JP2023166617A - Determining tissue composition via ultrasonic system - Google Patents

Abstract

To provide systems and methods for determining the composition of tissue via an ultrasonic surgical instrument.SOLUTION: Various systems and methods for determining the composition of tissue via an ultrasonic surgical instrument are disclosed. A control circuit 710 can be configured to monitor the change in a resonant frequency of an ultrasonic electromechanical system of the ultrasonic surgical instrument as an ultrasonic blade 718 oscillates against the tissue, and to determine the composition of the tissue accordingly. In some aspects, the control circuit can be configured to modify the operation of the ultrasonic electromechanical system or other operational parameters of the ultrasonic surgical instrument according to the detected tissue composition.SELECTED DRAWING: Figure 17

Description

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

This application is filed under 35 U.S.C. 35 U.S.C. 119(e) under U.S.C. Claims priority to Application No. 62/721,998.

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

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

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

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

This application is further entitled under 35 U.S.C. 119(e) entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," each disclosure of which is incorporated herein by reference in its entirety. U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, and U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, entitled “ESTIMATION STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.” 62/ Claims priority interest over No. 640,415.

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

This application further relates to a United States provisional patent filed December 28, 2017 entitled "INTERACTIVE SURGICAL PLATFORM," each disclosure of which is incorporated herein by reference in its entirety under 35 U.S.C. 119(e). Application No. 62/611,341, U.S. Provisional Patent Application No. 62/611,340 filed December 28, 2017, entitled “CLOUD-BASED MEDICAL ANALYTICS” and 2017 entitled “ROBOT ASSISTED SURGICAL PLATFORM” 12 claims priority to U.S. Provisional Patent Application No. 62/611,339, filed May 28, 2009.

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

In one general aspect, an ultrasonic electromechanical system for an ultrasonic surgical instrument. The ultrasonic electromechanical system includes an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, and a control circuit coupled to the ultrasonic transducer. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. The control circuit determines a first resonant frequency of the ultrasonic electromechanical system, determines a second resonant frequency of the ultrasonic electromechanical system as the ultrasonic blade vibrates against tissue, and The tissue composition of the tissue is configured to be determined according to a comparison between the resonant frequency and the second resonant frequency.

In another general aspect, an ultrasound generator connectable to an ultrasound electromechanical system comprising an ultrasound blade and an ultrasound transducer acoustically coupled to the ultrasound blade. The ultrasound generator includes a control circuit coupled to the ultrasound transducer. The control circuit applies a drive signal to the ultrasound transducer to cause the ultrasound transducer to vibrate the ultrasound blade, determine a first resonant frequency of the ultrasound electromechanical system, and cause the ultrasound blade to strike the tissue. and configured to determine a second resonant frequency of the ultrasonic electromechanical system when vibrating with the ultrasonic electromechanical system, and to determine a tissue composition of the tissue according to a comparison between the first resonant frequency and the second resonant frequency. ing.

In another general aspect, an end effector comprising an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, and an infrared ray configured to radiate infrared energy to tissue within the end effector. An ultrasonic surgical instrument comprising: a source, an infrared detector, and a control circuit coupled to the ultrasonic transducer and the infrared detector. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. The control circuit is configured to receive infrared energy reflected by the tissue via the infrared detector and to determine a tissue composition of the tissue according to the reflected infrared energy.

The features of various aspects are set forth in detail in the appended claims. However, various aspects of both the mechanism and the method of operation, together with further objects and advantages thereof, can best be understood by reference to the following description, taken in conjunction with the accompanying drawings, in which: FIG.
1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure. FIG. 1 is a surgical system used to perform a surgical procedure within an operating room in accordance with at least one aspect of the present disclosure. A surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. 1 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing, in accordance with at least one aspect of the present disclosure; FIG. 1 is a perspective view of a combination generator module with bipolar, ultrasonic, and monopolar contacts and smoke evacuation components in accordance with at least one aspect of the present disclosure; FIG. FIG. 6 illustrates individual power bus attachments of a plurality of lateral docking ports of a lateral modular housing configured to receive a plurality of modules in accordance with at least one aspect of the present disclosure. 2 illustrates a vertical modular housing configured to receive a plurality of modules in accordance with at least one aspect of the present disclosure. A modular device located in one or more operating rooms of a medical facility, or any room within a medical facility with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure, can be placed in the cloud. 1 illustrates a surgical data network with modular communication hubs configured to connect; 1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. 2 illustrates a surgical hub with multiple modules coupled to a modular control tower in accordance with 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 surgical instrument or tool control system in accordance with at least one aspect of the present disclosure. 1 illustrates a control circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 2 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 3 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of a robotic surgical instrument configured to manipulate the surgical tools described herein, according to at least one aspect of the present disclosure. FIG. 3 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure. 1 is a circuit diagram of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure. FIG. 1 is a system configured to execute an adaptive ultrasound blade control algorithm within a surgical data network that includes a modular communication hub, in accordance with at least one aspect of the present disclosure. 3 illustrates one example of a generator in accordance with at least one aspect of the present disclosure. 1 is a surgical system comprising a generator and various surgical instruments usable with the generator, according to at least one aspect of the present disclosure. 1 is an end effector according to at least one aspect of the present disclosure. 23 is an illustration of the surgical system of FIG. 22, in accordance with at least one aspect of the present disclosure. FIG. 3 is a model illustrating operational branch currents in accordance with at least one aspect of the present disclosure. FIG. 2 is a structural diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. 1 is a structural and functional aspect of a generator in accordance with at least one aspect of the present disclosure. 1 is a structural and functional aspect of a generator in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of one embodiment of an ultrasonic drive circuit. FIG. 2 is a circuit diagram of a control circuit in accordance with at least one aspect of the present disclosure. FIG. 3 shows a simplified block circuit diagram illustrating another electrical circuit contained within a modular ultrasonic surgical instrument in accordance with at least one aspect of the present disclosure. 4 illustrates a generator circuit divided into multiple stages in accordance with at least one aspect of the present disclosure. 2 illustrates a generator circuit divided into multiple stages, with a first stage circuit in common with a second stage circuit, in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of one aspect of a drive circuit configured to drive radio frequency current (RF) in accordance with at least one aspect of the present disclosure. A digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate a plurality of electrical signal waveforms for use in a surgical instrument, according to at least one aspect of the present disclosure. 1 illustrates one aspect of the basic architecture. 1 illustrates one aspect of a direct digital synthesis (DDS) circuit configured to generate a plurality of electrical signal waveforms for use in a surgical instrument, in accordance with at least one aspect of the present disclosure. One cycle of a discrete-time digital electrical signal waveform according to at least one aspect of the present disclosure of an analog waveform (shown superimposed on a discrete-time digital electrical signal waveform for comparison purposes) according to at least one aspect of the present disclosure. show. A control configured to provide progressive closure of the closure member as the closure member is advanced distally to close the clamp arm and apply a closure force load at a desired rate, according to one aspect of the present disclosure. FIG. 2 is a diagram of the system. 1 illustrates a proportional-integral-derivative (PID) controller feedback control system in accordance with 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. FIG. 3 is a circuit diagram of various components of a surgical instrument with motor control functionality in accordance with at least one aspect of the present disclosure. 1 is an alternative system for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system in accordance with at least one aspect of the present disclosure. 2 is a graphical representation of impedance phase angle as a function of resonant frequency for the same ultrasound device with cold (blue) and hot (red) ultrasound blades; FIG. 2 is a graphical representation of impedance magnitude as a function of resonant frequency for the same ultrasound device with cold (blue) and hot (red) ultrasound blades; FIG. FIG. 3 is an illustration of a Kalman filter that improves a temperature estimator and state-space model based on impedance across an ultrasound transducer measured at various frequencies, in accordance with at least one aspect of the present disclosure. 44 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 ultrasound device without temperature control reaching a maximum temperature of 490°C. 3 is a graphical representation of temperature versus time for an ultrasound device with temperature control reaching a maximum temperature of 320° C., in accordance with at least one aspect of the present disclosure; FIG. Graphical representation of a feedback control for regulating the ultrasound power applied to the ultrasound transducer when a sudden temperature drop in the ultrasound blade is detected, with a graphical representation of the ultrasound power as a function of time. be. 2 is a graphical representation of a feedback control for adjusting ultrasound power applied to an ultrasound transducer as a function of time when a rapid temperature drop of an ultrasound blade is detected, according to at least one aspect of the present disclosure; A plot of ultrasonic blade temperature as shown in FIG. FIG. 2 is a process logic flow diagram illustrating a control program or logic arrangement for controlling the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. 3 is a graphical representation of ultrasound blade temperature as a function of time during vascular firing, in accordance with at least one aspect of the present disclosure; FIG. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic arrangement for 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 logic flow diagram of a process illustrating a control program or logic 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 instability of the ultrasonic transducer, according to at least one aspect of the present disclosure. 1 is a logical flow diagram of a process showing a control program or logical structure; FIG. FIG. 3 is a logic flow diagram of a process 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. 2 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. 3 is a bottom view of an ultrasound end effector showing a clamp arm and an ultrasound blade depicting tissue positioning within the ultrasound end effector in accordance with at least one aspect of the present disclosure. 5 is a graphical representation illustrating a change 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. 5 is a graphical representation illustrating a change 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. 2 is a logical flow diagram of a process illustrating a control program or logic configuration for specifying operation at 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 end effector of an ultrasonic surgical instrument with an infrared (IR) sensor located on a jaw member, according to at least one aspect of the present disclosure. The IR sensor shown in FIG. 59 illustrates one aspect of a flexible circuit that can be integrally attached or formed, according to one aspect of the present disclosure. FIG. 3 is a cross-sectional view of an ultrasonic end effector with a clamp arm and an ultrasonic blade in accordance with at least one aspect of the present disclosure. 3 illustrates an IR refraction detection sensor circuit mounted on a flexible circuit board shown in top view, in accordance with at least one aspect of the present disclosure. FIG. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic arrangement for measuring IR reflectance to determine tissue composition and adjusting ultrasound transducer amplitude in accordance with at least one aspect of the present disclosure. for identifying collagen transformation points according to various aspects of the present disclosure, where time is shown along the horizontal axis and changes in clamp arm position are shown along the vertical axis, according to at least one aspect of the present disclosure; 1 is a graphical representation of clamp arm closure rate versus time; 64A is an enlarged portion of the graphical display shown in FIG. 64A. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic configuration for detecting collagen transformation points and controlling clamp arm closure rate or ultrasound transducer amplitude in accordance with at least one aspect of the present disclosure. To determine collagen/elastin ratio according to various aspects of the present disclosure, wherein tissue temperature is shown along the horizontal axis and ultrasound transducer impedance is shown along the vertical axis, according to at least one aspect of the present disclosure. 1 is a graphical representation of the identification of collagen transformation temperature points in FIG. FIG. 3 is a logic flow diagram of a process illustrating a control program or logic configuration for determining collagen transformation temperature to determine collagen/elastin ratio, in accordance with at least one aspect of the present disclosure. 2 is a graphical representation of a compressive load distribution across an ultrasonic blade in accordance with at least one aspect of the present disclosure. 1 is a graphical representation of pressure applied to tissue versus time in accordance with at least one aspect of the present disclosure. 3 illustrates an end effector including a single jaw electrode array for detecting tissue location in accordance with at least one aspect of the present disclosure. 71 is an activation matrix of the single jaw electrode array of FIG. 70, in accordance with at least one aspect of the present disclosure; FIG. 3 illustrates an end effector including a dual-jaw electrode array for detecting tissue location in accordance with at least one aspect of the present disclosure. FIG. 73 is an activation matrix of the dual-jaw electrode array of FIG. 72, in accordance with at least one aspect of the present disclosure; FIG. 74 depicts 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; FIG. 3 illustrates an end effector including a dual-jaw segmented electrode array according to at least one aspect of the present disclosure. FIG. 3 illustrates tissue superimposed on a jaw including a segmented electrode array in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of a segmented electrode array circuit including a bandpass filter, according to at least one aspect of the present disclosure. 77 is a graphical representation of the frequency response corresponding to the tissue grasped in FIG. 76, in accordance with at least one aspect of the present disclosure. 3 is a graphical representation of the frequency of an ultrasonic transducer system as a function of drive frequency and ultrasonic blade temperature drift, in accordance with at least one aspect of the present disclosure; FIG. 3 is a graphical representation of ultrasound transducer temperature as a function of time in accordance with at least one aspect of the present disclosure. 3 is a graphical representation of a modal shift in resonant frequency based on the temperature of an ultrasonic blade that moves the resonant frequency as a function of the temperature of the ultrasonic blade, in accordance with at least one aspect of the present disclosure; FIG. 2 is a spectrum of an ultrasonic surgical instrument with various different states and conditions of the end effector, in which the phase and magnitude of the impedance of the ultrasonic transducer are plotted as a function of frequency, according to at least one aspect of the present disclosure; . 3 is a methodology for classification of data based on a set of training data S, in accordance with at least one aspect of the present disclosure, in which the magnitude and phase of an ultrasound transducer impedance are plotted as a function of frequency; FIG. 3 is a logic flow diagram illustrating a control program or logic arrangement for determining the state of a jaw based on a complex impedance characteristic pattern (fingerprint) in accordance with at least one aspect of the present disclosure. 3 is a timeline illustrating situational awareness of a surgical hub in accordance with at least one aspect of the present disclosure.

The applicant of this application owns the following United States patent applications filed August 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
- U.S. Patent Application Docket No. END8536USNP2/180107-2 entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";
- United States patent application docket number END8560USNP2/180106-2 entitled "TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";
- U.S. Patent Application Docket No. END8561USNP1/180144-1 entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS";
- United States Patent Application Docket No. END8563USNP1/180139-1 entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION";
・U.S. Patent Application Docket No. END8563USNP2/18 entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE" 0139-2,
・U.S. Patent Application Docket No. END8563USNP4/18013 entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT" 9-4,
- United States patent application docket number END8563USNP5/180139-5 entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR";
- United States Patent Application Docket No. END8564USNP1/180140-1 entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS";
- U.S. Patent Application Docket No. END8564USNP2/18 entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT" 0140-2,
- United States patent application docket number END8564USNP3/180140-3 entitled "DETECTION OF END EFFECTOR IMMERSION IN LIQUID";
- United States Patent Application Docket No. END8565USNP1/180142-1 entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING";
- United States patent application docket number END8565USNP2/180142-2 entitled "INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP";
- U.S. Patent Application Docket No. END8566USNP1/180143-1 entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY," and - United States Patent Application Docket No. END8573USNP1/180145-1 entitled ``ACTIVATION OF ENERGY DEVICES.''

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

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

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

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

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

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

The applicant of this application owns the following United States patent applications filed March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
- U.S. Patent Application No. 15/940,641 entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
- U.S. Patent Application No. 15/940,648 entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES";
- U.S. Patent Application No. 15/940,656 entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";
- U.S. Patent Application No. 15/940,666 entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS";
- U.S. Patent Application No. 15/940,670 entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS";
- U.S. Patent Application No. 15/940,677 entitled "SURGICAL HUB CONTROL ARRANGEMENTS";
- U.S. Patent Application No. 15/940,632 entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
・“COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUDS BAS U.S. Patent Application No. 15/940,640 entitled ``ED ANALYTICS SYSTEMS'';
- U.S. Patent Application No. 15/940,645 entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
- U.S. Patent Application No. 15/940,649 entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
- U.S. Patent Application No. 15/940,654 entitled "SURGICAL HUB SITUATIONAL AWARENESS";
- U.S. Patent Application No. 15/940,663 entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
- U.S. Patent Application No. 15/940,668 entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
- U.S. Patent Application No. 15/940,671 entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
- U.S. Patent Application No. 15/940,686 entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE";
- U.S. Patent Application No. 15/940,700 entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
- U.S. Patent Application No. 15/940,629 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
- U.S. Patent Application No. 15/940,704 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
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. 15/940,742 entitled "DUAL CMOS ARRAY IMAGING."
- U.S. Patent Application No. 15/940,636 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
- U.S. Patent Application No. 15/940,653 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS";
- U.S. Patent Application No. 15/940,660 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER,"
・“CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGE DATA U.S. Patent Application No. 15/940,679 entitled ``SET'';
- U.S. Patent Application No. 15/940, 6 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION" No. 94,
- U.S. Patent Application No. 15/940,634 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
- U.S. patent application Ser. US patent application Ser. No. 15/940,675 entitled ``ICAL DEVICES''.
- U.S. Patent Application No. 15/940,627 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,637 entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,642 entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,676 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,680 entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,683 entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,690 entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" U.S. Patent Application No. 15/940,711 entitled "ED SURGICAL PLATFORMS".

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The irrigation tube can be in fluid communication with a fluid source and the suction tube can be in fluid communication with a vacuum source. A fluid source and/or a vacuum source may be housed within the aspiration/irrigation module 128. In one example, the fluid source and/or vacuum source may be housed within the hub housing 136 separately from the aspiration/irrigation module 128. In such embodiments, the fluidic 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's modular housing 136 align the docking ports of the modules with the docking stations of the hub's modular housing 136. may include an alignment mechanism configured to engage these mating parts within. For example, as shown in FIG. 4, the combination generator module 145 includes a side bracket configured to slidably engage a corresponding bracket 156 of a corresponding docking station 151 of the hub's modular housing 136. Contains 155. The brackets cooperate to direct the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub's modular housing 136.

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

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

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

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

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

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

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

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

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

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

FIG. 8 shows how a cloud-based system (e.g. storage 2 shows a surgical data network 201 with a modular communication hub 203 configured to connect to a cloud 204, which may include a remote server 213 coupled to a device 205. In one aspect, modular communications hub 203 includes a network hub 207 and/or a network switch 209 that communicates with a network router. Modular communication hub 203 may further be coupled to local computer system 210 to provide local computer processing and data manipulation. Surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to go from one device (or segment) to another device (or segment) and to cloud computing resources. The intelligent surgical data network includes additional mechanisms that allow traffic to pass through the monitored surgical data network and configure each port within the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

Modular devices 1a-1n located in the operating room may be coupled to a modular communication hub 203. Network hub 207 and/or network switch 209 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with devices 1a-1n may be transferred via a router to a cloud-based computer for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 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 communications hub 203 may be housed within a modular control tower configured to receive a plurality of devices 1a-1n/2a-2m. Local computer system 210 may also be housed in the modular control tower. The modular communication hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n/2a-2m, eg, during a surgical procedure. In various aspects, the devices 1a-1n/2a-2m include, for example, an imaging module 138 coupled to an endoscope, among other modular devices that may be connected to the modular communications hub 203 of the surgical data network 201. , a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, an aspiration/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and/or Alternatively, various modules such as a non-contact sensor module may be mentioned.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

System memory includes volatile memory and non-volatile memory. The basic input/output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during startup, is stored in non-volatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which functions as external cache memory. Furthermore, RAM includes SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sink link DRAM (SLDRAM), and direct RAM bus RAM (DRRAM). is available in many forms.

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

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

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

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

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

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

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

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

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

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

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

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

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

Microcontroller 461 may be programmed to perform various functions, such as precise control of the speed and position of the knife, articulation system, clamp arm, or combinations of the above. In one aspect, microcontroller 461 includes a processor 462 and memory 468. Electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical connection to an articulation or knife system. In one aspect, motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system. A detailed description of absolute positioning systems can be found in U.S. Patent Application Publication No. 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," published October 19, 2017, which is incorporated herein by reference in its entirety. 2017/ No. 0296213.

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

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

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

Tracking system 480 includes controlled motor drive circuitry that includes a position sensor 472 according to one aspect of the present disclosure. A position sensor 472 for the absolute 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 mating engagement with a corresponding drive gear of a gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamp arm, which may be adapted and configured to include a rack of drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to open and close a clamp arm of a stapler, ultrasonic, or electrosurgical device, or a combination of the above. Accordingly, as used herein, the term displacement member is used generally to refer to any movable member of a surgical instrument or tool, such as a drive member, a clamp arm, or any element that can be displaced. be done. 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 may be configured to track the position of the clamp arm during the opening and closing process. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Accordingly, the longitudinally movable drive member or the clamp arm, or a combination thereof, may be coupled to any suitable linear displacement sensor. Linear displacement sensors may include contact or non-contact displacement sensors. Linear displacement sensors include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), sliding potentiometers, movable magnets, and a series of linear displacement sensors. a magnetic sensing system comprising a Hall effect sensor disposed, a magnetic sensing system comprising a fixed magnet and a Hall effect sensor disposed on a series of movable straight lines, a movable light source and a Hall effect sensor disposed on a series of movable straight lines; It may include an optical detection system comprising a photodiode or photodetector, an optical detection system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof. .

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

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

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

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

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

Tracking system 480 with 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) include U.S. Pat. , 345,481, and U.S. Patent Application Publication No. 2014/0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety. TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed June 20, 2017, incorporated herein by reference. As described in U.S. Patent Application No. 15/628,175 Examples include sensor mechanisms such as objects. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. Absolute positioning systems use comparison and combination circuits to combine the calculated response with the measured response, using algorithms such as weighted averaging and theoretical control loops to drive the calculated response towards the measured response. can be provided. The calculated response of a physical system takes into account properties such as mass, inertia, viscous friction, induced drag, etc. in order to predict what the state and output of the physical system will be by knowing the inputs.

Absolute positioning systems do not reset the displacement member (as may be required with conventional rotary encoders where the motor 482 simply counts the number of steps forward or backward that it has taken to estimate the position of a device actuator, drive bar, knife, etc.). Provides the absolute position of the displacement member upon power-up of the instrument without retracting or advancing to a zero or home) position.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In certain examples, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In certain examples, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform multiple 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 certain examples, power supply 628 may be used to power microcontroller 620, for example. In certain examples, power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power the surgical instrument 600. A number of battery cells connected in series may be used as the power source 628. In certain examples, power source 628 may be replaceable and/or rechargeable, for example.

In various examples, processor 622 can control motor driver 626 to control the position, direction of rotation, and/or speed of motors coupled to common control module 610. In certain examples, processor 622 can signal motor driver 626 to stop and/or disable motors coupled to common control module 610. The term "processor" as used herein refers to any suitable microprocessor, microcontroller, or central processing unit (CPU) of a computer that combines the functionality 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 results as output. This is an example of sequential digital logic since it has internal memory. Processors operate with numbers and symbols that are represented in a binary system.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In one aspect, sensor 738 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 a light sensor, IR sensor, UV sensor, among others. Additionally, the switch may be a solid state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, sensors 738 may include conductor-free switches, ultrasonic switches, accelerometers, and inertial sensors, among others.

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

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

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

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

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

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

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

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

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

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

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

The actual drive system of the surgical instrument 750 is a brushed DC motor with a gearbox and a mechanical connection to the articulation and/or knife system to drive the displacement, cutting, or closure member 764. It is composed of Another example is, for example, an electric motor 754 that operates the displacement member and articulation driver of an interchangeable shaft assembly. External influences are unmeasured and unpredictable influences such as friction on tissues, surrounding bodies, 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 its desired behavior.

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

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

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

FIG. 19 is a 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. The surgical instrument 790 includes a clamp arm 766, a closure member 764, and an ultrasonic blade 768 that may be replaced with or operate in conjunction with one or more RF electrodes 796 (shown in phantom). and an end effector 792 that may include. Ultrasonic blade 768 is coupled to an ultrasonic transducer 769 that is driven by an ultrasonic generator 771.

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

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

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

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

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

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

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

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

FIG. 20 is a system 800 configured to execute an adaptive ultrasound blade control algorithm within a surgical data network with a modular communication hub in accordance with at least one aspect of the present disclosure. In one aspect, generator module 240 is configured to execute adaptive ultrasonic blade control algorithm(s) 802 described herein with reference to FIGS. 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 device/instrument 235 and device/instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 described herein with reference to FIGS. 43A-54. be done.

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

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

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

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

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

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

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

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

As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, usually memory or some other data stream. 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 a number of dedicated "processors". be done.

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

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

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

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

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

0282
The modular device includes modules receivable within a surgical hub (e.g., as described in connection with FIGS. 3 and 9) and connected to various modules for connection or pairing with a corresponding surgical hub. and a surgical device or instrument for obtaining. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, energy generators, ventilators, inhalers, and displays. The modular devices described herein can be controlled by a control algorithm. Control algorithms may be implemented on the modular device itself, on the surgical hub to which a particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). ), can be executed. In some examples, a control algorithm for a modular device relies on data sensed by the modular device itself (i.e., by sensors within, on, or connected to the modular device). control the device based on This data may be related to the patient during surgery (eg, tissue properties or injection pressure) or to the modular device itself (eg, advancing knife speed, motor current, or energy level). For example, a control algorithm for a surgical stapling and cutting instrument can control the speed at which the instrument's motor drives the knife through tissue based on the resistance the knife encounters as it advances.

0283
FIG. 22 shows one form of a surgical system 1000 that includes a generator 1100 and various surgical instruments 1104, 1106, 1108 that can be used therewith, where surgical instrument 1104 is an ultrasonic surgical instrument; Surgical instrument 1106 is an RF electrosurgical instrument and multifunctional surgical instrument 1108 is a combination ultrasound/RF electrosurgical instrument. Generator 1100 is configurable for use with a variety of surgical instruments. According to various embodiments, the generator 1100 is a multifunctional surgical instrument that integrates, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and RF and ultrasound energy simultaneously delivered from the generator 1100. The surgical instrument 1108 may be configurable for use with a variety of surgical devices of a variety of types. Although in the form of FIG. 22, generator 1100 is shown separately from surgical instruments 1104, 1106, 1108, in one form, generator 1100 may be attached to any of surgical instruments 1104, 1106, 1108. and may be integrally formed to form an integrated surgical system. Generator 1100 includes an input device 1110 located on the front panel of the console of generator 1100. Input device 1110 may comprise any suitable device that generates signals suitable for programming the operation of generator 1100. Generator 1100 may be configured for wired or wireless communication.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Other approaches include weighted least squares estimation, Kalman filtering, and space vector-based techniques. Substantially all of the processing in FFT or DFT techniques may be performed in the digital domain using, for example, a two-channel high speed ADC 1780, 1800. In one technique, digital signal samples of voltage and current signals are Fourier transformed with an FFT or DFT. The phase angle φ at any time can be calculated by the following formula:
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 termination of the pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage and current signals. In one aspect, the pulse train can be passed through an averaging filter to obtain a phase difference measurement. Additionally, positive to negative zero crossings can be used in a similar manner to reduce any effects of DC and harmonic components when the results are averaged. In one implementation, the analog voltage V _g (t) and current I _g (t) signals are converted to digital signals that are high when the analog signal is positive and low when the analog signal is negative. . Accurate phase estimation requires abrupt transitions between high and low. In one aspect, a Schmitt trigger can be used with an RC stabilization network to convert an analog signal to a digital signal. In other aspects, edge-triggered RS flip-flops and auxiliary circuits may be used. In yet another aspect, the zero crossing technique may use an eXclusive OR (XOR) gate.

Other techniques for determining the phase difference between voltage and current signals include Lissajous diagram and image monitoring, methods such as the three voltmeter method, the crossed coil method, the vector voltmeter and vector impedance methods, and Phase Standard Instruments, Phase-Locked Loops, and Phase Measurement, Peter O'Shea, 2000 CRC Press LLC, <http://www. engnetbase. com>, 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 a current amplitude set point. The current amplitude setting may be specified directly or determined indirectly based on the specified voltage amplitude and power setting. In certain aspects, control of current amplitude may be performed by a control algorithm, such as a proportional-integral-derivative (PID) control algorithm within processor 1740, for example. Variables controlled by the control algorithm to properly control the current amplitude of the drive signal include, for example, scaling of LUT waveform samples stored in programmable logic 1660 and/or scaling of the DAC 1680 via DAC 1860. provides the input to power amplifier 1620).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FIG. 29 is a circuit diagram of one aspect of an electrical circuit 2900 suitable for driving an ultrasound transducer, such as ultrasound transducer 1120, in accordance with at least one aspect of the present disclosure. Electrical circuit 2900 includes an analog multiplexer 2980. Analog multiplexer 2980 multiplexes various signals from upstream channels SCL-A, SDA-A, such as ultrasound, battery, and power control circuits. A current sensor 2982 is coupled in series with the return or ground terminal of the power supply circuit and measures the current provided by the power supply. A field effect transistor (FET) temperature sensor 2984 provides ambient temperature. A pulse width modulation (PWM) watchdog timer 2988 automatically causes a system reset if the main program fails to provide a periodic system reset. This is provided to automatically reset the electrical circuit 2900 if it hangs up or freezes due to a software or hardware failure. It will be appreciated that electrical circuit 2900 may be configured as an RF driver circuit for driving an ultrasound transducer or for driving an RF electrode, such as electrical circuit 3600 shown in FIG. 34, for example. Thus, referring now again to FIG. 29, electrical circuit 2900 can be used to alternately drive both the ultrasound transducer and the RF electrode. In the case of simultaneous driving, a filter circuit may be provided in the corresponding first stage circuit 3404 (FIG. 32) to select either the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned United States 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.

Drive circuit 2986 provides left and right ultrasound energy outputs. Digital signals representing signal waveforms are provided to the SCL-A and SDA-A inputs of analog multiplexer 2980 from a control circuit such as control circuit 3200 (FIG. 30). A digital-to-analog converter 2990 (DAC) converts the digital input to an analog output to drive a PWM circuit 2992 coupled to an oscillator 2994. PWM circuit 2992 provides a first signal to a first gate drive circuit 2996a coupled to first transistor output stage 2998a to drive a first ultrasonic (left side) energy output. PWM circuit 2992 also provides a second signal to a second gate drive circuit 2996b coupled to second transistor output stage 2998b to drive a second ultrasonic (right side) energy output. A voltage sensor 2999 is coupled between the ultrasound left/right output terminals to measure the output voltage. Drive circuit 2986, first drive circuit 2996a and second drive circuit 2996b, and first transistor output stage 2998a and second transistor output stage 2998b define a first stage amplifier circuit. In operation, the control circuit 3200 (FIG. 30) generates a 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 present disclosure. Control circuit 3200 is located within the housing of the battery assembly. The battery assembly is the energy source for various local power sources 3215. The control circuitry connects the main processor 3214 to various downstream circuits via an interface master 3218, e.g., by outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. Be prepared. In one aspect, interface master 3218 is a general purpose serial interface, such as an I ² C serial interface. The main processor 3214 is also configured to drive a switch 3224 via a general purposes input/output (GPIO) 3220, a display 3226 (e.g., an LCD display), and various indicators 3228 via a GPIO 3222. It is composed of A watchdog processor 3216 is provided to control main processor 3214. A switch 3230 is provided in series with the battery 3211 to activate the control circuit 3212 when the battery assembly is inserted into the handle assembly of the surgical instrument.

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

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

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

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

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

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

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

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

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

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

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

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

In one aspect, the present disclosure provides a battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, the processor configured to generate a digital waveform. a handle assembly including a first stage circuit coupled to a 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 the digital waveform into a digital waveform; a handle assembly configured to convert the waveform to an analog waveform, the first stage amplifier circuit configured to receive and amplify the analog waveform; a shaft assembly including a second stage circuit coupled to the first stage amplifier circuit for application to a load device, the battery assembly and the shaft assembly being configured to mechanically and electrically connect with the handle assembly. provides surgical instruments.

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

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

In another aspect, the present disclosure provides a battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, the processor configured to generate a digital waveform. a 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; a handle assembly configured to receive a digital waveform and convert the digital waveform to an analog waveform, and a common first stage amplifier circuit configured to receive and amplify the analog waveform; a shaft assembly including a second stage circuit coupled to a common first stage amplifier circuit for amplifying an analog waveform and applying the analog waveform to a load device; the battery assembly and the shaft assembly are connected to a handle assembly; A surgical instrument is provided that is configured to make mechanical and electrical connections.

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

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

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

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

Referring now to FIG. 32, generator circuit 3400 is divided into multiple stages located within multiple modular assemblies of surgical instruments, such as the surgical instruments of surgical system 1000 described herein. . In one aspect, the control stage circuit 3402 may be located within a surgical instrument battery assembly 3410. Control stage circuit 3402 is control circuit 3200 described in connection with FIG. Control circuit 3200 includes a processor 3214 that includes internal memory 3217 (FIG. 32) (eg, volatile and non-volatile memory) and is electrically coupled to battery 3211. Battery 3211 supplies power to first stage circuit 3404, second stage circuit 3406, and third stage circuit 3408, respectively. As previously discussed, control circuit 3200 generates digital waveform 4300 (FIG. 37) using the circuitry and techniques described in connection with FIGS. 35 and 36. Referring again to FIG. 32, digital waveform 4300 may be configured to drive ultrasound transducers, radio frequency (eg, RF) electrodes, or a combination thereof either individually or simultaneously. In the case of simultaneous driving, a filter circuit may be provided in the corresponding first stage circuit 3404 to select either the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned United States Patent 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 first stage circuit 3404 (eg, a first stage ultrasonic drive circuit 3420, a first stage RF drive circuit 3422, and a first stage sensor drive circuit 3424) is located within the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides an ultrasonic driving signal to the first stage ultrasonic driving circuit 3420 through outputs SCL-A and SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 will be described in detail with respect to FIG. The control circuit 3200 provides an RF drive signal to the first stage RF drive circuit 3422 via the outputs SCL-B and SDA-B of the control circuit 3200. The first stage RF drive circuit 3422 will be described in detail in connection with FIG. The control circuit 3200 provides a sensor drive signal to the first stage sensor drive circuit 3424 via the outputs SCL-C and SDA-C of the control circuit 3200. Generally, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section 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 modules are plugged into control circuit 3200. For example, the control circuit 3200 may determine whether a first stage ultrasonic drive circuit 3420, a first stage RF drive circuit 3422, or a first stage sensor drive circuit 3424 located within the handle assembly 3412 is connected to the battery assembly 3410. Configured to detect. Similarly, each of the first stage circuits 3404 can detect which second stage circuits 3406 are connected to it, and that information is used by the control circuits 3200 to determine the type of signal waveform to generate. will be returned to. Similarly, each of the second stage circuits 3406 can detect which third stage circuits 3408 or components are connected to it, and that information is used to determine the type of signal waveform to generate. It is returned to control circuit 3200.

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

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

FIG. 33 illustrates a generator circuit 3500 divided into multiple stages, with a first stage circuit 3504 in common with a second stage circuit 3506, in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of surgical system 1000 described herein may include a generator circuit 3500 that is divided into multiple stages. For example, the surgical instruments of surgical system 1000 may include an amplifying circuit that enables operation of at least two circuits: radio frequency (RF) energy only, ultrasound energy only, and/or a combination of RF energy and ultrasound energy. A generator circuit 3500 may be provided that is divided into a first stage circuit 3504 and a second stage circuit 3506. The combination modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 that is integral with the modular shaft assembly 3514. As previously discussed throughout this description in connection with the surgical instruments of surgical system 1000, battery assembly 3510 and shaft assembly 3514 are configured to mechanically and electrically connect with handle assembly 3512. The end effector assembly is configured to mechanically and electrically connect 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 control circuit 3200 previously described. The handle assembly 3512 that connects to the battery assembly 3510 includes a common first stage drive circuit 3420. As previously discussed, the first stage drive circuit 3420 is configured to drive ultrasound, radio frequency (RF) current, and sensor loads. The output of the common first stage drive circuit 3420 is connected to a second stage circuit 3506 such as a second stage ultrasonic drive circuit 3430, a second stage radio frequency (RF) current drive circuit 3432, and/or a second stage sensor drive circuit 3434. Any one of them can be driven. Common first stage drive circuit 3420 detects which second stage circuit 3506 is located within shaft assembly 3514 when shaft assembly 3514 is connected to handle assembly 3512. When shaft assembly 3514 is connected to handle assembly 3512, common first stage drive circuit 3420 connects second stage circuit 3506 (e.g., second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and/or or second stage sensor drive circuit 3434 ) is located within shaft assembly 3514 . This information is used to provide the appropriate digital waveform 4300 (FIG. 37) to the second stage circuit 3506 located within the handle assembly 3512 to drive the appropriate load, e.g., ultrasound, RF, or sensor. The control circuit 3200 is provided with the It will be appreciated that identification circuitry may be included in various assemblies 3516 within third stage circuitry 3508, such as ultrasound transducer 1120, electrodes 3074a, 3074b, or sensor 3440. Thus, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

FIG. 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 includes an analog multiplexer 3680. Analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A, such as RF, battery, and power control circuits. A current sensor 3682 is coupled in series with the return or ground terminal of the power supply circuit and measures the current provided by the power supply. A field effect transistor (FET) temperature sensor 3684 provides ambient temperature. A pulse width modulation (PWM) watchdog timer 3688 automatically causes a system reset if the main program fails to provide a periodic system reset. This is provided to automatically reset the electrical circuit 3600 if it hangs up or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 3600 may be configured to drive an RF electrode or to drive an ultrasound transducer 1120, for example, as described with respect to FIG. 29. Thus, referring now again to FIG. 34, electrical circuit 3600 can be used to alternately drive both the ultrasound and RF electrodes.

Drive circuit 3686 provides left and right RF energy outputs. Digital signals representing signal waveforms are provided to the SCL-A and SDA-A inputs of analog multiplexer 3680 from a control circuit such as control circuit 3200 (FIG. 30). A digital-to-analog converter 3690 (DAC) converts the digital input to an analog output to drive a PWM circuit 3692 coupled to an oscillator 3694. PWM circuit 3692 provides a first signal to a first gate drive circuit 3696a coupled to first transistor output stage 3698a to drive a first RF+ (left) energy output. PWM circuit 3692 also provides a second signal to a second gate drive circuit 3696b coupled to second transistor output stage 3698b to drive a second RF (right side) energy output. A voltage sensor 3699 is coupled between the RF left/RF output terminals to measure the output voltage. Drive circuit 3686, first drive circuit 3696a and second drive circuit 3696b, and first transistor output stage 3698a and second transistor output stage 3698b define a first stage amplifier circuit. In operation, the control circuit 3200 (FIG. 30) generates a 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 ultrasound or high frequency current generator of surgical system 1000 digitally converts an electrical signal waveform into a digital waveform, preferably using a predetermined number of phase points stored in a look-up table. may be configured to generate. The phase points may be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 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 lookup table 4104, which in turn provides various digital input values to DAC circuit 4108 that powers the power amplifier. Addresses may be scanned according to the target frequency. Use of such a lookup table 4104 can be provided within a tissue, or within a transducer, an RF electrode, multiple transducers simultaneously, multiple RF electrodes simultaneously, or a combination of RF and ultrasound instruments. , making it possible to generate various types of waveforms. Additionally, multiple lookup tables 4104 representing multiple waveforms can be created, stored, and applied from the generator to the tissue.

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

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

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

Since the DDS circuit 4100 is a sampled data system, issues associated with sampling such as quantization noise, aliasing, filtering, etc. must be considered. For example, higher harmonics of the output of a phase-locked-loop (PLL) based synthesizer may be filtered, whereas higher harmonics of the DAC circuit 4108 output frequency may be folded 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.

DDS circuit 4100 may include a plurality of lookup tables 4104 that store waveforms represented by a predetermined number of samples, the samples defining a predetermined waveform shape. Accordingly, waveforms with unique shapes can be stored in lookup tables 4104 to provide various tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for superficial tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. Can be mentioned. In one aspect, the DDS circuit 4100 can create a plurality of waveform lookup tables 4104 as desired during a tissue treatment procedure (e.g., "on the fly" or in substantially real time based on user or sensor input) Switching can occur between various waveforms stored in separate lookup tables 4104 based on tissue effects and/or tissue feedback.

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

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

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

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

In one aspect, the waveform that may be digitized 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. Although the number of phase points is 2n, the electrical signal waveform may be digitized into 1024 (210) phase points. The electrical signal waveform may be represented as A _n (θ _n ), where the normalized amplitude A _n at point n is represented by the phase angle θ _n and is referred to as the phase point at point n. The number of distinct phase points n determines the tuning resolution of DDS circuit 4200 (as well as DDS circuit 4100 shown in FIG. 35).

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

The generator circuit algorithm and digital control circuit scan the addresses in the lookup table 4210, which in turn provides various digital input values to the DAC circuit 4212 that powers the filter 4214 and power amplifier. Addresses may be scanned according to the target frequency. Using a look-up table, it is converted to an analog output signal by a DAC circuit 4212, filtered by a filter 4214, amplified by a power amplifier coupled to the output of the generator circuit, and delivered to the tissue in the form of RF energy. It is possible to generate various types of shapes that can be applied to the tissue in the form of ultrasonic vibrations that are supplied to the ultrasound transducer or delivered to the tissue in the form of heat. The output of the amplifier can be applied, for example, to a single RF electrode, multiple RF electrodes simultaneously, a single ultrasound transducer, multiple ultrasound transducers simultaneously or a combination of RF transducers and ultrasound transducers. 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, the phase register 1708 will "roll over" twice as fast and the output frequency will double. This can be generalized as follows.

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

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

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

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

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

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

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 the memory. The generated electrical signal waveform includes at least one waveform. Additionally, providing the generated electrical signal waveform to at least one surgical instrument includes simultaneously providing the electrical signal waveform to at least two surgical instruments.

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

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

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

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

FIG. 37 illustrates one cycle of a discrete-time digital electrical signal waveform 4300 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison purposes) in accordance with at least one aspect of the present disclosure of an analog waveform 4304. The horizontal axis represents time (t) and the vertical axis represents digital phase points. Digital electrical signal waveform 4300 is, for example, a digital discrete time version of desired analog waveform 4304. Digital electrical signal waveform 4300 is generated by storing amplitude phase points 4302 representing the amplitude every clock cycle T _clk over one cycle or period T _o . Digital electrical signal waveform 4300 is generated by any suitable digital processing circuitry over a period of time T _o . Amplitude phase points are digital words stored in memory circuitry. In the embodiments 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 embodiments shown in FIGS. 35 and 36 are for illustrative purposes and that in actual implementations the resolution may be much higher. The digital amplitude phase points 4302 over one cycle To are stored in memory as a string of string words in look-up tables 4104, 4210, such as those described in connection with FIGS. 35 and 36, for example. To generate an analog version of the analog waveform 4304, the amplitude phase points 4302 are sequentially read from memory from 0 to T _o every clock cycle T _clk , as also described with respect to FIGS. 35 and 36; and is converted by DAC circuits 4108 and 4212. Additional cycles can be generated by repeatedly reading the amplitude phase points 4302 of the digital electrical signal waveform 4300 from 0 to T _o for as many cycles or periods as may be desired. A smooth analog version of the analog waveform 4304 is achieved by filtering the output of the DAC circuits 4108, 4212 by filters 4112, 4214 (FIGS. 35 and 36). The filtered analog output signals 4114, 4222 (FIGS. 35 and 36) are applied to the input of a power amplifier.

FIG. 38 illustrates providing gradual closure of a closure member (e.g., closure tube) when the displacement member is distally advanced and coupled with a clamp arm (e.g., an anvil), according to one aspect of the present disclosure; FIG. 12 is a diagram of a control system 12950 configured to reduce the closure force load on the closure member at a desired rate and reduce the firing force load on the firing member. In one aspect, control system 12950 may be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) for continuously calculating an error value as the difference between a desired set point and a measured process variable, with proportional, integral, and derivative terms (respectively P , I, and D). Nested PID controller feedback control system 12950 includes a primary controller 12952 in a primary (outer) feedback loop 12954 and a secondary controller 12955 in a secondary (inner) feedback loop 12956. The primary controller 12952 may be a PID controller 12972 as shown in FIG. 39, and the secondary controller 12955 may also be a PID controller 12972 as shown in FIG. Primary controller 12952 controls primary process 12958 and secondary controller 12955 controls secondary process 12960. The output 12966 of the primary process 12958 is subtracted from the primary set point SP ₁ by a first adder 12962. First adder 12962 produces a single sum output signal that is applied to primary controller 12952. The output of primary controller 12952 is secondary set point _SP2 . The output 12968 of the secondary process 12960 is subtracted from the secondary set point SP ₂ by a second adder 12964.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FIG. 41 is a circuit diagram of a circuit 7925 of various components of a surgical instrument with motor control functionality, in accordance with at least one aspect of the present disclosure. In various aspects, the surgical instruments 6480 described herein are configured to drive shafts and/or gear components to perform various operations associated with the surgical instruments 6480. A drive mechanism 7930 may also be included. In one aspect, the drive mechanism 7930 includes a rotational drive train 7932 configured to rotate the end effector, for example, about a longitudinal axis relative to the handle housing. Drive mechanism 7930 further includes a closure drive train 7934 configured to close the jaw members and grasp tissue with the end effector. Further, the drive mechanism 7930 includes a firing drive train 7936 configured to open and close a clamp arm portion of the end effector to grasp tissue with the end effector.

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

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

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

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

Controller 7952 and/or other controllers of this disclosure may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both. Examples of integrated hardware elements include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor devices, chips, microchips, chipsets, microcontrollers, system onboards, etc. 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 a hybrid circuit that includes, for example, discrete and integrated circuit elements or components on one or more substrates.

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

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

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

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

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

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

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

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

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

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

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

0472
As shown in FIG. 43A, when the ultrasonic blade is at a low temperature, such as room temperature, and is not heated by friction, the electromechanical resonant frequency f _o of the ultrasonic device is approximately 55,500 Hz, and the ultrasonic transducer The excitation frequency of is set to 55,500Hz. Therefore, when the ultrasound transducer is excited at the electromechanical resonant frequency f _o and the ultrasound blade is cold, the phase angle φ is at a minimum or about 0 Rad, as shown by the cold blade plot 133002. As shown in FIG. 43B, when the ultrasonic blade is cold and the ultrasonic transducer is excited at the electromechanical resonant frequency _fo , the impedance magnitude |Z| is 800Ω, e.g. |Z| is the minimum impedance and the drive signal amplitude is maximum due to the series resonant equivalent circuit of the ultrasonic electromechanical system shown in FIG.

Referring again to FIGS. 43A and 43B, the ultrasonic transducer is driven at an electromechanical resonant frequency f _o of 55,500 Hz by the generator voltage V _g (t) signal and the generator current I _g (t) signal. When driven, the phase angle φ between the generator voltage V _g (t) signal and the generator current I _g (t) signal is zero and the impedance magnitude |Z| is the minimum impedance, e.g. 800 Ω. , the signal amplitude is at its peak or maximum due to the series resonant equivalent circuit of the ultrasound electromechanical system. As the temperature of the ultrasonic blade increases, the electromechanical resonant frequency _fo ' of the ultrasonic device decreases due to the frictional heat generated during use. Since the ultrasound transducer is still driven by the generator voltage Vg(t) signal and the generator current Ig(t) signal at the previous (cold blade) electromechanical resonance frequency f _o of 55,500 Hz, the ultrasound device operates at 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 the impedance magnitude |Z| and a decrease in the peak magnitude of the drive signal for the previous (cold blade) electromechanical resonant frequency of 55,500 Hz. Therefore, the temperature of the ultrasonic blade changes the phase angle φ between the generator voltage V _g (t) signal and the generator current I _g (t) signal to the electromechanical resonant frequency f due to the temperature change of the ultrasonic blade. It can be estimated by measuring the change in _o .

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

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

0476
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 ultrasound transducer. The phase angle φ can be calculated using Fourier analysis, weighted least squares estimation, Kalman filtering, space vector-based techniques, zero-crossing methods, Lissajous diagrams, three-voltmeter methods, crossed-coil methods, vector voltmeters and vectors, among other techniques mentioned above. It can be determined by impedance methods, phase standard equipment, and phase locked loops. The generator can continuously monitor the phase angle φ and adjust the drive frequency until the phase angle φ is zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. Changes in phase angle φ and/or generator drive frequency can be used as indirect or inferential measurements of ultrasonic blade temperature.

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

ここで発生器駆動周波数の範囲は装置モデルに固有である。

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

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

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

状態空間モデルは、固有周波数Ｆ_ｎ（ｔ）、温度Ｔ（ｔ）、エネルギーＥ（ｔ）、及び時間ｔに対する、電気機械的超音波システムの固有周波数

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

の変化率及び超音波ブレードの温度

rate of change and temperature of ultrasonic blade

represents the rate of change.

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

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

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

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

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

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

, and the complete feedback control variables are F _n (t) of the electromechanical ultrasound system, an estimate of the temperature of the ultrasound blade T(t), the energy applied to the ultrasound blade E(t), and the phase It includes the angle φ and the time t. The input to 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。

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

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

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

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

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

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

Process 3
The third step uses the state estimator 133026 within 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 estimates, in accordance with at least one aspect of the present disclosure. The probability distributions include a prior probability distribution 133042, a predicted (state) probability distribution 133044, and an observed probability distribution 133046. Three probability distributions 133042, 133044, 1330467 are applied to the ultrasound transducer to adjust temperature based on impedance across the ultrasound transducer measured at various frequencies according to at least one aspect of the present disclosure. used for feedback control of power. 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 ultrasound transducer measured at various frequencies in accordance with at least one aspect of the present disclosure.

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

状態変動

state fluctuation

は、予測（状態）確率分布１３３０４４として表されるシステムの次の状態を予測するために使用される。観測確率分布１３３０４６は、観測分散σ_ｍが以下の式によって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 a predicted (state) probability distribution 133044. The observation probability distribution 133046 is the probability distribution of the actual observed values of the system state that is used to define the gain where the observation variance σ _m is given by:

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

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

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

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

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

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

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

あるいは同等に、超音波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) signal and the current I _g (t) signal applied to the ultrasound transducer. The phase angle φ information may also be used to estimate the state of the ultrasonic blade. As discussed in detail herein, the phase angle φ changes as a function of the temperature of the ultrasonic blade. Therefore, the phase angle φ information may be used to control the temperature of the ultrasonic blade. This, for example, reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at excessively high temperatures, and reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at excessively low temperatures. This can be done by increasing the power applied. 47A-47B are graphical representations of temperature feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a rapid temperature drop in 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 ultrasound generator is shown along the vertical axis and time (in 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 (in seconds) is shown along the horizontal axis. The temperature of the ultrasonic blade is increased by applying constant power 133072, as shown in FIG. 47A. During use, the temperature of the ultrasonic blade drops rapidly. This can be due to a variety of conditions, but during use, the temperature of the ultrasound blade when it is immersed in a fluid-filled surgical field (e.g. blood, saline, water, etc.) can be estimated to decrease. At time t ₀ , the temperature of the ultrasonic blade decreases below the desired minimum temperature 133082, and the frequency-temperature feedback control algorithm detects the decrease in temperature and increases the power ramp delivered to the ultrasonic blade. A power increase or "ramp up" indicated by 133074 is initiated to begin raising the temperature of the ultrasonic blade above the desired minimum temperature 133082.

47A and 47B, the ultrasonic generator outputs substantially constant power 133072 as long as the temperature of the ultrasonic blade remains above the desired minimum temperature 133082. At t ₀ , the processor and/or control circuit of the generator or instrument detects that the temperature of the ultrasonic blade drops below the desired minimum temperature 133072 and initiates a frequency-temperature feedback control algorithm to Raise the temperature of the sonic blade above the lowest desired temperature 133082. Therefore, the power of the generator starts increasing at t ₁ (133074), which corresponds to the detection of a sudden drop in the temperature of the ultrasonic blade at t ₀ . Under the frequency-temperature feedback control algorithm, the power continues to increase (133074) until the ultrasonic blade temperature exceeds the desired minimum temperature 133082.

FIG. 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 circuit of the generator or instrument executes one aspect of the frequency-temperature feedback control algorithm described in connection with FIGS. 47A and 47B to 133092 to achieve the desired temperature in the ultrasonic blade. The generator monitors the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal applied to drive the ultrasound transducer (133094). Based on the phase angle φ, the generator estimates the temperature of the ultrasonic blade using the techniques described herein in connection with FIGS. 43A-45 (133096). The generator determines whether the temperature of the ultrasonic blade is less than a desired minimum temperature by comparing the estimated temperature of the ultrasonic blade to a predetermined desired temperature (133098). The generator then adjusts the power level applied to the ultrasound transducer based on the comparison. For example, when the ultrasonic blade temperature is above the desired minimum temperature, the process proceeds along the "no" branch, and when the ultrasonic blade temperature is below the desired minimum temperature, the process proceeds along the "yes" branch. Proceed. When the temperature of the ultrasonic blade is below the desired minimum temperature, the generator applies a voltage to the ultrasonic transducer, e.g. by increasing the voltage V _g (t) signal and/or the current I _g (t) signal. The power level is increased (133100) to increase the temperature of the ultrasonic blade and the power level applied to the ultrasonic transducer continues to increase until the temperature of the ultrasonic blade increases and exceeds the lowest desired temperature.

Adaptive Advanced Tissue Treatment Pad Saver Mode FIG. 49 is a graphical representation 133110 of ultrasound blade temperature as a function of time during vascular firing, in accordance with 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 capabilities. 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 pad.

As shown in FIG. 49, the optimum temperature 133114 for vessel sealing is marked as the first target temperature T ₁ and the optimum temperature 133116 for "infinite" clamp arm pad life 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 temperature of the ultrasonic blade 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 optimal ultrasonic blade temperature to seal the blood vessel and extend the life of the clamp arm pad.

Initially, the temperature of the ultrasonic blade increases as the blade heats up and finally exceeds the first target temperature threshold T ₁ . A frequency-temperature feedback control algorithm takes over and controls the blade temperature to T ₁ until the vessel transsection is completed at t ₀ (133118) and the ultrasound blade temperature is below a second target temperature threshold T ₂ . A processor and/or control circuit of the generator or instrument detects when the ultrasonic blade contacts the clamp arm pad. Once the vessel transsection is completed and detected at t ₀ , the frequency-temperature feedback control algorithm controls the temperature of the ultrasound blade to a second target threshold T ₂ to extend the life of the crumb arm pad. Switch to The optimal clamp arm pad life temperature for TEFLON clamp arm pads is approximately 325°C. In one aspect, advanced tissue treatment 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 the two temperature setpoints shown in FIG. 49, in accordance with at least one aspect of the present disclosure. . According to this process, the generator executes 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 ultrasound transducer. A first power level is applied to the ultrasound transducer by adjusting the signal to set the ultrasound blade temperature to a first target T ₁ optimized for vessel sealing (133122). As previously mentioned, the generator monitors the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal applied to the ultrasound transducer (133124) and adjusts the phase angle φ to Based on this, the generator estimates the temperature of the ultrasonic blade using the techniques described herein in connection with FIGS. 43A-45 (133126). According to a frequency-temperature feedback control algorithm, the generator or instrument processor and/or control circuit maintains the ultrasonic blade temperature at the first target temperature T ₁ until the transsection is completed. A frequency-temperature feedback control algorithm may be used to detect completion of the vessel transsection process. The processor and/or control circuit of the generator or instrument determines when the vessel transsection is complete (133128). The process follows the "no" branch when the vessel transsection is not completed, and the "yes" branch when the vessel transsection is completed.

If the vessel transect is not completed, the processor or control circuit of the generator or instrument, or both, sets the temperature of the ultrasound blade to a temperature _T1 optimized for vessel sealing and transect. (133130). If the ultrasonic blade temperature is set to T ₁ , the process proceeds along the "yes" branch, and the processor or control circuit of the generator or instrument, or both, is applied to the ultrasonic transducer and the phase angle φ Continue monitoring (133124) of the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal based on the current I g (t) signal. If the ultrasonic blade temperature is not set to _T1 , the process proceeds along the "no" branch and the generator or instrument processor and/or control circuitry continues to direct the ultrasonic transducer to the first Apply a power level (133122).

Once the vessel transsection is complete, the processor and/or control circuit of the generator or instrument applies a second power level to the ultrasound transducer (133132) to cause the ultrasound blade to extend the life of the clamp arm pad. Set a second target temperature T ₂ optimized for maintenance or extension. The processor and/or control circuit of the generator or instrument determines (133134) whether the temperature of the ultrasonic blade is at the set point temperature _T2 . If the ultrasound blade temperature is set to T2, the process completes the vessel transsection procedure (133136).

Blade Start Temperature By knowing the temperature of the ultrasonic blade at the beginning of the transverse cut, the generator can deliver the appropriate amount of power to heat the blade for quick cutting, or if the blade is already hot. If so, it may be possible to add as much power as needed. This technique can achieve more consistent transverse cutting times and extend the life of crumb arm pads (eg, TEFLON clamp arm pads). Knowing the temperature of the ultrasonic blade at the beginning of the transverse cut may enable the generator to deliver the correct amount of power to the ultrasonic transducer to effect 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 at the manufacturing plant. The baseline frequency value is recorded and stored in a look-up table of the generator and/or instrument. The baseline value is used to generate the transfer function. At the beginning of the ultrasonic transducer start-up cycle, the generator measures the resonant frequency of the ultrasonic blade (133142), compares the measured resonant frequency with the baseline resonant frequency value (133144), and determines the frequency difference (Δf ) is determined. Δf is compared to a corrected ultrasonic blade temperature look-up table or transfer function. The resonant frequency of the ultrasonic blade may 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 is the frequency at which the phase angle φ voltage V _g (t) signal and current I _g (t) signal are zero, as described herein.

Once the resonant frequency of the ultrasonic blade is determined, the processor and/or control circuit 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 ultrasound transducer: sets the power level delivered to the ultrasound transducer.

The processor and/or control circuit of the generator or instrument determines 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 processor and/or control circuit applies a high power level to the ultrasonic transducer (133152). , increases the temperature of the ultrasound blade and completes the vessel transection procedure (133156).

If the initial temperature of the ultrasonic blade is not low, the process proceeds along the "no" branch and the processor and/or control circuit 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 processor and/or control circuit of the generator or instrument applies a lower power level to the ultrasonic transducer (133154). , lowers the temperature of the ultrasound blade and completes the vessel transsection procedure (133156). If the initial temperature of the ultrasound blade is not high, the process proceeds along the "no" branch and the generator or instrument processor and/or control circuit completes the vessel transsection (133156).

Smart Blade Technology to Control 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 temperatures. Using this known relationship, 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 approaching instability and subsequently reducing power to an ultrasonic transducer to prevent instability of the ultrasonic transducer, according to at least one aspect of the present disclosure. FIG. 133160 is a process logic flow diagram illustrating a control program or logical configuration that adjusts. The frequency/temperature relationship of an ultrasonic blade exhibiting displacement or modal instability is determined 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 mapped by recording. A function or relationship is generated that can be used/interpreted by a 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 is configured to increase the frequency - such that the drive power level is reduced (e.g., by reducing the drive voltage V _g (t) or current I _g (t) or both applied to the ultrasound transducer). A temperature feedback control algorithm processing function and closed loop response are implemented to modulate the temperature of the ultrasonic blade below a trigger point to prevent a given blade from reaching instability.

Advantages include the simplification of the ultrasonic blade configuration such that the instability characteristics of the ultrasonic blade do not have to be excluded from the design and can be compensated for using the instability control technique of the present invention. It will be done. The instability control technique of the present invention can further enable new ultrasonic blade geometries and improve the stress profile of heated ultrasonic blades. Additionally, the ultrasonic blade may be configured to reduce the performance of the ultrasonic blade when used with a generator that does not use this technology.

According to the process illustrated by logic flow diagram 133160, the generator or instrument processor and/or control circuitry determines the voltage V _g (t) signal and current I _g (t) signal applied to the ultrasound transducer. The phase angle φ between is monitored (133162). The processor and/or control circuit of the generator or instrument generates ultrasonic waves based on the phase angle φ between the voltage V _g (t) signal and the current I _g (t) signal applied to the ultrasonic transducer. Estimate the blade temperature (133164). The processor and/or control circuit of the generator or instrument compares the estimated temperature of the ultrasonic blade to an ultrasonic blade instability trigger point threshold (133166). The processor and/or control circuit of the generator or instrument determines whether the ultrasonic blade is approaching instability (133168). If not, the process proceeds along the "no" branch, monitors the phase angle φ (133162), estimates the temperature of the ultrasonic blade (133164), and continues using the ultrasonic blade until the ultrasonic blade approaches instability. The estimated temperature of is compared to the ultrasonic blade instability trigger point threshold (133166). The process then proceeds along the "yes" branch, where the processor and/or control circuit of the generator or instrument adjusts (133170) the power level applied to the ultrasonic transducer to adjust the temperature of the ultrasonic blade. Modulate.

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

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

Optimal tissue effect is obtained by increasing the power level driving the ultrasound transducer early in the sealing cycle (e.g., driving voltage V _g (t) or current I _g (t) applied to the ultrasound transducer). Rapidly heating and drying the tissue (by increasing V _g It is known that the final seal can be obtained by forming the final seal gradually (by lowering the current I _g (t) or the current I g (t) or both). In one aspect, a frequency-temperature feedback control algorithm according to the present disclosure sets a limit on a temperature threshold that the tissue can reach as it heats during the high power level phase and subsequently The temperature of the ultrasonic blade is controlled by reducing the power level based on the melting point of the TEFLON to complete the seal. The control algorithm can be implemented by actuating an energy button on the device 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 processor and/or control circuit of the generator or instrument activates (133182) the sensing of the ultrasonic blade using spectroscopy (e.g. smart blade) and detects 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 mentioned 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.

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

The processor and/or control circuit of the generator or instrument compares the measured resonant frequency of the ultrasound electromechanical system to the first desired frequency f _x (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 circuit of the generator or instrument , increasing the power level applied to the ultrasonic transducer (133188) to increase the temperature of the ultrasonic blade until the measured resonant frequency of the ultrasonic electromechanical system exceeds the first desired frequency f _x . In this case, the tissue coagulation process is completed and the process controls the temperature of the ultrasonic blade to a second desired temperature corresponding to the second desired frequency f _y .

The process proceeds along the "yes" branch, where the processor and/or control circuit of the generator or instrument reduces the power level applied to the ultrasonic transducer (133190) to reduce the temperature of the ultrasonic blade. let The processor and/or control circuit of the generator or instrument measures the resonant frequency of the ultrasound electromechanical system (133192) 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 circuit of the generator or instrument causes 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 f _y (e.g., the temperature of the ultrasonic blade is below the temperature of the melting point of the clamp arm pad). ), the generator then performs an increase in the power level applied to the ultrasound transducer to increase the temperature of the ultrasound blade until the tissue traversing process is completed (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. 53. Graphical illustration 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 optimal solidification temperature of 450°C. Once the ultrasonic blade temperature reaches 450 °C, the frequency-temperature feedback control algorithm reduces the transducer current I _g ( t).

Tissue Type Identification or Parameterization In various embodiments, a surgical instrument (e.g., an ultrasonic surgical instrument) identifies or parameterizes the tissue grasped by an end effector and responds to various operations of the surgical instrument. 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 the end effector, and the like. In one example, discussed in more detail below, the ultrasonic surgical instrument is configured to adjust the displacement amplitude of the distal tip of the ultrasonic blade according to the collagen/elastin ratio of the tissue detected within the jaws of the end effector. It is configured. As previously mentioned, the ultrasonic instrument includes an ultrasonic transducer acoustically coupled to an ultrasonic blade via an ultrasonic waveguide. The displacement of the ultrasound blade is a function of the power applied to the ultrasound transducer, and thus the power delivered to the ultrasound transducer can be modulated according to the detected collagen/elastin ratio of the tissue. In another example, discussed in more detail below, the force exerted by the clamp arm on the tissue can be modulated according to the position of the tissue relative to the end effector. Various techniques for identifying or parameterizing 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.

0525
Determining Tissue Position Through Impedance Changes Referring back to FIG. 23, an end effector 1122 is shown including an ultrasonic blade 1128 and a clamp arm 1140, in accordance with at least one aspect of the present disclosure. FIG. 55 is a bottom view of the ultrasound end effector 1122 showing the clamp arm 1140 and the ultrasound blade 1128 and depicting the positioning of tissue within the ultrasound end effector 1122, in accordance with at least one aspect of the present disclosure. Tissue positioning between clamp arm 1140 and ultrasonic blade 1128 includes distal region 130420 and proximal region 130422 . etc., may be delineated according to the area or area in which the tissue is located.

23 and 55, an ultrasonic end effector 1122 grasps tissue between an ultrasonic blade 1128 and a clamp arm 1140, as described herein. Once the tissue is grasped, an ultrasound generator (e.g., generator 1100 described in connection with FIG. 22) is acoustically coupled to the ultrasound blade 1128 via an ultrasound waveguide. The ultrasound transducer may be activated to apply power to the ultrasound transducer. The power applied to the ultrasound transducer can be at energy levels in the therapeutic or non-therapeutic range. At non-therapeutic ranges of applied power, the resulting displacement of the ultrasonic blade 1128 has no or only minimal effect on the grasped tissue, so as not to coagulate or cut the tissue. Non-therapeutic excitation can be particularly useful in determining the impedance of an ultrasound transducer, which can be determined depending on, for example, tissue type, tissue location within the end effector, different tissue types, among other conditions. and the temperature of the ultrasonic blade, depending on various conditions present at the end effector 1122. A variety of these conditions are described herein. The impedance of the ultrasound 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 the conditions at the ultrasound end effector 1122 are determined using non-therapeutic ultrasound energy levels, tissue treatment, effective sealing, transverse incision, etc. , and duration, therapeutic ultrasound energy may be applied based on the determined end effector 1122 condition. The therapeutic energy is sufficient to coagulate and cut tissue.

In one aspect, the present disclosure describes the thickness and thickness of tissue located within the jaws of ultrasonic end effector 1122 (i.e., between clamp arm 1140 and ultrasonic blade 1128), as shown in FIGS. 23 and 55. Provide a control process, such as an algorithm, to determine the type. Further details regarding detecting various states and characteristics of objects gripped by end effector 1122 are provided below in the DETERMINING JAW STATE section and in the SMART ENERGY DEVICES section. Discussed in U.S. Provisional Application No. 62/692,768.

FIG. 56 is a graph illustrating changes in ultrasound transducer impedance as a function of tissue position within 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 130,000. Horizontal axis 130004 represents tissue position and 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, depict different positions of tissue grasped within the ultrasound end effector 1122 or be able to accommodate them. A depiction of the proximal and distal tissue locations is shown schematically 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. Therefore, the position of the tissue corresponds to the position of the plot obtained for the 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 located in 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 located at the distal end 130012 of the end effector 1122. This can be seen from the fact that the first plot 130006 exceeds the proximal limit 130010 and/or is located near the distal limit 130012. As shown by plots 130006, 130008, δ ₂ is much larger than δ ₁ .

When applying power (voltage and current) to the ultrasound transducer to operate the ultrasound blade 1128 in a non-therapeutic range (e.g., power not sufficient to cut or coagulate tissue), the resulting measured Transducer impedance (Ω) is a useful indicator of tissue location within the jaws of end effector 1122, whether at the distal end 130420 or proximal end 130422 of the ultrasonic blade 1128 as shown in FIG. It is. The position of the tissue within the end effector 1122 changes as the non-therapeutic power level applied to the ultrasound transducer changes from a minimum power level (e.g., L ₁ ) to a maximum power level (e.g., L ₂ ). It can be determined based on the change in δ. In some aspects, the non-therapeutic power level(s) applied to the ultrasound transducer causes the ultrasound blade 1128 to move below the sensing amplitude or the minimum therapeutic amplitude (e.g., at the distal end of the ultrasound blade 1128 and and/or 35 μm or less at the proximal end). Calculation of impedance has been discussed previously in this disclosure. A measurement of the first transducer impedance Z ₁ is taken when the first power level L ₁ is applied, which provides an initial measurement, until the applied power increases until the second power level L ₂ Subsequent impedance Z ₂ measurements are taken again when 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 is maintained constant. . The resulting longitudinal displacement amplitude of the ultrasonic blade 1128 based on the applied power level provides an indication of the position of the tissue within the jaws of the end effector 1122. In one exemplary implementation, the first power level L ₁ produces a longitudinal displacement amplitude of 35 μm at the distal end 130420 and 15 μm at the proximal end 130422. Further, in this example, the second power level L ₂ produces a longitudinal amplitude of 70 μm at the distal end 130420 and 35 μm at the 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 location, with higher changes in impedance representing the location of tissue distributed at the distal end 130012 and lower changes in impedance representing the location of the tissue distributed at the proximal end 130010 of the end effector 1122. This indicates the position of the tissue distributed in the area. In short, if there is a large change in impedance as the power level increases from _L1 to _L2 , tissue will only be positioned distally within the end effector 1122. Conversely, if there is only a slight change in impedance as the power level increases from _L1 to _L2 , the tissue will be more dispersed within the end effector 1122.

0530
FIG. 57 is a graphical representation 130050 illustrating a change in ultrasound transducer impedance as a function of time versus position of tissue 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 the change in transducer impedance (δ) versus time (t) for proximal and distal position of the tissue within the penetration of the clamp arm 1140. With respect to the proximal and distal tissue positions, a force of the clamp arm 1140 is applied to hold the tissue within the ultrasound 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 understood 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 circuit portion of the generator or surgical instrument (e.g., processor 902 of FIG. 21 or control circuit 760 of FIG. 18) determines the first power level of the proximal and distal tissue locations. and the second power level. As shown in connection with the first plot 130060, if the difference in transducer impedance (δ) is below a first threshold 130056, the algorithm determines that the tissue is located within the proximal portion 130422 of the end effector 1122. Then it is determined. In the first plot 130060, the transducer impedance difference between measurements increases over time 130062 until it plateaus or maintains 130064 below a first threshold 130056. If the difference in transducer impedance (δ) exceeds a second threshold 130058, as shown in connection with the first plot 130066, the algorithm determines that tissue is located within the distal portion 130420 of the end effector 1122. Then it is determined. In the second plot 130066, the transducer impedance difference between the measurements increases over time 130068 until it plateaus or remains above the second threshold 130058 130070. If the difference in transducer impedance (δ) is between the first and second thresholds 130056, 130058, the algorithm determines that tissue is present within the central portion 130424 of the end effector 1122, e.g., between the proximal and distal portions of the end effector. It is determined that it is located between the two parts.

FIG. 58 illustrates the logic of a process 130100 that illustrates a control program or logic configuration for specifying operation in a non-therapeutic range of power applied to an instrument to determine tissue positioning, in accordance with at least one aspect of the present disclosure. It is a flow diagram. 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 will be described as being executed by a processor, but it is to 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 causes clamp arm 1140 and ultrasonic blade 1128 . Apply a control signal to capture the tissue between. After the clamp arm 1140 is closed over 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 the process 130100 includes that feedback control can be used to verify that the first power is set below a therapeutic power level. In this aspect, the processor determines whether the first power level is less than the therapeutic power level (130106). If the first power level is greater than or equal to the therapeutic power level, the process 130100 proceeds along the "no" branch and the processor decreases the applied power (130108) and the first power level is equal to or greater than the therapeutic power level. Continue looping until below level. The process 130100 then continues along the "yes" branch and 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 being greater than the first power level and less than the therapeutic power level. Again, optionally, feedback control can be used to verify that the second power level is not only higher than the first power level, but also below the therapeutic power level. In this aspect, the processor determines whether the second power level is less than the therapeutic power level (130114). If the second power level is greater than the therapeutic power level, the process 130100 proceeds along the "no" branch and the processor decreases the second power level (130108) until it falls below the therapeutic power level threshold. Continue the loop until. The process 130100 then continues along the "yes" branch and the processor measures a second impedance Z _g2 (t) of the ultrasound transducer corresponding to the second power level (130116). The impedance of an ultrasound transducer can be measured using various techniques discussed herein. The processor then calculates a difference in transducer impedance between the applied first power level and the second power level (130118).
δ=Z _g2 (t)−Z _g1 (t).

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

The processor compares the transducer impedance difference to first and second thresholds, where if the transducer impedance difference (δ) is less than the first threshold 130056, as shown in FIG. , the algorithm determines that the tissue is located within the proximal portion 130422 of the end effector 1122 and the transducer impedance difference (δ) is greater than the second threshold 130058. It is determined that it is located at . If the transducer impedance difference (δ) is between the first and second thresholds 130056, 130058, the algorithm determines that tissue is present within the central portion 130424 of the end effector 1122, e.g., in the proximal portion of the end effector 1122 and It is determined 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 positions of the end effector 1122, and then the appropriate treatment power is determined. Levels can be applied.

Switchless Mode Based on Tissue Positioning In various embodiments, the response of the ultrasound instrument depends on 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 may be based on compressibility or composition. Thus, the generator or ultrasonic surgical instrument implements an algorithm that controls the time between clamping the tissue within the jaws of the end effector and activating the ultrasonic transducer to treat the tissue. may contain and/or execute instructions. When no tissue is sensed, the ultrasound generator activation button or pedal may be assigned a different meaning to perform a different function. 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 the ultrasound transducer, thereby initiating a tissue coagulation cycle. In another aspect, the compression characteristics and situational awareness may also enable automatic activation of the device and adjust the parameters of the algorithm for the sensed tissue type. For example, advanced generators may ignore activation of a button or foot pedal unless tissue is sensed in contact with the end effector jaws. This configuration eliminates inadvertent activation queues 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 the ultrasonic surgical instruments described throughout this disclosure, may be operated in a switchless mode. It may be configured to operate in In switchless 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, a control algorithm that controls activation of an ultrasonic surgical instrument when operating in an automatic energy activation (or "switchless" mode) mode is activated when not operating in a switchless mode. The ultrasound instrument may be configured to initially apply less energy than otherwise. Further, the ultrasound generator or instrument can be configured to determine both the tissue contact and the type of tissue 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. The algorithm can be adjusted to achieve the best overall coagulation of tissue within the end effector jaws. In other aspects, instead of automatically activating the surgical instrument and/or generator, a control algorithm executed by a processor or control circuit of the generator or ultrasonic instrument detects the presence of tissue within the end effector. Activation of the generator or ultrasonic instrument may be prevented unless otherwise specified.

In one aspect, the present disclosure provides a method for determining the presence of tissue and the type of tissue located within the jaws of an end effector, performed by a processor or control circuit located in either a generator or a handheld ultrasound instrument. We provide an algorithm for In one aspect, the control algorithm operates through the techniques described herein for determining tissue location, such as those described below in the section "Determining Tissue Location Via Electrode Conduction." may 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 automatically upon detection of tissue accordingly. (e.g., by initiating application of power to the surgical instrument to a generator to which the surgical instrument is coupled) or configured to enable activation of the surgical instrument; Can be done. When the surgical instrument and/or generator is operated in a switchless mode, the control algorithm can be further configured to activate the surgical instrument at a particular power level, which It may or may not be different from the standard initial startup power level. In some embodiments, the control algorithm can detect, e.g., via the techniques described below in the section "Determining the Collagen to Elastin Ratio of Tissues as a Response to IR Surface Reflectance and Emissivity." It can be configured to activate or permit activation of the surgical instrument according to the particular type or composition of tissue. For example, the control algorithm may be configured to activate a surgical instrument when tissue with a high collagen composition is grasped, but not when tissue with a high elastin composition is grasped. Not necessarily. In some aspects, the control algorithm determines whether the grasped tissue is at a particular location within the end effector, e.g., through the techniques described below in the section "Determining Tissue Position Via Electrode Conduction." or whether a certain amount of tissue is being grasped by the end effector. For example, the control algorithm can be configured to activate the surgical instrument when the grasped tissue covers a certain percentage of the end effector. As another example, the control algorithm may 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 No. 62/659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety. SITUATIONAL AWARENESS and whether tissue is being grasped by the end effector, the type or composition of the tissue, and It may be configured to determine end effector or other characteristics of the tissue. In these embodiments, the surgical hub 106 (FIGS. 1-11) to which surgical instruments and/or generators are connected may be connected to Data can be received from the device and inferences can be made about the surgical procedure being performed or specific steps thereof. Thus, the situational awareness system can estimate which type(s) of tissue is being operated on at any given moment or step, and the control algorithm can then 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, if so, what type of tissue, allows the ultrasound instrument to operate in a switchless mode of operation; Operations are permitted based on the sensing capabilities of the ultrasound instrument. In some embodiments, the control algorithm controls the generator and/or the activation button coupled to the ultrasonic surgical instrument, the foot pedal, and It can be configured to ignore activation of other input devices, thereby preventing unintentional activation of the instrument. In some aspects, the control algorithm includes an activation button coupled to the generator and/or the ultrasonic surgical instrument depending on whether tissue is sensed in contact with the jaws/end effector of the surgical instrument; Foot pedal and other input device inputs can be configured to assign different meanings. For example, the control algorithm may be configured to activate a 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 within the jaws of the end effector is permissive allowing the instrument to change to a switchless mode and then initiate operation of an automatic coagulation cycle when tissue is detected. plays an important role, leading to longer uptime usage of the instrument and allowing the user to proceed based on its predictive ability. In addition to detecting the presence of tissue, the ability to further detect tissue type allows the algorithm to adjust and calculate the best clotting opportunities.

Adjusting the Ultrasonic System According to Tissue Composition In various embodiments, the ultrasonic surgical instrument detects the composition of the tissue grasped by or at the end effector and adjusts the ultrasonic transducer and/or the ultrasound system accordingly. A processor or control circuit may be included that executes an adaptive ultrasonic blade control algorithm to control operating parameters of the ultrasonic blade. Tissue composition can include, for example, the ratio of collagen to elastin within the tissue, the stiffness of the tissue, or the thickness of the tissue. 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. The adaptive ultrasonic blade control algorithm may be executed by a control circuit or processor located on either the generator or the surgical instrument.

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

Determining the Collagen to Elastin Ratio of the Tissue According to a Frequency Shift In various embodiments, the control algorithm determines the collagen to elastin ratio of the tissue by detecting the natural frequency of the ultrasound blade and the shift of the ultrasound blade waveform (e.g. , 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 ultrasound instrument. In one aspect, the present disclosure provides an adaptive ultrasound blade control algorithm for detecting shifts in the natural frequency and waveform of an ultrasound blade to detect tissue composition in contact with the ultrasound blade. In another aspect, an adaptive ultrasound blade control algorithm is configured to detect collagen and elastin composition content of the tissue and adjust the therapeutic heat flux of the ultrasound blade based on the detected collagen content of the tissue. may be configured. 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 in connection with FIGS. 1-54. There is. Therefore, in the interest 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 look-up table. A look-up 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 that is determined empirically.

Determining the Collagen to Elastin Ratio of the Tissue According to IR Surface Reflectance and Emissivity In various embodiments, the control algorithm adjusts the amplitude of the distal tip of the ultrasound blade (e.g., by determining the IR reflectance of the tissue). (in order to) determine the collagen to elastin ratio of a tissue. For example, FIG. 59 shows an ultrasound system 130164 that includes an ultrasound generator 130152 coupled to an ultrasound instrument 130150. Ultrasonic instrument 130150 includes ultrasonic waveguide 130154. to the ultrasound 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. End effector 130400 of ultrasonic surgical instrument 130150 includes an IR sensor located on clamp arm 130402 (eg, jaw member) in accordance with at least one aspect of the present disclosure. Ultrasonic generator 130152 and/or ultrasound instrument 130150 are coupled to surgical hub 130160 and/or cloud 130162 via wireless or wired connections, as described in connection with FIGS. 1-11. Good too.

FIG. 60 shows an IR reflectance detection sensor circuit 130409 that can be integrally attached to or integrally formed with a clamp arm 130402 of an ultrasound end effector 130400 to detect tissue composition, according to at least one aspect of the present disclosure. shows. IR sensor circuit 130409 includes an IR source 130416 (eg, an IR transmitter) and an IR detector 130418 (eg, an 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 ultrasound blade 130404). A portion of the emitted IR energy is absorbed by tissue 130410, a portion of the emitted IR energy is transmitted through tissue 130410, and a portion of the emitted IR energy is reflected by tissue 130410. IR detector 130418 receives IR energy reflected by tissue 130410 and produces an output voltage V _o or signal that is applied to control circuit 130420 for processing.

59 and 60, in one aspect, an ultrasound generator 130152 controls for driving an IR source 130416 and an IR detector 130418 located on or within the clamp arm 130402 of an ultrasound end effector 130400. Includes circuit 130420. In other aspects, the ultrasound instrument 130150 includes a control circuit 130420 for driving an IR source 130416 and an IR detector 130418 located on or within the clamp arm 130402 of the ultrasound end effector 130400. In either embodiment, when tissue 130410 is grasped between ultrasonic blade 130404 and clamp arm 130402, IR source 130416 is energized, e.g., by control circuit 130420 by closing switch SW1, to provide IR radiation to the tissue. Irradiates with energy. In one aspect, IR detector 130418 generates a voltage V _o that is proportional to the IR energy reflected by tissue 130410. The total IR energy emitted by the IR source 130416 is equal to the sum of the IR energy reflected by the tissue 130410, the IR energy absorbed by the tissue 130410, the IR energy passed through the tissue 130410, and any losses. Accordingly, control circuit 130420 or processor may 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. The IR source 130416 and IR detector 130418 and algorithm are calibrated to provide useful measurements of the collagen content of the tissue 130410 using IR reflectance principles.

The IR reflectance detection sensor circuit 130409 shown in FIG. 60 provides IR surface reflectance and emissivity to determine the elastin to collagen ratio. IR reflectance can be used to determine tissue composition for adjusting ultrasound transducer amplitude. Refractive index is an optical constant that controls light-related reflections of IR light. Refractive index can be used to differentiate between 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 comparison method is to determine the exact ratio (as detailed above) using an energy dissection device, such as an ultrasonic blade 130404, and then use that index as a baseline to compare all Predict the collagen ratio for further actuation. In this manner, the endoscope may update the cutting device (eg, ultrasound blade 130404) based on the collagen ratio. The prediction can be fine-tuned each time the dissection device is activated to perform the actual collagen-denaturing firing. An alternative method may employ absolute refractive index with a look-up table, which can distinguish between surface irregularities and subsurface collagen concentration. Further information on the IR refractive index properties of tissues can be found in Visible To Near-Infrared Refractive Properties OF Freshly-Excised Human-Liver Tissues: Marking Hepatic Mali Panagiotis Giannios, Konstantinos G. Toutouzas, Maria Matiatou, Konstantinos Stasinos, Manousos M. 2016, 6:27910," which is incorporated herein by reference.

In other aspects, the ultrasonic dissection device can be configured to vary the ideal temperature of the ultrasonic blade control algorithm proportionally to the collagen ratio. For example, the ultrasonic blade temperature control algorithm can be modified based on the collagen ratio received from control circuit 130420. As one particular example, the ultrasonic blade temperature control algorithm lowers the set of temperatures at which the ultrasonic blade 130404 is maintained such that the ultrasonic blade 130404 lowers the temperature set at which the ultrasonic blade 130404 is maintained due to the higher concentration of collagen within the grasped tissue 130410. 130410 can be configured to increase the retention time in contact with 130410. As another example, the wait time for the algorithm to repeat full activation can be varied based on collagen ratio. Various temperature control algorithms for ultrasonic blades are described in connection with FIGS. 43-54.

FIG. 61 is a cross-sectional view of an ultrasonic end effector 130400 with a clamp arm 130402 and an ultrasonic blade 130404, according to one aspect of the present disclosure. Clamp arm 130402 includes IR reflectance detection sensor circuits 130409a, 130409b that may be integrally attached to or integrally formed with clamp arm 130402 of ultrasound end effector 130400 to detect the composition of tissue 130410. The IR reflectance detection sensor circuits 130409a, 130409b may be mounted on a flexible circuit board 130412 shown in plan view in FIG. 62. Flexible circuit board 130412 includes three elongate elements 130408a, 130408b, 130408c to which are attached IR reflectance detection sensor circuits 130409a, 130409b and IR sensors 130414a, 130414b. IR sensors 130414a, 130414b may include an IR source 130416 and an IR detector 130418 as shown in FIG.

FIG. 63 is a logic flow diagram of a process 130200 illustrating a control program or logic structure 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. 21. For brevity, process 130200 will be described as being performed by control circuitry, but it is to be understood that the following description encompasses variations of the foregoing.

Accordingly, with reference to FIGS. 1-54 and 59-63, in one aspect, a control circuit energizes (130202) an IR source 130416 clamped within an end effector 13400 of an ultrasound instrument 130150. IR energy is applied to tissue 130410. Control circuitry then detects IR energy reflected by tissue 130410 via IR detector 130418 (130204). Accordingly, the control circuit determines the collagen to elastin ratio of the tissue 130410 based on the detected IR energy reflected by the tissue 130410 (130206). The control circuit adjusts the ultrasonic blade temperature control algorithm based on the determined collagen to elastin ratio of the tissue, as discussed in U.S. Provisional Application No. 62/692,768 entitled "SMART ENERGY DEVICES." (130208). In one aspect, the collagen content of tissue 130410 may be detected according to the reflectance of 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 end temperature of the ultrasonic blade 130404. In yet another aspect, the composition of the tissue 130410, which may be the thickness or stiffness of the tissue, may be used to influence the ultrasonic blade transducer control program.

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

Determining the Collagen to Elastin Ratio of Tissues According to the Collagen Transformation Point Different types of tissues are composed of varying amounts of structural proteins such as collagen and elastin providing different types of tissues with different properties. When heat is applied to tissue (eg, by an ultrasound blade), structural proteins are denatured, 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 a tissue) can be estimated. In various aspects, the control algorithm can be configured to determine the collagen to elastin ratio of the tissue by determining the collagen transformation point of the tissue. 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.

16-19 schematically illustrate a motorized clamp arm closure 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, according to an aspect of the present disclosure, and FIG. 1 is a circuit diagram of various components of a surgical instrument with motor control functionality, according to one aspect of the present disclosure. FIG. For example, FIG. 35 shows a drive mechanism 7930 that includes a closing drive train 7934 configured to close the jaw members and grasp tissue with the end effector. 38-39 illustrate a control system 12950, 12970 for controlling the closure rate of a jaw member, such as a clamp arm portion of an ultrasonic end effector, where FIG. FIG. 39 is an illustration of a control system 12950 configured to provide gradual closure of a closure member as the closure member is advanced distally to close and apply a closure force at a desired rate; 12970 illustrates a proportional-integral-derivative (PID) controller feedback control system 12970 in accordance with an aspect of the present disclosure. Accordingly, 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, reference should be made to FIGS. 16-19 and 38-41.

In one aspect, the control algorithm detects the collagen transformation point of the grasped tissue and controls the phase and/or amplitude of the ultrasound transducer drive signal or the closure rate of the clamp arm accordingly. The device may be configured to control delivery of ultrasound energy to the device. 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 controls the position of the clamp arm actuating member and its rate of change while maintaining the clamp arm load constant within a bonding pressure within a set operating range (e.g., 130-180 psi) corresponding to the particular instrument type. This can be achieved by measuring.

FIG. 64A is a graphical representation 130250 of displacement of clamp arm 1140 (FIG. 23) versus time when clamp arm 1140 is closed to identify collagen transformation points, in accordance with at least one aspect of the present disclosure. FIG. 64B is an enlarged portion 130256 of the graphical representation 130250 shown in FIG. 64A. 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 tighten the tissue when the ultrasonic blade 1128 (FIG. 23) heats the tissue according to the tissue's collagen transformation point (e.g., by controlling the closure rate of the clamp arm 1140). can be configured to control the load applied to the load. 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 can be a particular value (e.g., 4.5 lbs) or a range of values ( For example, within the range of 3.5-5 lbs). At that point, the control algorithm sets a rate-of-change threshold θ of clamp arm displacement and clamp arm 1140 . monitor the displacement of As long as the rate of change of clamp arm displacement remains within a predetermined negative limit (ie, below a threshold θ), the control algorithm can determine that the tissue is below the transformation temperature. As shown in the graphical representations of FIGS. 64A and 64B, when the control algorithm determines that the rate of change in 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 the transition temperature is reached, the control algorithm can be configured to change the operation of the ultrasound instrument accordingly. For example, the control algorithm can switch the surgical instrument from load control (of 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 a rate of change threshold of clamp arm displacement is reached. The second clamp arm displacement rate of change threshold can correspond, for example, to the transition temperature of elastin. The location of the collagen and/or elastin transition temperature in the plot 130258 of clamp arm displacement over time can be referred to as the "knee" in the plot 130258. Thus, in this aspect, the control algorithm operates the ultrasound instrument according to whether a second clamp rate displacement rate-of-change threshold (or elastin "knee") is reached and changes the operation of the ultrasound instrument accordingly. can be configured to change. For example, the control algorithm may switch the surgical instrument from load control (of clamp arm 1140) to temperature control when an 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, and elastin has a different melting temperature. Furthermore, as the collagen absorbs heat, the temperature should level out. In some embodiments, the control algorithm is configured around a particular temperature or temperature range (e.g., the range of expected temperatures for collagen and/or elastin transformation) to ascertain exactly when the monitored event occurs. ) may be configured to sample the position of the clamp arm and/or clamp arm displacement member at a higher rate within ).

In the embodiment shown in FIGS. 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 t _m . Without changing the surgical instrument to temperature control, the clamp arm displacement would increase geometrically, as shown in projection plot 130260. In one aspect, a control algorithm operating in a temperature control mode reduces the amplitude of the ultrasonic transducer drive signal to cause the ultrasonic blade 1128 to decrease as shown by the flat portion of the plot 130258 after reaching the threshold θ. Change the heat flux produced. In some aspects, the control algorithm increases the amplitude of the ultrasound transducer drive signal after a certain period of time, for example, to measure the rate of temperature rise to determine when the elastin transformation temperature is reached. Can be configured. Therefore, as the clamp arm closure rate approaches the next knee (i.e., the elastin knee), the clamp arm closure rate may decrease. Load control of the clamp arm 1140 may be beneficial in some cases as it may provide the best sealing of the blood vessel.

FIG. 65 is a logical flow of a process 130300 illustrating a control program or logic configuration for detecting a collagen transformation point and controlling the closure rate of a clamp arm or the amplitude of an ultrasound transducer 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 a surgical instrument or generator. Accordingly, the control circuit implementing process 130300 measures the position of the clamp arm actuation member and its rate of change while maintaining the load on the clamp constant (130302). As previously mentioned, in one aspect, the load on the clamp arm is maintained within the bonding pressure within the preferred range (130-180 psi) set by the ultrasonic surgical instrument. When the jaws reach a certain clamp arm load (e.g., 4.5 lbs), or when the clamp arm load is within a certain range (e.g., 3.5 to 5 lbs), the control circuit controls the rate of change of the clamp arm displacement. and monitors the position of the clamp arm actuating 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 a collagen transformation temperature) (130304). Accordingly, the control determines whether the rate of change in clamp arm displacement exceeds a set threshold, in other words, determines whether the tissue has reached a transition temperature (130306). If the transition temperature is reached, the process 130300 follows the "yes" branch and the control circuitry switches the surgical instrument to temperature control (130308) (e.g., controls an ultrasonic transducer to control the ultrasonic blade). temperature (reduce or maintain temperature). In one aspect, the control circuit continues to monitor collagen transformation temperature. Alternatively, in the embodiment shown in FIG. 65, if the transition temperature has not been reached, the process 130300 then proceeds along the "no" branch and the control circuit maintains load control of the clamp arm 1140 and is not gripped. The rate of change in clamp arm displacement is monitored (130310) to determine when the next transition point (eg, elastin transition point) occurs for the tissue that has been transferred. The control circuit can do this, for example, to prevent the temperature of the tissue from rising above the elastin transformation temperature.

It should be understood that collagen transformation should be constant for a given heat flux (45°C to 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 metamorphosis is occurring, the temperature of the tissue should be flattened while 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). Further, the control circuit can adjust the amplitude of the ultrasound transducer drive signal to control the heat flux produced by the ultrasound blade 1128 at different points in the surgical procedure. For example, the control circuit can reduce ultrasound transducer amplitude during periods of collagen metamorphosis. As another example, the control circuit may increase the amplitude of the ultrasound transducer to measure the rate at which temperature increases as elastin knee occurs. It should be appreciated that as the elastin knee approaches, the rate of temperature change decreases.

In another aspect, the control algorithm can be configured to detect the collagen transformation temperature to determine the collagen/elastin ratio of the grasped tissue. As discussed 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 identification of collagen transformation temperature points to determine collagen/elastin ratio in accordance with at least one aspect of the present disclosure. Vertical axis 130352 represents ultrasound transducer impedance and horizontal axis 130632 represents tissue temperature. The point at which the rate of change of the impedance of the ultrasound transducer shifts corresponds to the collagen/tissue composition of the tissue in an empirically determined manner. For example, if the rate of change of the impedance of the ultrasound transducer shifts at the first temperature 130362, the tissue composition is 100% collagen. Therefore, if the rate of change of the impedance of the ultrasound transducer shifts at the second temperature 130364, the tissue composition is 100% elastin. When the rate of change of impedance of the ultrasound transducer 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 determine 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 at a first rate of change (slope) as a function of temperature (T) at the tissue contact area. At the collagen transition temperature shown in the plot at point 130358, the rate of change of impedance (Z) as a function of temperature (T) decreases to a second rate of change. At the point 130358 where the slope of plot 130356 changes, the collagen to elastin ratio may correspond to an 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 determines from memory (e.g., a 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 can be performed, for example, by a control circuit of a processor located within a surgical instrument or generator. Accordingly, the control circuit monitors the impedance (Z) of the ultrasound transducer as a function of temperature (T) (130452). As mentioned above, the temperature (T) at the tissue-ultrasonic blade interface can be estimated by the algorithms described herein. The control circuit determines the rate of change of the ultrasound transducer impedance, ΔZ/ΔT (130454). As the temperature at the ultrasound blade/tissue interface increases, the impedance (Z) increases linearly at a first rate, as shown in FIG. 66. Accordingly, the control circuit determines whether the slope ΔZ/ΔT has changed (eg, decreased) (130456). If the slope ΔZ/ΔT has not changed, the process 130450 follows the "no" branch and continues to determine the slope ΔZ/ΔT (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 look-up table. A look-up table can be stored in memory (eg, memory 3326 of FIG. 31) and includes a ratio of elastin to collagen and a collagen transformation point that corresponds to a particular ratio that is 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 within 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 location of the tissue within the jaw, e.g., where the tissue is located 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 the compression ratio on the tissue is then 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 position of the clamp arm actuator is monitored during load control as a way to determine tissue compressibility and thus tissue type/disease status.

FIG. 68 is a graphical representation 130500 of a compressive load distribution across an ultrasonic blade 130404 in accordance with at least one aspect of the present disclosure. Vertical axis 130502 represents force applied to tissue by clamp arm 1140 and horizontal axis 130504 represents position. The ultrasonic blade 130404 is dimensioned such that there are periodic nodes and antinodes that occur along the length of the blade. The position of the node/anti-node is determined by the wavelength of the ultrasonic displacement induced in the ultrasonic blade 130404 by the ultrasonic transducer. The ultrasound 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 a first plot 130506 and a second plot 130508. As represented by either plot 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. Accordingly, tissue 130410 located at the distal end of the ultrasound blade 130404 experiences much lower compressive forces compared to tissue 130410 located proximal to the proximal end of the ultrasound blade 130404. The first plot 130506 may represent the default closure of the clamp arm 1140 and the resulting force applied to the distal tissue 130410 is _F1 . Generally, the amount of force applied to the tissue 130410 by the clamp arm 1140 is increased widely without consideration because excessive force may be applied to the tissue 130410 located proximally along the ultrasound blade 130404. It is not possible. However, by monitoring the position of the tissue 130410 along the ultrasonic blade 130404 (e.g., in the section "Determining the position of tissue via impedance changes" above and "Determining the position of the tissue via electrode conduction" below) 68), the control algorithm determines whether tissue 130410 is attached to tissue 130410 by clamp arm 1140 in situations where tissue 130410 is located only at the distal end of ultrasound blade 130404, similar to the situation shown in FIG. The applied force can be amplified. For example, second plot 130508 may represent a modified closure of clamp arm 1140 where the control algorithm determines that tissue 130410 is located only at the distal end of ultrasound blade 130404 and, correspondingly, The force applied by clamp arm 1140 to 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 in accordance with one aspect of the present disclosure. Vertical axis 130522 represents pressure applied to tissue (eg, N/mm ² ) and horizontal axis 130524 represents time. The first plot 130526 represents the normal or default compressive force applied to the 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 the amplified compression force eventually returns to the normal compression level (130532) and is applied through the clamp arm 1140 pad. Prevent burning/melting.

Determining Tissue Location Via Electrode Conduction In various aspects, the control algorithm determines electrical conduction across an array of bipolar (i.e., positive and negative) electrodes positioned along the jaw or jaws of the end effector. Accordingly, the position of tissue within or relative to the end effector can be configured to be determined. The location of the tissue detectable by the bipolar electrode array may correspond to a particular location of the tissue relative to the jaw(s) and/or a percentage of the jaw(s) covered by the tissue. In one aspect, the positive and negative electrodes are separated by a physical gap such that when tissue bridges the positive and negative electrodes, electrical continuity is established between the electrodes. The positive and negative electrodes are arranged in a matrix or array, thereby causing a processor or control circuit to detect where tissue is located between the positive and negative electrodes by monitoring or scanning the electrode array. It can be configured as follows. 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 may be configured to detect electrical continuity between adjacent electrodes to detect the presence of tissue adjacent thereto. In another aspect, a bipolar electrode array can be positioned along opposing jaws of the end effector. Accordingly, a control circuit or processor coupled to the bipolar electrode array may be configured to detect electrical continuity between opposing jaws to detect the presence of tissue therebetween.

By determining which surface area of the jaw(s) is covered with tissue, the control algorithm determines the appropriate bonding pressure for the amount of tissue grasped by the end effector and then applies the corresponding clamp arm load. allows to calculate. Clamp arm loading 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. Generator power output may be a function of various constants, variables, or minimums (e.g., 45 W, 35 W, or 5 W), various variables associated with the surgical instrument and/or generator (e.g., ultrasonic blade or clamp arm force amplitude) or may be directed by an algorithm to control the generator according to its power curve (eg, during ramp-up of the generator).

FIG. 70 illustrates an end effector 130400 that includes a single jaw electrode array for detecting tissue location in accordance with at least one aspect of the present disclosure. In the illustrated embodiment, 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 may include an end effector for an ultrasonic surgical instrument, and the second jaw 130432 may include, for example, an ultrasonic blade 1128 (FIG. 23), an electrosurgical instrument, a surgical stapling and cutting instrument. end effectors, etc. The second jaw 130432 can include, for example, an ultrasonic blade 1128 (FIG. 23) or the 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 a physical gap, alternating in polarity, or coupled to opposing terminals (i.e., supply and return terminals) of an 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 a supply terminal of a power source) and odd numbered electrodes 130429 can be of a second polarity. (e.g., negative polarity, or coupled to the return terminal of a power supply). Thus, when tissue 130410 contacts adjacent electrode 130429, tissue 130410 physically and electrically bridges bipolar electrode 130429, allowing current to flow between them. Current flow between bipolar electrodes 130429 can be detected by a control algorithm executed by a control circuit or processor coupled to electrode array 130431, thereby allowing the control circuit or processor to detect the presence of tissue 130410. enable.

Tissue detection by electrode array 130431 can be represented graphically by an activation matrix. For example, FIG. 71 shows an activation matrix 130550 showing the location of tissue 130410 with the electrode array 130431 shown in FIG. Vertical axis 130554 and horizontal axis 130555 both represent electrodes 130429 of electrode array 130431, and numbers along axes 130554, 130555 represent corresponding numbered electrodes 130429. Activated regions 130552 indicate where there is continuity between corresponding electrodes 130429, ie, where tissue 130410 is present. In FIG. 70, tissue 130410 is present across first, second, and third electrodes 130429, and as described above, electrodes 130429 can 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 described embodiment, there is no continuity between the first and third electrodes 130429 because they are of the same polarity. Continuity between these electrodes 130429 is illustrated schematically by activated regions 130552 within activated matrix 130550. Also, the region 130553 bounded by the activated region 130552 is not shown as activated because, in this described embodiment, the electrode 130429 cannot have electrical conduction with itself. Please note. A control algorithm executed by a control circuit or processor coupled to electrode array 130431 controls tissue 130410 within end effector 130400 because the location of the tissue corresponds to the particular electrode 130429 with which electrical communication has been established. (as the position of electrode 130429 is known), the proportion of jaws 130430, 130432 of end effector 130400 covered by tissue 130410, etc.

FIG. 72 illustrates an end effector 130400 that includes a dual jaw electrode array for detecting tissue location in accordance with at least one aspect of the present disclosure. In the illustrated embodiment, the end effector 130400 includes 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. Jaw 130432. Electrode arrays 130431, 130433 each include electrodes 130429 coupled to an energy source, such as an RF generator. The end effector 130400 can include an end effector for an electrosurgical instrument, an end effector for a surgical stapling and cutting instrument, and the like. As discussed above, the number, shape, and/or arrangement of electrodes 130429 may vary in a variety of ways. For example, in FIG. 75, electrode arrays 130431, 130433 are arranged in an overlapping tiled or rectangular pattern.

In one aspect, 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 opposite terminals of the energy source (i.e., supply terminals and return terminal). For example, in the illustrated embodiment, the first electrode array 130431 can be of a first polarity (e.g., positive polarity, or coupled to a supply terminal of a power source) and the second electrode array 130433 can be of a second polarity. polarity (e.g., negative polarity, or coupled to the return terminal of a power supply). Thus, when tissue 130410 contacts electrodes 130429 of each of opposing electrode arrays 130431, 130433, 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 arrays 130431, 130433, thereby causing the control circuit or processor to detect the presence of tissue 130410. make it possible to

As mentioned above, the activation matrix can graphically represent the presence of tissue. For example, FIG. 73 shows an activation matrix 130556 showing 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 The corresponding numbered electrodes 130429 of FIG. Activated regions 130552 indicate where there is continuity between corresponding electrodes 130429, ie, where tissue 130410 is present. In FIG. 74, the tissue 130410 is connected to the first, second, and third electrodes 130431a, 130431b, 130431c of the first electrode array 130431 and the first, second, and third electrodes of the second electrode array 130433. It is positioned in contact with electrodes 130433a, 130433b, and 130433c. Therefore, electrical continuity exists between each of these sets of electrodes of the opposing electrode arrays 130431, 130433, as current can flow between these sets of opposing electrodes. The electrodes where there is conduction due to the location of the grasped tissue 130410 are schematically illustrated by activation regions 130552 within activation matrix 130556 in FIG. 73. Additionally, the tissue 130410 is connected to 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 whether the position of the tissue within the end effector 130400 corresponds to the particular electrode 130429 with which electrical communication has been established. configured to estimate the position of tissue 130410 (since the position of electrode 130429 is known, as shown in FIG. 74), the proportion 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 that overlap and with tissue 130410 disposed between them.

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

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 is shown. Additionally, FIG. 76 shows tissue 130410 placed over second jaw 130432 and grasped by end effector 130400. In one aspect, the first electrode array 130431 is configured to transmit signals at various frequencies (e.g., non-therapeutic frequencies), and the second electrode array 130433 transmits 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 a segmented electrode array circuit 130600 as shown in FIG. include. Each bandpass filter 130601 can include one or more capacitors 130604 and one or more inductors 130606, and the number, arrangement, and value of capacitors 130604 and inductors 130606 are determined by each bandpass filter. 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 a control algorithm executed by a 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 thereby detected. be able to. In the illustrated embodiment, the electrode array 130431, 130433 includes six electrode segments 130602 arranged in a generally tiled pattern with semicircular 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 the frequency response corresponding to the tissue 130410 grasped in FIG. 76, in accordance with at least one aspect of the present disclosure. The vertical axis 130652 represents amplitude and the horizontal axis 130654 represents RF frequency. In one aspect, the second electrode array 130433 includes a first electrode circuit segment 130602a tuned to a frequency band defined by a first center frequency f _S1 (e.g., 5 MHz), a second electrode circuit segment 130602a tuned to a frequency band defined by a first 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 includes a sensing frequency range 130656 defined by f _T1 (e.g., 300 kHz) to f _T2 (e.g., 500 kHz) and/or a preferred treatment frequency (e.g., 350 kHz). A frequency range 130658 is defined. In one aspect, the center sense frequencies f _S1 , f _S2 , f _S3 , f _S4 within sense frequency range 130658 are each separated by a defined frequency value (eg, 5 MHz). Further, although sensing frequency range 130658 is shown as including four sensing frequency bands, this is for illustrative purposes only. In the illustrated example, grasped tissue 130410 is in contact with second, third, and fourth electrode circuit segments 130602b, 130602c, 130602d. Therefore, the detected frequency response includes peaks 130655b, 130655c, 130655d at each of the corresponding frequencies. Accordingly, the control algorithm can estimate the position of the tissue 130410 from the detected frequency response, i.e., the control circuitry can estimate the position of the tissue 130410 from the detected frequency response; 130602d and not other circuit segments. 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 proportion 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. The operating parameters controlled or adjusted by the adaptive ultrasonic blade control algorithm may include, for example, the amplitude of the ultrasonic blade, the control signal driving the ultrasonic transducer, the pressure applied by the clamp arm, etc. . The adaptive ultrasonic blade control algorithm may be executed by a control circuit or processor located in either the generator or the surgical instrument.

In one example, described in more detail below, an adaptive ultrasonic blade control algorithm dynamically monitors the temperature of the ultrasonic blade and provides the amplitude of the ultrasonic blade and/or the ultrasonic transducer accordingly. Adjust the signal. In another example, described in more detail below, an adaptive ultrasonic blade control algorithm dynamically monitors the ultrasonic blade temperature 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. Other techniques for determining ultrasonic blade temperature use 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, an adaptive ultrasound blade control algorithm can be configured to adjust operating parameters of the ultrasound system based on the temperature of the ultrasound blade. As mentioned above in the "Temperature Estimation" section, the natural frequency of the ultrasonic blade/transducer moves with temperature, and therefore the temperature of the ultrasonic blade depends on the voltage signal applied to drive the ultrasonic transducer. can be estimated from the phase angle between the current signal and the current signal. Furthermore, the ultrasound blade temperature corresponds to the tissue temperature. In some aspects, the adaptive ultrasonic blade control algorithm can be configured to detect 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 may correspond, for example, to the magnitude or amplitude of the current supplied to the ultrasonic transducer), applied by the clamp arm. pressure applied, etc. The adaptive ultrasonic blade control algorithm may be executed by a control circuit or processor located in either the generator or the surgical instrument.

Thus, in one aspect, the adaptive ultrasonic blade control algorithm detects the resonant frequency of the ultrasonic blade and then detects a modal shift in the resonant frequency waveform, as described above in the "Temperature Estimation" section. To do this, the resonant frequency is monitored over time. A shift in the resonant waveform can be correlated with the occurrence of system changes, such as an increase in the temperature of the ultrasonic blade. In some aspects, the adaptive ultrasound blade control algorithm can be configured to adjust the amplitude of the ultrasound drive signal, and thus the amplitude of the ultrasound blade displacement, to measure tissue temperature. In other aspects, the adaptive ultrasound blade control algorithm is configured to maintain the temperature of the ultrasound blade and/or tissue within a predetermined temperature or a predetermined threshold (e.g., when the ultrasound 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 the tissue, in order to allow the ultrasonic blade to cool in case) Can be done. In yet other aspects, the adaptive ultrasound blade control algorithm adjusts the heat flux of the ultrasound blade according to tissue impedance, tissue temperature, and/or ultrasound blade temperature, for example, to minimize temperature overshoot or adjust the ultrasound blade heat flux. The electrosurgical instrument can be configured to modulate the RF power and waveform to change the electrosurgical instrument. Further details regarding these and other features are described with reference to, for example, FIGS. 95-100.

FIG. 79 is a graphical representation 130700 of the frequency of an ultrasonic transducer system as a function of drive frequency and ultrasonic blade temperature drift, in accordance with at least one aspect of the present disclosure. Horizontal axis 130704 represents the drive frequency (e.g., Hz) applied to the ultrasound system (e.g., ultrasound transducer and/or ultrasound blade), and vertical axis 130702 represents the resulting impedance phase angle (e.g., , radian). The 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 ultrasound system increases, the characteristic waveforms of the ultrasound blade and ultrasound transducer (indicated by the first plot 130706) shift to the left, e.g. Shift to range. Due to the shift in the frequency waveform of the ultrasound system, the ultrasound system is no longer in phase when driven at the excitation frequency f _e . Rather, the resonant frequency is shifted down to f'e. Accordingly, a control circuit coupled to the ultrasound system detects changes in the ultrasound system's resonant frequency and/or detects when the ultrasound system is out of phase when driven at a previously established resonant frequency. By detecting that a temperature change in the ultrasound system can be detected or estimated.

Correspondingly, in some aspects, a control circuit coupled to the ultrasound system controls the ultrasound system by the generator according to the estimated temperature of the ultrasound system to maintain the ultrasound system in phase. The drive signal may be configured to control the applied drive signal. Maintaining the ultrasound system in phase can be utilized, for example, to control the temperature of the ultrasound system. As mentioned 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 (e.g., 55.5 kHz) at normal temperature to f'e Shift to. Therefore, when 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. For further explanation of the adaptive ultrasonic blade control algorithm, please refer to the discussion associated with FIGS. 43A-54 above.

FIG. 80 is a graphical representation 130750 of ultrasound transducer temperature as a function of time in accordance with at least one aspect of the present disclosure. The vertical axis 130752 represents the temperature of the ultrasound transducer and the horizontal axis 130754 represents time. In one aspect, when the ultrasound transducer temperature (represented by plot 130756) meets or exceeds a temperature threshold _T1 , the adaptive ultrasound blade control algorithm controls the ultrasound transducer to The temperature of the vessel is maintained below the threshold temperature _T1 . The adaptive ultrasound blade control algorithm can control the temperature of the ultrasound transducer, for example, by modulating the power and/or drive signal applied to the ultrasound transducer. Further description of algorithms and techniques for controlling the temperature of ultrasonic blades/transducers can be found in the sections "Feedback Control" and "Ultrasonic Sealing Algorithms 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," incorporated herein by reference.

FIG. 81 is a graphical representation of a modal shift in resonant frequency based on the temperature of an ultrasonic blade that shifts the resonant frequency as a function of the temperature of the ultrasonic blade, 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 ultrasound transducer drive 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). The first graph 130810 represents the frequency shift of the ultrasound system due to temperature changes. The second graph 130820 represents the current or amplitude adjustment within the ultrasound transducer to maintain stable frequency and temperature. A third graph 130830 represents temperature changes in the tissue and/or ultrasound system. 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 (e.g., the ultrasound transducer and/or the ultrasound blade) when the temperature of the ultrasound system approaches a temperature threshold _T1 . In one aspect, the control algorithm can be configured to determine that a temperature threshold T ₁ is approaching or reached according to whether the resonant frequency of the ultrasound system has decreased by a threshold Δf _R. As shown by the first graph 130800, the change in frequency threshold Δf _R corresponding to the threshold temperature T ₁ is likewise a function of the driving frequency f _D of the ultrasound system (as represented by the plot 130806). could be. As shown by the second graph 130810 and the fourth graph 130830, as the temperature of the tissue and/or ultrasound blade increases (represented by temperature plot 130836), the resonant frequency decreases accordingly ( (represented by 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 frequency change threshold Δf _R of the control algorithm; This causes the control algorithm to act to stabilize the ultrasound system temperature. By monitoring changes in the resonant frequency of the ultrasound system, the adaptive ultrasound blade control algorithm can thereby monitor the temperature of the ultrasound system. Additionally, an adaptive ultrasound blade control algorithm applies the voltage applied to the ultrasound transducer to stabilize the temperature and/or resonant frequency of the tissue and/or ultrasound blade when the temperature meets or exceeds a threshold _T1 . The ultrasonic blade may be configured to adjust (e.g., decrease) the current applied or otherwise adjust the amplitude of the ultrasonic blade (represented by current plot 130826).

In another aspect, the adaptive ultrasound blade control algorithm can be configured to adjust (e.g., decrease) the pressure applied to the tissue by the clamp arm when the temperature meets or exceeds the threshold _T1 . . In various other aspects, the adaptive ultrasound blade control algorithm can be configured to adjust various other operating parameters associated with the ultrasound 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 T ₂ may represent, for example, a melting or failure temperature of the clamp arm. Accordingly, the adaptive ultrasonic blade control algorithm can be configured to take the same or different actions according to a particular temperature threshold that is met or exceeded.

In various aspects, non-contact imaging may be used to determine the temperature of the ultrasonic blade in addition to or in place of the techniques described above. For example, shortwave thermography may be used to measure blade temperature by imaging the blade from a stationary surrounding location via a CMOS image sensor. Thermographic non-contact monitoring of the temperature of an ultrasound waveguide or blade 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 near-IR detection techniques may improve tissue and/or ultrasonic blade temperature.

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

Ultrasonic spectroscopy smart blade algorithm technology configured to drive an ultrasonic 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。

is used to estimate the condition of the jaws (clamp arm pad burn-through, staples, broken blades, bone in the jaws, tissue in the jaws, backcuts with the jaws closed, etc.) 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 within the material is measured, allowing determination of the material's complex modulus. Spectroscopy applied to ultrasound devices involves exciting the tip of an ultrasound blade with a sweep of frequencies (synthetic signal or conventional frequency sweep) and measuring the resulting complex impedance at each frequency. Complex impedance measurements of the ultrasound transducer over a range of frequencies are used in a classifier or model to estimate the properties of the ultrasound end effector. In one aspect, the present disclosure provides techniques for determining the state of ultrasound end effectors (clamp arms, jaws) to facilitate automation of ultrasound devices (e.g., power reduction to protect the device). disabling, running adaptive algorithms, retrieving information, identifying organizations, etc.).

FIG. 82 illustrates various different states and conditions of an end effector in which 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. This is the spectrum 132030 of an ultrasonic 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. has been done.

Spectral analysis of different jaw bites and equipment conditions produces different complex impedance characteristic patterns (fingerprints) over frequency ranges 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 the conditions and states of the end effector. FIG. 82 shows spectra for air 132032, clamp arm pad 132034, chamois 132036, staple 132038, and broken blade 132040. Chamois 132036 can be used to characterize different types of tissue.

The spectrum 132030 can be evaluated by applying a low power electrical signal across the ultrasound transducer to produce non-therapeutic excitation of the ultrasound blade. A low power electrical signal is calculated using FFT to determine the impedance across the ultrasound transducer in series (swept) or parallel (combined signal) frequency ranges.

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 composite Fourier series to measure .

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

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

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. 13 is a graphical representation of plot 132042 of set (S). The 3D training dataset (S) plot 132042 has phase (in radians) plotted along the x-axis, frequency (Hz) along the y-axis, and magnitude (in ohms) along the z-axis. A parametric Fourier series is fitted to a 3D training data set (S). The method for classifying the data is based on a 3D training dataset (S0 is used to generate plot 132042).

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

New points

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。

It is possible to estimate the probability of

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

Similarly, when the ultrasonic blade is likely to be in contact with the clamp arm pad (e.g., without tissue in between), or the ultrasonic blade is damaged, or the ultrasonic blade is attached to metal (e.g., staples) ), the power delivery can be reduced. Additionally, backcuts may be inhibited if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad.

Integration of other data to improve classification The system uses probability functions and Kalman filters to combine data from this process with previously described data such as sensor, user, patient metrics, environmental factors, etc. It can be used in conjunction with other information provided by. A Kalman filter determines the maximum likelihood of a state or condition occurring given excessively uncertain measurements of varying 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 the state of a jaw 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 pad 132034, chamois 132036, as shown in FIG. A reference complex impedance characteristic pattern or training data set (S) is populated that characterizes various jaw conditions, including staples 132038, broken blades 132040, and various tissue types and conditions. Full-bite or chipped, dry or wet chamois may be used to characterize different types of tissues. The data points used to generate the reference complex impedance characteristic pattern or training data set (S) are obtained by applying a subtherapeutic level drive signal to the ultrasound transducer and from below resonance to below resonance over a predetermined frequency range. Obtained by sweeping the driving 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 applied to a reference complex impedance characteristic pattern or training data set (S) is now described.

Once the reference complex impedance characteristic pattern or training data set (S) is generated, the ultrasound instrument measures new data points, classifies the new points, and combines the new data points into the reference complex impedance characteristic pattern or training data set (S). Determine whether it should be added to the set (S).

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

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

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

In one aspect, a processor or control circuit receives a reference complex impedance characteristic pattern from a database or memory coupled to the processor. In one aspect, a processor or control circuit generates a reference complex impedance characteristic pattern as follows. A drive circuit coupled to the processor or control circuit applies a non-therapeutic drive signal to the ultrasound transducer starting at an initial frequency, ending at a final frequency, and at multiple frequencies therebetween. A processor or control circuit measures the impedance of the ultrasound transducer at each frequency and stores data points corresponding to each impedance measurement. The processor or control circuit curve-fits the plurality of data points to generate 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, a processor or control circuit receives a new impedance measurement data point and uses a Euclidean vertical distance from the new impedance measurement data point to a trajectory fitted to a reference complex impedance characteristic pattern to determine the new impedance measurement data point. Classify measurement data points. A processor or control circuit estimates the probability that the new impedance measurement data point will be correctly classified. A processor or control circuit adds the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point. In one aspect, the processor or control circuit classifies the data based on a training dataset (S), the training dataset (S) includes a plurality of complex impedance measurements and is 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 condition of the 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, a timeline 5200 is shown illustrating 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 the context information that the surgical hub 106, 206 may derive from the data it receives from the data sources at each step of the surgical procedure. Time line 5200 is taken by nurses, surgeons, and other medical personnel during the course of a segmental lung resection surgery, starting with setting up the operating room and ending with transferring the patient to the post-operative recovery room. A typical process is shown below.

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

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

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

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

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

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

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

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

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

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 instrument is being fired, and therefore infers that the surgeon is in the process of dissecting 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 are completed). It can be determined that the instrument is compatible with the cutting process. In certain examples, the energy instrument may be an energy tool attached to a robotic arm of a robotic surgical system.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Example 1. Ultrasonic electromechanical systems for ultrasonic surgical instruments. The ultrasonic electromechanical system includes an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, and a control circuit coupled to the ultrasonic transducer. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. The control circuit determines a first resonant frequency of the ultrasonic electromechanical system, determines a second resonant frequency of the ultrasonic electromechanical system as the ultrasonic blade vibrates against tissue, and The tissue composition of the tissue is configured to be determined according to a comparison between the resonant frequency and the second resonant frequency.

Example 2. The ultrasonic electromechanical system of Example 1, wherein the tissue composition comprises tissue to elastin ratio.

Example 3. 3. The ultrasonic electromechanical system of Example 1 or 2, wherein the control circuit is configured to adjust operating parameters of the ultrasonic surgical instrument according to tissue composition.

Example 4. The ultrasonic electromechanical system of Example 3, wherein the operating parameter includes at least one of a tissue temperature threshold, an ultrasonic blade warming time, or an ultrasonic blade temperature threshold.

Example 5. Example 1, wherein the control circuit is configured to control the ultrasound transducer to cause the ultrasound blade to vibrate at a non-therapeutic frequency to determine a first resonant frequency and a second resonant frequency. The ultrasonic electromechanical system according to any one of items 1 to 4.

Example 6. 6. The ultrasonic electromechanical system of any one of Examples 1-5, further comprising a memory coupled to the control circuit. The memory stores multiple tissue compositions according to the resonant frequency shift. The control circuit is configured to determine a tissue composition of the tissue by retrieving from memory which of the plurality of tissue compositions corresponds to a difference between the first resonant frequency and the second resonant frequency. It is configured.

Example 7. A control circuit applies a drive signal to the ultrasonic transducer at a plurality of frequencies over a frequency range, a first one according to a frequency within a frequency range in which the voltage and current signals of the ultrasonic electromechanical system resulting from the drive signal are in phase. The ultrasonic electromechanical system according to any one of Examples 1 to 6, configured to determine a resonant frequency or a second resonant frequency of the ultrasonic electromechanical system.

Example 8. An ultrasonic generator connectable to an ultrasonic electromechanical system comprising an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade. The ultrasound generator includes a control circuit coupled to the ultrasound transducer. The control circuit applies a drive signal to the ultrasound transducer to cause the ultrasound transducer to vibrate the ultrasound blade, determine a first resonant frequency of the ultrasound electromechanical system, and cause the ultrasound blade to strike the tissue. and configured to determine a second resonant frequency of the ultrasonic electromechanical system when vibrating with the ultrasonic electromechanical system, and to determine a tissue composition of the tissue according to a comparison between the first resonant frequency and the second resonant frequency. ing.

Example 9. The ultrasound generator of Example 8, wherein the tissue composition comprises tissue to elastin ratio.

Example 10. 10. The ultrasound generator of example 8 or 9, wherein the control circuit is configured to adjust operating parameters of the ultrasound electromechanical system according to tissue composition.

Example 11. The ultrasound generator of Example 10, wherein the operating parameter includes at least one of a tissue temperature threshold, an ultrasound blade warming time, or an ultrasound blade temperature threshold.

Example 12. Example 8, wherein the control circuit is configured to control the ultrasound transducer to cause the ultrasound blade to vibrate at a non-therapeutic frequency to determine a first resonant frequency and a second resonant frequency. The ultrasonic generator according to any one of items 1 to 11.

Example 13. The ultrasonic generator according to any one of Examples 8-12, further comprising a memory coupled to the control circuit. The memory stores multiple tissue compositions according to the resonant frequency shift. The control circuit is configured to determine a tissue composition of the tissue by retrieving from memory which of the plurality of tissue compositions corresponds to a difference between the first resonant frequency and the second resonant frequency. It is configured.

Example 14. A control circuit applies a drive signal to the ultrasonic transducer at a plurality of frequencies over a frequency range, a first one according to a frequency within a frequency range in which the voltage and current signals of the ultrasonic electromechanical system resulting from the drive signal are in phase. The ultrasonic generator according to any one of Examples 8 to 13, configured to determine the resonant frequency or the second resonant frequency of the ultrasonic generator.

Example 15. an end effector comprising an ultrasound blade, an ultrasound transducer acoustically coupled to the ultrasound blade, an infrared source configured to radiate infrared energy to tissue within the end effector, and an infrared detector; an ultrasonic surgical instrument comprising: an ultrasonic transducer and a control circuit coupled to an infrared detector. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal. The control circuit is configured to receive infrared energy reflected by the tissue via the infrared detector and to determine a tissue composition of the tissue according to the reflected infrared energy.

Example 16. The ultrasonic surgical instrument of Example 15, wherein the tissue composition comprises tissue to elastin ratio.

Example 17. 17. The ultrasonic surgical instrument of Example 15 or 16, wherein the control circuit is further configured to adjust operating parameters of the ultrasonic surgical instrument according to tissue composition.

Example 18. 18. The ultrasonic surgical instrument of Example 17, wherein the operating parameter includes at least one of a tissue temperature threshold, an ultrasonic blade warming time, or an ultrasonic blade temperature threshold.

Example 19. 19. The ultrasonic surgical instrument of any one of Examples 15-18, further comprising a memory coupled to the control circuit. The memory stores multiple tissue compositions according to the reflected infrared energy. The control circuit is configured to determine the tissue composition of the tissue by retrieving from the memory which of the plurality of tissue compositions corresponds to the reflected infrared energy.

Example 20. Examples 15-19, wherein the end effector further comprises a clamp arm pivotally movable with respect to the ultrasonic blade, and at least one of an infrared source and an infrared detector is disposed on the clamp arm. The ultrasonic surgical instrument according to any one of .

[Mode of implementation]
(1) An ultrasonic electromechanical system for an ultrasonic surgical instrument, the system comprising:
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 ultrasound transducer, the control circuit comprising:
determining a first resonant frequency of the ultrasonic electromechanical system;
determining a second resonant frequency of the ultrasonic electromechanical system when the ultrasonic blade vibrates against tissue; and according to a comparison between the first resonant frequency and the second resonant frequency; An ultrasound electromechanical system configured to determine tissue composition of the tissue.
(2) The ultrasonic electromechanical system of embodiment 1, wherein the tissue composition comprises a tissue to elastin ratio.
(3) The ultrasonic electromechanical system of embodiment 1, wherein the control circuit is configured to adjust operating parameters of the ultrasonic surgical instrument according to the tissue composition.
(4) The ultrasonic electromechanical system of embodiment 3, wherein the operating parameter includes at least one of a tissue temperature threshold, a warming time of the ultrasonic blade, or an ultrasonic blade temperature threshold.
(5) the control circuit controls the ultrasonic transducer to vibrate the ultrasonic blade at a non-therapeutic frequency to determine the first resonant frequency and the second resonant frequency; The ultrasonic electromechanical system of embodiment 1, wherein the ultrasonic electromechanical system is configured.

(6) further comprising a memory coupled to the control circuit, the memory storing a plurality of tissue compositions according to a resonant frequency shift;
The control circuit is configured to adjust the composition of the tissue by retrieving from the memory which of the plurality of tissue compositions corresponds to a difference between the first resonant frequency and the second resonant frequency. 5. The ultrasound electromechanical system of embodiment 1, configured to determine tissue composition.
(7) The control circuit,
applying the drive signal to the ultrasonic transducer at a plurality of frequencies over a frequency range, and according to a frequency within the frequency range at which voltage and current signals of the ultrasonic electromechanical system resulting from the drive signal are in phase. , the ultrasonic electromechanical system of embodiment 1, configured to determine the first resonant frequency or the second resonant frequency.
(8) An ultrasonic generator connectable to an ultrasonic electromechanical system comprising an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade, the ultrasonic generator comprising: ,
a control circuit coupled to the ultrasound transducer, the control circuit comprising:
applying a drive signal to the ultrasonic transducer to cause the ultrasonic transducer to vibrate the ultrasonic blade;
determining a first resonant frequency of the ultrasonic electromechanical system;
determining a second resonant frequency of the ultrasonic electromechanical system as the ultrasonic blade vibrates against tissue; and according to a comparison between the first resonant frequency and the second resonant frequency. , an ultrasound generator configured to determine a tissue composition of the tissue.
(9) The ultrasound generator of embodiment 8, wherein the tissue composition includes tissue to elastin ratio.
10. The ultrasound generator of embodiment 8, wherein the control circuit is configured to adjust operating parameters of the ultrasound surgical electromechanical system according to the tissue composition.

(11) The ultrasound generator according to embodiment 10, wherein the operating parameter includes at least one of a tissue temperature threshold, a heating time of the ultrasound blade, or an ultrasound blade temperature threshold.
(12) the control circuit controls the ultrasonic transducer to vibrate the ultrasonic blade at a non-therapeutic frequency to determine the first resonant frequency and the second resonant frequency; 9. The ultrasonic generator of embodiment 8, comprising:
(13) further comprising a memory coupled to the control circuit, the memory storing a plurality of tissue compositions according to a resonant frequency shift;
The control circuit is configured to adjust the composition of the tissue by retrieving from the memory which of the plurality of tissue compositions corresponds to a difference between the first resonant frequency and the second resonant frequency. 9. The ultrasound generator of embodiment 8, configured to determine tissue composition.
(14) The control circuit,
applying the drive signal to the ultrasonic transducer at a plurality of frequencies over a frequency range, and according to a frequency within the frequency range at which voltage and current signals of the ultrasonic electromechanical system resulting from the drive signal are in phase. 9. The ultrasound generator of embodiment 8, wherein the ultrasound generator is configured to determine the first resonant frequency or the second resonant frequency.
(15) An ultrasonic surgical instrument,
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;
an infrared source configured to emit infrared energy to tissue within the end effector;
an infrared detector,
a control circuit coupled to the ultrasound transducer and the infrared detector, the control circuit comprising:
An ultrasonic surgical instrument configured to receive infrared energy reflected by the tissue via the infrared detector, and to determine a tissue composition of the tissue according to the reflected infrared energy.

16. The ultrasonic surgical instrument of embodiment 15, wherein the tissue composition comprises tissue to elastin ratio.
17. The ultrasonic surgical instrument of embodiment 15, wherein the control circuit is further configured to adjust operating parameters of the ultrasonic surgical instrument according to the tissue composition.
18. The ultrasonic surgical instrument of embodiment 17, wherein the operating parameter includes at least one of a tissue temperature threshold, a warming time of the ultrasonic blade, or an ultrasonic blade temperature threshold.
(19) further comprising a memory coupled to the control circuit, the memory storing a plurality of tissue compositions according to reflected infrared energy;
the control circuit is configured to determine the tissue composition of the tissue by retrieving from the memory which of the plurality of tissue compositions corresponds to the reflected infrared energy; An ultrasonic surgical instrument according to embodiment 15.
(20) The end effector further includes a clamp arm that is pivotably movable with respect to the ultrasonic blade,
16. The ultrasonic surgical instrument of embodiment 15, wherein at least one of the infrared source and the infrared detector is disposed on the clamp arm.

Claims (6)

An ultrasonic surgical instrument,
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;
an infrared source configured to emit infrared energy to tissue within the end effector;
an infrared detector,
a control circuit coupled to the ultrasound transducer and the infrared detector, the control circuit comprising:
An ultrasonic surgical instrument configured to receive infrared energy reflected by the tissue via the infrared detector, and to determine a tissue composition of the tissue according to the reflected infrared energy. The ultrasonic surgical instrument of claim 1, wherein the tissue composition comprises tissue to elastin ratio. The ultrasonic surgical instrument of claim 1, wherein the control circuit is further configured to adjust operating parameters of the ultrasonic surgical instrument according to the tissue composition. The ultrasonic surgical instrument of claim 3, wherein the operating parameter includes at least one of a tissue temperature threshold, a warming time of the ultrasonic blade, or an ultrasonic blade temperature threshold. further comprising a memory coupled to the control circuit, the memory storing a plurality of tissue compositions according to reflected infrared energy;
the control circuit is configured to determine the tissue composition of the tissue by retrieving from the memory which of the plurality of tissue compositions corresponds to the reflected infrared energy; The ultrasonic surgical instrument of claim 1. the end effector further comprising a clamp arm pivotally movable with respect to the ultrasonic blade;
The ultrasonic surgical instrument of claim 1, wherein at least one of the infrared source and the infrared detector is disposed on the clamp arm.

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