by curve 130756) reaches or exceeds a temperature threshold T₁In time, the adaptive ultrasonic blade control algorithm controls the ultrasonic transducer to maintain the temperature of the ultrasonic transducer at the threshold temperature T₁At or below the threshold temperature. The adaptive ultrasonic blade control algorithm may control the temperature of the ultrasonic transducer, for example, by modulating the power and/or drive signal applied to the ultrasonic transducer. Other descriptions of algorithms and techniques for controlling the TEMPERATURE of the ultrasonic blade/transducer may be found in the title "feedback CONTROL" and "ultrasonic sealing algorithm with TEMPERATURE CONTROL" and U.S. provisional patent application No. 62/640,417 filed on 3/8.2018 (entitled "TEMPERATURE CONTROL in an ultrasonic device and its CONTROL SYSTEM (temparature CONTROL in ultrasonic SYSTEM DEVICE AND CONTROL SYSTEM) the disclosure of which is hereby incorporated by reference herein).

FIG. 81 is a graphical representation of modal shift of resonant frequency based on temperature of an ultrasonic blade moving resonant frequency as a function of temperature of the ultrasonic blade in accordance with at least one aspect of the present disclosure. In the first curve 130800, the vertical axis 130802 represents the change in resonant frequency (Δ f), while the horizontal axis 130804 represents the ultrasonic transducer drive frequency of the generator. In the second, third, and

fourth curves

130810, 130820, 130830, the

vertical axis

130812, 130822, 130832 represents frequency (f), current (I), and temperature (T), respectively, while the

horizontal axis

130814, 130824, 130834 represents time (T). A first curve 130810 represents the frequency shift of the ultrasound system due to temperature changes. A second curve 130820 represents the current or amplitude adjustment in the ultrasonic transducer in order to maintain a stable frequency and temperature. A third curve 130830 represents the temperature change of the tissue and/or the ultrasound system. Together, the set of

curves

130800, 130810, 130820, 130830 demonstrate the functionality of a control algorithm configured to control the temperature of the ultrasound system.

The control algorithm may be configured to approach the temperature threshold T at the temperature of the ultrasound system₁The ultrasound system (e.g., ultrasound transducer and/or ultrasound blade) is controlled time-wise. In one aspect, the control algorithm may be configured to determine whether the resonant frequency of the ultrasound system has dropped by a threshold Δ f_RTo determine that the temperature threshold T is approaching or has been reached₁. As shown by the first curve 130800, corresponding to the threshold temperature T₁Frequency threshold change Δ f of_RWhich may in turn be the drive frequency f of the ultrasound system_DIs shown by curve 130806. As shown by the second curve 130810 and the fourth curve 130830, as the temperature of the tissue and/or the ultrasonic blade increases (represented by temperature curve 130836), the resonant frequency correspondingly decreases (represented by frequency curve 130816). When the temperature curve 130836 is at time t₁Is close to the temperature threshold T₁(e.g., 130 deg.C.) the resonant frequency has been shifted from f₁Down to f₂To bring the resonant frequency to the frequency threshold change Δ f of the control algorithm_RThereby enabling the control algorithm to function to stabilize the ultrasound system temperature. Therefore, by monitoring the change in the resonant frequency of the ultrasound system, the adaptive ultrasonic blade control algorithm can monitor the temperature of the ultrasound system. Further, the adaptive ultrasonic blade control algorithm may be configured to adjust (e.g., decrease) the current applied to the ultrasonic transducer or otherwise adjust the amplitude of the ultrasonic blade (represented by current curve 130826) to reach or exceed the threshold T at the temperature₁The tissue and/or ultrasonic blade temperature and/or resonant frequency is stabilized.

In another aspect, the adaptive ultrasonic blade control algorithm may be configured to meet or exceed a threshold T at temperature₁The pressure applied to the tissue by the clamp arms is adjusted (e.g., reduced). In various other aspects, the adaptive ultrasonic blade control algorithm may be configured to adjust various other operating parameters associated with the ultrasound system as a function of temperature. In another aspect, the adaptive ultrasonic blade control algorithm may be configured to monitor a plurality of temperature thresholds. For example, the second temperature threshold T₂May represent, for example, the melting temperature or the failure temperature of the gripper arms. Thus, the adaptive ultrasonic blade control algorithm may be configured to operate in accordance with the already-existing adaptive ultrasonic blade control algorithmThe same or different actions are taken with respect to a particular temperature threshold being reached or exceeded.

In various aspects, non-contact imaging may be employed to determine the temperature of the ultrasonic blade in addition to or in lieu of the foregoing techniques. For example, short wave thermal imaging methods may be employed to measure blade temperature by imaging the blade from a stationary surrounding ground via a CMOS imaging sensor. Thermal imaging non-contact monitoring of the temperature of the ultrasonic waveguide or ultrasonic blade may be used to control tissue temperature. In other aspects, non-contact imaging may be employed to determine the topography and finish of the ultrasonic blade to improve the temperature of the tissue and/or ultrasonic blade by near IR detection techniques.

Determining jaw status

The challenge of ultrasonic energy delivery is that applying ultrasonic sound on the wrong material or the wrong tissue can cause device failure, such as clamp arm pad burn-through or ultrasonic blade fracture. It is also desirable to detect what is in and the state of the jaws of an end effector of an ultrasonic device without adding additional sensors in the jaws. Positioning the sensor in the jaws of an ultrasonic end effector has challenges in terms of reliability, cost, and complexity.

In accordance with at least one aspect of the present disclosure, an ultrasonic spectral smart knife algorithm technique may be employed based on the impedance of an ultrasonic transducer configured to drive an ultrasonic transducer knife

To estimate the status of the jaws (burning through of the clamping arm pads, staples, breaking knives, bone in the jaws, tissue in the jaws, back cut when the jaws are closed, etc.). Plotting impedance Z_g(t), magnitude | Z | and phase

As a function of the 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. A sinusoidal stress is applied to the material and the strain in the material is measured so that the complex modulus of the material can be determined. Spectroscopy as applied to ultrasound devices involves exciting the tip of an ultrasonic blade by frequency scanning (complex signal or conventional frequency scanning) and measuring the complex impedance produced at each frequency. Complex impedance measurements of the ultrasound transducer over a range of frequencies are used in a classifier or model to infer characteristics of the ultrasound end effector. In one aspect, the present disclosure provides a technique for determining the state of an ultrasonic end effector (clamp arm, jaws) to drive automation in an ultrasonic device, such as disabling power to protect the device, performing adaptive algorithms, retrieving information, identifying tissue, and the like.

FIG. 82 is a graph 132030 of an ultrasound device having a plurality of different states and conditions of an end effector, where the impedance Z is_g(t), magnitude | Z | and phase

Plotted as a function of frequency f. Spectrogram 132030 is plotted in three-dimensional space, with frequency (Hz) plotted along the x-axis, phase (Rad) plotted along the y-axis, and magnitude (ohm) plotted along the z-axis.

Spectral analysis of different jaw engagements and device conditions over a range of frequencies for different conditions and conditions can produce different complex impedance signature patterns (fingerprints). When rendered, each state or condition has a different characteristic pattern in 3D space. These characteristic patterns can be used to estimate the condition and state of the end effector. Fig. 82 shows spectra of air 132032, clamp arm pad 132034, chamois 132036, nail 132038, and break knife 132040. Antelope skin 132036 can be used to characterize different types of tissues.

The spectral pattern 132030 may be evaluated by applying a low power electrical signal to the ultrasound transducer to produce a non-therapeutic excitation of the ultrasound blade. The low power electrical signal may be applied in the form of a sweep or complex Fourier series to measure impedance across the ultrasound transducer using FFT over a range of series (sweep) or parallel (complex signal) frequencies

New numberAccording to the classification method

For each feature pattern, the parameter lines may be fitted to the data used for training using a polynomial, fourier series, or any other form of parametric formula that is convenient. A new data point is then received and classified by using the euclidean vertical distance from the new data point to the trajectory that has been fitted to the feature pattern training data. The vertical distance of the new data point to each trajectory (each trajectory representing a different state or condition) is used to assign the point to a certain state or condition.

The probability distribution of the distance of each point in the training data to the fitted curve can be used to estimate the probability of a correctly classified new data point. This essentially constructs a two-dimensional probability distribution in a plane perpendicular to the fitted trajectory at each new data point of the fitted trajectory. The new data points may then be included in the training set based on their probability of correct classification to form an adaptive learning classifier that can easily detect high frequency changes in state, but can accommodate deviations in system performance that occur slowly, such as device dirtying or pad wear.

FIG. 83 is a graphical representation of a graph 132042 of a set of 3D training data sets (S) in which an ultrasound transducer impedance Z is_g(t), magnitude | Z | and phase

Plotted as a function of frequency f. The 3D training data set (S) curve 132042 is graphically depicted in three-dimensional space with phase (Rad) plotted along the x-axis, frequency (Hz) plotted along the y-axis, magnitude (ohm) plotted along the z-axis, and a parametric fourier series fitted to the 3D training data set (S). The method for data classification is based on a 3D training data set (S0 for generating graph 132042).

The parametric fourier series fitted to the 3D training data set (S) is given by:

for new points

From

To

The vertical distance of (a) is:

when:

then:

D＝D_⊥

the probability distribution of D can be used to estimate the data points belonging to group S

The probability of (c).

Control of

Based on the classification of the data measured before, during, or after activation of the ultrasound transducer/blade, a variety of automated tasks and safety measures may be implemented. Similarly, the state of the tissue located in the end effector and the temperature of the ultrasonic blade may also be inferred to some extent and used to better inform the user of the state of the ultrasonic device or protect critical structures, etc. TEMPERATURE CONTROL of an ULTRASONIC blade is described IN commonly owned U.S. provisional patent application No. 62/640,417 entitled TEMPERATURE CONTROL and CONTROL SYSTEM thereof IN an ULTRASONIC DEVICE (temparature CONTROL IN ULTRASONIC DEVICE) filed on 8/3.2018, which is incorporated herein by reference IN its entirety.

Similarly, power delivery may be reduced when the ultrasonic blade is most likely to contact the clamp arm pad (e.g., no tissue therebetween), or if the ultrasonic blade is likely to have broken or the ultrasonic blade is likely to contact metal (e.g., staples). Further, if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad, a reverse cut is not allowed.

Integrating other data to improve classification

The system can be used in conjunction with other information provided by sensors, users, patient indices, environmental factors, etc., by combining data from the process with the above data using probability functions and kalman filters. Given a large number of uncertain measurements of different confidence levels, the kalman filter determines the maximum likelihood of a state or condition occurring. Since the method allows assigning probabilities to newly classified data points, the information of the algorithm can be implemented with other measurements or estimates in the kalman filter.

Fig. 84 is a logic flow diagram 132044 depicting a control program or logic configuration for determining jaw condition based on a complex impedance signature pattern (fingerprint) in accordance with at least one aspect of the present disclosure. Prior to determining jaw conditions based on the complex impedance signature pattern (fingerprint), the database is populated with a reference complex impedance signature pattern or training data set (S) characterizing various jaw conditions, including but not limited to air 132032, clamp arm pad 132034, chamois 132036, staples 132038, break blade 132040, and a variety of tissue types and conditions as shown in fig. 82. Antelope skin (dry or wet, full-byte or terminal) can be used to characterize different types of tissues. Data points for generating a reference complex impedance signature pattern or training data set (S) are obtained as follows: the drive frequency is swept from below resonance to above resonance over a predetermined range of frequencies by applying sub-treatment drive signals to the ultrasound transducer, measuring the complex impedance at each frequency and recording data points. The data points are then fitted to a curve using a variety of numerical methods, including polynomial curve fitting, fourier series, and/or parametric equations. A parametric fourier series fit to a reference complex impedance signature pattern or training data set (S) is described herein.

Once the reference complex impedance signature pattern or training data set (S) is generated, the ultrasound instrument measures new data points, classifies the new points, and determines whether the new data points should be added to the reference complex impedance signature pattern or training data set (S).

Turning now to the logic flow diagram of FIG. 84, in one aspect, a processor or control circuit measures 132046 a complex impedance of an ultrasound transducer, where the complex impedance is defined as

A processor or control circuit receives 132048 the complex impedance measurement data points and compares 132050 the complex impedance measurement data points to data points in a reference complex impedance signature pattern. The processor or control circuit classifies 132052 the complex impedance measurement data points based on the results of the comparative analysis and assigns 132054 a state of the end effector based on the results of the comparative analysis.

In one aspect, a processor or control circuit receives a reference complex impedance signature pattern from a database or memory coupled to the processor. In one aspect, a processor or control circuit generates a reference complex impedance signature pattern as follows. A drive circuit coupled to the processor or control circuit applies a non-therapeutic drive signal to the ultrasound transducer, the non-therapeutic drive signal beginning at an initial frequency, ending at a final frequency, and at a plurality of frequencies therebetween. A processor or control circuit measures the impedance of the ultrasonic transducer at each frequency and stores data points corresponding to each impedance measurement. A processor or control circuit curve fits the plurality of data points to generate a three-dimensional curve representing a reference complex impedance signature, wherein magnitude | Z | and phase

Plotted as a function of frequency f. The curve fitting includes polynomial curve fitting, fourier series, and/or parametric equations.

In one aspect, a processor or control circuit receives a new impedance measurement data point and classifies the new impedance measurement data point using the euclidean vertical distance from the new impedance measurement data point to the trajectory that has been fitted to the reference complex impedance feature pattern. The processor or control circuit estimates the probability of correctly classifying the new impedance measurement data point. The processor or control circuit adds the new impedance measurement data points to the reference complex impedance signature pattern based on the estimated probability of correctly classifying the new impedance measurement data points. In one aspect, the processor or control circuit classifies data based on a training data set (S), wherein the training data set (S) includes a plurality of complex impedance measurement data, and a curve is fitted to the training data set (S) using a parametric fourier series, wherein S is defined herein, and wherein a probability distribution is used to estimate the probability of new impedance measurement data points belonging to group S.

Additional details regarding determining or estimating the state of a jaw or an overall surgical instrument may be found in U.S. provisional patent application No. 62/692,768, entitled "smart energy device (SMART ENERGY DEVICES)".

Situation awareness

Referring now to fig. 85, a timeline 5200 depicting situational awareness of a hub, such as the surgical hub 106 or 206 (fig. 1-11), for example, is shown. The time axis 5200 is illustrative of a surgical procedure and background information that the

surgical hub

106, 206 may derive from data received from the data source at each step in the surgical procedure. The time axis 5200 depicts typical steps that nurses, surgeons, and other medical personnel will take during a lung segment resection procedure, starting from the establishment of an operating room and ending with the transfer of the patient to a post-operative recovery room.

The situation aware

surgical hub

106, 206 receives data from data sources throughout the course of a surgical procedure, including data generated each time a medical professional utilizes a modular device paired with the

surgical hub

106, 206. The

surgical hub

106, 206 may receive this data from the paired modular devices and other data sources, and continually derive inferences about the ongoing procedure (i.e., background information) as new data is received, such as which step of the procedure is performed at any given time. The situational awareness system of the

surgical hub

106, 206 can, for example, record data related to the procedure used to generate the report, verify that the medical personnel are taking steps, provide data or prompts that may be related to particular procedure steps (e.g., via a display screen), adjust the modular device based on context (e.g., activate a monitor, adjust a field of view (FOV) of a medical imaging device, or change an energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such actions described above.

As a first step 5202 in the exemplary procedure, the hospital staff retrieves the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the

surgical hub

106, 206 determines that the procedure to be performed is a chest procedure.

In a second step 5204, the staff scans the incoming medical supply for the procedure. The

surgical hub

106, 206 cross-references the scanned supplies with a list of supplies used in various types of protocols and confirms that the supplied mix corresponds to a chest protocol. In addition, the

surgical hub

106, 206 is also able to determine that the procedure is not a wedge procedure (because the incoming supplies lack some of the supplies required for the chest wedge procedure, or otherwise do not correspond to the chest wedge procedure).

In a third step 5206, medical personnel scan the patient belt via a scanner communicatively coupled to the

surgical hub hubs

106, 206. The

surgical hub

106, 206 may then confirm the identity of the patient based on the scanned data.

Fourth, the medical staff opens the ancillary equipment 5208. The ancillary equipment utilized may vary depending on the type of surgical procedure and the technique to be used by the surgeon, but in this exemplary case they include smoke ejectors, insufflators, and medical imaging devices. When activated, the auxiliary device as a modular device may be automatically paired with a

surgical hub

106, 206 located in a specific vicinity of the modular device as part of its initialization process. The

surgical hub

106, 206 may then derive contextual information about the surgical procedure by detecting the type of modular device with which it is paired during the 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 the combination of data from the patient's EMR, the list of medical supplies used in the procedure, and the type of modular device connected to the hub, the

surgical hub

106, 206 can generally infer the specific procedure that the surgical team will perform. Once the

surgical hub

106, 206 knows what specific procedure is being performed, the

surgical hub

106, 206 may retrieve the steps of the procedure from memory or cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular devices and patient monitoring devices) to infer what steps of the surgical procedure are being performed by the surgical team.

In a fifth step 5210, the staff member attaches EKG electrodes and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with the

surgical hubs

106, 206. When the

surgical hub

106, 206 begins to receive data from the patient monitoring device, the

surgical hub

106, 206 thus confirms that the patient is in the operating room.

Sixth step 5212, the medical personnel induce anesthesia in the patient. The

surgical hub

106, 206 may infer that the patient is under anesthesia based on data from the modular device and/or the patient monitoring device, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Upon completion of the sixth step 5212, the pre-operative portion of the lung segmentation resection procedure is completed and the surgical portion begins.

In a seventh step 5214, the patient's lungs being operated on are collapsed (while ventilation is switched to the contralateral lungs). For example, the

surgical hub

106, 206 may infer from the ventilator data that the patient's lungs have collapsed. The

surgical hub

106, 206 may infer that the surgical portion of the procedure has begun because it may compare the detection of the patient's lung collapse to the expected steps of the procedure (which may have been previously visited or retrieved) to determine that collapsing the lungs is the surgical step in that particular procedure.

In an eighth step 5216, a medical imaging device (e.g., an endoscope) is inserted and video from the medical imaging device is initiated. The

surgical hub

106, 206 receives medical imaging device data (i.e., video or image data) through its connection to the medical imaging device. After receiving the medical imaging device data, the

surgical hub

106, 206 may determine that a laparoscopic portion of the surgical procedure has begun. In addition, the

surgical hub

106, 206 may determine that the particular procedure being performed is a segmental resection, rather than a leaf resection (note that the wedge procedure has been excluded based on the data received by the

surgical hub

106, 206 at the second step 5204 of the procedure). Data from the medical imaging device 124 (fig. 2) may be used to determine contextual information relating to the type of procedure being performed in a number of different ways, including by determining the angle of visualization orientation of the medical imaging device relative to the patient anatomy, monitoring the number of medical imaging devices utilized (i.e., activated and paired with the surgical hub 106, 206), and monitoring the type of visualization devices utilized. For example, one technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's chest above the septum, while one technique for performing a VATS segmental resection places the camera in an anterior intercostal location relative to the segmental cleft. For example, using pattern recognition or machine learning techniques, the situational awareness system may be trained to recognize the positioning of the medical imaging device from a 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 segmental resection utilizes multiple cameras. As another example, one technique for performing VATS segmental resection utilizes an infrared light source (which may be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental fissures that are not used in VATS pulmonary resection. By tracking any or all of this data from the medical imaging device, the

surgical hub

106, 206 can thus determine the specific type of surgical procedure being performed and/or the technique being used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step of the procedure. The

surgical hub

106, 206 may infer that the surgeon is dissecting to mobilize the patient's lungs because it receives data from the RF generator or ultrasound generator indicating that the energy instrument is being fired. The

surgical hub

106, 206 may intersect the received data with the retrieved steps of the surgical procedure to determine that the energy instrument fired at that point in the procedure (i.e., after completion of the previously discussed procedure steps) corresponds to an anatomical step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of a robotic surgical system.

In a tenth step 5220, the surgical team continues with the ligation step of the procedure. The

surgical hub

106, 206 may infer that the surgeon is ligating arteries and veins because it receives data from the surgical stapling and severing instrument indicating that the instrument is being fired. Similar to the previous steps, the

surgical hub

106, 206 may deduce the inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the retrieval steps in the procedure. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.

An eleventh step 5222, a segmental resection portion of the procedure is performed. The

surgical hub

106, 206 may infer that the surgeon is transecting soft tissue based on data from the surgical stapling and severing instrument, including data from its cartridge. The cartridge data may correspond to, for example, the size or type of staples fired by the instrument. Since different types of staples are used for 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 for soft tissue (or other similar tissue type), which allows the

surgical hub

106, 206 to infer that a segmental resection portion of the procedure is in progress.

A twelfth step 5224 node dissection step is then performed. The

surgical hub

106, 206 may infer that the surgical team is dissecting a node and performing a leak test based on data received from the generator indicating that the RF or ultrasonic instrument is being fired. For this particular procedure, the RF or ultrasound instruments used after transecting soft tissue correspond to a node dissection step that allows the

surgical hub

106, 206 to make such inferences. It should be noted that the surgeon periodically switches back and forth between the surgical stapling/severing instrument and the surgical energy (i.e., RF or ultrasonic) instrument according to specific steps in the procedure, as different instruments are better suited to the particular task. Thus, the particular sequence in which the stapling/severing instrument and the surgical energy instrument are used may indicate the steps of the procedure being performed by the surgeon. Further, in some cases, robotic implements may be used for one or more steps in a surgical procedure, and/or hand-held surgical instruments may be used for one or more steps in a surgical procedure. One or more surgeons may alternate and/or may use the device simultaneously, for example, between a robotic tool and a hand-held surgical instrument. Upon completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.

A thirteenth step 5226, reverse anesthetizing the patient. For example, the

surgical hub

106, 206 may infer that the patient is waking up from anesthesia based on, for example, ventilator data (i.e., the patient's breathing rate begins to increase).

Finally, a fourteenth step 5228 is for the medical personnel to remove various patient monitoring devices from the patient. Thus, when the hub loses EKG, BP, and other data from the patient monitoring device, the

surgical hub

106, 206 may infer that the patient is being transferred to a recovery room. As can be seen from the description of the exemplary procedure, the

surgical hub

106, 206 may determine or infer when each step of a given surgical procedure occurs from data received from various data sources communicatively coupled to the

surgical hub

106, 206.

Situational awareness is further described in U.S. provisional patent application serial No. 62/659,900 (entitled METHOD OF HUB COMMUNICATION) filed on 19/4/2018, which is incorporated herein by reference in its entirety. In certain instances, operation of the robotic surgical system (including the various robotic surgical systems disclosed herein) may be controlled by the

hub

106, 206 based on its situational awareness and/or feedback from its components and/or based on information from the cloud 102.

While several forms have been illustrated and described, it is not the intention of the applicants to restrict or limit the scope of the appended claims to such detail. Numerous modifications, changes, variations, substitutions, combinations, and equivalents of these forms can be made without departing from the scope of the present disclosure, and will occur to those skilled in the art. Further, the structure of each element associated with the described forms may alternatively be described as a means for providing the function performed by the element. In addition, where materials for certain components are disclosed, other materials may also be used. It is, therefore, to be understood that the foregoing detailed description and appended claims are intended to cover all such modifications, combinations and variations as fall within the scope of the disclosed forms of the invention. It is intended that the following claims cover all such modifications, changes, variations, substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of the devices and/or methods via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein, in whole or in part, can be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., 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 one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the electronic circuitry and/or writing the code for the software and or hardware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as one or more program products in a variety of forms, and that an exemplary form of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution.

The instructions for programming logic to perform the various disclosed aspects may be stored within a memory within the system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Further, the instructions may be distributed via a network or through other computer readable media. Thus, a machine-readable medium may include a mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, read-only memories (CD-ROMs), magneto-optical disks, read-only memories (ROMs), Random Access Memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memory, or a tangible, machine-readable storage device used in transmitting information over the internet via electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

As used in any aspect herein, the term "control circuitry" can refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor that includes one or more separate instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Programmable Logic Arrays (PLAs), Field Programmable Gate Arrays (FPGAs)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry that forms part of a larger system, e.g., an Integrated Circuit (IC), an Application Specific Integrated Circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that implements, at least in part, the methods and/or apparatus described herein, or a microprocessor configured by a computer program that implements, at least in part, the methods and/or apparatus described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion, or some combination thereof.

As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to perform any of the foregoing operations. The 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 instruction sets and/or data that are hard-coded (e.g., non-volatile) in a memory device.

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

An "algorithm," as used in any aspect herein, is a self-consistent sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states which may (but are not necessarily) take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. And are used 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 and are merely convenient labels applied to these quantities and/or conditions.

The network may comprise a packet switched network. The communication devices may be capable of communicating with each other using the selected packet switched network communication protocol. One exemplary communication protocol may include an ethernet communication protocol that may allow communication using the transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with the ethernet standard entitled "IEEE 802.3 standard" promulgated by the Institute of Electrical and Electronics Engineers (IEEE) at 12 months 2008 and/or higher versions of this standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an x.25 communication protocol. The x.25 communication protocol may conform to or conform to standards promulgated by the international telecommunication union, telecommunication standardization sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or conform to standards promulgated by the international committee for telephone and telephone negotiations (CCITT) and/or the American National Standards Institute (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 entitled "ATM-MPLS network interworking 2.0" promulgated by the ATM forum at 8 months 2001 and/or higher versions of that standard. Of course, different and/or later-developed connection-oriented network communication protocols are also contemplated herein.

Unless specifically stated otherwise as apparent from the above discussion, it is appreciated that throughout the above disclosure, discussions utilizing terms such as "processing," "computing," "calculating," "determining," "displaying" or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

One or more components may be referred to herein as "configured," "configurable," "operable," "adaptable," "capable," "conformable," or the like. Those skilled in the art will recognize that "configured to" may generally encompass components in an active state and/or components in an inactive state and/or components in a standby state unless the context indicates otherwise.

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

Those skilled in the art will recognize that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claims. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); this also applies to the use of definite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Further, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such construction is intended to have a meaning that one of skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include, but not be limited to, systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such construction is intended to have a meaning that one of skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" would include but not be limited to systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). It will also be understood by those within the art that, in general, disjunctive words and/or phrases having two or more alternative terms, whether appearing in the detailed description, claims, or drawings, should be understood to encompass the possibility of including one of the terms, either of the terms, or both terms, unless the context indicates otherwise. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".

Those skilled in the art will appreciate from the appended claims that the operations recited therein may generally be performed in any order. Additionally, while the various operational flow diagrams are presented in one or more sequences, it should be understood that the various operations may be performed in other sequences than those shown, or may be performed concurrently. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, complementary, simultaneous, reverse, or other altered orderings, unless context dictates otherwise. Furthermore, unless the context dictates otherwise, terms like "responsive," "related," or other past adjectives are generally not intended to exclude such variations.

It is worthy to note that any reference to "an aspect," "an example" means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, the appearances of the phrases "in one aspect," "in an example" in various places throughout this specification are not necessarily all referring 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 applications, patents, non-patent publications or other published materials mentioned in this specification and/or listed in any application data sheet are herein incorporated by reference, to the extent that the incorporated materials are not inconsistent herewith. Thus, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

In summary, a number of benefits resulting from employing the concepts described herein have been described. The foregoing detailed description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The form or forms selected and described are to be illustrative of the principles and practical applications to thereby enable one of ordinary skill in the art to utilize the various forms and modifications as are suited to the particular use contemplated. The claims as filed herewith are intended to define the full scope.

Various aspects of the subject matter described herein are set forth in the following numbered examples:

example 1: an ultrasonic electromechanical system for an ultrasonic surgical instrument. The ultrasound electromechanical system includes: the ultrasonic blade includes an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, and a control circuit coupled to the ultrasonic transducer. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. The control circuit is configured to: a first resonant frequency of the ultrasonic electromechanical system is determined, a second resonant frequency of the ultrasonic electromechanical system is determined while the ultrasonic blade is vibrated against tissue, and a condition of the ultrasonic surgical instrument is determined based on a comparison between the first resonant frequency and the second resonant frequency.

Example 2: the ultrasonic electromechanical system of embodiment 1, wherein the state of the ultrasonic surgical instrument comprises a temperature of the ultrasonic blade.

Example 3: the ultrasonic surgical instrument of embodiment 2 wherein said control circuit is configured to control said ultrasonic transducer to adjust an amplitude of said ultrasonic blade as a function of a temperature of said ultrasonic transducer.

Example 4: the ultrasonic electromechanical system of embodiment 3, wherein the control circuit is configured to adjust the amplitude of the ultrasonic blade to maintain the temperature of the ultrasonic blade at a predetermined temperature.

Example 5: the ultrasound electromechanical system according to any one of embodiments 1-4, wherein the control circuitry is configured to: the drive signal is applied to the ultrasonic transducer at a plurality of frequencies within a frequency range, and a voltage signal and a current signal of the ultrasonic transducer corresponding to each frequency of the drive signal within the frequency range are determined. The first resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

Example 6: the ultrasound electromechanical system according to any one of embodiments 1-5, wherein the control circuitry is configured to: monitoring a voltage signal and a current signal applied to the ultrasonic transducer while the ultrasonic blade is vibrating, and adjusting the drive signal until the voltage signal and the current signal are in phase. The second resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

Example 7: the ultrasound electromechanical system according to any one of embodiments 1-6, further comprising a memory coupled to the control circuit. The memory stores a plurality of states of the ultrasonic surgical instrument as a function of the shift in resonant frequency. The control circuit is configured to determine a state of the ultrasonic surgical instrument by retrieving from memory which of a plurality of states of the ultrasonic surgical instrument corresponds to a difference between the first resonant frequency and the second resonant frequency.

Example 8: an ultrasonic generator connectable to an ultrasonic electromechanical system for an ultrasonic surgical instrument. The ultrasonic electromechanical system includes an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade. The ultrasound generator includes a control circuit capable of being coupled to the ultrasound transducer. The control circuit is configured to: applying a drive signal to the ultrasonic transducer to vibrate the ultrasonic blade, determining a first resonant frequency of the ultrasonic electromechanical system, determining a second resonant frequency of the ultrasonic electromechanical system while the ultrasonic blade is vibrating against tissue, and determining a status of the ultrasonic surgical instrument based on a comparison between the first resonant frequency and the second resonant frequency.

Example 9: the ultrasonic generator of embodiment 8, wherein the state of the ultrasonic surgical instrument comprises a temperature of the ultrasonic blade.

Example 10: the ultrasonic generator of embodiment 9, wherein the control circuit is configured to control the ultrasonic transducer to adjust an amplitude of the ultrasonic blade as a function of a temperature of the ultrasonic transducer.

Example 11: the ultrasonic generator of embodiment 10, wherein the control circuit is configured to adjust the amplitude of the ultrasonic blade to maintain the temperature of the ultrasonic blade at a predetermined temperature.

Example 12: the ultrasonic generator of any of embodiments 8-11, wherein the control circuit is configured to: the drive signal is applied to the ultrasonic transducer at a plurality of frequencies within a frequency range, and a voltage signal and a current signal of the ultrasonic transducer corresponding to each frequency of the drive signal within the frequency range are determined. The first resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

Example 13: the ultrasonic generator of any of embodiments 8-12, wherein the control circuit is configured to: monitoring a voltage signal and a current signal applied to the ultrasonic transducer while the ultrasonic blade is vibrating, and adjusting the drive signal until the voltage signal and the current signal are in phase. The second resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

Example 14: the ultrasonic generator of any of embodiments 8-13, further comprising a memory coupled to the control circuit. The memory stores a plurality of states of the ultrasonic surgical instrument as a function of the shift in resonant frequency. The control circuit is configured to determine a state of the ultrasonic surgical instrument by retrieving from memory which of a plurality of states of the ultrasonic surgical instrument corresponds to a difference between the first resonant frequency and the second resonant frequency.

Example 15: a method of controlling an ultrasonic electromechanical system for an ultrasonic surgical instrument. The ultrasonic electromechanical system includes an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade. The method comprises the following steps: determining, by a control circuit coupled to the ultrasound electromechanical system, a natural resonant frequency of the ultrasound electromechanical system; monitoring, by the control circuit, a resonant frequency of the ultrasonic electromechanical system while the ultrasonic blade is vibrating; and determining, by the control circuit, whether a change in state of the ultrasound electromechanical system has occurred as a function of whether a resonant frequency of the ultrasound electromechanical system has deviated from the natural resonant frequency.

Example 16: the method of embodiment 15, wherein the change in state of the ultrasonic surgical instrument comprises an increase in temperature of the ultrasonic blade.

Example 17: the method of embodiment 16, further comprising controlling, by the control circuit, the ultrasonic transducer to adjust an amplitude of the ultrasonic blade as a function of the temperature increase of the ultrasonic transducer.

Example 18: the method of embodiment 17, further comprising controlling, by the control circuit, the ultrasonic transducer to adjust an amplitude of the ultrasonic blade to maintain a temperature of the ultrasonic blade at a predetermined temperature.

Example 19: the method of any of embodiments 15-18, further comprising: applying, by the control circuit, a drive signal to the ultrasonic electromechanical system at a plurality of frequencies within a frequency range to vibrate the ultrasonic blade, and determining, by the control circuit, a voltage signal and a current signal of the ultrasonic transducer corresponding to each frequency of the drive signal within the frequency range. The natural resonant frequency corresponds to the frequency at which the voltage signal and the current signal are in phase.

Example 20: the method of any of embodiments 15-19, further comprising: applying, by the control circuit, a drive signal to the ultrasonic electromechanical system to vibrate the ultrasonic blade; monitoring, by the control circuit, a voltage signal and a current signal of the ultrasonic electromechanical system generated by the drive signal as the ultrasonic blade vibrates; and adjusting, by the control circuit, the drive signal until the voltage signal and the current signal are in phase. The resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

Example 21: the method of any of embodiments 15-20, further comprising: retrieving, from a memory coupled to the control circuit, a state of the ultrasonic surgical instrument corresponding to a difference between the resonant frequency and the natural resonant frequency; and determining whether the change in state has occurred based on whether the state of the ultrasonic surgical instrument corresponds to a previous state of the ultrasonic surgical instrument.

Claims

1. An ultrasonic electromechanical system for an ultrasonic surgical instrument, the ultrasonic electromechanical system comprising:

an ultrasonic blade;

an ultrasonic transducer acoustically coupled to the ultrasonic blade, the ultrasonic transducer configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal; and

a control circuit coupled to the ultrasound transducer, the control circuit configured to:

determining a first resonant frequency of the ultrasound electromechanical system;

determining a second resonant frequency of the ultrasonic electromechanical system as the ultrasonic blade vibrates against tissue; and is

Determining a state of the ultrasonic surgical instrument based on a comparison between the first resonant frequency and the second resonant frequency.

2. The ultrasonic electromechanical system according to claim 1, wherein the state of the ultrasonic surgical instrument includes a temperature of the ultrasonic blade.

3. The ultrasonic electromechanical system according to claim 2, wherein the control circuit is configured to control the ultrasonic transducer to adjust an amplitude of the ultrasonic blade as a function of a temperature of the ultrasonic transducer.

4. The ultrasonic electromechanical system according to claim 3, wherein the control circuit is configured to adjust the amplitude of the ultrasonic blade to maintain the temperature of the ultrasonic blade at a predetermined temperature.

5. The ultrasound electromechanical system according to claim 1, wherein the control circuit is configured to:

applying the drive signal to the ultrasonic transducer at a plurality of frequencies within a frequency range; and is

Determining a voltage signal and a current signal of the ultrasonic transducer corresponding to each frequency of the drive signal within the frequency range;

wherein the first resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

6. The ultrasound electromechanical system according to claim 1, wherein the control circuit is configured to:

monitoring a voltage signal and a current signal applied to the ultrasonic transducer while the ultrasonic blade is vibrating; and is

Adjusting the drive signal until the voltage signal and the current signal are in phase;

wherein the second resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

7. The ultrasonic electromechanical system according to claim 1, further comprising:

a memory coupled to the control circuit, the memory storing a plurality of states of the ultrasonic surgical instrument according to a resonant frequency shift;

wherein the control circuit is configured to determine the state of the ultrasonic surgical instrument by retrieving from the memory which of the plurality of states of the ultrasonic surgical instrument corresponds to the difference between the first resonant frequency and the second resonant frequency.

8. An ultrasonic generator connectable to an ultrasonic electromechanical system for an ultrasonic surgical instrument, the ultrasonic electromechanical system including an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade, the ultrasonic generator comprising:

a control circuit coupleable to the ultrasound transducer, the control circuit configured to:

applying a drive signal to the ultrasonic transducer to vibrate an ultrasonic blade;

determining a second resonant frequency of the ultrasonic electromechanical system as the ultrasonic blade vibrates against tissue; and

9. The ultrasonic generator of claim 8, wherein the state of the ultrasonic surgical instrument comprises a temperature of the ultrasonic blade.

10. The ultrasonic generator of claim 9, wherein the control circuit is configured to control the ultrasonic transducer to adjust an amplitude of the ultrasonic blade as a function of a temperature of the ultrasonic transducer.

11. The ultrasonic generator of claim 10, wherein the control circuit is configured to adjust an amplitude of the ultrasonic blade to maintain a temperature of the ultrasonic blade at a predetermined temperature.

12. The ultrasonic generator of claim 8, wherein the control circuit is configured to:

applying the drive signal to the ultrasonic transducer at a plurality of frequencies within a frequency range; and

13. The ultrasonic generator of claim 8, wherein the control circuit is configured to:

monitoring a voltage signal and a current signal applied to the ultrasonic transducer while the ultrasonic blade is vibrating; and

14. The ultrasonic generator of claim 8, further comprising:

15. A method of controlling an ultrasonic electromechanical system for an ultrasonic surgical instrument, the ultrasonic electromechanical system comprising an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade, the method comprising:

determining, by a control circuit coupled to the ultrasound electromechanical system, a natural resonant frequency of the ultrasound electromechanical system;

monitoring, by the control circuit, a resonant frequency of the ultrasonic electromechanical system while the ultrasonic blade is vibrating; and

determining, by the control circuit, whether a change of state of the ultrasound electromechanical system has occurred as a function of whether the resonant frequency of the ultrasound electromechanical system has deviated from the natural resonant frequency.

16. The method of claim 15, wherein the change in state of the ultrasonic surgical instrument comprises an increase in temperature of the ultrasonic blade.

17. The method of claim 16, further comprising controlling, by the control circuit, the ultrasonic transducer to adjust an amplitude of the ultrasonic blade as a function of the temperature increase of the ultrasonic transducer.

18. The method of claim 17, further comprising controlling, by the control circuit, the ultrasonic transducer to adjust an amplitude of the ultrasonic blade to maintain a temperature of the ultrasonic blade at a predetermined temperature.

19. The method of claim 15, further comprising:

applying, by the control circuit, drive signals to the ultrasonic electromechanical system at a plurality of frequencies within a frequency range to vibrate the ultrasonic blade; and

determining, by the control circuit, a voltage signal and a current signal of the ultrasonic transducer corresponding to each frequency of the drive signal within the frequency range;

wherein the natural resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

20. The method of claim 15, further comprising:

applying, by the control circuit, a drive signal to the ultrasonic electromechanical system to vibrate the ultrasonic blade;

monitoring, by the control circuit, a voltage signal and a current signal of the ultrasonic electromechanical system generated by the drive signal as the ultrasonic blade vibrates; and

adjusting, by the control circuit, the drive signal until the voltage signal and the current signal are in phase;

wherein the resonant frequency corresponds to a frequency at which the voltage signal and the current signal are in phase.

21. The method of claim 15, further comprising:

retrieving, from a memory coupled to the control circuit, a state of the ultrasonic surgical instrument corresponding to a difference between the resonant frequency and the natural resonant frequency; and

determining whether the state change has occurred as a function of whether a state of the ultrasonic surgical instrument corresponds to a previous state of the ultrasonic surgical instrument.