JP7279051B2 - Determining the state of the ultrasonic end effector - Google Patents

Description

(Cross reference to related applications)
This application is filed under 35 U.S.C. Priority is claimed to US Provisional Patent Application Serial No. 62/721,996, filed on May 1, 2009.

This application is further divided under 35 U.S.C. U.S. Provisional Application No. 62/692,748 and priority to U.S. Provisional Application No. 62/692,768, filed Jun. 30, 2018, entitled "SMART ENERGY DEVICES."

This application is further filed under 35 U.S.C. 119(e) under 35 U.S.C. U.S. Provisional Application No. 62/640,417, filed March 8, and U.S. Provisional Application No. 62/640, filed March 8, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR," Claim priority benefit of '415.

This application is filed under 35 U.S.C. It claims the benefit of priority to US Provisional Patent Application No. 62/650,898, filed on May 7, 2009.

Surgical environments may require smart energy devices within a smart energy architecture environment.

In one general aspect, an ultrasonic surgical instrument includes an end effector comprising an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, and a control coupled to the ultrasonic transducer. An ultrasonic surgical instrument comprising a circuit. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. A control circuit measures a complex impedance of the ultrasonic transducer and compares the complex impedance to a plurality of reference complex impedance patterns, each of the plurality of reference complex impedance patterns corresponding to a state of the end effector. and determining a state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to.

In another general aspect, an ultrasonic generator for driving an ultrasonic surgical instrument comprising an end effector, an ultrasonic blade, and an ultrasonic transducer acoustically coupled to the ultrasonic blade. , an ultrasonic generator. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. The ultrasonic generator includes control circuitry coupled to the ultrasonic transducer. The control circuit applies a drive signal to the ultrasonic transducer, measures a complex impedance of the ultrasonic transducer, and compares the complex impedance to a plurality of reference complex impedance patterns, wherein the plurality of reference complex impedance patterns comparing, each of the patterns corresponding to a state of the end effector; and determining the state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to. configured to do so.

In another general aspect, a method of controlling an ultrasonic surgical instrument comprising an end effector, an ultrasonic blade, and an ultrasonic transducer acoustically coupled to the ultrasonic blade. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal from the generator. The method comprises measuring, with a control circuit coupled to the ultrasonic transducer, a complex impedance of the ultrasonic transducer; comparing, with the control circuit, the complex impedance to a plurality of reference complex impedance patterns; each of the plurality of reference complex impedance patterns corresponding to a state of the end effector, the comparing and control circuitry according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to; determining the state of the .

Features of various aspects are set forth with particularity in the appended claims. The various aspects, both as to organization and method of operation, however, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings, which follow.
1 is a block diagram of a computer-implemented interactive surgical system, according to at least one aspect of the present disclosure; FIG. A surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure; FIG. 122 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing in accordance with at least one aspect of the present disclosure; 1 is a perspective view of a combination generator module comprising bipolar, ultrasonic, and monopolar contacts and smoke evacuation components in accordance with at least one aspect of the present disclosure; FIG. 4 illustrates individual power bus attachments for multiple lateral docking ports of a lateral modular housing configured to receive multiple modules, in accordance with at least one aspect of the present disclosure; 1 illustrates a vertical modular housing configured to receive multiple modules, according to at least one aspect of the present disclosure; Cloud modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure. 1 illustrates a surgical data network with modular communication hubs configured to connect; 1 illustrates a computer-implemented interactive surgical system, according to at least one aspect of the present disclosure; 1 illustrates a surgical hub comprising multiple modules coupled to a modular control tower, according to at least one aspect of the present disclosure; 1 illustrates one aspect of a universal serial bus (USB) network hub device, in accordance with at least one aspect of the present disclosure; 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 1 illustrates a control circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 11 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 4 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; 1 illustrates a surgical instrument or tool comprising multiple motors that can be activated to perform various functions, in accordance with at least one aspect of the present disclosure; 1 is a schematic diagram of a robotic surgical instrument configured to manipulate a surgical tool described herein, according to at least one aspect of the present disclosure; FIG. FIG. 10 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member, according to at least one aspect of the present disclosure; 1 is a circuit diagram of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure; FIG. A system configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network comprising a modular communication hub, according to at least one aspect of the present disclosure. 1 illustrates one example of a generator, in accordance with at least one aspect of the present disclosure; A surgical system comprising a generator and various surgical instruments usable with the generator, according to at least one aspect of the present disclosure. An end effector according to at least one aspect of the present disclosure. 23 is a diagram of the surgical system of FIG. 22 in accordance with at least one aspect of the present disclosure; FIG. 4 is a model illustrating operating branch currents, in accordance with at least one aspect of the present disclosure; 2 is a structural diagram of a generator architecture, according to at least one aspect of the present disclosure; FIG. FIG. 4 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure; FIG. 4 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure; FIG. 4 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure; 4A-4B are structural and functional aspects of a generator, in accordance with at least one aspect of the present disclosure; 4A-4B are structural and functional aspects of a generator, in accordance with at least one aspect of the present disclosure; 1 is a circuit diagram of one aspect of an ultrasonic drive circuit; FIG. 4 is a circuit diagram of a control circuit, according to at least one aspect of the present disclosure; FIG. FIG. 4 shows a simplified block circuit diagram illustrating another electrical circuit housed within a modular ultrasonic surgical instrument in accordance with at least one aspect of the present disclosure; 2 illustrates a generator circuit divided into multiple stages, in accordance with at least one aspect of the present disclosure; 1 illustrates a generator circuit divided into multiple stages, with a first stage circuit in common with a second stage circuit, in accordance with at least one aspect of the present disclosure; 1 is a circuit diagram of one aspect of a drive circuit configured to drive radio frequency current (RF), in accordance with at least one aspect of the present disclosure; FIG. A digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms of electrical signal waveforms for use in a surgical instrument, according to at least one aspect of the present disclosure. 1 shows one aspect of the basic architecture. 1 illustrates one aspect of direct digital synthesis (DDS) circuitry configured to generate multiple waveforms of an electrical signal waveform for use in a surgical instrument, according to at least one aspect of the present disclosure; One cycle of the discrete-time digital electrical signal waveform according to at least one aspect of the present disclosure of the analog waveform (shown superimposed on the discrete-time digital electrical signal waveform for comparison purposes) according to at least one aspect of the present disclosure show. According to one aspect of the present disclosure, a control configured to provide gradual closure of the closure member as the closure member advances distally to close the clamp arm and apply a closure force load at a desired rate. 1 is a diagram of a system; FIG. 1 illustrates a proportional-integral-derivative (PID) controller feedback control system, according to one aspect of the present disclosure; 1 is a system diagram of a segmented circuit comprising multiple independently operating circuit segments, in accordance with at least one aspect of the present disclosure; FIG. 1 is a circuit diagram of various components of a surgical instrument with motor control capabilities, in accordance with at least one aspect of the present disclosure; FIG. An alternative system for controlling the frequency and detecting impedance of an ultrasonic electromechanical system, according to at least one aspect of the present disclosure. FIG. 4 is a graphical representation of impedance phase angle as a function of resonant frequency for the same ultrasonic device with cold (blue) and hot (red) ultrasonic blades. FIG. 4 is a graphical representation of impedance magnitude as a function of resonant frequency for the same ultrasonic device with cold (blue) and hot (red) ultrasonic blades. FIG. 4 is a diagram of a Kalman filter that refines a temperature estimator and state-space model based on impedance across an ultrasonic transducer measured at various frequencies, in accordance with at least one aspect of the present disclosure; 45 are three probability distributions employed by the Kalman filter state estimator shown in FIG. 44 to maximize estimation, in accordance with at least one aspect of the present disclosure; 1 is a graphical representation of temperature versus time for an ultrasonic device without temperature control reaching a maximum temperature of 490°C. 4 is a graphical representation of temperature versus time for an ultrasound device having temperature control to reach a maximum temperature of 320° C., according to at least one aspect of the present disclosure; FIG. 10 is a graphical representation of feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a rapid temperature drop of the ultrasonic blade is detected, and is a graphical representation of ultrasonic power as a function of time; FIG. be. FIG. 4 is a graphical representation of feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a rapid temperature drop of the ultrasonic blade is detected, as a function of time, according to at least one aspect of the present disclosure; FIG. 4 is a plot of ultrasonic blade temperature as . FIG. 3 is a process logic flow diagram illustrating a control program or logic configuration for controlling the temperature of an ultrasonic blade, in accordance with at least one aspect of the present disclosure; 4 is a graphical representation of ultrasonic blade temperature as a function of time during vessel firing, in accordance with at least one aspect of the present disclosure; FIG. 3 is a logic flow diagram of a process showing a control program or logic configuration for controlling the temperature of an ultrasonic blade between two temperature setpoints in accordance with at least one aspect of the present disclosure; FIG. 3 is a process logic flow diagram illustrating a control program or logic configuration for determining an initial temperature of an ultrasonic blade, in accordance with at least one aspect of the present disclosure; for determining when an ultrasonic blade is approaching instability and subsequently adjusting power to an ultrasonic transducer to prevent ultrasonic transducer instability, according to at least one aspect of the present disclosure; FIG. 4 is a logic flow diagram of a process showing control programs or logic constructs. FIG. 3 is a logic flow diagram of a process showing a control program or logic configuration for providing ultrasonic sealing with temperature control, in accordance with at least one aspect of the present disclosure; 4 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. 19 is a bottom view of an ultrasonic end effector showing a clamp arm and ultrasonic blade depicting tissue positioning within the ultrasonic end effector, in accordance with at least one aspect of the present disclosure; 4 is a graphical representation showing changes in ultrasound transducer impedance as a function of tissue position within an ultrasound end effector over a range of increasing predetermined ultrasound generator power levels, in accordance with at least one aspect of the present disclosure; 4 is a graphical representation showing changes in ultrasound transducer impedance as a function of time versus tissue position within an ultrasound end effector, in accordance with at least one aspect of the present disclosure; 4 is a logic flow diagram of a process showing a control program or logic configuration for specifying operation in a non-therapeutic range of power applied to an ultrasound transducer to determine tissue positioning, in accordance with at least one aspect of the present disclosure; FIG. be. 1 illustrates one aspect of an ultrasonic surgical instrument end effector including an infrared (IR) sensor located on a jaw member, in accordance with at least one aspect of the present disclosure; The IR sensor shown in FIG. 59, according to one aspect of the present disclosure, illustrates one aspect of a flexible circuit that may be integrally attached or formed. 3 is a cross-sectional view of an ultrasonic end effector comprising a clamp arm and an ultrasonic blade in accordance with at least one aspect of the present disclosure; FIG. FIG. 11 illustrates an IR refraction detection sensor circuit mounted on a flexible circuit board shown in plan view, according to at least one aspect of the present disclosure; FIG. FIG. 4 is a logic flow diagram of a process showing a control program or logic configuration for measuring IR reflectance to determine tissue composition and adjusting ultrasound transducer amplitude, in accordance with at least one aspect of the present disclosure; For determining a collagen transformation point according to various aspects of the present disclosure, with time shown along the horizontal axis and changes in clamp arm position shown along the vertical axis, according to at least one aspect of the present disclosure: Fig. 10 is a graphical representation of clamp arm closure rate versus time; 64B is an enlarged portion of the graphical representation shown in FIG. 64A. FIG. 4 is a logic flow diagram of a process showing a control program or logic configuration for detecting a collagen transformation point and controlling a clamp arm closure rate or an ultrasonic transducer amplitude, in accordance with at least one aspect of the present disclosure; To determine the collagen/elastin ratio according to various aspects of the present disclosure, with tissue temperature shown along the horizontal axis and ultrasound transducer impedance shown along the vertical axis, according to at least one aspect of the present disclosure. is a graphical representation of the identification of collagen transformation temperature points in . FIG. 10 is a logic flow diagram of a process showing a control program or logic configuration for identifying a collagen transformation temperature to identify a collagen/elastin ratio, in accordance with at least one aspect of the present disclosure; 4 is a graphical representation of compressive load distribution across an ultrasonic blade, according to at least one aspect of the present disclosure; 4 is a graphical representation of pressure applied to tissue versus time, according to at least one aspect of the present disclosure; 10 illustrates an end effector including a single jaw electrode array for detecting tissue position, in accordance with at least one aspect of the present disclosure; 71 is an activation matrix for the single-jaw electrode array of FIG. 70, according to at least one aspect of the present disclosure; 10 illustrates an end effector including a dual-jaw electrode array for detecting tissue position, according to at least one aspect of the present disclosure; 73 is an activation matrix for the dual jaw electrode array of FIG. 72, according to at least one aspect of the present disclosure; 74 illustrates opposing sets of electrodes superimposed on tissue grasped by an end effector corresponding to the activation matrix of FIG. 73, according to at least one aspect of the present disclosure; 10 illustrates an end effector including a dual jaw segmented electrode array, according to at least one aspect of the present disclosure; FIG. 11 illustrates tissue superimposed on jaws including a segmented electrode array, according to at least one aspect of the present disclosure; FIG. FIG. 3 is a schematic diagram of a segmented electrode array circuit including a bandpass filter, in accordance with at least one aspect of the present disclosure; 77 is a graphical representation of frequency response corresponding to the tissue grasped in FIG. 76, in accordance with at least one aspect of the present disclosure; 4 is a graphical representation of ultrasonic transducer system frequency as a function of drive frequency and ultrasonic blade temperature drift, in accordance with at least one aspect of the present disclosure; 4 is a graphical representation of ultrasonic transducer temperature as a function of time, in accordance with at least one aspect of the present disclosure; 4 is a graphical representation of a modal shift in resonant frequency based on ultrasonic blade temperature shifting resonant frequency as a function of ultrasonic blade temperature, in accordance with at least one aspect of the present disclosure; 4 is a spectrum of an ultrasonic surgical instrument having various different end effector states and conditions in which the phase and magnitude of the impedance of the ultrasonic transducer are plotted as a function of frequency, in accordance with at least one aspect of the present disclosure; . A methodology for classification of data based on a set of training data S, wherein magnitude and phase of ultrasound transducer impedance are plotted as a function of frequency, according to at least one aspect of the present disclosure. FIG. 4 is a logic flow diagram illustrating a control program or logic configuration for determining jaw status based on a complex impedance signature pattern (fingerprint), in accordance with at least one aspect of the present disclosure; 4 is a timeline illustrating surgical hub situational awareness, in accordance with at least one aspect of the present disclosure;

The applicant of this application owns the following US patent applications filed Aug. 28, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Patent Application Serial No. END8536USNP2/180107-2 entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";
U.S. Patent Application Serial No. END8560USNP2/180106-2 entitled "TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";
U.S. Patent Application Serial No. END8561USNP1/180144-1 entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED COMBINED ELECTRICAL SIGNALS";
U.S. Patent Application Serial No. END8563USNP1/180139-1 entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION";
U.S. Patent Application Docket No. END8563USNP2/180139-2, entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE";
U.S. Patent Application Serial No. END8563USNP3/180139-3 entitled "DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM";
- U.S. Patent Application Serial No. END8563USNP4/180139-4 entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT";
- U.S. Patent Application Serial No. END8564USNP1/180140-1, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS";
U.S. Patent Application Serial No. END8564USNP2/180140-2, entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT";
U.S. Patent Application Docket No. END8564USNP3/180140-3 entitled "DETECTION OF END EFFECTOR IMMERSION IN LIQUID";
U.S. Patent Application Docket No. END8565USNP1/180142-1 entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING";
- U.S. Patent Application Serial No. END8565USNP2/180142-2 entitled "INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP";
U.S. Patent Application Serial No. END8566USNP1/180143-1 entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY";ES", docket number END8573USNP1/180145-1.

The applicant of this application owns the following US patent applications filed Aug. 23, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Provisional Patent Application No. 62/721,995 entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION";
- U.S. Provisional Patent Application No. 62/721,998 entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS";
U.S. Provisional Patent Application No. 62/721,999 entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING";
U.S. Provisional Patent Application No. 62/721,994 entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY"; U.S. Provisional Patent Application Serial No. 62, entitled ELIVERING COMBINED ELECTRICAL SIGNALS 721,996.

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

The applicant of this application owns the following US patent applications filed June 29, 2018, the entire disclosures of each of which are incorporated herein by reference:
- U.S. Patent Application No. 16/024,090 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS";
- U.S. patent application Ser.
U.S. patent application Ser.
U.S. Patent Application No. 16/024,075 entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING";
- U.S. Patent Application No. 16/024,083 entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING";
- U.S. Patent Application No. 16/024,094 entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES";
U.S. patent application Ser.
U.S. Patent Application No. 16/024,150 entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES";
- U.S. Patent Application No. 16/024,160 entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY";
- U.S. Patent Application No. 16/024,124 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
- U.S. Patent Application No. 16/024,132 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT";
- U.S. Patent Application No. 16/024,141 entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY";
- U.S. Patent Application No. 16/024,162 entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES";
- U.S. Patent Application No. 16/024,066 entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
- U.S. Patent Application No. 16/024,096 entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS";
- U.S. Patent Application No. 16/024,116 entitled "SURGICAL EVACUATION FLOW PATHS";
U.S. Patent Application No. 16/024,149 entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL";
- U.S. Patent Application No. 16/024,180 entitled "SURGICAL EVACUATION SENSING AND DISPLAY";
- U.S. patent application Ser.
- U.S. patent application Ser.
- U.S. patent application Ser. L IN-SERIES LARGE AND SMALL DROPLET FILTERS. Application Serial No. 16/024,273.

The applicant of this application owns the following US provisional patent applications filed June 28, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Provisional Patent Application No. 62/691,228 entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES";
- U.S. Provisional Patent Application No. 62/691,227, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";
- U.S. Provisional Patent Application No. 62/691,230 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
- U.S. Provisional Patent Application No. 62/691,219 entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
"Communication OF SMOKE Evacutations to Hub or Cloud IN SMOKE EVACUATION MODULE FORGIVE SURGICAL SURGICAL PLATFORM "US Patent Open application No. 62/691, 257,
U.S. Provisional Patent Application No. 62/691,262 entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE"; AL IN-SERIES LARGE AND SMALL DROPLET FILTERS Provisional Patent Application No. 62/691,251.

The applicant of this application owns the following US provisional patent applications, filed April 19, 2018, the entire disclosures of each of which are incorporated herein by reference:
• US Provisional Patent Application No. 62/659,900 entitled "METHOD OF HUB COMMUNICATION".

The applicant of this application owns the following US provisional patent applications filed March 30, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Provisional Patent Application No. 62/650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS";
- U.S. Provisional Patent Application No. 62/650,887 entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES";
U.S. Provisional Patent Application No. 62/650,882 entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; , 877.

The applicant of this application owns the following US patent applications filed March 29, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Patent Application No. 15/940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
- U.S. patent application Ser.
U.S. Patent Application No. 15/940,656 entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";
- U.S. patent application Ser.
U.S. Patent Application No. 15/940,670 entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS";
- U.S. Patent Application No. 15/940,677 entitled "SURGICAL HUB CONTROL ARRANGEMENTS";
- U.S. patent application Ser.
- U.S. Patent Application No. entitled "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS" 15/940,640,
U.S. Patent Application No. 15/940,645, entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
U.S. Patent Application No. 15/940,649, entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
- U.S. Patent Application No. 15/940,654 entitled "SURGICAL HUB SITUATIONAL AWARENESS";
- U.S. Patent Application No. 15/940,663 entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
- U.S. Patent Application No. 15/940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
- U.S. Patent Application No. 15/940,671 entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER"
U.S. Patent Application No. 15/940,686, entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINE STAPLE LINE";
- U.S. Patent Application No. 15/940,700, entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
U.S. Patent Application No. 15/940,629 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
- U.S. patent application Ser.
U.S. Patent Application No. 15/940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY," and U.S. Patent Application No. 15/940, entitled "DUAL CMOS ARRAY IMAGING." , 742.
U.S. patent application Ser. No. 15/940,636 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. patent application Ser. No. 15/940,653 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS";
- U.S. Patent Application No. 15/940,660 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER"
- U.S. patent application Ser.
U.S. patent application Ser.
- U.S. Patent Application No. 15/940,634 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"
U.S. Patent Application No. 15/940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; No. 675.
- US patent application Ser.
- U.S. Patent Application No. 15/940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- US patent application Ser.
- US patent application Ser.
- US patent application Ser.
U.S. patent application Ser.
U.S. Patent Application No. 15/940,690, entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and U.S. patent application Ser. No. 15/940,711.

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

The applicant of this application owns the following US provisional patent applications filed March 8, 2018, the entire disclosures of each of which are incorporated herein by reference:
- U.S. Provisional Patent Application No. 62/640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR"; U.S. Provisional Patent Application Serial No. 62/640 entitled EM THEREFOR , No. 415.

The applicant of this application owns the following US provisional patent applications, filed December 28, 2017, the entire disclosures of each of which are incorporated herein by reference:
- U.S. Provisional Patent Application No. U.S. Provisional Application No. 62/611,341 entitled "INTERACTIVE SURGICAL PLATFORM";
• US Provisional Patent Application No. 62/611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," and • US Provisional Patent Application No. 62/611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM."

Before describing various aspects of surgical devices and generators in detail, it is noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts set forth in the accompanying drawings and description. It should be noted. Example embodiments may be practiced with or incorporated in other aspects, variations, and modifications, and may be practiced or carried out in various ways. Further, unless otherwise stated, the terms and expressions used herein have been chosen for the convenience of the reader for the purpose of describing example embodiments and not for purposes of limitation thereof. . Further, one or more of the aspects, implementations of aspects and/or examples described below may be combined with any of the other aspects, implementations of aspects and/or examples described below. It should be understood that one or more can be combined.

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

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

FIG. 3 shows an example of surgical system 102 used to perform a surgical procedure on a patient lying on operating table 114 in surgical operating room 116 . Robotic system 110 is used as part of surgical system 102 in a surgical procedure. Robotic system 110 includes a surgeon's console 118 , a patient-side cart 120 (surgical robot), and a surgical robot hub 122 . The patient-side cart 120 is capable of manipulating at least one releasably coupled surgical tool 117 while the surgeon views the surgical site via the surgeon's console 118 during minimally invasive incisions in the patient's body. . Images of the surgical site may be obtained by a medical imaging device 124 , which may be manipulated by the patient-side cart 120 to orient the imaging device 124 . The robotic hub 122 can 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 can be readily adapted for use with surgical system 102 . Various examples of robotic systems and surgical tools suitable for use with the present disclosure are entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed Dec. 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. See US Provisional Patent Application No. 62/611,339.

Various examples of cloud-based analytics performed by the cloud 104 and suitable for use with the present disclosure are described in "CLOUD-BASED MEDICAL US Provisional Patent Application No. 62/611,340 entitled ANALYTICS.

In various aspects, imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.

The optical components of 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 a portion of the surgical field. One or more image sensors can receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.

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

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

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

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

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

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

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

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

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

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

During surgical procedures, the application of energy to tissue for sealing and/or cutting is generally accompanied by evacuation of smoke, aspiration of excess fluid, and/or irrigation of tissue. Fluid, power, and/or data lines from different sources often become entangled during surgical procedures. Valuable time may be lost in addressing this issue during a surgical procedure. Untangling the lines may require uncoupling the lines from their corresponding modules, which may require the modules to be reset. The hub's modular housing 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines.

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

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

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

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

Further to the above, the modular surgical enclosure includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy; a second docking station comprising a second docking port including data and power contacts of the second energy generator module slidably moved into electrical engagement with the power and data contacts; Yes, and the second energy generator module is slidably moveable out of electrical engagement with the second power and data contacts.

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

Referring to FIGS. 3-7, aspects of the present disclosure are presented for a hub modular housing 136 that allows for modular integration of the generator module 140, the smoke evacuation module 126, and the aspiration/irrigation module 128. be done. The modular housing 136 of the hub further facilitates two-way communication between the modules 140,126,128. As shown in FIG. 5, the generator module 140 is an integrated monopolar, bipolar, and hyperpolar generator supported within a single housing unit 139 that is slidably insertable into the hub's modular housing 136 . It may be a generator module comprising an acoustic wave component. As shown in FIG. 5, the generator module 140 can be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasound device 148. FIG. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules interacting through the hub modular housing 136 . The modular housing 136 of the hub provides bi-directional switching between the insertion of multiple generators and the generators docked to the modular housing 136 of the hub so that multiple generators function as a single generator. may be configured to facilitate communication.

In one aspect, the hub's modular housing 136 is a modular power and power module with external and wireless communication headers to allow removable attachment of modules 140, 126, 128 and bi-directional communication therebetween. A communications backplane 149 is provided.

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

In various aspects, the smoke evacuation module 126 includes a fluid line 154 that carries captured/collected smoke and/or fluid away from the surgical site, eg, to the smoke evacuation module 126 . The vacuum suction generated by the smoke evacuation module 126 can draw smoke into the openings of utility conduits at the surgical site. A utility conduit coupled to the fluid line may be in the form of flexible tubing that terminates in the smoke evacuation module 126 . The utility conduits and fluid lines define fluid pathways that extend toward the smoke extraction module 126 received within the hub housing 136 .

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

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

The irrigation tube can be in fluid communication with a fluid source and the suction tube can be in fluid communication with a vacuum source. A fluid source and/or a vacuum source may be housed within the aspiration/irrigation module 128 . In one example, the fluid and/or vacuum source may be housed within hub housing 136 separately from aspiration/irrigation module 128 . In such examples, the fluid interface may be configured to connect the aspiration/irrigation module 128 to a fluid source and/or a vacuum source.

In one aspect, the modules 140, 126, 128 and/or their corresponding docking stations on the hub modular housing 136 align the docking ports of the modules to the docking stations of the hub modular housing 136. Alignment features configured to engage their counterparts therein may be included. For example, as shown in FIG. 4, combination generator module 145 has side brackets configured to slidably engage corresponding brackets 156 of corresponding docking stations 151 of hub modular housing 136 . 155 included. The brackets cooperate to guide the docking port contacts of the combination 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 within the drawers 151 . For example, side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. In other aspects, drawers 151 vary in size, each designed to accommodate a particular module.

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

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

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

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

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

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

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

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

Various image processors and imagers suitable for use with the present disclosure are described in U.S. Patent No. 1, issued Aug. 9, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which is incorporated herein by reference in its entirety. 7,995,045. Further, U.S. Patent No. 7,982,776, issued July 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is incorporated herein by reference in its entirety, removes motion artifacts from image data. Various systems for doing so are described. Such systems may be integrated with imaging module 138 . See also U.S. Patent Application Publication No. 2011/0306840, published Dec. 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS" and "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE August 28, 2014 entitled "SURGICAL PROCEDURE" Published US Patent Application Publication No. 2014/0243597 is each incorporated herein by reference in its entirety.

FIG. 8 illustrates a cloud-based system (e.g., storage) of modular equipment located in one or more operating rooms of a medical facility, or any room within a medical facility with specialized equipment for surgical procedures. A surgical data network 201 is shown comprising a modular communication hub 203 configured to connect to a cloud 204 ), which may include a remote server 213 coupled to devices 205 . In one aspect, modular communication hub 203 comprises network hub 207 and/or network switch 209 that communicate with network routers. Modular communication hub 203 can also be coupled to local computer system 210 to provide local computer processing and data manipulation. Surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a data conduit, allowing data to go from one device (or segment) to another device (or segment) and to cloud computing resources. The intelligent surgical data network includes additional mechanisms that allow traffic to pass through the monitored surgical data network and configure each port within network hub 207 or network switch 209 . An intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

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

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

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

By applying cloud computer data processing techniques to data collected by devices 1a-1n/2a-2m, surgical data networks provide improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n/2a-2m can be used to monitor the condition of the tissue after the tissue sealing and cutting procedure to assess leakage or perfusion of the sealed tissue. . at least one of the devices 1a-1n/2a-2m for diagnostic examination of data comprising images of body tissue samples to identify medical conditions such as disease effects using cloud-based computing; Several can be used. This includes tissue and phenotype localization and margin confirmation. Devices 1a-1n/2a for identifying body anatomy using various sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. At least some of ~2 m can be used. Data collected by devices 1a-1n/2a-2m, including image data, may be transferred to cloud 204 or local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. . The data will help guide surgical interventions by determining whether additional therapies such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and precision robotic applications for tissue-specific sites and conditions can be performed. Can be analyzed to improve results. Such data analysis may further employ prognostic analysis processing, using a standardized approach to confirm surgical intervention and surgeon behavior, or suggest modifications to surgical intervention and surgeon behavior. You can provide useful feedback for any of the

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. Network hub 207 may, in one aspect, be implemented as a local network broadcast device that functions above the physical layer of the Open Systems Interconnection (OSI) model. A network hub provides connectivity to devices 1a-1n located within the same operating room network. Network hub 207 collects the data in packet form and sends them to the router in half-duplex mode. Network hub 207 does not store any Media Access Control/Internet Protocol (MAC/IP) for transferring device data. Only one of the devices 1a-1n can transmit data through the network hub 207 at a time. Network hub 207 does not have routing tables or intelligence about where to send information, it broadcasts all network data across each connection and to remote server 213 (FIG. 9) on cloud 204 . Although the network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can be a security risk and create bottlenecks.

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

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

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

In another embodiment, operating room devices 1a-1n/2a-2m exchange data from fixed and mobile devices over short distances (using short wavelength UHF radio waves in the 2.4-2.485 GHz ISM band). ), and can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard to build a personal area network (PAN). In another aspect, the operating room devices 1a-1n/2a-2m support Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long-term evolution, LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any designated 3G, 4G, 5G, and later can communicate with modular communication hub 203 via numerous wireless or wired communication standards or protocols, including but not limited to other wireless and wired protocols. A computing module may include multiple communication modules. For example, a first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc. may be dedicated to long-range wireless communication.

The modular communication hub 203 can serve as the central connection for one or all of the operating room devices 1a-1n/2a-2m and handles data types known as frames. The frames carry data generated by the devices 1a-1n/2a-2m. As frames are received by modular communication hub 203, the frames are amplified and transmitted to network router 211, which uses a number of wireless or wired communication standards or protocols described herein to transmit the frames. Transfer this data to cloud computing resources.

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

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

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

Surgical hub 206 uses non-contact sensor module 242 to measure the dimensions of the operating room and to generate a map of the surgical field using either ultrasonic or laser-based non-contact measurement devices. Section "Surgical Hub Spatial Awareness Within an Operating Room" of U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed Dec. 28, 2017, which is hereby incorporated by reference in its entirety. An ultrasound-based non-contact sensor module scans an operating room by transmitting bursts of ultrasound and receiving echoes when the bursts of ultrasound reflect off the outer wall of the operating room. , where the sensor module is configured to determine the size of the operating room and adjust the distance limit of the Bluetooth pairing. A laser-based non-contact sensor module, for example, transmits a laser light pulse, receives a laser light pulse that reflects off the outer wall of an operating room, compares the phase of the transmitted pulse with the received pulse, and compares the phase of the operating room. Scan the operating room by determining the size and adjusting the Bluetooth pairing distance limit.

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

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

In one aspect, the processor 244 may include a safety controller that includes two controller family families, such as the TMS570 and RM4x, also known by the trade designation Hercules ARM Cortex R4, also manufactured by Texas Instruments. Safety controllers may be configured specifically for IEC61508 and ISO26262 safety limit applications to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

System memory includes both volatile and nonvolatile 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, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory can include random access memory (RAM), which acts as external cache memory. Further, RAM includes SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync link DRAM (SLDRAM), and direct RAM bus RAM (DRRAM). available in many forms.

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

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

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

Computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices, or other general network nodes, etc., and are typically computers Includes many or all of the elements described for the system. For simplicity, only the memory storage device is shown along with the remote computer(s). Remote computer(s) are logically connected to the computer system through a network interface and then physically connected via a communications connection. The network interface encompasses communication networks such as local area networks (LAN) and wide area networks (WAN). LAN technologies include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5, and so on. WAN technologies include point-to-point links, circuit-switched networks such as integrated services digital networks (ISDN) and variations thereof, packet-switched networks, and digital subscriber lines (DSL). are not limited to these.

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

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

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

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

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

In various aspects, the USB network hub 300 can connect 127 functions organized in up to 6 logical layers (hierarchies) to a single computer. Additionally, the USB network hub 300 can connect to all peripherals using a standardized four wire cable that provides both communication and power distribution. The power configurations are bus power mode and self power mode. USB network hub 300 has four power management capabilities: a bus-powered hub with either individual port power management or ganged port power management, and a self-powered hub with either individual port power management or ganged port power management. It may be configured to support two modes. In one aspect, using a USB cable, USB network hub 300, the upstream USB transmit/receive port 302 plugs into a USB host controller and the downstream USB transmit/receive ports 304, 306, 308 connect USB compatible devices. and so on.

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

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

In one aspect, microcontroller 461 may include a safety controller that includes two controller family families, such as TMS570 and RM4x, also known by the trade designation Hercules ARM Cortex R4, also manufactured by Texas Instruments. Safety controllers may be configured specifically for IEC61508 and ISO26262 safety limit applications to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

Microcontroller 461 may be programmed to perform various functions such as precise control of the speed and position of the knife, articulation system, clamp arm, or 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 with a gearbox and a mechanical connection to the articulation or knife system. In one aspect, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system. A detailed description of absolute positioning systems can be found in U.S. Patent Application Publication No. 2017, published October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is hereby incorporated by reference in its entirety. 0296213.

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

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

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

Tracking system 480 comprises controlled motor drive circuitry comprising position sensor 472 according to one aspect of the present disclosure. A 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 comprising a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamp arm, which may be adapted and configured to include a rack of drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to open and close a clamp arm of a stapler, ultrasonic, or electrosurgical device, or a combination of the above. 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, clamp arm, or any element that can be displaced. be done. Thus, the absolute positioning system can actually track the displacement of the clamp arm by tracking the linear displacement of the longitudinally movable drive member.

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

The electric motor 482 may include a rotatable shaft that operably interfaces with a gear assembly that is mounted in meshing engagement with a set or rack of drive teeth on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gearing and sensor mechanism can be connected to the linear actuator by a rack and pinion mechanism or to the rotary actuator by spur gears or other connections. A power supply can power the absolute positioning system and an output indicator can display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member having 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 that opens and closes the clamp arm.

One rotation _of the sensor element associated with the position sensor 472 corresponds to the longitudinal linear displacement _d1 of the displacement member, which is the distance after one rotation of the sensor element coupled to the displacement member that the displacement member reaches the point "a ” to point “b”. The sensor mechanism may be connected via a gear reduction that results in the position sensor 472 completing one or more revolutions for a full stroke of the displacement member. The position sensor 472 can complete multiple revolutions for a full stroke of the displacement member.

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

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

In one aspect, position sensor 472 of tracking system 480 comprising an absolute positioning system comprises a gyromagnetic absolute positioning system. Position sensor 472 may be implemented as an AS5055EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. Position sensor 472 cooperates with microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage, low power component and includes four Hall effect elements in the area of the position sensor 472 located above the magnets. Additionally, a high resolution ADC and a smart power management controller are provided on-chip. To implement simple and efficient algorithms for computing hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shift, and table lookup operations, digit-by-digit method and boulder A coordinate rotation digital computer (CORDIC) processor, also known as Volder's algorithm, is provided. Angular position, alarm bits, and magnetic field information are transmitted to microcontroller 461 via a standard serial communication interface, such as a serial peripheral interface (SPI) interface. Position sensor 472 provides 12-bit or 14-bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

Tracking system 480, which includes an absolute positioning system, may include and/or be programmed to implement feedback controllers such as PID, state feedback, and adaptive controllers. A power supply converts the signal from the feedback controller into a physical input to the system, in this case voltage. Other examples include voltage, current and force PWM. In addition to the position measured by position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, the other sensor(s) includes US Pat. , 345,481, U.S. Patent Application Publication No. 2014/0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; US patent application Ser. Sensor mechanisms such as objects can be mentioned. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has finite resolution and sampling frequency. Absolute positioning systems use algorithms such as weighted averages and theoretical control loops to drive the calculated response toward the measured response, and compare and combine circuits to combine the calculated response with the measured response. can be provided. The calculated response of a physical system takes into account properties such as mass, inertia, viscous friction, and induced drag in order to predict what the state and output of the physical system will be given the inputs.

The absolute positioning system resets the displacement members, such as might be required with a conventional rotary encoder where the motor 482 simply counts the number of steps taken forward or backward to estimate the position of machine actuators, drive bars, knives, etc. It provides the absolute position of the displacement member at power up of the instrument without retraction or advancement to the zero (or home) position.

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

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

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

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

FIG. 13 illustrates a control circuit 500 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. Control circuitry 500 may be configured to implement various processes described herein. Control circuitry 500 may comprise a microcontroller comprising one or more processors 502 (eg, microprocessors, microcontrollers) coupled to at least one memory circuit 504 . Memory circuitry 504 stores machine-executable instructions that, when executed by processor 502, cause processor 502 to execute machine instructions to implement various processes described herein. Processor 502 may be any one of numerous single or multi-core processors known in the art. Memory circuit 504 may include volatile and non-volatile storage media. Processor 502 may include an instruction processing unit 506 and 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 combinatorial logic 510 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. Combinatorial logic 510 may be configured to implement various processes described herein. Combinatorial logic 510 is a finite state machine including combinatorial logic 512 configured to receive data associated with a surgical instrument or tool at input 514 , process the data through combinatorial logic 512 , and provide output 516 . can include

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

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

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

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

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

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

In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, a common control module 610 can serve one of multiple motors at a time. For example, a common control module 610 may be individually couplable and detachable for multiple motors of the robotic surgical instrument. In certain examples, multiple motors of a surgical instrument or tool may share one or more common control modules, such as common control module 610 . In certain examples, multiple motors of a surgical instrument or tool can independently and selectively engage a common control module 610 . In certain examples, the common control module 610 is configured to selectively communicate with one of the motors of the surgical instrument or tool to the other of the motors of the surgical instrument or tool. You can switch.

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

Each of the motors 602, 603, 606a, 606b may include a torque sensor for measuring the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor outside the jaws or by a torque sensor on the motor that actuates the jaws.

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

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

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

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

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

In particular examples, memory 624 may contain program instructions for controlling each motor of surgical instrument 600 that may be coupled to a common control module 610 . For example, memory 624 may contain program instructions for controlling firing motor 602, closing motor 603, and articulation motors 606a, 606b. Such program instructions may cause processor 622 to control the firing, closing, and articulating functions according to inputs from an algorithm or control program of the surgical instrument or tool.

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

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

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

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

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

In one aspect, control circuit 710 may generate a motor setpoint signal. Motor setpoint signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e comprise one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e, as described herein. may In some embodiments, motors 704a-704e may be brushed DC electric motors. For example, the speed of motors 704a-704e may be proportional to their respective motor drive signals. In some embodiments, motors 704a-704e may be brushless DC electric motors, with respective motor drive signals provided to one or more stator windings of motors 704a-704e using PWM signal may be included. Also, in some embodiments, the motor controllers 708a-708e may be omitted and the control circuit 710 may directly generate the motor drive signals.

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

In one aspect, the motors 704a-704e may receive power from the energy source 712. Energy source 712 may be a DC power source powered by mains AC power, batteries, supercapacitors, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to respective movable mechanical elements such as closure member 714, clamp arm 716, shaft 740, joint 742a, and joint 742b via respective transmissions 706a-706e. good. The transmissions 706a-706e may include one or more gears or other coupling components for coupling the motors 704a-704e to the movable mechanical elements. A position sensor 734 may sense the position of the closure member 714 . Position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of closure member 714 . In some examples, position sensor 734 may include an encoder configured to provide a series of pulses to control circuit 710 as closure member 714 translates distally and proximally. Control circuit 710 may track the pulses to determine the position of closure member 714 . Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors can provide other signals indicative of movement of closure member 714 . Also, in some embodiments, position sensor 734 may be omitted. If any of motors 704a-704e are stepper motors, control circuit 710 may track the position of closure member 714 by summing the number and direction of steps that motor 704 is instructed to perform. can. The position sensor 734 can be located within the end effector 702 or any other portion of the instrument. Each output 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, control circuit 710 is configured to drive a firing member, such as closure member 714 portion of end effector 702 . Control circuit 710 provides motor settings to motor control 708a, and motor control 708a provides drive signals to motor 704a. The output shaft of motor 704a is coupled to torque sensor 744a. Torque sensor 744 a is coupled to transmission device 706 a that is coupled to closure member 714 . Transmission device 706a includes moveable mechanical elements, such as rotating and firing members, for controlling movement of closure member 714 distally and proximally along the longitudinal axis of end effector 702. FIG. In one aspect, motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. Torque sensor 744 a provides a firing force feedback signal to control circuit 710 . The firing force signal represents the force required to fire or displace closure member 714 . Position sensor 734 may be configured to provide the position of closure member 714 along the firing stroke or the position of the firing member as a feedback signal to control circuit 710 . End effector 702 may include additional sensors 738 configured to provide feedback signals to control circuitry 710 . When ready for use, control circuit 710 can provide a fire signal to motor control 708a. In response to the firing signal, motor 704a drives the firing member distally along the longitudinal axis of end effector 702 from a proximal stroke start position to a stroke end position distal to the stroke start position. be able to. As closure member 714 is translated distally, clamp arm 716 closes toward ultrasonic blade 718 .

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

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

In one aspect, control circuit 710 is configured to articulate end effector 702 . Control circuit 710 provides motor setpoints to motor control 708d, which provides drive signals to motor 704d. The output shaft of motor 704d is coupled to torque sensor 744d. Torque sensor 744d is coupled to transmission 706d that is coupled to articulation member 742a. Transmission device 706d comprises a moveable mechanical element, such as an articulation element for controlling ±65° articulation of end effector 702 . In one aspect, the motor 704d is coupled to an articulation nut that is rotatably journalled on the proximal end portion of the distal spine portion and articulated on the proximal end portion of the distal spine portion. It is rotatably driven by a motion gear assembly. Torque sensor 744 d provides an articulation force feedback signal to 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 articulation position of end effector 702 to control circuit 710 .

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

In one aspect, one or more of the motors 704a-704e may comprise brushed DC motors with gearboxes and mechanical connections to the firing, closing, or articulating members. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation connections, closed tubes, and shafts. External influences are unmeasured and unpredictable influences such as friction on tissues, surroundings, and physical systems. Such an external influence is sometimes referred to as a drag acting against one of the electric motors 704a-704e. External influences, such as disturbances, can cause the behavior of a physical system to deviate from the desired behavior 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 comprise a gyromagnetic absolute positioning system implemented as an AS5055EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. A position sensor 734 can interface with the control circuit 710 to provide an absolute positioning system. The position is located above the magnet and provided to implement simple and efficient algorithms for computing hyperbolic and trigonometric functions, requiring only addition, subtraction, bit-shifting, and table lookup operations. It may include multiple Hall effect elements coupled to the CORDIC processor, also known as the digit-by-digit method and the Boulder algorithm.

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

In one aspect, the one or more sensors 738 may comprise strain gauges, such as micro strain gauges, configured to measure the amount of strain in the clamp arm 716 during clamping conditions. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 738 may comprise a pressure sensor configured to detect pressure created by the presence of compressed tissue between clamp arm 716 and ultrasonic blade 718 . The sensor 738 may be configured to detect the impedance of the tissue portion located between the clamp arm 716 and the ultrasonic blade 718, which impedance is the thickness and/or the thickness of the tissue located between them. Indicates fullness.

In one aspect, the sensor 738 includes one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magneto-resistive (MR) devices, giant magneto-resistive devices, among others. , GMR) device, may be implemented as a magnetometer. In other implementations, 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, among others. Additionally, the switch may be a solid state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, sensors 738 may include conductorless switches, ultrasonic switches, accelerometers, and inertial sensors, among others.

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

In one aspect, a current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements, such as closure member 714, corresponds to the current drawn by one of motors 704a-704e. The force is converted to a digital signal and provided to control circuit 710 . Control circuitry 710 may be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the closure member 714 within the end effector 702 at or near the target velocity. The robotic surgical instrument 700 can include a feedback controller, for example, any feedback controller including, but not limited to, PID, state feedback, linear-quadratic (LQR), and/or adaptive controllers. may be any one of Robotic surgical instrument 700 can include a power supply for converting signals from the feedback controller into physical inputs such as, for example, case voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force. . Further details are disclosed in U.S. patent application Ser. No. 15/636,829, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT," filed Jun. 29, 2017, which is incorporated herein by reference in its entirety. It is

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

The position, movement, displacement and/or translation of a linear displacement member such as closure member 764 can be measured by absolute positioning system, sensor mechanism 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 using the position sensor 784. can be done. Accordingly, in the discussion below, the position, displacement, and/or translation of closure member 764 may be accomplished by position sensor 784 as described herein. Control circuitry 760 may be programmed to control translation of a displacement member, such as closure member 764 . In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or processors to control the displacement member, such as the closure member 764, in the manner described. Other suitable processors may be provided for execution. In one aspect, timer/counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate the position of closure member 764 determined by position sensor 784 with the output of timer/counter 781. , so that the control circuit 760 can determine the position of the closure member 764 at a particular time (t) relative to the starting position. Timer/counter 781 may be configured to measure elapsed time, count external events, or time external events.

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

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

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

The one or more sensors 788 may comprise strain gauges, such as micro strain gauges, configured to measure the amount of strain in the clamp arm 766 during clamping conditions. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 788 may comprise a pressure sensor configured to detect pressure created by the presence of compressed tissue between clamp arm 766 and ultrasonic blade 768 . The sensor 788 may be configured to detect the impedance of the tissue section located between the clamp arm 766 and the ultrasonic blade 768, which impedance is the thickness and/or the thickness of the tissue located between them. Indicates fullness.

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

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

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

The actual drive system of surgical instrument 750 is such that the displacement member, cutting member, or closure member 764 is driven by a gearbox and brushed DC motor with mechanical connection to the articulation and/or knife system. is configured to Another example is, for example, an electric motor 754 that operates displacement members and articulation drivers of interchangeable shaft assemblies. External influences are unmeasured and unpredictable influences such as friction on tissues, surroundings and physical systems. Such external influences can be referred to as disturbances acting against the electric motor 754 . External influences, such as disturbances, can cause the behavior of a physical system to deviate from the desired behavior of the physical system.

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

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

In some embodiments, control circuit 760 may initially operate motor 754 in an open loop configuration for a first open loop portion of the stroke of the displacement member. Based on the response of instrument 750 during the open-loop portion of the stroke, control circuit 760 may select a firing control program. The response of the instrument includes the translational distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, and the total pulse width of the motor drive signal. etc. can be mentioned. After the open loop portion, control circuit 760 may implement the selected firing control program for the second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, control circuit 760 may closed-loop modulate motor 754 based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity. Further details can be found in U.S. patent application Ser. disclosed in

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

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

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

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

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

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

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

Generator Hardware Adaptive Ultrasonic Blade 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 tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize the tissue type. Algorithms for detecting the collagen/elasticity ratio of tissue for adjusting the amplitude of the distal tip of the ultrasonic blade are described in the following sections of this disclosure. Various aspects of smart ultrasonic energy devices are described herein, for example, in connection with FIGS. 1-85. Accordingly, the following description of adaptive ultrasonic blade control algorithms should be read in conjunction with FIGS. 1-85 and their associated descriptions.

Tissue Type Identification and Device Parameter Adjustment In certain surgical procedures, it is desirable to use adaptive ultrasonic blade control algorithms. In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust the parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device may be adjusted based on the position of the tissue within the jaws of the ultrasonic end effector, eg, the position of the tissue between the clamp arm and the ultrasonic blade. The impedance of the ultrasound transducer may be used to identify which percentage of tissue is located at the distal or proximal end of the end effector. The response of the ultrasound device can be based on tissue type or tissue compressibility. In another aspect, ultrasound system parameters 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 adjusted based on the ratio of collagen to elastin tissue detected during the tissue identification procedure. The ratio of collagen to elastin tissue can be detected using various techniques, including infrared (IR) surface reflectance and emissivity. The force exerted on tissue by the clamping arm and/or the stroke of the clamping arm to create gaps and compression. Electrical continuity across the electroded jaws can be used to determine what percentage of the jaws is covered with tissue.

FIG. 20 is a system 800 configured to execute adaptive ultrasonic blade control algorithms within a surgical data network comprising 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 the adaptive ultrasonic blade control algorithm(s) 802 described herein with reference to FIGS. 43A-54. In another aspect, the device/instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm(s) 804 described herein with reference to FIGS. 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 described herein with reference to FIGS. be done.

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

The generator module 240, or the device/instrument 235, or both, may be used, for example, in intelligent surgical instruments, robots, and other computers located in the operating room, such as those described with reference to FIGS. It is coupled to a modular control tower 236 that is connected to multiple operating room equipment, such as a facilitator.

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

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

In one aspect, the impedance is equal to either the first voltage sensing circuit 912 coupled across the terminal labeled ENERGY ₁ /RETURN or the second voltage sensing circuit 924 coupled across the terminal labeled ENERGY ₂ /RETURN. This output may be determined by processor 902 by dividing by the output of current sensing circuit 914 placed in series with the RETURN leg on the secondary side of power transformer 908 . The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to separate isolation transformers 916 , 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 916 . Digitized voltage and current sensing measurements from ADC circuitry 926 are provided to processor 902 for calculating impedance. As an example, the first energy modality ENERGY ₁ may be ultrasonic energy and the second energy modality ENERGY ₂ may be RF energy. Yet, in addition to ultrasound energy modalities 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 illustrated in FIG. 21 shows that a single return path (RETURN) may be provided to more than one energy modality, in other aspects multiple return paths RETURN _n may May be provided for each energy modality ENERGY _n . Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914, and the tissue impedance is the second It may be measured by dividing the voltage sensing circuit 924 output by 2 by the current sensing circuit 914 .

As shown in FIG. 21, the generator 900, including at least one output port, provides power, e.g., ultrasound, bipolar or monopolar RF, irreversible and/or or reversible electroporation, and/or a power transformer having a single output and having multiple taps to provide an end effector in the form of one or more energy modalities such as microwave energy. A device 908 can be included. For example, the generator 900 drives RF electrodes for tissue sealing using either monopolar or bipolar RF electrosurgical electrodes with high voltage and low current to drive the ultrasonic transducer. Energy can be delivered at low voltage and high current for spot coagulation, or in a coagulation waveform for spot coagulation. The output waveform from generator 900 may be induced, switched, or filtered to provide frequencies to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the generator 900 output will preferably be located between the output labeled ENERGY ₁ and RETURN as shown in FIG. In one embodiment, the connection to the output of the RF bipolar electrode generator 900 will preferably be located between the output labeled ENERGY ₂ and RETURN. For unipolar outputs, the preferred connections would be active electrodes (eg pencil or other probes) to suitable return pads connected to the ENERGY ₂ and RETURN outputs.

Further details can be found in the U.S. Patent, published Mar. 30, 2017, entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety. Application Publication No. 2017/0086914 disclosed in No.

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

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

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

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

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

Any processor or microcontroller described herein may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor has on-chip memory, e.g., 256 KB of single-cycle flash memory or other non-volatile memory at up to 40 MHz, details of which are available in the product datasheet, to improve performance beyond 40 MHz. 1 or 2 prefetch buffers, 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2 KB electrically erasable programmable read-only memory (EEPROM) One or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels ), including the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.

In one aspect, the processor may include a safety controller that includes two controller family families, such as the TMS570 and RM4x, also known by the trade designation Hercules ARM Cortex R4, also manufactured by Texas Instruments. Safety controllers may be configured specifically for IEC61508 and ISO26262 safety limit applications to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

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

FIG. 22 shows one form of surgical system 1000 comprising a generator 1100 and various surgical instruments 1104, 1106, 1108 usable therewith, wherein surgical instrument 1104 is an ultrasonic surgical instrument; Surgical instrument 1106 is an RF electrosurgical instrument and multi-function surgical instrument 1108 is a combined ultrasonic/RF electrosurgical instrument. Generator 1100 is configurable for use with various surgical instruments. According to various aspects, the generator 1100 is, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument that integrates RF and ultrasonic energy simultaneously delivered from the generator 1100. The surgical instrument 1108 may be configurable for use with various types of various surgical devices. In the form of FIG. 22, generator 1100 is shown separate from surgical instruments 1104, 1106, 1108, but in one form, generator 1100 is attached to any of surgical instruments 1104, 1106, 1108. It may be formed integrally with the same to form an integrated surgical system. The generator 1100 has an input device 1110 located on the front panel of the console of the generator 1100 . Input device 1110 may comprise any suitable device for generating signals suitable for programming the operation of generator 1100 . Generator 1100 may be configured for wired or wireless communication.

Generator 1100 is configured to drive multiple surgical instruments 1104 , 1106 , 1108 . The first surgical instrument is an ultrasonic surgical instrument 1104 , comprising a handpiece 1105 (HP), an ultrasonic transducer 1120 , a shaft 1126 and an end effector 1122 . End effector 1122 comprises ultrasonic blade 1128 and clamp arm 1140 acoustically coupled to ultrasonic transducer 1120 . Handpiece 1105 includes a trigger 1143 to operate clamp arm 1140 and a combination of toggle buttons 1134a, 1134b, 1134c to energize and drive ultrasonic blade 1128 or other functions. Toggle buttons 1134 a , 1134 b , 1134 c can be configured to energize ultrasonic transducer 1120 with generator 1100 .

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

Generator 1100 is also configured to drive multi-function surgical instrument 1108 . Multi-function surgical instrument 1108 includes handpiece 1109 (HP), shaft 1129 and end effector 1125 . End effector 1125 includes ultrasonic blade 1149 and clamp arm 1146 . Ultrasonic blade 1149 is acoustically coupled with ultrasonic transducer 1120 . Handpiece 1109 includes a trigger 1147 to operate clamp arm 1146 and a combination of toggle buttons 1137a, 1137b, 1137c to energize and drive ultrasonic blade 1149 or other functions. Toggle buttons 1137a, 1137b, 1137c are used to energize the ultrasonic transducer 1120 with the generator 1100 and to energize the ultrasonic blade 1149 with the bipolar energy source also contained within the generator 1100. Can be configured.

Generator 1100 is configurable for use with various surgical instruments. According to various aspects, the generator 1100 is, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument that integrates RF and ultrasonic energy simultaneously delivered from the generator 1100. The surgical instrument 1108 may be configurable for use with various types of various surgical devices. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108; Either one may be integrally formed to form an integrated surgical system. As mentioned 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 comprise any suitable device for generating signals suitable for programming the operation of generator 1100 . Generator 1100 may also include one or more output devices 1112 . Further aspects of a generator for digitally generating electrical signal waveforms and surgical instruments are described in US Patent Application Publication No. 2017-0086914-A1, which is incorporated herein by reference in its entirety. there is

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

Generator 1100 may be activated to provide drive signals to ultrasonic transducer 1120 in any suitable manner. For example, generator 1100 may include footswitch 1430 (FIG. 24) coupled to generator 1100 via footswitch cable 1432 . The clinician may activate the ultrasound transducer 1120 by depressing the footswitch 1430 and thereby activate the ultrasound transducer 1120 and the blade 1128 . In addition to or in lieu of footswitch 1430, some versions of device 1104 may employ one or more switches located on handpiece 1105 that, when activated, , the generator 1100 can activate the ultrasonic transducer 1120 . In one aspect, for example, one or more switches may include a pair of toggle buttons 1134a, 1134b, 1134c (FIG. 22), for example, to determine the operational mode of device 1104. FIG. For example, when toggle button 1134a is depressed, ultrasonic generator 1100 can provide a maximum drive signal to ultrasonic transducer 1120, causing ultrasonic transducer 1120 to produce maximum ultrasonic energy output. Pressing toggle button 1134b causes ultrasonic generator 1100 to provide a user-selectable drive signal to ultrasonic transducer 1120 to cause ultrasonic transducer 1120 to produce less than maximum ultrasonic energy output. . Device 1104 may additionally or alternatively include a second switch for indicating the position of a jaw closure trigger, for example to manipulate the jaws via clamp arm 1140 of end effector 1122 . Also, in some aspects, the ultrasonic generator 1100 can be activated based on the position of the jaw closure trigger (eg, when the clinician depresses the jaw closure trigger to close the jaws via the clamp arm 1140). , ultrasonic energy can be applied).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FIG. 25 shows an equivalent circuit 1500 of an ultrasonic transducer, such as ultrasonic transducer 1120, according to one aspect. Circuit 1500 includes a first "working" branch having series-connected inductance L _s , resistance R _s and capacitance C _s and a second branch having capacitance C ₀ that defines the electromechanical properties of the resonator. and a capacitive branch of . With the operating current I _m (t) flowing through the first branch and the currents I _g (t)-I _m (t) flowing through the capacitive branches, the driving current I _g (t) is the generator may be received at a drive voltage V _g (t) from . Control of the electromechanical properties of an ultrasonic transducer may be achieved by suitably controlling I _g (t) and V _g (t). As noted above, known generator architectures require a capacitance C ₀ in the parallel resonant circuit at the resonant frequency such that substantially all of the current output I _g (t) of the generator flows through the working branch. A tuning inductor L _t (shown in phantom in FIG. 25) may be included to tune out the . In this method, control of the operating branch current I _m (t) is achieved by controlling the current output I _g (t) of the generator. The tuning inductor _Lt is specific to the capacitance _C0 of the ultrasonic transducer, but different ultrasonic transducers with different static capacitances require different tuning inductors _Lt. Also, since the tuning inductor L _t matches the nominal value of the capacitance C ₀ at a single resonant frequency, accurate control of the operating branch current _Im (t) is guaranteed only at that frequency. Accurate control of the operating branch currents is compromised as the frequency drops with the temperature of the converter.

Various aspects of generator 1100 can monitor operating branch currents _Im (t) without resorting to tuning inductor _Lt. Rather, generator 1100 applies power for a particular ultrasonic surgical device 1104 to determine the value of operating branch current I _m (t) on a dynamic and ongoing basis (eg, in real-time). A measurement of the capacitance C ₀ between can be used (along with the drive signal voltage and current feedback data). Thus, such aspects of the generator 1100 can be tuned with any value of capacitance _C0 at any frequency, not just at a single resonant frequency determined by the nominal value of capacitance _C0 , or Virtual adjustments can be provided to simulate resonant systems.

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

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

In certain aspects, and as described in further detail in connection with FIGS. 28A-28B, programmable logic 1660 in conjunction with processor 1740 implements a direct digital synthesizer (DDS) control scheme to The waveform shape, frequency, and/or amplitude of the drive signal output by device 1100 may be controlled. In one aspect, for example, programmable logic 1660 implements DDS control by calling waveform samples stored in a dynamically updated lookup table (LUT), such as a RAM LUT, which may be embedded in an FPGA. Algorithm 2680 (FIG. 28A) may be executed. This control algorithm is particularly useful in ultrasonic applications where an ultrasonic transducer, such as ultrasonic transducer 1120, can be driven by a distinct sinusoidal current at its resonant frequency. Since other frequencies can excite parasitic resonances, minimizing or reducing the total distortion of the operating branch currents can correspondingly minimize or reduce undesirable resonance effects. Since the waveform shape of the drive signal output by generator 1100 can be affected by various distortion sources present in the output drive circuit (eg, power transformer 1560, power amplifier 1620), the voltage and current based on the drive signal The feedback data can be input to an algorithm, such as an error control algorithm executed by processor 1740, which, on a dynamic, ongoing basis (e.g., in real time), feeds waveform samples stored in the LUT. Compensate for the distortion by appropriately predistorting or modifying it. In one aspect, the amount or degree of predistortion applied to the LUT samples may be based on the error between the calculated operating branch current and the desired current waveform shape, the error being determined on a sample-by-sample basis. In this way, the pre-distorted LUT samples, when processed by the drive circuit, produce an operating branch drive signal having a desired waveform shape (e.g., sinusoidal) to optimally drive the ultrasonic transducer. can occur. Thus, in such an aspect, the LUT waveform samples are not the desired waveform shape of the drive signal, but rather the desired waveform required to ultimately produce the desired waveform of the operating branch drive signal when distortion effects are taken into account. Represents waveform shape.

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

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

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

Evaluating the Fourier transform at the frequency of the sinusoid gives

Other approaches include weighted least squares estimation, Kalman filtering, and space vector-based techniques. Substantially all of the processing in the FFT or DFT technique may be performed in the digital domain using, for example, 2-channel high speed ADCs 1780, 1800. In one technique, digital signal samples of the voltage and current signals are Fourier transformed with an FFT or DFT. The phase angle φ at any point in time can be calculated by the following formula:
φ=2πft+φ ₀
where φ is the phase angle, f is the frequency, t is the time, and φ ₀ is the phase at t=0.

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

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

In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the drive signal at the current amplitude setpoint. The current amplitude setting may be specified directly or indirectly determined based on the specified voltage amplitude and power settings. In certain aspects, control of current amplitude may be performed by a control algorithm, such as, for example, a proportional-integral-derivative (PID) control algorithm within processor 1740 . Variables controlled by the control algorithm to properly control the current amplitude of the drive signal include, for example, scaling of LUT waveform samples stored in programmable logic 1660 and/or DAC 1680 via DAC 1860 (which supplies the input to power amplifier 1620).

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

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

The non-isolated stage 1540 includes a controller 1960 (FIG. 26, FIG. 27B) can also be included. In certain aspects, controller 1960 may comprise at least one processor and/or other controller device in communication with processor 1900 . In one aspect, for example, the controller 1960 is a processor (eg, Mega1688 available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. bit controller). In one aspect, controller 1960 can comprise a touchscreen controller (eg, QT5480 touchscreen controller available from Atmel) for controlling and managing acquisition of touch data from a capacitive touchscreen.

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

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

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

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

In one aspect, the instrument interface circuit 1980 includes programmable logic 2000 (or other elements of the instrument interface circuit 1980) located within or otherwise associated with the surgical device. A first data circuit interface 2040 may be provided to allow information exchange with the first data circuit. In certain aspects, for example, the first data circuit 2060 may reside within a cable integrally attached to a hand piece of a surgical device or within an adapter for interfacing a particular surgical device type or model with the generator 1100 . may be placed within In certain aspects, the first data circuit may comprise a non-volatile storage device, such as an electrically erasable programmable read only memory (EEPROM) device. In certain aspects, and referring again to FIG. 26, the first data circuit interface 2040 can be implemented separately from the programmable logic 2000 and can be implemented separately from the programmable logic 2000 and the first data circuit. Any suitable circuitry (eg, discrete logic, processor) may be provided to enable communication between the . In other aspects, first data circuit interface 2040 may be integral with programmable logic 2000 .

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

As noted above, the surgical instruments may be removable from the handpiece (eg, instrument 1106 may be removable from handpiece 1107 to facilitate interchangeability and/or disposability of the instruments). may be used). In such cases, known generators may be limited in their ability to recognize the particular instrument configuration being used and correspondingly optimize the control and diagnostic processes. However, adding a readable data circuit to the surgical instrumentation to address this issue is problematic from a compatibility standpoint. For example, it is impractical to design a surgical device to be backward compatible with generators that lack the necessary data readout capabilities, due to, for example, different signal schemes, design complexity, and cost. Sometimes. Other aspects of the instrument economically use data circuitry that can be implemented in existing surgical instruments and minimize design changes to maintain compatibility between surgical devices and modern generator platforms. address these concerns by

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

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

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

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

28A-28B illustrate certain functional and structural aspects of one aspect of generator 1100. FIG. Feedback indicative of the current and voltage output from secondary winding 1580 of power transformer 1560 is received by ADCs 1780, 1800, respectively. As shown, the ADCs 1780, 1800 can be implemented as 2-channel ADCs and are fast (e.g., 80 Msps) to allow oversampling of the drive signal (e.g., approximately 200x oversampling). A feedback signal can be sampled. Current and voltage feedback signals may be appropriately conditioned (eg, amplified, filtered) in the analog domain prior to processing by ADCs 1780, 1800. Current and voltage feedback samples from ADCs 1780 , 1800 may be individually buffered and then multiplexed or interleaved into a single data stream within block 2120 of programmable logic 1660 . In the embodiment of Figures 28A-28B, programmable logic 1660 comprises an FPGA.

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

Block 2200 of processor 1740 can implement a pre-distortion algorithm to pre-distort or modify the LUT samples stored in programmable logic 1660 on a dynamic, ongoing basis. As noted above, predistortion of the LUT samples can compensate for various sources of distortion present in the output driver circuitry of generator 1100 . The pre-distorted LUT samples thus, when processed by the drive circuit, yield a drive signal having the desired waveform shape (eg, sinusoidal) to optimally drive the ultrasonic transducer.

At block 2220 of the predistortion algorithm, the current through the working branch of the ultrasound transducer is determined. The operating branch currents are, for example, current and voltage feedback samples stored in memory location 2180 (which, when scaled appropriately, may represent the I _g and V _g of the model of FIG. 25 above), ultrasonic transduction Based on the value of the device capacitance _C0 (measured or known a priori) and the known value of the drive frequency, it can be determined using Kirchhoff's current law. An operating branch current sample may be determined for each set of stored current and voltage feedback samples associated with the LUT sample.

At block 2240 of the predistortion algorithm, each operating branch current sample determined at block 2220 is compared to samples of the desired current waveform shape to determine the difference or sample amplitude error between the compared samples. For this determination, current waveform shape samples may be provided, for example, from a waveform shape LUT 2260 containing amplitude samples for one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT 2260 used for comparison may be determined by the LUT sample address associated with the operating branch current sample used for comparison. Thus, the input to block 2240 of operation branch currents can be synchronized with the input to block 2240 of its associated LUT sample address. Therefore, the LUT samples stored in programmable logic 1660 and the LUT samples stored in waveform shape LUT 2260 can be of equivalent numerical value. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT 2260 can be a fundamental sine wave. Other corrugation shapes may be desirable. superimposed with one or more other drive signals at other wavelengths, such as the third harmonic to drive at least two mechanical resonances for lateral or other modes of beneficial vibration It is envisioned that a fundamental sine wave could be used to drive the primary longitudinal motion of the ultrasonic transducer.

Each value of sample amplitude error determined at block 2240, along with its associated LUT address index, can be communicated to the LUT of programmable logic 1660 (shown at block 2280 in FIG. 28A). Based on the sample amplitude error value and its associated address (and optionally the sample amplitude error value for the same previously received LUT address), LUT 2280 (or other control block of programmable logic 1660) ) can pre-distort or modify the values of the LUT samples stored at the LUT addresses, thereby reducing or minimizing the sample amplitude error. Such predistortion or modification of each LUT sample in an iterative manner over the range of LUT addresses causes the waveform shape of the generator's output current to match the desired current waveform shape represented by the samples of waveform shape LUT 2260. Matching or matching is understood.

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

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

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

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

At block 2400, the generator apparent output power measurement P _a may be determined as the product V _rms ·I _rms .

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

In certain aspects, the numerical values I _rms , V _rms , P _r , P _a , and Z _m determined in blocks 2340, 2360, 2380, 2400, and 2420 are controlled by any of a number of control and/or diagnostic processes. can be used by generator 1100 to implement: In certain aspects, any of these values can be transmitted, for example, via an output device 2140 integral with the generator 1100 or connected to the generator 1100 via a suitable communication interface (eg, a USB interface). can be communicated to the user through Various diagnostic processes include, for example, handpiece integrity, instrument integrity, instrument mount integrity, instrument overload, instrument overload approaching, frequency locking failure, over voltage condition, over current condition, over power condition, voltage sensing failure. , current sensing failure, audible indication failure, visual indication failure, short circuit condition, power supply failure, or blocking capacitor failure.

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

The phase control algorithm receives as input current and voltage feedback samples stored in memory location 2180 . Before using them in the phase control algorithm, the feedback samples are appropriately scaled and, in certain aspects, an appropriate filter 2460 ( may be processed through a filter 2320). The filtered voltage and current samples can thus substantially represent the fundamental frequency of the generator's drive output signal.

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

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

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

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

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

In aspects where the drive signal voltage is the controlled variable, the current demand I _d maintains the desired voltage set point 2620B (V _sp ) given the load impedance magnitude Z _m measured at block 2420, for example. can be specified indirectly based on the current required to do so (eg, I _d =V _sp /Z _m ). Similarly, in aspects where the drive signal power is the controlled variable, the current demand I _d will maintain the desired power setpoint 2620C (P _sp ) given the voltage V _rms measured at block 2360, for example. can be indirectly specified based on the current required for (eg, I _d =P _sp /V _rms ).

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

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

FIG. 29 is a circuit diagram of one aspect of an electrical circuit 2900 suitable for driving an ultrasound transducer, such as ultrasound transducer 1120, in accordance with at least one aspect of the present disclosure. Electrical circuit 2900 comprises analog multiplexer 2980 . Analog multiplexer 2980 multiplexes various signals from upstream channels 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 leg of the power supply circuit to measure the current supplied by the power supply. A field effect transistor (FET) temperature sensor 2984 provides the ambient temperature. A pulse width modulation (PWM) watchdog timer 2988 automatically causes system resets if the main program fails to provide periodic system resets. This is provided to automatically reset the electrical circuit 2900 if the electrical circuit 2900 hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 2900 may be configured as an RF driver circuit for driving an ultrasound transducer or for driving an RF electrode such as the electrical circuit 3600 shown in FIG. 34, for example. Thus, referring now again to FIG. 29, an electrical circuit 2900 can be used to alternately drive both the ultrasonic transducer and the RF electrodes. A filter circuit may be provided in the corresponding first stage circuit 3404 (FIG. 32) to select either the ultrasound waveform or the RF waveform when driven simultaneously. Such filtering techniques are described in commonly owned US Patent Application Publication No. US-2017-0086910-A1, entitled "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR," which is incorporated herein by reference in its entirety.

A drive circuit 2986 provides left and right ultrasonic energy outputs. Digital signals representing signal waveforms are provided to the SCL-A, SDA-A inputs of analog multiplexer 2980 from a control circuit such as control circuit 3200 (FIG. 30). A digital-to-analog converter 2990 (DAC) converts a digital input to an analog output to drive a PWM circuit 2992 coupled to oscillator 2994 . A 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 across the ultrasound left/right output terminals to measure the output voltage. Driver circuit 2986, first driver circuit 2996a and second driver circuit 2996b, and first transistor output stage 2998a and second transistor output stage 2998b define a first stage amplifier circuit. In operation, control circuit 3200 (Fig. 30) generates digital waveform 4300 (Fig. 37) using circuits such as direct digital synthesis (DDS) circuits 4100, 4200 (Figs. 35 and 36). DAC 2990 receives digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

FIG. 30 is a circuit diagram of a control circuit 3200, such as control circuit 3212, in accordance with at least one aspect of the disclosure. Control circuitry 3200 is located within the housing of the battery assembly. The battery assembly is the energy source for various local power sources 3215 . The control circuit provides main processor 3214 coupled to various downstream circuits via interface master 3218 by outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C, for example. Prepare. In one aspect, interface master 3218 is a universal serial interface, such as an ^I2C serial interface. Main processor 3214 also drives switch 3224 via general purpose input/output (GPIO) 3220 , display 3226 (eg, and LCD display), and various indicators 3228 via GPIO 3222 . configured to A watchdog processor 3216 is provided 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, main processor 3214 is coupled to electrical circuit 2900 (FIG. 29) by output terminals SCL-A, SDA-A. Main processor 3214 includes memory for storing, for example, a table of digitized drive signals or waveforms that are transmitted to electrical circuitry 2900 to drive ultrasonic transducer 1120 . In other aspects, main processor 3214 may generate a digital waveform and transmit it to electrical circuit 2900 or may store the digital waveform for later transmission to electrical circuit 2900 . Main processor 3214 also provides RF drive via output terminals SCL-B, SDA-B and various sensors (eg, Hall effect sensors, magneto-rheological fluid (MRF) sensors, etc.) via output terminals SCL-C, SDA-C. may be provided. In one aspect, the main processor 3214 is configured to sense the presence of ultrasound and/or RF drive circuitry to enable appropriate software and user interface functionality.

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

FIG. 31 shows a simplified block circuit diagram showing another electrical circuit 3300 housed within a modular ultrasonic surgical instrument 3334, according to at least one aspect of the present disclosure. The electrical circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power source 3304 (eg, a battery), a switch 3306 such as a metal oxide semiconductor field effect transistor (MOSFET) power switch, a drive circuit 3308 (PLL), a transformer 3310, a signal A smoothing circuit 3312 (also called a matching circuit, which can be, for example, a tank circuit), a sensing circuit 3314, a transducer 1120, and an ultrasonic blade (e.g., an ultrasonic blade 1128, 1149) with ultrasonic transmission waveguides (eg, shaft assemblies 1126, 1129).

One feature of the present disclosure that breaks the dependency on high voltage (120 VAC) input power (a characteristic of typical ultrasonic cutting equipment) is the use of low voltage switching throughout the wave forming process and just prior to the transformer stage. is the amplification of the drive signal limited to For this reason, in one aspect of the present disclosure, power is derived only from a battery or batteries small enough to fit either within the handle assembly. State-of-the-art battery technology provides powerful batteries that are several centimeters in height and width and several millimeters in depth. Reduced manufacturing costs can be achieved by combining features of the present disclosure to provide a self-contained and self-powered ultrasound system.

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

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

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

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

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

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

According to at least one aspect of the present disclosure, a PLL portion of drive circuitry 3308 coupled to processor 3302 can determine the frequency of waveguide motion and communicate that frequency to processor 3302 . Processor 3302 stores this frequency value in memory 3326 when the device is turned off. By reading the clock 3330, the processor 3302 can determine the elapsed time after the device has been shut off, and if the elapsed time is less than a predetermined value, read the last frequency of waveguide motion. . The device can then start at the last frequency, which is presumably the optimum frequency for the current load.

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

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

The loading device may include any one of an ultrasonic transducer, electrodes, or sensors, or any combination thereof. The first stage circuit may comprise a first stage ultrasonic driver circuit and a first stage high frequency current driver circuit. The control circuit may be configured to drive the first stage ultrasonic drive circuit and the first stage high frequency current drive circuit separately or simultaneously. The first stage ultrasonic drive circuit may be configured to couple to the second stage ultrasonic drive circuit. A second stage ultrasound drive circuit may be configured to couple with the ultrasound transducer. The first stage high frequency current drive circuit may be configured to be coupled to the second stage high frequency drive circuit. A second stage RF drive circuit may be configured to couple to the electrode.

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

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

The loading device may include any one of an ultrasonic transducer, electrodes, or sensors, or any combination thereof. A common first stage circuit may be configured to drive ultrasound, high frequency current, or sensor circuits. A common first stage driver circuit may be configured to be coupled with a second stage ultrasonic driver circuit, a second stage radio frequency driver circuit, or a second stage sensor driver circuit. A second stage ultrasonic drive circuit may be configured to couple with the ultrasonic transducer, a second stage radio frequency drive circuit configured to couple with the electrode, and a second stage sensor drive circuit coupled with the sensor. is configured as

In another aspect, the present disclosure is a control circuit including a memory coupled to a processor, the processor configured to generate a digital waveform, and a common first stage circuit coupled to the processor. wherein the common first stage circuit is configured to receive the digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform; a shaft assembly including a second stage circuit coupled with the common first stage circuit for amplifying and amplifying, the shaft assembly configured to mechanically and electrically connect with the handle assembly; Provides surgical instruments.

A common first stage circuit may be configured to drive ultrasound, high frequency current, or sensor circuits. A common first stage driver circuit may be configured to be coupled with a second stage ultrasonic driver circuit, a second stage radio frequency driver circuit, or a second stage sensor driver circuit. A second stage ultrasonic drive circuit may be configured to couple with the ultrasonic transducer, a second stage radio frequency drive circuit configured to couple with the electrode, and a second stage sensor drive circuit coupled with the sensor. is configured as

FIG. 32 shows a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406, according to at least one aspect of the disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3400 divided into multiple stages. For example, the surgical instrument of surgical system 1000 may include at least two circuits: an amplification first stage circuit that enables operation of RF energy only, ultrasonic energy only, and/or a combination of RF energy and ultrasonic energy. A generator circuit 3400 may be provided divided into 3404 and a second stage circuit 3406 . The combination modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within the handle assembly 3412 and a modular second stage circuit 3406 integral with the modular shaft assembly 3414 . Battery assembly 3410 and shaft assembly 3414 are configured to mechanically and electrically connect with handle assembly 3412 as described above in connection with the surgical instruments of surgical system 1000 throughout this description. The end effector assembly is configured to mechanically and electrically connect with shaft assembly 3414 .

Referring now to FIG. 32, generator circuit 3400 is divided into multiple stages located within multiple modular assemblies of a surgical instrument, such as the surgical instrument of surgical system 1000 described herein. . In one aspect, the control stage circuitry 3402 may be located within the battery assembly 3410 of the surgical instrument. Control stage circuit 3402 is control circuit 3200 described in connection with FIG. Control circuit 3200 comprises a processor 3214 including internal memory 3217 (FIG. 32) (eg, volatile and non-volatile memory) and electrically coupled to battery 3211 . Battery 3211 powers first stage circuitry 3404, second stage circuitry 3406, and third stage circuitry 3408, respectively. As previously described, control circuit 3200 generates digital waveform 4300 (FIG. 37) using the circuits and techniques described in connection with FIGS. Referring again to FIG. 32, digital waveform 4300 can be configured to drive ultrasonic transducers, radio frequency (eg, RF) electrodes, or combinations thereof either individually or simultaneously. A filter circuit may be provided in the corresponding first stage circuit 3404 to select either the ultrasound waveform or the RF waveform when driven simultaneously. Such filtering techniques are described in commonly owned US Patent Application Publication No. US-2017-0086910-A1, entitled "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR," which is incorporated herein by reference in its entirety.

First stage circuitry 3404 (eg, first stage ultrasound driver circuitry 3420, first stage RF driver circuitry 3422, and first stage sensor driver circuitry 3424) is located within handle assembly 3412 of the surgical instrument. Control circuit 3200 provides ultrasonic drive signals to first stage ultrasonic drive circuit 3420 via outputs SCL-A, SDA-A of control circuit 3200 . The first stage ultrasound driver circuit 3420 is described in detail in connection with FIG. Control circuit 3200 provides RF drive signals to first stage RF drive circuit 3422 via outputs SCL-B, SDA-B of control circuit 3200 . The first stage RF drive circuit 3422 is described in detail in connection with FIG. Control circuit 3200 provides sensor drive signals to first stage sensor drive circuit 3424 via outputs SCL-C, SDA-C of control circuit 3200 . In general, each first stage circuit 3404 includes a digital-to-analog (DAC) converter and first stage amplifier section for driving the second stage circuit 3406 . The output of first stage circuit 3404 is provided to the input of second stage circuit 3406 .

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

In one aspect, second stage circuitry 3406 (eg, ultrasonically driven second stage circuitry 3430, RF driven second stage circuitry 3432, and sensor driven second stage circuitry 3434) is located within shaft assembly 3414 of the surgical instrument. do. First stage ultrasound driver circuit 3420 provides a signal to second stage ultrasound driver circuit 3430 via output US left/US right. Second stage ultrasound drive circuitry 3430 may include, for example, transformers, filters, amplifiers, and/or signal conditioning circuitry. A first stage radio frequency (RF) current drive circuit 3422 provides a signal to a second stage RF drive circuit 3432 via outputs RF left/RF right. In addition to transformers and blocking capacitors, second stage RF drive circuitry 3432 may also include filters, amplifiers, and signal conditioning circuitry. First stage sensor drive circuit 3424 provides a signal to second stage sensor drive circuit 3434 via output sensor 1/sensor 2 . Second stage sensor drive circuitry 3434 may include filters, amplifiers, and signal conditioning circuitry depending on the type of sensor. The output of second stage circuit 3406 is provided to the input of third stage circuit 3408 .

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

FIG. 33 illustrates a multistage divided generator circuit 3500 in which a first stage circuit 3504 is common with a second stage circuit 3506, in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3500 divided into multiple stages. For example, the surgical instrument of surgical system 1000 includes at least two circuits of amplification that enable operation of radio frequency (RF) energy only, ultrasonic energy only, and/or a combination of RF and ultrasonic energy. The generator circuit 3500 may be divided into a first stage circuit 3504 and a second stage circuit 3506 . The combination modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 integral with the modular shaft assembly 3514 . Battery assembly 3510 and shaft assembly 3514 are configured to mechanically and electrically connect with handle assembly 3512 as previously described throughout this description with respect to the surgical instruments of surgical system 1000 . The end effector assembly is configured to mechanically and electrically connect shaft assembly 3514 .

As shown in the embodiment of FIG. 33, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes the control circuit 3200 previously described. The handle assembly 3512 that connects to the battery assembly 3510 includes a common first stage drive circuit 3420 . As previously described, the first stage drive circuit 3420 is configured to drive ultrasound, radio frequency (RF) current, and sensor loads. The output of the common first stage driver circuit 3420 is used by a second stage circuit 3506 such as a second stage ultrasonic driver circuit 3430, a second stage radio frequency (RF) current driver circuit 3432, and/or a second stage sensor driver circuit 3434. can be driven. A common first stage drive circuit 3420 detects which second stage circuit 3506 is located within the shaft assembly 3514 when the shaft assembly 3514 is connected to the handle assembly 3512 . When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 is connected to the second stage circuit 3506 (e.g., second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and/or or determine which one of the second stage sensor drive circuits 3434 ) is located within the shaft assembly 3514 . This information is located within handle assembly 3512 to provide appropriate digital waveforms 4300 (FIG. 37) to second stage circuitry 3506 to drive appropriate loads, such as ultrasound, RF, or sensors. provided to a control circuit 3200 that It will be appreciated that identification circuitry may be included in various assemblies 3516 within the third stage circuitry 3508 such as the ultrasound transducer 1120, the electrodes 3074a, 3074b, or the sensor 3440. FIG. 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 circuit diagram of one aspect of an electrical circuit 3600 configured to drive radio frequency current (RF), in accordance with at least one aspect of the present disclosure. Electrical circuit 3600 comprises an analog multiplexer 3680 . Analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A such as RF, battery, and power control circuits. A current sensor 3682 is coupled in series with the return or ground leg of the power supply circuit to measure the current supplied by the power supply. A field effect transistor (FET) temperature sensor 3684 provides the ambient temperature. A pulse width modulation (PWM) watchdog timer 3688 automatically causes system resets if the main program fails to provide periodic system resets. This is provided to automatically reset the electrical circuit 3600 if the electrical circuit 3600 hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 3600 may be configured, for example, to drive RF electrodes or to drive an ultrasonic transducer 1120, as described with respect to FIG. Thus, referring again to FIG. 34, an electrical circuit 3600 can be used to alternately drive both the ultrasound and RF electrodes.

A drive circuit 3686 provides left and right RF energy outputs. Digital signals representing signal waveforms are provided to the SCL-A, SDA-A inputs of analog multiplexer 3680 from a control circuit such as control circuit 3200 (FIG. 30). A digital-to-analog converter 3690 (DAC) converts a digital input to an analog output to drive a PWM circuit 3692 coupled to oscillator 3694 . PWM circuit 3692 provides a first signal to a first gate drive circuit 3696a coupled to a first transistor output stage 3698a to drive a first RF+ (left) energy output. PWM circuit 3692 also provides a second signal to a second gate drive circuit 3696b coupled to a second transistor output stage 3698b to drive a second RF (right) energy output. A voltage sensor 3699 is coupled across the RF left/RF output terminals to measure the output voltage. Driver circuit 3686, first driver circuit 3696a and second driver circuit 3696b, and first transistor output stage 3698a and second transistor output stage 3698b define a first stage amplifier circuit. In operation, control circuit 3200 (Fig. 30) generates digital waveform 4300 (Fig. 37) using circuits such as direct digital synthesis (DDS) circuits 4100, 4200 (Figs. 35 and 36). DAC 3690 receives digital waveform 4300 and converts it to an analog waveform, which 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 digitally converts the electrical signal waveform, preferably using a predetermined number of phase points stored in a lookup table, to digitize the waveform. can be configured to generate The phase points may be stored in a table defined in memory, field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 35 illustrates one aspect of a basic architecture for a digital synthesis circuit, such as direct digital synthesis (DDS) circuit 4100, configured to generate multiple waveforms for electrical signal waveforms. The generator software and digital control can instruct the FPGA to scan addresses in the lookup table 4104, which in turn provide various digital input values to the DAC circuit 4108 that powers the power amplifier. Addresses may be scanned according to the frequency of interest. Using such a lookup table 4104 can be provided within tissue, or within a transducer, an RF electrode, multiple transducers simultaneously, multiple RF electrodes simultaneously, or a combination of RF and ultrasound instruments. , allows to generate various types of waveforms. Additionally, multiple lookup tables 4104 representing multiple waveforms can be created, stored, and applied to tissue from the generator.

The waveform signal is the output current, output voltage, Or it may be configured to control at least one of the output power. Additionally, if the surgical instrument comprises an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Accordingly, the generator may be configured to provide a waveform signal to at least one surgical instrument, the waveform signal responsive to at least one waveform of the plurality of waveforms in the table. Note that the waveform signals provided to the two surgical instruments may include two or more waveforms. The table may contain information related to multiple waveforms, and the table may be stored within the generator. In one aspect or example, the table may be a direct digital synthesis table and may be stored within the FPGA of the generator. The table may be addressed by any method that is convenient for categorizing waveforms. According to one aspect, the table, which may be a direct digital synthesis table, is addressed according to the frequency of the waveform signal. Further, information related to multiple waveforms may be stored in a table as digital information.

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

With the widespread use of digital techniques in instrumentation and communication systems, a digital control method for generating multiple frequencies from a reference frequency has evolved and is called direct digital synthesis. The basic architecture is shown in FIG. In this simplified block diagram, the DDS circuitry is coupled to the processor, controller, or logic of the generator circuit and memory circuitry located within the generator circuit of surgical system 1000 . DDS circuit 4100 comprises address counter 4102 , lookup table 4104 , register 4106 , DAC circuit 4108 and filter 4112 . Stable clock f _c is received by address counter 4102 and register 4106 is a programmable read-only register that stores one or more integers of cycles of a sine wave (or any other waveform) in lookup table 4104. Drive the memory (PROM). As address counter 4102 steps through the memory locations, the values stored in lookup table 4104 are written to register 4106 which is coupled to DAC circuitry 4108 . The corresponding digital amplitude of the signal at the location of lookup table 4104 drives DAC circuit 4108 which in turn generates analog output signal 4110 . The spectral purity of analog output signal 4110 is primarily determined by DAC circuitry 4108 . The phase noise is essentially that of the reference clock f _c . A first analog output signal 4110 output from DAC circuit 4108 is filtered by filter 4112 and a second analog output signal 4114 output by filter 4112 is an amplifier having an output coupled to the output of the generator circuit. provided to. The second analog output signal has a frequency f _out .

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

The DDS circuit 4100 may include a plurality of lookup tables 4104 that store waveforms represented by a predetermined number of samples, the samples defining a predetermined waveform shape. Thus, multiple waveforms with unique shapes can 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 superficial tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. mentioned. In one aspect, the DDS circuit 4100 can create a plurality of waveform lookup tables 4104 to generate desired waveforms during a tissue treatment procedure (eg, "on the fly" or in substantially real-time based on user or sensor input). Switching between different waveforms stored in individual lookup tables 4104 can be performed based on tissue effects and/or tissue feedback.

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

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

DDS circuit 4200 includes a sample clock that generates clock frequency _fc , a phase accumulator 4206, and a lookup table 4210 (eg, a phase-to-amplitude converter). The contents of phase accumulator 4206 are updated once every clock cycle _fc . As phase accumulator 4206 is updated, digital number M stored in parallel delta phase register 4204 is added to the number in phase register 4208 by adder circuit 4216 . The numbers in parallel delta phase register 4204 are 00 . . . 01 and the initial contents of phase accumulator 4206 is 00 . . . 00. Phase accumulator 4206 increments 00 . . . 01. When phase accumulator 4206 is 32-bit wide, phase accumulator 4206 is 00 . . . It takes 232 clock cycles (over 4 billion) to return to 00 and the cycle repeats.

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

In one aspect, the waveform that can be digitized is any suitable waveform in the range of 256 (28) to 281, 474, 976, 710, 656 (248) (where n is a positive integer, as shown in Table 1). An electrical signal waveform may be digitized into 1024 (210) phase points, despite the number of 2n phase points being equal. An electrical signal waveform may be represented as A _n (θ _n ), and the normalized amplitude A _n at point n is represented by the phase angle θ _n and is called the phase point at point n. The number of distinct phase points n determines the adjustment resolution of DDS circuit 4200 (as well as DDS circuit 4100 shown in FIG. 35).

Table 1 identifies the electrical signal waveform digitized to a number of phase points.

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

Referring again to FIG. 35, for n=32 and M=1, phase accumulator 4206 steps through 232 possible outputs before overflowing and restarting. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M=2, phase register 1708 "rolls over" at twice the rate, doubling the output frequency. This can be generalized as follows.

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

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

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

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

An electrical signal waveform may be characterized by current, voltage, or power at a given frequency. Additionally, if the surgical instruments of surgical system 1000 include ultrasonic components, the electrical signal waveforms may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Accordingly, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, which electrical signal waveform is stored in lookup table 4210 (or lookup table 4104 of FIG. 35). characterized by a pre-determined waveform. Note that the electrical signal waveform may be a combination of two or more waveforms. The lookup table 4210 may contain information related to multiple waveforms. In one aspect or example, lookup table 4210 may be generated by DDS circuit 4200 and is sometimes referred to as a direct digital synthesis table. The DDS operates by first storing large repetitive waveforms in on-board memory. A cycle of a waveform (sine, triangle, square, arbitrary) can be represented by a predetermined number of phase points and stored in memory, as shown in Table 1. Once the waveforms are stored inside memory, waveforms can be generated at very precise frequencies. The direct digital synthesis table may be stored within non-volatile memory of the generator circuit and/or implemented with FPGA circuitry within the generator circuit. Lookup table 4210 may be addressed by any suitable technique convenient for categorizing waveforms. According to one aspect, lookup table 4210 is addressed according to the frequency of the electrical signal waveform. Further, information relating to multiple waveforms may be stored as digital information in memory or as part of lookup table 4210 .

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

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

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

In addition to conventional sine/cosine waveforms, the generator circuit may be configured to generate waveform(s) (ie, trapezoidal or square waves) that maximize power to the tissue per cycle. Provided that the generator circuit includes a circuit topology that allows it to drive RF and ultrasonic signals simultaneously, the generator circuit will drive the RF and ultrasonic signals simultaneously into the load. Waveform(s) can be provided that are synchronized to maximize delivered power and to maintain ultrasound frequency lock. Additionally, custom waveforms specific to an instrument and its tissue effect can be stored in non-volatile memory (NVM) or in the instrument's EEPROM, and any one of the surgical instruments of surgical system 1000 can be used as a generator circuit. can be fetched when connecting to

DDS circuit 4200 may comprise a plurality of lookup tables 4104, where lookup table 4210 stores waveforms represented by a predetermined number of phase points (sometimes referred to as samples), where the phase points correspond to predetermined waveforms. defines the shape of Thus, multiple waveforms with unique shapes can be stored in multiple lookup 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 superficial tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. mentioned. In one aspect, the DDS circuitry 4200 can create a plurality of waveform lookup tables 4210 to perform desired waveforms during a tissue treatment procedure (eg, "on the fly" based on user or sensor input or in substantially real-time). Switching between different waveforms stored in different lookup tables 4210 can be performed based on tissue effects and/or tissue feedback.

Thus, switching between waveforms can be based on tissue impedance and other factors, for example. In other aspects, the lookup table 4210 can store electrical signal waveforms (ie, trapezoidal or square waves) shaped to maximize the power delivered into the tissue each cycle. In other aspects, the lookup table 4210 can store synchronized waveforms so that when the waveforms deliver the RF and ultrasound drive signals, one of the surgical instruments of the surgical system 1000 Maximize power delivery by any one. In yet another aspect, the lookup table 4210 can store electrical signal waveforms that simultaneously drive ultrasound and RF therapeutic and/or sub-therapeutic energy while maintaining ultrasound frequency lock. In general, the output waveform may be in the form of sine wave, cosine wave, pulse wave, square wave, and the like. Nevertheless, more complex custom waveforms specific to different instruments and their tissue effects can be stored in the generator circuit's non-volatile memory, or in the surgical instrument's non-volatile memory (e.g., EEPROM). and can be fetched when connecting the surgical instrument to the generator circuit. An example of a custom waveform is the exponentially decaying sinusoidal waveform used in many high crest factor "coagulation" waveforms, as shown in FIG.

FIG. 37 shows one cycle of a discrete-time digital electrical signal waveform 4300 according to at least one aspect of the present disclosure of an analog waveform 4304 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison purposes). The horizontal axis represents time (t) and the vertical axis represents digital phase points. Digital electrical signal waveform 4300 is, for example, a digital discrete-time version of desired analog waveform 4304 . A digital electrical signal waveform 4300 is generated by storing amplitude phase points 4302, which represent the amplitude for each clock cycle _Tclk over one cycle or period _To . Digital electrical signal waveform 4300 is generated over a period of _time To by any suitable digital processing circuit. Amplitude phase points are digital words stored in a memory circuit. In the examples shown in FIGS. 35 and 36, the digital word is a 6-bit word capable of storing amplitude-phase points with 26 or 64-bit resolution. It will be appreciated that the examples shown in Figures 35 and 36 are for illustrative purposes and that in actual implementations the resolution can be much higher. The digital amplitude phase points 4302 over one cycle To are stored in memory, eg, as strings of string words in lookup tables 4104, 4210 as described in connection with FIGS. To generate the analog version of the analog waveform ₄₃₀₄ , also described with respect to _FIGS . and converted by DAC circuits 4108 and 4212 . Additional cycles can be generated by repeatedly reading amplitude phase points 4302 of digital electrical signal waveform 4300 from 0 to T ₀ for as many cycles or periods as may be desired. A smoothed analog version of the analog waveform 4304 is achieved by filtering the output of the DAC circuits 4108, 4212 by filters 4112, 4214 (FIGS. 35 and 36). The filtered analog output signals 4114, 4222 (FIGS. 35 and 36) are applied to the inputs of the power amplifiers.

FIG. 38 illustrates, according to one aspect of the present disclosure, providing gradual closure of a closure member (e.g., obturator tube) as the displacement member advances distally and engages a clamp arm (e.g., anvil); 12950 is an illustration of a control system 12950 configured to decrease the closing force load on the closing member at a desired rate to decrease the firing force load on the firing member. FIG. In one aspect, control system 12950 may be implemented as a nested PID feedback controller. A PID controller is a control-loop feedback mechanism (controller) for continuously calculating an error value as the difference between a desired setpoint and a measured process variable, with proportional, integral, and derivative terms (P , I, and D). Nested PID controller feedback control system 12950 includes primary controller 12952 in primary (outer) feedback loop 12954 and secondary controller 12955 in secondary (inner) feedback loop 12956 . Primary controller 12952 may be PID controller 12972 as shown in FIG. 39 and secondary controller 12955 may also be PID controller 12972 as shown in FIG. Primary controller 12952 controls primary process 12958 and secondary controller 12955 controls secondary process 12960 . The output 12966 of the primary process 12958 is subtracted from the primary set point SP ₁ by a first adder 12962 . First adder 12962 produces a single sum output signal that is applied to primary controller 12952 . The output of primary controller 12952 is secondary setpoint _SP2 . The output 12968 of secondary process 12960 is subtracted from secondary setpoint _SP2 by a second adder 12964 .

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

FIG. 39 illustrates a PID feedback control system 12970, according to one aspect of the present disclosure. Primary controller 12952 or secondary controller 12955 or both may be implemented as 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 P element 12974 , I element 12976 and D element 12978 are summed by adder 12986 which provides control variable μ(t) to process 12980 . The output of process 12980 is process variable y(t). A summer 12984 calculates the difference between the desired setpoint r(t) and the measured process variable y(t). The PID controller 12972 provides an error value e( t) (e.g., the difference between the closure force threshold and the measured closure force), calculated by proportional component 12974 (P), integral component 12976 (I), and derivative component 12978 (D), respectively. Apply corrections based on proportional, integral, and derivative terms. PID controller 12972 attempts to minimize error e(t) over time by adjusting control variables μ(t) (eg, velocity and direction of the closed tube).

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

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

Ultrasonic surgical devices, such as ultrasonic scalpels, are finding increasingly widespread use in surgical procedures due to their unique performance characteristics. Certain device configurations and operating parameters allow ultrasonic surgical devices to provide substantially simultaneous transsection of tissue and homeostasis by coagulation, desirably minimizing patient trauma. Ultrasonic surgical devices are coupled to a handpiece that includes an ultrasonic transducer and an ultrasonic transducer having a distally mounted end effector (e.g., blade tip) to cut and seal tissue. It may contain instruments that have been installed. In some cases, the instrument can be permanently attached to the handpiece. In other cases, the instrument may be removable from the handpiece, such as in the case of disposable or replaceable instruments. The end effector transmits ultrasonic energy to tissue in contact with the end effector to effect cutting and sealing action. Such ultrasonic surgical devices can be configured for open surgical applications, laparoscopic or endoscopic surgery, including robotic-assisted surgery.

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

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

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

Moreover, electromagnetic interference in noisy environments reduces the generator's ability to maintain a fixed resonant frequency of the ultrasonic transducer, increasing the likelihood of invalid control algorithm inputs.

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

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. RF energy is a form of electrical energy that can be in the frequency range 300 kHz to 1 MHz 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. Frequencies above 200 kHz are typically used for monopolar applications to avoid unnecessary stimulation of nerves and muscles resulting from the use of low frequency currents. Lower frequencies can be used for bipolar techniques if the risk analysis indicates that the likelihood of neuromuscular stimulation has been mitigated to an acceptable level. To minimize problems associated with high frequency leakage currents, frequencies above 5 MHz are typically not used. 10 mA is generally recognized as the lower threshold for thermal effects on tissue.

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

Due to their inherent drive signal, sensing and feedback needs, ultrasonic and electrosurgical devices have generally required different generators. Additionally, where instruments are disposable or compatible with handpieces, ultrasonic and electrosurgical generators recognize the specific instrument configuration used, thus optimizing the control and diagnostic process. limited ability to In addition, capacitive coupling between the non-isolated circuitry of the generator and the patient-isolated circuitry can result in exposure of the patient to unacceptable levels of leakage current, especially when higher voltages and frequencies are used.

Additionally, due to their inherent drive signal, sensing and feedback needs, ultrasonic and electrosurgical devices have typically required different user interfaces for different generators. In such conventional ultrasonic and electrosurgical devices, one user interface may be configured for use with an ultrasonic instrument, while another user interface is configured for use with an electrosurgical instrument. be. Such user interfaces include hand and/or foot activated user interfaces, such as hand activated switches and/or foot activated switches. Various aspects of combined generators for use with both ultrasonic and electrosurgical instruments are contemplated in subsequent disclosure, thus working with both ultrasonic and/or electrosurgical instrument generators. Additional user interfaces configured to: are also contemplated.

Additional user interfaces for providing feedback to either the user or other machines to provide feedback indicative of operational modes or states of any of the ultrasonic and/or electrosurgical instruments are provided in subsequent disclosures. be considered. Providing user and/or machine feedback for operating a combination of ultrasonic and/or electrosurgical instruments provides sensory feedback to the user and electrical/mechanical/electromechanical feedback to the machine. need to do. Visual feedback devices (e.g., LCD display screens, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., Feedback devices incorporating haptic actuators) are discussed in subsequent disclosures.

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

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

Aspects of the generator use digital signal processing as well as high-speed analog-to-digital sampling of the generator drive signal current and voltage (eg, oversampling by a factor of approximately 200 depending on frequency), providing many advantages over known generator architectures. provide the advantages and benefits of In one aspect, the generator may determine the operating branch currents of the ultrasonic transducer based, for example, on current and voltage feedback data, ultrasonic transducer capacitance values, and drive signal frequency values. This provides the benefit of a substantially tuned system, simulating the presence of a system tuned or resonant with any value of capacitance (e.g., C ₀ in FIG. 25) at any frequency. do. Therefore, control of the operating branch currents can be achieved by tuning out the effect of capacitance without the need for tuning inductors. Additionally, elimination of tuning inductors may not degrade the frequency locking capability of the generator, as frequency locking can be achieved by appropriately processing current and voltage feedback data.

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

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

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

Various aspects provide that the generator uses an existing multi-conductor generator/handpiece cable to place a data circuit (e.g., known under the trade designation "1-Wire") in an instrument attached to the handpiece. provide a simple and economical means to read from and optionally write to a single-wire bus device, such as a single-wire protocol EEPROM that can In this manner, the generator can retrieve and process instrument-specific data from instruments attached to the handpiece. This may allow 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 creates possible new functionality in, for example, tracking instrument usage and capturing operational data. In addition, the use of frequency bands allows backward compatibility of instruments including existing generator bus devices.

The disclosed aspects of the generator provide active elimination of leakage currents caused by unintended capacitive coupling between non-isolated and patient-isolated circuits of the generator. In addition to reducing patient risk, reducing leakage current can also reduce electromagnetic emissions.

FIG. 40 is a system diagram 7400 of a segmentation circuit 7401 comprising a plurality of independently operating circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440, according to at least one aspect of the present disclosure. A circuit segment of the plurality of circuit segments of the segmentation circuit 7401 is one or more circuits and a set of one or more machine-executable instructions stored in one or more memory devices. and including. One or more circuits of a circuit segment are coupled for telecommunication through one or more wired or wireless connection media. The plurality of circuit segments are configured to transition between three modes including sleep mode, standby mode and operating mode.

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

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

Referring again to system diagram 7400 of FIG. 40, segmentation circuitry 7401 includes transition circuitry segment 7402, processor circuitry segment 7414, handle circuitry segment 7416, communications circuitry segment 7420, display circuitry segment 7424, motor control circuitry segment 7428, energy treatment circuitry. A plurality of circuit segments are provided, including circuit segment 7434 and shaft circuit segment 7440 . The transition circuitry segment comprises wakeup circuitry 7404 , boost current circuitry 7406 , voltage control circuitry 7408 , safety controller 7410 and POST controller 7412 . Transition circuit segment 7402 is configured to implement de-energization and energization sequences, safety detection protocols, and POST.

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

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

An energization sequence or a de-energization sequence can be defined based on the accelerometer button sensor 7405 . For example, the accelerometer button sensor 7405 can sense a particular motion or sequence of motions indicating 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 directs one or more of the plurality of circuit segments when the processor is energized. A signal can be sent to the processor. Based on this signal, the processor determines an energization sequence that includes the selected one or more circuit segments. Additionally or alternatively, a user of the surgical instrument 6480 described herein can select the number and order of circuit segments to determine the energization sequence or sequence based on interaction with the surgical instrument's graphical user interface (GUI). A de-energization sequence can be defined.

In various aspects, the accelerometer button sensor 7405 detects movement of the surgical instrument 6480 described herein or external movement within a predetermined vicinity above a predetermined threshold. can signal the voltage control circuit 7408 and signal the processor only when For example, a signal may be sent only if movement is sensed for 5 seconds or more, or if the surgical instrument is moved 5 inches or more. In other aspects, the accelerometer button sensor 7405 can signal the voltage control circuit 7408 and signal the processor only when the accelerometer button sensor 7405 detects vibratory movement of the surgical instrument. . The predetermined threshold reduces inadvertent transitions of circuit segments of the surgical instrument. As noted above, transitions may include transitions to an operational mode following an energization sequence, transitions to a low energy mode following a de-energization sequence, or transitions to a sleep mode following a de-energization sequence. In some aspects, the surgical instrument comprises an actuator that can be actuated by a user of the surgical instrument. This actuation is sensed by accelerometer button sensor 7405 . Actuators may be sliders, toggle switches, or momentary contact switches. Based on the sensed actuation, the accelerometer button sensor 7405 can send a signal to the voltage control circuit 7408 and send a signal to the processor.

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

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

Safety controller 7410 is configured to perform safety checks on circuit segments. In some aspects, safety controller 7410 performs safety checks when one or more individual circuit segments are in operational mode. Safety checks may be performed to determine if there are any errors or deficiencies in the functioning or operation of the circuit segments. Safety controller 7410 can monitor one or more parameters of the multiple circuit segments. Safety controller 7410 can verify the identity and operation of multiple circuit segments by comparing one or more parameters to predetermined parameters. For example, when the RF energy modality is selected, the safety controller 7410 verifies that the shaft articulation parameters match the predetermined articulation parameters of the surgical instrument 6480 described herein. The operation of RF energy modalities can be verified. In some aspects, the safety controller 7410 may monitor predetermined relationships between one or more characteristics of the surgical instrument to detect faults via sensors. A failure can occur when one or more properties do not conform to a predetermined relationship. If the safety controller 7410 determines that a fault exists, an error exists, or that the operation of some of the multiple circuit segments has not been verified, the safety controller 7410 detects that fault, error, or verification failure. Prevent or disable the action of the particular circuit segment that occurred.

POST controller 7412 performs POST to verify proper operation of multiple circuit segments. In some aspects, POST energizes individual circuits of a plurality of circuit segments before voltage control circuit 7408 applies voltages to the individual circuit segments to transition the individual circuit segments from standby or sleep mode to operational mode. Performed on segments. If the individual circuit segment does not pass POST, the particular circuit segment will not transition from standby or sleep mode to operational mode. POST of handle circuit segment 7416 may include, for example, testing whether handle control sensor 7418 senses actuation of a handle control of surgical instrument 6480 described herein. In some aspects, the POST controller 7412 can signal the accelerometer button sensor 7405 to verify operation of individual circuit segments as part of POST. For example, after receiving the signal, the accelerometer button sensor 7405 can prompt the user of the surgical instrument to move the surgical instrument to multiple different positions to confirm operation of the surgical instrument. . The accelerometer button sensor 7405 may also monitor the output of the circuit segment or the circuitry of the circuit segment as part of POST. For example, accelerometer button sensor 7405 can sense incremental motor pulses generated by motor 7432 to verify operation. A motor controller of motor control circuit 7430 may be used to control 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 a control program stored in the memory device of voltage control circuit 7408 . The control program can cause the POST controller 7412 to send signals requesting matching encryption parameters from multiple circuit segments. Failure to receive matching encryption parameters from an individual circuit segment indicates to POST controller 7412 that the corresponding circuit segment is corrupted or malfunctioning. In some aspects, if POST controller 7412 determines that a processor is corrupted or malfunctioning based on POST, POST controller 7412 signals one or more secondary processors to Or, two or more secondary processors can be made to perform marginal functions that the processors cannot perform. In some aspects, if POST controller 7412 determines based on POST that one or more circuit segments are not working properly, POST controller 7412 either fails POST or A low performance mode can be initiated for properly operating circuit segments while locking out non-operating circuit segments. A locked out circuit segment can function similarly to a circuit segment in standby mode or sleep mode.

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

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

Communications circuitry segment 7420 includes communications circuitry 7422 . Communication circuitry 7422 provides a communication interface for facilitating signal communication between individual circuit segments of the plurality of circuit segments. In some aspects, communication circuitry 7422 provides a pathway for the modular components of surgical instrument 6480 described herein to communicate electrically. For example, when the modular shaft and modular transducer are integrally attached to the handle of a surgical instrument, control programs can be uploaded to the handle via communication circuitry 7422 .

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

Motor control circuitry segment 7428 comprises motor control circuitry 7430 coupled to motor 7432 . The motor 7432 is coupled to the processor by drivers and transistors such as FETs. In various aspects, the motor control circuit 7430 includes a motor current sensor in signal communication with the processor to provide the processor with a signal indicative of a measurement of the current draw of the motor. A processor sends a signal to the display. The display receives this signal and displays the measured current draw of motor 7432 . Using the signals, the processor, for example, monitors that the current draw of the motor 7432 is within an acceptable range, compares the current draw to one or more parameters of the plurality of circuit segments, and One or more parameters of the treatment site can be determined. In various aspects, the motor control circuit 7430 comprises a motor controller that controls the operation of the motor. For example, motor control circuitry 7430 controls various motor parameters, such as by adjusting the speed, torque, and acceleration of motor 7432 . This adjustment is based on the current through the motor 7432 as measured by the motor current sensor.

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

Energy treatment circuitry segment 7434 includes RF amplifier and safety circuitry 7436 and ultrasound signal generator circuitry 7438 to implement the energy module functionality of 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 RF signals. The ultrasound signal generator circuit 7438 is configured to control ultrasound energy modalities by generating ultrasound signals. The RF amplifier and safety circuit 7436 and the ultrasonic signal generator circuit 7438 can jointly operate to control the combined RF and ultrasonic energy modalities.

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

FIG. 41 is a circuit diagram of circuitry 7925 of various components of a surgical instrument with motor control capabilities, according to at least one aspect of the present disclosure. In various aspects, the surgical instruments 6480 described herein are configured to drive shafts and/or gear components to perform various operations associated with the surgical instruments 6480. A drive mechanism 7930 may also be included. In one aspect, the drive mechanism 7930 includes a rotary drive train 7932 configured, for example, to rotate the end effector about a longitudinal axis with respect to the handle housing. Drive mechanism 7930 further includes a closing drive train 7934 configured to close the jaw members and grasp tissue with the end effector. Additionally, the drive mechanism 7930 includes a firing drive train 7936 configured to open and close 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 can be located within the handle assembly of the surgical instrument. Proximal to the selector gearbox assembly 7938 is an optional second motor 7944 and motor drive circuit 7946 for selectively positioning one of the drive trains 7932, 7934, 7936 (second motor 7944 and motor drive circuit 7946). (shown in dashed lines to indicate that the drive circuit 7946 is an optional component) to selectively move the gear elements within the selector gearbox assembly 7938 into engagement with the input drive components. , there is a function selection module that includes a first motor 7942 .

With continued reference to FIG. 41, motors 7942, 7944 are coupled to motor control circuits 7946, 7948, respectively, which include electrical energy flow from power source 7950 to motors 7942, 7944. It is configured to control the operation of the 7944. Power source 7950 may be a DC battery (eg, rechargeable lead-based, nickel-based, lithium-ion-based batteries, etc.) or any other power source suitable for providing electrical energy to surgical instruments.

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

Processor 7954 may communicate with motor control circuitry 7946 . Further, memory 7956, when executed by processor 7954 in response to user input 7958 or feedback element 7960, causes motor control circuit 7946 to stimulate motor 7942 to generate at least one rotary motion, selector gearbox assembly 7938 to can be selectively moved to selectively position one of the drive trains 7932, 7934, 7936 into engagement with the input drive component of the second motor 7944; Program instructions can be stored. Additionally, processor 7954 may communicate with motor control circuitry 7948 . Memory 7956 also causes motor control circuit 7948 to stimulate motor 7944 to generate at least one rotational motion, e.g., input drive of second motor 7948, when executed by processor 7954 in response to user input 7958 Program instructions can be stored that can drive a drive train that is engaged with the component.

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

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

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

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

For example, using self-diagnostics to determine when a surgical instrument is capable of performing its function prior to resterilization, or when some of its components should be replaced and/or repaired. can be done. Evaluation of the drive mechanism and its components, including but not limited to rotary drivetrain 7932, closing drivetrain 7934, and/or firing drivetrain 7936, can be accomplished in a variety of ways. The magnitude of deviation from predicted performance can be used to determine the perceived likelihood of failure and the severity of such failure. Several metrics may be used, including periodic analysis of repeatable and predictable events, peaks or drops above expected thresholds and width of faults.

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

With continued reference to FIG. 41, surgical instrument 7930 was configured to record and analyze one or more acoustic outputs of one or more of drivetrains 7932, 7934, 7936. Includes drivetrain fault detection module 7962 . Processor 7954 may communicate with or otherwise control module 7962 . As described in more detail below, module 7962 comprises a computer readable medium (eg, memory 7956) storing computer readable program instructions executable by circuitry, hardware, a processing unit (eg, processor 7954). It can be embodied in various means such as a computer program product, or some combination thereof. In some aspects, processor 36 may include or otherwise control module 7962 .

FIG. 42 is an alternative system 132000 for controlling the frequency and detecting impedance of an ultrasonic electromechanical system 132002, according to at least one aspect of the present disclosure. System 132000 may be incorporated into the generator. A processor 132004 coupled to a memory 132026 programs a programmable counter 132006 to tune to the output frequency f _o of the ultrasonic electromechanical system 132002 . The input frequency is generated by crystal oscillator 132008 and input to fixed counter 132010 to scale the frequency to a suitable value. The outputs of fixed counter 132010 and programmable counter 132006 are applied to phase/frequency detector 132012 . The output of the phase/frequency detector 132012 is applied to an amplifier/active filter circuit 132014 to generate a regulated voltage _Vt that is applied to a voltage controlled oscillator (VCO) 132016. VCO 132016 applies output frequency _fo to the ultrasonic transducer portion of ultrasonic electromechanical system 132002, which is shown modeled herein as an equivalent electrical circuit. Voltage and current signals applied to the ultrasonic transducer are monitored by voltage sensor 132018 and current sensor 132020 .

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

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

Temperature Estimation FIGS. 43A-43B are graphical representations 133000, 133010 of complex impedance spectra of the same ultrasonic device with cold (room temperature) and hot ultrasonic blades, according to at least one aspect of the present disclosure. As used herein, a cold ultrasonic blade refers to a room temperature ultrasonic blade and a hot ultrasonic blade refers to an ultrasonic blade after it has been heated by friction during use. 43A is a graphical representation 133000 of impedance phase angle φ as a function of resonant frequency f _o of the same ultrasonic device with cold and hot ultrasonic blades, and FIG. 43B is a graphical representation 133000 of the same 133010 is a graphical representation 133010 of impedance magnitude |Z| as a function of resonant frequency _fo of an ultrasound system. The impedance phase angle φ and the impedance magnitude |Z| are minimal at the resonant frequency _fo .

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

As shown in FIG. 43A, when the ultrasonic blade is at a low temperature, _e.g. is set to 55,500 Hz. Therefore, when the ultrasonic transducer is excited at the electromechanical resonant frequency _fo and the ultrasonic blade is cold, the phase angle φ is at a minimum or about 0 Rad as shown by cold blade plot 133002 . As shown in FIG. 43B, when the ultrasonic blade is cold and the ultrasonic transducer is excited at the electromechanical resonance frequency _fo , the impedance magnitude |Z| is the minimum impedance and the drive signal amplitude is maximum due to the series-resonant equivalent circuit of the ultrasonic electromechanical system shown in FIG.

Referring now again to FIGS. 43A and 43B, the ultrasonic transducer is energized at an electromechanical resonant frequency f _o of 55,500 Hz by the generator voltage V _g (t) and generator current I _g (t) signals. When driven, the phase angle φ between the generator voltage V _g (t) and generator current I _g (t) signals is zero and the impedance magnitude |Z| Yes, the signal amplitude is peak or maximum due to the series resonant equivalent circuit of the ultrasonic electromechanical system. As the temperature of the ultrasonic blade increases, the electromechanical resonant frequency f _o ' of the ultrasonic device decreases due to frictional heat generated during use. Since the ultrasonic transducer is still driven by the generator voltage Vg(t) and generator current Ig(t) signals at the previous (cold blade) electromechanical resonance frequency _fo of 55,500 Hz, the ultrasonic device operates off-resonance f _o ', causing a shift in the phase angle φ between the generator voltage Vg(t) and generator current Ig(t) signals. There is also an increase in drive signal impedance magnitude |Z| and a decrease in peak magnitude for the (cold blade) electromechanical resonance frequency before 55,500 Hz. Therefore, the temperature of the ultrasonic blade changes the phase angle φ between the generator voltage V _g (t) and generator current I _g (t) signals to the electromechanical resonance frequency f It can be estimated by measuring as the change in _o .

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

Stated another way, at resonance, the analogous inductive impedance of the electromechanical ultrasound system equals the analogous capacitive impedance of the electromechanical ultrasound system. The compliance of the ultrasonic blade (modeled as an equivalent capacitance) changes the resonant frequency of the electromechanical ultrasonic system as it heats, for example due to frictional engagement with tissue. In this example, as the temperature of the ultrasonic blade increases, the resonant frequency of the electromechanical ultrasonic system decreases. Therefore, the analogous inductive impedance of the electromechanical ultrasound system is no longer equal to the analogous capacitive impedance of the electromechanical ultrasound system, so that the driving frequency of the electromechanical ultrasound system and the new resonant frequency causes an inconsistency between Therefore, for hot ultrasonic blades, the electromechanical ultrasonic system operates "off resonance". The mismatch between the driving frequency and the resonant frequency manifests itself as a phase angle φ between the voltage V _g (t) and current I _g (t) signals applied to the ultrasonic transducer.

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

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

ここで発生器駆動周波数の範囲は装置モデルに固有である。

Here the range of generator drive frequencies is device model specific.

Methods of Temperature Estimation One aspect of estimating or inferring the temperature of an ultrasonic blade may involve three steps. First, we define a time- and energy-dependent temperature and frequency state-space model. To model the 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, apply a Kalman filter to improve the accuracy of the temperature estimator and state-space model over time. Third, a state estimator is provided in the feedback loop of the Kalman filter to control the power applied to the ultrasonic transducer and thus the ultrasonic blade to regulate the temperature of the ultrasonic blade. The three steps are described below.

Process 1
The first step is to define a time- and energy-dependent temperature and frequency state-space model. To model the 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 the following equations.

The state-space model describes the eigenfrequencies of an electromechanical ultrasound system for eigenfrequencies F _n (t), temperature T(t), energy E(t), and time t

の変化率及び超音波ブレードの温度

rate of change and the temperature of the ultrasonic blade

の変化率を表す。

represents the rate of change of

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

are measurable and observable such as the natural frequency number _Fn (t) of the electromechanical ultrasonic system, the temperature T(t) of the ultrasonic blade, the energy E(t) applied to the ultrasonic blade, and the time t Represents the observability of possible variables. The ultrasonic blade temperature T(t) is observable as an estimate.

Process 2
The second step is to apply a Kalman filter to improve the temperature estimator and state-space model. FIG. 44 is a diagram of a Kalman filter 133020 for improving temperature estimators and state-space models based on impedance, according to the equation,

これは、本開示の少なくとも１つの態様による、様々な周波数で測定された超音波変換器にわたるインピーダンスを表す。

It represents the impedance across the ultrasonic transducer measured at various frequencies according to at least one aspect of the present disclosure.

The Kalman Filter 133020 may be used to improve temperature estimation performance, allowing augmentation of external sensors, models, or prior information to improve temperature prediction in noisy data. Kalman filter 133020 includes regulator 133022 and plant 133024 . In control theory, the plant 133024 is a combination of processes and actuators. Plant 133024 may be referred to as a transfer function that describes the relationship between the input and output signals of the system. Regulator 133022 includes state estimator 133026 and controller K 133028 . State regulator 133026 includes feedback loop 133030 . State regulator 133026 receives as inputs y, the output of plant 133024, and feedback variable u. State Estimator 133026 is an internal feedback system that converges on the true value of the state of the system. The output of state estimator 133026 is

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

and the complete feedback control variables are F _n (t) of the electromechanical ultrasonic system, an estimate of the temperature of the ultrasonic blade T(t), the energy E(t) applied to the ultrasonic blade, the phase Includes angle φ and time t. The input to the controller K133028 is

であり、コントローラＫ１３３０２８の出力ｕは、状態推定器１３３０２６及びプラント１３３０２４のｔにフィードバックされる。

and the output u of controller K 133028 is fed back to state estimator 133026 and t of plant 133024 .

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

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

The Kalman filter 133020 effectively handles the uncertainty due to noisy measurements of the signal applied to the ultrasonic transducer and also the uncertainty due to random external factors to measure the natural frequency and phase shift data. Handle certainty effectively. Kalman filter 133020 produces an estimate of the state of the electromechanical ultrasound system as the average of the predicted state of the system using weighted averaging and the new measurements. Weighted values provide better (ie, smaller) estimation uncertainties and are more "reliable" than unweighted values. Weights may be calculated from the covariance, which is a measure of the estimated uncertainty 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, with better estimation uncertainty than either alone. This process is repeated at every time step and the new estimate and its covariance provide the prediction used in the next iteration. This recursive nature of the Kalman filter 133020 requires only the last "best guess" to compute a new state rather than the entire history of states of the electromechanical ultrasound system.

The relative certainty of measurements and current state estimates is an important consideration, and it is common to discuss the filter's response with respect to gain K of Kalman filter 133020 . The Kalman gain K is the relative weight given to measurements and current state estimates that can be "tuned" to achieve a particular performance. For high gain K, the Kalman filter 133020 places more weight on the most recent measurements and therefore follows them more responsively. For low gain K, the Kalman filter 133020 follows the model predictions more closely. At the extremes, high gains close to 1 lead to more variable estimated trajectories, low gains close to zero remove noise but reduce responsiveness.

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

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

FIG. 45 is a graphical representation 133040 of three probability distributions employed by the state estimator 133026 of the Kalman filter 133020 shown in FIG. 44 to maximize the estimate, according to at least one aspect of the present disclosure. The probability distributions include a prior probability distribution 133042 , a predicted (state) probability distribution 133044 and an observed probability distribution 133046 . Three probability distributions 133042, 133044, 1330467 are applied to the ultrasonic transducer to adjust the temperature based on the impedance across the ultrasonic transducer measured at various frequencies, according to at least one aspect of the present disclosure. used for power feedback control. The estimator used for feedback control of the power applied to the ultrasonic transducer to regulate temperature based on impedance is given by

これは、本開示の少なくとも１つの態様による、様々な周波数で測定された超音波変換器にわたるインピーダンスである。

This is the impedance across the ultrasonic transducer measured at various frequencies according to at least one aspect of the present disclosure.

Prior probability distribution 133042 contains state variations defined by the following equation.

状態変動

status change

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

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

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

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

FIG. 46A is a graphical representation 133050 of temperature versus time for an ultrasound system without temperature feedback control. The temperature of the ultrasonic blade (°C) is shown along the vertical axis and time (sec) is shown along the horizontal axis. Testing was performed with a chamois placed in the jaws of the ultrasound machine. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade was excited at a resonant frequency while frictionally engaging a chamois clamped between the ultrasonic blade and the clamp arm. Over time, the temperature (°C) of the ultrasonic blade increases due to its frictional engagement with the chamois. Over time, the temperature profile 133052 of the ultrasonic blade increases until the chamois sample is cut at a temperature of 220° C. after about 19.5 seconds indicated by point 133054 . Without temperature feedback control, the temperature of the ultrasonic blade rises well above the melting point of TEFLON, which is about 380° C., to a maximum temperature of about 490° C. after the chamois sample is cut. At point 133056, the temperature of the ultrasonic blade reaches a maximum temperature of 490°C until the TEFLON pad is completely melted. The temperature of the ultrasonic blade drops slightly from the peak temperature at point 133056 after the pad has completely disappeared.

46B is a plot of temperature versus time for an ultrasound device with temperature feedback control, according to at least one aspect of the present disclosure; FIG. The temperature of the ultrasonic blade (°C) is shown along the vertical axis and time (sec) is shown along the horizontal axis. The test was performed with a chamois sample placed in the jaws of the ultrasound machine. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade was excited at a resonant frequency while frictionally engaging a chamois clamped between the ultrasonic blade and the clamp arm pad. Over time, the temperature profile 133062 of the ultrasonic blade increases until the chamois sample is cut at a temperature of 220° C. after about 23 seconds indicated by point 133064 . With temperature feedback control, the temperature of the ultrasonic blade increases to a maximum temperature of about 380°C, just below the TEFLON melting point, indicated by point 133066, and then decreases to an average of about 330°C, generally indicated by region 133068. , thereby preventing the TEFLON pads from melting.

Application of Smart Ultrasonic Blade Technology When an ultrasonic blade is immersed in a fluid-filled surgical field, it cools during activation, making it less effective for sealing and cutting tissue in contact with it. be done. Cooling the ultrasonic blade may result in longer start-up times and/or hemostasis problems because not enough heat is delivered to the tissue. To overcome the cooling of the ultrasonic blade, more energy delivery may be required to shorten the transection time and achieve adequate hemostasis under these fluid immersion conditions. Using a frequency-temperature feedback control system, the ultrasonic blade temperature either starts below a certain temperature or remains below a certain temperature for a certain period of time. is detected, the generator output power can be increased to offset the cooling due to blood/saline/other fluids present in the surgical field.

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

As previously mentioned, the temperature of the ultrasonic blade is to detect the impedance of the ultrasonic transducer given by the formula:

あるいは同等に、超音波変換器に印加される電圧Ｖ_ｇ（ｔ）信号と電流Ｉ_ｇ（ｔ）信号との間の位相角φを検出することによって推定することができる。位相角φの情報はまた、超音波ブレードの状態を推定するために使用されてもよい。本明細書で詳細に論じられるように、位相角φは、超音波ブレードの温度の関数として変化する。したがって、位相角φ情報は、超音波ブレードの温度を制御するために用いられてもよい。これは、例えば、超音波ブレードが過度に高温で動作しているときは超音波ブレードに送達される電力を低減し、超音波ブレードが過度に低温で動作しているときは超音波ブレードに送達される電力を増加させることによって行われ得る。図４７Ａ～図４７Ｂは、超音波ブレードの急激な温度低下が検出されたときに超音波変換器に印加される超音波電力を調節するための温度フィードバック制御のグラフ表示である。

Or equivalently, it can be estimated by detecting the phase angle φ between the voltage V _g (t) and current I _g (t) signals applied to the ultrasonic transducer. Information of the phase angle φ may also be used to estimate the state of the ultrasonic blade. As discussed in detail herein, the phase angle φ varies as a function of ultrasonic blade temperature. Therefore, the phase angle φ information may be used to control the temperature of the ultrasonic blade. This reduces, for example, the power delivered to the ultrasonic blade when it is operating too hot, and the power delivered to the ultrasonic blade when it is operating too cold. This can be done by increasing the power applied. 47A-47B are graphical representations of temperature feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a sudden drop in temperature of the ultrasonic blade is detected.

FIG. 47A is a graphical representation of ultrasound 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. Ultrasonic blade temperature is shown along the vertical axis and time (seconds) is shown along the horizontal axis. The temperature of the ultrasonic blade is increased by applying a constant power 133072 as shown in Figure 47A. During use, the temperature of the ultrasonic blade drops rapidly. This can be attributed to a variety of conditions, but during use, the temperature of the ultrasonic blade when it is immersed in a fluid-filled surgical field (e.g., blood, saline, water, etc.) can be estimated to decrease. At time t ₀ the temperature of the ultrasonic blade drops below the desired minimum temperature of 133082 and the frequency-temperature feedback control algorithm detects the drop in temperature and increases the power ramp delivered to the ultrasonic blade. A power ramp up or “ramp up” indicated by 133074 is initiated to begin raising the temperature of the ultrasonic blade above the desired minimum temperature 133082 .

47A and 47B, as long as the temperature of the ultrasonic blade remains above the desired minimum temperature 133082, the ultrasonic generator outputs substantially constant power 133072. Referring to FIGS. At t ₀ , when the generator or instrument processor and/or control circuitry detects that the temperature of the ultrasonic blade has dropped below the desired minimum temperature of 133072, it initiates a frequency-temperature feedback control algorithm to Raise the temperature of the sonic blade above the lowest desired temperature of 133082. Thus, the generator power begins to increase at t ₁ (133074) corresponding to the detection of a sudden drop in temperature of the ultrasonic blade at t ₀ . Under the frequency-temperature feedback control algorithm, the power continues to increase (133074) until the temperature of the ultrasonic blade exceeds the desired minimum temperature 133082.

FIG. 48 is a process logic flow diagram 133090 illustrating a control program or logic configuration for controlling the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. According to this process, the processor and/or control circuitry of the generator or instrument executes one aspect of the frequency-temperature feedback control algorithm described in connection with FIGS. 133092 to achieve the desired temperature in the ultrasonic blade. The generator monitors the phase angle φ between the voltage V _g (t) and current I _g (t) signals applied to drive the ultrasonic transducer (133094). Based on the phase angle φ, the generator estimates (133096) the temperature of the ultrasonic blade using techniques described herein in connection with FIGS. The generator determines (133098) whether the temperature of the ultrasonic blade is below the desired minimum temperature by comparing the estimated temperature of the ultrasonic blade to a predetermined desired temperature. The generator then adjusts the power level applied to the ultrasonic transducer based on the comparison. For example, when the ultrasonic blade temperature is greater than or equal to the desired minimum temperature, the process proceeds along the "no" branch, and when the ultrasonic blade temperature is less than the desired minimum temperature, the process proceeds along the "yes" branch. to proceed. When the temperature of the ultrasonic blade is below the desired minimum temperature, the generator increases the voltage to the ultrasonic transducer, e.g., by increasing the voltage V _g (t) and/or current I _g (t) signals. Increase the power level (133100) to increase the temperature of the ultrasonic blade and continue increasing the power level applied to the ultrasonic transducer until the temperature of the ultrasonic blade increases and exceeds the minimum desired temperature.

Adaptive Advanced Tissue Treatment Pad Saver Mode FIG. 49 is a graphical representation 133110 of ultrasonic blade temperature as a function of time during vessel firing, according to at least one aspect of the present disclosure. A plot 133112 of ultrasonic blade temperature is graphed along the vertical axis as a function of time along the horizontal axis. A frequency-temperature feedback control algorithm combines the temperature of ultrasonic blade feedback control with jaw sensing capability. A frequency-temperature feedback control algorithm provides optimal hemostasis balanced with device durability, and can intelligently deliver energy for the best seal while protecting the clamp arm pads.

As shown in FIG. 49, the optimum temperature for vessel sealing 133114 is marked as the first target temperature _T1 , and the optimum temperature for "infinite" clamp arm pad life 133116 is marked as the second target temperature T1. Marked as _T2 . A frequency-temperature feedback control algorithm estimates the temperature of the ultrasonic blade and maintains the ultrasonic blade temperature between a first target temperature threshold T ₁ and a second target temperature threshold T ₂ . Therefore, the generator power output is driven to achieve the optimum ultrasonic blade temperature for vessel sealing and extended clamp arm pad life.

Initially, the blade heats up to increase the temperature of the ultrasonic blade, and eventually when the first target temperature threshold _T1 is exceeded, the temperature of the ultrasonic blade increases. The frequency-temperature feedback control algorithm takes over to control the temperature of the blade to T ₁ until the vessel transsection is completed at t ₀ (133118) and the ultrasonic blade temperature is below the second target temperature threshold T ₂ . The generator or instrument processor and/or control circuitry detect when the ultrasonic blade contacts the clamp arm pads. Once the vessel transsection is complete and detected at _t0 , the frequency-temperature feedback control algorithm controls the temperature of the ultrasonic blade to a second target threshold _T2 to extend the life of the clam arm pad. switch to The optimum clamp arm pad life temperature for TEFLON clamp arm pads is about 325°C. In one aspect, advanced tissue therapy may be announced to the user with a second activation tone.

FIG. 50 is a process logic flow diagram 133120 illustrating a control program or logic configuration for controlling the temperature of an ultrasonic blade between two temperature setpoints shown in FIG. 49, according to at least one aspect of the present disclosure. . According to this process, the generator implements an aspect of a frequency-temperature feedback control algorithm to generate, for example, a voltage V _g (t) signal and/or a current I _g (t) applied to the ultrasonic transducer. A first power level is applied to the ultrasonic transducer by adjusting the signal to set the ultrasonic blade temperature to a first target _T1 optimized for vessel sealing (133122). As previously mentioned, the generator monitors (133124) the phase angle φ between the voltage V _g (t) and current I _g (t) signals applied to the ultrasonic transducer, and the phase angle φ Based on this, the generator estimates (133126) the temperature of the ultrasonic blade using the techniques described herein in connection with FIGS. 43A-45. According to a frequency-temperature feedback control algorithm, the processor and/or control circuitry of the generator or instrument maintains the ultrasonic blade temperature at the first target temperature T ₁ until the transection is completed. A frequency-temperature feedback control algorithm may be used to detect completion of the transvessel dissection process. The processor and/or control circuitry of the generator or instrument determine when the vessel transection is complete (133128). The process proceeds along the "no" branch when the transection has not been completed and along the "yes" branch when the transection has been completed.

If the vessel transection has not been completed, the processor and/or control circuitry of the generator or instrument sets the temperature of the ultrasonic blade to the temperature _T1 optimized for vessel sealing and transection. (133130). If the ultrasonic blade temperature is set to _T1 , the process proceeds along the "yes" branch and the processor or control circuit of the generator or instrument or both apply to the ultrasonic transducer and the phase angle φ Continue monitoring (133124) the phase angle φ between the voltage V _g (t) and current I _g (t) signals based on . If the ultrasonic blade temperature has not been set to _T1 , the process proceeds along the "no" branch and the processor and/or control circuitry of the generator or instrument continues to direct the ultrasonic transducer to the first Apply power level (133122).

Once the transvessel dissection is completed, the generator or the instrument's processor and/or control circuitry applies a second power level to the ultrasonic transducer (133132) to extend the life of the ultrasonic blade and clamp arm pads. Set a second target temperature _T2 optimized for maintenance or prolongation. The processor and/or control circuitry of the generator or instrument determines (133134) if the temperature of the ultrasonic blade is the set temperature _T2 . If the ultrasonic blade temperature is set to T2, the process completes the transvessel procedure (133136).

Blade Start Temperature Knowing the temperature of the ultrasonic blade at the start of the traverse cut allows the generator to deliver the appropriate amount of power to heat the blade for rapid cutting, or if the blade is already hot. , it may be possible to add as much power as needed. This technique can achieve more consistent transection times and extend the life of clam arm pads (eg, TEFLON clamp arm pads). Knowing the temperature of the ultrasonic blade at the start of the transverse incision may allow the generator to deliver the correct amount of power to the ultrasonic transducer to produce the desired amount of displacement of the ultrasonic blade.

FIG. 51 is a process logic flow diagram 133140 illustrating a control program or logic configuration for determining 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 in the manufacturing plant. A baseline frequency value is recorded and stored in a lookup table on the generator and/or the instrument. Baseline values are used to generate a transfer function. At the beginning of the ultrasonic transducer activation cycle, the generator measures the resonant frequency of the ultrasonic blade (133142), compares the measured resonant frequency to the baseline resonant frequency value (133144), and determines the frequency difference (Δf ) is determined. Δf is compared to a corrected ultrasonic blade temperature lookup table or transfer function. The resonant frequency of the ultrasonic blade can be determined by sweeping the frequencies of the voltage V _g (t) and current I _g (t) signals applied to the ultrasonic transducer. The resonant frequency, as described herein, is the frequency at which the phase angle φ voltage V _g (t) and current I _g (t) signals are zero.

Once the resonant frequency of the ultrasonic blade is determined, the processor and/or control circuitry of the generator or instrument determines the initial temperature of the ultrasonic blade based on the difference between the measured resonant frequency and the baseline resonant frequency. is determined (133146). The generator may, for example, adjust the voltage V _g (t) drive signal or the current I _g (t) drive signal or both to one of the following values before activating the ultrasonic transducer: sets the power level delivered to the ultrasound transducer.

The processor and/or control circuitry of the generator or instrument determine whether the initial temperature of the ultrasonic blade is low (133148). If the initial temperature of the ultrasonic blade is low, the process proceeds along the "yes" branch and the generator or instrument's processor and/or control circuitry applies a high power level to the ultrasonic transducer (133152). , raises the temperature of the ultrasonic blade and completes the transvessel procedure (133156).

If the initial temperature of the ultrasonic blade is not low, the process continues along the "no" branch and the processor and/or control circuitry of the generator or instrument determines whether the initial temperature of the ultrasonic blade is high. (133150). If the initial temperature of the ultrasonic blade is high, the process proceeds along the "yes" branch and the generator or instrument's processor and/or control circuitry applies a low power level to the ultrasonic transducer (133154). , lowers the temperature of the ultrasonic blade and completes the transvessel dissection procedure (133156). If the initial temperature of the ultrasonic blade is not high, the process proceeds along the "no" branch and the generator or instrument processor and/or control circuitry completes the vessel transection (133156).

Smart Blade Technology for Controlling Blade Instability The temperature of the ultrasonic blade and the contents within the jaws of the ultrasonic end effector can be determined using the frequency-temperature feedback control algorithm described herein. can. The frequency/temperature relationship of the ultrasonic blade is used to control the instability of the ultrasonic blade with temperature.

As described herein, there is a well-known relationship between frequency and temperature in ultrasonic blades. Some ultrasonic blades exhibit displacement instability or modal instability in the presence of elevated temperature. This known relationship can be used to interpret when the ultrasonic blade is approaching instability and then adjust the power level driving the ultrasonic transducer (e.g., the drive voltage applied to the ultrasonic transducer By adjusting the V _g (t) signal or the current I _g (t) signal or both), the temperature of the ultrasonic blade can be modulated to prevent ultrasonic blade instability.

FIG. 52 illustrates determining when an ultrasonic blade is nearing instability and subsequently reducing power to the ultrasonic transducer to prevent ultrasonic transducer instability, in accordance with at least one aspect of the present disclosure; Figure 133160 is a process logic flow diagram showing a control program or logic construct to adjust. The frequency/temperature relationship of an ultrasonic blade exhibiting displacement or modal instability is obtained by sweeping the frequency of the drive voltage V _g (t) signal or current I _g (t) signal or both over the temperature of the ultrasonic blade, resulting in is mapped by recording A function or relationship is generated that can be used/interpreted by the control algorithm executed by the generator. A trigger point can be established using this relationship to notify the generator that the ultrasonic blade is approaching a known blade instability. The generator may _be configured to reduce the _frequency- A temperature feedback control algorithm processing function and closed loop response is implemented to modulate the temperature of the ultrasonic blade below the trigger point to prevent a given blade from reaching instability.

Advantages include the simplification of ultrasonic blade construction such that the instability characteristics of the ultrasonic blade need not be excluded from the design and can be compensated for using the instability control techniques of the present invention. be done. The instability control technique of the present invention can also enable new ultrasonic blade geometries and improve the stress profile of heated ultrasonic blades. Additionally, the ultrasonic blade can be configured to degrade the performance of the ultrasonic blade when used with generators that do not use this technology.

According to the process illustrated by logic flow diagram 133160, the processor and/or control circuitry of the generator or instrument generates voltage V _g (t) and current I _g (t) signals applied to the ultrasonic transducer and Monitor the phase angle φ between (133162). The processor and/or control circuitry of the generator or instrument generates ultrasonic waves based on the phase angle φ between the voltage V _g (t) and current I _g (t) signals applied to the ultrasonic transducer. Estimate the temperature of the blade (133164). The generator or instrument processor and/or control circuitry compares the estimated temperature of the ultrasonic blade to the ultrasonic blade instability trigger point threshold (133166). The processor and/or control circuitry of the generator or instrument determine if the ultrasonic blade is approaching instability (133168). If not, the process proceeds along the "no" branch and monitors the phase angle φ (133162), estimates the temperature of the ultrasonic blade (133164), and keeps the ultrasonic blade warm until it approaches instability (133164). is compared to the ultrasonic blade instability trigger point threshold (133166). The process then proceeds along the "yes" branch where the generator or instrument processor and/or control circuitry adjusts (133170) the power level applied to the ultrasonic transducer to increase the temperature of the ultrasonic blade. modulate the

Ultrasonic Sealing Algorithm with Temperature Control The ultrasonic sealing algorithm for ultrasonic blade temperature control uses the frequency-temperature feedback control algorithm described herein to improve hemostasis and It can be employed to take advantage of the frequency/temperature relationship.

In one aspect, as described in various aspects of the present disclosure, a frequency-temperature feedback control algorithm is employed to generate ultrasonic waves based on measured temperature-related resonant frequencies (using spectroscopy). The power level applied to the converter can be changed. In one aspect, the frequency-temperature feedback control algorithm may be activated by an energy button on the ultrasound instrument.

Optimal tissue effect is achieved by increasing the power level driving the ultrasonic transducer early in the sealing cycle (e.g., driving voltage V _g (t) or current I _g (t) applied to the ultrasonic transducer). Rapidly heating and drying the tissue (by increasing both or both) followed by reducing the power level driving the ultrasound transducer (e.g., driving voltage V _g applied to the ultrasound transducer ( t) or by lowering the current I _g (t) or both) can be obtained by gradually forming the final seal. In one aspect, a frequency-temperature feedback control algorithm according to the present disclosure sets a limit above the temperature threshold that tissue can reach as it heats up during a high power level phase, followed by clamping jaw pads (e.g., The power level is reduced to control the temperature of the ultrasonic blade based on the melting point of TEFLON) to complete the seal. A control algorithm can be implemented by activating an energy button on the instrument for a more responsive/adaptive seal to reduce the complexity of the hemostasis algorithm.

FIG. 53 is a process logic flow diagram 133180 illustrating a control program or logic configuration for providing ultrasonic sealing with temperature control in accordance with at least one aspect of the present disclosure. According to the control algorithm, the generator or instrument's processor and/or control circuitry activates 133182 the sensing of the ultrasonic blade using spectroscopy (e.g. smart blade) and the resonant frequency of the ultrasonic blade (e.g. The resonant frequency of the ultrasonic electromechanical system) is measured 133184 to determine the temperature of the ultrasonic blade using the frequency-temperature feedback control algorithm (spectroscopy) described herein. As described above, 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.

A first desired resonant frequency f _x of the ultrasonic electromechanical system corresponds to a first desired temperature Z° of the ultrasonic blade. In one aspect, the first desired ultrasonic blade temperature Z° is the optimum temperature for tissue coagulation (eg, 450° C.). A second desired frequency f _Y of the ultrasonic electromechanical system corresponds to a second desired temperature ZZ° of the ultrasonic blade. In one aspect, the second desired ultrasonic blade temperature ZZ° is a temperature of 330° C., which is below the melting point of the clamp arm pad, which is about 380° C. for TEFLON.

The processor and/or control circuitry of the generator or instrument compares the measured resonant frequency of the ultrasonic electromechanical system to the first desired frequency _fx (133186). In other words, the process determines whether the temperature of the ultrasonic blade is below the temperature for optimal tissue coagulation. If the measured resonant frequency of the ultrasonic electromechanical system is lower than the first desired frequency _fx , the process proceeds along the "no" branch and the processor and/or control circuitry of the generator or instrument , increasing the power level applied to the ultrasonic transducer (133188) to raise the temperature of the ultrasonic blade until the measured resonant frequency of the ultrasonic electromechanical system exceeds the first desired frequency _fx . . In this case, the tissue coagulation process is complete and the process controls the temperature of the ultrasonic blade to a second desired temperature corresponding to a second desired frequency _fy .

The process proceeds along the "yes" branch and the generator or instrument processor and/or control circuitry reduces (133190) the power level applied to the ultrasonic transducer to reduce the temperature of the ultrasonic blade. Let The processor and/or control circuitry of the generator or instrument measures 133192 the resonant frequency of the ultrasonic electromechanical system and compares the measured resonant frequency to a second desired frequency _fY . If the measured resonant frequency is greater than or equal to the second desired frequency _fY , the processor and/or control circuitry of the generator or instrument will cause the measured resonant frequency to be less than the second desired frequency _fY . (133190). A frequency-temperature feedback control algorithm maintains the measured resonant frequency of the ultrasonic electromechanical system below a second desired frequency _fy (e.g., the temperature of the ultrasonic blade is below the temperature of the melting point of the clamp arm pad). ), the generator subsequently performs an increase in the power level applied to the ultrasonic transducer to increase the temperature of the ultrasonic blade until the tissue transcision 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 results of applying the frequency-temperature feedback control algorithm described in FIG. Graphical representation 133200 shows a first plot 133202 of ultrasonic blade temperature as a function of time against a second plot 133204 of ultrasonic transducer current I _g (t) as a function of time. As shown, the transducer I _g (t) is kept constant until the ultrasonic blade temperature reaches the optimum freezing temperature of 450°C. When the ultrasonic blade temperature reaches 450° C., the frequency-temperature feedback control algorithm, for example, increases the transducer current I _g ( t) is decreased.

Identification or Parameterization of Tissue Type In various aspects, a surgical instrument (e.g., an ultrasonic surgical instrument) identifies or parameterizes tissue grasped by an end effector, and various operations of the surgical instrument are performed accordingly. Configured to adjust parameters. Tissue identification or parameterization can include tissue type (eg, physiological tissue type), tissue physical properties or attributes, tissue composition, tissue location within or relative to an end effector, and the like. In one example, discussed in more detail below, the ultrasonic surgical instrument adjusts the displacement amplitude of the distal tip of the ultrasonic blade according to the tissue collagen/elastin ratio detected within the jaws of the end effector. It is configured. As previously mentioned, the ultrasonic instrument comprises an ultrasonic transducer acoustically coupled to an ultrasonic blade via an ultrasonic waveguide. The displacement of the ultrasonic blade is a function of the power applied to the ultrasonic transducer, so the power supplied 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 tissue can be modulated according to the position of the tissue relative to the end effector. Various techniques for identifying or parameterizing tissue are described herein, and further details can be found, for example, in "SMART ENERGY DEVICES," the disclosure of which is incorporated herein by reference in its entirety. No. 62/692,768, filed June 30, 2018, entitled

Determining Tissue Position Via Impedance Changes Referring back to FIG. 23, there is shown an end effector 1122 comprising an ultrasonic blade 1128 and a clamp arm 1140, according to at least one aspect of the present disclosure. FIG. 55 is a bottom view of the ultrasonic end effector 1122 showing the clamp arm 1140 and ultrasonic blade 1128 and depicting positioning of tissue within the ultrasonic end effector 1122, according to at least one aspect of the present disclosure. Tissue positioning between the clamp arm 1140 and the ultrasonic blade 1128 is controlled by distal region 130420 and proximal region 130422 . , etc., can be delineated according to the region or area where the tissue is located.

23 and 55, ultrasonic end effector 1122 grasps tissue between ultrasonic blade 1128 and clamp arm 1140 as described herein. Once tissue is grasped, an ultrasonic generator (eg, generator 1100 described in connection with FIG. 22) is acoustically coupled to ultrasonic blade 1128 via an ultrasonic waveguide. It can be activated to apply power to the ultrasonic transducer. The power applied to the ultrasound transducer can be in a therapeutic or non-therapeutic range of energy levels. In the non-therapeutic range of applied power, the resulting displacement of the ultrasonic blade 1128 has no or minimal effect on the grasped tissue so as not to coagulate or cut the tissue. Non-therapeutic excitation can be particularly useful for determining the impedance of an ultrasound transducer, which can be used, for example, in tissue type, tissue location within the end effector, different tissue types, among other conditions. , and the temperature of the ultrasonic blade. A variety of these conditions are described herein. The impedance of the ultrasonic transducer, as described herein, is

によって与えられる。超音波エンドエフェクタ１１２２での状態が、非治療的超音波エネルギーレベルを使用して決定されると、特定の外科処置に関連付けられた他の変数の中でも、組織治療、効果的なシール、横切開、及び期間を最適化するために、決定されたエンドエフェクタ１１２２の状態に基づいて治療的超音波エネルギーが印加され得る。治療エネルギーは、組織を凝固及び切断するのに十分である。

given by Once conditions at the ultrasonic end effector 1122 are determined using non-therapeutic ultrasonic energy levels, tissue treatment, effective sealing, transverse incision, among other variables associated with a particular surgical procedure, can be determined. , and duration, therapeutic ultrasound energy may be applied based on the determined state of the end effector 1122 . The therapeutic energy is sufficient to coagulate and cut tissue.

In one aspect, the present disclosure provides the thickness and thickness 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 FIGS. Provide a control process, such as an algorithm for determining type. Further details regarding detecting various states and characteristics of an object grasped by the end effector 1122 are provided below in the "DETERMINING JAW STATE" section and under "SMART ENERGY DEVICES". are discussed in entitled US Provisional Patent Application No. 62/692,768.

FIG. 56 is a graph illustrating changes in ultrasound transducer impedance as a function of tissue position within the ultrasound end effector 1122 over a range of increasing predetermined ultrasound generator power levels, in accordance with at least one aspect of the present disclosure. The display is 130000. The horizontal axis 130004 represents tissue position and the vertical axis 130002 represents transducer impedance (Ω). Various limits along the horizontal axis 130004, such as a first or proximal limit 130010 and a second or distal limit 130012, delineate different positions of tissue grasped within the ultrasonic end effector 1122, or can correspond to them. A depiction of proximal and distal tissue locations is schematically shown in FIG. 55 (ie, proximal portion 130422 and distal portion 130420). Plots 130006, 130008 show the transducer impedance Ω as the power applied to the ultrasound transducer varies from a minimum or first non-therapeutic power level _L1 to a maximum or second non-therapeutic power level _L2 . represents change. The greater the change in transducer impedance Ω, the closer the resulting plot is to the distal limit 130012 . Thus, tissue locations correspond to locations in plots obtained for various limits (eg, proximal limit 130010 and distal limit 130012). In the first plot 130006, δ1 represents the change in transducer impedance when tissue is positioned 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 second plot 130008 δ2 represents the change in transducer impedance when tissue is positioned at the distal end 130012 of the end effector 1122 . This can be seen from the fact that the first plot 130006 lies beyond the proximal limit 130010 and/or near the distal limit 130012 . As shown by plots 130006, 130008, _δ2 is much larger than _δ1 .

The measured Transducer impedance (Ω) is a useful indicator of tissue position 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. is. The position of tissue within the end effector 1122 changes the transducer impedance as the non-therapeutic power level applied to the ultrasound transducer changes from a minimum power level (eg, L ₁ ) to a maximum power level (eg, L ₂ ). It can be determined based on the change in δ. In some aspects, the non-therapeutic power level(s) applied to the ultrasonic transducer causes the ultrasonic blade 1128 to move below a sensed or minimum therapeutic amplitude (e.g., at the distal end of the ultrasonic blade 1128 and /or 35 μm or less at the proximal end). Calculation of impedance has been previously discussed in this disclosure. A measurement of the first transducer impedance _Z1 is taken when the first power level _L1 is applied, which provides an initial measurement, until the applied power reaches the second power level _L2 . Subsequent impedance _Z2 measurements are taken again as it is increased. In one aspect, the first power level L ₁ =0.2 A and the second power level L ₂ =0.4 A or twice the first power level L ₁ while the voltage remains constant . The resulting longitudinal displacement amplitude of the ultrasonic blade 1128 based on the applied power level provides an indication of tissue position within the jaws of the end effector 1122 . In one exemplary implementation, the first power level _L1 produces a longitudinal displacement amplitude of 35 μm at distal end 130420 and 15 μm at proximal end 130422 . Further, in this example, the second power level _L2 produces a longitudinal amplitude of 70 μm at distal end 130420 and 35 μm at proximal end 130422 . The algorithm calculates the difference in transducer impedance δ between the first and second measurements to find the change in impedance ΔZ _g (t). The change in impedance δ is plotted against tissue position, with higher changes in impedance representing tissue position distributed at the distal end 130012 and lower changes in impedance representing the proximal end 130010 of the end effector 1122. represents the position of the tissue distributed in the In short, tissue is only distally positioned within the end effector 1122 when there is a large change in impedance as the power level increases from L ₁ to L ₂ . Conversely, if there is only a small change in impedance as the power level increases from L ₁ to L ₂ , the tissue will be more distributed within the end effector 1122 .

FIG. 57 is a graphical representation 130050 showing changes in ultrasound transducer impedance as a function of time versus tissue position within an ultrasound 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 (δ) between the first and second measurements. Plots 130060, 130066 show changes in transducer impedance (δ) versus time (t) for proximal and distal positions of tissue within the bite of clamp arm 1140 . With respect to the proximal and distal tissue positions, clamp arm 1140 force is applied to hold the tissue within the ultrasonic end effector 1122 and a delay period is applied before the first low power level is applied. , the transducer impedance is measured. The system then applies a second, higher power level and measures the impedance again. It should be appreciated that both the first and second power levels applied to the ultrasound transducer are non-therapeutic power levels. An algorithm executed by a processor or control circuitry portion of the generator or surgical instrument (e.g., processor 902 of FIG. 21 or control circuitry 760 of FIG. 18) determines first power levels of the proximal and distal tissue locations. and the second power level. If the difference in transducer impedances (δ) is below a first threshold 130056 , as shown in connection with first plot 130060 , the algorithm determines that tissue is within proximal portion 130422 of end effector 1122 . Then judge. In the first plot 130060, the transducer impedance difference between the measurements increases 130062 over time until it plateaus or remains 130064 below the first threshold 130056. If the difference in transducer impedances (δ) exceeds a second threshold 130058, as shown in connection with the first plot 130066, the algorithm determines that tissue is positioned within the distal portion 130420 of the end effector 1122. Then judge. In a second plot 130066, the difference in transducer impedance between measurements increases 130068 over time until it plateaus or maintains 130070 above a second threshold 130058. If the difference in transducer impedance (δ) is between the first and second thresholds 130056, 130058, the algorithm determines that tissue is within the central portion 130424 of the end effector 1122, e.g. It is determined that it is located between and between the parts.

FIG. 58 shows the logic of process 130100, a control program or logic configuration for specifying operation in the non-therapeutic range of power applied to the instrument to determine tissue positioning, in accordance with at least one aspect of the present disclosure. It is a flow chart. Process 130100 may be performed by a processor or control circuit of a surgical instrument, such as control circuit 760 of FIG. 18, or of a generator, such as processor 902 of FIG. For brevity, process 130100 is described as being executed by a processor, but it should be understood that the following description encompasses variations of the foregoing.

According to one aspect of process 130100, the processor closes clamp arm 1140 and separates clamp arm 1140 and ultrasonic blade 1128 . Apply a control signal to trap tissue between After the clamp arm 1140 closes on the tissue, the processor waits a predetermined delay period to allow the tissue to soften and give up some moisture. After the delay period, the processor sets the power level applied to the ultrasound transducer to a first non-therapeutic power level (130102). Optionally, one aspect of process 130100 includes that feedback control can be used to verify that the first power is set below the therapy 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 greater than or equal to the therapy power level, process 130100 continues along the "no" branch and the processor decreases the applied power (130108) and the first power level is equal to or greater than therapy power. Continue looping until less than level. The process 130100 then continues along the "yes" branch where the processor measures a first impedance Z _g1 (t) of the ultrasound transducer corresponding to the first power level (130110). The processor then sets the power level applied to the ultrasound transducer to a second non-therapeutic power level (130112), the second power level being greater than the first power level and less than the therapeutic power level. Again, feedback control may optionally be used to verify that the second power level is not only above the first power level, but below 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 therapy power level, the process 130100 continues along the "no" branch and the processor decreases the second power level (130108) until it falls below the therapy power level threshold. Continue looping until . The process 130100 then continues along the "yes" branch where the processor measures a second impedance Z _g2 (t) of the ultrasound transducer corresponding to the second power level (130116). The impedance of an ultrasonic transducer can be measured using various techniques discussed herein. The processor then calculates (130118) the difference in transformer impedance between the applied first power level and the second power level.
δ=Z _g2 (t)−Z _g1 (t).

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

The processor compares the transducer impedance difference to first and second thresholds, where if the transducer impedance difference (δ) is below the first threshold 130056 as shown in FIG. , the tissue is located within the proximal portion 130422 of the end effector 1122, and if the transducer impedance difference (δ) exceeds a second threshold 130058, the algorithm determines that the tissue is within the distal portion 130420 of the end effector 1122. is determined to be located at If the transducer impedance difference (δ) is between the first and second thresholds 130056, 130058, the algorithm determines that tissue is within the central portion 130424 of the end effector 1122, e.g. Determine that it is located between the distal portions 130422,130420. According to the described process, the impedance of the ultrasound transducer is used to distinguish what percentage of the tissue is located distal, proximal, or intermediate to the end effector 1122, and then the appropriate therapeutic power is applied. level can be applied.

Switchless Mode Based on Tissue Positioning In various embodiments, the response of the ultrasonic instrument is determined by whether tissue is present within the end effector, the type of tissue located within the end effector, or the type of tissue located within the end effector. It can be based on compressibility or composition. Thus, the generator or ultrasonic surgical instrument implements an algorithm that controls the time between clamping tissue in the jaws of the end effector and activating the ultrasonic transducer to treat the tissue. may contain and/or execute instructions for If no tissue is sensed, the ultrasound generator activation button or pedal may be assigned different meanings to perform different functions. In one aspect, the advanced energy device may use detection of the presence of tissue within the jaws of the end effector as a cue to activate an ultrasonic transducer, thereby initiating a tissue coagulation cycle. In another aspect, the compression properties and situational awareness can also allow automatic activation of the device and adjustment of algorithmic parameters to the tissue type sensed. For example, advanced generators may ignore button or foot pedal actuation unless tissue is sensed in contact with the jaws of the end effector. This configuration eliminates inadvertent start-up queuing allowing the device to operate in a simpler manner.

Accordingly, advanced generators, such as the advanced generators described in connection with FIGS. 1-42, and/or surgical instruments, such as ultrasonic surgical instruments described throughout this disclosure, are switchedless mode. may be configured to operate with In switchless mode mode, the ultrasound device is automatically activated in coagulation mode upon sensing or detecting the presence of tissue within the jaws of the end effector. In one aspect, when operating in automatic energy activation (or "switchless" mode) mode, the control algorithm controlling activation of the ultrasonic surgical instrument is activated when not operating in switchless mode. It can be configured to initially apply less energy to the ultrasonic instrument than is the case. Additionally, the ultrasonic generator or instrument can be configured to determine both contact with and tissue type located within the jaws of the end effector. Based on sensing or detecting the presence of tissue within the jaws of the end effector, a control algorithm executed by either the generator or the ultrasonic instrument's processor or control circuitry causes the ultrasonic instrument to run in a switchless mode. and the algorithm can be adjusted to achieve the best global coagulation of the tissue within the jaws of the end effector. In another aspect, instead of automatically activating the surgical instrument and/or the generator, a control algorithm executed by a processor or control circuit of the generator or ultrasonic instrument detects the presence of tissue within the end effector. Activation of the generator or ultrasonic instrument can be prevented unless indicated otherwise.

In one aspect, the present disclosure is performed by a processor or control circuit located in either the generator or the handheld ultrasonic instrument to determine the presence and type of tissue located within the jaws of the end effector. provide an algorithm that In one aspect, the control algorithm is via the techniques described herein for determining tissue location, as described below in the "Determining Tissue Location Via Electrode Continuity" section. can be configured to determine that tissue is located within the end effector. For example, the control algorithm determines whether tissue is within the end effector according to whether there is any continuity between the electrodes (as described below), and accordingly, automatically upon detection of tissue. (e.g., by initiating application of power to the surgical instrument to a generator to which the surgical instrument is coupled) or configured to allow activation of the surgical instrument can be done. When the surgical instrument and/or generator are operated in switchless mode, the control algorithm can be further configured to activate the surgical instrument at a particular power level, which is the power level of the surgical instrument. It may or may not be different from the normal initial startup power level. In some aspects, the control algorithm can be detected, for example, via the techniques described below in the section "Determining Tissue Collagen-to-Elastin Ratio as a Function of IR Surface Reflectance and Emissivity". It can be configured to activate or authorize activation of the surgical instrument according to a particular type or composition of tissue. For example, the control algorithm may be configured to activate the surgical instrument when tissue with high collagen composition is grasped, but activate the surgical instrument when tissue with high elastin composition is grasped. not necessarily. In some aspects, the control algorithm directs the grasped tissue to a specific location within the end effector, for example, via techniques described below in the section titled "Determining Tissue Location Via Electrode Continuity." or whether a particular amount of tissue has been grasped by the end effector to activate or permit actuation of the surgical instrument. For example, the control algorithm can be configured to activate the surgical instrument when the grasped tissue covers a particular percentage of the end effector. As another example, the control algorithm can be configured to activate the surgical instrument when grasped tissue is located at the distal end of the end effector.

In other aspects, the control algorithm is described in U.S. Provisional Patent Application Serial No. 62/659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety. whether tissue is being grasped by the end effector, the tissue type or composition, and It can be configured to determine other characteristics of the end effector or tissue. In these aspects, the surgical hub 106 (FIGS. 1-11) to which the surgical instruments and/or generators are connected is a surgical instrument, generator, and/or other medical device utilized in the operating room. Data can be received from the device and inferences can be made about the surgical procedure being performed or a particular step thereof. Thus, the situational awareness system can deduce what type(s) of tissue is being operated on at any given moment or step, and then the control algorithm can adjust the surgical instruments accordingly. control, including automatically activating surgical instruments as appropriate. For example, the control algorithm may automatically activate or permit activation of the surgical instrument when the tissue grasped by the end effector corresponds to the tissue type or tissue composition expected by the situational awareness system. Can be configured.

Having the ability to detect whether the instrument is in contact with tissue and what type of tissue it is when in contact allows the ultrasonic instrument to operate in a switchless mode of operation, Motion is permitted based on the sensing capabilities of the ultrasonic instrument. In some aspects, the control algorithm controls activation buttons, foot pedals, and activation buttons coupled to the generator and/or the ultrasonic surgical instrument unless tissue is sensed in contact with the jaws/end effectors of the surgical instrument. It can be configured to ignore activation of other input devices, thereby preventing unintended activation of the instrument. In some aspects, the control algorithm controls activation buttons coupled to the generator and/or the ultrasonic surgical instrument depending on whether tissue is sensed in contact with the jaws/end effectors of the surgical instrument; Foot pedals and other input device inputs can be configured to be assigned different meanings. For example, the control algorithm can be configured to activate the surgical instrument in response to an activated activation button when tissue is present within the end effector, however, when tissue is not present within the end effector. , the control algorithm can be configured to perform some different or secondary action when the activation button is activated.

The ability to determine the absence of tissue present in the jaws of the end effector is permissive allowing the instrument to change to switchless mode and then initiate operation of an automatic coagulation cycle when tissue is detected. play a role, leading to longer uptime use of the instrument and allowing the user to proceed based on their predictive capabilities. In addition to detecting the presence of tissue, the ability to also detect tissue type allows the algorithm to adjust and calculate the best clotting chance.

Adjusting the Ultrasound System According to Tissue Composition In various aspects, the ultrasonic surgical instrument detects the composition of the tissue grasped by or grasped by the end effector and adjusts the ultrasonic transducer and/or A processor or control circuit may be included that executes adaptive ultrasonic blade control algorithms for controlling operating parameters of the ultrasonic blade. Tissue composition can include, for example, the ratio of collagen to elastin in the tissue, tissue stiffness, or tissue thickness. Operating parameters controlled or adjusted by the adaptive ultrasonic blade control algorithm may include, for example, ultrasonic blade amplitude, ultrasonic blade temperature or heat flux, and the like. Adaptive ultrasonic blade control algorithms may be executed by a control circuit or processor located either on the generator or on the surgical instrument.

In one example, described in more detail below, the adaptive ultrasonic blade control algorithm can be configured to control the amplitude of the ultrasonic blade according to the collagen to elastin ratio of the tissue. A tissue's collagen to elastin ratio can be determined through a variety of techniques, such as those described below. In another embodiment, described in more detail below, the adaptive ultrasonic blade control algorithm controls the ultrasonic transducer/ultrasound blade to provide longer warming times and the termination of the ultrasonic blade. The lower temperature can be configured to lower the collagen content of the tissue.

Determining Tissue Collagen to Elastin Ratio According to Frequency Shift In various aspects, the control algorithm determines the tissue collagen to elastin ratio by detecting shifts in the ultrasonic blade's natural frequency and the ultrasonic blade waveform (e.g., , to adjust 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 collagen to elastin ratio of tissue located within the end effector of an ultrasonic instrument. In one aspect, the present disclosure provides an adaptive ultrasonic blade control algorithm for detecting shifts in the natural frequency and waveform of an ultrasonic blade to detect tissue composition in contact with the ultrasonic blade. In another aspect, the adaptive ultrasonic blade control algorithm detects the collagen and elastin composition content of the tissue and adjusts the therapeutic heat flux of the ultrasonic blade based on the detected collagen content of the tissue. may be configured to Techniques for monitoring deviations in the natural frequency of an ultrasonic blade based on the type of tissue located within the jaws of an end effector of an ultrasonic instrument are described herein with respect to FIGS. 1-54. there is Accordingly, for the sake of brevity and clarity of disclosure, such techniques are not repeated here.

The ratio of elastin to collagen can be determined by monitoring the shift in the natural frequency of the ultrasonic blade and comparing the natural frequency to a lookup table. The lookup table can be stored in memory (eg, memory 3326 of FIG. 31) and includes the ratio of elastin to collagen and the natural frequency shift corresponding to the particular ratio determined empirically.

Determine Collagen to Elastin Ratio of Tissue According to IR Surface Reflectance and Emissivity to determine the collagen to elastin ratio of a tissue. For example, FIG. 59 shows an ultrasound system 130164 comprising an ultrasound generator 130152 coupled to an ultrasound instrument 130150 . Ultrasonic instrument 130150 includes ultrasonic waveguides 130154 . to the ultrasonic end effector 130400 via. The ultrasound generator 130152 may be integral with the ultrasound instrument 130150 or may be connected to the ultrasound instrument 130150 using wired or wireless electrical/electronic coupling techniques. The end effector 130400 of the ultrasonic surgical instrument 130150 includes an IR sensor located on the clamp arm 130402 (eg, jaw member) in accordance with at least one aspect of the present disclosure. Ultrasonic generator 130152 and/or ultrasonic instrument 130150 are coupled to surgical hub 130160 and/or cloud 130162 via wireless or wired connections, as described in connection with FIGS. good too.

FIG. 60 illustrates an IR reflectance detection sensor circuit 130409 that may be integrally attached or formed with a clamp arm 130402 of an ultrasonic end effector 130400 to detect tissue composition, according to at least one aspect of the present disclosure. indicates The IR sensor circuit 130409 includes an IR source 130416 (eg IR transmitter) and an IR detector 130418 (eg IR receiver). IR source 130416 is coupled to voltage source V. Current is generated through R2 when control circuit 130420 closes switch SW1. When switch SW1 is closed, IR source 130416 emits IR energy toward tissue 130410 (eg, tissue clamped or placed between clamp arm 130402 and ultrasonic blade 130404). A portion of the emitted IR energy is absorbed by the tissue 130410, a portion of the emitted IR energy is transmitted through the tissue 130410, and a portion of the emitted IR energy is reflected by the tissue 130410. IR detector 130418 receives IR energy reflected by tissue 130410 and produces an output voltage Vo _or signal that is applied to control circuitry 130420 for processing.

59 and 60, in one aspect, an ultrasonic generator 130152 controls for driving an IR source 130416 and an IR detector 130418 located on or within the clamp arm 130402 of the ultrasonic end effector 130400. Includes circuit 130420. In another aspect, the ultrasonic instrument 130150 includes control circuitry 130420 for driving the IR source 130416 and IR detector 130418 located on or within the clamp arm 130402 of the ultrasonic end effector 130400. In either aspect, when tissue 130410 is grasped between ultrasonic blade 130404 and clamp arm 130402, IR source 130416 is energized, for example, by closing switch SW1 by control circuit 130420, to IR the tissue. Irradiate with energy. In one aspect, IR detector 130418 produces a voltage V _o proportional to IR energy reflected by tissue 130410 . 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, the IR energy passing through tissue 130410, and any losses. Control circuitry 130420 or processor may thus be configured to detect the collagen content of tissue 130410 by the amount of IR energy detected by IR detector 130418 relative to the total amount of IR energy emitted by IR source 130416 . The algorithm determines the collagen content of tissue 130410 by considering the amount of energy absorbed by and/or transmitted through tissue 130410 . IR source 130416 and IR detector 130418 and algorithms are calibrated to provide a useful measure of collagen content of tissue 130410 using principles of IR reflectance.

The IR reflectance detection sensor circuit 130409 shown in FIG. 60 provides IR surface reflectance and emissivity for determining the ratio of elastin to collagen. IR reflectance can be used to determine tissue composition for adjusting the amplitude of the ultrasound transducer. Refractive index is an optical constant that controls light-related reflection of IR light. 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. Refractive index can be used as an absolute or comparative measure of tissue differentiation.

A comparative method is to determine the exact ratio (as detailed above) using an energy dissection device such as, for example, an ultrasonic blade 130404, and then use that index as a baseline for all Predict the collagen ratio for further actuation of In this manner, the endoscope may update the dissection device (eg, ultrasonic blade 130404) based on the collagen ratio. The lancing device can fine-tune the prediction each time it is activated to deliver the actual collagen denaturation shot. An alternative method may employ absolute refractive index with a lookup table, which can distinguish between surface irregularities and subsurface collagen concentration. Further information on the IR refractive index properties of tissue can be found in "Visible To Near-Infrared Refractive Properties OF Freshly-Excised Human-Liver Tissues: Marking Hepatic Malignancies, Panagiotis Giannios, Konst antinos G. Toutouzas, Maria Matiatou, Konstantinos Stasinos, Manousos M.; Konstadoulakis, George C. Zografos, and Konstantinos Moutzourisa, Sci. Rep. 2016, 6:27910,” which is incorporated herein by reference.

In another aspect, the ultrasonic dissection device can 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 can be modified based on the collagen ratio received from the control circuit 130420. As one specific example, the ultrasonic blade temperature control algorithm lowers the set of temperatures at which the ultrasonic blade 130404 is maintained, causing the ultrasonic blade 130404 to heat the tissue 130404 for higher concentrations of collagen within the grasped tissue 130410. It can be configured to increase the retention time in contact with 130410. As another example, the waiting time for the algorithm to repeat full activation can be changed based on the collagen ratio. Various temperature control algorithms for ultrasonic blades are described in connection with FIGS. 43-54.

61 is a cross-sectional view of an ultrasonic end effector 130400 comprising a clamp arm 130402 and an ultrasonic blade 130404, according to one aspect of the present disclosure. The clamp arm 130402 includes IR reflectance detection sensor circuitry 130409a, 130409b that may be integrally attached or integrally formed with the clamp arm 130402 of the ultrasonic end effector 130400 to detect tissue 130410 composition. The IR reflectance detection sensor circuits 130409a, 130409b may be mounted on a flexible circuit board 130412 shown in plan view in FIG. Flexible circuit board 130412 includes three elongated elements 130408a, 130408b, 130408c to which IR reflectance detection sensor circuits 130409a, 130409b and IR sensors 130414a, 130414b are attached. IR sensors 130414a, 130414b may include IR source 130416 and IR detector 130418 as shown in FIG.

FIG. 63 is a logic flow diagram of process 130200 showing a control program or logic configuration for measuring IR reflectance to determine tissue composition and adjusting ultrasound transducer amplitude. Process 130200 may be performed by a processor or control circuit of a surgical instrument, such as control circuit 760 of FIG. 18, or of a generator, such as processor 902 of FIG. For the sake of brevity, process 130200 is described as being performed by the control circuit, but it should be understood that the following description encompasses variations of the foregoing.

1-54 and 59-63, in one aspect, the control circuit energizes (130202) the IR source 130416 to clamp within the end effector 13400 of the ultrasonic instrument 130150. Apply IR energy to tissue 130410; Control circuitry then detects IR energy reflected by tissue 130410 via IR detector 130418 (130204). Accordingly, control circuitry determines the collagen to elastin ratio of tissue 130410 based on the detected IR energy reflected by tissue 130410 (130206). A control circuit adjusts an ultrasonic blade temperature control algorithm as discussed in US Provisional Patent Application No. 62/692,768 entitled "SMART ENERGY DEVICES" based on the tissue's determined collagen to elastin ratio. (130208). In one aspect, the collagen content of the tissue 130410 can be detected according to 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 yet another aspect, the composition of the tissue 130410 may be tissue thickness or stiffness, which may be used to influence the ultrasonic blade transducer control program.

The elastin to collagen ratio can be determined by monitoring tissue IR reflectance and comparing the detected IR reflectance to a lookup table. The lookup table can be stored in memory (eg, memory 3326 of FIG. 31) and includes the ratio of elastin to collagen and the IR reflectance corresponding to the particular ratio determined empirically.

Determining the Collagen to Elastin Ratio of Tissue According to the Collagen Transformation Point Different types of tissue are composed of varying amounts of structural proteins such as collagen and elastin that provide different types of tissue with different properties. When heat is applied to tissue (eg, by an ultrasonic blade), structural proteins denature, affecting tissue integrity and other tissue properties. However, structural proteins denature at different known temperatures. For example, collagen denatures before elastin. Therefore, by detecting at what temperature tissue properties change, tissue composition (eg, the ratio of collagen to elastin within the tissue) can be estimated. In various aspects, the control algorithm can be configured to determine the tissue's collagen to elastin ratio by determining the tissue's collagen transformation point. The control algorithm can then control various operating parameters of the surgical instrument, such as the amplitude of the ultrasonic blade, according to the determined tissue composition. In one aspect, the control algorithm can determine the collagen transformation point of the tissue by measuring the position of the clamp arm actuation member and the rate of change of its displacement while maintaining a constant load on the clamp arm. In another aspect, the control algorithm can determine the collagen transformation point of the tissue by directly measuring the temperature of the tissue/blade interface to determine the collagen/elastin ratio.

Figures 16-19 schematically illustrate the motorized clamp arm closing mechanism. FIG. 40 is a system diagram 7400 of a segmentation circuit 7401 comprising a plurality of independently operating circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 and FIG. 1 is a circuit diagram of various components of a surgical instrument having motor control capabilities, according to one aspect of the present disclosure; FIG. For example, FIG. 35 shows a drive mechanism 7930 including a closed drive train 7934 configured to close jaw members and grasp tissue with an end effector. 38-39 illustrate control systems 12950, 12970 for controlling the closure rate of jaw members such as clamp arm portions of ultrasonic end effectors, wherein FIG. 39 is a control system 12950 configured to provide gradual closure of the closure member as it is advanced distally to close the , applying a closure force load at a desired rate; FIG. 12970 illustrates a proportional-integral-derivative (PID) controller feedback control system 12970, according to one aspect of the present disclosure. Accordingly, reference should be made to FIGS. 16-19 and 38-41 in the following description of an ultrasound system with a motorized clamp arm controller for controlling the closure rate and/or position of the clamp arm.

In one aspect, the control algorithm detects the collagen transformation point of the grasped tissue and controls the phase and/or amplitude of the ultrasonic transducer drive signal or the closure rate of the clamp arms accordingly to control the tissue. can be configured to control the delivery of ultrasonic energy to the For example, in one aspect, the control algorithm can be configured to control the force applied to the tissue by the clamp arm according to the collagen transformation point. This allows the position and rate of change of the clamp arm actuating member to be adjusted while maintaining a constant clamp arm load within a set operating range (eg, 130-180 psi) for a particular instrument type. can be achieved by measuring

64A is a graphical representation 130250 of displacement versus time of clamp arm 1140 (FIG. 23) as clamp arm 1140 is closed to identify the collagen transformation point, according to at least one aspect of the present disclosure. FIG. 64B is an enlarged portion 130256 of the graphical representation 130250 shown in FIG. 64A. Horizontal axis 130254 represents time (eg, seconds) and vertical axis 130252 represents clamp arm displacement δ (eg, mm). In one aspect, the control algorithm causes the clamp arm 1140 to heat the tissue (eg, by controlling the closure rate of the clamp arm 1140) as the ultrasonic blade 1128 (FIG. 23) heats the tissue according to the tissue's collagen transformation point. can be configured to control the load applied to the In one such aspect, the control algorithm can be configured to close the clamp arm 1140 until the clamp arm load reaches a threshold, where the threshold is a particular value (eg, 4.5 lbs) or range of values (eg, 4.5 lbs). for example, in the range of 3.5-5 lbs). At that point, the control algorithm sets a clamp arm displacement rate-of-change threshold θ to allow clamp arms 1140 . monitor the displacement of As long as the rate of change of clamp arm displacement remains within a predetermined negative limit (ie, less than threshold θ), the control algorithm can determine that the tissue is below its transformation temperature. As shown in the graphical representations of FIGS. 64A and 64B, when the control algorithm determines that the rate of change of clamp arm displacement exceeds a threshold θ, the control algorithm can determine that the melting temperature of collagen has been reached. .

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

Collagen transformation should be constant for a given heat flux between 45° C. and 50° C. for collagen, elastin has different melting temperatures. Additionally, the temperature should level as the collagen absorbs heat. In some aspects, the control algorithm may be configured around a particular temperature or temperature range (e.g., the expected range of temperatures for collagen and/or elastin transformation) to ascertain exactly when the monitored event occurs. ) to sample positions of the clamp arm and/or the clamp arm displacement member at a higher rate.

In the embodiment shown in Figures 64A and 64B, the control algorithm operates to change the surgical instrument from load control to temperature control when the collagen transformation point is detected at time _tm . Without changing the surgical instrument to temperature control, the clamp arm displacement would geometrically increase as shown in projected plot 130260 . In one aspect, the control algorithm operating in the temperature control mode reduces the amplitude of the ultrasonic transducer drive signal such that the ultrasonic blade 1128, as indicated by the flat portion of the plot 130258 after reaching the threshold .theta. Vary the heat flux generated. In some embodiments, the control algorithm increases the amplitude of the ultrasonic transducer drive signal after a certain period of time, e.g., to measure the rate of temperature rise and determine when the elastin transformation temperature is reached. Can be configured. Therefore, as the clamp arm closure rate approaches the next knee (ie, the elastin knee), the clamp arm closure rate may decrease. Load control of the clamp arm 1140 can be beneficial in some cases as it can provide the best sealing of the vessel.

FIG. 65 illustrates a logic flow of a process 130300 showing a control program or logic configuration for detecting collagen transformation point and controlling clamp arm closure rate or ultrasound transducer amplitude in accordance with at least one aspect of the present disclosure It is a diagram. Process 130300 may be performed by a control circuit or processor located within the surgical instrument or generator. Accordingly, the control circuit implementing process 130300 measures the position of the clamp arm actuating member and its rate of change while maintaining a constant load on the clamp (130302). As previously mentioned, in one aspect, the load on the clamp arm is maintained within the bond pressure within the preferred range (130-180 psi) set by the ultrasonic surgical instrument. When the jaws reach a specified clamp arm load (eg, 4.5 lbs), or the clamp arm load is within a specified range (eg, 3.5-5 lbs), the control circuit changes the rate of change of clamp arm displacement. and monitor the position of the clamp arm actuation member for a period of time during which the rate of change of clamp arm displacement remains within a predefined negative limit (corresponding to the tissue being below the collagen transformation temperature) (130304). Therefore, the control determines whether the rate of change of clamp arm displacement exceeds a set threshold, in other words whether the tissue has reached the transition temperature (130306). If the transition temperature is reached, the process 130300 proceeds along the "yes" branch and the control circuit switches the surgical instrument to temperature control (130308) (e.g., controls the ultrasonic transducer to control the ultrasonic blade). reduce or maintain the temperature of the In one aspect, the control circuit continues to monitor the collagen transformation temperature. Alternatively, in the embodiment shown in FIG. 65, if the transition temperature has not been reached, then process 130300 continues along the "no" branch and the control circuit maintains load control of clamp arm 1140 and grips. The rate of change of clamp arm displacement is monitored 130310 to determine when the next transition point (eg, elastin transition point) occurs for the tissue that has been moved. The control circuit may do this, for example, to prevent the temperature of the tissue from rising above the elastin transformation temperature.

It should be understood that the collagen transformation should be constant for a given heat flux (45-50°C). It should also be appreciated that load control of the clamp arm 1140 may, in some cases, provide the best seal for certain types of tissue (eg, blood vessels). During the period when collagen transformation is occurring, the temperature of the tissue should be flattened while the collagen absorbs heat. The control circuit can be configured to modulate the rate at which data points are collected around a particular temperature or temperature of interest (eg, transformation temperature). Additionally, the control circuit can adjust the amplitude of the ultrasonic transducer drive signal to control the heat flux generated by the ultrasonic blade 1128 at different points in the surgical procedure. For example, the control circuit can decrease the ultrasound transducer amplitude during periods of collagen transformation. As another example, the control circuit can increase the amplitude of the ultrasound transducer to measure the rate at which the temperature rises as elastin knee develops. It should be appreciated that the rate of temperature change decreases as the elastin knee approaches.

In another aspect, the control algorithm can be configured to detect the collagen transformation temperature to identify the collagen/elastin ratio of the grasped tissue. As described above, the control algorithm can 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 collagen transformation temperature points for identifying collagen/elastin ratios, according to at least one aspect of the present disclosure. The vertical axis 130352 represents ultrasound transducer impedance and 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 ultrasound transducer impedance shifts at the first temperature 130362, the tissue composition is 100% collagen. Thus, if the rate of change of ultrasound transducer impedance shifts at the second temperature 130364, the tissue composition is 100% elastin. When the rate of change of the ultrasonic transducer impedance shifts between the first temperature 130362 and the second temperature 130364, the tissue composition is a mixture of collagen and elastin.

The collagen transformation temperature can be used to directly identify the collagen/elastin ratio within the tissue, and the control algorithm can be configured to adjust the operation of the ultrasound device accordingly. As shown in FIG. 66, plot 130356 represents the empirical relationship between ultrasound transducer impedance and tissue temperature. As shown by plot 130356, the impedance (Z) of the ultrasound transducer increases linearly with a first rate of change (slope) as a function of temperature (T) at the tissue contact area. At the collagen transition temperature indicated in the plot of point 130358, 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 plot 130356 changes, the collagen to elastin ratio may correspond to empirically determined temperature 130360 (eg, 85%). In one aspect, a control circuit or processor executing the aforementioned algorithm determines at what temperature the rate of ultrasound transducer impedance changes, and then from memory (e.g., lookup table) the corresponding tissue composition ( For example, it can be configured to search for collagen percentage, elastin percentage, or collagen/elastin ratio.

FIG. 67 is a logic flow diagram of a process 130450 for identifying tissue composition according to changes in ultrasound transducer impedance, according to at least one aspect of the present disclosure. Process 130450 may be performed, for example, by control circuitry of a processor located within the surgical instrument or generator. Therefore, the control circuit monitors the impedance (Z) of the ultrasonic transducer as a function of temperature (T) (130452). As mentioned above, the temperature (T) at the tissue-ultrasound blade interface can be estimated by the algorithms described herein. The control circuit determines (130454) the rate of change ΔZ/ΔT of the ultrasound transducer impedance. As the temperature at the ultrasonic blade/tissue interface increases, the impedance (Z) increases linearly at a first rate, as shown in FIG. Accordingly, the control circuit determines whether the slope ΔZ/ΔT has changed (eg, decreased) (130456). If the slope .DELTA.Z/.DELTA.T has not changed, process 130450 follows the "no" branch to continue determining the slope .DELTA.Z/.DELTA.T (130454). If the slope ΔZ/ΔT changes, the control circuit determines that the collagen transition temperature has been reached (130458).

The ratio of elastin to collagen can be determined by monitoring the collagen transformation point of the tissue and comparing the detected collagen transformation point to a lookup table. The lookup table can be stored in memory (eg, memory 3326 of FIG. 31) and includes the ratio of elastin to collagen and collagen transformation points corresponding to specific ratios determined empirically.

Adjusting Clamp Arm Force According to Tissue Position In various aspects, the control algorithm can be configured to determine the position of tissue in or relative to the end effector and adjust the clamp arm force accordingly. In one aspect, the tissue is identified or parameterized by measuring the compressive force load on the clamp arm and the position of the tissue within the jaws, e.g., where the tissue is positioned along the length of the ultrasonic blade. can do. In one aspect, the time to initial measured load on the clamp arm is measured and then the compression ratio on the tissue is measured to determine the compressibility of the tissue relative to the amount of tissue located over the length of the jaw. The rate of change of clamp arm actuator position is monitored during load control as a method of determining tissue compressibility and hence tissue type/disease status.

FIG. 68 is a graphical representation 130500 of the distribution of compressive loads across an ultrasonic blade 130404, according to at least one aspect of the present disclosure. The vertical axis 130502 represents force exerted on tissue by the clamp arm 1140 and the horizontal axis 130504 represents position. The ultrasonic blade 130404 is dimensioned such that there are periodic nodes and antinodes occurring along the length of the blade. The node/antinode position 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 the horizontal axis 130504 . Graphical representation 130500 includes first plot 130506 and second plot 130508 . As represented by either of the plots 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. Therefore, tissue 130410 located at the distal end of the ultrasonic blade 130404 experiences much lower compressive forces as compared to tissue 130410 located closer to the proximal end of the ultrasonic blade 130404 . A first plot 130506 can represent the default closure of clamp arm 1140 and the resulting force applied to distal tissue 130410 is _F1 . Generally, the amount of force applied to the tissue 130410 by the clamp arm 1140 is increased broadly without consideration, as excessive force may be applied to the tissue 130410 located proximally along the ultrasonic blade 130404. It is not possible. However, by monitoring the position of the tissue 130410 along the ultrasonic blade 130404 (e.g., "Determining Tissue Location Via Impedance Changes" section above and "Locating Tissue Via Electrode Conduction" below). 68), the control algorithm applies clamp arm 1140 to tissue 130410 in situations where tissue 130410 is located only at the distal end of ultrasonic blade 130404, similar to the situation shown in FIG. The applied force can be amplified. For example, the second plot 130508 may represent a modified closure of the clamp arm 1140, the control algorithm determines that the tissue 130410 is located only at the distal end of the ultrasonic blade 130404, and correspondingly: The force exerted by clamp arm 1140 on distal tissue 130410 is increased to F ₂ (F ₂ >F ₁ ).

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 (eg, N/mm ² ) and horizontal axis 130524 represents time. A first plot 130526 represents the normal or default compressive force applied to distal tissue 130410 without amplification. During default closure of clamp arm 1140, the compressive force applied to tissue 130410 is maintained at a constant value after an initial ramp-up period. A second plot 130528 represents the amplified compressive force applied to distal tissue 130410 to compensate for the presence of distal tissue 130410 alone. In the modified closure of the clamp arm 1140, the pressure is increased (130530) compared to the default closure, and finally the amplified compression force returns (130532) to the normal compression level and passes through the clamp arm 1140 pads. prevent burning/melting.

Determining Tissue Location Via Electrode Conduction In various aspects, the control algorithm determines electrical continuity across an array of bipolar (i.e., positive and negative) electrodes positioned along the jaw or jaws of the end effector. It can be configured to determine the position of tissue in or relative to the end effector according to. The location of tissue detectable by a bipolar electrode array may correspond to a particular location of tissue relative to the jaw(s) and/or the percentage of jaw(s) covered by 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 arranged in a matrix or array whereby a processor or control circuit detects where tissue is located between the positive and negative electrodes by monitoring or scanning the electrode array. can be configured as In one aspect, a 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 can be configured to detect electrical continuity between adjacent electrodes to detect the presence of tissue in contact therewith. In another aspect, bipolar electrode arrays can be positioned along opposing jaws of the end effector. Accordingly, a control circuit or processor coupled to the bipolar electrode array can be configured to detect electrical continuity between the opposing jaws to detect the presence of tissue therebetween.

By determining which surface area of the jaw(s) is covered with tissue, a control algorithm determines the appropriate apposition pressure for the amount of tissue grasped by the end effector, and then the corresponding clamp arm load. allows us to compute Clamp arm load can be expressed in terms of applied pressure (eg, 130-180 psi) or applied force (eg, 3.5-5 lbs or nominally 4.5 lbs). In some aspects, a bipolar electrode array may have power delivered to the positive and negative electrodes from a monopolar or bipolar RF electrosurgical generator. The generator power output may be a function of various constants, variables, or minimums (e.g., 45W, 35W, or 5W), various variables associated with the surgical instrument and/or generator (e.g., ultrasonic blade or clamp arm force amplitude), or may be dictated by an algorithm for controlling the generator according to its power curve (eg, during generator ramp-up).

FIG. 70 shows an end effector 130400 including a single jaw electrode array for detecting tissue position, according to at least one aspect of the present disclosure. In the illustrated 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, the second jaw 130432 can be, for example, an ultrasonic blade 1128 (FIG. 23), an electrosurgical instrument, a surgical stapling and cutting instrument. end effector for The second jaw 130432 can include, for example, an ultrasonic blade 1128 (FIG. 23), or cooperating jaws of an electrosurgical or surgical stapling and cutting instrument. In the illustrated embodiment, electrode array 130431 includes twelve electrodes 130429 arranged in a generally herringbone-shaped pattern. However, the number, shape, and arrangement of electrodes 130429 within electrode array 130431 are for illustrative purposes only. Accordingly, electrode array 130431 can include various numbers, shapes, and/or arrangements of electrodes 130429 . For example, the number of electrodes 130429 can be adjusted according to the desired resolution for detecting tissue location.

In one aspect, the electrode array 130431 can include electrodes 130429 separated by physical gaps, alternating in polarity, or coupled to opposite terminals (ie, supply and return terminals) of the energy source. For example, in the illustrated embodiment, even numbered electrodes 130429 can be of a first polarity (e.g., positive polarity or coupled to the supply terminal of a power supply) and odd numbered electrodes 130429 can be of a second polarity. (eg, negative polarity, or coupled to the return terminal of the power supply). Thus, when tissue 130410 contacts adjacent electrodes 130429, tissue 130410 physically and electrically bridges bipolar electrodes 130429, allowing current to flow between them. Current flow between the bipolar electrodes 130429 can be detected by a control algorithm executed by a control circuit or processor coupled to the electrode array 130431, whereby the control circuit or processor detects the presence of tissue 130410. enable

Detection of tissue by the electrode array 130431 can be graphically represented by an activation matrix. For example, FIG. 71 shows an activation matrix 130550 indicating the location of tissue 130410 with the electrode array 130431 shown in FIG. Both the vertical axis 130554 and the horizontal axis 130555 represent the electrodes 130429 of the electrode array 130431 and the numbers along the axes 130554, 130555 represent the corresponding numbered electrodes 130429. Activated areas 130552 indicate where continuity exists between corresponding electrodes 130429, ie, where tissue 130410 exists. In FIG. 70, tissue 130410 is present across first, second, and third electrodes 130429, and as described above, electrodes 130429 may alternate in polarity in some aspects. Therefore, electrical continuity exists between the first and second electrodes 130429 and between the second and third electrodes 130429 . Note that in this illustrated embodiment there is no conduction between the first and third electrodes 130429 as they are of the same polarity. Conduction between these electrodes 130429 is shown diagrammatically by activated regions 130552 within activation matrix 130550 . Also note that the region 130553 bounded by the active region 130552 is not shown as active because, in this described embodiment, the electrode 130429 cannot have electrical continuity with itself. Please note. A control algorithm executed by a control circuit or processor coupled to the electrode array 130431 determines that the tissue 130410 within the end effector 130400 is positioned as the tissue location corresponds to a particular electrode 130429 with which electrical communication has been established. (because the position of the electrode 130429 is known), the percentage of jaws 130430, 130432 of the end effector 130400 that are covered by tissue 130410, and the like.

FIG. 72 shows an end effector 130400 including a dual jaw electrode array for detecting tissue position, according to at least one aspect of the present disclosure. In the illustrated embodiment, the end effector 130400 has a first jaw 130430 having a first electrode array 130431 disposed thereon and a second jaw 130430 having a second electrode array 130433 disposed thereon. including jaws 130432; Electrode arrays 130431, 130433 each include electrodes 130429 coupled to an energy source, such as an RF generator. End effectors 130400 can include end effectors for electrosurgical instruments, end effectors for surgical stapling and cutting instruments, and the like. As noted above, the number, shape, and/or arrangement of electrodes 130429 may vary in various ways. For example, in FIG. 75 the electrode arrays 130431, 130433 are arranged in an overlapping tiled or rectangular pattern.

In one aspect, the opposing electrodes 130429 of the electrode arrays 130431, 130433 are separated by a physical gap and each electrode array 130431, 130433 is of opposite polarity or opposing terminals (i.e., supply terminals) of the energy source. and return terminals). For example, in the illustrated embodiment, the first electrode array 130431 can be of a first polarity (eg, positive polarity or coupled to the supply terminal of a power source) and the second electrode array 130433 can be of a second polarity. (eg, negative polarity, or coupled to the return terminal of the power supply). Thus, when tissue 130410 contacts the electrodes 130429 of each of the opposing electrode arrays 130431, 130433, the tissue 130410 physically and electrically bridges the bipolar electrodes 130429 causing current to flow between them. Current flow between the bipolar electrodes 130429 can be detected by a control algorithm executed by a control circuit or processor coupled to the electrode arrays 130431, 130433, whereby the control circuit or processor detects the presence of tissue 130410. make it possible to

As noted above, the activation matrix can graphically represent the presence of tissue. For example, FIG. 73 shows activation matrix 130556 indicating the location of tissue 130410 as shown in FIG. The vertical axis 130557 represents the electrodes 130429 of the first electrode array 130431, the horizontal axis 130558 represents the electrodes 130429 of the second electrode array 130433, and the numbers along the axes 130557, 130558 are for each electrode array 130431, 130433 represents the corresponding numbered electrodes 130429 of . Activated areas 130552 indicate where continuity exists between corresponding electrodes 130429, ie, where tissue 130410 exists. In FIG. 74, the tissue 130410 has first, second, and third electrodes 130431a, 130431b, 130431c of the first electrode array 130431 and first, second, and third electrodes 130431c of the second electrode array 130433. Positioned in contact with electrodes 130433a, 130433b, 130433c. Thus, electrical continuity exists between each of these sets of electrodes of the opposing electrode arrays 130431, 130433 as current can flow between these opposing sets of electrodes. Electrodes for which there is continuity due to the position of grasped tissue 130410 are schematically indicated by activation regions 130552 in activation matrix 130556 of FIG. Further, the tissue 130410 includes the fourth, fifth and sixth electrodes 130431d, 130431e, 130431f of the first electrode array 130431 and the fourth, fifth and sixth electrodes 130433d of the second electrode array 130433. , 130433e, 130433f, there is no electrical continuity between these electrodes. A control algorithm executed by a control circuit or processor coupled to the electrode arrays 130431, 130433 determines that tissue locations within the end effector 130400 correspond to specific electrodes 130429 with which electrical communication has been established. configured to estimate the position of tissue 130410 (because the position of electrode 130429 is known, as shown in FIG. 74), the percentage of jaws 130430, 130432 of end effector 130400 covered by tissue 130410, etc. can do. In the illustrated example, the activated electrodes of the first and second electrode arrays 130431, 130433 are electrodes 130429 which overlap and have tissue 130410 placed therebetween.

In another aspect, the end effector can be configured to transmit multiple signals or pings at various frequencies, and the electrode arrays each detect a specific frequency signal or signal via frequency conversion. can be coupled to a circuit including a corresponding bandpass filter that can Various portions of the electrode array circuitry may contain bandpass filters tuned to different frequencies. Accordingly, the position of tissue grasped by the end effector corresponds to a particular detected signal. Signals can be transmitted, for example, at non-therapeutic frequencies (eg, at frequencies above the therapeutic frequency range of RF electrosurgical instruments). The electrode array circuitry can include, for example, flex circuitry.

FIG. 75 shows an end effector including a first jaw 130430 having a first segmented electrode array 130431 and a second jaw 130432 having a second segmented electrode array 130433, according to at least one aspect of the present disclosure 130400. Additionally, FIG. 76 shows tissue 130410 being grasped by end effector 130400 overlying second jaw 130432 . In one aspect, the first electrode array 130431 is configured to transmit signals at various frequencies (eg, non-therapeutic frequencies) and the second electrode array 130433 is configured to transmit signals to the tissue 130410 grasped by the end effector 130400. (ie, when tissue 130410 is in contact with both electrode arrays 130431, 130433). The second electrode array 130433 can include segmented electrode array circuitry 130600 as shown in FIG. include. Each bandpass filter 130601 may include one or more capacitors 130604 and one or more inductors 130606, the number, arrangement, and value of capacitors 130604 and inductors 130606 being 130601 can be selected to tune to a particular frequency or frequency band. The tissue 130410 acts as a signal conducting medium between the electrode arrays 130431, 130433, and different portions of the second electrode array 130433 are tuned to detect signals of various frequencies (differently tuned bandpass through the filter 130601), the control algorithm executed by the control circuit or processor coupled to the electrode arrays 130431, 130433 is configured to estimate the position of the tissue 130410 according to which signals are detected thereby. be able to. In the illustrated embodiment, the electrode arrays 130431, 130433 include six electrode segments 130602 arranged in a generally tiled pattern with semi-circular end segments; Numbers, shapes, and arrangements are for illustrative purposes only. Accordingly, electrode arrays 130431 , 130433 can include varying numbers, shapes, and/or arrangements of electrodes 130602 . For example, the number of electrodes 130602 can be adjusted according to the desired resolution for detecting tissue location.

FIG. 78 is a graphical representation 130650 of frequency response corresponding to the tissue 130410 grasped in FIG. 76, in accordance with at least one aspect of the present disclosure. Vertical axis 130652 represents amplitude and horizontal axis 130654 represents RF frequency. In one aspect, the second electrode array 130433 comprises a first electrode circuit segment 130602a tuned to a frequency band defined by a first center frequency f _S1 (eg, 5 MHz), a second center frequency f _S2 ( a second electrode circuit segment 130602b tuned to a frequency band defined by a third center frequency f _S3 (e.g., 15 MHz); 130602c, and a fourth electrode circuit segment 130602d tuned to a frequency band defined by a fourth center frequency f _S4 (eg, 20 MHz). As shown in FIG. 78, the sensing frequency band may range from f _T1 (eg, 300 kHz) to f _T2 (eg, 500 kHz) and/or sensing above the therapeutic frequency range 130656 defined by the preferred therapeutic frequency (eg, 350 kHz). A frequency range 130658 is defined. In one aspect, the center sensed frequencies f _S1 , f _S2 , f _S3 , f _S4 within the sensed frequency range 130658 are each separated by a defined frequency value (eg, 5 MHz). Additionally, although the sensing frequency range 130658 is shown as including four sensing frequency bands, this is for illustrative purposes only. In the illustrated example, the grasped tissue 130410 contacts the second, third and fourth electrode circuit segments 130602b, 130602c, 130602d. Accordingly, the detected frequency response includes peaks 130655b, 130655c, 130655d at each of the corresponding frequencies. Therefore, the control algorithm can estimate the position of the tissue 130410 from the detected frequency response, i.e., the control circuit determines that the tissue 130410 is located on the second, third, and fourth electrode circuit segments 130602b, 130602c, It can be determined to be positioned within end effector 130400 such that it contacts 130602d and no other circuit segment. Accordingly, the control algorithm can estimate the position of the tissue 130410 relative to the jaws 130430, 130432 of the end effector 130400 and/or the percentage of the jaws 130430, 130432 in contact with the tissue 130410.

Adaptive Ultrasonic Blade Temperature Monitoring In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust various parameters of the ultrasonic system based on the temperature of the ultrasonic blade. Operating parameters controlled or adjusted by the adaptive ultrasonic blade control algorithm can 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. . Adaptive ultrasonic blade control algorithms may be executed by a control circuit or processor located either on the generator or on the 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 accordingly provides the amplitude of the ultrasonic blade and/or the ultrasonic transducer. adjusts the signal that 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 measures the temperature of the ultrasonic blade through various techniques, such as by analyzing the frequency spectrum of the ultrasonic transducer, as discussed in the "Temperature Estimation" section above. be able to. Another technique for determining the temperature of an ultrasonic blade uses non-contact imaging. These and other techniques are described in detail herein, and additional details can be found in US Provisional Patent Application No. 62/692,768 entitled "SMART ENERGY DEVICES."

Adjusting Ultrasonic System Parameters According to Temperature In one aspect, the adaptive ultrasonic blade control algorithm can be configured to adjust operating parameters of the ultrasonic system based on the temperature of the ultrasonic blade. As discussed above in the "Temperature Estimation" section, the natural frequency of the ultrasonic blade/transducer moves with temperature, and thus the temperature of the ultrasonic blade is the voltage signal applied to drive the ultrasonic transducer. and the current signal. Additionally, ultrasonic blade temperature corresponds to tissue temperature. In some aspects, the adaptive ultrasonic blade control algorithm can be configured to sense the ultrasonic blade temperature and modulate operating parameters of the surgical instrument according to the temperature. Operating parameters include, for example, the frequency of the ultrasonic transducer drive signal, the amplitude of the ultrasonic blade (which can correspond, for example, to the magnitude or amplitude of the current supplied to the ultrasonic transducer), the pressure applied, and the like. Adaptive ultrasonic blade control algorithms may be executed by a control circuit or processor located either on the generator or on the surgical instrument.

Thus, in one aspect, the adaptive ultrasonic blade control algorithm detects the resonant frequency of the ultrasonic blade and then detects the modal shift of the resonant frequency waveform, as described above in the "Temperature Estimation" section. To this end, the resonant frequency is monitored over time. A shift in the resonant waveform can be correlated with the occurrence of a system change, such as an increase in temperature of the ultrasonic blade. In some aspects, the adaptive ultrasonic blade control algorithm can be configured to adjust the amplitude of the ultrasonic drive signal, and thus the amplitude of the ultrasonic blade displacement, to measure tissue temperature. In other aspects, the adaptive ultrasonic blade control algorithm is configured to maintain the temperature of the ultrasonic blade and/or tissue within a predetermined temperature or predetermined threshold (e.g., when the ultrasonic blade temperature becomes too high). configured to control the amplitude of the ultrasonic drive signal, and thus the amplitude of the ultrasonic blade displacement, according to the temperature of the ultrasonic blade and/or tissue, in order to allow cooling of the ultrasonic blade, if applicable. can be done. In yet another aspect, the adaptive ultrasonic blade control algorithm can, for example, minimize temperature overshoots or reduce ultrasonic blade heat flux according to tissue impedance, tissue temperature, and/or ultrasonic blade temperature. It can be configured to modulate the RF power and waveform of the electrosurgical instrument in order to modify the power. Further details regarding these and other functions are described, for example, with reference to Figures 95-100.

FIG. 79 is a graphical representation 130700 of ultrasonic transducer system frequency as a function of drive frequency and ultrasonic blade temperature drift, in accordance with at least one aspect of the present disclosure. The horizontal axis 130704 represents the drive frequency (eg, Hz) applied to the ultrasonic system (eg, ultrasonic transducer and/or ultrasonic blade), and the vertical axis 130702 represents the resulting impedance phase angle (eg, , radians). A first plot 130706 represents the characteristic resonant waveform of the ultrasound system at normal or ambient temperature. As can be seen in the first plot 130706, the ultrasound system is in-phase when driven at the excitation frequency f _e (because the impedance phase angle is at or near 0 radians). Therefore, f _e represents the resonant frequency of the ultrasound system at ambient temperature. A second plot 130708 represents the characteristic waveform of the ultrasound system as the temperature of the ultrasound system increases. As shown in FIG. 79, as the temperature of the ultrasonic system increases, the characteristic waveforms of the ultrasonic blade and ultrasonic transducer (indicated by the first plot 130706) shift to the left, e.g., to lower frequencies. Shift to range. Due to the frequency waveform shift of the ultrasound system, the ultrasound system is no longer in phase when driven at the excitation frequency _fe . Rather, the resonant frequency is shifted lower to f'e. Accordingly, a control circuit coupled to the ultrasound system detects a change in the resonant frequency of the ultrasound system and/or determines whether the ultrasound system is out of phase when driven at a previously established resonant frequency. By detecting something, temperature changes in the ultrasound system can be detected or estimated.

Correspondingly, in some aspects, a control circuit coupled to the ultrasound system causes the generator to heat the ultrasound system according to the estimated temperature of the ultrasound system to maintain the ultrasound system in phase. It can be configured to control the applied drive signal. Maintaining the ultrasound system in phase can be used, for example, to control the temperature of the ultrasound system. As noted 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 increases from f _e (eg, 55.5 kHz) at normal temperature to f'e shift to Thus, as the temperature of the ultrasound system increases, the control circuit controls the generator to shift the frequency at which the ultrasound system is driven from f _e to f′ e so that the ultrasound system is driven by the generator drive signal. can be maintained in phase with See the discussion associated with FIGS. 43A-54 above for further discussion of adaptive ultrasonic blade control algorithms.

FIG. 80 is a graphical representation 130750 of ultrasonic transducer temperature as a function of time, in accordance with at least one aspect of the present disclosure. Vertical axis 130752 represents ultrasonic transducer temperature and horizontal axis 130754 represents time. In one aspect, when the ultrasonic transducer temperature (represented by plot 130756) meets or exceeds the temperature threshold _T1 , the adaptive ultrasonic blade control algorithm controls the ultrasonic transducer to Keep the temperature of the vessel below the threshold temperature _T1 . The adaptive ultrasonic blade control algorithm can control the temperature of the ultrasonic transducer, for example, by modulating the power and/or drive signal applied to the ultrasonic transducer. Further description of algorithms and techniques for controlling the temperature of an ultrasonic blade/transducer can be found in the sections "Feedback Control" and "Ultrasonic Sealing Algorithm with Temperature Control", the disclosures of which are incorporated herein by reference. No. 62/640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR", which is incorporated by reference herein.

FIG. 81 is a graphical representation of a modal shift in resonant frequency based on ultrasonic blade temperature shifting resonant frequency as a function of ultrasonic blade temperature, in accordance with at least one aspect of the present disclosure; In the first graph 130800, the vertical axis 130802 represents the change in resonant frequency (Δf) and the horizontal axis 130804 represents the ultrasonic transducer driving frequency of the generator. In the second, third, and fourth graphs 130810, 130820, 130830, vertical axes 130812, 130822, 130832 represent frequency (f), current (I), and temperature (T), respectively, and horizontal axes 130814, 130824 , 130834 represents time (t). A first graph 130810 represents the frequency shift of the ultrasound system due to temperature changes. A second graph 130820 represents current or amplitude adjustments in the ultrasonic transducer to maintain stable frequency and temperature. A third graph 130830 represents changes in tissue and/or ultrasound system temperature. The set of graphs 130800, 130810, 130820, 130830 together demonstrate the functionality of a control algorithm configured to control the temperature of an ultrasound system.

The control algorithm can be configured to control the ultrasound system (eg, the ultrasound transducer and/or the ultrasound blade) when the temperature of the ultrasound system approaches the temperature threshold _T1 . In one aspect, the control algorithm can be configured to determine when the temperature threshold _T1 is approached or reached according to whether the resonant frequency of the ultrasound system has decreased by a threshold _ΔfR . As shown by the first graph 130800, the frequency change threshold Δf _R corresponding to the threshold temperature T ₁ is similarly a function of the driving frequency f _D of the ultrasound system (as represented by plot 130806). could be. As illustrated by the second graph 130810 and the fourth graph 130830, as the temperature of the tissue and/or the ultrasonic blade increases (represented by the temperature plot 130836), the resonant frequency correspondingly decreases ( represented by the frequency plot 130816). When the temperature plot 130836 approaches the temperature threshold T ₁ (e.g., 130° C.) at time t ₁ , the resonant frequency decreases from f ₁ to f ₂ , causing the resonant frequency to reach the control algorithm's frequency change threshold Δf _R ; This causes the control algorithm to act to stabilize the ultrasound system temperature. By monitoring changes in the resonant frequency of the ultrasonic system, the adaptive ultrasonic blade control algorithm can thereby monitor the temperature of the ultrasonic system. In addition, _the adaptive ultrasonic blade control algorithm applies a It can be configured to adjust (eg, decrease) the current drawn or otherwise adjust the amplitude of the ultrasonic blade (represented by current plot 130826).

In another aspect, the adaptive ultrasonic blade control algorithm can be configured to adjust (eg, decrease) the pressure applied by the clamp arm to the tissue when the temperature meets or exceeds the threshold _T1 . . In various other aspects, the adaptive ultrasonic blade control algorithm can be configured to adjust various other operating parameters associated with the ultrasonic system according to temperature. In another aspect, the adaptive ultrasonic blade control algorithm can be configured to monitor multiple temperature thresholds. For example, the second temperature threshold _T2 can represent, for example, the melting or failure temperature of the clamp arm. Accordingly, adaptive ultrasonic blade control algorithms can be configured to take the same or different actions according to the specific temperature thresholds met or exceeded.

In various aspects, non-contact imaging may be used to determine the temperature of the ultrasonic blade in addition to or instead of the techniques described above. For example, short wave thermography may be used to measure blade temperature by imaging the blade from a stationary ambient location via a CMOS imaging sensor. Thermographic non-contact monitoring of ultrasonic waveguide or ultrasonic blade temperature may be used to control tissue temperature. In other aspects, non-contact imaging may be used to determine the surface condition and finish of the ultrasonic blade and improve tissue and/or ultrasonic blade temperature through near-IR sensing techniques.

Determining Jaw Condition A challenge with ultrasonic energy delivery is that ultrasonic sound applied to the wrong material or the wrong tissue can lead to device failure, e.g., clamp arm pad burn-through, or ultrasonic blade breakage. It can be the result. It is also desirable to detect what is within the jaws of an end effector of an ultrasound system and the state of the jaws without adding additional sensors within the jaws. Positioning sensors within the jaws of an ultrasonic end effector poses reliability, cost, and complexity challenges.

Ultrasound transducer impedance configured for ultrasound spectroscopy smart blade algorithm technology to drive an ultrasound transducer blade according to at least one aspect of the present disclosure

に基づいて、ジョーの状態（クランプアームパッドの溶け落ち、ステープル、破損ブレード、ジョー内の骨、ジョー内の組織、ジョーを閉じた状態でのバックカットなど）を推定するために用いられてもよい。インピーダンスＺ_ｇ（ｔ）、大きさ｜Ｚ｜、及び位相φは、周波数ｆの関数としてプロットされる。

Based on the good. Impedance Z _g (t), magnitude |Z|, and phase φ are plotted as a function of frequency f.

Dynamic mechanical analysis (DMA), also known as dynamic mechanical spectroscopy or simply mechanical spectroscopy, is a technique used to study and characterize materials. A sinusoidal stress is applied to the material and the strain in the material is measured, allowing the determination of the material's complex elastic modulus. Spectroscopy applied to ultrasonic devices involves exciting the tip of an ultrasonic blade with a sweep of frequencies (either a synthetic signal or a conventional frequency sweep) and measuring the resulting complex impedance at each frequency. Complex impedance measurements of the ultrasonic transducer over a range of frequencies are used in a classifier or model to estimate the properties of the ultrasonic end effector. In one aspect, the present disclosure provides techniques for determining the state of ultrasonic end effectors (clamp arms, jaws) to facilitate automation of ultrasonic devices (e.g., power consumption to protect the device). disabling, running adaptive algorithms, retrieving information, identifying organizations, etc.).

FIG. 82 illustrates various different states and conditions of the end effector with impedance Z _g (t), magnitude |Z|, and phase φ plotted as a function of frequency f, according to at least one aspect of the present disclosure. 132030 of an ultrasound device with The spectrum 132030 is plotted in three-dimensional space, with frequency (Hz) plotted along the x-axis, phase (radians) plotted along the y-axis, and magnitude (ohms) plotted along the z-axis. It is

Spectral analysis of different joovites and device conditions produces different complex impedance characteristic patterns (fingerprints) over the frequency range for different conditions and conditions. Each state or condition has a different characteristic pattern in 3D space when plotted. These characteristic patterns can be used to estimate end effector conditions and states. FIG. 82 shows the spectra of air 132032, clamp arm pad 132034, chamois 132036, staple 132038, and broken blade 132040. FIG. Chamois 132036 can be used to characterize different types of tissue.

Spectrum 132030 can be evaluated by applying a low power electrical signal across an ultrasonic transducer to produce non-therapeutic excitation of the ultrasonic blade. A low-power electrical signal is obtained using FFT to determine the impedance across the ultrasonic transducer in the frequency range in series (swept) or parallel (combined signal).

を測定するために、掃引又は合成フーリエ級数の形で適用することができる。

can be applied in the form of a swept or synthetic Fourier series to measure

New Data Classification Methods For each feature pattern, a parametric line is fitted to the data used for training using a polynomial, Fourier series, or any other form of parametric equation as may be defined for convenience. can be done. A new data point is then received and classified by using the Euclidean vertical distance from the new data point to the trajectory fitted to the characteristic pattern training data. The vertical distance from a new data point to each trajectory (each trajectory representing a different state or condition) is used to assign points to states or conditions.

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

FIG. 83 shows a set of 3D training data in which ultrasound transducer impedance Z _g (t), magnitude |Z|, and phase φ are plotted as a function of frequency f, in accordance with at least one aspect of the present disclosure; 132042 is a graphical representation of set (S) plot 132042; The 3D training data set (S) plot 132042 has phase (radians) plotted along the x-axis, frequency (Hz) plotted along the y-axis, and magnitude (ohms) plotted along the z-axis. , where a parametric Fourier series is fitted to the 3D training data set (S). The method for classifying the data is based on the 3D training dataset (S0 is used to generate plot 132042).

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

new point

について、

about,

までの垂直距離は、次式よって見出される。

The vertical distance to is found by

次の場合、

If

すると、
Ｄ＝Ｄ_⊥

Then,
D = _D⊥

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

の確率を推定することができる。

can be estimated.

Controls Various automated tasks and safety measures can be implemented based on classification of data measured before, during, or after activation of the ultrasonic transducer/ultrasound blade. Similarly, the condition of the tissue located within the end effector and the temperature of the ultrasonic blade can also be estimated to some extent and used to better inform the user of the condition of the ultrasonic device, protect critical structures, etc. You can also Temperature control of ultrasonic blades is disclosed in a commonly owned U.S. provisional patent entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR" filed March 8, 2018, which is incorporated herein by reference in its entirety. See application Ser. No. 62/640,417.

Similarly, when the ultrasonic blade is likely in contact with the clamp arm pad (e.g., with no tissue in between), or the ultrasonic blade is broken, or the ultrasonic blade is metal (e.g., staples). ), power delivery can be reduced. Additionally, backcutting can be inhibited if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad.

Integrating Other Data to Improve Classification This system uses probability functions and Kalman filters to combine the data from this process with the data described above to provide information about sensors, users, patient metrics, environmental factors, etc. can be used with other information provided by The Kalman filter determines the maximum likelihood of a state or condition occurring considering various overly uncertain measurements of reliability. Since this method allows the assignment of probabilities to newly classified data points, the information in this algorithm can be implemented using other measurements or estimates within the Kalman filter.

FIG. 84 is a process logic flow diagram 132044 illustrating a control program or logic configuration for determining jaw status based on a complex impedance pattern (fingerprint), in accordance with at least one aspect of the present disclosure. Prior to determining the state of the jaws based on the complex impedance characteristic pattern (fingerprint), the database includes, but is not limited to, air 132032, clamp arm pads 132034, chamois 132036, as shown in FIG. A reference complex impedance signature pattern or training data set (S) is populated that characterizes various jaw conditions, including staples 132038, failed blades 132040, and various tissue types and conditions. Full bite or chip dry or wet chamois may be used to characterize different types of tissue. The data points used to generate the reference complex impedance characteristic pattern or training data set (S) were obtained by applying a sub-therapeutic drive signal to the ultrasound transducer and moving from below resonance to above resonance over a given frequency range. It is obtained by sweeping the drive frequency over, measuring the complex impedance at each frequency, and recording the data points. The data points are then fitted to a curve using various numerical techniques including polynomial curve fitting, Fourier series, and/or parametric equations. A parametric Fourier series fitted to a reference complex impedance characteristic pattern or training data set (S) is now described.

Once the reference complex impedance signature pattern or training data set (S) is generated, the ultrasonic instrument measures new data points, classifies the new points, and converts the new data points to the reference complex impedance signature pattern or training data set. Determine whether to add to set (S).

Referring now to the logic flow diagram of FIG. 84, in one aspect, the processor or control circuit measures (132046) the complex impedance of the ultrasonic transducer, the complex impedance being:

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

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 the reference complex impedance characteristic pattern. A processor or control circuit classifies (132052) the complex impedance measurement data points based on the results of the comparative analysis and assigns (132054) an end effector state or condition based on the results of the comparative analysis.

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

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

Further details regarding determining or estimating the state of jaws or surgical instruments as a whole can be found in US Provisional Patent Application No. 62/692,768, entitled "SMART ENERGY DEVICES."

Situational Awareness Referring now to FIG. 85, there is shown a timeline 5200 illustrating the situational awareness of a hub such as, for example, surgical hub 106 or 206 (FIGS. 1-11). Timeline 5200 is an exemplary surgical procedure and contextual information that surgical hubs 106, 206 can derive from data received from data sources at each step of the surgical procedure. Timeline 5200 is taken by nurses, surgeons, and other medical personnel during the course of a segmentectomy surgery, beginning with setting up the operating room and ending with transferring the patient to the post-operative recovery room. A typical process that might be followed is shown.

The situational awareness surgical hub 106, 206 sources data throughout the course of a surgical procedure, including data generated each time a modular device paired with the surgical hub 106, 206 is used. receive from The surgical hubs 106, 206 receive this data from paired modular devices and other data sources to receive new data such as what steps of the procedure are being performed at any given time. Once done, inferences (ie, contextual information) about the ongoing procedure can be continuously derived. The situational awareness system of the surgical hub 106, 206 may, for example, record data regarding procedures to generate reports, verify steps being taken by medical personnel, collect data that may be relevant to a particular procedure step, or Provide prompts (e.g., via a display screen), adjust modular devices based on context (e.g., activate a monitor, adjust the field of view (FOV) of a medical imaging device, or perform ultrasound surgical changing the energy level of the instrument or RF electrosurgical instrument), and any other such actions described above.

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

In a second step 5204, personnel scan incoming medical supplies for treatment. The surgical hub 106, 206 cross-references the scanned supplies with lists of supplies utilized in various types of procedures to confirm that the mix of supplies corresponds to the thoracic procedure. Additionally, the surgical hub 106, 206 can also determine that the procedure is not a wedge procedure (either the incoming product does not include the specific product required for a thoracic wedge procedure or the otherwise thoracic wedge procedure). either because it does not correspond to the wedge treatment).

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

In a fourth step 5208, the medical staff turns on the assistive device. The auxiliary devices utilized may vary according to the type of surgical procedure and the technique used by the surgeon, but in this exemplary case they include smoke evacuators, inhalers, and medical imaging equipment. When activated, an auxiliary device that is a modular device can automatically pair with surgical hubs 106, 206 located within a particular proximity of the modular device as part of its initialization process. . The surgical hub 106, 206 can then derive contextual information about the surgical procedure by detecting the type of modular device paired with it during this preoperative or initialization phase. In this particular example, surgical hubs 106, 206 determine 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 surgery, and the type of modular device that connects to the hub, the surgical hub 106, 206 can approximate the specific procedure to be performed by the surgical team. can be estimated. Once the surgical hub 106, 206 knows what particular procedure is being performed, then the surgical hub 106, 206 retrieves the procedures for that procedure from memory or from the cloud and then connects. Data subsequently received from other data sources (eg, modular devices and patient monitors) can be cross-referenced to deduce which steps of the surgical procedure the surgical team is performing.

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

In a sixth step 5212, medical personnel induce anesthesia in the patient. The surgical hub 106, 206 determines that the patient is under anesthesia based on data from the modular device and/or patient monitor including, for example, EKG data, blood pressure data, ventilator data, or combinations thereof. can be estimated. Completion of the sixth step 5212 completes the preoperative portion of the segmentectomy surgery and begins the surgical portion.

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

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

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

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

In an eleventh step 5222, the segmental excision portion of the treatment is performed. The surgical hub 106, 206 can infer that the surgeon is transsecting parenchyma based on data from the surgical stapling and cutting instrument, including data from its cartridge. The cartridge data can correspond, for example, to the size or type of staples fired by the instrument. Since different types of staples are utilized on different types of tissue, the cartridge data can indicate the type of tissue being stapled and/or transected. In this case, the types of staples fired are applied to parenchymal tissue (or other similar tissue types) so that the surgical hub 106, 206 assumes that the segmentectomy portion of the procedure is being performed. can be done.

Subsequently, in a twelfth step 5224, a knot dissection step is performed. The surgical hub 106, 206 infers that the surgical team is incising the nodule and performing a leak test based on data received from the generator indicating RF or ultrasonic instruments are being fired. can be done. For this particular procedure, the RF or ultrasonic instruments used after the parenchymal tissue is transected correspond to the knototomy process that allows the surgical hub 106, 206 to make this estimate. It becomes possible. Surgeons routinely combine surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) depending on the particular step in the procedure, as different instruments are better suited to specific tasks. ) instruments. Thus, the particular sequence in which stapling/cutting instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. Additionally, in certain instances, robotic tools may be used for one or more steps during a surgical procedure and/or hand-held surgical instruments may be used for one or more steps during a surgical procedure. can be used. The surgeon(s) may, for example, alternate between robotic tools and handheld surgical instruments and/or may use the devices simultaneously, for example. Upon completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.

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

Finally, a fourteenth step 5228 is for medical personnel to remove various patient monitors from the patient. Therefore, the surgical hub 106, 206 can assume that the patient is being transported to the recovery room when the hub loses EKG, BP, and other data from the patient monitor. As can be seen from this exemplary procedure description, surgical hubs 106, 206 may perform a given surgical procedure based on data received from various data sources communicatively coupled with surgical hubs 106, 206. can be determined or estimated when each step of is occurring.

Situational awareness is further described in U.S. Provisional Patent Application No. 62/659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety. . In certain examples, operation of a robotic surgical system, including, for example, various robotic surgical systems disclosed herein, is based on its situational awareness and/or feedback from its components and/or from cloud 102. can be controlled by the hub 106, 206 based on the information in the

Although several forms have been illustrated and described, it is not the applicant's intention to limit or limit the appended claims to such recitations. Numerous modifications, variations, changes, permutations, combinations and equivalents of these forms can be implemented and will occur to those skilled in the art without departing from the scope of this disclosure. Further, the structure of each element associated with the described form can be alternatively described as a means for providing the function performed by that element. Also, although materials are disclosed for particular components, other materials may be used. Accordingly, the above description and appended claims are intended to cover all such modifications, combinations, and variations as included within the scope of the disclosed forms. Please understand. The appended claims are intended to cover all such modifications, variations, variations, substitutions, modifications and equivalents.

The foregoing detailed description has described various aspects of apparatus and/or processes using block diagrams, flowcharts, and/or examples. To the extent such block diagrams, flowcharts, and/or embodiments include one or more functions and/or operations, it should be understood by those skilled in the art that such block diagrams, flowcharts, and/or examples Each function and/or operation included in the embodiments may be implemented individually and/or collectively by various hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will appreciate that all or part of some aspects of the forms disclosed herein can be understood as one or more computer programs (e.g., one or more computer programs) running on one or more computers. 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., one or more as one or more programs running on a microprocessor), as firmware, or substantially any combination thereof, equivalently embodied on an integrated circuit; , and/or writing software and/or firmware code is within the skill of one of ordinary skill in the art in view of the present disclosure. Moreover, those skilled in the art will appreciate that the subject matter described herein may be distributed in a variety of forms as one or more program products, and is incorporated herein by reference. The specific forms of subject matter described are used regardless of the particular type of signal-bearing medium used to implement the distribution.

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

As used in any aspect herein, the term "control circuitry" includes, for example, hardwired circuits, programmable circuits (e.g., computer processors including one or more individual instruction processing cores, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic unit (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuit, programmable circuit can refer to firmware that stores instructions to be executed by the , and any combination thereof. Control circuits, collectively or individually, can be, for example, integrated circuits (ICs), application-specific integrated circuits (ASICs), systems-on-chips (SoCs), desktop computers, laptop computers, tablet computers, servers, smart phones, etc. , may be embodied as circuits forming part of a larger system. Thus, as used herein, the term “control circuit” includes an electrical circuit having at least one discrete electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application specific integrated circuit, A circuit, a general-purpose computing device configured with a computer program (e.g., a general-purpose computer configured with a computer program that executes, at least in part, a process and/or apparatus described herein, or a process described herein) and/or a microprocessor configured by a computer program that at least partially executes the device); an electrical circuit forming a memory device (e.g., in the form of a random access memory); (modems, communications switches, or optical-to-electrical equipment). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.

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

As used in any aspect of this specification, terms such as "component," "system," and "module" refer to either hardware, a combination of hardware and software, software, or software in execution. can refer to a computer-related entity that is

As used in any aspect herein, "algorithm" refers to a self-consistent sequence of steps leading to a desired result; Refers to the comparison and manipulation of physical quantities and/or logical states, which may take the form of electrical or magnetic signals capable of being otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or states.

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

Unless expressly specified otherwise, terms such as "process", "calculate", "calculate", "determine", "display", etc. are used throughout the foregoing disclosure as is apparent from the foregoing disclosure. Discussions using the term refer to data represented as physical (electronic) quantities in computer system registers and memory as physical quantities in computer system memory or registers or in any such information storage, transmission, or display device. It will be understood to refer to the actions and processes of a computer system or similar electronic computing device that manipulates and transforms other data that may be similarly represented.

As used herein, one or more components are “configured to,” “configurable to,” “operable/to operable/operative to, adapted/adaptable, capable to, conformable/conformed to)”, etc. Those skilled in the art will understand that "configured to" generally refers to active components and/or inactive components and/or standby configurations, unless the context requires otherwise. It will be understood that it may contain elements.

The terms "proximal" and "distal" are used herein with reference to the clinician manipulating the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located farther from the clinician. It will further be appreciated that for convenience and clarity, spatial terms such as "vertical," "horizontal," "above," and "below" may be used herein with respect to the drawings. However, surgical instruments 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 appreciate that the terms used herein generally, and particularly in the appended claims (e.g., the appended claim text), are generally intended as "open" terms. (e.g., the term "including" is to be interpreted as "including but not limited to"; the term "having" is to be interpreted as "including but not limited to"); should be interpreted as "having at least" and the term "includes" should be interpreted as "includes but is not limited to" should be done, etc.). Moreover, where a particular number is intended in an introduced claim recitation, such intent is clearly set forth in the claim; will be understood by those skilled in the art. For example, as an aid to understanding, the appended claims that follow use the introductory phrases "at least one" and "one or more" to refer to May be included to introduce description. However, use of such phrases may be used to refer to "one or more" or "at least one" even within the same claim when introducing claim recitations by the indefinite article "a" or "an". and the indefinite article "a" or "an", any particular claim containing such an introduced claim recitation shall be subject to claims containing only one such recitation. should not be construed as to be implied as limiting (e.g., "a" and/or "an" are generally taken to mean "at least one" or "one or more"). should be interpreted). the same holds true where the definite article is used to introduce claim recitations.

Moreover, even if a specific number is specified in the introduced claim statement, such statement should typically be construed to mean at least the stated number. , as will be recognized by those skilled in the art (e.g., where there is simply a statement "two statements" without other modifiers, generally there are at least two statements, or two or more statements matter). Further, where notations like "at least one of A, B, and C, etc." are used, such syntax is generally intended in the sense that one skilled in the art would understand the notation (e.g. , "a system having at least one of A, B, and C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C, and/or all of A and B and C, etc.). Where notations like "at least one of A, B, or C, etc." are used, such syntax is generally intended in the sense that one skilled in the art would understand the notation (e.g., " A system having at least one of A, B, or C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C (including systems having both, and/or all of A and B and C, etc.). Further, typically any disjunctive word and/or phrase representing two or more alternative terms is used in the specification unless the context requires otherwise. It is understood to be intended to include one of the terms, either of the terms, or both terms, whether in the claims, or in the drawings. Those skilled in the art will understand that it should. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B."

With regard to the appended claims, those skilled in the art will understand that the operations recited herein can generally be performed in any order. Additionally, while the flow diagrams of various acts are depicted in sequence(s), it is understood that the various acts may occur in orders other than those illustrated, or may occur simultaneously. It should be. Examples of such alternative orderings include overlapping, interleaving, interrupting, reordering, incremental, preliminary, additional, simultaneous, reverse, or other different orderings, unless the context requires otherwise. may include Further, terms such as "response to", "related to", or other past tense adjectives generally exclude such variations unless the context dictates otherwise. not intended.

Any reference to "an aspect", "an aspect", "exemplary", "an example", etc., includes in at least one aspect the particular feature, structure, or property described in connection with that aspect. It is worth noting that it means Thus, the appearances of the phrases "in one aspect," "in an aspect," "in an example," and "in an example" in various places throughout this specification do not necessarily all refer to the same aspect. Moreover, 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 disclosure material referenced herein and/or listed in any application data sheet is, to the extent the material incorporated herein, is not inconsistent with this specification. , incorporated herein by reference. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting statements incorporated herein by reference. Any content, or portion thereof, that is inconsistent with the current definitions, opinions, or other disclosures set forth herein, is hereby incorporated by reference, but the reference content and the current disclosure are hereby incorporated by reference. References shall be made only to the extent that there is no inconsistency between

In summary, a number of benefits have been described that result from using the concepts described herein. The foregoing description of one or more aspects has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to be limited to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. One or more embodiments illustrate principles and practical applications, thereby making the various forms, with various modifications, available to those skilled in the art as suitable for the particular use envisioned. It is selected and described for the purpose. It is intended that the claims presented herewith define the overall scope.

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

Example 1. An ultrasonic surgical instrument comprising an end effector comprising an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, and a control circuit coupled to the ultrasonic transducer. Sonic surgical instruments. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. A control circuit measures a complex impedance of the ultrasonic transducer and compares the complex impedance to a plurality of reference complex impedance patterns, each of the plurality of reference complex impedance patterns corresponding to a state of the end effector. and determining a state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to.

Example 2. According to Example 1, wherein the plurality of reference complex impedance patterns correspond to at least one of an ultrasonic blade in contact with air, a broken ultrasonic blade, or an ultrasonic blade in contact with metal. An ultrasonic surgical instrument as described.

Example 3. A surgical instrument according to example 1 or 2, further comprising a memory coupled to the control circuit. A memory stores a plurality of reference complex impedance patterns. The control circuit is configured to retrieve a plurality of reference complex impedance patterns from memory.

Example 4. The ultrasonic surgical instrument of any one of Examples 1-3, wherein the reference complex impedance pattern comprises a fitted curve plotted from the data points of the reference complex impedance pattern.

Example 5. 5. As described in example 4, wherein the control circuit is configured to determine to which of the plurality of reference complex impedance patterns the complex impedance corresponds according to a Euclidean vertical distance between the complex impedance and the fitted curve. of ultrasonic surgical instruments.

Example 6. 6. The ultrasonic surgical instrument of example 5, wherein the complex impedance corresponds to one of the fitted curves that the complex impedance has the smallest Euclidean vertical distance between them.

Example 7. The ultrasonic surgical instrument of any one of Examples 1-6, wherein the complex impedance corresponds to the ratio of the voltage and current signals that excite the ultrasonic transducer.

Example 8. An ultrasonic generator for driving an ultrasonic surgical instrument comprising an end effector, an ultrasonic blade, and an ultrasonic transducer acoustically coupled to the ultrasonic blade . The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. The ultrasonic generator includes control circuitry coupled to the ultrasonic transducer. The control circuit applies a drive signal to the ultrasonic transducer, measures a complex impedance of the ultrasonic transducer, and compares the complex impedance to a plurality of reference complex impedance patterns, the plurality of reference complex impedance patterns. comparing each of the complex impedance patterns corresponds to a state of the end effector; and determining the state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to. , is configured to

Example 9. According to Example 8, wherein the plurality of reference complex impedance patterns correspond to at least one of an ultrasonic blade in contact with air, an ultrasonic blade that is broken, or an ultrasonic blade in contact with metal. An ultrasonic generator as described.

Example 10. 10. An ultrasound generator as in example 8 or 9 further comprising a memory coupled to the control circuit. A memory stores a plurality of reference complex impedance patterns. The control circuit is configured to retrieve a plurality of reference complex impedance patterns from memory.

Example 11. 11. The ultrasonic generator of at least one of Examples 8-10, wherein the reference complex impedance pattern comprises a fitted curve plotted from the data points of the reference complex impedance pattern.

Example 12. 12. As described in embodiment 11, wherein the control circuit is configured to determine to which of the plurality of reference complex impedance patterns the complex impedance corresponds according to a Euclidean vertical distance between the complex impedance and the fitted curve. ultrasonic generator.

Example 13. 13. The ultrasonic generator of example 12, wherein the complex impedances correspond to those of the approximation curves where the complex impedances have the smallest Euclidean vertical distance between them.

Example 14. 14. An ultrasonic generator as in any one of embodiments 8-13, wherein the complex impedance corresponds to the ratio of the voltage and current signals that excite the ultrasonic transducer.

Example 15. A method of controlling an ultrasonic surgical instrument comprising an end effector, an ultrasonic blade, and an ultrasonic transducer acoustically coupled to the ultrasonic blade. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal from the generator. The method comprises measuring, with a control circuit coupled to the ultrasonic transducer, a complex impedance of the ultrasonic transducer; comparing, with the control circuit, the complex impedance to a plurality of reference complex impedance patterns; each of the plurality of reference complex impedance patterns corresponding to a state of the end effector, the comparing and control circuitry according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to; determining the state of the .

Example 16. According to Example 15, wherein the plurality of reference complex impedance patterns correspond to at least one of an ultrasonic blade in contact with air, a broken ultrasonic blade, or an ultrasonic blade in contact with metal. described method.

Example 17. 17. The method of embodiment 15 or 16, further comprising, by the control circuit, retrieving a plurality of reference complex impedance patterns from memory.

Example 18. 18. The method of any one of Examples 15-17, wherein the reference complex impedance pattern comprises a fitted curve plotted from the data points of the reference complex impedance pattern.

Example 19. 19. The method of example 18, further comprising, with the control circuit, determining to which of the plurality of reference complex impedance patterns the complex impedance corresponds according to a Euclidean vertical distance between the complex impedance and the fitted curve. .

Example 20. 20. The method of example 19, wherein the complex impedances correspond to those of the fitted curves where the complex impedances have the smallest Euclidean vertical distance between them.

Example 21. 21. The method of any one of Examples 15-20, wherein the complex impedance corresponds to the ratio of the voltage and current signals that excite the ultrasonic transducer.

[Mode of implementation]
(1) An ultrasonic surgical instrument comprising:
an end effector comprising an ultrasonic blade;
an ultrasonic transducer acoustically coupled to the ultrasonic blade and configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal;
a control circuit coupled to the ultrasonic transducer, the control circuit comprising:
measuring the complex impedance of the ultrasonic transducer;
comparing the complex impedance to a plurality of reference complex impedance patterns, each of the plurality of reference complex impedance patterns corresponding to a state of the end effector;
determining the state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to.
(2) the plurality of reference complex impedance patterns are in at least one of the ultrasonic blade in contact with air, the ultrasonic blade that is damaged, or the ultrasonic blade in contact with metal; 3. Correspondingly, the ultrasonic surgical instrument of embodiment 1.
(3) further comprising a memory coupled to said control circuit, said memory storing said plurality of reference complex impedance patterns;
2. The ultrasonic surgical instrument of claim 1, wherein the control circuit is configured to retrieve the plurality of reference complex impedance patterns from the memory.
Clause 4. The ultrasonic surgical instrument of clause 1, wherein the reference complex impedance pattern comprises an approximate curve plotted from data points of the reference complex impedance pattern.
(5) The control circuit determines which of the plurality of reference complex impedance patterns the complex impedance corresponds to according to a Euclidean perpendicular distance between the complex impedance and the approximation curve. 5. The ultrasonic surgical instrument of embodiment 4, wherein the ultrasonic surgical instrument is configured to:

Clause 6. The ultrasonic surgical instrument of Clause 5, wherein the complex impedance corresponds to one of the fitted curves that the complex impedance has the smallest Euclidean vertical distance therebetween.
Clause 7. The ultrasonic surgical instrument of Clause 1, wherein the complex impedance corresponds to a ratio of a voltage signal to a current signal that excites the ultrasonic transducer.
(8) An ultrasonic generator for driving an ultrasonic surgical instrument comprising an end effector, an ultrasonic blade, and an ultrasonic transducer acoustically coupled to the ultrasonic blade, wherein an ultrasonic transducer configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal, the ultrasonic generator comprising:
a control circuit coupled to the ultrasonic transducer, the control circuit comprising:
applying the drive signal to the ultrasonic transducer;
measuring the complex impedance of the ultrasonic transducer;
comparing the complex impedance to a plurality of reference complex impedance patterns, each of the plurality of reference complex impedance patterns corresponding to a state of the end effector;
determining the state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to.
(9) the plurality of reference complex impedance patterns are in at least one of the ultrasonic blade in contact with air, the ultrasonic blade that is damaged, or the ultrasonic blade in contact with metal; Correspondingly, the ultrasonic generator of embodiment 8.
(10) further comprising a memory coupled to the control circuit, the memory storing the plurality of reference complex impedance patterns;
9. The ultrasonic generator of embodiment 8, wherein the control circuit is configured to retrieve the plurality of reference complex impedance patterns from the memory.

(11) The ultrasonic generator of claim 8, wherein the reference complex impedance pattern includes an approximate curve plotted from data points of the reference complex impedance pattern.
(12) The control circuit is configured to determine to which of the plurality of reference complex impedance patterns the complex impedance corresponds according to a Euclidean vertical distance between the complex impedance and the approximation curve. 12. The ultrasonic generator of embodiment 11, wherein
13. The ultrasonic generator of claim 12, wherein the complex impedance corresponds to one of the approximation curves that the complex impedance has the smallest vertical Euclidean distance between them.
14. The ultrasonic generator of claim 8, wherein the complex impedance corresponds to a ratio of voltage and current signals that excite the ultrasonic transducer.
(15) A method of controlling an ultrasonic surgical instrument comprising an end effector, an ultrasonic blade, and an ultrasonic transducer acoustically coupled to the ultrasonic blade, wherein the ultrasonic transducer comprises and ultrasonically vibrating the ultrasonic blade in response to a drive signal from a generator, the method comprising:
measuring the complex impedance of the ultrasonic transducer with a control circuit coupled to the ultrasonic transducer;
comparing, by the control circuit, the complex impedance to a plurality of reference complex impedance patterns, each of the plurality of reference complex impedance patterns corresponding to a state of the end effector;
determining, by the control circuit, the state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to.

(16) the plurality of reference complex impedance patterns are in at least one of the ultrasonic blade in contact with air, the ultrasonic blade that is broken, or the ultrasonic blade in contact with metal; Correspondingly, the method of embodiment 15.
17. The method of claim 15, further comprising retrieving, by the control circuit, the plurality of reference complex impedance patterns from memory.
18. The method of claim 15, wherein the reference complex impedance pattern comprises a fitted curve plotted from data points of the reference complex impedance pattern.
(19) further comprising determining, by the control circuit, to which of the plurality of reference complex impedance patterns the complex impedance corresponds according to the Euclidean vertical distance between the complex impedance and the approximation curve. 19. The method of claim 18.
20. The method of claim 19, wherein the complex impedances correspond to those of the approximation curves that the complex impedances have the smallest vertical Euclidean distance between them.

21. The method of claim 15, wherein the complex impedance corresponds to a ratio of voltage and current signals that excite the ultrasonic transducer.

Claims (18)

An ultrasonic surgical instrument comprising:
an end effector comprising an ultrasonic blade;
an ultrasonic transducer acoustically coupled to the ultrasonic blade and configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal;
a control circuit coupled to the ultrasonic transducer, the control circuit comprising:
measuring the complex impedance of the ultrasonic transducer;
comparing the complex impedance to a plurality of reference complex impedance patterns, each of the plurality of reference complex impedance patterns corresponding to a state of the end effector;
determining the state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to;
An ultrasonic surgical instrument, wherein the reference complex impedance pattern comprises a fitted curve plotted from data points of the reference complex impedance pattern . wherein the plurality of reference complex impedance patterns correspond to at least one of the ultrasonic blade contacting air, the ultrasonic blade being broken, or the ultrasonic blade contacting metal; The ultrasonic surgical instrument of claim 1. further comprising a memory coupled to said control circuit, said memory storing said plurality of reference complex impedance patterns;
The ultrasonic surgical instrument of claim 1, wherein the control circuit is configured to retrieve the plurality of reference complex impedance patterns from the memory. the control circuit is configured to determine to which of the plurality of reference complex impedance patterns the complex impedance corresponds according to a Euclidean vertical distance between the complex impedance and the approximation curve; The ultrasonic surgical instrument of claim 1 . 5. The ultrasonic surgical instrument of claim 4 , wherein the complex impedance corresponds to one of the approximation curves for which the complex impedance has the smallest Euclidean vertical distance therebetween. The ultrasonic surgical instrument of claim 1, wherein the complex impedance corresponds to a ratio of voltage and current signals that excite the ultrasonic transducer. An ultrasonic generator for driving an ultrasonic surgical instrument comprising an end effector, an ultrasonic blade, and an ultrasonic transducer acoustically coupled to said ultrasonic blade, said ultrasonic transducer a device configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal, the ultrasonic generator comprising:
a control circuit coupled to the ultrasonic transducer, the control circuit comprising:
applying the drive signal to the ultrasonic transducer;
measuring the complex impedance of the ultrasonic transducer;
comparing the complex impedance to a plurality of reference complex impedance patterns, each of the plurality of reference complex impedance patterns corresponding to a state of the end effector;
determining the state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to;
The ultrasonic generator of claim 1, wherein the reference complex impedance pattern comprises an approximation curve plotted from data points of the reference complex impedance pattern . wherein the plurality of reference complex impedance patterns correspond to at least one of the ultrasonic blade contacting air, the ultrasonic blade being broken, or the ultrasonic blade contacting metal; An ultrasonic generator according to claim 7 . further comprising a memory coupled to said control circuit, said memory storing said plurality of reference complex impedance patterns;
8. The ultrasonic generator of claim 7 , wherein the control circuit is configured to retrieve the plurality of reference complex impedance patterns from the memory. the control circuit is configured to determine to which of the plurality of reference complex impedance patterns the complex impedance corresponds according to a Euclidean vertical distance between the complex impedance and the approximation curve; An ultrasonic generator according to claim 7 . 11. The ultrasonic generator of claim 10 , wherein the complex impedance corresponds to one of the approximation curves that the complex impedance has the smallest vertical Euclidean distance between them. 8. The ultrasonic generator of claim 7 , wherein the complex impedance corresponds to the ratio of voltage and current signals that excite the ultrasonic transducer. A method of operating an ultrasonic surgical instrument comprising an end effector, an ultrasonic blade, and an ultrasonic transducer acoustically coupled to the ultrasonic blade, wherein the ultrasonic transducer receives a signal from a generator. is configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal of
a control circuit coupled to the ultrasonic transducer measuring a complex impedance of the ultrasonic transducer;
the control circuit comparing the complex impedance to a plurality of reference complex impedance patterns, each of the plurality of reference complex impedance patterns corresponding to a state of the end effector;
the control circuit determining the state of the end effector according to which of the plurality of reference complex impedance patterns the complex impedance corresponds to;
A method of operation, wherein said reference complex impedance pattern comprises an approximation curve plotted from data points of said reference complex impedance pattern . wherein the plurality of reference complex impedance patterns correspond to at least one of the ultrasonic blade contacting air, the ultrasonic blade being broken, or the ultrasonic blade contacting metal; Method of operation according to claim 1-3 . 14. The method of operation of claim 13 , further comprising: said control circuit retrieving said plurality of reference complex impedance patterns from memory. 3. The control circuit further comprising determining which of the plurality of reference complex impedance patterns the complex impedance corresponds to according to the Euclidean vertical distance between the complex impedance and the approximation curve. 1-3 . 17. The method of claim 16 , wherein said complex impedance corresponds to one of said approximation curves that said complex impedance has the smallest vertical Euclidean distance between them. 14. The method of operation according to claim 13 , wherein said complex impedance corresponds to the ratio of voltage and current signals that excite said ultrasonic transducer.

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