CN111526816B

CN111526816B - Detecting presence of end effector in liquid

Info

Publication number: CN111526816B
Application number: CN201880084539.6A
Authority: CN
Inventors: F·E·谢尔顿四世; J·D·梅瑟利; J·L·哈里斯; D·C·耶茨; A·S·索奈伊; S·M·鲁克; B·D·布莱克; E·M·罗伯逊
Original assignee: Ethicon LLC
Current assignee: Ethicon LLC
Priority date: 2017-12-28
Filing date: 2018-10-12
Publication date: 2024-03-08
Anticipated expiration: 2038-10-12
Also published as: BR112020013057B1; WO2019130110A1; CN111526816A; JP2021509046A; BR112020013057A2; JP7391852B2

Abstract

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

Description

Detecting presence of end effector in liquid

Cross Reference to Related Applications

This patent application claims priority from U.S. provisional patent application 62/721,995 entitled control of ultrasonic surgical instruments (CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION) according to tissue location, filed on publication No. 35, clause 119 (e), clause 2018, 8, 23, the disclosure of which is incorporated herein by reference in its entirety.

This patent application claims priority from U.S. provisional patent application 62/721,998 entitled situation awareness (SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS) to electrosurgical System filed on day 23, 8, 35 of the United states code, clause 119 (e), which is incorporated herein by reference in its entirety.

This patent application claims priority from U.S. provisional patent application 62/721,999 entitled energy interruption due to unintentional capacitive COUPLING (INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING), filed on clause 119 (e) of the united states code, volume 35, the disclosure of which is incorporated herein by reference in its entirety.

This patent application claims priority from U.S. provisional patent application 62/721,994 entitled bipolar combination device (BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY) for automatically adjusting pressure based on energy modality, filed on even date 8, 23, clause 119 (e) of the united states code, volume 35, the disclosure of which is incorporated herein by reference in its entirety.

This patent application claims priority from U.S. provisional patent application 62/721,996 entitled RADIO FREQUENCY energy device (RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS) for delivering combined electrical signals, filed on clause 119 (e) of the united states code, 35, the disclosure of which is incorporated herein by reference in its entirety.

The present patent application also requires priority from U.S. provisional patent application 62/692,747 entitled intelligent energy device (SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE) filed on U.S. provisional patent application 62/692,748 entitled intelligent energy ARCHITECTURE (SMART ENERGY architure) filed on U.S. provisional patent application 62/692,748 entitled intelligent energy device (SMART ENERGY DEVICES) filed on U.S. edition of act 35, clause 119 (e), 30, and U.S. provisional patent application 62/692,768 filed on U.S. edition of act 6, 30, each of which is incorporated herein by reference in its entirety.

The present patent application also requires the benefit of the priority of U.S. provisional patent application Ser. No. 62/640,417, entitled ultrasonic device temperature control, filed on U.S. code 35, clause 119 (e), and U.S. provisional patent application Ser. No. 62/640,415, entitled control System (TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR) therefor, filed on U.S. code 35, and U.S. provisional patent application Ser. No. 62/640,415, entitled control System (ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR) therefor, each of which is incorporated herein by reference in its entirety.

The present patent application also claims the benefit of U.S. provisional patent application serial No. 62/650,898, filed on U.S. code 35, clause 119 (e), entitled capacitive coupled return path pad with SEPARABLE array elements (CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS), U.S. provisional patent application serial No. 62/650,887, filed on 3, 30, 2018, entitled SURGICAL system with optimized sensing capability (surgecal SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES), U.S. provisional patent application serial No. 62/650,882, 882, filed on 3, 30, 2018, entitled smoke evacuation module (SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) for an interactive SURGICAL platform, filed on 3, 30, 2018, entitled SURGICAL smoke sensing and control (SURGICAL SMOKE EVACUATION SENSING AND control), the disclosure of each of these provisional patent applications being incorporated herein by reference in its entirety.

The present patent application also claims the benefit of priority from U.S. provisional patent application Ser. No. 62/611,341, filed on U.S. code 35, clause 119 (e), and entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM) at 12, 28, and U.S. provisional patent application Ser. No. 62/611,340, filed on 12, 28, and entitled robotic assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM) at 35, filed on 28, and entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS), the disclosure of each of which is incorporated herein by reference in its entirety.

Background

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

Drawings

The features of the various aspects are particularly described in the appended claims. However, various aspects (both as to the surgical organization and method) and further objects and advantages thereof may best be understood by reference to the following description taken in conjunction with the accompanying drawings.

Fig. 1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.

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

Fig. 3 is a surgical hub paired with a visualization system, robotic system, and intelligent instrument, in accordance with at least one aspect of the present disclosure.

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

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

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

Fig. 7 illustrates a vertical modular housing configured to house a plurality of modules in accordance with at least one aspect of the present disclosure.

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

Fig. 9 is a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.

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

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

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

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

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

Fig. 15 illustrates 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.

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

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

Fig. 18 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure.

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

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

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

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

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

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

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

Fig. 26 is a structural view of a generator architecture in accordance with at least one aspect of the present disclosure.

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

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

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

Fig. 30 is a schematic diagram of a transformer coupled to the ultrasound drive circuit shown in fig. 29 in accordance with at least one aspect of the present disclosure.

Fig. 31 is a schematic diagram of the transformer shown in fig. 30 coupled to a test circuit in accordance with at least one aspect of the present disclosure.

Fig. 32 is a schematic diagram of a control circuit in accordance with at least one aspect of the present disclosure.

Fig. 33 illustrates a simplified circuit block diagram illustrating another circuit included within a modular ultrasonic surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 34 illustrates a generator circuit divided into a plurality of stages in accordance with at least one aspect of the present disclosure.

Fig. 35 illustrates a generator circuit divided into multiple stages, where a first stage circuit is common to a second stage circuit, in accordance with at least one aspect of the present disclosure.

Fig. 36 is a schematic diagram of one aspect of a drive circuit configured to drive high frequency current (RF) in accordance with at least one aspect of the present disclosure.

Fig. 37 is a schematic diagram of a transformer coupled to the RF drive circuit shown in fig. 34 in accordance with at least one aspect of the present disclosure.

Fig. 38 is a schematic diagram of a circuit including separate power sources for a high power energy/drive circuit and a low power circuit according to one aspect of the present disclosure.

Fig. 39 illustrates a control circuit that allows the dual generator system to switch between the RF generator and ultrasound generator energy modes of the surgical instrument.

FIG. 40 illustrates a schematic view of one aspect of a surgical instrument including a feedback system for use with the surgical instrument in accordance with one aspect of the present disclosure.

Fig. 41 illustrates one aspect of a basic architecture of a digital synthesis circuit, such as a Direct Digital Synthesis (DDS) circuit, configured to generate a plurality of wave shapes for electrical signal waveforms in a surgical instrument, in accordance with at least one aspect of the present disclosure.

Fig. 42 illustrates one aspect of a Direct Digital Synthesis (DDS) circuit configured to generate a plurality of wave shapes for an electrical signal waveform in a surgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 43 illustrates one cycle of a discrete-time digital electrical signal according to at least one aspect of the present disclosure according to an analog waveform (shown superimposed on a discrete-time digital electrical signal waveform for comparison purposes) in accordance with at least one aspect of the present disclosure.

Fig. 44 is an illustration of a control system configured to provide progressive closure of a closure member as the closure member advances distally to close a clamp arm to apply a closure force load at a desired rate, in accordance with an aspect of the present disclosure.

FIG. 45 illustrates a proportional-integral-derivative (PID) controller feedback control system according to an aspect of the disclosure.

Fig. 46 is an exploded front view of a modular hand-held ultrasonic surgical instrument showing the left housing half removed from the handle assembly, exposing a device identifier communicatively coupled to the multi-lead handle terminal assembly, in accordance with one aspect of the present disclosure.

Fig. 47 is a detailed view of the trigger portion and switch of the ultrasonic surgical instrument shown in fig. 46 in accordance with at least one aspect of the present disclosure.

Fig. 48 is an enlarged partial perspective view of an end effector from a distal end having jaw members in an open position in accordance with at least one aspect of the present disclosure.

Fig. 49 is a system diagram of a segmented circuit including a plurality of independently operated circuit segments in accordance with at least one aspect of the present disclosure.

Fig. 50 is a circuit diagram of various components of a surgical instrument having a motor control function in accordance with at least one aspect of the present disclosure.

FIG. 51 illustrates one aspect of an end effector including an RF data sensor coupled to a jaw member in accordance with at least one aspect of the present disclosure.

Fig. 52 illustrates one aspect of the flexible circuit shown in fig. 51, wherein a sensor may be mounted to or integrally formed with the flexible circuit, in accordance with at least one aspect of the present disclosure.

Fig. 53 is an alternative system for controlling the frequency and detecting the impedance of an ultrasonic electro-mechanical system in accordance with at least one aspect of the present disclosure.

FIG. 54 is a spectrum of the same ultrasonic device with multiple different states and conditions of an end effector in accordance with at least one aspect of the present disclosure, wherein the phase and magnitude of the impedance of the ultrasonic transducer are plotted as a function of frequency.

Fig. 55 is a graphical representation of a set of graphs of 3D training data S in which ultrasound transducer impedance magnitude and phase are plotted as a function of frequency in accordance with at least one aspect of the present disclosure.

Fig. 56 is a logic flow diagram depicting a control program or logic configuration for determining jaw condition based on complex impedance feature patterns (fingerprints), in accordance with at least one aspect of the present disclosure.

Fig. 57 is a circular graph of complex impedance plotted as a relationship between an imaginary component and a real component of a piezoelectric vibrator in accordance with at least one aspect of the present disclosure.

Fig. 58 is a circular graph of complex admittances plotted as a relationship between imaginary and real components of a piezoelectric vibrator in accordance with at least one aspect of the present disclosure.

Fig. 59 is a circular graph of the complex admittance of a 55.5kHz ultrasonic piezoelectric transducer.

Fig. 60 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure, showing an impedance/admittance circle graph for an open jaw and no-load ultrasound device, with red depicting admittance and blue depicting impedance.

Fig. 61 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure, showing an impedance/admittance circle of an ultrasound device with jaws clamped on a dry antelope skin, wherein red depicts admittance and blue depicts impedance.

Fig. 62 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure, showing an impedance/admittance circle of an ultrasonic device with a jaw tip clamped on a moist antelope skin, wherein red depicts admittance and blue depicts impedance.

Fig. 63 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure, showing an impedance/admittance circle of an ultrasound device with jaws fully clamped on a wet antelope skin, wherein red depicts admittance and blue depicts impedance.

Fig. 64 is a graphical display of an impedance analyzer in accordance with at least one aspect of the present disclosure, showing impedance/admittance plots in which frequencies are swept from 48kHz to 62kHz to capture multiple resonances of an ultrasound device with jaws open, with gray coverage helping to see circles.

Fig. 65 is a logic flow diagram depicting a process of a control program or logic configuration for determining jaw condition based on an estimate of the radius and offset of an impedance/admittance circle in accordance with at least one aspect of the present disclosure.

66A-66B are complex impedance spectra of the same ultrasonic device with cold (blue) and warm (red) ultrasonic blades in accordance with at least one aspect of the present disclosure, wherein

FIG. 66A is a graphical representation of impedance phase angle as a function of resonant frequency for the same ultrasonic device with cold (blue) and warm (red) ultrasonic blades; and is also provided with

Fig. 66B is a graphical representation of impedance magnitude as a function of resonant frequency for the same ultrasonic device with a cold (blue) and warm (red) ultrasonic blade.

Fig. 67 is a schematic diagram of a kalman filter that improves a temperature estimator and a state space model based on impedance across an ultrasound transducer measured at multiple frequencies, in accordance with at least one aspect of the present disclosure.

Fig. 68 is three probability distributions employed by the state estimator of the kalman filter shown in fig. 67 to maximize the estimation in accordance with at least one aspect of the present disclosure.

FIG. 69A is a graphical representation of temperature versus time for an ultrasonic device that reached a maximum temperature of 490℃ without temperature control.

Fig. 69B is a graphical representation of temperature versus time of an ultrasound device reaching a maximum temperature of 320 ℃ with temperature control in accordance with at least one aspect of the present disclosure.

FIGS. 70A-70B are graphical representations of adjusting ultrasonic power applied to an ultrasonic transducer to put feedback control upon detection of a sudden drop in temperature of an ultrasonic blade, wherein

FIG. 70A is a graphical representation of ultrasonic power as a function of time; and is also provided with

FIG. 70B is a graph of ultrasonic blade temperature as a function of time in accordance with at least one aspect of the present disclosure.

Fig. 71 is a logic flow diagram depicting a process of controlling a control program or logic configuration of the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure.

Fig. 72 is a timeline depicting situational awareness of a surgical hub in accordance with at least one aspect of the present disclosure.

Fig. 73 illustrates an end effector of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 74 is a graph depicting amplitude versus time of a treatment cycle generated by a transducer of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 75A illustrates various stages of closure of the end effector of fig. 73.

Fig. 75B illustrates various stages of closure of the end effector of fig. 73.

Fig. 76 is a logic flow diagram depicting a process for selecting a control program or logic configuration for an energy operation mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 77 is a logic flow diagram depicting a process for selecting a control program or logic configuration for an energy operation mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 78 is a logic flow diagram depicting a process for selecting a control program or logic configuration for an energy operation mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 78A is a schematic of a tissue contacting circuit showing the completion of the circuit to a pair of spaced apart contact plates upon contact with tissue.

Fig. 79 is a logic flow diagram depicting a process for selecting a control program or logic configuration for an energy operation mode of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 80 is a schematic diagram illustrating a control circuit including an absolute positioning system in accordance with at least one aspect of the present disclosure.

Fig. 81 is a logic flow diagram depicting a process of a control program or logic configuration for switching between energy operation modes of an electrosurgical instrument in accordance with at least one aspect of the present disclosure.

Fig. 82 is a logic flow diagram depicting a process for adjusting a control program or logic configuration of energy delivered to tissue clamped by an end effector of an electrosurgical instrument and energy delivered to a motor of the electrosurgical instrument based on predetermined thresholds of monitored parameters in accordance with at least one aspect of the present disclosure.

Fig. 83 is a logic flow diagram depicting a process for adjusting control programs or logic configurations of different electromechanical systems of an ultrasonic surgical instrument based on predetermined thresholds of monitored parameters in accordance with at least one aspect of the present disclosure.

FIG. 84 is a graph representing tissue impedance (Z), power (P), and force (F) at a distal portion (tip) of an end effector of an electrosurgical instrument clamping tissue plotted on the Y-axis versus time (t) on the X-axis in accordance with at least one aspect of the present invention.

Fig. 85 is a graph showing power (P) as a function of time (t) in a diagnostic mode (upper graph) and a response mode (lower graph).

Fig. 86 is a logic flow diagram depicting a process of detecting and compensating for a control program or logic configuration of an ultrasonic blade immersed in a liquid in accordance with at least one aspect of the present disclosure.

FIG. 87 depicts a graphical representation of power (p) delivered to an end effector and tissue temperature as a function of closure driver displacement in accordance with at least one aspect of the present disclosure.

Fig. 88 is a logic flow diagram depicting a process of detecting and compensating for a control program or logic configuration of an ultrasonic blade immersed in a liquid in accordance with at least one aspect of the present disclosure.

Fig. 89 is a graph including four curves, wherein a first curve from the top represents voltage (V) and current (I) versus time (T), a second curve represents power (P) versus time (T), a third curve represents temperature (T) versus time (T), and a fourth curve represents tissue impedance (Z) versus time (T), in accordance with at least one aspect of the present disclosure.

Fig. 90 is a logic flow diagram depicting a process of a control program or logic configuration for stepping up a voltage (V) toward the end of a tissue treatment cycle applied to tissue by an end effector of an electrosurgical instrument using a value of tissue impedance (Z) as a trigger condition in accordance with at least one aspect of the present disclosure.

Fig. 91 is a logic flow diagram depicting a process of a control program or logic configuration for stepping up a voltage (V) toward the end of a tissue treatment cycle applied to tissue by an end effector of an electrosurgical instrument using a value of tissue temperature (T) as a trigger condition in accordance with at least one aspect of the present disclosure.

Fig. 92 is a logic flow diagram depicting a process for adjusting a control program or logic configuration of a power (P) of an RF component of a combined device based on a temperature (T) monitored by an ultrasonic component of the combined device in accordance with at least one aspect of the present disclosure.

Fig. 93 is a graph including three curves, wherein a first curve from the top represents power (P) delivered to tissue captured between jaws of a bipolar RF component of a combination device, wherein a second curve represents tissue temperature measured by an ultrasound component of the combination device, and wherein a third curve represents dual non-therapeutic frequencies used by the ultrasound component to determine tissue temperature, in accordance with at least one aspect of the present disclosure.

Fig. 94 is a logic flow diagram depicting a process for actively adjusting a control program or logic configuration of a frequency of an RF waveform of an RF component of an RF electrosurgical instrument or combination device based on measured tissue impedance in accordance with at least one aspect of the present disclosure.

Disclosure of Invention

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

In various embodiments, a surgical instrument is disclosed that includes an end effector that includes an ultrasonic blade and a clamp arm. The clamping arm is movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamping arm. The surgical instrument further includes an ultrasonic transducer configured to generate an ultrasonic energy output, a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade, and a drive member configured to actuate movement of the clamp arm to transition the end effector to the closed configuration. The surgical instrument further includes a control circuit configured to monitor a position of the drive member, monitor a temperature of the ultrasonic blade, and prevent the temperature from exceeding a predetermined threshold prior to the closed configuration.

In various embodiments, a surgical instrument is disclosed that includes an end effector that includes a first jaw and a second jaw. The second jaw is movable relative to the first jaw to transition the end effector between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw. The end effector further includes an ultrasonic component configured to deliver ultrasonic energy to the grasped tissue and a Radio Frequency (RF) component configured to deliver RF energy to the grasped tissue. The surgical instrument further includes control circuitry configured to operate the ultrasonic component in a non-therapeutic diagnostic mode while operating the RF component in a therapeutic mode to treat the grasped tissue.

Detailed Description

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

U.S. patent application Ser. No. END8536USNP2/180107-2 entitled estimated state of an ultrasonic END effector and control system therefor (ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR);

U.S. patent application Ser. No. END8560USNP2/180106-2 entitled ultrasonic END effector temperature control and control system (TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR);

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

U.S. patent application Ser. No. END8563USNP1/180139-1 entitled control of an ultrasonic surgical instrument according to tissue location (CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION);

U.S. patent application Ser. No. END8563USNP2/180139-2 entitled control OF the activation OF an ultrasonic surgical instrument according to the presence OF TISSUE (CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE);

U.S. patent application Ser. No. END8563USNP3/180139-3, entitled determination of tissue composition via ultrasound System (DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM);

U.S. patent application Ser. No. END8563USNP4/180139-4 entitled determining the status of an ultrasonic electro-mechanical system based on frequency shift (DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT);

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

U.S. patent application Ser. No. END8564USNP1/180140-1 entitled situation awareness of electrosurgical systems (SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS);

U.S. patent application Ser. No. END8564USNP2/180140-2 entitled mechanism (MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT) for controlling different electromechanical systems of an electrosurgical instrument;

U.S. patent application Ser. No. END8565USNP1/180142-1 entitled energy interruption due to improper capacitive COUPLING (INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING);

U.S. patent application Ser. No. END8565USNP2/180142-2, entitled increasing radio frequency to generate a non-PAD monopole loop (PAD-LESS);

U.S. patent application Ser. No. END8566USNP1/180143-1 entitled bipolar combination device (BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY) for automatically adjusting pressure based on energy modality; and

U.S. patent application Ser. No. END8573USNP1/180145-1, titled ACTIVATION energy device (ACTIVATION OF ENERGY DEVICES).

The applicant of the present patent application owns the following U.S. patent applications filed on date 2018, 8, 23, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application 62/721,995 entitled control of an ultrasonic surgical instrument (CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION) according to tissue location;

U.S. provisional patent application 62/721,998 entitled situation awareness of electrosurgical systems (SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS);

U.S. provisional patent application 62/721,999 entitled energy interruption due to unintentional capacitive COUPLING (INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING);

U.S. provisional patent application 62/721,994 entitled bipolar combination device (BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY) for automatically adjusting pressure based on energy modality; and

U.S. provisional patent application 62/721,996 entitled RADIO FREQUENCY energy device (RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS) for delivering combined electrical signals.

The applicant of the present patent application owns the following U.S. patent applications filed on date 30 of 2018, 6, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application 62/692,747 entitled intelligent activation of an energy device by another device (SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE);

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

U.S. provisional patent application 62/692,768 entitled intelligent energy device (SMART ENERGY DEVICES).

The applicant of the present patent application owns the following U.S. patent applications filed on date 29 of 2018, 6, the disclosures of each of which are incorporated herein by reference in their entirety:

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

U.S. patent application Ser. No. 16/024,057, entitled control of surgical instruments (CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS) based on sensed closure parameters;

U.S. patent application Ser. No. 16/024,067, entitled System (SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION) for adjusting end effector parameters based on information during surgery;

U.S. patent application Ser. No. 16/024,075 entitled safety System for Intelligent powered surgical stapling (SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING);

U.S. patent application Ser. No. 16/024,083 entitled safety System for Intelligent powered surgical stapling (SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING);

U.S. patent application Ser. No. 16/024,094 entitled surgical System (SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES) for detecting end effector tissue maldistribution;

U.S. patent application Ser. No. 16/024,138, entitled system (SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE) for detecting the proximity of a surgical end effector to cancerous tissue;

U.S. patent application Ser. No. 16/024,150, entitled surgical instrument cartridge sensor assembly (SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES);

U.S. patent application Ser. No. 16/024,160, entitled variable output cartridge sensor assembly (VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY);

U.S. patent application Ser. No. 16/024,124, entitled surgical instrument (SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE) with flexible electrode;

U.S. patent application Ser. No. 16/024,132 entitled surgical instrument (SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT) with flexible circuit;

U.S. patent application Ser. No. 16/024,141, entitled surgical instrument (SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY) with tissue marking assembly;

U.S. patent application Ser. No. 16/024,162 entitled SURGICAL System with priority data transmission capability (SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES);

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

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

U.S. patent application Ser. No. 16/024,116, entitled surgical drainage flow path (SURGICAL EVACUATION FLOW PATHS);

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

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

U.S. patent application serial No. 16/024,245, entitled delivery of smoke evacuation system parameters to a hub or cloud (COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) in a smoke evacuation module for an interactive surgical platform;

U.S. patent application Ser. No. 16/024,258 entitled smoke evacuation system (SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM) including a segmented control circuit for an interactive surgical platform;

U.S. patent application Ser. No. 16/024,265 entitled surgical drainage system (SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE) with communication circuitry for communication between a filter and a fume extractor; and

U.S. patent application Ser. No. 16/024,273, entitled DUAL tandem large DROPLET filter and small DROPLET filter (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS).

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

U.S. provisional patent application Ser. No. 62/691,228 entitled method (A Method of using reinforced flex circuits with multiple sensors with electrosurgical devices) of using an enhanced flex circuit with multiple sensors with electrosurgical devices;

U.S. provisional patent application Ser. No. 62/691,227, entitled control of a surgical instrument (controlling a surgical instrument according to sensed closure parameters) based on sensed closure parameters;

U.S. provisional patent application Ser. No. 62/691,230 entitled surgical instrument (SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE) with flexible electrode;

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

U.S. provisional patent application serial No. 62/691,257 entitled delivery of smoke evacuation system parameters to a hub or cloud (COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) in a smoke evacuation module for an interactive surgical platform;

U.S. provisional patent application serial No. 62/691,262 entitled surgical evacuation system (SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE) having communication circuitry for communication between the filter and the fume extractor; and

U.S. provisional patent application Ser. No. 62/691,251, entitled DUAL serial large DROPLET filter and small DROPLET filter (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on date 19 of 2018, 4, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application Ser. No. 62/659,900, entitled hub communication method (METHOD OF HUB COMMUNICATION).

The applicant of the present patent application owns the following U.S. provisional patent applications filed on 3.30.2018, the disclosures of each of which are incorporated herein by reference in their entirety:

U.S. provisional patent application 62/650,898 filed on 3/30 of 2018, entitled capacitively coupled return path pad with SEPARABLE array elements (CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS);

U.S. provisional patent application Ser. No. 62/650,887 entitled SURGICAL System with optimized sensing capability (SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES);

U.S. patent application Ser. No. 62/650,882, entitled smoke evacuation module (SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM) for an interactive surgical platform; and

U.S. patent application Ser. No. 62/650,877, entitled surgical smoke sensing and control (SURGICAL SMOKE EVACUATION SENSING AND CONTROL).

The applicant of the present patent application owns the following U.S. patent applications filed on the date 29 of 3.2018, the disclosures of each of which are incorporated herein by reference in their entirety:

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

U.S. patent application Ser. No. 15/940,648 entitled interactive surgical System (INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA Capobilities) with conditional processing apparatus and data CAPABILITIES;

U.S. patent application Ser. No. 15/940,656 entitled surgical hub coordination of operating room device control and communication (SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES);

U.S. patent application Ser. No. 15/940,666 entitled spatial perception of surgical hubs in operating theatres (SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS);

U.S. patent application Ser. No. 15/940,670, entitled cooperative utilization of data exported from a secondary source by a smart surgical hub (COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS);

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

U.S. patent application Ser. No. 15/940,632, entitled data stripping method (DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD) for querying patient records for data and creating anonymous records;

U.S. patent application Ser. No. 15/940,640 entitled communication hub and storage device (COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS) for storing parameters and conditions of surgical devices to be shared with CLOUD-BASED analysis systems;

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

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

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

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

U.S. patent application Ser. No. 15/940,668 entitled aggregation and reporting of surgical hub data (AGGREGATION AND REPORTING OF SURGICAL HUB DATA);

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

U.S. patent application Ser. No. 15/940,686, entitled TO display alignment of staple cartridge with previous linear staple lines (DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE);

U.S. patent application Ser. No. 15/940,700, entitled sterile field interactive CONTROL display (STERILE FIELD INTERACTIVE CONTROL display);

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

U.S. patent application Ser. No. 15/940,704, entitled determination OF the characteristics OF backscattered light using laser and red-GREEN-blue color development (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT);

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

U.S. patent application Ser. No. 15/940,742, entitled Dual Complementary Metal Oxide Semiconductor (CMOS) array imaging (DUAL CMOS ARRAY IMAGING).

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

U.S. patent application Ser. No. 15/940,653, entitled adaptive control program update for surgical hubs (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS);

U.S. patent application Ser. No. 15/940,660, entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER) for customization and recommendation to users;

U.S. patent application Ser. No. 15/940,679 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET) for linking local usage trends with resource acquisition behavior of larger datasets;

U.S. patent application Ser. No. 15/940,694 entitled CLOUD-BASED medical analysis of medical facilities FOR personalizing instrument function segments (CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION);

U.S. patent application Ser. No. 15/940,634 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES) for security and authentication trend and reactivity measurements;

U.S. patent application Ser. No. 15/940,706, entitled data processing and priority (DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK) in a cloud analysis network; and

U.S. patent application Ser. No. 15/940,675, entitled cloud interface (CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES) for coupled surgical devices.

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

U.S. patent application Ser. No. 15/940,637 entitled communication arrangement for robotic-assisted surgical platforms (COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,642, entitled control for robotic-assisted surgical platforms (CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,676, entitled automatic tool adjustment for robotic-assisted surgical platforms (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,680, entitled controller for robotic-assisted surgical platform (CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

U.S. patent application Ser. No. 15/940,683, entitled cooperative surgical action for robotic-assisted surgical platform (COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);

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

U.S. patent application Ser. No. 15/940,711, entitled sensing arrangement FOR robotic-assisted surgical platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS).

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

U.S. provisional patent application Ser. No. 62/649,302 entitled interactive surgical System (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES) with encrypted communication capability;

U.S. provisional patent application Ser. No. 62/649,294 entitled data stripping method (DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD) for querying patient records and creating anonymous records;

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

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

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

U.S. provisional patent application Ser. No. 62/649,291 entitled determination OF the characteristics OF backscattered light using laser and red-GREEN-blue color development (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT);

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

U.S. provisional patent application Ser. No. 62/649,333 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER) for customization and recommendation to a user;

U.S. provisional patent application Ser. No. 62/649,327 entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES) for security and authentication trend and reactivity measurements;

U.S. provisional patent application Ser. No. 62/649,315, entitled data processing and priority in a cloud analysis network (DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK);

U.S. patent application Ser. No. 62/649,313, entitled cloud interface (CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES) for coupled surgical devices;

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

U.S. provisional patent application Ser. No. 62/649,307 entitled automatic tool adjustment for robotic-assisted surgical platforms (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS); and

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

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

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

U.S. provisional patent application Ser. No. 62/640,415, entitled to estimate the status of an ultrasonic end effector and control system therefor (ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR).

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

U.S. provisional patent application Ser. No. 62/611,341, entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM);

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

U.S. patent application Ser. No. 62/611,339, entitled robot-assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM).

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

Aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical device may be configured for transecting and/or coagulating tissue, for example, during a surgical procedure. Aspects of the electrosurgical device may be configured for transecting, coagulating, scaling, welding, and/or drying tissue, for example, during a surgical procedure.

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

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

Other types of robotic systems may be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,339 entitled robotic-assisted surgical platform (ROBOT ASSISTED SURGICAL PLATFORM), filed on 12/2017, the disclosure of which is incorporated herein by reference in its entirety.

Various examples of CLOUD-BASED analysis performed by the CLOUD 104 and suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,340 entitled "CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS)" filed on date 12, 2017, the disclosure of which is incorporated herein by reference in its entirety.

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

The optical components of the imaging device 124 may include one or more illumination sources and/or one or more lenses. One or more illumination sources may be directed to illuminate multiple portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum (sometimes referred to as the optical spectrum or the luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye, and may be referred to as visible light or simple light. A typical human eye will respond to wavelengths in the air of about 380nm to about 750 nm.

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

In various aspects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophageal-duodenal scopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngeal-renal endoscopes, sigmoidoscopes, thoracoscopes, and hysteroscopes.

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

It is self-evident that the operating room and surgical equipment need to be strictly sterilized during any surgical procedure. The stringent sanitary and sterilization conditions required in the "surgery room" (i.e., operating or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is the need to sterilize the patient or any substance penetrating the sterile field, including the imaging device 124 and its attachments and components. It should be understood that a sterile field may be considered a designated area that is considered to be free of microorganisms, such as within a tray or within a sterile towel, or a sterile field may be considered an area surrounding a patient that is ready for a surgical procedure. The sterile field may include scrubbing team members that are properly worn, as well as all furniture and fixtures in the area.

In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays strategically placed with respect to the sterile field, as shown in fig. 2. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the heading "advanced imaging acquisition module (Advanced Imaging Acquisition Module)" of U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on date 28 of 2017, the disclosure of which is incorporated herein by reference in its entirety.

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

In one aspect, hub 106 is further configured to route diagnostic inputs or feedback entered by a non-sterile operator at visualization tower 111 to a main display 119 within the sterile field, where it is viewable by a sterile operator on the console. In one example, the input may be a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be routed through the hub 106 to the main display 119.

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

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

During a surgical procedure, the energy applied to tissue for sealing and/or cutting is typically associated with smoke evacuation, aspiration of excess fluid, and/or irrigation of the tissue. Fluid lines, power lines, and/or data lines from different sources are often entangled during a surgical procedure. Solving this problem during a surgical procedure can lose valuable time. Disconnecting the pipeline may require disconnecting the pipeline from its respective module, which may require resetting the module. The hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of entanglement between such lines.

Aspects of the present disclosure provide a surgical hub for a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably received in a docking bay of the hub housing. The docking station includes a data contact and a power contact. The combined generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component that are housed in a single unit. In one aspect, the combination generator module further comprises a smoke evacuation component for connecting the combination generator module to at least one energy delivery cable of the surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluids and/or particulates generated by application of therapeutic energy to tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.

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

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

Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving 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 station including a first docking port including a first data and power contact, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contact, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contact,

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

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

Referring to fig. 3-7, aspects of the present disclosure are presented as a hub modular housing 136 that allows for modular integration of the generator module 140, smoke evacuation module 126, and suction/irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. As shown in fig. 5, the generator module 140 may be a generator module with integrated monopolar, bipolar and ultrasonic components supported in a single housing unit 139 slidably inserted into the hub modular housing 136. As shown in fig. 5, the generator module 140 may be configured to be connected to a monopolar device 146, a bipolar device 147, and an ultrasound device 148. Alternatively, the generator module 140 may include a series of monopolar generator modules, bipolar generator modules, and/or an ultrasound generator module that interact through the hub modular housing 136. The hub modular housing 136 may be configured to facilitate interactive communication between the insertion and docking of multiple generators into the hub modular housing 136 such that the generators will act as a single generator.

In one aspect, the hub modular housing 136 includes a modular power and communication backplane 149 having external and wireless communication connectors to enable removable attachment of the modules 140, 126, 128 and interactive communication therebetween.

In one aspect, the hub modular housing 136 includes a docking bay 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 the surgical hub housing 136 and the combined generator module 145 slidably receivable in the docking cradle 151 of the surgical hub housing 136. Docking ports 152 having power and data contacts on the back of the combination generator module 145 are configured to engage corresponding docking ports 150 with the power and data contacts of corresponding docking bays 151 of the hub module housing 136 when the combination generator module 145 is slid into place within the corresponding docking bays 151 of the hub module housing 136. In one aspect, the combined generator module 145 includes a bipolar, ultrasound and monopolar module and a smoke evacuation module integrated together into a single housing unit 139, as shown in fig. 5.

In various aspects, smoke evacuation module 126 includes a fluid line 154, which fluid line 154 conveys trapped/collected smoke and/or fluid from the surgical site to, for example, smoke evacuation module 126. Vacuum suction from smoke evacuation module 126 may draw smoke into the opening of the common conduit at the surgical site. The common conduit coupled to the fluid lines may be in the form of a flexible tube terminating at the smoke evacuation module 126. The common conduit and fluid lines define a fluid path extending toward the smoke evacuation module 126 received in 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 an aspiration fluid line. In one example, the aspiration and aspiration fluid lines are in the form of flexible tubing extending from the surgical site toward the aspiration/irrigation module 128. The one or more drive systems may be configured to flush fluid to and aspirate fluid from the surgical site.

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

The flush tube may be in fluid communication with a fluid source and the draft tube may be in fluid communication with a vacuum source. A fluid source and/or a vacuum source may be housed in the suction/irrigation module 128. In one example, a fluid source and/or a vacuum source may be housed in the hub housing 136 independently of the suction/irrigation module 128. In such examples, the fluid interface can 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 bays on the hub modular housing 136 may include alignment features configured to align the docking ports of the modules into engagement with their corresponding ports in the docking bays of the hub modular housing 136. For example, as shown in fig. 4, combined generator module 145 includes side brackets 155, side brackets 155 configured to slidably engage corresponding brackets 156 of corresponding docking bays 151 of hub modular housing 136. The brackets cooperate to guide the mating port contacts of the combined generator module 145 into electrical engagement with the mating port contacts of the hub modular housing 136.

In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the size of the modules are adjusted to be received in 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 sized differently and each is designed to accommodate a particular module.

In addition, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting the module into a drawer having unmatched contacts.

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

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

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

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

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

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

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

Various image processors and imaging devices suitable for use in the present disclosure are described in U.S. patent 7,995,045, entitled combined SBI and conventional image processor (COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR), published 8.8.9 2011, which is incorporated by reference herein in its entirety. Furthermore, U.S. patent 7,982,776, entitled SBI motion artifact removal apparatus and method (SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD), published in 2011, 7, 19, which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such a system may be integrated with the imaging module 138. Further, U.S. patent application publication 2011/0306840 entitled controllable magnetic source (CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS) to a fastener body internal device published on 12/15 2011 and U.S. patent application publication 2014/0243597 entitled system for performing minimally invasive surgical procedures (SYSTEM FOR PERFORMING AMINIMALLY INVASIVE SURGICAL PROCEDURE) published on 8/2014, each of which is incorporated herein by reference in its entirety.

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

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

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

In one aspect, the surgical data network 201 may include a combination of one or more hubs, one or more network switches, and one or more network routers that connect the devices 1a-1n/2a-2m to the cloud. Any or all of the devices 1a-1n/2a-2m coupled to the hub or switch may collect data in real time and transmit the data to the cloud computer for data processing and manipulation. It should be appreciated that cloud computing relies on shared computing resources, rather than using local servers or personal devices to process software applications. The term "cloud" may be used as a metaphor for "internet," although the term is not so limited. Thus, the term "cloud computing" may be used herein to refer to "types of internet-based computing" in which different services (such as servers, memory, and applications) are delivered to modular communication hub 203 and/or computer system 210 located in a surgical room (e.g., stationary, mobile, temporary, or in-situ operating room or space) and devices connected to modular communication hub 203 and/or computer system 210 through the internet. The cloud infrastructure may be maintained by a cloud service provider. In this case, the cloud service provider may be an entity that coordinates the use and control of the devices 1a-1n/2a-2m located in one or more operating rooms. The cloud computing service may perform a large amount of computation based on data collected by intelligent surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and memory.

Applying cloud computer data processing techniques to the data collected by the devices 1a-1n/2a-2m, the surgical data network provides improved surgical results, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n/2a-2m may be employed to observe tissue conditions to assess leakage or perfusion of sealed tissue following tissue sealing and cutting procedures. At least some of the devices 1a-1n/2a-2m may be employed to identify pathologies, such as the effects of a disease, and data including images of body tissue samples for diagnostic purposes may be examined using cloud-based computing. This includes localization and marginal confirmation of tissue and phenotype. At least some of the devices 1a-1n/2a-2m may be employed to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques, such as overlapping images captured by multiple imaging devices. The data (including image data) collected by the devices 1a-1n/2a-2m may be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve surgical procedure results by determining whether further treatment (such as endoscopic interventions, emerging techniques, targeted radiation, targeted interventions, and the application of precise robots to tissue-specific sites and conditions) can be continued. Such data analysis may further employ a result analysis process and may provide beneficial feedback to confirm or suggest modification of the surgical treatment and surgeon's behavior using standardized methods.

In one implementation, operating room devices 1a-1n may be connected to modular communication hub 203 via a wired channel or a wireless channel, depending on the configuration of devices 1a-1n to the hub. In one aspect, hub 207 may be implemented as a local network broadcaster operating on the physical layer of the Open Systems Interconnection (OSI) model. The hub provides a connection to the devices 1a-1n located in the same operating room network. The hub 207 collects data in the form of packets and sends it to the router in half duplex mode. The hub 207 does not store any media access control/internet protocol (MAC/IP) for transmitting device data. Only one of the devices 1a-1n may transmit data through the hub 207 at a time. The hub 207 has no routing tables or intelligence about where to send information and broadcast all network data on each connection and all network data to the remote server 213 (fig. 9) through the cloud 204. Hub 207 may detect basic network errors such as collisions, but broadcasting all information to multiple ports may pose a security risk and cause bottlenecks.

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

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

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

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

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

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

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

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

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

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

The controller 244 may be any single or multi-core processor, such as those provided by Texas instruments (Texas Instruments) under the trade name ARM Cortex. In one aspect, the processor may be an on-chip memory available from, for example, texas instruments (Texas Instruments) LM4F230H5QR ARM Cortex-M4F processor core including 256KB of single-cycle flash memory or other non-volatile memory (up to 40 MHz) for improving 40MHz or more Prefetch buffer, 32KB single cycle Sequential Random Access Memory (SRAM), loaded with PerformanceInternal read-only memory (ROM) of software, 2KB electrically erasable programmable read-only memory (EEPROM), and/or one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Inputs (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, the details of which can be seen in the product data sheet.

In one aspect, the processor 244 may include a security controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by texas instruments (Texas Instruments). The security controller may be configured specifically for IEC 61508 and ISO 26262 security critical applications, etc. to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.

The system memory includes volatile memory and nonvolatile memory. A basic input/output system (BIOS), containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in nonvolatile memory. For example, the non-volatile memory may include ROM, programmable ROM (PROM), electrically Programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes Random Access Memory (RAM), which acts as external cache memory. In addition, RAM is available in a variety of forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), dual data rate SDRAM (DDR SDRAM) Enhanced SDRAM (ESDRAM), synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM).

Computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media such as, for example, magnetic 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, the disk storage can include storage media separately or in combination with other storage media including, but not limited to, an optical disk drive such as a compact disk ROM device (CD-ROM), compact disk recordable drive (CD-R drive), compact disk rewritable drive (CD-RW drive) or a digital versatile disk ROM drive (DVD-ROM). To facilitate connection of the disk storage devices to the system bus, a removable or non-removable interface may be used.

It is to be appreciated that computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in suitable operating environment. Such software includes an operating system. An operating system, which may be stored on disk storage, is used to control and allocate resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored either in system memory or on disk storage. It is to be appreciated that the various components described herein can be implemented with various operating systems or combinations of operating systems.

A user enters commands or information into the computer system 210 through one or more input devices coupled to the I/O interface 251. Input devices include, but are not limited to, a pointing device such as a mouse, trackball, stylus, touch pad, keyboard, microphone, joystick, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices are connected to the processor through the system bus via one or more interface ports. The one or more interface ports include, for example, serial ports, parallel ports, game ports, and USB. The one or more output devices use the same type of ports as the one or more input devices. Thus, for example, a USB port may be used to provide input to a computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (e.g., monitors, displays, speakers, and printers) that require special adapters among other output devices.

Computer system 210 may operate in a networked environment using logical connections to one or more remote computers, such as one or more cloud computers, or local computers. The one or more remote cloud computers may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or other common network nodes, or the like, and typically include many or all of the elements described relative to the computer system. For simplicity, only memory storage devices having one or more remote computers are shown. One or more remote computers are logically connected to the computer system through a network interface and then physically connected via communication connections. The network interface encompasses communication networks such as local-area networks (LAN) and wide-area networks (WAN). LAN technologies include Fiber Distributed Data Interface (FDDI), copper Distributed Data Interface (CDDI), ethernet/IEEE 802.3, token ring/IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks like Integrated Services Digital Networks (ISDN) and variations thereon, packet switching networks, and Digital Subscriber Lines (DSL).

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

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

Fig. 11 illustrates a functional block diagram of one aspect of a USB hub 300 device in accordance with at least one aspect of the present disclosure. In the illustrated aspect, USB hub device 300 employs a TUSB2036 integrated circuit hub of texas instruments (Texas Instruments). The USB hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP 0) input paired with a differential data positive (DM 0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, with each port including differential data positive (DP 1-DP 3) outputs paired with differential data negative (DM 1-DM 3) outputs.

The USB hub 300 device is implemented with a digital state machine rather than a microcontroller and does not require firmware programming. Fully compatible USB transceivers are integrated into the circuitry for the upstream USB transceiver port 302 and all of the downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full speed and low speed devices by automatically setting the slew rate according to the speed of the device attached to the port. The USB hub 300 device may be configured in a bus power mode or a self-powered mode and include hub power logic 312 for managing power.

The USB hub 300 device includes a serial interface engine 310 (SIE). SIE 310 is the front end of the USB hub 300 hardware and handles most of the protocols described in chapter 8 of the USB specification. SIE 310 generally includes signaling up to the transaction level. The processing functions thereof can include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, non return to zero inversion (NRZI) data encoding/decoding and digit stuffing, CRC generation and checking (token and data), packet ID (PID) generation and checking/decoding, and/or serial-parallel/parallel-serial conversion. 310 receives a clock input 314 and is coupled to pause/resume logic and frame timer 316 circuitry and hub repeater circuitry 318 to control communications between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 via port logic circuits 320, 322, 324. SIE 310 is coupled to command decoder 326 via interface logic to control commands from a serial EEPROM via serial EEPROM interface 330.

In various aspects, the USB hub 300 may connect 127 functions configured in up to six logical layers (tiers) to a single computer. Further, the USB hub 300 may be connected to all external devices using a standardized four-wire cable that provides both communication and power distribution. The power is configured in a bus power mode and a self-powered mode. USB hub 300 may be configured to support four power management modes: bus-powered hubs with individual port power management or ganged port power management, and self-powered hubs with individual port power management or ganged port power management. In one aspect, the USB hub 300, the upstream USB transceiver port 302, are plugged into a USB host controller using USB cables, and the downstream USB transceiver ports 304, 306, 308 are exposed for connection to USB compatible devices, etc.

Surgical instrument hardware

Fig. 12 illustrates a logic diagram of a control system 470 for a surgical instrument or tool in accordance with one or more aspects of the present disclosure. The system 470 includes control circuitry. The control circuit includes a microcontroller 461 that includes a processor 462 and memory 468. For example, one or more of the sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482, driven by a motor driver 492, is operably coupled to the longitudinally movable displacement member to drive the clamp arm closing member. The tracking system 480 is configured to determine a position of the longitudinally movable displacement member. The position information is provided to a processor 462, which processor 462 may be programmed or configured to determine the position of the longitudinally movable drive member and the position of the closure member. Additional motors may be provided at the tool driver interface to control closure tube travel, shaft rotation, articulation, or clamp arm closure, or a combination thereof. The display 473 displays various operating conditions of the instrument and may include touch screen functionality for data input. The information displayed on the display 473 may be superimposed with the image acquired via the endoscopic imaging module.

In one aspect, microprocessor 461 may be any single or multi-core processor, such as those known under the trade name ARM Cortex, manufactured by Texas instruments Inc. (Texas Instruments). In one aspect, the microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor core available from, for example, texas instruments Inc. (Texas Instruments), which includes 256KB of single-cycle flash memory or other non-volatile memory (up to 40 MHz) on-chip memory, a prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, loaded withInternal ROM for software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, the details of which can be seen in the product data sheet.

In one aspect, the microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by texas instruments (Texas Instruments). The security controller may be configured specifically for IEC 61508 and ISO 26262 security critical applications, etc. to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.

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

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

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

Driver 492 may be a3941 available from Allegro microsystems, inc (Allegro Microsystems, inc). A3941 492 is a full bridge controller for use with an external N-channel power Metal Oxide Semiconductor Field Effect Transistor (MOSFET) specifically designed for inductive loads, such as brushed DC motors. The driver 492 includes a unique charge pump regulator that provides full (> 10V) gate drive for battery voltages as low as 7V and allows a3941 to operate with reduced gate drive as low as 5.5V. A bootstrap capacitor may be employed to provide the above-described battery supply voltage required for an N-channel MOSFET. The internal charge pump of the high side drive allows dc (100% duty cycle) operation. Diodes or synchronous rectification may be used to drive the full bridge in either a fast decay mode or a slow decay mode. In slow decay mode, current recirculation may pass through either the high-side FET or the low-side FET. The dead time, which is adjustable by a resistor, protects the power FET from breakdown. The overall diagnostics provide indications of brown-out, over-temperature, and power bridge faults, and may be configured to protect the power MOSFET during most short circuit conditions. Other motor drives may be readily replaced for use in tracking system 480, including an absolute positioning system.

Tracking system 480 includes a controlled motor drive circuit arrangement including a position sensor 472 in accordance with an 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 that includes a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured as a rack that includes drive teeth. In a further aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamping arm, which longitudinal displacement member may be adapted and configured as a rack comprising drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to close and open a clamp arm of a stapler, a clamp arm of an ultrasonic or electrosurgical device, or a combination thereof. Thus, as used herein, the term displacement member is used generically to refer to any movable member of a surgical instrument or tool, such as a drive member, a clamping arm, or any displaceable element. Thus, the absolute positioning system can actually track the displacement of the clamping 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 closing or opening. In various other aspects, the displacement member may be coupled to any position sensor 472 adapted to measure linear displacement. Thus, the longitudinally movable drive member, or the clamping arm, or a combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may comprise a contact type displacement sensor or a non-contact type displacement sensor. The linear displacement sensor may comprise a Linear Variable Differential Transformer (LVDT), a Differential Variable Reluctance Transducer (DVRT), a sliding potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged hall effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.

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

A single rotation of the sensor element associated with the position sensor 472 is equivalent to the longitudinal linear displacement d of the displacement member ₁ Wherein d is ₁ To be coupled to displacementThe longitudinal linear distance that the displacement member moves from point "a" to point "b" after a single rotation of the sensor element of the member. The sensor arrangement may be connected via gear reduction that causes the position sensor 472 to complete only one or more rotations for the full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a full stroke of the displacement member.

A series of switches (where n is an integer greater than one) may be employed alone or in combination with gear reduction to provide a unique position signal for more than one revolution of the position sensor 472. The state of the switch is fed back to the microcontroller 461, which microcontroller 461 applies logic to determine the longitudinal linear displacement d corresponding to the displacement member ₁ +d ₂ +…d _n Is provided. The output of the position sensor 472 is provided to a microcontroller 461. The position sensor 472 of the sensor arrangement may include a magnetic sensor, an analog rotation sensor (e.g., a potentiometer), an array of analog hall effect elements that output a unique combination of position signals or values.

The position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or vector component of the magnetic field. Technologies for producing the two types of magnetic sensors described above cover a number of aspects of physics and electronics. Techniques for magnetic field sensing include probe coils, fluxgates, optical pumps, nuclear spin, superconducting quantum interferometers (SQUIDs), hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoresistance, magnetostriction/piezoelectric composites, magneto-sensitive diodes, magneto-sensitive transistors, optical fibers, magneto-optical, and microelectromechanical system based magnetic sensors, among others.

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

The tracking system 480, including an absolute positioning system, may include and/or may be programmed to implement feedback controllers such as PID, status feedback, and adaptive controllers. The power source converts the signal from the feedback controller into a physical input to the system: in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the location measured by the location sensor 472, one or more other sensors may be provided to measure physical parameters of the physical system. In some aspects, the one or more other sensors may include a sensor arrangement such as those described in U.S. patent 9,345,481 to a cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE tissu THICKNESS) issued at month 5 and 24 of 2016, which is incorporated herein by reference in its entirety; U.S. patent application publication 2014/0263552 entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE tissu THICKNESS), published at 9, 18, 2014, which is incorporated herein by reference in its entirety; and U.S. patent application Ser. No. 15/628,175, entitled technique for adaptive control of motor speed for surgical stapling and cutting instruments (TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT), filed on 6/20 of 2017, which is incorporated herein by reference in its entirety. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, wherein the output of the absolute positioning system will have a limited resolution and sampling frequency. The absolute positioning system may include a comparison and combination circuit to combine the calculated response with the measured response using an algorithm (such as a weighted average and a theoretical control loop) that drives the calculated response toward the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, inductance and resistance to predict the state and output of the physical system by knowing the inputs.

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

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

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

The microcontroller 461 can use measurements of tissue compression, tissue thickness, and/or force required to close the end effector, as measured by the sensors 474, 476, respectively, to characterize corresponding values of the selected position of the firing member and/or the speed of the firing member. In one case, the memory 468 may store techniques, formulas, and/or look-up tables that may be employed by the microcontroller 461 in the evaluation.

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

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

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

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

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

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

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

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

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

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

In at least one example, the common control module 610 can be selectively switched between operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or the closure motor 603. In at least one example, as shown in fig. 16, the switch 614 may move or transition between a plurality of positions and/or states. In the first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602; in the second position 617, the switch 614 may electrically couple the common control module 610 to the close motor 603; in the third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606a; and in the fourth position 618b, the switch 614 may electrically couple the common control module 610 to, for example, the second articulation motor 606b. In some instances, a separate common control module 610 may be electrically coupled to the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b simultaneously. In some cases, the switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.

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

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

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

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

In various circumstances, the processor 622 may control the motor driver 626 to control the position, rotational direction, and/or speed of the motor coupled to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and/or deactivate the motor coupled to the common controller 610. It should be appreciated that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that incorporates the functionality of the Central Processing Unit (CPU) of a computer on one integrated circuit or at most a few integrated circuits. Processor 622 is a versatile programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides the result as output. Because the processor has internal memory, this is an example of sequential digital logic. The objects of operation of the processor are numbers and symbols represented in a binary digital system.

In one case, the processor 622 may be any single or multi-core processor, such as those known under the trade name ARM Cortex, produced by Texas instruments Inc. (Texas Instruments). In some cases, microcontroller 620 may be, for example, LM4F230H5QR, available from texas instruments (Texas Instruments). In at least one example, texas Instruments LM F230H5QR is an ARM Cortex-M4F processor core, comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, loaded withInternal ROM for software, EEPROM for 2KB, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels,As well as other features that are readily available. Other microcontrollers could be easily replaced for use with the module 4410. Accordingly, the present disclosure should not be limited in this context.

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

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

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

In one aspect, the robotic surgical instrument 700 includes a control circuit 710, the control circuit 710 configured to control the clamp arm 716 and closure member 714 portions of the end effector 702, an ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721, a shaft 740, and one or more articulation members 742a, 742b via a plurality of motors 704a-704 e. The position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710. Other sensors 738 may be configured to provide feedback to control circuit 710. Timer/counter 731 provides timing and count 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 may be individually operated in open loop or closed loop feedback control by control circuit 710.

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

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

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

In some examples, control circuit 710 may initially operate each of motors 704a-704e in an open loop configuration for a first open loop portion of the travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open loop portion of the stroke, the control circuit 710 may select a firing control routine in a closed loop configuration. The response of the instrument may include the sum of 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 pulse width of the motor drive signal, etc. After the open loop portion, the control circuit 710 may implement a selected firing control routine for a second portion of the displacement member travel. For example, during a closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e to translate the displacement member at a constant speed based on translation data describing the position of the displacement member in a closed-loop manner.

In one aspect, motors 704a-704e may receive power from an energy source 712. The energy source 712 may be a DC power source driven by a main alternating current power source, a battery, a super capacitor, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to separate movable mechanical elements, such as closure member 714, clamp arm 716, shaft 740, articulation 742a, and articulation 742b via respective transmissions 706a-706 e. The actuators 706a-706e may include one or more gears or other linkage members to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the closure member 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the closure member 714 translates distally and proximally. The control circuit 710 may track the pulses to determine the position of the closure member 714. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the closure member 714. Also, in some examples, the position sensor 734 may be omitted. Where motors 704a-704e are stepper motors, control circuit 710 may track the position of closure member 714 by aggregating the number and direction of steps that motor 704 has been instructed to perform. The position sensor 734 may be located in the end effector 702 or at any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firing member, such as a closure member 714 portion of the end effector 702. Control circuit 710 provides a motor setpoint to motor control 708a, which provides a drive signal to motor 704 a. An output shaft of motor 704a is coupled to torque sensor 744a. The torque sensor 744a is coupled to the transmission 706a, and the transmission 706a is coupled to the closure member 714. The transmission 706a includes movable mechanical elements such as rotary elements and firing members to control the movement of the closure member 714 distally and proximally along the longitudinal axis of the 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 is indicative of the force required to fire or displace the closure member 714. The position sensor 734 may be configured to provide the position of the closure member 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710. The end effector 702 may include additional sensors 738 configured to provide feedback signals to the control circuit 710. When ready for use, the control circuit 710 may provide a firing signal to the motor control 708 a. In response to the firing signal, the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal stroke start position to an end-of-stroke position distal to the stroke start position. As the closure member 714 translates distally, the clamping arms 716 close toward the ultrasonic blade 718.

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

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

In one aspect, the control circuitry 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor set point to the motor control 708d, which motor control 708d provides a drive signal to the motor 704 d. The output of motor 704d is coupled to torque sensor 744d. The torque sensor 744d is coupled to the transmission 706d that is coupled to the articulation member 742 a. The transmission 706d includes a movable mechanical element, such as an articulation element, to control articulation of the end effector 702 + -65 deg.. In one aspect, the motor 704d is coupled to an articulation nut rotatably journaled on the proximal end portion of the distal spine and rotatably driven thereon by an articulation gear assembly. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal is representative of the articulation 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 function of the robotic surgical system 700 may include two articulation members or links 742a, 742b. These articulation members 742a, 742b are driven by separate discs on the robotic interface (rack) that are driven by the two motors 708d, 708 e. When a separate firing motor 704a is provided, each of the articulation links 742a, 742b may be antagonistic driven relative to the other link to provide resistance preserving motion and load to the head when the head is not moving and articulation when the head is articulating. The articulation members 742a, 742b attach to the head at a fixed radius as the head rotates. Thus, the mechanical advantage of the push-pull link changes as the head rotates. This variation in mechanical advantage may be more pronounced for other articulation link drive systems.

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

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

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

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

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

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

In one aspect, a current sensor 736 may be used to measure the current consumed by each of the motors 704a-704 e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current consumed by one of the motors 704a-704 e. The force is converted to a digital signal and provided to the processor 710. Control circuitry 710 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the closure member 714 in the end effector 702 at or near a target speed. Robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers including, but not limited to, for example, PID, state feedback, linear square (LQR), and/or adaptive controllers. The robotic surgical instrument 700 may include a power source to convert signals from a feedback controller into physical inputs, such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example. Additional details are disclosed in U.S. patent application Ser. No. 15/636,829, entitled closed loop speed control technique for robotic surgical instruments (CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT), filed on publication No. 6/29, 2017, which is incorporated herein by reference in its entirety.

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

The position, movement, displacement, and/or translation of a linear displacement member, such as the closure member 764, may be measured by an absolute positioning system, a sensor arrangement, and a position sensor 784. Since the closure member 764 is coupled to the longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member with the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the closure member 764 may be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control translation of a displacement member, such as the closure member 764. In some examples, the control circuit 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the closure member 764) in the manner described. In one aspect, timer/counter 781 provides an output signal, such as a time elapsed 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 control circuit 760 can determine the position of 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 set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide motor drive signals 774 to the motor 754 to drive the 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 examples, the motor controller 758 may be omitted and the control circuit 760 may generate the motor drive signal 774 directly.

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

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

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

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

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

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

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

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

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

In some examples, control circuit 760 may operate motor 754 initially in an open loop configuration for a first open loop portion of the travel of the displacement member. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control routine. The response of the instrument may include the sum of 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, the pulse width of the motor drive signal, and the like. After the open loop portion, the control circuit 760 may implement a selected firing control routine for a second portion of the displacement member travel. For example, during a closed-loop portion of the stroke, the control circuit 760 may adjust the motor 754 based on translation data describing the position of the displacement member in a closed-loop manner to translate the displacement member at a constant speed. Additional details are disclosed in U.S. patent application Ser. No. 15/720,852, entitled System and method for controlling a display of a surgical instrument (SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT), filed on publication No. 9/29 of 2017, which is incorporated herein by reference in its entirety.

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

In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid state switch, a hall effect device, an MR device, a GMR device, a magnetometer, or the like. In other implementations, the sensor 638 may be implemented as a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and so forth. Also, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensor 788 may include a no-electrical-conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and so forth.

In one aspect, the position sensor 784 may be implemented AS an absolute positioning system including a single-piece magnetic rotational position sensor implemented AS5055EQFT, which is available from australian microelectronics (Austria Microsystems, AG). Position sensor 784 may interface with controller 760 to provide an absolute positioning system. The location may include a hall effect element located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition operations, subtraction operations, digital displacement operations and table lookup operations.

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

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

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

Additional details are disclosed in U.S. patent application Ser. No. 15/636,096, filed on 6/28 at 2017, entitled surgical System coupleable with a staple cartridge and a RADIO FREQUENCY cartridge, and methods of use thereof (SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME), which is incorporated herein by reference in its entirety.

Self-adaptive ultrasonic knife control algorithm

In various aspects, the intelligent ultrasonic energy apparatus may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to identify tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize tissue types. The following section of the present disclosure describes an algorithm for detecting the collagen/elastic ratio of tissue to tune the amplitude of the distal tip of an ultrasonic blade. Various aspects of the intelligent ultrasonic energy apparatus are described herein in connection with, for example, fig. 1-94. Accordingly, the following description of the adaptive ultrasonic blade control algorithm should be read in connection with FIGS. 1-94 and the description associated therewith.

Tissue type identification and device parameter adjustment

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

Fig. 20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub in accordance with at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute one or more adaptive ultrasonic blade control algorithms 802 as described herein with reference to fig. 53-94. In another aspect, the device/instrument 235 is configured to execute one or more adaptive ultrasonic blade control algorithms 804 as described herein with reference to fig. 53-94. In another aspect, both the device/instrument 235 and the device/instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 as described herein with reference to fig. 53-94.

The generator module 240 may include a patient isolation stage in communication with a non-isolation stage via a power transformer. The secondary windings of the power transformer are contained in the isolation stage and may include a tap configuration (e.g., a center-tap or non-center-tap configuration) to define drive signal outputs for delivering drive signals to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-functional surgical instruments including ultrasonic energy modes and RF energy modes that can be delivered separately or simultaneously. Specifically, the drive signal output may output an ultrasonic drive signal (e.g., 420V Root Mean Square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output may output an RF electrosurgical drive signal (e.g., 100V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to fig. 21-28B.

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

Fig. 21 illustrates an example of a generator 900, which is one form of a generator configured to be coupled to an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, as shown in fig. 20. Generator 900 is configured to deliver a plurality of energy modalities to a surgical instrument. Generator 900 provides an RF signal and an ultrasonic signal for delivering energy to the surgical instrument independently or simultaneously. The RF signal and the ultrasonic signal may be provided separately or in combination, and may be provided simultaneously. As described above, at least one generator output may deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation and/or microwave energy, etc.) through a single port, and these signals may be delivered separately or simultaneously to an end effector to treat tissue. Generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory coupled to the processor 902, which is not shown for clarity of the present disclosure. The digital information associated with the waveform is provided to a waveform generator 904, which waveform generator 904 includes one or more DAC circuits to convert the digital input to an analog output. The analog output is fed to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled to a secondary side of the patient isolated side through a power transformer 908. A first signal of a first ENERGY modality is provided to a signal labeled ENERGY ₁ And a surgical instrument between the terminals of RETURN. A second signal of a second ENERGY modality is coupled across capacitor 910 and provided to a capacitor labeled enable ₂ And a surgical instrument between the terminals of RETURN. It should be appreciated that more than two ENERGY modes may be output, and thus the subscript "n" may be used to designate that up to n ENERGY may be provided _n A terminal, wherein n is a positive integer greater than 1. It should also be appreciated that up to n RETURN paths RETURN may be provided without departing from the scope of the present disclosure _n 。

First voltage sense circuit 912 is coupled to a voltage source labeled ENERGY ₁ And both ends of the terminal of the RETURN path to measure the output voltage therebetween. Second voltage sensing circuit 924 is coupled to a voltage source labeled ENERGY ₂ And both ends of the terminal of the RETURN path to measure the output voltage therebetween. As shown, a current sensing circuit 914 is provided in series with the RETURN leg on the secondary side of the power transformer 908 to measure the output current of either energy mode. If a different return path is provided for each energy modality, a separate current sensing circuit should be provided in each return branch. First voltage sensing circuit 912 and a first voltage sensing circuitThe output of the two voltage sensing circuits 924 is provided to respective isolation transformers 916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The output of the isolation transformers 916, 928, 922 on the primary side of the power transformer 908 (non-patient isolated side) is provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and computation. Output voltage and output current feedback information may be used to adjust the output voltage and current provided to the surgical instrument and calculate output impedance, among other parameters. Input/output communications between the processor 902 and patient isolation circuitry are provided through interface circuitry 920. The sensor may also be in electrical communication with the processor 902 through the interface 920.

In one aspect, the impedance may be determined by processor 902 by coupling a signal labeled ENERGY ₁ First voltage sensing circuit 912 across the terminals of RETURN or coupled to a voltage source labeled ENERGY ₂ The output of the second voltage sensing circuit 924 across the terminals of RETURN is divided by the output of the current sensing circuit 914 placed in series with the RETURN leg on the secondary side of the power transformer 908. The outputs of the first and second voltage sensing circuits 912, 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to the other isolation transformer 916. The digitized voltage and current sense measurements from ADC circuit 926 are provided to processor 902 for use in calculating impedance. For example, a first ENERGY modality ENERGY ₁ Can be ultrasonic ENERGY, and a second ENERGY mode ENERGY ₂ May be RF energy. However, other energy modes besides ultrasound and bipolar or monopolar RF energy modes include irreversible and/or reversible electroporation and/or microwave energy, and the like. Moreover, while the example shown in fig. 21 illustrates that a single RETURN path RETURN may be provided for two or more ENERGY modes, in other aspects, ENERGY may be provided for each ENERGY mode _n Providing multiple RETURN paths _n . Thus, as described herein, the ultrasound transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914, and the tissue impedance may be measured by dividing the second voltage sensing circuit924 divided by the output of the current sense circuit 914.

As shown in fig. 21, a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to the end effector in one or more energy modes (such as ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, generator 900 may deliver energy with a higher voltage and lower current to drive an ultrasound transducer, a lower voltage and higher current to drive an RF electrode for sealing tissue, or a coagulation waveform for use with monopolar or bipolar RF electrosurgical electrodes. The output waveform from generator 900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasound transducer to the output of generator 900 will preferably be located at what is labeled ENERGY ₁ And the output of RETURN, as shown in fig. 21. In one example, the connection of the RF bipolar electrode to the generator 900 output will preferably be located at what is labeled ENERGY ₂ And the output of RETURN. In the case of monopolar output, the preferred connection would be an active electrode (e.g., cone of light (pencil) or other probe) to ENERGY ₂ And a suitable RETURN pad output and connected to the RETURN output.

Additional details are disclosed in U.S. patent application publication 2017/0086914 entitled techniques for operating a generator and housing instrument for digitally generating electrical signal waveforms (TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS), published at 30/3/2017, which is incorporated herein by reference in its entirety.

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

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

As used herein, a system-on-chip or system-on-chip (SoC or SoC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all of the components of a computer or other electronic system. It may contain digital, analog, mixed signal and typically radio frequency functions-all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with advanced peripheral devices such as a Graphics Processing Unit (GPU), wi-Fi module, or coprocessor. The SoC may or may not include built-in memory.

As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuitry and memory. The microcontroller (or MCU of the microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; the SoC may include a microcontroller as one of its components. The microcontroller may include one or more Core Processing Units (CPUs), memory and programmable input/output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory or OTP ROM, as well as small amounts of RAM are often included on the chip. Microcontrollers may be used in embedded applications, as opposed to microprocessors used in personal computers or other general purpose applications consisting of various discrete chips.

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

Any of the processors or microcontrollers as described herein may be any single or multi-core processor, such as those provided by texas instruments (Texas Instruments) under the trade name ARM Cortex. In one aspect, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from texas instruments (Texas Instruments), comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle Serial Random Access Memory (SRAM), load withInternal read-only memory (ROM) of software, electrically erasable programmable read-only memory (EEPROM) of 2KB, one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, and other features that are readily available.

In one example, the processor may include a security controller that includes two controller-based families, such as TMS570 and RM4x, also provided by texas instruments (Texas Instruments) under the trade name Hercules ARM Cortex R4. The security controller may be configured specifically for IEC 61508 and ISO 26262 security critical applications, etc. to provide advanced integrated security features while delivering scalable performance, connectivity, and memory options.

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

Fig. 22 illustrates one form of a surgical system 1000 that includes a generator 1100 and various surgical instruments 1104, 1106, 1108 that may be used therewith, wherein the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunctional surgical instrument 1108 is a combination of ultrasonic/RF electrosurgical instruments. The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-functional surgical instrument 1108 that integrates both RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, in one form the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on the front panel of the generator 1100 console. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may be configured for wired or wireless communication.

The generator 1100 is configured to drive a plurality of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and includes a handpiece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 that are acoustically coupled to an ultrasonic transducer 1120. The handpiece 1105 includes a combination of a trigger 1143 for operating the clamp arm 1140 and switch buttons 1134a, 1134b, 1134c for powering the ultrasonic blade 1128 and driving the ultrasonic blade 1128 or other functions. The toggle buttons 1134a, 1134b, 1134c may be configured to power the ultrasound transducer 1120 with the generator 1100.

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

The generator 1100 is further configured to drive a multifunction surgical instrument 1108. The multifunction surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The 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 combination of a trigger 1147 for operating the clamp arm 1146 and switch buttons 1137a, 1137b, 1137c for powering the ultrasonic blade 1149 and driving the ultrasonic blade 1149 or other functions. The toggle buttons 1137a, 1137b, 1137c may be configured to power the ultrasonic transducer 1120 with the generator 1100 and to power the ultrasonic blade 1149 with a bipolar energy source also contained within the generator 1100.

The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 integrating RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, in another form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. As discussed above, the generator 1100 includes an input device 1110 located on the front panel of the generator 1100 console. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may also include one or more output devices 1112. Additional aspects of generators and surgical instruments for digitally generating electrical signal waveforms are described in U.S. patent publication US-2017-0086914-A1, which is incorporated herein by reference in its entirety.

Fig. 23 is an end effector 1122 of an example ultrasound device 1104 in accordance with at least one aspect of the present disclosure. The end effector 1122 may include a blade 1128, which blade 1128 may be coupled to an ultrasonic transducer 1120 via a waveguide. The blade 1128 may vibrate when driven by the ultrasonic transducer 1120 and may cut and/or coagulate tissue when in contact with tissue, as described herein. According to various aspects, and as shown in fig. 23, the end effector 1122 may further comprise a clamp arm 1140, which clamp arm 1140 may be configured to act in concert with a knife 1128 of the end effector 1122. With the knife 1128, the clamping arm 1140 can comprise a set of jaws. The clamp arm 1140 may be pivotally connected at a distal end of the shaft 1126 of the instrument portion 1104. The clamp arm 1140 may include a clamp arm tissue pad 1163, the clamp arm tissue pad 1163 may be formed fromOr other suitable low friction material. The pad 1163 may be mounted for cooperation with the knife 1128, wherein pivotal movement of the clamp arm 1140 positions the clamp pad 1163 generally parallel to and in contact with the knife 1128. With this configuration, the tissue bite to be clamped can be grasped between the tissue pad 1163 and the knife 1128. Tissue pad 1163 may have serrations Configured to include a plurality of axially spaced proximally extending grasping teeth 1161 to cooperate with the knife 1128 to enhance grasping of tissue. The clamp arm 1140 may be transitioned from the open position shown in fig. 23 to the closed position in any suitable manner (with the clamp arm 1140 in contact with the knife 1128 or in proximity to the knife 1128). For example, the handpiece 1105 may include a jaw closure trigger. The jaw closure trigger, when actuated by the clinician, may pivot the clamping arm 1140 in any suitable manner.

The generator 1100 may be activated to provide a drive signal to the transducer 1120 in any suitable manner. For example, the generator 1100 may include a foot switch 1430 (fig. 24), the foot switch 1430 being coupled to the generator 1100 via a foot switch cable 1432. The clinician may activate the ultrasound transducer 1120 by depressing the foot switch 1430 and thereby activate the ultrasound transducer 1120 and knife 1128. In addition to, or in lieu of, the foot switch 1430, some aspects of the device 1104 may utilize one or more switches positioned on the handpiece 1105 that, when activated, may cause the generator 1100 to activate the transducer 1120. In one aspect, for example, the one or more switches may include a pair of switch buttons 1134a, 1134b, 1134c (fig. 22), for example, to determine the mode of operation of the device 1104. When the toggle button 1134a is depressed, for example, the ultrasonic generator 1100 can provide a maximum drive signal to the transducer 1120, causing it to produce a maximum ultrasonic energy output. Depressing the toggle button 1134b may cause the ultrasonic generator 1100 to provide a user-selectable drive signal to the ultrasonic transducer 1120, causing it to produce an ultrasonic energy output that is less than a maximum value. Additionally or alternatively, the device 1104 can include a second switch to indicate, for example, a position of a jaw closure trigger for operating the jaws via the clamping arm 1140 of the end effector 1122. Further, in some aspects, the ultrasonic generator 1100 can be activated based on the position of the jaw closure trigger (e.g., ultrasonic energy can be applied when a clinician depresses the jaw closure trigger to close the jaws via the clamping arm 1140).

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

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

In certain aspects, a two-position switch may be provided in place of toggle button 1134c (fig. 22). For example, the device 1104 may include a toggle button 1134a and a two-position toggle button 1134b for generating a continuous output at a maximum power level. In the first detent position, the toggle button 1134b may generate a continuous output that is less than the maximum power level, and in the second detent position, the toggle button 1134b may generate a pulsed output (e.g., at or less than the maximum power level, depending on the EEPROM setting).

In some aspects, the RF electrosurgical end effectors 1124, 1125 (fig. 22) may also include a pair of electrodes. The electrodes may be in communication with the generator 1100, for example, via a cable. The electrodes may be used, for example, to measure the impedance of tissue bite existing between the clamp arms 1142a, 1146 and the blades 1142b, 1149. The generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrode. For example, the impedance of tissue occlusion may be found by monitoring the current, voltage, etc. of the signal.

In various aspects, the generator 1100 may include several independent functional elements, such as modules and/or blocks, as shown in the illustrations of the surgical system 1000 of fig. 24, 22. Different functional elements or modules may be configured to drive different kinds of surgical devices 1104, 1106, 1108. For example, the ultrasonic generator module may drive an ultrasonic device, such as ultrasonic surgical device 1104. The electrosurgical/RF generator module may drive the electrosurgical device 1106. For example, the modules may generate respective drive signals for driving the surgical devices 1104, 1106, 1108. In various aspects, the ultrasound generator module and/or the electrosurgical/RF generator module may each be integrally formed with the generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100. (the modules are shown in phantom to illustrate this portion.) furthermore, in some aspects, the electrosurgical/RF generator module may be integrally formed with the ultrasound generator module, or vice versa.

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

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

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

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

While certain modules and/or blocks of the generator 1100 may be described by way of example, it is to be understood that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the described aspects. Moreover, although the various aspects may be described in terms of modules and/or blocks for purposes of illustration, such modules and/or blocks may be implemented by one or more hardware components (e.g., processors, digital Signal Processors (DSPs), programmable Logic Devices (PLDs), application Specific Integrated Circuits (ASICs), circuits, registers) and/or software components (e.g., programs, subroutines, logic), and/or combinations of hardware and software components.

In one aspect, the ultrasound generator drive module and the electrosurgical/RF drive module 1110 (fig. 22) can include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may include various executable modules, such as software, programs, data, drivers, application Program Interfaces (APIs), and the like. The firmware may be stored in a non-volatile memory (NVM), such as bit-masked Read Only Memory (ROM) or flash memory. In various implementations, storing the firmware in ROM may protect the flash memory. The NVM may include other types of memory including, for example, programmable ROM (PROM), erasable Programmable ROM (EPROM), electrically Erasable Programmable ROM (EEPROM), or battery-backed Random Access Memory (RAM), such as Dynamic RAM (DRAM), double data rate DRAM (DDRAM), and/or Synchronous DRAM (SDRAM).

In one aspect, the module includes hardware components implemented as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1104, 1106, 1108 and generating corresponding output drive signals for operating the devices 1104, 1106, 1108. In aspects in which the generator 1100 is used in conjunction with the device 1104, the drive signals may drive the ultrasonic transducer 1120 in a cutting and/or coagulation mode of operation. The electrical characteristics of the device 1104 and/or tissue may be measured and used to control operational aspects of the generator 1100 and/or may be provided as feedback to a user. In aspects in which the generator 1100 is used in conjunction with the device 1106, the drive signal can supply electrical energy (e.g., RF energy) to the end effector 1124 in a cutting, coagulation, and/or dehydration mode. The electrical characteristics of the device 1106 and/or tissue may be measured and used to control an operational aspect of the generator 1100 and/or may be provided as feedback to a user. In various aspects, as described above, the hardware components may be implemented as DSP, PLD, ASIC, circuits, and/or registers. In one aspect, the processor may be configured to store and execute computer software program instructions to generate step function output signals for driving the various components of the devices 1104, 1106, 1108 (e.g., the ultrasonic transducer 1120 and the end effectors 1122, 1124, 1125).

The electromechanical ultrasound system comprises an ultrasound transducer, a waveguide and an ultrasound blade. The electromechanical ultrasound system has an initial resonant frequency defined by the physical characteristics of the ultrasound transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer being excited by an alternating voltage V _g (t) Signal and Current I _g (t) letterThe resonant frequency of the number is equal to the electromechanical ultrasound system. When the ultrasonic electromechanical system is at resonance, voltage V _g (t) Signal and Current I _g The phase difference between the (t) signals is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. When the ultrasonic blade heats up, the compliance of the ultrasonic blade (modeled as equivalent capacitance) causes the resonant frequency of the electro-mechanical ultrasonic system to shift. Thus, the inductive impedance is no longer equal to the capacitive impedance, resulting in a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasound system. The system now runs "off-resonance". The mismatch between the drive frequency and the resonance frequency is manifested by a voltage V applied to the ultrasound transducer _g (t) Signal and Current I _g (t) phase differences between the signals. The generator electronics can easily monitor the voltage V _g (t) and current I _g (t) phase difference between the signals and the drive frequency can be continuously adjusted until the phase difference is again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. The change in phase and/or frequency may be used as an indirect measurement of the temperature of the ultrasonic blade.

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

FIG. 25 shows the rootAn equivalent circuit 1500 of an ultrasound transducer according to one aspect, such as ultrasound transducer 1120. The circuit 1500 includes a series connected inductor L with an electromechanical characteristic defining a resonator _s Resistance R _s And capacitor C _s A first "dynamic" branch of (C) and a second capacitive branch with static capacitance C ₀ . Can be at the driving voltage V _g Receiving a drive current I from the generator at (t) _g (t) wherein the dynamic current I _m (t) flow through the first branch and current I _g (t)-I _m (t) flow through the capacitive branch. By appropriately controlling I _g (t) and V _g (t) effecting control of the electromechanical properties of the ultrasound transducer. As described above, known generator architectures may include a tuning inductor L in a parallel resonant circuit _t (shown in phantom in fig. 25) for coupling the static capacitance C ₀ Tuned to a resonant frequency such that substantially the current output I of the generator _g All flow in (t) passes through the dynamic leg. In this way, by controlling the generator current output I _g (t) implementing the dynamic branch current I _m Control of (t). However, tuning inductor L _t Static capacitance C for ultrasonic transducer ₀ Is specific and different ultrasound transducers with different static capacitances require different tuning inductors L _t . In addition, because of the tuning inductor L _t At a single resonant frequency with static capacitance C ₀ So that the dynamic branch current I is ensured only at this frequency _m (t) precise control. As the frequency shifts downward with the passage of transducer temperature, precise control of the dynamic arm current is compromised.

Various aspects of the generator 1100 may not rely on tuning the inductor L _t To monitor dynamic branch current I _m (t). Conversely, the generator 1100 may use an electrostatic capacitance C between the application of power for a particular ultrasonic surgical device 1104 ₀ To determine the dynamic branch current I on a dynamic travel basis (e.g., in real time) _m The value of (t). Thus, such aspects of the generator 1100 can provide virtual tuning to simulate being tunedOr with electrostatic capacitance C at any frequency ₀ Any value of (2) resonates, not just at static capacitance C ₀ Is resonant at a single resonant frequency indicated by the nominal value of (c).

Fig. 26 is a simplified block diagram of one aspect of a generator 1100 that provides for inductor-less tuning, among other benefits, as described above. Fig. 27A-27C illustrate an architecture of the generator 1100 of fig. 26, according to an aspect. Referring to fig. 26, the generator 1100 may include a patient isolation stage 1520 that communicates with a non-isolation stage 1540 via a power transformer 1560. Secondary windings 1580 of power transformers 1560 are included in isolation stage 1520 and may include a tap configuration (e.g., a center-tap or non-center-tap configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to different surgical devices (such as, for example, ultrasonic surgical device 1104 and electrosurgical device 1106). Specifically, the drive signal outputs 1600a, 1600b, 1600c may output drive signals (e.g., 420V RMS drive signals) to the ultrasonic surgical device 1104, and the drive signal outputs 1600a, 1600b, 1600c may output drive signals (e.g., 100V RMS drive signals) to the electrosurgical device 1106, where the output 1600b corresponds to a center tap of the power transformer 1560. The non-isolated stage 1540 may include a power amplifier 1620, the power amplifier 1620 having an output connected to a primary winding 1640 of a power transformer 1560. In certain aspects, the power amplifier 1620 may comprise, for example, a push-pull amplifier. The non-isolated stage 1540 may also include a programmable logic device 1660, the programmable logic device 1660 being configured to supply digital output to a digital-to-analog converter (DAC) 1680, which in turn, supplies a corresponding analog signal to an input of the power amplifier 1620. In certain aspects, programmable logic device 1660 may comprise, for example, a Field Programmable Gate Array (FPGA). As the input of the power amplifier 1620 is controlled via DAC 1680, the programmable logic device 1660 can thus control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal that appears at the drive signal outputs 1600a, 1600b, 1600 c. In certain aspects and as described below, programmable logic device 1660, in conjunction with a processor (e.g., processor 1740 described below), can implement a plurality of Digital Signal Processing (DSP) based algorithms and/or other control algorithms to control parameters of the drive signals output by generator 1100.

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

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

The non-isolated stage 1540 may further include an ADC 1780 and an ADC 1800, the ADC 1780 and ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 for sampling the voltage and current, respectively, of the drive signal output by the generator 1100. In certain aspects, the ADCs 1780, 1800 may be configured to sample at a high speed (e.g., 80 Msps) to enable oversampling of the drive signal. In one aspect, for example, the sampling rate of the ADCs 1780, 1800 may enable over-sampling of the drive signal by about 200X (depending on frequency). In certain aspects, the sampling operation of the ADCs 1780, 1800 may be performed by a single ADC that receives the input voltage signal and the current signal via a two-way multiplexer. By using high-speed sampling in aspects of the generator 1100, among other things, computation of complex currents flowing through the dynamic legs (which in some aspects may be used to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and computation of actual power consumption with high accuracy may be achieved. The voltage and current feedback data output by the ADCs 1780, 1800 may be received and processed (e.g., FIFO buffered, multiplexed) by the programmable logic device 1660 and stored in a data memory for subsequent retrieval by, for example, the DSP processor 1740. As described above, the voltage and current feedback data can be used as inputs to the algorithm for pre-distorting or modifying LUT waveform samples in a dynamic progression manner. In certain aspects, when voltage and current feedback data pairs are collected, this may entail indexing each stored voltage and current feedback data pair based on or otherwise associated with a corresponding LUT sample output by programmable logic device 1660. Synchronizing LUT samples and voltage and current feedback data in this manner helps in the accurate timing and stability of the predistortion algorithm.

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

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

evaluating the fourier transform at sinusoidal frequencies yields:

other methods include weighted least squares estimation, kalman filtering, and space vector based techniques. For example, almost all of the processing in FFT or DFT techniques may be performed in the digital domain with the assistance of, for example, 2-channel high speed ADCs 1780, 1800. In one technique, digital signal samples of the voltage signal and the current signal are fourier transformed with an FFT or DFT. The phase angle at any point in time can be calculated by the following formula

Wherein the method comprises the steps ofIs the phase angle, f is the frequency, t is the time, and +.>Is the phase at t=0.

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

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

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

The non-isolated stage 1540 may further include a processor 1900 for providing, among other things, user Interface (UI) functionality. In one aspect, processor 1900 may comprise, for example, an Atmel AT91SAM9263 processor with an ARM 926EJ-S core available from altmeyer company (Atmel Corporation, san Jose, calif.) of San Jose, california. Examples of UI functions supported by processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with foot switch 1430, communication with input device 2150 (e.g., a touch screen display), and communication with output device 2140 (e.g., a speaker). Processor 1900 may be in communication with processor 1740 and a programmable logic device (e.g., via a Serial Peripheral Interface (SPI) bus). Although processor 1900 may support primarily UI functions, in some aspects it may also cooperate with processor 1740 to achieve risk mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user inputs and/or other inputs (e.g., touch screen inputs 2150, foot switch 1430 inputs, temperature sensor inputs 2160) and deactivate the drive output of the generator 1100 when an error condition is detected.

In certain aspects, processor 1740 (fig. 26, 27A) and processor 1900 (fig. 26, 27B) may determine and monitor the operational state of generator 1100. For processor 1740, the operating state of generator 1100 may, for example, indicate which control and/or diagnostic processes are implemented by processor 1740. For processor 1900, the operating state of generator 1100 may indicate, for example, which elements of the user interface (e.g., display, sound) are presented to the user. Processors 1740, 1900 may independently maintain the current operating state of generator 1100 and identify and evaluate possible transitions of the current operating state. Processor 1740 may serve as a host in this relationship and determine when a transition between operating states will occur. Processor 1900 may note the valid transitions between operating states and may verify that a particular transition is appropriate. For example, when processor 1740 indicates that processor 1900 transitioned to a particular state, processor 1900 may verify that the requested transition is valid. In the event that processor 1900 determines that the requested inter-state transition is invalid, processor 1900 may cause generator 1100 to enter a failure mode.

The non-isolated stage 1540 may further include a controller 1960 (fig. 26, 27B) for monitoring the input device 2150 (e.g., capacitive touch sensor, capacitive touch screen for turning the generator 1100 on and off). In certain aspects, the controller 1960 may include at least one processor and/or other controller device in communication with the processor 1900. In one aspect, for example, the controller 1960 may include a processor (e.g., a Mega168 bit controller available from Atmel corporation (Atemel)) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, the controller 1960 can include a touch screen controller (e.g., QT5480 touch screen controller available from Atmel corporation (Atemel)) to control and manage the acquisition of touch data from a capacitive touch screen.

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

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

In certain aspects, isolation stage 1520 can include instrument interface circuitry 1980 to provide a communication interface, for example, between control circuitry of the surgical device (e.g., control circuitry including a handpiece switch) and components of non-isolation stage 1540 (such as, for example, programmable logic device 1660, processor 1740, and/or processor 1900). The instrument interface circuit 1980 may exchange information with components of the non-isolation stage 1540 via a communication link (such as, for example, an Infrared (IR) based communication link) that maintains a suitable degree of electrical isolation between the stages 1520, 1540. For example, instrument interface circuit 1980 may be powered using a low drop-out voltage regulator powered by an isolation transformer, which is driven from non-isolation stage 1540.

In one aspect, instrument interface circuit 1980 may include programmable logic device 2000 in communication with signal conditioning circuit 2020 (fig. 26 and 27C). The signal conditioning circuit 2020 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the programmable logic device 2000 to generate bipolar interrogation signals having the same frequency. For example, the interrogation signal may be generated using a bipolar current source fed by a differential amplifier. The interrogation signal may be sent to the surgical device control circuitry (e.g., through the use of conductive pairs in a cable connecting the generator 1100 to the surgical device) and monitored to determine the status or configuration of the control circuitry. For example, the control circuit may include a plurality of switches, resistors, and/or diodes to modify one or more characteristics (e.g., amplitude, correction) of the interrogation signal such that a state or configuration of the control circuit may be uniquely discerned based on the one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may include an ADC for generating samples of the voltage signal that are present in the input of the control circuit as a result of the interrogation signal passing through the control circuit. The programmable logic device 2000 (or a component of the non-isolation stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.

In one aspect, instrument interface circuit 1980 may include a first data circuit interface 2040 to enable exchange of information between programmable logic device 2000 (or other elements of instrument interface circuit 1980) and first data circuits disposed in or otherwise associated with a surgical device. In certain aspects, for example, the first data circuit 2060 can be disposed in a cable integrally attached to the surgical device handpiece, or an adapter for interfacing a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit may include a non-volatile memory device, such as an Electrically Erasable Programmable Read Only Memory (EEPROM) device. In certain aspects and referring again to fig. 26, the first data circuit interface 2040 may be implemented separately from the programmable logic device 2000 and include suitable circuitry (e.g., discrete logic devices, processors) to enable communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 may be integral with the logic device 2000.

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

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

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

In certain aspects, the second data circuit and the second data circuit interface 2100 may be configured such that communication between the programmable logic device 2000 and the second data circuit may be achieved without providing additional conductors for this (e.g., dedicated conductors of a cable connecting the handpiece to the generator 1100). In one aspect, for example, information may be transferred to and from the second data circuit using a single bus communication scheme implemented on an existing cable, such as one of the conductors used to transfer interrogation signals from the signal conditioning circuit 2020 to the control circuit in the hand piece. In this way, design changes or modifications of the surgical device that may otherwise be necessary may be minimized or reduced. Furthermore, because different types of communications may be implemented on a common physical channel (with or without frequency band separation), the presence of the second data circuit may be "stealth" to a generator that does not have the requisite data reading functionality, thus enabling backward compatibility of the surgical device instrument.

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

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

Fig. 28A-28B illustrate certain functional and structural aspects of one aspect of the generator 1100. Feedback indicative of 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 may be implemented as 2-channel ADCs and may sample the feedback signal at a high speed (e.g., 80 Msps) to allow the drive signal to be oversampled (e.g., approximately 200x oversampled). The current feedback signal and the voltage feedback signal may be appropriately conditioned (e.g., amplified, filtered) in the analog domain prior to processing by the ADCs 1780, 1800. The current and voltage feedback samples from the ADCs 1780, 1800 may be buffered separately and then multiplexed or interleaved into a single data stream within the block 2120 of the programmable logic device 1660. In the aspect of fig. 28A-28B, programmable logic device 1660 comprises an FPGA.

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

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

At block 2220 of the predistortion algorithm, the current through the dynamic leg of the ultrasound transducer is determined. May be based on, for example, current and voltage feedback samples stored at memory location 2180 (which, when properly scaled, may represent I in the model of fig. 25 discussed above) _g And V _g ) Static capacitance C of ultrasonic transducer ₀ And a known value of the drive frequency, using kirchhoff's current law. Can be used forA dynamic branch current sample is determined for each set of stored current and voltage feedback samples associated with the LUT sample.

At block 2240 of the predistortion algorithm, each dynamic branch current sample determined at block 2220 is compared to a sample of the desired current waveform shape to determine a difference or sample amplitude error between the compared samples. For this determination, samples of the desired current waveform shape may be supplied, for example, from waveform shape LUT 2260, the waveform shape LUT 2260 containing amplitude samples of one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT 2260 for comparison may be determined by the LUT sample address associated with the dynamic branch current sample for comparison. Thus, the input of the moving branch current to block 2240 may be synchronized to the input of its associated LUT sample address to block 2240. Accordingly, the number of LUT samples stored in programmable logic device 1660 and LUT samples stored in waveform shape LUT 2260 may be equal. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT 2260 may be a fundamental sine wave. Other waveform shapes may be desirable. For example, it is contemplated that a fundamental sine wave for driving the primary longitudinal motion of an ultrasound transducer superimposed with one or more other driving signals at other frequencies may be used, such as third order harmonics for driving at least two mechanical resonances for the advantageous vibrations of the transverse or other modes.

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

The current and voltage amplitude measurements, power measurements, and impedance measurements may be determined at block 2300 of processor 1740 based on current and voltage feedback samples stored at memory location 2180. Before determining these quantities, the feedback samples may be appropriately scaled and, in some aspects, processed through a suitable filter 2320 to remove noise generated by, for example, the data acquisition process and the induced harmonic components. Thus, the filtered voltage and current samples may substantially represent the fundamental frequency of the drive output signal of the generator. In certain aspects, the filter 2320 may be a Finite Impulse Response (FIR) filter applied to the frequency domain. Such aspects may use a Fast Fourier Transform (FFT) of the output drive signal current and voltage signals. In certain aspects, the resulting spectrum may be used to provide additional generator functionality. In one aspect, for example, the ratio of the second order harmonic component and/or the third order harmonic component relative to the fundamental frequency component may be used as a diagnostic indicator.

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

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

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

At block 2400, a measurement P of the apparent output power of the generator _a Can be determined as the product V _rms ·I _rms 。

At block 2420, a measurement Z of the load resistance magnitude _m Can be determined as quotient V _rms /I _rms 。

In certain aspects, at blocks 2340, 2360Quantity I determined at 2380, 2400 and 2420 _rms 、V _rms 、P _r 、P _a And Z _m May be used by the generator 1100 to implement any of a number of control and/or diagnostic processes. In certain aspects, any of these quantities may be communicated to the user via, for example, an output 2140 integral to the generator 1100 or an output 2140 connected to the generator 1100 by a suitable communication interface (e.g., USB interface). For example, various diagnostic processes may include, but are not limited to, handpiece integrity, instrument attachment integrity, instrument overload, proximity instrument overload, frequency lock failure, over-current condition, over-power condition, voltage sense failure, current sense failure, audio indication failure, visual indication failure, short circuit condition, power delivery failure, or blocking capacitor failure.

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

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

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

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

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

At block 2560 (fig. 28A) of the phase control algorithm, a frequency output for controlling the frequency of the drive signal is determined based on the value of the phase error determined at block 2520 and the magnitude of the impedance determined at block 2420. The value of the frequency output may be continuously adjusted by block 2560 and transmitted to DDS control block 2680 (discussed below) to maintain the impedance phase determined at block 2500 at a phase set point (e.g., zero phase error). In certain aspects, the impedance phase may be adjusted to a 0 ° phase set point. In this way, any harmonic distortion will be centered around the peak of the voltage waveform, enhancing the accuracy of the phase impedance determination.

Block 2580 of processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal to control the drive signal current, voltage and power according to a user-specified set point or according to requirements specified by other processes or algorithms implemented by generator 1100. Control of these amounts may be achieved, for example, by scaling LUT samples in LUT 2280 and/or by adjusting the full-scale output voltage of DAC 1680 (which supplies input to power amplifier 1620) via DAC 1860. Block 2600 (which may be implemented in some aspects as a PID controller) may receive as input current feedback samples (which may be appropriately scaled and filtered) from memory location 2180. The current feedback sample may be combined with a "current demand" I specified by a controlled variable (e.g., current, voltage, or power) _d The values are compared to determine if the drive signal supplies the necessary current. In terms of drive signal current as a control variable, current demand I _d Can be controlled by the current set point 2620A (I _sp ) Direct assignment. For example, one canThe RMS value of the current feedback data (as determined in block 2340) is compared to the user-specified RMS current setpoint I _sp A comparison is made to determine the appropriate controller action. For example, if the current feedback data indicates that the RMS value is less than the current set point I _sp The LUT scaling and/or full scale output voltage of DAC 1680 may be adjusted by block 2600 such that the drive signal current increases. Conversely, when the current feedback data indicates that the RMS value is greater than the current set point I _sp Block 2600, in turn, may adjust the LUT scaling and/or full scale output voltage of DAC 1680 to reduce the drive signal current.

In terms of drive signal voltage as control variable, current demand I _d May be based, for example, on maintaining the load impedance magnitude Z measured at block 2420 _m Given the desired voltage set point 2620B (V _sp ) The required current is indirectly specified (e.g., I _d ＝V _sp /Z _m ). Similarly, in terms of drive signal power as a control variable, current demand I _d May be based, for example, on the voltage V measured at block 2360 _rms Given the desired set point 2620C (P _sp ) The required current is indirectly specified (e.g., I _d ＝P _sp /V _rms )。

Block 2680 (fig. 28A) may implement a DDS control algorithm for controlling the drive signals by retrieving LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm may be a digital controlled oscillator (NCO) algorithm for generating samples of waveforms at a fixed clock rate using a point (memory location) -skip technique. The NCO algorithm may implement a phase accumulator or frequency-to-phase converter that is used as an address pointer for retrieving LUT samples from LUT 2280. In one aspect, the phase accumulator may be a D-step, modulus N phase accumulator, where D is a positive integer representing the frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of d=1 may cause the phase accumulator to sequentially point to each address of LUT 2280, producing a waveform output that replicates the waveform stored in LUT 2280. When D >1, the phase accumulator may skip addresses in LUT 2280, producing a waveform output with a higher frequency. Accordingly, the frequency of the waveform generated by the DDS control algorithm can thus be controlled by appropriately changing the frequency control value. In certain aspects, the frequency control value may be determined based on the output of the phase control algorithm implemented at block 2440. The output of block 2680 may supply the input of DAC 1680, which in turn DAC 1680 supplies the corresponding analog signal to the input of power amplifier 1620.

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

Fig. 29 is a schematic diagram of one aspect of a circuit 2900 suitable for driving an ultrasound transducer (such as ultrasound transducer 1120) in accordance with at least one aspect of the present disclosure. Circuit 2900 includes an analog multiplexer 2980. Analog multiplexer 2980 multiplexes the various signals from upstream channels SCL-A, SDA-A such as ultrasound, battery and power control circuitry. The current sensor 2982 is coupled in series with a return leg or ground of the power source circuit to measure the current provided by the power source. A Field Effect Transistor (FET) temperature sensor 2984 provides ambient temperature. Pulse Width Modulation (PWM) watchdog timer 2988 automatically generates a system reset if the main program ignores maintenance on it periodically. It is set to auto-reset circuit 2900 when it stalls or freezes due to a software or hardware failure. It should be appreciated that circuit 2900 may be configured as an RF driver circuit for driving an ultrasound transducer or for driving an RF electrode such as circuit 3600 shown in fig. 36, for example. Thus, referring back now to fig. 29, circuit 2900 may be used to interchangeably drive both the ultrasound transducer and the RF electrode. If driven simultaneously, filter circuits may be provided in the corresponding first stage circuit 3404 (FIG. 34) to select an ultrasonic waveform or an RF waveform. Such filtering techniques are described in commonly owned U.S. patent publication US-2017-0086910-A1, entitled technique for circuit topology for a combined generator (TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR), which is incorporated herein by reference in its entirety.

The drive circuit 2986 provides a left ultrasonic energy output and a right ultrasonic energy output. A digital signal representing the signal waveform is provided from a control circuit, such as control circuit 3200 (fig. 32), to the SCL-A, SDA-A input of analog multiplexer 2980. Digital-to-analog converter 2990 (DAC) converts a digital input to an analog output to drive Pulse Width Modulation (PWM) circuit 2992 coupled to oscillator 2994. The PWM circuit 2992 provides a first signal to a first gate drive circuit 2996a coupled to the first transistor output stage 2998a to drive a first ultrasonic (LEFT) energy output. The PWM circuit 2992 also provides a second signal to a second gate drive circuit 2996b coupled to the second transistor output stage 2998b to drive a second ultrasonic (RIGHT) energy output. A voltage sensor 2999 is coupled between the ultrasonic LEFT/RIGHT output terminals to measure the output voltage. The drive circuit 2986, the first and second drive circuits 2996a and 2996b, and the first and second transistor output stages 2998a and 2998b define a first stage amplifier circuit. In operation, the control circuit 3200 (fig. 32) generates a digital waveform 4300 (fig. 43) using circuitry such as Direct Digital Synthesis (DDS) circuits 4100, 4200 (fig. 41 and 42). DAC 2990 receives digital waveform 4300 and converts it to an analog waveform that is received and amplified by the first stage amplifier circuit.

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

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

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

In one aspect, the master processor 3214 is coupled to the circuit 2900 (fig. 29) through an output terminal SCL-A, SDA-A. The main processor 3214 includes a memory for storing a table of digitized drive signals or waveforms that are transmitted, for example, to the circuit 2900 to drive the ultrasonic transducer 1120. In other aspects, the host processor 3214 may generate and transmit digital waveforms to the circuit 2900, or may store digital waveforms for later transmission to the circuit 2900. The main processor 3214 may also provide RF drive through output terminals SCL-B, SDA-B, and may provide various sensors (e.g., hall effect sensors, magnetorheological fluid (MRF) sensors, etc.) through output terminals SCL-C, SDA-C. In one aspect, the 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 functions.

In one aspect, the main processor 3214 may be, for example, LM4F230H5QR, available from texas instruments (Texas Instruments). In at least one example, LM4F230H5QR of texas instruments (Texas Instruments) is an ARM Cortex-M4F processor core comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle Serial Random Access Memory (SRAM), load withThe present disclosure should not be limited in this context as other processors may be readily substituted for, and thus should not be limited in this context.

Fig. 33 illustrates a simplified circuit block diagram illustrating another circuit 3300 included within a modular ultrasonic surgical instrument 3334 in accordance with at least one aspect of the present disclosure. The circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power source 3304 (e.g., a battery), a switch 3306 (such as a Metal Oxide Semiconductor Field Effect Transistor (MOSFET) power switch), a drive circuit 3308 (PLL), a transformer 3310, a signal smoothing circuit 3312 (also referred to as a matching circuit, and may be, for example, a tank circuit), a sensing circuit 3314, a transducer 1120, and a shaft assembly (e.g., shaft assemblies 1126, 1129) including an ultrasound transmission waveguide, which may be referred to herein simply as a waveguide, terminating at an ultrasound blade (e.g., ultrasound blades 1128, 1149).

One feature of the present disclosure that cuts off the dependence on the high voltage (120 vac) input power (a feature of typical ultrasonic cutting devices) is to utilize a low voltage switch during the entire waveform formation process and amplify the drive signal just prior to the transformer stage. Thus, in one aspect of the present disclosure, power is derived from only one battery or a group of batteries, which are small enough to fit within the handle assembly. Battery technology in the art provides high power batteries with a height and width of a few centimeters and a depth of a few millimeters. By combining features of the present disclosure to provide self-contained and self-powered ultrasound devices, a reduction in manufacturing costs may be achieved.

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

The output of the power source 3304 is also directed to a switch 3306 having a duty cycle controlled by the processor 3302. By controlling the on-time of the switch 3306, the processor 3302 can specify the total amount of power that is ultimately delivered to the transducer 1120. In one aspect, the switch 3306 is a MOSFET, but other switches and switch configurations are adaptable. The output of the switch 3306 is fed to a drive circuit 3308, which drive circuit 3308 comprises, for example, a phase detection Phase Locked Loop (PLL) and/or a low pass filter and/or a voltage controlled oscillator. The output of the switch 3306 is sampled by a processor 3302 to determine the voltage and current (V) of the output signal, respectively _IN And I _IN ). These values are used in a feedback architecture to adjust the pulse of switch 3306And (5) wide modulation. For example, the duty cycle of the switch 3306 may vary in the range of about 20% to about 80%, depending on the desired output and the actual output from the switch 3306.

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

The output of the drive circuit 3308 is a transformer 3310 capable of boosting one or more low voltage signals to a higher voltage. It should be noted that the upstream switching prior to the transformer 3310 is performed at a low (e.g., battery-driven) voltage, which has heretofore not been possible with ultrasonic cutting and cauterization devices. This is due, at least in part, to the fact that the devices advantageously use low on-resistance MOSFET switching devices. Low on-resistance MOSFET switches are advantageous because they produce lower switching losses and less heat than conventional MOSFET devices and allow higher currents to pass. Thus, the switching stage (pre-transformer) can be characterized as low voltage/high current. To ensure a low on-resistance of the one or more amplifier MOSFETs, the one or more MOSFETs are operated at, for example, 10V. In this case, a separate 10VDC power source may be used to power the MOSFET gate, which ensures that the MOSFET is fully on and a fairly low on-resistance is achieved. In one aspect of the disclosure, the 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 herein.

In the circuit configuration, circuit component degradation can negatively impact circuit performance of the circuit. One factor that directly affects component performance is heat. Known circuits typically monitor the switching temperature (e.g., MOSFET temperature). However, due to advances in MOSFET design and corresponding size reduction, MOSFET temperature is no longer an effective indicator of circuit load and heat. Thus, in accordance with at least one aspect of the present disclosure, the sensing circuit 3314 senses the temperature of the transformer 3310. This temperature sensing is advantageous because the transformer 3310 operates at or very near its maximum temperature during use of the device. The additional temperature will cause the core material (e.g., ferrite) to fracture and permanent damage may occur. The present disclosure may respond to the maximum temperature of the transformer 3310 by, for example, reducing the drive power in the transformer 3310, signaling a user, turning off the power, pulsing the power, or other suitable response.

In one aspect of the disclosure, the processor 3302 is communicatively coupled to an end effector (e.g., 1122, 1125) for placing material in physical contact with an ultrasonic blade (e.g., 1128, 1149). A sensor is provided that measures the clamping force value (present in a known range) at the end effector and based on the received clamping force value, the processor 3302 changes the dynamic voltage V _M . Since a high force value in combination with a set rate of movement may produce a high knife temperature, the temperature sensor 3332 may be communicatively coupled to the processor 3302, wherein the processor 3302 is operable to receive and interpret signals indicative of the current temperature of the knife from the temperature sensor 3336 and determine a target frequency of knife movement based on the received temperature. In another aspect, a force sensor, such as a strain sensor or a pressure sensor, may be coupled to the trigger (e.g., 1143, 1147) to measure the force applied to the trigger by the user. In another aspect, a force sensor, such as a strain sensor or a pressure sensor, may be coupled to the switch button such that the displacement intensity corresponds to the force applied to the switch button by the user.

In accordance with at least one aspect of the present disclosure, the PLL portion of the drive circuit 3308 coupled to the processor 3302 is capable of determining the frequency of the waveguide motion and transmitting that frequency to the processor 3302. When the device is turned off, the processor 3302 stores the frequency value in the memory 3326. By reading the clock 3330, the processor 3302 can determine the elapsed time after the device is turned off and if the elapsed time is less than a predetermined value, retrieve the last waveguide movement frequency. The device may then be started at the last frequency, which is probably the optimal frequency for the current load.

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

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

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

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

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

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

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

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

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

Fig. 34 illustrates a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406 in accordance with at least one aspect of the present disclosure. In one aspect, a surgical instrument of the surgical system 1000 described herein may include a generator circuit 3400 divided into a plurality of stages. For example, the surgical instrument of the surgical system 1000 may include a generator circuit 3400 divided into at least two circuits: a first stage circuit 3404 and a second stage circuit 3406 that implement only RF energy operation, only ultrasonic energy operation, and/or a combination of RF energy operation and ultrasonic energy operation. The 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 integrally formed with the modular shaft assembly 3414. As previously discussed throughout this specification in connection with the surgical instruments of the surgical system 1000, the battery assembly 3410 and the shaft assembly 3414 are configured to be mechanically and electrically connected to the handle assembly 3412. The end effector assembly is configured to mechanically and electrically connect the shaft assembly 3414.

Turning now to fig. 34, the generator circuit 3400 is divided into a plurality of stages in a plurality of modular assemblies of a surgical instrument (such as the surgical instrument of the surgical system 1000 described herein). In one aspect, the control level circuit 3402 may be located in a battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is a control circuit 3200 as described in connection with fig. 32. The control circuit 3200 includes a processor 3214, the processor 3214 includes an internal memory 3217 (fig. 34) (e.g., volatile and non-volatile memory) and is electrically coupled to the battery 3211. The battery 3211 supplies power to the first stage circuit 3404, the second stage circuit 3406, and the third stage circuit 3408, respectively. As previously described, the control circuit 3200 uses the circuits and techniques described in connection with fig. 41 and 42 to generate the digital waveform 4300 (fig. 43). Returning to fig. 34, the digital waveform 4300 may be configured to drive an ultrasonic transducer, a high frequency (e.g., RF) electrode, or a combination thereof, independently or simultaneously. If driven simultaneously, filter circuits may be provided in the corresponding first stage circuit 3404 to select an ultrasonic waveform or an RF waveform. Such filtering techniques are described in commonly owned U.S. patent publication US-2017-0086910-A1, entitled technique for circuit topology for a combined generator (TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR), which is incorporated herein by reference in its entirety.

The first stage circuit 3404 (e.g., first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, and first stage sensor drive circuit 3424) is located in the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides an ultrasonic drive signal to the first stage ultrasonic drive circuit 3420 via the output SCL-A, SDA-A of the control circuit 3200. The first stage ultrasound drive circuit 3420 is described in detail in connection with fig. 29. The control circuit 3200 provides an RF drive signal to the first stage RF drive circuit 3422 via the output SCL-B, SDA-B of the control circuit 3200. The first stage RF driver circuit 3422 is described in detail in connection with fig. 36. The control circuit 3200 provides a sensor drive signal to the first stage sensor drive circuit 3424 via the output SCL-C, SDA-C of the control circuit 3200. Generally, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section to drive the second stage circuit 3406. The output of the first stage 3404 is provided to the input 3406 of the second stage.

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

In one aspect, the second stage circuit 3406 (e.g., ultrasound-driven second stage circuit 3430, RF-driven second stage circuit 3432, and sensor-driven second stage circuit 3434) is located in a shaft assembly 3414 of the surgical instrument. The first stage ultrasonic drive circuit 3420 provides a signal to the second stage ultrasonic drive circuit 3430 via the output US-Left/US-Right. The second stage ultrasonic drive circuit 3430 is described in detail in connection with fig. 30 and 31. The second stage ultrasonic drive circuit 3430 may include a filter, an amplifier, and a signal conditioning circuit in addition to the transformer (fig. 30 and 31). The first stage high frequency (RF) current drive circuit 3422 provides signals to the second stage RF drive circuit 3432 via an output RF-Left/RF-Right. The second stage RF driver circuit 3432 may include filters, amplifiers, and signal conditioning circuits in addition to transformers and blocking capacitors. The first stage Sensor driving circuit 3424 provides signals to the second stage Sensor driving circuit 3434 via the output Sensor-1/Sensor-2. The second stage sensor drive circuit 3434 may include filters, amplifiers, and signal conditioning circuitry, depending on the type of sensor. The output of the second stage 3406 is provided to the input of the third stage 3408.

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

Fig. 35 illustrates a generator circuit 3500 divided into a plurality of stages, wherein a first stage circuit 3504 is common to a second stage circuit 3506, in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3500 divided into a plurality of stages. For example, the surgical instrument of the surgical system 1000 may include a generator circuit 3500 that is divided into at least two circuits: a first stage amplification circuit 3504 and a second stage amplification circuit 3506 that implement only high frequency (RF) energy operation, only ultrasonic energy operation, and/or a combination of RF energy operation and ultrasonic energy operation. The modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 integrally formed with the modular shaft assembly 3514. As previously discussed throughout this specification in connection with the surgical instrument of the surgical system 1000, the battery assembly 3510 and the shaft assembly 3514 are configured to be mechanically and electrically connected to the handle assembly 3512. The end effector assembly is configured to mechanically and electrically couple to the shaft assembly 3514.

As shown in the example of fig. 35, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502, the first control circuit 3502 including the previously described control circuit 3200. Handle assembly 3512, which is connected to battery assembly 3510, includes a common first stage drive circuit 3420. As previously described, the first stage drive circuit 3420 is configured to drive ultrasound, high frequency (RF) current, and sensor loads. The output of the common first stage drive circuit 3420 may drive any of the second stage circuits 3506, such as the second stage ultrasonic drive circuit 3430, the second stage high frequency (RF) current drive circuit 3432, and/or the second stage sensor drive circuit 3434. When shaft assembly 3514 is connected to handle assembly 3512, common first stage drive circuit 3420 detects which second stage circuit 3506 is located in shaft assembly 3514. When shaft assembly 3514 is connected to handle assembly 3512, common first stage drive circuit 3420 determines which of second stage circuits 3506 (e.g., second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and/or second stage sensor drive circuit 3434) is located in shaft assembly 3514. This information is provided to control circuitry 3200 located in handle assembly 3512 to provide second stage circuitry 3506 with a suitable digital waveform 4300 (fig. 43) to drive a suitable load, such as ultrasound, RF, or a sensor. It should be appreciated that the identification circuit may be included in various components 3516 in the third stage circuit 3508, such as the ultrasonic transducer 1120, the electrodes 3074a, 3074b, or the sensor 3440. Therefore, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

Fig. 36 is a schematic diagram of one aspect of a circuit 3600 configured to drive a high frequency current (RF) in accordance with at least one aspect of the present disclosure. Circuit 3600 includes analog multiplexer 3680. Analog multiplexer 3680 multiplexes the various signals from upstream channels SCL-A, SDA-A such as RF, battery and power control circuits. A current sensor 3682 is coupled in series with the return leg or ground of the power source circuit to measure the current provided by the power source. A Field Effect Transistor (FET) temperature sensor 3684 provides ambient temperature. Pulse Width Modulation (PWM) watchdog timer 3688 automatically generates a system reset if the main program ignores maintenance on it periodically. It is set to the auto reset circuit 3600 when it stalls or freezes due to a software or hardware failure. It should be appreciated that, for example, the circuit 3600 may be configured for driving an RF electrode or for driving an ultrasonic transducer 1120, as described in connection with fig. 29. Thus, referring back now to fig. 36, circuit 3600 can be used to interchangeably drive both the ultrasound electrode and the RF electrode.

Driver circuit 3686 provides a Left RF energy output and a Right RF energy output. A digital signal representing the signal waveform is provided from a control circuit, such as control circuit 3200 (fig. 32), to the SCL-A, SDA-A input of analog multiplexer 3680. Digital-to-analog converter 3690 (DAC) converts the digital input to an analog output to drive Pulse Width Modulation (PWM) circuit 3692 coupled to oscillator 3694. PWM circuit 3692 provides a first gate drive circuit 3696a to a first transistor output stage 3698a to drive a first rf+ (Left) energy output. PWM circuit 3692 also provides a second gate drive circuit 3696b to be coupled to the second transistor output stage 3698b to drive the second RF- (Right) energy output. A voltage sensor 3699 is coupled between the RF Left/RF output terminals to measure the output voltage. The drive circuit 3686, the first and second drive circuits 3696a and 3696b, and the first and second transistor output stages 3698a and 3698b define a first stage amplifier circuit. In operation, the control circuit 3200 (fig. 32) generates a digital waveform 4300 (fig. 43) using circuitry such as Direct Digital Synthesis (DDS) circuits 4100, 4200 (fig. 41 and 42). DAC 3690 receives digital waveform 4300 and converts it to an analog waveform that is received and amplified by the first stage amplifier circuit.

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

Fig. 38 is a schematic diagram of a circuit 3800 according to at least one aspect of the present disclosure, the circuit 3800 including separate power sources for a high power energy/drive circuit and a low power circuit. The power source 3812 includes a primary battery pack including a first main battery 3815 and a second main battery 3817 (e.g., lithium ion batteries) connected in a circuit 3800 by a switch 3818, and a secondary battery pack including a secondary battery 3820, the secondary battery 3820 being connected in the circuit by a switch 3823 when the power source 3812 is inserted into the battery assembly. The secondary battery 3820 is a sag resistant battery having a component portion that is resistant to gamma or other radiation sterilization. For example, a switch-mode power supply 3827 and optional charging circuitry within the battery assembly may be incorporated to allow the secondary battery 3820 to reduce the voltage drop of the primary batteries 3815, 3817. This ensures that the fully charged unit is easily introduced into the sterile field at the beginning of surgery. The primary batteries 3815, 3817 may be used to directly power the motor control circuit 3836 and the energy circuit 3832. The motor control circuit 3826 is configured to control a motor, such as motor 3829. The power source/battery pack 3812 may include a dual-type battery assembly including primary Li-ion batteries 3815, 3817 and a secondary NiMH battery 3820 having a dedicated energy unit 3820 to control the handle electronics 3830 from the dedicated energy units 3815, 3817 to operate the motor control circuit 3826 and the energy circuit 3832. In this case, when the primary batteries 3815, 3817 related to the drive energy circuit 3832 and/or the motor control circuit 3826 are lowered, the circuit 3810 is pulled from the secondary battery 3820 related to the drive handle electronic circuit 3830. In one aspect, the circuit 3810 may include a unidirectional diode that will not allow current to flow in the opposite direction (e.g., from a battery related to the drive energy circuit and/or the motor control circuit to a motor control circuit related to the drive electronics circuit).

In addition, a gamma friendly charging circuit may be provided that includes a switch mode power supply 3827, the switch mode power supply 3827 using diodes and vacuum tube components to minimize voltage drops at predetermined levels. In the case of a divided minimum drop voltage including for NiMH voltages (3 NiMH cells), the switch-mode power supply 3827 may be eliminated. In addition, a modular system may be provided wherein the radiation hardened component is located in the module such that the module may be sterilized by radiation sterilization. Other non-radiation hardened components may be included in other modular components and connections made between modular components such that the component parts operate together as if the components were located together on the same circuit board. If only two NiMH units are desired, diode and vacuum tube based switch mode power source 3827 allows for sterilizable electronics within a disposable primary battery pack.

Turning now to fig. 39, a control circuit 3900 for operating a battery 3901-powered RF generator circuit 3902 for use with a surgical instrument in accordance with at least one aspect of the present disclosure is illustrated. The surgical instrument is configured to perform a surgical coagulation/cutting process on living tissue using both ultrasonic vibration and high-frequency current, and to perform a surgical coagulation process on living tissue using high-frequency current.

Fig. 39 shows a control circuit 3900, which control circuit 3900 allows the dual generator system to switch between the RF generator circuit 3902 mode and the ultrasound generator circuit 3920 mode of the surgical instrument of the surgical system 1000. In one aspect, a current threshold in an RF signal is detected. When the impedance of the tissue is low, the high frequency current through the tissue is high when the RF energy is used as a therapeutic source for the tissue. According to one aspect, the visual indicator 3912 or light located on the surgical instrument of the surgical system 1000 may be configured to be in an on state during the high current period. When the current is below the threshold, the visual indicator 3912 is in an off state. Accordingly, phototransistor 3914 can be configured to detect a transition from an on state to an off state and dissociate RF energy as shown in control circuit 3900 shown in fig. 39. Accordingly, when the energy button is released and the energy switch 3926 is turned on, the control circuit 3900 is reset and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 remain off.

Referring to fig. 39, in one aspect, a method of managing an RF generator circuit 3902 and an ultrasonic generator circuit 3920 is provided. The RF generator circuit 3902 and/or the ultrasonic generator circuit 3920 may be located in, for example, the handle assembly 1109, the ultrasonic transducer/RF generator assembly 1120, the battery assembly, the shaft assembly 1129, and/or the nozzle of the multi-functional electrosurgical instrument 1108. If the energy switch 3926 is off (e.g., open), the control circuit 3900 remains in the reset state. Thus, when the energy switch 3926 is turned on, the control circuit 3900 is reset, and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 are turned off. When the energy switch 3926 is squeezed and the energy switch 3926 is engaged (e.g., closed), RF energy is delivered to the tissue and the visual indicator 3912 operated by the current sense step-up transformer 3904 will light up when the tissue impedance is low. Light from the visual indicator 3912 provides a logic signal to maintain the ultrasonic generator circuit 3920 in an off state. Once the tissue impedance increases above the threshold and the high frequency current through the tissue decreases below the threshold, the visual indicator 3912 turns off and the light transitions to an off state. The logic signal generated by this transition turns off relay 3908, thereby turning off RF generator circuit 3902 and turning on ultrasonic generator circuit 3920 to complete the coagulation and cutting cycle.

Still referring to fig. 39, in one aspect, the dual generator circuit configuration employs an on-board RF generator circuit 3902 powered by a battery 3901 for one modality and a second, on-board ultrasonic generator circuit 3920, which ultrasonic generator circuit 3920 may be onboard the handle assembly 1109, battery assembly, shaft assembly 1129, nozzle, and/or ultrasonic transducer/RF generator assembly 1120 of the multifunction electrosurgical instrument 1108. Ultrasonic generator circuit 3920 is also battery 3901 operated. In various aspects, the RF generator circuit 3902 and the ultrasonic generator circuit 3920 can be integrated or separable components of the handle assembly 1109. According to various aspects, having dual RF generator circuit 3902/ultrasonic generator circuit 3920 as part of handle assembly 1109 may eliminate the need for complex cabling. The RF generator circuit 3902/ultrasonic generator circuit 3920 may be configured to provide the full capabilities of existing generators while simultaneously utilizing the capabilities of the cordless generator system.

Either type of system may have independent controls for modalities that do not communicate with each other. The surgeon activates RF and ultrasound separately and at their discretion. Another approach would be to provide a fully integrated communication scheme that shares buttons, tissue states, instrument operating parameters (such as jaw closure, forces, etc.), and algorithms for managing tissue processing. Various combinations of this integration may be implemented to provide an appropriate level of functionality and performance.

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

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

In operation, when switch contact 3909 of relay 3908 is open, active electrode 3906a is disconnected from the positive pole of bipolar RF generator circuit 3902 and no current flows through tissue, return electrode 3906b, and first winding 3910a of step-up transformer 3904. Thus, the visual indicator 3912 is not energized and does not emit light. When switch contact 3909 of relay 3908 is closed, active electrode 3906a is connected to the anode of bipolar RF generator circuit 3902, thereby enabling current to flow through tissue, return electrode 3906b, and first winding 3910a of step-up transformer 3904 to operate on tissue, such as cutting and cauterizing tissue.

As a function of the impedance of the tissue located between active electrode 3906a and return electrode 3906b, a first current flows through first winding 3910a, providing a first voltage across first winding 3910a of step-up transformer 3904. The boosted second voltage is induced on the second winding 3910b of the step-up transformer 3904. The secondary voltage appears across resistor R2 and energizes visual indicator 3912 when the current through the tissue is greater than a predetermined threshold, thereby causing the neon bulb to light. It should be understood that the circuit and component values are exemplary and not limited thereto. When switch contact 3909 of relay 3908 is closed, current flows through tissue and opens visual indicator 3912.

Turning now to the energy switch 3926 portion of the control circuit 3900, when the energy switch 3926 is in the open position, a logic high is applied to the input of the first inverter 3928 and a logic low is applied to one of the two inputs of the and gate 3932. Thus, the output of AND gate 3932 is low and transistor 3934 is open to prevent current from flowing through the winding of electromagnet 3936. When electromagnet 3936 is in the de-energized state, switch contact 3909 of relay 3908 remains open and prevents current from flowing through electrodes 3906a, 3906b. The logic low output of the first inverter 3928 is also applied to the second inverter 3930, thereby causing the output to go high and resetting the flip-flop 3918 (e.g., a D-type flip-flop). At this time, the Q output is made low to turn off the ultrasonic generator circuit 3920 andthe output goes high and is applied to the other input of and gate 3932.

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

As described above, the magnitude of the current flowing through electrodes 3906a, 3906b depends on the impedance of the tissue located between electrodes 3906a, 3906 b. Initially, tissue impedance is low and the magnitude of current through the tissue and first winding 3910a is high. Thus, the voltage applied across the second winding 3910b is high enough to turn on the visual indicator 3912. Light emitted by visual indicator 3912 turns on phototransistor 3914, which pulls the input of inverter 3916 low and the output of inverter 3916 high. The high input of CLK applied to flip-flop 3918 does not affect the Q or Q of flip-flop 3918Output, and Q output remains low, and +.>The output remains high. Thus, while the visual indicator 3912 remains energized, the ultrasonic generator circuit 3920 is turned off and the ultrasonic transducer 3922 and ultrasonic blade 3924 of the multi-function electrosurgical instrument are not activated.

When the tissue between electrodes 3906a, 3906b dries, the impedance of the tissue increases and the current through the tissue decreases due to the heat generated by the current flowing through the tissue. As the current through the first winding 3910a decreases, the voltage across the second winding 3910b also decreases, and when the voltage falls below a minimum threshold required to operate the visual indicator 3912, the visual indicator 3912 and the phototransistor 3914 are turned off. When phototransistor 3914 is turned off, a logic high is applied to the input of inverter 3916 and a logic low is applied to the CLK input of flip-flop 3918 to sum to the logic high to the Q output The logic low of the output is clocked. The logic high at the Q output turns on the ultrasonic generator circuit 3920 to activate the ultrasonic transducer 3922 and ultrasonic blade 3924 to begin cutting tissue located between the electrodes 3906a, 3906 a. Which is simultaneously or nearly simultaneously connected to the ultrasound generator circuit 3920,/for>Output flip-flop 3918 goes low and the output of and gate 3932 goes low and transistor 3934 is turned off, thereby powering off electromagnet 3936 and opening switch contact 3909 of relay 3908 to cut off the current flowing through electrodes 3906a, 3906 b.

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

When the user squeezes the energy switch 3926 on the instrument handle to keep the energy switch 3926 closed, the Q output of the trigger 3918 sumsThe output remains the same. Thus, when no current flows from bipolar RF generator circuit 3902 through electrodes 3906a, 3906b, ultrasonic blade 3924 remains activated and continues to cut tissue between the jaws of the end effector. When the user releases the energy switch 3926 on the instrument handle, the energy switch 3926 opens and the output of the first inverter 3928 goes low and the output of the second inverter 3930 goes high to reset the trigger 3918, thereby making the Q output low and turning off the ultrasonic generator circuit 3920. At the same time (I) >The output goes high and the circuit is now in an open state and ready for actuation of the energy switch 3926 on the instrument handle by the user to close the energy switch 3926, apply current to tissue located between the electrodes 3906a, 3906b, and repeat the cycle of applying RF energy and ultrasonic energy to tissue as described above.

Fig. 40 shows a diagram of a surgical system 4000, the surgical system 4000 representing one aspect of a surgical system 1000, including a feedback system for use with any of the surgical instruments of the surgical system 1000, which may include or implement many of the features described herein. Surgical system 4000 can include a generator 4002 coupled to a surgical instrument that includes an end effector 4006, which end effector 4006 can be activated when a trigger 4010 is operated by a clinician. In various aspects, the end effector 4006 can comprise an ultrasonic blade to deliver ultrasonic vibrations to perform surgical coagulation/cutting procedures on living tissue. In other aspects, the end effector 4006 can comprise a conductive element coupled to an electrosurgical high frequency current source for surgical coagulation or cauterization of living tissue, and a mechanical knife having a sharp edge or an ultrasonic knife for cutting living tissue. When trigger 4010 is actuated, force sensor 4012 can generate a signal indicative of an amount of force applied to trigger 4010. In addition to the force sensor 4012 or in lieu of the force sensor 4012, the surgical instrument can include a position sensor 4013 that can generate a signal indicative of the position of the trigger 4010 (e.g., the extent to which the trigger has been pressed or otherwise actuated). In one aspect, the position sensor 4013 can be a sensor that is positioned with an outer tubular sheath or a reciprocating tubular actuation member that is positioned within the outer tubular sheath of the surgical instrument. In one aspect, the sensor may be a hall effect sensor or any suitable transducer that changes its output voltage in response to a magnetic field. Hall effect sensors may be used for proximity switching, positioning, speed detection, and current sensing applications. In one aspect, the hall effect sensor operates as an analog transducer, returning the voltage directly. The distance from the hall plate can be determined using a known magnetic field.

The control circuit 4008 may receive signals from the sensors 4012 and/or 4013. The control circuit 4008 may comprise any suitable analog circuitry or digital circuitry components. The control circuit 4008 can also be in communication with the generator 4002 and/or transducer 4004 to modulate power delivered to the end effector 4006 and/or generator level or ultrasonic blade amplitude of the end effector 4006 based on force applied to the trigger 4010 and/or position of the outer tubular sheath relative to a reciprocating tubular actuation member located within the outer tubular sheath (e.g., as measured by a hall effect sensor and magnet combination) as described above. For example, as more force is applied to the trigger 4010, more power and/or higher ultrasonic blade amplitude can be delivered to the end effector 4006. According to various aspects, the force sensor 4012 can be replaced with a multi-position switch.

According to various aspects, the end effector 4006 can comprise a clamp or clamping mechanism. When trigger 4010 is initially actuated, the clamping mechanism can close, clamping tissue between the clamping arm and end effector 4006. As the force applied to the trigger increases (e.g., as sensed by force sensor 4012), control circuitry 4008 can increase the power delivered by transducer 4004 to end effector 4006 and/or the generator level or ultrasonic blade amplitude generated in end effector 4006. In one aspect, trigger position as sensed by position sensor 4013 or clamp arm position (e.g., with a hall effect sensor) as sensed by position sensor 4013 can be used by control circuit 4008 to set the power and/or amplitude of end effector 4006. For example, as the trigger moves further toward the fully actuated position, or the clamp or clamping arm moves further toward the ultrasonic blade (or end effector 4006), the power and/or amplitude of the end effector 4006 may increase.

According to various aspects, the surgical instrument of the surgical system 4000 can further include one or more feedback devices for indicating the amount of power delivered to the end effector 4006. For example, speaker 4014 can emit a signal indicative of end effector power. According to various aspects, the speaker 4014 may emit a series of pulsed sounds, wherein the frequency of the sounds is indicative of power. In addition to the speaker 4014 or in place of the speaker 4014, the surgical instrument can include a visual display 4016. The visual display 4016 can indicate end effector power according to any suitable method. For example, the visual display 4016 can comprise a series of LEDs, while the end effector power is indicated by the number of LEDs that are illuminated. The speaker 4014 and/or the visual display 4016 can be driven by the control circuitry 4008. According to various aspects, the surgical instrument can include a ratchet device coupled to the trigger 4010. The ratchet device may generate an audible sound as more force is applied to the trigger 4010, thereby providing an indirect indication of the end effector power. The surgical instrument may include other features that may enhance safety. For example, the control circuit 4008 may be configured to prevent delivery of power to the end effector 4006 that exceeds a predetermined threshold. Further, the control circuit 4008 can implement a delay between the time of indicating (e.g., through the speaker 4014 or visual display 4016) the change in end effector power and the time of delivering the change in end effector power. This gives the clinician sufficient warning: the level of ultrasonic power that is to be delivered to the end effector 4006 will vary.

In one aspect, the ultrasonic or high frequency current generator of the surgical system 1000 can be configured to digitally generate the electrical signal waveform such that it is desired to digitize the waveform using a predetermined number of phase points stored in a look-up table. The phase points may be stored in a table defined in memory, a Field Programmable Gate Array (FPGA), or any suitable non-volatile memory. Fig. 41 illustrates an aspect of a basic architecture of a digital synthesis circuit, such as a Direct Digital Synthesis (DDS) circuit 4100, the DDS circuit 4100 being configured to generate a plurality of wave shapes for an electrical signal waveform. The generator software and digital control may instruct the FPGA to scan the addresses in the look-up table 4104, which look-up table 4104 in turn provides varying digital input values to the DAC circuit 4108 feeding the power amplifier. Addresses may be scanned according to the frequency of interest. Using this look-up table 4104, various types of waveforms can be generated that can be fed simultaneously into tissue or transducers, RF electrodes, into multiple transducers, into multiple RF electrodes, or into a combination of RF and ultrasonic instruments. Further, a plurality of look-up tables 4104 representing a plurality of wave shapes may be created, stored, and applied to the tissue from the generator.

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

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

With the widespread use of digital technology in instruments and communication systems, digital control methods that generate multiple frequencies from a reference frequency source have evolved and are being usedKnown as direct digital synthesis. The infrastructure is shown in fig. 41. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic device of the generator circuit, and to a memory circuit located in the generator circuit of the surgical system 1000. DDS circuit 4100 includes address counter 4102, look-up table 4104, register 4106, DAC circuit 4108, and filter 4112. Stable clock f _c Is received by address counter 4102 and register 4106 drives a Programmable Read Only Memory (PROM) that stores one or more integer cycles of a sine wave (or other arbitrary waveform) in look-up table 4104. As the address counter 4102 steps through the memory locations, the values stored in the look-up table 4104 are written to a register 4106, which register 4106 is coupled to the DAC circuit 4108. The corresponding digital amplitude of the signal at the memory location of the look-up table 4104 drives the DAC circuit 4108, which DAC circuit 4108 in turn generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is determined primarily by the DAC circuit 4108. The phase noise being essentially the reference clock f _c Is a phase noise of (a) a (b). The first analog output signal 4110 output from the DAC circuit 4108 is filtered by the filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal has a frequency f _{Output of} 。

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

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

Thus, switching between waveforms may be based on, for example, tissue impedance and other factors. In other aspects, the look-up table 4104 may store an electrical signal waveform shaped to maximize the power delivered into tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the look-up table 4104 may store waveforms synchronized in such a way as to maximize power delivery by the multifunctional surgical instrument of the surgical system 1000 in delivering the RF drive signal and the ultrasound drive signal. In other aspects, the look-up table 4104 may store electrical signal waveforms to drive ultrasound energy and RF therapy energy, and/or sub-therapy energy simultaneously, while maintaining ultrasound lock-in. The custom waveforms specific to the different instruments and their tissue effects may be stored in the non-volatile memory of the generator circuit or in the non-volatile memory (e.g., EEPROM) of the surgical system 1000 and extracted when the multifunction surgical instrument is connected to the generator circuit. An example of an exponentially decaying sinusoid as used in many high crest factor "condensed" waveforms is shown in fig. 43.

A more flexible and efficient implementation of DDS circuit 4100 employs a digital circuit known as a Numerically Controlled Oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit, such as DDS circuit 4200, is shown in fig. 42. In this simplified block diagram, DDS circuit 4200 is coupled to a processor, controller, or logic device of a generator and to memory circuitry located in the generator or in any of the surgical instruments of surgical system 1000. DDS circuit 4200 includes load addressing Memory 4202, parallel increment phase register 4204, adder circuit 4216, phase register 4208, look-up table 4210 (phase-to-amplitude converter), DAC circuit 4212, and filter 4214. Adder circuit 4216 and phase register 4208 form part of phase accumulator 4206. Clock frequency f _c Is applied to phase register 4208 and DAC circuit 4212. The load register 4202 receives a signal specifying the output frequency as a reference clock frequency f _c Is a fractional tuning word of (a). The output of the load register 4202 is provided in tuning word M to the parallel delta phase register 4204.

DDS circuit 4200 includes a clock frequency f generator _c A phase accumulator 4206, and a lookup table 4210 (e.g., a phase-to-amplitude converter). Every clock cycle f _c The contents of phase accumulator 4206 are updated once. When the time of the phase accumulator 4206 is updated, the number M stored in the parallel delta phase register 4204 is added to the number in the phase register 4208 by the adder circuit 4216. Assume that the number in parallel delta phase register 4204 is 00 … 01 and the initial content of phase accumulator 4206 is 00 … 00. Phase accumulator 4206 is updated with 00 … each clock cycle. If phase accumulator 4206 is 232 bits wide, 232 clock cycles (over 40 hundred million) are required before phase accumulator 4206 returns to 00 … 00 and the cycle is repeated.

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

In one aspect, the electrical signal waveform may be digitized into 1024 (210) phase points, but the wave shape may be digitized into any suitable number of 2n phase points ranging from 256 (28) to 281,474,976,710,656 (248), where n is a positive integer, as shown in table 1. The waveform of the electrical signal can be represented as A _n (θ _n ) Wherein the normalized amplitude A at point n is determined by the phase angle θ called the phase point at point n _n And (3) representing. The number of discrete phase points n determines the tuning resolution of DDS circuit 4200 (and DDS circuit 4100 shown in fig. 41).

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

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

TABLE 1

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

Referring back to fig. 41, for n=32 and m=1, the phase accumulator 4206 steps through 232 possible outputs before it overflows and restarts. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If m=2, the phase register 1708 "roll over" is twice as fast and the output frequency is doubled. This can be generalized as follows.

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

the above formula is referred to as the DDS "tuning formula". Note that the frequency resolution of the system is equal toFor n=32, the resolution is greater than forty parts per billion. In one aspect of DDS circuit 4200, not all bits from phase accumulator 4206 are passed to lookup table 4210, but truncated, leaving only the first 13 to 15 Most Significant Bits (MSBs). This reduces the size of the look-up table 4210 and does not affect the frequency resolution. Phase cut-off only to final output A small but acceptable amount of phase noise is added.

The electrical signal waveform may be characterized by a current, voltage or power at a predetermined frequency. Additionally, where any of the surgical instruments of the surgical system 1000 include ultrasonic components, the electrical signal waveforms may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Thus, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, wherein the electrical signal waveform is characterized by a predetermined waveform shape stored in the look-up table 4210 (or look-up table 4104 of fig. 41). Further, the electrical signal waveform may be a combination of two or more wave shapes. The lookup table 4210 may comprise information associated with a plurality of waveforms. In one aspect or example, the lookup table 4210 may be generated by the DDS circuit 4200 and may be referred to as a direct digital synthesis table. The DDS works by first storing a number of repeated waveforms in an on-board memory. The cycle of waveforms (sine, triangle, square, arbitrary) may be represented by a predetermined number of phase points as shown in table 1 and stored in memory. Once the waveform is stored in memory, it can be generated at a very precise frequency. The direct digital synthesis table may be stored in a non-volatile memory of the generator circuit and/or may be implemented with FPGA circuitry in the generator circuit. The look-up table 4210 may be addressed by any suitable technique that facilitates classifying waveforms. According to one aspect, the look-up table 4210 is addressed according to the frequency of the electrical signal waveform. In addition, information associated with the plurality of waveforms may be stored in memory as digital information or as part of the look-up table 4210.

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

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

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

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

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

Thus, switching between waveforms may be based on, for example, tissue impedance and other factors. In other aspects, the look-up table 4210 may store electrical signal waveforms shaped to maximize the power delivered into tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the look-up table 4210 may store waveforms synchronized in such a way that they maximize power delivery through any of the surgical instruments of the surgical system 1000 when delivering the RF signal and the ultrasonic drive signal. In other aspects, the look-up table 4210 may store electrical signal waveforms to drive ultrasound energy and RF therapy energy, and/or sub-therapy energy simultaneously, while maintaining ultrasound lock-in. Generally, the output wave shape may be in the form of a sine wave, a cosine wave, a pulse wave, a square wave, or the like. However, more complex and customized waveforms specific to different instruments and their tissue effects may be stored in the non-volatile memory of the generator circuit or the non-volatile memory of the surgical instrument (e.g., EEPROM) and extracted when the surgical instrument is connected to the generator circuit. One example of a custom wave shape is an exponentially decaying sinusoid used in many high crest factor "condensed" waveforms, as shown in fig. 43.

Fig. 43 illustrates discrete-time digital telecommunications of an analog waveform 4304 in accordance with at least one aspect of the present disclosureOne cycle of the number waveform 4300 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison). The horizontal axis represents time (t) and the vertical axis represents the digital phase point. The digital electrical signal waveform 4300 is, for example, a digital discrete time version of the desired analog waveform 4304. Digital electrical signal waveform 4300 is generated by storing a magnitude phase 4302, the magnitude phase 4302 representing a cycle or period T _o Each clock cycle T _clk Is a function of the magnitude of (a). The digital electrical signal waveform 4300 is processed through any suitable digital processing circuitry for a period T _o And (5) generating. The amplitude phase point is a digital word stored in a memory circuit. In the examples shown in fig. 41, 42, the digital word is a six-bit word capable of storing the amplitude phase point at a resolution of 26 bits or 64 bits. It should be appreciated that the examples shown in fig. 41, 42 are for illustrative purposes, and that in actual implementations, the resolution may be higher. In one cycle T _o The above digital amplitude phase point 4302 is stored in memory as a string in the look-up tables 4104, 4210, as described in connection with fig. 41, 42, for example. To generate an analog version of analog waveform 4304, clock cycle T is cycled from memory _clk From 0 to T _o Amplitude phase point 4302 is read in turn and converted by DAC circuits 4108, 4212, also described in connection with fig. 41, 42. Can be obtained by moving the amplitude phase point 4302 of the digital electrical signal waveform 4300 from 0 to T _o The repeated reading generates as many cycles or periods as possible to generate additional cycles. The smooth analog version of the analog waveform 4304 is achieved by filtering the output of DAC circuits 4108, 4212 with filters 4112, 4214 (fig. 41 and 42). The filtered analog output signals 4114, 4222 (fig. 41 and 42) are applied to the inputs of the power amplifier.

Fig. 44 is a schematic view of a control system 12950 configured to provide progressive closure of a closure member (e.g., closure tube) as a displacement member is advanced distally and coupled to a clamp arm (e.g., anvil) to reduce the closure force load on the closure member and reduce the firing force load on the firing member at a desired rate, in accordance with an aspect of the present disclosure. In one aspect, the control system 12950 can be implemented as a nested PID feedback controller. PIDThe controller is a control loop feedback mechanism (controller) that is used to continuously calculate the difference between the desired set point and the measured process variable from the error value and apply corrections based on proportional, integral, and derivative terms (sometimes denoted as P, I and D, respectively). The nested PID controller feedback control system 12950 includes a primary controller 12952 in a primary (outer) feedback loop 12954 and a secondary controller 12955 in a secondary (inner) feedback loop 12956. The primary controller 12952 may be a PID controller 12972 as shown in fig. 45, and the secondary controller 12955 may also be a PID controller 12972 as shown in fig. 45. The primary controller 12952 controls a primary process 12958 and the secondary controller 12955 controls a secondary process 12960. The output 12966 of the primary process 12958 is from the primary set point SP ₁ The first summer 12962 is subtracted. The first summer 12962 produces a single sum output signal that is applied to the master controller 12952. The output of the main controller 12952 is the secondary set point SP ₂ . The output 12968 of the secondary process 12960 is from the secondary set point SP ₂ The second summer 12964 is subtracted.

In the case of controlling the displacement of the closure tube, the control system 12950 can be configured such that the main set point SP ₁ Is a desired closing force value, and the main controller 12952 is configured to receive the closing force from a torque sensor coupled to the output of the closing motor and determine the closing motor set point SP ₂ Motor speed. In other aspects, the closing force may be measured with a strain gauge, load cell, or other suitable force sensor. Will close the motor speed setpoint SP ₂ The actual speed of the closure tube is compared to the actual speed, which is determined by the secondary controller 12955. The actual speed of the closure tube can be measured by comparing the measured displacement of the closure tube with the position sensor and measuring the elapsed time with a timer/counter. Other techniques such as linear encoders or rotary encoders may be employed to measure the displacement of the closure tube. The output 12968 of the secondary process 12960 is the actual speed of the closure tube. The closure tube speed output 12968 is provided to a primary process 12958, which primary process 12958 determines the force acting on the closure tube and feeds back to an adder 12962, which adder 12962 is from the main set point SP ₁ The measured closing force is subtracted. Main setpoint SP ₁ May be an upper threshold or a lower threshold. Based on the output of adder 12962, the main controller 12952 controls the speed and direction of the closing motor. Secondary controller 12955 is based on the actual speed of the closure tube measured by secondary process 12960 and a secondary set point SP ₂ To control the speed of the closing motor based on a comparison of the actual firing force with the upper and lower firing force thresholds.

Fig. 45 illustrates a PID feedback control system 12970 in accordance with an aspect of the present disclosure. The primary controller 12952 or the secondary controller 12955 or both may be implemented as PID controllers 12972. In one aspect, the PID controller 12972 can include a proportional element 12974 (P), an integral element 12976 (I), and a derivative element 12978 (D). The outputs of P-element 12974, I-element 12976, D-element 12978 are summed by summer 12986, which summer 12986 provides a control variable μ (t) to process 12980. The output of process 12980 is the process variable y (t). Summer 12984 calculates the difference between the desired set point r (t) and the measured process variable y (t). The PID controller 12972 continuously calculates an error value e (t) (e.g., the difference between the closing force threshold and the measured closing force) as the difference between the desired set point r (t) (e.g., the closing force threshold) and the measured process variable y (t) (e.g., the speed and direction of the closing tube) and applies a correction based on the proportional, integral, and derivative terms calculated by the proportional, integral, and derivative elements 12974 (P), 12976 (I), 12978 (D), respectively. The PID controller 12972 attempts to minimize the error e (t) over time by adjusting the control variable μ (t) (e.g., the speed and direction of the closed tube).

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

It should be appreciated that other variables and setpoints may be monitored and controlled in accordance with the feedback control systems 12950, 12970. For example, the adaptive closure member speed control algorithm described herein may measure at least two of the following parameters: firing member travel position, firing member load, displacement of the cutting element, speed of the cutting element, closure tube travel position, closure tube load, and the like.

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

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

The ultrasound transducer may be modeled as an equivalent circuit comprising a first branch having a static capacitance and a second "dynamic" branch having serially connected inductances, resistances and capacitances defining the electromechanical properties of the resonator. Known ultrasonic generators may include a tuning inductor for detuning a static capacitance at a resonant frequency such that substantially all of the drive signal current of the generator flows into the dynamic leg. Thus, by using a tuning inductor, the drive signal current of the generator is representative of the dynamic branch current, and thus the generator is able to control its drive signal to maintain the resonant frequency of the ultrasound transducer. Tuning the inductor may also transform the phase-impedance diagram of the ultrasound transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the particular static capacitance of the ultrasound transducer at the operating resonant frequency. In other words, different ultrasound transducers with different static capacitances require different tuning inductors.

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

Furthermore, electromagnetic interference in noisy environments can reduce the ability of the generator to maintain a lock on the resonant frequency of the ultrasound transducer, thereby increasing the likelihood of invalid control algorithm inputs.

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

The electrical energy applied by the electrosurgical device may be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy may be in the form of Radio Frequency (RF) energy. RF energy is a form of electrical energy that can be in the frequency range of 300kHz to 1MHz, as described in EN60601-2-2:2009+a11:2011, definition 201.3.218-high frequency. For example, frequencies in monopolar RF applications are typically limited to less than 5MHz. However, in bipolar RF applications, the frequency can be almost any value. Monopolar applications typically use frequencies above 200kHz in order to avoid undesirable stimulation of nerves and muscles due to the use of low frequency currents. Bipolar techniques may use lower frequencies if the risk analysis shows that the likelihood of neuromuscular stimulation has been reduced to acceptable levels. Typically, frequencies above 5MHz are not used to minimize the problems associated with high frequency leakage currents. It is generally considered that 10mA is the lower threshold for tissue heating effects.

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

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

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

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

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

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

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

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

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

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

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

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

It should be understood that the terms "proximal" and "distal" as used herein are with respect to a clinician gripping a handpiece assembly. Thus, the end effector is distal with respect to the more proximal handpiece. It should also be understood that for convenience and clarity, spatial terms such as "top" and "bottom" are also used herein with respect to the case where the clinician is holding the handpiece assembly. However, surgical devices are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

Fig. 46 is an exploded front view of a modular hand-held ultrasonic surgical instrument 6480 showing a left housing half removed from a handle assembly 6482, exposing a device identifier communicatively coupled to a multi-lead handle terminal assembly, in accordance with one aspect of the present disclosure. In additional aspects of the present disclosure, a smart or smart battery is used to power the modular hand-held ultrasonic surgical instrument 6480. However, the smart battery is not limited to the modular hand-held ultrasonic surgical instrument 6480, and as will be explained, may be used in a variety of devices that may or may not have power requirements (e.g., current and voltage) that are different from one another. According to one aspect of the present disclosure, the smart battery assembly 6486 is advantageously capable of identifying the particular device to which it is electrically coupled. It performs this operation by means of an encrypted or unencrypted identification method. For example, the smart battery assembly 6486 can have a connection portion, such as connection portion 6488. The handle assembly 6482 may also be provided with a device identifier communicatively coupled to the multi-lead handle terminal assembly 6491 and operable to communicate at least one piece of information about the handle assembly 6482. This information may relate to the number of times the handle assembly 6482 has been used, the number of times the ultrasonic transducer/generator assembly 6484 has been used (currently disconnected from the handle assembly 6482), the number of times the waveguide shaft assembly 6490 has been used (currently connected to the handle assembly 6482), the type of waveguide shaft assembly 6490 currently connected to the handle assembly 6482, the type or identity of the ultrasonic transducer/generator assembly 6484 currently connected to the handle assembly 6482, and/or many other features. When the smart battery assembly 6486 is inserted into the handle assembly 6482, the connection portion 6488 within the smart battery assembly 6486 is in communicative contact with the device identifier of the handle assembly 6482. The handle assembly 6482 can transmit information to the smart battery assembly 6486 (whether by self-starting or in response to a request from the smart battery assembly 6486) through hardware, software, or a combination thereof. The communication identifier is received by the connection portion 6488 of the smart battery assembly 6486. In one aspect, once the smart battery assembly 6486 receives the information, the communication portion is operable to control the output of the smart battery assembly 6486 to meet the specific power requirements of the device.

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

Thus, the smart battery assembly 6486 in accordance with at least one aspect of the present disclosure allows the battery assembly to be used between several surgical instruments. Because the smart battery assembly 6486 is able to identify which device it is attached to and change its output accordingly, operators of the various surgical instruments utilizing the smart battery assembly 6486 no longer need to worry about the power source they are attempting to install within the electronic device being used. This is particularly advantageous in operating environments where the battery assembly needs to be replaced or interchanged with another surgical instrument during a complex surgical procedure.

In another aspect of the present disclosure, the smart battery assembly 6486 stores a record of each use of a particular device in the memory 6497. The record may be useful for assessing the end of the usable or permissible life of the device. For example, once the device is used 20 times, such a battery in the smart battery assembly 6486 connected to the device will refuse to supply power thereto, as the device is defined as a "no longer reliable" surgical instrument. Reliability is determined based on a number of factors. One factor may be wear, which may be estimated in a variety of ways, including the number of times the device has been used or activated. After a certain number of uses, the components of the device may become worn and exceed tolerances between the components. For example, the smart battery assembly 6486 may sense the number of button pushes received by the handle assembly 6482 and may determine when the maximum number of button pushes is reached or exceeded. The smart battery assembly 6486 can also monitor the impedance of the button mechanism, which can change, for example, when the handle is contaminated with, for example, saline.

Such wear can lead to unacceptable failure during the procedure. In some aspects, the smart battery assembly 6486 can identify which components are grouped together in the device and even how many times the component has undergone use. For example, if the smart battery assembly 6486 is a smart battery according to the present disclosure, it may well identify the handle assembly 6482, the waveguide shaft assembly 6490, and the ultrasonic transducer/generator assembly 6484 before a user attempts to use the composite device. The memory 6497 within the smart battery assembly 6486 may, for example, record the time the ultrasound transducer/generator assembly 6484 was operated, the manner in which it was operated, when it was operated, and the duration of the operation. If the ultrasound transducer/generator assembly 6484 has a separate identifier, the smart battery assembly 6486 may track the use of the ultrasound transducer/generator assembly 6484 and refuse to power the ultrasound transducer/generator assembly 6484 once the handle assembly 6482 or the ultrasound transducer/generator assembly 6484 exceeds its maximum number of uses. The ultrasonic transducer/generator assembly 6484, handle assembly 6482, waveguide shaft assembly 6490, or other components may also include a memory chip that records this information. As such, any number of smart batteries in the smart battery assembly 6486 may be used with any number of ultrasound transducer/generator assemblies 6484, staplers, vascular sealers, etc., and still be able to determine the total number of uses or total time of use, or total actuation time, etc., or charge or discharge cycles of the ultrasound transducer/generator assemblies 6484, staplers, vascular sealers, etc. The intelligent functionality may reside external to the battery assembly 6486 and may reside, for example, in the handle assembly 6482, the ultrasonic transducer/generator assembly 6484, and/or the shaft assembly 6490.

When counting the use of the ultrasound transducer/generator assembly 6484 to intelligently terminate the life of the ultrasound transducer/generator assembly 6484, the surgical instrument accurately distinguishes between completion of actual use of the ultrasound transducer/generator assembly 6484 in a surgical procedure and momentary loss of actuation of the ultrasound transducer/generator assembly 6484 due to, for example, battery replacement or temporary delay in the surgical procedure. Thus, as an alternative to simply counting the number of activations of the ultrasound transducer/generator assembly 6484, a Real Time Clock (RTC) circuit may be implemented to track the amount of time that the ultrasound transducer/generator assembly 6484 is actually turned off. From the measured length of time, it can be determined by appropriate logic if the shut down is significant enough to be considered the end of a real use, or if the shut down time is too short to be considered the end of a use. Thus, in some applications, the method may more accurately determine the useful life of the ultrasound transducer/generator assembly 6484 than a simple "activation-based" algorithm, which may provide, for example, that ten "activations" occur in a surgical procedure, and thus ten activations should indicate that the counter is incremented by one. Generally, this type and internal clock of the system will prevent misuse of devices designed to fool a simple "activation-based" algorithm, and will prevent incorrect recording of full use in the event that simple decommissioning of the ultrasound transducer/generator assembly 6484 or the smart battery assembly 6486 is required for legal reasons only.

Although the ultrasonic transducer/generator assembly 6484 of the surgical instrument 6480 is reusable, in one aspect, a limited number of uses may be provided because the surgical instrument 6480 is subjected to harsh conditions during cleaning and sterilization. More specifically, the battery pack is configured to be sterilized. Regardless of the material used for the outer surface, the actual material used has a limited life expectancy. The lifetime is determined by various features, which may include, for example, the number of times the battery has actually been sterilized, the time the battery has been manufactured, and the number of times the battery has been recharged. In addition, the lifetime of the battery cell itself is limited. The software of the present disclosure employs the algorithm of the present disclosure that validates the number of uses of the ultrasound transducer/generator assembly 6484 and the smart battery assembly 6486 and disables the device when the number of uses is reached or exceeded. The outside of the battery can be analyzed with each of the possible sterilization methods. Based on the most severe sterilization process, the maximum number of sterilizations allowed may be defined and may be stored in the memory of the smart battery assembly 6486. If the charger is assumed to be non-sterile and the smart battery assembly 6486 is used after charging, the charge count may be defined as equal to the number of sterilizations encountered by that particular battery pack.

In one aspect, hardware in the battery pack may be disabled to minimize or eliminate safety issues due to continued leakage from the battery cells after the software disables the battery pack. Under certain low voltage conditions, there may be situations where the battery internal hardware cannot disable the battery. In such cases, in one aspect, the charger may be used to "kill" the battery. Due to the fact that the battery microcontroller is in its off state in its charger, an unsterilised System Management Bus (SMB) based Electrically Erasable Programmable Read Only Memory (EEPROM) can be used to exchange information between the battery microcontroller and the charger. Thus, serial EEPROMs may be used to store information that can be written to and read from even when the battery microcontroller is off, which is beneficial when attempting to exchange information with a charger or other peripheral device. The example EEPROM may be configured to include sufficient memory registers to store at least (a) a usage count limit (battery usage count) when the battery should be disabled, (b) a number of procedures that the battery has undergone (battery procedure count), and/or (c) a number of charges that the battery has undergone (charge count), among others. Some of the information stored in the EEPROM (such as a usage count register and a charge count register) is stored in the write-protected portion of the EEPROM to prevent the user from altering the information. In one aspect, usage and counters are stored with corresponding bit-reversed secondary detectors to detect data corruption.

Any residual voltage in the SMBus line can damage the microcontroller and damage the SMBus signal. Thus, to ensure that the SMBus line of the battery controller does not carry voltage when the microcontroller is off, a relay is provided between the external SMBus line and the battery microcontroller board.

During charging of the smart battery assembly 6486, an "end of charge" condition of the battery within the smart battery assembly 6486 is determined when the current flowing into the battery drops below a given threshold in a tapered manner, such as when a constant current/constant voltage charging scheme is employed. To accurately detect this "end of charge" condition, the battery microcontroller and the buck panel are de-energized and shut down during battery charging to reduce any current consumption that may be caused by the panel and may interfere with the taper current detection. In addition, the microcontroller and buck board are powered down during charging to prevent any damage to the SMBus signal.

Regarding the charger, in one aspect, the smart battery assembly 6486 is prevented from being inserted into the charger in any manner other than the correct insertion position. Thus, the exterior of the smart battery assembly 6486 is provided with a charger retaining feature. The cup used to securely hold the smart battery assembly 6486 in the charger is configured with a profile that matches the taper geometry to prevent accidental insertion of the smart battery assembly 6486 in any manner other than the correct (intended) manner. It is also contemplated that the presence of the smart battery assembly 6486 may be detected by the charger itself. For example, the charger may be configured to detect the presence of the SMBus transformer from the battery protection circuit and a resistor located in the protection board. In such cases, the charger will be able to control the voltage exposed at the pins of the charger until the smart battery assembly 6486 is properly seated or in place on the charger. This is because the exposed voltage at the pins of the charger will present a risk and risk that an electrical short may occur across the pins and cause the charger to inadvertently begin charging.

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

In yet another aspect of the present disclosure, the microcontroller in the ultrasound transducer/generator assembly 6484 enters a sleep mode when not in use for a predetermined period of time. Advantageously, the clock speed of the microcontroller is reduced when in sleep mode, thereby significantly curtailing current consumption. As the processor continues to ping waiting to sense the input, some current continues to be consumed. Advantageously, the microcontroller and battery controller may directly control the LEDs when the microcontroller is in the power saving sleep mode. For example, a decoder circuit may be built into the ultrasound transducer/generator assembly 6484 and connected to the communication pipeline, such that the LEDs may be independently controlled by the processor 6493 when the ultrasound transducer/generator assembly 6484 microcontroller is "off" or in "sleep mode". This is a power saving feature that eliminates the need to wake up the microcontroller in the ultrasound transducer/generator assembly 6484. Power is saved by allowing the generator to be turned off while still being able to effectively control the user interface indicator.

On the other hand, when not in use, one or more microcontrollers are slowed down to save power. For example, the clock frequency of the two microcontrollers may be reduced to save power. To maintain synchronous operation, the microcontroller coordinates the change in its respective clock frequency to decrease and then subsequently increase in frequency at about the same time when full speed operation is required. For example, the clock frequency decreases when entering idle mode and increases when exiting idle mode.

In another aspect, the smart battery assembly 6486 can determine the amount of available power remaining within its unit and be programmed to operate only the surgical instrument to which it is attached if it determines that there is sufficient battery power to predictably operate the device throughout the intended procedure. For example, if there is insufficient power within the unit to operate the surgical instrument for 20 seconds, the smart battery assembly 6486 can remain in a non-operational state. According to one aspect, the smart battery assembly 6486 determines the amount of power remaining within the battery at the end of its most recent previous function (e.g., surgical cut). Thus, in this regard, if, for example, during this procedure, the smart battery assembly 6486 determines that the power of the unit is insufficient, it will not allow for subsequent functions to be performed. Alternatively, if the smart battery assembly 6486 determines that there is sufficient power for the subsequent procedure during the procedure and below the threshold, it will not interrupt the ongoing procedure, but will allow it to complete, and then prevent additional procedures from occurring.

The advantages of using the device having the smart battery assembly 6486 of the present disclosure to the greatest extent are explained below. In this example, a different set of devices have different ultrasound transmission waveguides. By definition, the waveguide may have a corresponding maximum allowable power limit beyond which the waveguide is over-pressurized and eventually broken. One waveguide from the set of waveguides will naturally have the smallest maximum power tolerance. Because prior art batteries lack intelligent battery power management, the output of prior art batteries must be limited by the value of the minimum maximum allowable power input for the smallest/thinnest/weakest waveguide in the settings envisioned and used by the device/battery. Even though a larger, thicker waveguide may later be attached to the handle and by definition allow for the application of a greater force. This limitation also exists for maximum battery power. For example, if a battery is designed for use in multiple devices, its maximum output power will be limited by the lowest maximum power level of any of the devices that are to use the battery. With this configuration, one or more devices or device configurations will not be able to make maximum use of the battery, as the battery is not aware of the specific limitations of a particular device.

In one aspect, the smart battery assembly 6486 can be used to intelligently bypass the ultrasound device limitations described above. The smart battery assembly 6486 may generate one output for one device or a particular device configuration, and the same smart battery assembly 6486 may later generate a different output for a second device or device configuration. The universal intelligent battery surgical system is well suited for modern operating rooms where space and time are at a premium. By having the intelligent battery packs operate many different devices, nurses can easily manage the storage, retrieval and inventory of these battery packs. Advantageously, in one aspect, a smart battery system according to the present disclosure may employ a type of charging station, thereby increasing ease and efficiency of use and reducing the cost of the surgical room charging device.

In addition, other surgical instruments (such as a powered stapler) may have different power requirements than the modular hand-held ultrasonic surgical instrument 6480. According to various aspects of the present disclosure, the smart battery assembly 6486 may be used with any of a range of surgical instruments and may be manufactured to customize its own power output to the particular device in which it is installed. In one aspect, the power regulation is performed by controlling the duty cycle of a switch mode power source (such as buck, buck-boost, or other configuration integrally formed with or otherwise coupled to and controlled by the smart battery assembly 6486).

Fig. 47 is a detailed view of a trigger 6483 portion and switch of the ultrasonic surgical instrument 6480 shown in fig. 46, in accordance with at least one aspect of the present disclosure. The trigger 6483 is operably coupled to the jaw member 6495 of the end effector 6492. The ultrasonic blade 6496 is powered by the ultrasonic transducer/generator assembly 6484 when the activation switch 6485 is activated. Continuing now with fig. 46 and referring also to fig. 47, the trigger 6483 and activation switch 6485 are shown as components of the handle assembly 6482. The trigger 6483 activates the end effector 6492, which end effector 6492 is cooperatively associated with the ultrasonic blade 6496 of the waveguide shaft assembly 6490 to enable various types of contact between the end effector jaw member 6495 and the ultrasonic blade 6496 with tissue and/or other matter. The jaw member 6495 of the end effector 6492 is generally a pivoting jaw that is adapted to grasp or clamp onto tissue disposed between the jaw and the ultrasonic blade 6496. In one aspect, audible feedback is provided in the trigger when the trigger is fully depressed. Noise can be generated by the thin metal part of the trigger snap when closed. This feature adds an audible component to the user feedback that tells the user that the jaws are fully compressed against the waveguide and that sufficient clamping pressure is being applied to complete the vessel seal. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the trigger 6483 to measure the force applied to the trigger 6483 by the user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch 6485 button such that the displacement strength corresponds to the force applied to the switch 6485 button by the user.

When depressed, activating switch 6485 places modular hand-held ultrasonic surgical instrument 6480 in an ultrasonic mode of operation that induces ultrasonic motion at waveguide assembly 6490. In one aspect, depressing the activation switch 6485 causes electrical contacts within the switch to close, completing a circuit between the smart battery assembly 6486 and the ultrasound transducer/generator assembly 6484 to apply electrical energy to the ultrasound transducer, as previously described. On the other hand, depressing the activation switch 6485 closes an electrical contact to the smart battery assembly 6486. Of course, the description of closed electrical contacts in an electrical circuit herein is merely an exemplary general description of a switching operation. There are many alternative aspects that may include opening contacts or processor controlled power delivery that receive information from a switch and direct a corresponding circuit reaction based on the information.

Fig. 48 is an enlarged partial perspective view of an end effector 6492, seen from a distal end, in accordance with at least one aspect of the present disclosure, with a jaw member 6495 in an open position. Referring to fig. 48, a perspective partial view of the distal end 6498 of the waveguide shaft assembly 6490 is shown. The waveguide shaft assembly 6490 includes an outer tube 6494 surrounding a portion of a waveguide. The ultrasonic blade 6496 portion of the waveguide 6499 protrudes from the distal end 6498 of the outer tube 6494. Contacting the tissue and delivering its ultrasonic energy to the tissue during the medical procedure is the portion of the ultrasonic blade 6496. Waveguide shaft assembly 6490 also includes a jaw member 6495 coupled to an outer tube 6494 and an inner tube (not visible in this view). The jaw member 6495, along with the inner and outer tubes of the waveguide 6499 and the portion of the ultrasonic blade 6496, may be referred to as an end effector 6492. As will be explained below, the outer tube 6494 and the inner tube, not shown, slide longitudinally relative to each other. As relative movement between the outer tube 6494 and the inner tube, not shown, occurs, the jaw member 6495 pivots on a pivot point, causing the jaw member 6495 to open and close. When closed, the jaw member 6495 exerts a clamping force on tissue located between the jaw member 6495 and the ultrasonic blade 6496, thereby ensuring positive and effective blade-to-tissue contact.

Fig. 49 is a system diagram 7400 of a segmented circuit 7401 comprising a plurality of independently operating circuit sections 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 according to at least one aspect of the present disclosure. The circuit sections of the plurality of circuit sections of the segmented circuit 7401 include one or more circuits and one or more sets of machine-executable instructions stored in one or more memory devices. One or more circuits of the circuit section are coupled to communicate electrically over one or more wired or wireless connection media. The plurality of circuit sections are configured to transition between three modes including a sleep mode, a standby mode, and an operational mode.

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

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

Referring back to the system diagram 7400 in fig. 49, the segmentation circuit 7401 includes a plurality of circuit sections including a transition circuit section 7402, a processor circuit section 7414, a handle circuit section 7416, a communication circuit section 7420, a display circuit section 7424, a motor control circuit section 7428, an energy processing circuit section 7434, and a shaft circuit section 7440. The transition circuit section includes a wake-up circuit 7404, a boost current circuit 7406, a voltage control circuit 7408, a safety controller 7410, and a POST controller 7412. The transition circuit section 7402 is configured to implement power-off and power-on sequences, security detection protocols, and POST.

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

Additionally or alternatively, the accelerometer button sensor 7405 may sense external motion within a predetermined vicinity of the surgical instrument. For example, the accelerometer button sensor 7405 may sense that a user of the surgical instrument 6480 described herein moves a user's hand in a predetermined vicinity. When the accelerometer button sensor 7405 senses this external motion, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and to the processor, as previously described. After receiving the transmitted signal, the processor may begin a power-up sequence or a power-down sequence to transition one or more circuit segments between the three modes. In aspects, a signal sent to the voltage control circuit 7408 is sent to verify that the processor is in an operational mode. In some aspects, the accelerometer button sensor 7405 may sense when the surgical instrument has been dropped and send a signal to the processor based on the sensed drop. For example, the signal may indicate an error in the operation of the independent circuit section. One or more sensors may sense damage or failure of the affected individual circuit segments. Based on the sensed damage or failure, the POST controller 7412 may perform POST on the corresponding individual circuit sections.

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

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

Boost current circuit 7406 is coupled to the battery. The boost current circuit 7406 is a current amplifier (such as a relay or transistor) and is configured to amplify the magnitude of the current of the independent circuit section. The initial magnitude of the current corresponds to the source voltage provided by the battery to the segment circuit 7401. Suitable relay systems include solenoids. Suitable transistors include Field Effect Transistors (FETs), MOSFETs, and Bipolar Junction Transistors (BJTs). The boost current circuit 7406 may amplify the magnitude of the current corresponding to an independent circuit segment or circuit requiring more current consumption during operation of the surgical instrument 6480 described herein. For example, an increase in current to the motor control circuit section 7428 may be provided when the motor of the surgical instrument requires more input power. An increase in the current provided to an individual circuit section may result in a corresponding decrease in the current of another circuit section or sections. Additionally or alternatively, the increase in current may correspond to a voltage provided by an additional voltage source operating in conjunction with the battery.

The voltage control circuit 7408 is coupled to the battery. The voltage control circuit 7408 is configured to provide voltages to or remove voltages from the plurality of circuit segments. The voltage control circuit 7408 is further configured to increase or decrease the voltage provided to the plurality of circuit segments of the segmented circuit 7401. In various aspects, the voltage control circuit 7408 includes combinational logic circuitry such as a Multiplexer (MUX) for selecting inputs, a plurality of electronic switches, and a plurality of voltage converters. The electronic switches of the plurality of electronic switches may be configured to switch between an open and a closed configuration to disconnect the individual circuit segments from the battery or to connect the individual circuit segments to the battery. The plurality of electronic switches may be solid state devices such as transistors or other types of switches, such as wireless switches, ultrasonic switches, accelerometers, inertial sensors, and the like. The combinational logic circuit is configured to select individual electronic switches for switching to an open configuration to enable application of voltages to corresponding circuit sections. The combinational logic circuit is further configured to select individual electronic switches for switching to a closed configuration to enable removal of voltages from the corresponding circuit sections. By selecting a plurality of individual electronic switches, the combinational logic circuit may implement a power-down sequence or a power-up sequence. The plurality of voltage converters may provide a boost voltage or a buck voltage to the plurality of circuit sections. The voltage control circuit 7408 may also include a microprocessor and memory device.

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

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

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

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

The handle circuit section 7416 includes a handle control sensor 7418. The handle control sensor 7418 may sense actuation of one or more handle controls of the surgical instrument 6480 described herein. In various aspects, the one or more handle controls include a grip control, a release button, an articulation switch, an energy activation button, and/or any other suitable handle control. The user may activate the energy activation button to select between an RF energy mode, an ultrasonic energy mode, or a combination of RF energy and ultrasonic energy modes. The handle control sensor 7418 may also facilitate attachment of the modular handle to the surgical instrument. For example, the handle control sensor 7418 may sense the proper attachment of the modular handle to the surgical instrument and indicate the sensed attachment to a user of the surgical instrument. The LCD display 7426 may provide a graphical indication of the sensed attachment. In some aspects, the handle control sensor 7418 senses actuation of one or more handle controls. Based on the sensed actuation, the processor may begin a power-up sequence or a power-down sequence.

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

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

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

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

The energy processing circuit section 7434 includes RF amplifier and safety circuitry 7436 and ultrasonic signal generator circuitry 7438 to implement the energy modular functionality of the surgical instrument 6480 described herein. In various aspects, the RF amplifier and safety circuit 7436 is configured to control an RF modality of the surgical instrument by generating the RF signal. The ultrasonic signal generator circuit 7438 is configured to control the ultrasonic energy modality by generating ultrasonic signals. The RF amplifier and safety circuit 7436 and the ultrasonic signal generator circuit 7438 are operable in combination to control a combination of RF energy modes and ultrasonic energy modes.

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

Fig. 50 is a schematic diagram of an electrical circuit 7925 of various components of a surgical instrument having a motor control function in accordance with at least one aspect of the present disclosure. In various aspects, the surgical instrument 6480 described herein includes a drive mechanism 7930, the drive mechanism 7930 configured to drive shafts and/or gear components in order to perform various operations associated with the surgical instrument 6480. In one aspect, the drive mechanism 7930 includes a rotary drive train (7932) configured to rotate the end effector relative to the handle housing, for example, about a longitudinal axis. The drive mechanism 7930 also includes a closure drivetrain 7934 configured to close the jaw members to grasp tissue with the end effector. In addition, the drive mechanism 7930 includes a firing power train 7936 configured to open and close the clamp arm portion of the end effector to grasp tissue with the end effector.

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

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

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

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

The controller 7952 and/or other controllers of the present disclosure may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, ASIC, PLD, DSP, FPGA, logic gates, registers, semiconductor devices, chips, microchips, chip sets, microcontrollers, system-on-a-chip (SoC), and/or single-inline packages (SIP). Examples of discrete hardware elements may include circuits and/or circuit elements such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and/or relays. In some cases, for example, the controller 7952 may include a hybrid circuit that includes discrete and integrated circuit elements or components on one or more substrates.

In some cases, controller 7952 and/or other controllers of the present disclosure may be, for example, LM4F230H5QR purchased from texas instruments (Texas Instruments). In some cases, texas Instruments LM F230H5QR is an ARM Cortex-M4F processor core, comprising: on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40 MHz), prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, loaded with Internal ROM for software, 2KB EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, and other features that are readily available. Other microcontrollers may be conveniently substituted for use in conjunction with the present disclosure. Accordingly, the present disclosure should not be limited in this context.

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

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

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

In various cases, the signature of a properly functioning drive mechanism or one or more components thereof may be used to evaluate the state of the drive mechanism or one or more components thereof. One or more vibration sensors may be arranged with respect to the normally operating drive mechanism or one or more components thereof to register various vibrations occurring during operation of the normally operating drive mechanism or one or more components thereof. The recorded vibrations can be used to create a signature. Future waveforms may be compared to the signature waveforms to evaluate the status of the drive mechanism and its components.

Still referring to fig. 50, the surgical instrument 7930 includes a powertrain failure detection module 7962 configured to record and analyze one or more acoustic outputs of one or more of the powertrains 7932, 7934 and/or 7936. The processor 7954 may communicate with or otherwise control the module 7962. As described in more detail below, the module 7962 may be embodied as various means, such as circuitry, hardware, a computer program product comprising a computer readable medium (e.g., the memory 7956) storing computer readable program instructions executable by a processing device (e.g., the processor 7954), or some combination thereof. In some aspects, the processor 36 may include a module 7962 or otherwise control the module.

Turning now to fig. 51, end effector 8400 includes RF data sensors 8406, 8408a, 8408b located on jaw member 8402. The end effector 8400 includes a jaw member 8402 and an ultrasonic blade 8404. Jaw member 8402 is shown clamping tissue 8410 between jaw member 8402 and ultrasonic blade 8404. A first sensor 8406 is located in a central portion of jaw member 8402. Second sensor 8408a and third sensor 8408b are located on lateral portions of jaw member 8402. The sensors 8406, 8408a, 8408b are mounted or integrally formed with a flexible circuit 8412 (more particularly shown in fig. 52) configured to be fixedly mounted to the jaw member 8402.

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

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

Fig. 52 illustrates an aspect of the flexible circuit 8412 shown in fig. 51 to which the sensors 8406, 8408a, 8408b may be mounted or integrally formed. Flexible circuit 8412 is configured to be fixedly attached to jaw member 8402. As shown particularly in fig. 52, asymmetric temperature sensors 8414a, 8414b are mounted to a flexible circuit 8412 to enable measurement of the temperature of tissue 8410 (fig. 51).

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

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

Optionally tuning voltage V _t (the voltage and the output frequency f _o Proportional) may be fed back to the processor 132004 via the ADC 132024. This will provide the output frequency f to the processor 132004 _o A proportional feedback signal, and the feedback can be used to adjust and control the output frequency f _o 。

Estimating jaw state (pad burn-through, nail, fracture knife, bone in jaw, tissue in jaw)

The challenge with ultrasonic energy delivery is that the application of ultrasonic sound to the wrong material or wrong tissue can cause the device to fail, such as the clip arm pad burning through or the ultrasonic blade breaking. It is also desirable to detect what is located in the jaws of an end effector of an ultrasonic device and the status of the jaws without adding additional sensors in the jaws. Positioning the sensor in the jaw of an ultrasonic end effector presents challenges in terms of reliability, cost, and complexity.

In accordance with at least one aspect of the present disclosure, ultrasonic-spectrum smart blade algorithm techniques may be employed based on impedance of an ultrasonic transducer configured to drive an ultrasonic transducer bladeTo evaluate the state of the jaws (firing of the clamp arm pad, staples, a breaking knife, bone in the jaws, tissue in the jaws, back cutting when the jaws are closed, etc.). Drawing impedance Z _g (t), magnitude |Z| and phase +.>As a function of the frequency f.

Dynamic mechanical analysis (DMA, also known as dynamic mechanical spectroscopy or simply mechanical spectroscopy) is a technique used to study and characterize materials. Sinusoidal stress is applied to the material and the strain in the material is measured so that the complex modulus of the material can be determined. Spectroscopy applied to ultrasonic devices involves exciting the tip of an ultrasonic blade by frequency scanning (complex signals or conventional frequency scanning), and measuring the complex impedance produced at each frequency. Complex impedance measurements of the ultrasonic transducer over a range of frequencies are used in a classifier or model to infer characteristics of the ultrasonic end effector. In one aspect, the present disclosure provides a technique for determining the status of an ultrasonic end effector (clamping arm, jaw) to drive automation in an ultrasonic device (such as disabling power to protect the device, performing adaptive algorithms, retrieving information, identifying tissue, etc.).

FIG. 54 is a spectrum 132030 of an ultrasonic device having a plurality of different states and conditions of an end effector in accordance with at least one aspect of the present disclosure, wherein impedance Z _g (t), magnitude |Z| and phasePlotted as a function of frequency f. The spectrogram 132030 is plotted in three dimensions, with frequency (Hz) plotted along the x-axis, phase (Rad) plotted along the y-axis, and magnitude (ohm) plotted along the z-axis.

Spectral analysis of the different jaw bite and device states over a range of frequencies for different conditions and states can produce different complex impedance feature patterns (fingerprints). When rendered, each state or condition has a different pattern of features in 3D space. These feature patterns can be used to estimate the condition and state of the end effector. Fig. 54 shows the spectra of air 132032, clamp arm pad 132034, antelope 132036, pin 132038, and fracturing knife 132040. The antelope skin 132036 can be used to characterize different types of tissue.

The spectrogram 132030 can be evaluated by applying a low power electrical signal to the ultrasonic transducer to produce non-therapeutic excitation of the ultrasonic blade. The low power electrical signal may be applied in the form of a scan or complex fourier series to measure impedance on the ultrasound transducer using FFT over a series (scan) or parallel (complex signal) frequency range

New data classification method

For each feature pattern, the parameter lines may be fitted to the data used for training using polynomials, fourier series, or any other form of parameter formula that is convenient. A new data point is then received and classified by using the euclidean perpendicular distance from the new data point to the trajectory that has been fitted to the feature pattern training data. The vertical distance of the new data point to each track (each track representing a different state or condition) is used to assign the point to a state or condition.

The probability distribution of the distance of each point in the training data to the fitted curve can be used to estimate the probability of a new data point being correctly classified. This essentially constructs a two-dimensional probability distribution in a plane perpendicular to the fitted trajectory at each new data point of the fitted trajectory. The new data points may then be included in the training set based on their probability of correct classification to form an adaptive learning classifier that can easily detect high frequency changes in state, but can accommodate slowly occurring deviations in system performance, such as device dirtying or pad wear.

FIG. 55 is a graphical representation of a graph 132042 of a set of 3D training data sets (S) in which ultrasound transducer impedance Z in accordance with at least one aspect of the present disclosure _g (t), magnitude |Z| and phasePlotted as a function of frequency f. The 3D training dataset (S) curve 132042 is graphically depicted in three-dimensional space, with phase (Rad) plotted along the x-axis, frequency (Hz) plotted along the y-axis, magnitude (ohm) plotted along the z-axis, and a parametric fourier series fitted to the 3D training dataset (S). The method for data classification is based on a 3D training dataset (S0 for generating a graph 132042).

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

for new pointsFrom->To->Is found by:

when:

then:

D＝D _⊥

the probability distribution D can be used to estimate data points belonging to the group SIs a probability of (2).

Control of

Based on the classification of data measured before, during or after activation of the ultrasound transducer/blade, a variety of automation tasks and safety measures can be implemented. Similarly, the state of tissue located in the end effector and the temperature of the ultrasonic blade may also be inferred to some extent and used to better inform the user of the state of the ultrasonic device or to protect critical structures, etc. Temperature control of ultrasonic blades is described in commonly owned U.S. provisional patent application No. 62/640,417, entitled temperature control in ultrasonic devices and control systems therefor (TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR), which is incorporated herein by reference in its entirety, filed on 3-8 in 2018.

Similarly, power delivery may be reduced when the ultrasonic blade is most likely to contact the clamp arm pad (e.g., no tissue therebetween), or if the ultrasonic blade is likely to have broken or the ultrasonic blade is likely to contact metal (e.g., staples). Furthermore, if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad, a reverse cut is not allowed.

Integrating other data to improve classification

The system may be used in combination with other information provided by sensors, users, patient metrics, environmental factors, etc. by combining data from the process with the above data using probability functions and kalman filters. Given a large number of uncertain measurements of different confidence levels, the kalman filter determines the maximum likelihood that a state or condition will occur. Since this method allows probabilities to be assigned to newly classified data points, the information of the algorithm can be implemented with other measured or estimated values in the Kalman filter.

Fig. 56 is a logic flow diagram 132044 depicting a control program or logic configuration for determining jaw condition based on complex impedance feature patterns (fingerprints), in accordance with at least one aspect of the present disclosure. Prior to determining jaw conditions based on the complex impedance feature pattern (fingerprint), the database is populated with reference complex impedance feature patterns or training data sets (S) characterizing various jaw conditions, including but not limited to air 132032, clamp arm pad 132034, antelope 132036, staples 132038, fracturing knife 132040, and various tissue types and conditions as shown in fig. 82. Antelope (dry or wet, full byte or terminal) can be used to characterize different types of tissue. Data points for generating a reference complex impedance feature pattern or training data set (S) are obtained as follows: by applying sub-therapy drive signals to the ultrasound transducer, the drive frequency is swept from below resonance to above resonance within a predetermined range of frequencies, the complex impedance at each frequency is measured, and the data points are recorded. The data points are then fitted to the curve using a variety of numerical methods, including polynomial curve fitting, fourier series, and/or parametric formulas. A parametric fourier series fitted to a reference complex impedance feature pattern or training dataset (S) is described herein.

Once the reference complex impedance feature pattern or training data set is generated (S), the ultrasonic instrument measures new data points, classifies the new points, and determines whether new data points should be added to the reference complex impedance feature pattern or training data set (S).

Turning now to the logic flow diagram of fig. 56, in one aspect, a processor or control circuit measures 132046 the complex impedance of an ultrasound transducer, where the complex impedance is defined asA processor or control circuit receives 132048 the complex impedance measurement data points and compares 132050 the complex impedance measurement data points to data points in a reference complex impedance feature pattern. The processor or control circuit classifies 132052 the complex impedance measurement data points based on the results of the comparison analysis and assigns 132054 a state of the end effector based on the results of the comparison analysis.

In one aspect, a processor or control circuit receives a reference complex impedance feature pattern from a database or memory coupled to the processor. In one aspect, the processor or control circuit generates the reference complex impedance feature pattern as follows. A drive circuit coupled to the processor or control circuit applies a non-therapeutic drive signal to the ultrasound transducer beginning at an initial frequency and ending at a final frequency and at a plurality of frequencies therebetween. A processor or control circuit measures the impedance of the ultrasound transducer at each frequency and stores data points corresponding to each impedance measurement. A processor or control circuit curve-fits the plurality of data points to generate a three-dimensional curve representing a reference complex impedance feature pattern, wherein the magnitude |Z| and the phase Plotted as a function of frequency f. The curve fitting includes polynomial curve fitting, fourier series, and/or parametric formulas.

In one aspect, a processor or control circuit receives a new impedance measurement data point and classifies the new impedance measurement data point using Euclidean vertical distances from the new impedance measurement data point to a trace that has been fitted to a reference complex impedance feature pattern. The processor or control circuit estimates the probability of correctly classifying the new impedance measurement data point. The processor or control circuit adds the new impedance measurement data point to the reference complex impedance feature pattern based on the estimated probability of correctly classifying the new impedance measurement data point. In one aspect, a processor or control circuit classifies data based on a training data set (S), wherein the training data set (S) includes a plurality of complex impedance measurement data, and a curve fits the training data set (S) using a parametric fourier series, wherein S is defined herein, and wherein a probability distribution is used to estimate probabilities of new impedance measurement data points belonging to the group S.

Model-based jaw classifier state

There has been interest in classifying substances (including the type and condition of tissue) that are located within the jaws of an ultrasound device. In various aspects, it may be shown that such classification is possible with high data sampling and fine pattern recognition. The method is based on impedance as a function of frequency (where magnitude, phase and frequency are plotted in 3D, the pattern looks like the bands shown in fig. 54 and 55) and the logic flow diagram of fig. 56. The present disclosure provides alternative smart knife algorithm methods based on a mature model for a piezoelectric transducer.

For example, equivalent electrical lumped parameter models are known to be accurate models of physical piezoelectric transducers. It is based on Mittag-Leffler expansion of tangents near the mechanical resonance. When complex impedance or complex admittance is plotted as the relationship between the imaginary and real components, a circle is formed. Fig. 57 is a circular graph 132056 of complex impedance plotted as a relationship between an imaginary component and a real component of a piezoelectric vibrator in accordance with at least one aspect of the present disclosure. Fig. 58 is a circular graph 132058 of complex admittances plotted as a relationship between imaginary and real components of a piezoelectric vibrator in accordance with at least one aspect of the present disclosure. The circles depicted in fig. 57 and 58 are taken from the IEEE 177 standard, which is incorporated by reference herein in its entirety. Tables 1-4 are taken from the IEEE 177 standard and are disclosed herein for completeness.

When the frequency sweeps from below resonance to above resonance, a circle is formed. Instead of stretching the circle in 3D, the circle is determined and the radius (r) and offset (a, b) of the circle are estimated. These values are then compared to the established values for the given situation. These conditions may be: 1) jaw open and nothing, 2) end bite, 3) jaw fully bite and stapled. If the scan generates multiple resonances, then each resonance will have a circle of a different characteristic. If the resonances are separated, each circle will be drawn before the next. Instead of fitting a series of approximations to the 3D curve, the data is fitted with a circle. The radius (r) and offset (a, b) may be calculated using a processor programmed to perform a variety of mathematical or digital techniques as described below. These values can be estimated by capturing an image of the circle and using image processing techniques to estimate the radius (r) and offset (a, b) defining the circle.

Fig. 59 is a circular graph 132060 of the complex admittance of a 55.5kHz ultrasonic piezoelectric transducer with lumped parameter inputs and outputs specified below. The values of the lumped parameter model are used to generate the complex admittances. A medium load is applied in the model. The resulting admittance circles generated in MathCad are shown in fig. 59. When the frequency is swept from 54kHz to 58kHz, a circular graph 132060 is formed.

The lumped parameter input values are:

Co＝3.0nF

Cs＝8.22pF

Ls＝1.0H

Rs＝450Ω

the model output based on the input is:

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the output values are used to draw a circular graph 132060 shown in fig. 59. The circle graph 132060 has a radius (r) and the center 132062 is offset (a, b) from the origin 132064 as follows:

r＝1.012*10 ³

a＝1.013*10 ³

b＝-954.585

in accordance with at least one aspect of the present disclosure, the following specified sums A-E are needed to estimate the circle graph 132060 of the example given in FIG. 59. There are several algorithms to calculate the fit to the circle. The circle is defined by its radius (r) and a center offset (a, b) from the origin:

r ² ＝(x-a) ² +(y-b) ²

modified least squares (ubach and Jones) are convenient because there is a simple closed form solution for a, b and r.

The inserted symbols on the variable "a" represent an estimate of the true value. A. B, C, D and E are the sum of various products calculated from the data. For the sake of completeness, they are included herein as follows:

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Z1, i is the first vector of real components, called conductance;

z2, i is the second vector of imaginary components, called susceptance; and is also provided with

Z3, i is a third vector, representing the frequency of calculating admittance.

The present disclosure will apply to ultrasound systems and may be applied to electrosurgical systems even though the electrosurgical system is not dependent on resonance.

Fig. 60-64 illustrate images taken from an impedance analyzer showing impedance/admittance logs of an ultrasonic device with end effector jaws in various open or closed configurations and loads. In accordance with at least one aspect of the present disclosure, a circle plot in solid form depicts impedance, while a circle plot in dashed form depicts admittance. For example, an impedance/admittance dome map is generated by connecting an ultrasound device to an impedance analyzer. The display of the impedance analyzer is set to complex impedance and complex admittance, which can be selected from the front panel of the impedance analyzer. For example, as described below in connection with fig. 60, an initial display may be obtained with the jaws of the ultrasonic end effector in an open position and the ultrasonic device in an unloaded state. The auto-scaling display function of the impedance analyzer may be used to generate complex impedance and admittance logs. The same display is used for subsequent operation of the ultrasound device with different load conditions as shown in subsequent figures 60-64. The data file may be uploaded using a LabVIEW application. In another technique, a camera such as a smart phone camera (like an iPhone or Android) may be utilized to capture the display image. As such, the image of the display may include some "keystone distortion" and may generally appear non-parallel to the screen. Using this technique, the circle trace on the display will appear distorted in the captured image. With this method, material located in the jaws of an ultrasonic end effector can be classified.

The complex impedance and complex admittance are reciprocal of each other. Any new information cannot be added by observing both. Another consideration includes determining the sensitivity of the estimate to noise when using complex impedance or complex admittance.

In the examples shown in fig. 60-64, the range of the impedance analyzer is set to capture only the primary resonance. By scanning over a wider range of frequencies, more resonances may be encountered and multiple circles may be formed. The equivalent circuit of the ultrasound transducer can be modeled by a first "dynamic" branch having an inductance Ls, a resistance Rs and a capacitance Cs (which define the electromechanical performance of the resonator) connected in series, and a second capacitive branch having a static capacitance C0. In the impedance/admittance diagrams shown in the following 60-64, the component values of the equivalent circuit are:

Ls＝L1＝1.1068H

Rs＝R1＝311.352Ω

Cs＝C1＝7.43265pF

C0＝C0＝3.64026nF

the oscillator voltage applied to the ultrasonic transducer was 500mV and the frequency was swept from 55kHz to 56kHz. Impedance (Z) scale is 200Ω/div and admittance (Y) scale is 500 μS/div. Measurements of values that characterize the impedance (Z) and admittance (Y) circles can be obtained at locations on the circles indicated by the impedance cursor and admittance cursor.

State of jaws: open and no load

Fig. 60 is a graphical display 132066 of an impedance analyzer showing complex impedance (Z)/admittance (Y) circles 132068, 132070 of an open jaw and no-load ultrasound device, wherein a circle 132068 in solid form depicts the complex impedance and a circle 132070 in dashed form depicts the complex admittance, in accordance with at least one aspect of the present disclosure. The oscillator voltage applied to the ultrasonic transducer was 500mV and the frequency was swept from 55kHz to 56kHz. Impedance (Z) scale is 200Ω/div and admittance (Y) scale is 500 μS/div. Measurements of values that characterize complex impedance (Z) and complex admittance (Y) circles 132068, 132070 may be obtained at locations on circles 132068, 132070 indicated by impedance cursor 132072 and admittance cursor 132074. Thus, the impedance cursor 132072 is located at a portion of the impedance circle 132068 equal to about 55.55kHz and the admittance cursor 132074 is located at a portion of the admittance circle 132070 equal to about 55.29 kHz. As depicted in fig. 60, the position of the impedance cursor 132072 corresponds to the following values:

R＝1.66026Ω

X＝-697.309Ω

Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the position of admittance cursor 132074 corresponds to the following values:

G＝64.0322μS

B＝1.63007mS

where G is the conductance (real value) and B is the susceptance (imaginary value).

State of jaws: is clamped on the dried cornu Saigae Tataricae

Fig. 61 is a graphical display 132076 of an impedance analyzer showing complex impedance (Z)/admittance (Y) circles 132078, 132080 of an ultrasound device with jaws of an end effector clamped on a dry antelope skin, wherein the impedance circle 132078 is shown in solid lines and the admittance circle 132080 is shown in dashed lines, in accordance with at least one aspect of the present disclosure. The voltage applied to the ultrasonic transducer was 500mV, and the frequency was swept from 55kHz to 56kHz. Impedance (Z) scale is 200Ω/div and admittance (Y) scale is 500 μS/div.

Measurements of values that characterize complex impedance (Z) and complex admittance (Y) circles 132078, 132080 may be obtained at locations on circles 132078, 132080 indicated by impedance cursor 132082 and admittance cursor 132084. Thus, the impedance cursor 132082 is located at a portion of the impedance circle plot 132078 equal to about 55.68kHz and the admittance cursor 132084 is located at a portion of the admittance circle plot 132080 equal to about 55.29 kHz. As depicted in fig. 61, the position of the impedance cursor 132082 corresponds to the following values:

R＝434.577Ω

X＝-758.772Ω

Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the position of admittance cursor 132084 corresponds to the following values:

G＝85.1712μS

B＝1.49569mS

State of jaws: the terminal is clamped on the wet antelope skin

Fig. 62 is a graphical display 132086 of an impedance analyzer showing complex impedance (Z)/admittance (Y) circles 132098, 132090 of an ultrasound device with jaw ends clamped on a wet antelope skin, wherein the impedance circle 132088 is shown in solid lines and the admittance circle 132090 is shown in dashed lines, in accordance with at least one aspect of the present disclosure. The voltage applied to the ultrasonic transducer was 500mV, and the frequency was swept from 55kHz to 56kHz. Impedance (Z) scale is 200Ω/div and admittance (Y) scale is 500 μS/div.

Measurements of values that characterize complex impedance (Z) and complex admittance (Y) circles 132088, 132090 may be obtained at locations on circles 132088, 132090 indicated by impedance cursor 132092 and admittance cursor 132094. Thus, the impedance cursor 132092 is located at a portion of the impedance circle plot 132088 equal to about 55.68kHz and the admittance cursor 132094 is located at a portion of the admittance circle plot 132090 equal to about 55.29 kHz. As depicted in fig. 63, the impedance cursor 132092 corresponds to the following values:

R＝445.259Ω

X＝-750.082Ω

Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, admittance cursor 132094 corresponds to the following values:

G＝96.2179μS

B＝1.50236mS

State of jaws: is clamped on wet cornu Saigae Tataricae

Fig. 63 is a graphical display 132096 of an impedance analyzer showing complex impedance (Z)/admittance (Y) circles 132098, 132100 of an ultrasound device with jaws fully clamped on a wet antelope skin, wherein the impedance circle 132098 is shown in solid lines and the admittance circle 132100 is shown in dashed lines, in accordance with at least one aspect of the present disclosure. The voltage applied to the ultrasonic transducer was 500mV, and the frequency was swept from 55kHz to 56kHz. Impedance (Z) scale is 200Ω/div and admittance (Y) scale is 500 μS/div.

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

Similarly, admittance cursor 132104 corresponds to the following values:

G＝137.272μS

B＝1.48481mS

State of jaws: open and no load

Fig. 64 is a graphical display 132106 of an impedance analyzer in accordance with at least one aspect of the present disclosure showing impedance (Z)/admittance (Y) circles with a frequency sweep from 48kHz to 62kHz to capture multiple resonances of an open jaw and unloaded ultrasonic device, with the area represented by rectangle 132108 shown by dashed lines to help see impedance circles 132110a, 132110b, 132110c and admittance circles 132112a, 132112b, 132112c shown in solid lines. The voltage applied to the ultrasonic transducer was 500mV, and the frequency was swept from 48kHz to 62kHz. Impedance (Z) scale is 500 Ω/div and admittance (Y) scale is 500 μS/div.

Measurements of values that may characterize the impedance and admittance plots 132110a-c, 132112a-c may be obtained at locations on the impedance and admittance plots 132110a-c, 132112a-c indicated by the impedance cursor 132114 and admittance cursor 132116. Thus, the impedance cursor 132114 is located at a portion of the impedance circles 132110a-c equal to about 55.52kHz and the admittance cursor 132116 is located at a portion of the admittance circles 132112a-c equal to about 59.55 kHz. As depicted in fig. 64, the impedance cursor 132114 corresponds to the following values:

R＝1.86163kΩ

X＝-536.229Ω

Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, admittance cursor 132116 corresponds to the following values:

G＝649.956μS

B＝2.51975mS

Since there are only 400 samples over the entire scan range of the impedance analyzer, there are only a few points about resonance. Therefore, the circle on the right side becomes irregular. But this is only because of the impedance analyzer and the arrangement for covering a plurality of resonances.

When there are multiple resonances, more information is available to improve the classifier. A circle graph 132110a-c, 132112a-c fit may be calculated for each resonance encountered to keep the algorithm running quickly. Thus, once there are intersections of complex admittances (representing circles) during the scan, a fit can be calculated.

Benefits include well known models of data-based in-jaw classifiers and ultrasound systems. The counting and characterization of circles is well known in the vision system. Therefore, data processing is easy. For example, there is a closed form of solution where the radius of the circle and the axis offset can be calculated. The technique may be relatively fast.

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

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TABLE 2

Table 3 is a symbol list of the transport network (from IEEE 177 standard).

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* Refers to a real root; complex roots are ignored.

TABLE 3 Table 3

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

Solutions for various characteristic frequencies

* Refers to a real root; neglecting multiple roots

TABLE 4 Table 4

Table 5 shows the losses of three types of piezoelectric materials.

Ratio Q desired for various types of piezoelectric vibrators ^r Minimum value of r

TABLE 5

Table 6 shows jaw conditions, i.e. estimated parameters based on real-time measurements of complex impedance/admittance, radius (re) and offset (ae and be) of the circle represented by the measured variable Re, ge, xe, be, and parameters of a reference circle graph based on real-time measurements of complex impedance/admittance, radius (rr) and offset (ar, br) of the reference circle represented by the reference variable Rref, gref, xref, bref, as described in fig. 60-64. These values are then compared to the established values for the given situation. These conditions may be: 1) jaw open and nothing, 2) end bite, 3) jaw fully bite and stapled. The equivalent circuit of the ultrasound transducer was modeled as follows, and the frequency was swept from 55kHz to 56kHz:

Ls＝L1＝1.1068H

Rs＝R1＝311.352Ω

cs=c1= 7.43265pF, and

C0＝C0＝3.64026nF。

TABLE 6

In use, the ultrasonic generator scans the frequency, records the measured variable, and determines an estimate Re, ge, xe, be. These estimates are then compared to a reference variable Rref, gref, xref, bref stored in memory (e.g., in a look-up table) and the jaw condition determined. The reference jaw conditions shown in table 6 are merely examples. More or fewer reference jaw conditions may be categorized and stored in memory. These variables can be used to estimate the radius and offset of the impedance/admittance circle.

Fig. 65 is a logic flow diagram 132120 depicting a process of determining a control program or logic configuration for jaw condition based on an estimate of the radius (r) and offset (a, b) of an impedance/admittance circle in accordance with at least one aspect of the present disclosure. Initially, a database or look-up table is populated with reference values based on reference jaw conditions as described in connection with fig. 60-64 and table 6. The reference jaw condition is set and the frequency is scanned from a value below resonance to a value above resonance. The reference values Rref, gref, xref, bref defining the corresponding impedance/admittance plots are stored in a database or look-up table. During use, under control of a control program or logic configuration, the processor or control circuitry of the generator or instrument sweeps the frequency from below resonance 132122 to above resonance. The processor or control circuit measures and records 132124 variables Re, ge, xe, be defining the corresponding impedance/admittance pattern (e.g., stores them in memory) and compares 132126 them to reference values Rref, gref, xref, bref stored in a database or look-up table. The processor or control circuit determines 132128 (e.g., estimates) an end effector jaw condition based on the comparison.

Temperature inference

66A-66B are graphical representations 133000, 133010 of complex impedance spectra of the same ultrasonic device with a cold (room temperature) ultrasonic blade and a hot ultrasonic blade 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 hot ultrasonic blade refers to an ultrasonic blade that is frictionally heated in use. FIG. 66A is a graph of the resonant frequency f as the same ultrasonic device with a cold ultrasonic blade and a hot ultrasonic blade _o Impedance phase angle of a function of (2)133000 and FIG. 66B is a resonant frequency f as the same ultrasonic device with a cold ultrasonic blade and a hot ultrasonic blade _o A graphical representation 133010 of the impedance magnitude Z of the function. Impedance phase angle->And impedance magnitude |Z| at resonant frequency f _o At a minimum.

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

as shown in fig. 66A, when the ultrasonic blade is cold (e.g., at room temperature) and not frictionally heated, the electromechanical resonance frequency f of the ultrasonic device _o Is about 55,500hz, and the excitation frequency of the ultrasonic transducer is set to 55,500hz. Thus, when the ultrasonic transducer is at the electromechanical resonance frequency f _o Phase angle when lower excited and ultrasonic blade is coldAt a minimum or about 0Rad, as indicated by the cold knife graph 133002. As shown in fig. 66B, when the ultrasonic blade is cold and the ultrasonic transducer is at the electromechanical resonance frequency f _o When excited down, the impedance magnitude z| is 800 Ω, e.g., the impedance magnitude z| is at a minimum impedance, and the drive signal amplitude is at a maximum due to the series resonance equivalent circuit of the ultrasonic electromechanical system, as depicted in fig. 25.

Referring back now to fig. 66A and 66B, when the ultrasound transducer is at an electromechanical resonance frequency f of 55,500hz _o Lower by generator voltage V _g (t) Signal and Generator Current I _g (t) generator voltage V when signal driving _g (t) Signal and Generator Current I _g (t) phase angle between signalsAt zero, the impedance magnitude |z| is at a minimum impedance (e.g., 800 Ω), and the signal amplitude is at a peak or maximum due to the series resonance equivalent circuit of the ultrasonic electromechanical system. When the temperature of the ultrasonic blade increases, the electromechanical resonance frequency f of the ultrasonic device due to frictional heat generated in use _o 'decrease'. Because of the ultrasoundThe transducer is still at the previous (cold knife) electromechanical resonance frequency f of 55,500hz _o Lower by generator voltage V _g (t) Signal and Generator Current I _g (t) Signal drive so that the ultrasound device is non-resonant f _o ' operate to cause the generator voltage V _g (t) Signal and Generator Current I _g (t) phase angle between signals>Offset. There is also an increase in the magnitude of the impedance Z and a decrease in the peak magnitude of the drive signal relative to the previous (cold knife) electromechanical resonance frequency of 55,500 hz. Thus, the resonance frequency f of the electromagnetic wave can be adjusted by _o Measuring generator voltage V when changed due to temperature changes of ultrasonic blade _g (t) Signal and Generator Current I _g (t) phase angle between signals>To infer the temperature of the ultrasonic blade.

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

In other words, at resonance, the analog inductive impedance of the electro-mechanical ultrasound system is equal to the analog capacitive impedance of the electro-mechanical ultrasound system. As ultrasonic knife exampleCompliance of the ultrasonic blade (modeled as an analog capacitance) as heated by frictional engagement with tissue causes the resonant frequency of the electro-mechanical ultrasonic system to shift. In this example, as the temperature of the ultrasonic blade increases, the resonant frequency of the electromechanical ultrasonic system decreases. Thus, the simulated inductive impedance of the electro-mechanical ultrasound system is no longer equal to the simulated capacitive impedance of the electro-mechanical ultrasound system, resulting in a mismatch between the driving frequency of the electro-mechanical ultrasound system and the new resonant frequency. Thus, with a thermosonic blade, the electromechanical ultrasound system operates "off-resonance". The mismatch between the driving frequency and the resonant frequency is manifested as a voltage V applied to the ultrasound transducer _g (t) Signal and Current I _g (t) phase angle between signals

As previously discussed, the generator electronics can easily monitor the voltage V applied to the ultrasound transducer _g (t) Signal and Current I _g (t) phase angle between signalsPhase angle->Can be determined by fourier analysis, weighted least squares estimation, kalman filtering, space vector based techniques, zero crossing methods, lissajous diagrams, tri-vodkille methods, cross-coil methods, vector voltmeters and vector impedance methods, phase standard instruments, phase locked loops, etc. The generator can continuously monitor the phase angle +.>And adjusting the driving frequency until the phase angle + ->Becomes zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. Phase angle->And/or the change in the generator drive frequency may be used as an indirect or inferred measurement of the temperature of the ultrasonic blade.

Various techniques are available for estimating temperature from data in these spectra. Most notably, a time-varying set of nonlinear state space equations can be employed to model the dynamic relationship between the temperature of the ultrasonic blade and the measured impedance

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

Temperature estimation method

One aspect of estimating or inferring the temperature of the ultrasonic blade may include three steps. First, a state space model is defined that depends on temperature and frequency of time and energy. To model temperature as a function of frequency content, a set of nonlinear state space formulas is used to model the relationship between the electromechanical resonance frequency and the temperature of the ultrasonic blade. Second, a Kalman filter is applied to improve the accuracy of the temperature estimator and state space model over time. Again, a state estimator is provided in the feedback loop of the kalman filter to control the power applied to the ultrasonic transducer and thus the ultrasonic blade to adjust the temperature of the ultrasonic blade. These three steps are described below.

Step 1

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

the state space model representation is relative to the natural frequency F _n (T), temperature T (T), energy E (T), and natural frequency of the electromechanical ultrasound system for time TIs the rate of change of (2) and the temperature of the ultrasonic blade +.>Is a rate of change of (c). />Representing a measurable and observable variable (such as the natural frequency F of an electro-mechanical ultrasound system _n (T), the temperature T (T) of the ultrasonic blade, the energy E (T) applied to the ultrasonic blade, and the time T). The temperature T (T) of the ultrasonic blade can be observed as an estimated value.

Step 2

The second step is to apply a Kalman filter to improve the temperature estimator and state space model. Fig. 67 is a diagram of a kalman filter 133020 that improves the temperature estimator and state space model based on impedance according to the following equation:

which represents impedance across an ultrasound transducer measured at a plurality of frequencies in accordance with at least one aspect of the present disclosure.

A kalman filter 133020 may be employed to improve the performance of the temperature estimation and allow for the addition of external sensors, models, or previous information to improve temperature prediction in the noise data. The kalman filter 133020 includes a regulator 133022 and a device (plant) 133024. In a comparative theory, the device 133024 is a combination of a process and an actuator. The device 133024 is referred to as There is a transfer function that indicates the relationship between the input signal and the output signal of the system. The adjuster 133022 includes a state estimator 133026 and a controller K133028. The state adjuster 133026 includes a feedback loop 133030. The state adjuster 133026 receives as input the y, the output of the means 133024 and the feedback variable u. The state estimator 133026 is an internal feedback system that converges with true values of the system state. The output of the state estimator 133026 is a full feedback control variableNatural frequency F including an electromechanical ultrasound system _n (T), temperature T (T) of the ultrasonic blade, energy E (T) applied to the ultrasonic blade, phase angle +.>And time t. The input to the controller K133028 is +.>And the output u of the controller K133028 is fed back to the state estimator 133026 and t of the device 133024.

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

The kalman filter 133020 uses a dynamic model of the electromechanical ultrasound system, a control input known to the system, and a plurality of time-series measurements (observations) of the natural frequency and phase angle of the signal applied to the ultrasound transducer (e.g., the magnitude and phase of the electrical impedance of the ultrasound transducer) to form an estimate of the amount of change (its state) of the electromechanical ultrasound system, to be superior to predicting the temperature of the ultrasonic blade portion of the electromechanical ultrasound system using an estimate obtained using only one single measurement. Thus, the kalman filter 133020 is an algorithm that includes sensors and data fusion to provide a maximum likelihood estimate of the temperature of the ultrasonic blade.

The kalman filter 133020 effectively handles the uncertainty due to noise measurements of the signal applied to the ultrasound transducer to measure the natural frequency and phase shift data and also effectively handles the uncertainty due to random external factors. The kalman filter 133020 produces an estimate of the state of the electro-mechanical ultrasound system as an average of the predicted state of the system and the new measurements using a weighted average. Weighted values provide better (i.e., smaller) uncertainty of the estimate and are more "trustworthy" than unweighted values. The weights may be calculated from covariance, a measure of estimated uncertainty of the system state predictions. The result of the weighted average is a new state estimate that lies between the predicted state and the measured state and has a better estimation uncertainty than one alone. This process repeats at each step with the new estimate and its covariance informing of the predictions used in the following iterations. This recursive nature of the kalman filter 133020 only requires the last "best guess" of the state of the electro-mechanical ultrasound system to calculate a new state, rather than the entire history.

The relative certainty of measurement and current state estimation is an important consideration and it is common to discuss the response of the filter in terms of the gain K of the kalman filter 133020. The kalman gain K is a relative weight given to the measured value and the current state estimate and can be "tuned" to achieve a particular performance. With a high gain K, the kalman filter 133020 applies more weight to the most recent measurements and thus follows them more responsively. Using low gain K, the kalman filter 133020 more closely follows the model predictions. In extreme cases, a high gain close to one will result in a more jumpy estimated trajectory, while a low gain close to zero will smooth out the noise but reduce the response capability.

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

Step 3

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

Fig. 68 is a graphical depiction 133040 of three probability distributions that the state estimator 133026 of the kalman filter 133020 shown in fig. 67 uses to maximize an estimate in accordance with at least one aspect of the present disclosure. The probability distributions include a previous probability distribution 133042, a predicted (state) probability distribution 133044, and an observed probability distribution 133046. In accordance with at least one aspect of the present disclosure, three probability distributions 133042, 133044, 1330467 are used for feedback control of power applied to an ultrasound transducer to adjust temperature based on impedance across the ultrasound transducer measured at multiple frequencies. An estimator used in feedback control of power applied to an ultrasonic transducer to adjust temperature based on impedance is given by the following expression:

which is an impedance across an ultrasound transducer measured at a plurality of frequencies in accordance with at least one aspect of the present disclosure.

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

state variance For predicting the next state of the system, which state is denoted as predictive (state) probability distribution 133044. The observation probability distribution 133046 is the observation variance σ _m A probability distribution for an actual observation of the state of the system for defining a gain given by the expression:

feedback control

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

In one aspect, the initial proof of concept assumes that there is a static linear relationship between the natural frequency of the electro-mechanical ultrasonic system and the temperature of the ultrasonic blade. By reducing the power as a function of the natural frequency of the electro-mechanical ultrasonic system (i.e., adjusting the temperature with feedback control), the temperature of the ultrasonic blade tip can be directly controlled. In this example, the temperature of the distal tip of the ultrasonic blade may be controlled to not exceed the melting point of the Teflon pad.

Fig. 69A is a graphical representation 133050 of the temperature versus time of an ultrasound device without temperature feedback control. The temperature (c) of the ultrasonic blade is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. The test was performed with the antelope skin in the jaw of the ultrasound device. One jaw is an ultrasonic blade and the other jaw is a clamping arm with a TEFLON pad. The ultrasonic blade is excited at a resonant frequency while frictionally engaging the antelope skin held between the ultrasonic blade and the holding arm. Over time, the temperature of the ultrasonic blade (c) increased due to frictional engagement with the antelope skin. Over time, the temperature profile 133052 of the ultrasonic blade increased until the antelope skin sample was cut after about 19.5 seconds at a temperature of 220 ℃, as indicated at point 133054. Without temperature feedback control, after cutting the sample of antelope skin, the temperature of the ultrasonic blade was increased to a temperature well above the temperature of the TEFLON melting point-380 ℃ up to-490 ℃. At point 133056, the temperature of the ultrasonic blade reached a maximum temperature of 490 ℃ until the TEFLON pad was completely melted. After the pad has completely disappeared, the temperature of the ultrasonic blade drops slightly from the peak temperature at point 133056.

FIG. 69B is a graph of temperature versus time for an ultrasound device with temperature feedback control in accordance with at least one aspect of the present disclosure. The temperature (c) of the ultrasonic blade is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. The test was performed with a sample of antelope skin located in the jaw of the ultrasound device. One jaw is an ultrasonic blade and the other jaw is a clamping arm with a TEFLON pad. The ultrasonic blade is excited at a resonant frequency while frictionally engaging the antelope skin held between the ultrasonic blade and the holding arm pad. Over time, the temperature profile 133062 of the ultrasonic blade increased until the antelope skin sample was cut after about 23 seconds at a temperature of 220 ℃, as indicated at point 133064. In the case of temperature feedback control, the temperature of the ultrasonic blade increases up to a maximum temperature of about 380 ℃ as indicated at point 133066, just below the melting point of TEFLON, and then decreases to an average value of about 330 ℃ as indicated generally at region 133068, thereby preventing the TEFLON pad from melting.

Application of intelligent ultrasonic knife technology

When immersed in a fluid-filled surgical field, the ultrasonic blade cools during activation, making sealing and cutting of tissue in contact therewith less effective. Cooling of the ultrasonic blade may lead to longer activation times and/or hemostasis problems because insufficient heat is delivered to the tissue. To overcome the cooling of the ultrasonic blade, more energy delivery may be required to shorten the transection time and achieve proper hemostasis under these fluid immersion conditions. Using a frequency temperature feedback control system, if it is detected that the ultrasonic blade is beginning below a certain temperature or is held at a certain temperature for a period of time, the output power of the generator can be increased to compensate for cooling due to blood/saline/other fluids present in the surgical site.

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

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

or in other words by detecting the voltage V applied to the ultrasonic transducer _g (t) Signal and Current I _g (t) phase angle between signalsTo infer. Phase angle->The information can also be used to infer conditions of the ultrasonic blade. As specifically discussed herein, phase angleAs a function of the temperature of the ultrasonic blade. Thus, the phase angle +>The information may be used to control the temperature of the ultrasonic blade. This may be accomplished, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade is operating too hot and increasing the power delivered to the ultrasonic blade when the ultrasonic blade is operating too cold. FIGS. 70A-70B are graphical representations of temperature feedback control for adjusting ultrasonic power applied to an ultrasonic transducer when a temperature dip of an ultrasonic blade is detected.

Fig. 70A is a graphical representation of ultrasonic power output 133070 as a function of time in accordance with at least one aspect of the present disclosure. The power output of the ultrasonic generator is shown along the vertical axis and the time (seconds) is shown along the horizontal axis. Fig. 70B is a graphical representation of ultrasonic blade temperature 133080 as a function of time in accordance with at least one aspect of the present disclosure. Ultrasonic blade temperature is shown along the vertical axis and time (seconds) is shown along the horizontal axis. The temperature of the ultrasonic blade increases as constant power 133072 is applied, as shown in fig. 70A. During use, the temperature of the ultrasonic blade suddenly drops. This may be caused by a variety of conditions, however, during use, it may be inferred that the temperature of the ultrasonic blade drops as it is immersed in a fluid-filled surgical site (e.g., blood, saline, water, etc.). At time t ₀ At this point, the temperature of the ultrasonic blade falls below the desired minimum temperature 133082, and the frequency temperature feedback control algorithm detects the temperature drop and begins to increase or "ramp up" power, as shown by power ramp 133074 delivered to the ultrasonic blade, to begin to raise the temperature of the ultrasonic blade above the desired minimum temperature 133082.

Referring to fig. 70A and 70B, the ultrasonic generator output is substantially constant power 133072 as long as the temperature of the ultrasonic blade is maintained above the desired minimum temperature 133082. At t ₀ At this point, a processor or control circuit in the generator or instrument or both detects that the temperature of the ultrasonic blade has fallen below the desired minimum temperature 133072 and initiates a frequency temperature feedback control algorithm to raise the temperature of the ultrasonic blade above the minimum desired temperature 133082. Thus, the generator power corresponds to t ₀ T at which a sudden drop in temperature of the ultrasonic blade is detected ₁ Where a ramp-up 133074 begins. Under the frequency temperature feedback control algorithm, the power continues to ramp 133074 until the temperature of the ultrasonic blade is above the desired minimum temperature 133082.

Fig. 71 is a logic flow diagram 133090 depicting a process of controlling a control program or logic configuration of the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. In accordance with this process, the processor or control circuitry of the generator or instrument or both performs the discussion in connection with fig. 70A and 70BOne aspect of the frequency-temperature feedback control algorithm in question is to apply 133092 a power level to the ultrasonic transducer to achieve a desired temperature at the ultrasonic blade. The generator monitors 133094 the voltage V applied to drive the ultrasonic transducer _g (t) Signal and Current I _g (t) phase angle between signalsBased on phase angle->The generator uses the techniques described herein in connection with fig. 66A-68 to infer the temperature of the 133096 ultrasonic blade. The generator determines 133098 whether the temperature of the ultrasonic blade is below a desired minimum temperature by comparing the inferred temperature of the ultrasonic blade to a predetermined desired temperature. The generator then adjusts the power level applied to the ultrasound transducer based on the comparison. For example, the method continues along the "no" branch when the temperature of the ultrasonic blade reaches or is above the desired minimum temperature, and the process continues along the "yes" branch when the temperature of the ultrasonic blade is below the desired minimum temperature. When the temperature of the ultrasonic blade is below the desired minimum temperature, the generator is activated, for example, by increasing the voltage V _g (t) signal and/or current I _g (t) signal to increase 133100 the power level to the ultrasonic transducer to raise the temperature of the ultrasonic blade and continue to increase the power level applied to the ultrasonic transducer until the temperature of the ultrasonic blade increases above the minimum desired temperature.

Situational awareness

Referring now to fig. 72, a time axis 5200 depicting situational awareness of a hub, such as surgical hub 106 or 206, is shown. The timeline 5200 is illustrative of a surgical procedure and background information that the surgical hub 106, 206 may derive from data received from a data source for each step in the surgical procedure. The time axis 5200 depicts typical steps that nurses, surgeons and other medical personnel will take during a lung segment removal procedure, starting from the establishment of an operating room and until the patient is transferred to a post-operative recovery room.

The situation awareness surgical hubs 106, 206 receive data from the data sources throughout the surgical procedure, including data generated each time a medical professional utilizes a modular device paired with the surgical hubs 106, 206. The surgical hubs 106, 206 can receive this data from the paired modular device and other data sources and continually derive inferences about the ongoing procedure (i.e., background information) as new data is received, such as which step of the procedure to perform at any given time. The situational awareness system of the surgical hubs 106, 206 can, for example, record data related to the procedure used to generate the report, verify steps that medical personnel are taking, provide data or cues that may be related to particular procedure steps (e.g., via a display screen), adjust modular devices based on context (e.g., activate monitors, adjust the field of view (FOV) of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such action described above.

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

In a second step 5204, the staff member scans the incoming medical supplies for the protocol. The surgical hubs 106, 206 cross-reference the scanned supplies with the list of supplies used in the various types of protocols and confirm that the supplied mixture corresponds to the chest protocol. In addition, the surgical hubs 106, 206 can also determine that the procedure is not a wedge procedure (because the incoming supplies lack certain supplies required for, or otherwise do not correspond to, a chest wedge procedure).

Third step 5206, the medical personnel scans the patient belt via a scanner communicatively connected to the surgical hub hubs 106, 206. The surgical hub 106, 206 may then confirm the identity of the patient based on the scanned data.

Fourth step 5208, the medical staff opens the auxiliary equipment. The ancillary equipment utilized may vary depending on the type of surgical procedure and the technique to be used by the surgeon, but in this exemplary case they include smoke evacuators, insufflators and medical imaging devices. When activated, the auxiliary equipment as a modular device may automatically pair with a surgical hub 106, 206 located in a specific vicinity of the modular device as part of its initialization process. The surgical hub 106, 206 may then derive background information about the surgical procedure by detecting the type of modular device paired therewith during the pre-operative or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on the combination of data from the patient's EMR, the list of medical supplies used in the procedure and the type of modular device connected to the hub, the surgical hub 106, 206 can generally infer the specific procedure that the surgical team will perform. Once the surgical hub 106, 206 knows what specific procedure is being performed, the surgical hub 106, 206 can retrieve the steps of the procedure from memory or the cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular device and patient monitoring device) to infer what steps of the surgical procedure the surgical team is performing.

Fifth step 5210, the staff member attaches the EKG electrode and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with the surgical hubs 106, 206. When the surgical hub 106, 206 begins to receive data from the patient monitoring device, the surgical hub 106, 206 thus confirms that the patient is in the operating room.

Sixth step 5212, the medical personnel induce anesthesia in the patient. The surgical hubs 106, 206 may infer that the patient is under anesthesia based on data from the modular device and/or the patient monitoring device, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. At the completion of the sixth step 5212, the preoperative portion of the lung segmental resection procedure is complete and the operative portion begins.

Seventh step 5214, the patient's lungs being operated on are folded (while ventilation is switched to the contralateral lung). For example, the surgical hub 106, 206 may infer from the ventilator data that the patient's lungs have collapsed. The surgical hub 106, 206 may infer that the surgical portion of the procedure has begun because it may compare the detection of the patient's lung collapse to the expected steps of the procedure (which may be previously accessed or retrieved), thereby determining that collapsing the lung is a surgical step in that particular procedure.

Eighth step 5216, a medical imaging device (e.g., an endoscope) is inserted and video from the medical imaging device is activated. The surgical hubs 106, 206 receive medical imaging device data (i.e., video or image data) through their connection to the medical imaging device. After receiving the medical imaging device data, the surgical hub 106, 206 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmental resection, rather than a leaf resection (note that the wedge procedure has been excluded based on the surgical hub 106, 206 based on the data received at the second step 5204 of the procedure). The data from the medical imaging device 124 (fig. 2) can be used to determine background information related to the type of procedure being performed in a number of different ways, including by determining the angle of the visual orientation of the medical imaging device relative to the patient's anatomy, monitoring the number of medical imaging devices utilized (i.e., activated and paired with the surgical hub 106, 206), and monitoring the type of visualization device utilized. For example, one technique for performing a vat lobectomy places the camera in the lower anterior corner of the patient's chest over the septum, while one technique for performing a vat segmented resection places the camera in an anterior intercostal position relative to the segmented slit. For example, using pattern recognition or machine learning techniques, the situational awareness system may be trained to recognize the positioning of the medical imaging device from the visualization of the patient anatomy. As another example, one technique for performing a vat lobectomy utilizes a single medical imaging apparatus, while another technique for performing a vat segmented excision utilizes multiple cameras. As another example, a technique for performing vat segmental resections utilizes an infrared light source (which may be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental slots that are not used in vat pulmonary resections. By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can thus determine the particular type of surgical procedure being performed and/or the technique used for the particular type of surgical procedure.

Ninth step 5218, the surgical team begins the anatomical steps of the procedure. The surgical hub 106, 206 may infer that the surgeon is dissecting to mobilize the patient's lungs because it receives data from the RF generator or the ultrasound generator indicating that the energy instrument is being fired. The surgical hub 106, 206 may cross the received data with the retrieval step of the surgical procedure to determine that the energy instrument fired at that point in the procedure (i.e., after the previously discussed procedure steps are completed) corresponds to an anatomical step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of the robotic surgical system.

Tenth step 5220, the surgical team proceeds with the ligation step of the procedure. The surgical hubs 106, 206 can infer that the surgeon is ligating arteries and veins because they receive data from the surgical stapling and severing instrument indicating that the instrument is being fired. Similar to the previous steps, the surgical hubs 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the retrieval steps in the process. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, a segmental resection portion of the procedure is performed. The surgical hubs 106, 206 can infer that the surgeon is transecting soft tissue based on data from the surgical stapling and severing instrument, including data from its cartridge. The cartridge data may correspond to, for example, the size or type of staples fired by the instrument. Since different types of staples are used for different types of tissue, the cartridge data can be indicative of the type of tissue being stapled and/or transected. In this case, the type of staples being fired is used for soft tissue (or other similar tissue type), which allows the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is in progress.

A twelfth step 5224 node dissection step is then performed. The surgical hub 106, 206 may infer that the surgical team is dissecting nodes and performing leak tests based on data received from the generator indicating that the RF or ultrasonic instrument is being fired. For this particular procedure, the RF or ultrasonic instrument used after transecting the soft tissue corresponds to a node dissection step that allows the surgical hub 106, 206 to make such inferences. It should be noted that the surgeon switches back and forth between surgical stapling/cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments periodically, depending on the particular steps in the procedure, as the different instruments are better suited for the particular task. Thus, the particular sequence in which the stapling/severing instrument and the surgical energy instrument are used may dictate the steps of the procedure that the surgeon is performing. Further, in some cases, robotic tools may be used for one or more steps in a surgical procedure, and/or hand-held surgical instruments may be used for one or more steps in a surgical procedure. One or more surgeons may, for example, alternate between robotic tools and hand-held surgical instruments and/or may use the devices simultaneously. At the completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.

Thirteenth step 5226, the patient is reverse anesthetized. For example, the surgical hub 106, 206 may infer that the patient is waking from anesthesia based on, for example, ventilator data (i.e., the patient's respiration rate begins to increase).

Finally, a fourteenth step 5228 is for the medical personnel to remove the various patient monitoring devices from the patient. Thus, when the hub loses EKG, BP, and other data from the patient monitoring device, the surgical hub 106, 206 may infer that the patient is being transferred to the recovery room. As can be seen from the description of this exemplary procedure, the surgical hub 106, 206 can determine or infer when each step of a given surgical procedure occurs from data received from various data sources communicatively coupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. provisional patent application serial No. 62/611,341 entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM) filed on month 12, 2017, which is incorporated herein by reference in its entirety. In some cases, operation of robotic surgical systems (including the various robotic surgical systems disclosed herein) may be controlled by hubs 106, 206 based on their situational awareness and/or feedback from their components and/or based on information from cloud 102.

Situation awareness for electrosurgical systems

Electrosurgical instruments are used to treat various tissue types by applying energy to the tissue. As described in connection with fig. 22-24, an electrosurgical instrument (e.g., surgical instruments 1104, 1106, 1108) may be connected to the generator 1100 and include an end effector (e.g., end effectors 1122, 1124, 1125) configured to grasp tissue and deliver therapeutic energy to the tissue.

In various aspects, the end effector can be used to seal, weld, or coagulate a blood vessel by applying energy to the blood vessel while tissue, such as the blood vessel, is grasped by the end effector. Since the blood vessel is typically surrounded by protective tissue, the tissue must be separated to expose the blood vessel to achieve an effective seal. However, the energy required for tissue separation is lower than the energy required for tissue sealing or coagulation. Moreover, the amount of tissue to be separated varies depending on, for example, the anatomical location of the blood vessel, the state of the tissue, and the type of surgical procedure being performed.

One technique for treating tissue, including blood vessels, involves separating the inner muscle layer of the blood vessel and moving it away from the adventitia layer prior to sealing and/or transecting the blood vessel. To more effectively separate the tissue layers of the blood vessel, a low level of energy may be generated and delivered to the tissue sufficient to separate the tissue but insufficient to coagulate or seal the tissue. Subsequently, high levels of energy are used to seal or coagulate tissue.

Successful energy treatment of tissue grasped by the end effector depends on selecting the appropriate energy operating mode for each closing phase of the end effector. Further, the closing phase of the end effector may be determined by various situational parameters such as tissue type, anatomical location, and/or composition. Various suitable situational parameters are described under the heading "situational awareness" in connection with fig. 72.

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

In various aspects, tissue interaction with the end effector during closure provides one or more situational parameters that can be used to select or adjust an energy pattern for treating tissue. Fig. 73 shows the end effector 131000 extending from the shaft 131001 and undergoing a closing motion to grasp tissue "T". The end effector 131000 includes a first jaw 131002 and a second jaw 131004. At least one of the first jaw 131002 and the second jaw 131004 is movable relative to the other to grasp tissue therebetween. In various aspects, the closing phase can be defined by one or more angular positions of the first jaw 131002 relative to the second jaw 131004 or one or more angular distances between the first jaw 131002 and the second jaw 131004.

In the example of fig. 73, the first jaw 131002 can be moved relative to the second jaw 131004 to transition the end effector between an open configuration and a closed configuration through different stages of closure to clamp tissue between the jaws 131002, 131004. Fig. 73 depicts two closure phases. In a first closing phase, the first jaw 131002 is moved an angular distance θ1 from the open configuration.

The first closing phase is followed by a second closing phase that extends an angular distance θ2 from the open configuration of the end effector 131000. Although only two closure phases are depicted in the example of fig. 73, an end effector according to the present disclosure may be transitioned through more or less than two closure phases.

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

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

A second treatment cycle 131014 is also depicted in graph 131010 of fig. 74. The second treatment cycle 131014 only includes a tissue sealing energy mode. In other words, in the second treatment cycle 131014, the tissue sealing energy pattern does not follow the initial tissue separation energy pattern. The second treatment cycle 131014 is applicable to certain situations where tissue separation is not required.

Fig. 76 is a logic flow diagram depicting a process 131020 for selecting a control program or logic configuration for an energy operation mode of an electrosurgical instrument. Process 131020 detects 131022 the closing phase of end effector 131000. The process 131020 further selects 131024 between energy modes delivering different energy outputs based on detected closing phases of the end effector 131000. In one example, a first energy mode that delivers a first energy output is selected in a first closing phase and a second energy mode that delivers a second energy output that is greater than the first energy output is selected in a second closing phase. The first energy output is sufficient to separate tissue "T" but insufficient to seal tissue "T", while the second energy output is sufficient to seal tissue "T".

In certain aspects, one or more processes of the present disclosure may be performed by control circuitry of an electrosurgical instrument (such as control circuitry 710 of surgical instrument 700, control circuitry 760 of surgical instrument 750, and/or control circuitry 760 of surgical instrument 790). In certain aspects, as shown in fig. 13, the control circuitry 500 for performing one or more processes of the present disclosure may comprise one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504 that stores program instructions that, when executed by the processor 502, cause the processor 502 to perform the one or more processes. Alternatively, one or more processes of the present disclosure may be performed by one or more control circuits depicted in fig. 14, 15. In certain aspects, the electrosurgical instrument may include a non-transitory storage medium storing one or more algorithms for performing one or more processes of the present disclosure.

Fig. 77 is another logic flow diagram depicting a process 131030 for selecting a control program or logic configuration for an energy operation mode of an electrosurgical instrument. The process 131030 selects an operating mode from operating modes delivering different energy outputs based on sensor signals indicative of the closing phase of the end effector 131000. In one example, the process of fig. 77 is performed by control circuitry connected to one or more sensors configured to generate sensor signals indicative of the closing phase of end effector 131000. The sensor signals are received 131032 by a control circuit that selects an energy operating mode from operating modes delivering different energy outputs based on the received sensor signals. For example, the control circuitry determines 131034 if the received sensor signal indicates that the end effector 131000 is in the first closed phase. If so, the control circuitry selects a first mode of operation that causes the first energy output to be delivered 131036 to the tissue "T". If the received sensor signal does not indicate that the end effector is in the first closing phase, the control circuitry further determines 131038 if the received sensor signal indicates that the end effector 131000 is in the second closing phase. If so, the control circuitry selects a second mode of operation that causes a second energy output greater than the first energy output to be delivered 131039 to the tissue "T".

In various examples, the control circuitry of the ultrasonic surgical instrument is configured to cause the transducer to change the magnitude of the ultrasonic energy output in response to the clamp member transitioning from the first closing phase to the second closing phase.

In various examples, the control circuit is configured to correlate a change in magnitude of the energy output with a transition from the first closing phase to the second closing phase. In various examples, the second energy output is sufficient to seal and coagulate tissue, while the first energy output is sufficient to separate tissue but insufficient to seal and coagulate tissue. Although only two energy modes of operation are depicted in the example of fig. 77, electrosurgical instruments according to the present disclosure may include more or less than two energy modes of operation, each corresponding to a predetermined closing phase of end effector 131000. In various examples, the tissue separation mode is defined by a lower amplitude and/or frequency than the tissue coagulation and sealing modes.

Fig. 78 is another logic flow diagram depicting a process 131040 for selecting a control program or logic configuration for an energy operation mode of an electrosurgical instrument. The process 131040 is similar in many respects to the process of fig. 76. In addition, the procedure 131040 determines 131042 when initial contact with tissue "T" is achieved as the first jaw 131002 moves through the closing phase between the open and closed configurations (see fig. 75A). More specifically, the selection between the energy operating modes of the electrosurgical instrument is based on a closing phase in which an initial contact with the tissue "T" is detected.

In various aspects, initial tissue contact can be detected by a tissue contact circuit that includes a first jaw electrode and a second jaw electrode. The first jaw electrode is coupled to one pole of the electrosurgical energy source and the second jaw electrode is coupled to an opposite pole of the electrosurgical energy source. When tissue is simultaneously in contact with the first and second jaw electrodes, the tissue contacting circuit is in a closed configuration, allowing non-therapeutic signals to pass between the jaws 131002, 131004. Thus, electrical continuity is established when tissue is located between jaws 131002, 131004, and not when no tissue is located between jaws 131002, 131004.

In various aspects, initial tissue contact is achieved when the jaws 131002, 131004 apply sufficient compression to tissue "T" captured therebetween to close the sensing circuit "SC".

Fig. 78A is a schematic diagram of an exemplary tissue contacting circuit showing the completion of the circuit to a pair of spaced apart contact plates upon contact with tissue. Contact of the jaws 131002, 131004 with tissue "T" closes an otherwise open sensing circuit "SC" by establishing contact with a pair of opposing plates "P1, P2" disposed on the jaws 131002, 131004. Closure of the sensing circuit "SC" causes the sensor signal to be transmitted to the control circuit (e.g., fig. 13-14, fig. 17-19). The sensor signal indicates that initial tissue contact has been established. Fig. 78A and other examples are further described in U.S. patent No. 8,181,839 (titled surgical instrument with sensor (SURGICAL INSTRUMENT EMPLOYING SENSORS), published 5/2012, the entire disclosure of which is incorporated herein by reference) filed on 2011 at 6/27.

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

The process 131050 further determines 131054 whether the first sensor signal indicates that the end effector 131000 is in the first closed phase. If so, the process 131050 further determines 131056 if the second sensor signal indicates that initial tissue contact has been established.

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

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

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

In other words, detecting initial contact with tissue in a first closing phase causes the control circuit to cause a first energy output to be delivered to tissue "T", and detecting initial contact with tissue in a second closing phase causes the control circuit to cause a second energy output to be delivered to tissue "T". As described above, in various aspects, the second energy output is sufficient to seal and coagulate tissue, while the first energy output is sufficient to separate tissue but insufficient to seal and coagulate tissue.

In various aspects, as described in greater detail above, the closing phase can be defined by an angular position or range of angular positions of the first jaw 131002 relative to the second jaw 131004. In some cases, the first and second closing stages can span a predetermined portion of a maximum angular distance between the jaws 131002, 131004 in the open configuration. The end effector 131000 completes a complete closing cycle by moving the first jaw 131002 a maximum angular distance relative to the second jaw 131004.

In one example, the first closing phase spans a first angular distance and the second closing phase spans a second angular distance. In one example, the first angular distance and the second angular distance are equal or at least substantially equal. In one example, the second angular distance directly follows the first angular distance. Alternatively, in another example, the first angular distance is spaced apart from the second angular distance. In one example, the ratio of the first angular distance to the second angular distance is selected from a range of, for example, about half to about two.

In one example, the first closing phase spans a first half of the maximum angular distance and the second closing phase spans a second half of the maximum angular distance. Thus, according to procedure 131050, detecting initial tissue contact at any point up to 50% of the complete closed cycle of end effector 131000 results in a first energy output, while detecting initial tissue contact at points exceeding 50% of the mark results in a second energy output.

The angular position is not a unique identifying feature of the closing phase of the end effector 131000. As described below in connection with fig. 80, the closing motion of the end effector 131000 is driven by a longitudinally movable drive member 131110. The longitudinal position of the longitudinally movable drive member 131110 is another identifying feature of the closing phase. The longitudinal movement of the longitudinally movable drive member 131110 corresponds to the angular movement of the first jaw 131002 relative to the second jaw 131004 and is monitored by the absolute positioning system 7000.

In various examples, the control circuitry (e.g., fig. 13-14, 17-19) of the electrosurgical instrument includes a storage medium that stores, among other things, information characteristics of the closing phase of the end effector 131000, such as a start point of the closing phase, an end point of the closing phase, one or more angular positions of the first jaw 131002 associated with the closing phase, and/or one or more longitudinal positions of the longitudinally movable drive member 131110 associated with the closing phase.

As shown in fig. 80, absolute positioning system 7000 is configured to track closure of end effector 131000. By virtue of the stored information and the output of the absolute positioning system 7000, the control circuitry of the electrosurgical instrument (e.g., fig. 13-14, 17-19) can determine the closing phase of the end effector 131000 as it transitions between the open and closed configurations.

In certain aspects, the drive system is configured to apply a driving motion to actuate the end effector 131000 through the closing phase. The drive system may employ an electric motor 131102. In various forms, the motor 131102 can be, for example, a DC brush drive motor having a maximum rotation of about 25,000 rpm. In other arrangements, the motor 131102 can comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. A battery 1104 (or "power source" or "power pack") such as a lithium ion battery, for example, may provide power to the control circuit and ultimately to the motor 131102.

The electric motor 131102 can include a rotatable shaft 7016 operably interfacing with a gear reducer assembly 7014 that is mounted for meshing engagement with a set of drive teeth or racks on a longitudinally movable drive member 131110. In use, the polarity of the voltage provided by the battery 1104 may operate the electric motor 131102 in a clockwise direction, wherein the polarity of the voltage applied by the battery 1104 to the electric motor 131102 may be reversed to operate the electric motor 131102 in a counter-clockwise direction. When the electric motor 131102 is rotated in one direction, the longitudinally movable drive member 131110 will be driven axially in the distal direction "D" to move the first jaw 131002 from the open configuration to the closed configuration through the closing phase. When the motor 131102 is driven in the opposite rotational direction, the drive member 131110 will be driven axially in the proximal direction "P" to transition the first jaw 131002 back to the open configuration.

Fig. 80 is a schematic diagram of an absolute positioning system 7000 according to an embodiment, which includes a motor drive circuit arrangement controlled by a microcontroller 7004, which arrangement includes a sensor arrangement 7002. The electrical and electronic circuit elements associated with the absolute positioning system 7000 and/or the sensor arrangement 7002 are supported by the control circuit board assembly. The microcontroller 7004 generally includes a memory 7006 and a microprocessor 7008 ("processor") operatively coupled thereto. The processor 7008 controls the motor driver 7010 circuitry to control the position and speed of the motor 131102. The motor 131102 is operatively coupled to the sensor arrangement 7002 and the absolute position sensor 7012 arrangement to provide a unique position signal to the microcontroller 7004 for each possible position of the longitudinally movable drive member 131110 and thus each possible position of the first jaw 131002.

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

In addition, other sensors 7018 may be provided to measure other parameters associated with the absolute positioning system 7000. One or more display indicators 7020 may also be provided, which may include audible components.

The sensor arrangement 7002 provides a unique position signal corresponding to the position of the longitudinally movable drive member 131110. The electric motor 131102 can include a rotatable shaft 7016 operably interfacing with a gear assembly 7014 that is mounted for meshing engagement with a set of drive teeth or racks on a longitudinally movable drive member 131110. The sensor element 7026 may be operably coupled to the gear assembly 7014 such that a single revolution of the sensor element 7026 corresponds to some linear longitudinal translation of the longitudinally movable drive member 131110.

The sensor arrangement 7002 of the absolute positioning system 7000 employs a position sensor 7012 that generates a unique position signal for each rotational position of the sensor element associated with the position sensor 7012 in a single revolution. Thus, a single revolution of the sensor element associated with the position sensor 7012 corresponds to a longitudinal linear displacement d1 of the longitudinally movable drive member 131110. In other words, d1 is the longitudinal linear distance that the longitudinally movable drive member 131110 moves from point "a" to point "b" after a single revolution of the sensor element coupled to the longitudinally movable drive member 131110. A series of switches 7022a to 7022n (where n is an integer greater than one) may be employed alone or in combination with gear reduction to provide unique position signals for more than one rotation of the position sensor 7012. The state of the switches 7022a-7022n is fed back to the microcontroller 7004, which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+ … dn of the longitudinally movable drive member 131110, which corresponds to a unique position of the first jaw 131002 between the open and closed configurations.

In various aspects, the position sensor 7012 of the sensor arrangement 7002 may include, for example, one or more magnetic sensors, an analog rotation sensor (e.g., a potentiometer), an array of analog hall effect elements, or the like, that output a unique combination of position signals or values.

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

In various aspects, the microcontroller 7004 can be programmed to perform various functions, such as precisely controlling the speed and position of the first jaw 131002. With known physical characteristics, the microcontroller 7004 can be designed to determine the position of the first jaw 131002 and/or the rate of movement of the first jaw 131002 throughout its range of movement, which can further be used to determine the current closing phase of the first jaw 131002. Additional details regarding absolute positioning systems are disclosed in U.S. patent application Ser. No. 13/803,210, entitled sensor arrangement (SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS) for an absolute positioning system for a surgical instrument, filed on day 14 of 3.2013, which is hereby incorporated by reference in its entirety).

In certain aspects, the closing phase is defined or characterized by a predetermined location that may be stored in a storage medium of the control circuit (e.g., fig. 13-15, fig. 17-19). The position sensor 7012 transmits a sensor signal to the control circuit indicating the position of the longitudinally movable drive member 131110 along its range of motion. Since the position of the longitudinally movable drive member 131110 corresponds to the position of the first jaw 131002, the control circuitry can evaluate the closing phase of the end effector 131000 based on the received sensor signals and predetermined position data stored in the storage medium.

For example, the first closing phase may span a first range of positions, while the second closing phase may span a second range of positions that exceeds the first range of positions. Thus, a sensor signal from the position sensor 7012 indicating that the position of the longitudinally movable drive member 131110 is within the first position range causes the processor 7008 to determine that the end effector 131000 is in the first closed phase and thus select the first energy mode of operation. In another aspect, a sensor signal from the position sensor 7012 indicating that the position of the longitudinally movable drive member 131110 is within the second position range causes the processor 7008 to determine that the end effector 131000 is in the second closed phase and thus select a second energy operation mode that is different from the first energy operation mode. As described above, the second energy operation mode may produce a second energy output sufficient to seal and coagulate tissue, while the first energy operation mode may produce a first energy output sufficient to separate tissue but insufficient to seal and coagulate tissue.

Another identifying feature of the closing phase of the end effector 131000 includes closing velocity. The motor 131102 (fig. 80) can be configured to actuate the movable drive member 131110 that longitudinally drives the first jaw 131002 at a constant speed. However, as the first jaw 131002 interacts with the tissue "T", the closing speed can vary depending on the characteristics of the portion of tissue "T" that interacts with the first jaw 131002. Thus, the change in closing speed may be an identifying feature of the closing phase of the end effector 131000. The closing speed may vary as the end effector 131000 transitions from one tissue portion to another (e.g., from a tissue portion suitable for tissue separation to a tissue portion suitable for tissue sealing). A change in the rate of movement of the first jaw 131002 can indicate completion of tissue separation prior to tissue sealing and coagulation.

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

Another identification feature of the closing phase of the end effector 131000 includes a clamp load. Like the closing speed, the load exerted by the end effector 131000 on the tissue "T" can vary depending on the characteristics of the portion of tissue "T" that interacts with the first jaw 131002. Thus, the change in clamping load may be an identifying feature of the closing phase of the end effector 131000. The clamping load may vary as the end effector 131000 transitions from one tissue portion to another (e.g., from a tissue portion suitable for tissue separation to a tissue portion suitable for tissue sealing). A change in clamping load may indicate completion of tissue separation prior to tissue sealing and coagulation.

Fig. 81 is a logic flow diagram depicting a process 131070 for switching a control program or logic configuration between energy operation modes of an electrosurgical instrument in accordance with at least one aspect of the present disclosure. The process 131070 includes detecting 131072 end effector 131000 closing speed and clamp load. The closing speed may be monitored via the absolute positioning system 7000. The clamp load may be determined using sensors 8406, 8408a, 8408b, as described in connection with fig. 51, 52. The sensors 8406, 8408a, 8408b are electrically connected to a control circuit, such as the control circuit 7400 (fig. 49), via an interface circuit. The process 131070 also includes determining 131074 whether the closing speed has changed beyond a predetermined threshold. The storage medium of the control circuit executing the process 131070 can store a value of a predetermined threshold. The current closing velocity may be compared to a predetermined threshold to determine whether the current closing velocity meets or exceeds the predetermined threshold. The process 131070 also determines 131076 if the clamp load has changed beyond a predetermined threshold. The storage medium of the control circuit executing the process 131070 can store a value of a predetermined threshold. The current clamp load may be compared to a predetermined threshold to determine whether the current clamp load meets or exceeds the predetermined threshold. Either occurrence will cause the process 131070 to switch 131078 from the tissue separation energy mode to the tissue sealing energy mode.

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

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

In various aspects, the first ultrasonic frequency may be first set during a first closing phase to mechanically separate a layer of musculature of the vessel prior to application of the second ultrasonic frequency during a second closing phase to cut and seal the vessel.

The ultrasonic generator module is programmed to output a first drive frequency f1 during a first closing phase, wherein the first frequency f1 is a significantly off-set resonant frequency, such as fo/2, 2fo or other structural resonant frequency, wherein fo is a resonant frequency (e.g., 55.5 kHz). The first frequency f1 in combination with the clamping force provides a low level of mechanical vibration to the ultrasonic blade to mechanically separate the musculature layers of the blood vessel (sub-treatment) without causing significant heating phenomena that typically occur when resonating. During the second closing phase, the ultrasound generator module is programmed to automatically switch the drive frequency to the resonance frequency fo to transect and seal the blood vessel.

In various aspects, the ultrasonic surgical instrument is connected to a surgical hub that interacts with a cloud-based system, as described in connection with fig. 1-11. In such cases, the control circuitry of the electrosurgical instrument may receive input regarding various situational parameters collected by the surgical hub and/or the cloud-based system. Such inputs may be useful in selecting an appropriate energy mode of operation. Furthermore, the energy level generated by the transducer may be specifically adapted to the type of tissue being treated. Situation parameters include, but are not limited to, tissue type, tissue anatomical location, and/or tissue composition. For example, the energy required for tissue separation in the liver or other solid organ may be different from that of the other organ. In addition, the energy level for tissue separation can be increased to accommodate tissue adhesion or other adventitious connective tissue as reported by a surgical hub. Additional details regarding situational awareness for surgical hubs, cloud-based systems, and various surgical instruments are described under the heading "situational awareness".

Different electromechanical systems for controlling electrosurgical instruments

Various surgical instruments include end effectors that clamp tissue and apply RF energy, ultrasonic energy, or a combination of RF and ultrasonic energy to the clamped tissue as described in connection with FIGS. 22-24. Optimal tissue treatment is achieved by carefully modulating the energy application to the tissue and tissue compression, which are achieved by separate systems that affect each other's effects on the tissue. For example, the application of energy to tissue may be affected by the moisture content of the tissue, which is affected by the compression applied to the tissue. Increasing the compression applied to the tissue increases the rate at which the moisture content of the tissue flows out of the tissue held by the end effector, thereby affecting tissue conductivity.

Aspects of the present disclosure provide various procedures for systems for modulating electrosurgical instruments that act on tissue alone, but have a related impact on tissue. The use of the same parameters to modulate the individual systems of the electrosurgical instrument that have an associated effect on the tissue ensures consistency of the effect of the system on the tissue. In other words, coordinating the operation of such systems by means of the same parameters may achieve better correlation of effects on the organization.

In certain aspects, one or more of the disclosed processes may be performed by control circuitry of an electrosurgical instrument (such as control circuitry 710 of surgical instrument 700 and/or control circuitry 760 of surgical instruments 750, 790). In certain aspects, as shown in fig. 13, the control circuitry for performing one or more processes may include one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504 that stores program instructions that, when executed by the processor 502, cause the processor 502 to perform the one or more processes. Alternatively, one or more of the processes may be performed by one or more of the control circuits depicted in fig. 14, 15. In certain aspects, the electrosurgical instrument may include a non-transitory storage medium storing one or more algorithms for performing one or more procedures.

Fig. 82 is a logic flow diagram depicting a process 131100 for modulating a control program or logic configuration of a system of surgical instruments (e.g., surgical instruments 700, 750, 790, 1104, 1106, 1108) in accordance with at least one aspect of the present disclosure. The process 131100 monitors 131101 parameters of the surgical instrument. In various examples, the electrosurgical instrument includes an end effector 131000. In some examples, the parameter is an impedance of tissue grasped by the end effector 131000. In another example, the parameter is a temperature of the tissue being grasped.

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

In the example of fig. 82, the change in end effector closure is achieved by varying the energy delivered to the motor. In other cases, the change in end effector closure may be accomplished differently, for example, by a gearbox assembly. The clutch mechanism may be configured to engage or disengage the gearbox assembly in order to increase or decrease the speed of a drive shaft coupled to the motor, which in turn causes a desired change in end effector closure.

Where tissue impedance (Z) is the monitored parameter, tissue impedance (Z) may be monitored by one or more sensors as described in connection with fig. 18, 19, 21, 78A. For example, end effector 131000 may be equipped with the tissue contacting circuit of fig. 78A, wherein tissue "T" is grasped between plates P1, P2. Tissue impedance (Z) may be calculated based on _{Tissue of} )：

Where V is voltage, I is current, and Z _{Sensing circuit} Is the predetermined impedance of the sensing circuit "SC" as shown in fig. 78A. In various examples, as shown in connection with fig. 21, tissue impedance (Z) may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.

Where tissue impedance (Z) is the monitored parameter, tissue impedance (Z) may be monitored by one or more temperature sensors. Alternatively, tissue temperature may be determined, as described above in connection with fig. 51-53, wherein flexible circuit 8412 may include a temperature sensor embedded in one or more layers of flexible circuit 8412. The one or more temperature sensors may be symmetrically or asymmetrically arranged and provide tissue 8410 temperature feedback to the ultrasound drive circuitry and/or control circuitry of the RF drive circuitry. In other examples, as shown in connection with FIGS. 66A-66B, the phase angleAnd/or the change in generator drive frequency may be used as an indirect or inferred measurement of the temperature of the ultrasonic blade, which in turn may be used to estimate or infer the temperature of tissue grasped between the ultrasonic blade and the clamping member of the ultrasonic end effector.

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

Fig. 84 is a graph 131130 illustrating an implementation 131120 of an ultrasonic surgical instrument incorporating the ultrasonic end effector 1122 of fig. 23. The first electromechanical system is represented by a transducer 1120 and an ultrasonic blade 1128, which is acoustically coupled to the ultrasonic transducer 1120 via a waveguide. The ultrasonic transducer 1120 may be energized with a generator 1100. The ultrasonic blade 1128 may vibrate when driven by the ultrasonic transducer 1120 and may cut and/or coagulate tissue when in contact with tissue, as described herein.

The second electromechanical system is represented by the motorized clamping arm 1140 of the end effector 1122. The motorized movement of the clamping arm of the ultrasonic surgical instrument is described in more detail in connection with fig. 46-50. The clamp arm 1140 may be operably coupled to a motor that may drive the clamp arm 1140 to transition the end effector 1122 between an open configuration and a closed configuration to grasp tissue between the clamp arm 1122 and the ultrasonic blade 1128.

Referring to fig. 84, graph 131130 includes three curves 131132, 131134, 131136 showing tissue impedance (Z), power (P), and force (F) plotted on the Y-axis versus time (t) on the X-axis. Force (F) is determined at the distal portion (tip) of end effector 1122. The upper and lower thresholds are defined in the impedance curve 131132. At t ₁ And t ₄ At this point, when the impedance (Z) reaches or exceeds the upper threshold defined in the impedance curve 131132, the power (P) is regulated in the power curve 131134. Thus, the energy delivered to the transducer 1120 of the first electrosurgical system is controlled by the upper threshold of the impedance (Z) parameter. At t ₂ And t ₃ Where the adjustment in force curve 131136 occurs when the impedance value reaches or exceeds a lower threshold defined in impedance curve 131132End force (F). Thus, the force applied to the tissue by the clamping member 1122 is controlled by the lower threshold of the impedance (Z) parameter.

In various examples, when tissue impedance (Z) reaches or exceeds a lower threshold, current (I) delivered to the motor may be varied in order to achieve a change in the force applied to the tissue by clamping member 1122. In at least one example, as shown in fig. 84, when tissue impedance (Z) reaches or exceeds a lower predetermined threshold, motor current (I) may be increased to increase the clamping force applied to the tissue.

Due to the pivotal movement of the clamping arm of the ultrasonic surgical instrument, more compression is applied to tissue positioned proximally between the jaws than to tissue positioned distally between the jaws. The reduced compression of the tissue at the distal portion of the jaws can reduce the heat flux of the tissue at the distal portion of the jaws below a threshold level required to effectively treat the tissue.

In various aspects, the clamping arm can be equipped with tissue sensing circuitry configured to determine a position of tissue clamped between jaws of the end effector. Examples of suitable tissue sensing circuits are further described in U.S. patent No. 8,181,839 (titled surgical instrument with sensor (SURGICAL INSTRUMENT EMPLOYING SENSORS), published 5/2012, the entire disclosure of which is incorporated herein by reference) filed on 2011 at 6/27. Various tissue sensing techniques are also described in U.S. provisional application No. 62/650,887 (titled SURGICAL system with optimized sensing capability (surica SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES), which is hereby incorporated by reference in its entirety) filed on 3/30 at 2018. In at least one example, the tissue sensing circuit includes two electrodes spaced apart. When tissue is in contact with both electrodes, the tissue sensing circuit is closed, causing a sensor signal indicative of the presence of tissue to be transmitted to the control circuit (e.g., fig. 13-14, 17-19).

The clamp arm load may be adjusted based on the detected tissue position. For example, where tissue is concentrated at the distal portion of the jaws, a higher load may be applied. A higher clamping arm load can be maintained until the clamping tissue at the distal portion of the jaws is nearly completely coagulated. The clamp arm load is then reduced to avoid driving the ultrasonic blade into the pads of the clamp arm. In one example, a higher clamp arm load may be maintained up to a predetermined angular distance between the clamp arm and the ultrasonic blade. Once the clamp arm reaches or exceeds the predetermined angular distance, the clamp arm load is reduced.

In certain aspects, in combination with the combination device, RF energy can be mixed with modulation of the clamp arm load so as to provide sufficient heat flux to coagulate tissue concentrated at the distal tip portion of the jaws.

Detecting presence of end effector in liquid

The frequency response associated with immersing the ultrasonic blade in the liquid is similar to the frequency response associated with thick tissue clamped between the clamping member and the ultrasonic blade. In order to avoid the generator from falsely triggering tissue treatment specific to thick tissue, it is desirable to detect when the ultrasonic blade is immersed in the liquid.

As described above in connection with fig. 70A-71, an ultrasonic surgical instrument or combination electrosurgical instrument including an ultrasonic component is configured to detect immersion of an ultrasonic blade in a liquid (e.g., blood, saline, water, etc.) by detecting that the temperature of the ultrasonic blade thereof is significantly below a predetermined threshold.

or in other words by detecting the voltage V applied to the ultrasonic transducer _g (t) Signal and Current I _g (t) phase angle between signalsTo infer. Phase angle->Information can also be used for pushingBreaking the ultrasonic knife. As specifically discussed herein, phase angle +. >As a function of the temperature of the ultrasonic blade. Thus, the phase angle +>The information may be used to control the temperature of the ultrasonic blade.

FIGS. 70A-70B are graphical representations of temperature feedback control for adjusting ultrasonic power applied to an ultrasonic transducer when a temperature dip of an ultrasonic blade is detected. The temperature of the ultrasonic blade increases with the applied power 133072 as shown in fig. 70A. During use, the temperature of the ultrasonic blade suddenly drops. It can be inferred that the temperature of the ultrasonic blade decreases when it is immersed in a fluid-filled surgical field (e.g., blood, saline, water, etc.).

Immersion of the ultrasonic blade in the liquid may cause a portion of the heat generated by the ultrasonic blade to be dissipated into the liquid. Thus, the immersion increases the heat flux required to effect effective treatments such as tissue coagulation. The generator modulates the power delivered to the ultrasound transducer in order to modulate the heat flux to a level sufficient for effective treatment.

In some cases, a mixture of RF energy and ultrasonic energy may be employed to adjust the heat flux to a level sufficient for effective treatment. In some cases, the compressive force applied to the tissue between the ultrasonic blade and the clamp arm of the surgical instrument may be modulated to adjust the heat flux to a level sufficient for effective treatment.

In another aspect, as shown in fig. 85, detection of immersion of the ultrasonic blade in a liquid may be inferred from the frequency response of the waveguide/transducer.

Referring to fig. 85, power (P) is plotted as a function of time in diagnostic mode (as shown in curve 131140) and in response mode (as shown in curve 131142). The power (P) is plotted on the vertical axis and the time (t) is plotted on the horizontal axis. The frequency response of the waveguide/transducer in the liquid is different from the ideal frequency response of the waveguide/transducer in air and is below the predetermined threshold curve 131141. When the ultrasonic blade is immersed in a liquid, the frequency response curve 131143 of the waveguide/transducer flattens out rather than having the characteristic increase and flat area expected in the ideal frequency response curve 131145 for effective tissue treatment.

Fig. 86 is a logic flow diagram depicting a process 131150 of detecting and compensating for a control program or logic configuration of an ultrasonic blade immersed in a liquid in accordance with at least one aspect of the present disclosure. The process 131150 monitors 131152 the power delivered to tissue over time and compares it to a predetermined threshold. As shown in fig. 85, the process 131150 can sample the power change (δp/δt) over a predetermined period of time and compare it to a predetermined threshold slope. If the determined slope (δp/δt) is below the threshold slope, it can be inferred that the ultrasonic blade is immersed in a liquid that wets/cools the blade, thereby increasing the heat flux required by the blade to perform effective treatment (curve 131145). To compensate 131156, more power (curve 131147) is delivered to the transducer. When adjusted by the wetting effect of the liquid, the increased power is selected to be sufficient to produce the desired frequency response (curve 131145). However, if the determined slope (δp/δt) is greater than the threshold slope, power delivery to the ultrasound transducer is continued as planned.

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

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

Depending on the degree to which the end effector is immersed in the fluid and/or the temperature of the fluid, an algorithm may be selected to compensate for the heat dissipated into the fluid in order to achieve effective treatment of the tissue. In at least one example, the power (P) delivered to the ultrasound transducer may be modulated as described above to counteract the effects of immersion. Alternatively, a compressive force may be applied to the tissue between the clamping arm and the ultrasonic blade to counteract the effects of immersion. In various aspects, both power (P) and tissue compression may be modulated to counteract the effects of liquid immersion. The mixed RF and ultrasonic energy modes may also be used to minimize the effects of immersion and may be used in conjunction with increasing ultrasonic power, RF power, or clamp arm pressure to achieve effective treatment of tissue.

Referring to fig. 87, graph 131160 depicts power (P) delivered to tissue by an end effector 131000 (fig. 73) of an electrosurgical instrument and temperature (T) of tissue grasped by the end effector 131000 as a function of closure driver (e.g., closure member 764 of fig. 18, 19) displacement to control transition of the end effector 131000 to a closed configuration. As described herein, the end effector 131000 treats tissue by grasping tissue and applying RF energy and/or ultrasonic energy to the grasped tissue.

In addition to the above, a closure driver is operably coupled to at least one of the jaws 131002, 131004 and is movable to transition the end effector 131000 between an open configuration and a closed configuration to clamp tissue between the jaws 131002, 131004. Thus, movement of the closure actuator may represent or be associated with a closure movement of the end effector 131000. Thus, there is a correlation between the compressive force applied by the end effector 131000 to the tissue captured between the jaws 131002, 131004 and the closure driver displacement.

Graph 131160 shows a tissue treatment cycle of end effector 131000. The power (P) is represented on the left vertical axis, the temperature (T) is represented on the right vertical axis, and the closing actuator displacement or translation (δ) is represented on the horizontal axis. Each delta on the horizontal axis of the graph 131160 represents the distance traveled by the closure actuator from the starting position.

The phase of the tissue treatment cycle is defined by the closed actuator position. In various aspects, it is desirable to maintain the tissue at a desired temperature or within a desired temperature range at one or more stages of the tissue treatment cycle. The power (P) delivered to the tissue can be regulated to maintain tight control over the tissue temperature.

In the example of fig. 87, the initial phase 131162 depicts the power (P) gradually increasing to the power level (P1) as the closing driver translates to δ1. The power (P) is then maintained at a power level (P1) corresponding to a temperature of about 60 ℃ in a first stage 131164. At this temperature, the tissue undergoes collagen denaturation. Near the end of the first phase 131164, the power level is again raised to a power level (P2) at the beginning of the second phase 131166, which corresponds to a temperature between 60 ℃ and 100 ℃. Near the end of the second phase 131166, the power level is again raised to a power level (P4) configured to bring the tissue to and/or above a temperature of 100 ℃.

On the horizontal axis, the first stage 131164 is defined between a first position at δ1 and a second position at δ2. When the closing driver translates to a second position at δ2, the power (P) is maintained at a power level (P1). The tissue temperature was maintained at 60 ℃ to promote collagen denaturation.

The second stage 131166 is defined between the second position at δ2 and the third position at δ3. When the closing driver translates to a third position at delta 3, the power (P) is maintained at the power level (P2). During the second stage 131166, it is desirable to maintain the tissue temperature between 60 ℃ and 100 ℃ to minimize collateral damage to surrounding tissue that may be caused by steam generated at 100 ℃. However, in some cases, as shown in the curve portion 131168 of graph 131160, the tissue temperature may reach delta at the closing driver _{Maximum value} Previously raised prematurely to 100 ℃. In various aspects, as shown in fig. 87, a predetermined power threshold (P3) is set to prevent the tissue from prematurely reaching a boiling temperature of 100 ℃.

FIG. 88 is a drawing ofPictorially when the clamp arm transitions to delta _{Maximum value} A logic flow diagram of a control program or logic configuration process 131170 for maintaining tissue temperature below 100 ℃ in a closed configuration. The process 131170 monitors 131172 the closure actuator position and/or displacement. In one example, the closure actuator position and/or displacement may be monitored by an absolute positioning system 7000 as described in more detail in connection with fig. 80.

The process 131170 also monitors 131172 tissue temperature, which may be estimated based on the temperature of the ultrasonic blade, for example. If the end effector 131000 is in the form of an ultrasonic end effector or a combination end effector, the ultrasonic blade temperature may be determined by detecting the impedance of the ultrasonic transducer given by the following expression:

Or in other words by detecting the voltage V applied to the ultrasonic transducer _g (t) Signal and Current I _g (t) phase angle between signalsTo infer as described herein. Alternatively, the end effector 131000 may be equipped with one or more temperature sensors for measuring tissue temperature.

Based on the monitored temperature and position information, process 131170 determines 131174 whether the temperature of tissue will reach or exceed δ at the closing actuator _{Maximum value} Previously reached or exceeded 100 c prematurely as shown by the curved portion 131168 of graph 131160. If so, process 131170 adjusts 131176 the power (P) to a level less than or equal to the predetermined power threshold (P3) to prevent the temperature (T) of the tissue from reaching or exceeding delta at the closing actuator _{Maximum value} Previously 100 c was reached as shown in the curve 131169.

In certain aspects, the process 131170 may be performed, at least in part, by a control circuit (fig. 13) comprising one or more processors 502 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 504 that stores program instructions that, when executed by the processor 502, cause the processor 502 to perform the process 131170. For example, the control circuit may receive the closed drive position information from the absolute positioning system 7000. The tissue temperature may be determined by the processor 502 from temperature sensor readings or determined ultrasonic blade temperatures, as described herein.

In addition to the above, it may be determined whether the temperature of the 131174 tissue will reach or exceed delta at the time of closing the actuator, for example, by calculating a temperature trajectory from the position, power and/or temperature data at the end of the second phase 131166 _{Maximum value} Prematurely reaching or exceeding 100 ℃. In one example, the processor 502 may be configured to calculate a temperature trace from one or more tables and/or formulas stored in the memory circuit 504, for example.

In various aspects, the process 131170 can be performed by one or more control circuits depicted in fig. 14, 15. In certain aspects, the electrosurgical instrument may include a non-transitory storage medium storing one or more algorithms for performing the procedure 131170.

In at least one example, as shown in FIG. 87, at less than δ _{Maximum value} Meeting or exceeding a predetermined threshold temperature T between 60 ℃ and 100 ℃ at a predetermined threshold position delta 3 of (c) ₁ Can indicate that the temperature of the tissue will reach or exceed delta at the closing actuator _{Maximum value} Previously, 100 ℃ was reached or exceeded prematurely. Thus, if the determined temperature is greater than or equal to the predetermined threshold temperature T at the predetermined position threshold δ3 ₁ Then process 131170 determines 131174 that the temperature of the tissue will reach or exceed delta at the closing actuator _{Maximum value} And prematurely reaches or exceeds 100 ℃.

Referring to fig. 89, graph 131180 includes four curves 131182, 131184, 131186, 131188. Curve 131182 shows voltage (V) and current (I) versus time (T), curve 131184 shows power (P) versus time (T), curve 131186 shows temperature (T) versus time (T), and curve 131188 shows tissue impedance (Z) versus time (T). In curve 131188, an impedance bathtub (e.g., tissue impedance initially decreases with respect to time, then stabilizes and eventually increases, the curve resembling a bathtub shape) is depicted.

Here, time zero represents a first point in time at which electrosurgical energy is applied to tissue at the surgical site. The Y-axis represents the level of tissue impedance (Z) that exists when a substantially constant level of power (P) is applied to the tissue (as shown in the corresponding portion of curve 131184). At time zero, the tissue exhibits an initial impedance level (ZInitially). The initial impedance level (ZInitially) may be based on natural physiological characteristics about the tissue such as density, moisture content, and the type of tissue thereof. The impedance level actually drops slightly as power is continuously applied to the tissue over a short period of time. Eventually reaching a minimum impedance level (zmin). From here on, the total impedance level increases.

As tissue impedance (Z) decreases toward a minimum tissue impedance (zmin) over time (t 1), current (I) increases and voltage (V) decreases. The current curve depicted in curve 131182 corresponds to voltage curve L1. The current curves corresponding to voltage curves L2 and L3 are omitted for clarity. During the initial period (t 1), the temperature of the tissue gradually increases to 100 ℃. Once the water in the tissue begins to evaporate, the tissue impedance (Z) increases significantly, resulting in a decay of the current (I) through the tissue. As tissue impedance (Z) increases to 100 Ω, the tissue temperature also increases to 110 ℃, which constitutes the boiling point of some tissue oils.

In order to achieve effective tissue treatment, it is desirable to maintain the tissue below a predetermined maximum temperature. To prevent the temperature of the tissue from exceeding a predetermined maximum threshold temperature, the voltage (V) is raised as shown in voltage (V) curves L2 and L3. Increasing the voltage (V) prevents the temperature of the tissue from exceeding a predetermined threshold temperature, as shown in a temperature curve L3 "corresponding to the voltage curve L3, or at least rapidly restores the temperature of the tissue below the predetermined threshold temperature, as shown in a temperature curve L2" corresponding to the voltage curve L2. In contrast, without increasing the voltage (V), as shown in the voltage curve L1, the tissue temperature of the tissue increases significantly above the predetermined threshold temperature, as shown in the corresponding temperature curve L1 ".

In at least one example, as shown in fig. 89, the predetermined maximum temperature is about 130 ℃. In order to keep the tissue below a predetermined maximum temperature, the voltage (V) is raised in order to slow down the further increase in temperature and eventually reverse the increase in temperature.

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

Procedures 131190 (fig. 90) and 131200 (fig. 91) depict a control program or logic configuration that uses such values of tissue impedance (Z) and temperature (T) as trigger conditions to raise voltage (V) toward the end of a tissue treatment cycle applied by end effector 131000 as shown in fig. 89. The present disclosure contemplates other values of tissue impedance (Z) and tissue temperature (T) that may be used as trigger conditions to raise voltage (V). In various examples, the threshold tissue impedance (Z) may be about 100 Ω as shown in curve 131188 of fig. 89. In other examples, the threshold tissue impedance (Z) may be about 450 Ω. In various examples, as shown in curve 131186 of fig. 89, the threshold temperature (T) may be about 110 ℃. In other examples, the threshold temperature (T) may be about 130 ℃.

In one example, as shown in process 131190 of fig. 90, 131192 tissue impedance (Z) can be monitored and used to determine 131194 when trigger voltage (V) increases 131196. As described herein in connection with fig. 78A, for example, the sensing circuit may be used to determine tissue impedance (Z). Control circuitry (e.g., fig. 13-15) of the ultrasound drive circuitry and/or the RF drive circuitry may be used to perform the process 131190 based on input received from the sensing circuitry.

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

In various examples, the voltage (V) increases in a stepwise manner, as shown by voltage curves L2, L3. In other examples, the voltage (V) may gradually increase.

In at least one example, two different upper limit temperatures are set to affect the power level. In addition to the maximum temperature threshold, primary and secondary minimum shutdown temperature thresholds may be used.

Ultrasonic and radio frequency surgical instrument combination

As described above, the end effector 131000 (fig. 73) may be adapted for use with a combination electrosurgical instrument that provides tissue treatment by applying Radio Frequency (RF) energy alone or in combination with ultrasonic vibrations. Examples of generators configured to drive an ultrasonic transducer and an RF electrode of an end effector are discussed in more detail in U.S. patent publication 2017/0202609 (titled modular battery-powered hand-held surgical instrument (Modular Battery Powered Hand-Held Surgical Instrument With Curved End Effectors Having Asymmetric Engagement Between Jaw and Blade) with a curved end effector having an asymmetric engagement between the jaws and the knife, which is incorporated by reference in its entirety).

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

Fig. 92 is a process 131210 depicting a control program or logic configuration for utilizing an ultrasound component in a non-therapeutic diagnostic mode and an RF component in a therapeutic mode.

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

As described in connection with fig. 66A-68, the generator is based on a phase angle between the voltage Vg (t) signal and the current Ig (t) signal applied to drive the ultrasound transducerTo infer the temperature of the ultrasonic blade. Because the temperature of the ultrasonic blade corresponds to the temperature of the tissue captured by the end effector 131000 of the combination device, the ultrasonic component can be used to diagnose non-therapeutic modes to monitor tissue temperature and provide feedback information to adjust the power level of the RF component.

Fig. 93 is a graph 131220 illustrating an execution process 131210 in accordance with at least one aspect of the present disclosure. Graph 131220 includes three curves 131222, 131224, 131226, which depict power (P), temperature (T), and phase, respectively, on the vertical axis. Curve 131222 represents the power (P) versus time (t) delivered to tissue captured between jaws 131002, 131004 of an end effector 131000 of a combined device. Curve 131224 shows the temperature (T) versus time (T) of the ultrasonic blade of end effector 131000. Curve 131226 represents the dual non-therapeutic frequency at which the ultrasound component is used to determine the temperature of the ultrasound blade and, thus, the temperature of the tissue (as described in more detail in connection with fig. 66A-68). The ultrasound component may be configured to detect a transition of the tissue temperature to or above a predetermined threshold temperature (T _{Threshold value} ) As shown in curve 131224. The power (P) level of the RF component (from P1 to P2) can then be adjusted to prevent excessive temperatures, as shown in curve 131222.

In at least one example, the power (P) level of the RF component is adjusted to maintain the tissue temperature below 100 ℃ to prevent steam from causing collateral damage to surrounding tissue while still causing localized coagulation of collagen in tissue grasped by the end effector 131000 of the combined device. In at least one example, the power (P) level of the RF component is adjusted to maintain tissue temperature below 130 ℃ to prevent charring of tissue that may occur at such temperatures. In at least one example, the temperature feedback provided by the ultrasound component allows the RF component to adjust the power slope according to tissue phase transitions during a tissue treatment cycle.

In various aspects, a process includes a control program or logic configuration for distinguishing sections of an ultrasonic blade based on temperature. This process separates the very hot smaller section of the ultrasonic blade from the medium hot larger section. In at least one aspect, the process includes applying multiple frequencies through 55.5Khz (which is the standard frequency), and then alternatively using 3 times the frequency, e.g., 150Khz, to determine two different resonant frequencies, which would allow a small portion of an ultrasonic blade having a very hot temperature, or a larger portion of an ultrasonic blade having a moderately hot temperature, to be determined.

Fig. 94 is a logic flow diagram depicting a process 131230 of a control program or logic configuration for adjusting the frequency of an RF waveform of an RF component of an RF electrosurgical instrument or combination device based on measured tissue impedance in accordance with at least one aspect of the present disclosure. In at least one example, 131232 tissue impedance is measured before or during an initial portion of a tissue treatment cycle and this measurement is used to select 131231 between predetermined high frequency 131234 and low frequency 131236 options of an RF waveform applied to tissue.

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

In various aspects, one or more processes of the present disclosure may be performed by control circuitry of an electrosurgical instrument (such as control circuitry 710 of surgical instrument 700, control circuitry 760 of surgical instrument 750, and/or control circuitry 760 of surgical instrument 790). In certain aspects, as shown in fig. 13, the control circuitry for performing one or more processes of the present disclosure may comprise one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504 that stores program instructions that, when executed by the processor 502, cause the processor 502 to perform the one or more processes. Alternatively, one or more processes of the present disclosure may be performed by one or more control circuits depicted in fig. 14, 15. In certain aspects, the electrosurgical instrument may include a non-transitory storage medium storing one or more algorithms for performing one or more processes of the present disclosure.

Various aspects of the subject matter described herein are set forth in the following numbered embodiments:

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

Example 2-the surgical instrument of example 1, wherein detecting immersion comprises monitoring a phase angle between a voltage Vg (t) signal and a current Ig (t) signal applied to the ultrasonic transducerBased on the phase angle between the voltage Vg (t) signal and the current Ig (t) signal applied to the ultrasound transducer>To infer the temperature of the ultrasonic blade And comparing the inferred temperature of the ultrasonic blade to a predetermined temperature.

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

Embodiment 4-the surgical instrument of any one of embodiments 1-3, wherein compensating for heat flux is achieved by adjusting power to the ultrasonic transducer.

Embodiment 5-the surgical instrument of any one of embodiments 1-4, wherein compensating for heat flux is achieved by adjusting a compressive load applied to the tissue clamped between the clamping arm and the ultrasonic blade.

Example 6-a surgical instrument comprising an end effector comprising an ultrasonic blade and a clamp arm. The clamping arm is movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamping arm. The surgical instrument further includes an ultrasonic transducer configured to generate an ultrasonic energy output, a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade, and a drive member configured to actuate movement of the clamp arm to transition the end effector to the closed configuration. The surgical instrument further includes a control circuit configured to monitor a position of the drive member, monitor a temperature of the ultrasonic blade, and prevent the temperature from exceeding a predetermined threshold prior to the closed configuration.

Embodiment 7-the surgical instrument of embodiment 6, wherein the phase angle between the voltage Vg (t) signal and the current Ig (t) signal based on the voltage Vg (t) signal applied to the ultrasonic transducerTo infer the temperature.

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

Embodiment 9-the surgical instrument of any one of embodiments 6-8, wherein the predetermined threshold is 100 ℃.

Embodiment 10-the surgical instrument of any one of embodiments 6-9, wherein preventing the temperature from exceeding a predetermined threshold is achieved by adjusting power delivered to the ultrasonic transducer.

Embodiment 11-the surgical instrument of any one of embodiments 6-10, wherein the closed configuration corresponds to a predetermined distance traveled by the drive member from the starting position.

Embodiment 12-the surgical instrument of any one of embodiments 6-10, wherein the closed configuration corresponds to a maximum compression applied to tissue by the clamping arm.

Example 13-a surgical instrument comprising an end effector comprising a first jaw and a second jaw. The second jaw is movable relative to the first jaw to transition the end effector between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw. The end effector further includes an ultrasonic component configured to deliver ultrasonic energy to the grasped tissue and a Radio Frequency (RF) component configured to deliver RF energy to the grasped tissue. The surgical instrument further includes control circuitry configured to operate the ultrasonic component in a non-therapeutic diagnostic mode while operating the RF component in a therapeutic mode to treat the grasped tissue.

Embodiment 14-the surgical instrument of embodiment 13, wherein the non-therapeutic diagnostic mode comprises determining at least one temperature of the grasped tissue.

Embodiment 15-the surgical instrument of embodiment 13 or embodiment 14, wherein the ultrasonic component comprises an ultrasonic transducer.

Embodiment 16-the surgical instrument of embodiment 15, wherein the phase angle between the voltage Vg (t) signal and the current Ig (t) signal based on the voltage Vg (t) signal applied to the ultrasonic transducerTo infer the temperature.

Embodiment 17-the surgical instrument of any of embodiments 13-16, wherein the treatment mode comprises applying RF energy to seal the grasped tissue.

Embodiment 18-the surgical instrument of any one of embodiments 13-17, wherein the ultrasonic component comprises an ultrasonic transducer, and wherein the RF component comprises an RF electrode.

Embodiment 19-the surgical instrument of embodiment 18, further comprising a generator configured to drive the ultrasonic transducer and the RF electrode.

While various forms have been illustrated and described, it is not the intention of the applicant to restrict or limit the scope of the appended claims to such detail. Many modifications, variations, changes, substitutions, combinations, and equivalents of these forms may be made by one skilled in the art without departing from the scope of the disclosure. Furthermore, the structure of each element associated with the described form may alternatively be described as a means for providing the function performed by the element. In addition, where materials for certain components are disclosed, other materials may be used. It is, therefore, to be understood that the foregoing detailed description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed forms of the invention. The appended claims are intended to cover all such modifications, changes, variations, substitutions, modifications and equivalents.

The foregoing detailed description has set forth various forms of the apparatus and/or methods via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein may be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the electronic circuitry and/or writing the code for the software and/or hardware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as a program product or products in a variety of forms, and that an illustrative form of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution.

Instructions for programming logic to perform the various disclosed aspects can be stored within a memory within a system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Furthermore, the instructions may be distributed via a network or by other computer readable media. Thus, a machine-readable medium may include, but is not limited to, a mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), a floppy disk, an optical disk, a compact disk, a read-only memory (CD-ROM), a magneto-optical disk, a read-only memory (ROM), a Random Access Memory (RAM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a magnetic or optical card, a flash memory, or a tangible, machine-readable storage device for use in transmitting information over the internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

As used in any aspect herein, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, digital Signal Processors (DSPs), programmable Logic Devices (PLDs), programmable Logic Arrays (PLAs), field Programmable Gate Arrays (FPGAs)), state machine circuitry, firmware storing instructions executed by the programmable circuitry, and any combination thereof. The control circuitry may be implemented together or separately as circuitry forming part of a larger system, such as an Integrated Circuit (IC), application Specific Integrated Circuit (ASIC), system-on-chip (SoC), desktop computer, laptop computer, tablet computer, server, smart phone, or the like. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially carries out the processes and/or devices described herein, or a microprocessor configured by a computer program that at least partially carries out the processes and/or devices described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital fashion, or some combination thereof.

As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to perform any of the foregoing operations. The software may be embodied as software packages, code, instructions, instruction sets, and/or data recorded on a non-transitory computer readable storage medium. The firmware may be embodied as code, instructions or a set of instructions and/or data that are hard-coded (e.g., non-volatile) in a memory device.

As used in any aspect herein, the terms "component," "system," "module," and the like can refer to a computer-related entity, hardware, a combination of hardware and software, or software in execution.

As used in any aspect herein, an "algorithm" refers to an organized sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states, which may, but need not, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. Are often used to refer to signals such as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or conditions.

The network may comprise a packet switched network. The communication devices may be capable of communicating with each other using the selected packet switched network communication protocol. One exemplary communication protocol may include an ethernet communication protocol that may allow for communication using transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with an ethernet standard known as the "IEEE 802.3 standard" published by the Institute of Electrical and Electronics Engineers (IEEE) at month 12 of 2008 and/or a higher version of the standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an x.25 communication protocol. The x.25 communication protocol may conform to or conform to standards promulgated by the international telecommunications union telecommunication standardization sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or conform to standards promulgated by the international committee for telephone and telephone negotiations (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard promulgated by the ATM forum at month 8 of 2001 under the name "ATM-MPLS network interworking 2.0" and/or a higher version of the standard. Of course, different and/or later developed connection oriented network communication protocols are likewise contemplated herein.

Unless specifically stated otherwise as apparent from the above disclosure, it is appreciated that throughout the above disclosure, discussions utilizing terms such as "processing," "computing," "calculating," "determining," "displaying" or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

One or more components may be referred to herein as "configured", "configurable", "operable/operable", "adapted/adaptable", "capable", "conformable/conforming" and the like. Those skilled in the art will recognize that "configured to" may generally encompass active state components and/or inactive state components and/or standby state components unless the context indicates otherwise.

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

Those skilled in the art will recognize that, in general, terms used herein, and particularly in the appended claims (e.g., bodies of the appended claims) are generally intended to be "open" terms (e.g., the term "including" should be construed as "including but not limited to," the term "having" should be construed as "having at least," the term "comprising" should be construed as "including but not limited to," etc.). It will be further understood by those with skill in the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim(s). However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Moreover, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include but not be limited to systems having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" shall include but not be limited to systems having only a, only B, only C, A and B together, a and C together, B and C together, and/or A, B and C together, etc.). It will be further understood by those within the art that, in general, unless the context indicates otherwise, disjunctive words and/or phrases presenting two or more alternative terms in the detailed description, claims, or drawings should be understood to encompass the possibility of including one of the terms, either of the terms, or both. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".

For the purposes of the appended claims, those skilled in the art will understand that the operations recited therein can generally be performed in any order. Additionally, while various operational flow diagrams are set forth in one or more sequences, it should be understood that various operations may be performed in other sequences than the illustrated sequences, or may be performed concurrently. Examples of such alternative ordering may include overlapping, staggered, interrupted, reordered, incremental, preparatory, supplemental, simultaneous, reverse, or other altered ordering unless the context dictates otherwise. Moreover, unless the context dictates otherwise, terms such as "responsive to," "related to," or other past-type adjectives are generally not intended to exclude such variants.

It is worth mentioning that any reference to "an aspect", "an example" means that a particular feature, structure or characteristic described in connection with the aspect is included in at least one aspect. Thus, the appearances of the phrases "in one aspect," "in an example," and "in an example" in various places throughout this specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or other disclosure material referred to in this specification and/or listed in any application data sheet is incorporated herein by reference, as if the incorporated material was not inconsistent herewith. Accordingly, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

In summary, many of the benefits resulting from employing the concepts described herein have been described. The foregoing detailed description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations of the present invention are possible in light of the above teachings. One or more of the forms selected and described are chosen to illustrate principles and practical application to thereby enable one of ordinary skill in the art to utilize various forms and with various modifications as are suited to the particular use contemplated. The claims filed herewith are intended to define the full scope.

Claims

1. A surgical instrument, comprising:

an end effector, the end effector comprising:

an ultrasonic knife; and

a clamping arm movable relative to the ultrasonic blade to transition the end effector between an open configuration and a closed configuration to clamp tissue between the ultrasonic blade and the clamping arm;

an ultrasonic transducer configured to generate an ultrasonic energy output;

a waveguide configured to transmit the ultrasonic energy output to the ultrasonic blade; and

a control circuit configured to:

detecting immersion of the end effector in a liquid; and

compensating for heat flux losses due to the immersion of the end effector in the liquid.

2. The surgical instrument of claim 1, wherein detecting the immersion comprises:

monitoring a phase angle phi between a voltage Vg (t) signal and a current Ig (t) signal applied to the ultrasonic transducer;

inferring a temperature of an ultrasonic blade based on a phase angle phi between the voltage Vg (t) signal and the current Ig (t) signal applied to the ultrasonic transducer; and

the inferred temperature of the ultrasonic blade is compared to a predetermined temperature.

3. The surgical instrument of claim 1, further comprising a liquid sensing circuit, and wherein detecting the immersion comprises receiving a signal from the liquid sensing circuit.

4. The surgical instrument of claim 1, wherein compensation for heat flux is achieved by adjusting power to the ultrasonic transducer.

5. The surgical instrument of claim 1, wherein compensation for heat flux is achieved by adjusting a compressive load applied to the tissue clamped between the clamping arm and the ultrasonic blade.

6. The surgical instrument of claim 1, further comprising:

a drive member configured to actuate movement of the clamp arm to transition the end effector to the closed configuration, wherein the control circuit is further configured to:

monitoring the position of the drive member;

monitoring the temperature of the ultrasonic blade; and

preventing the temperature from exceeding a predetermined threshold prior to the closed configuration.

7. The surgical instrument of claim 6, wherein the temperature is inferred based on a phase angle Φ between a voltage Vg (t) signal and a current Ig (t) signal applied to the ultrasonic transducer.

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

9. The surgical instrument of claim 6, wherein the predetermined threshold is 100 ℃.

10. The surgical instrument of claim 6, wherein preventing the temperature from exceeding the predetermined threshold is achieved by adjusting power delivered to the ultrasonic transducer.

11. The surgical instrument of claim 6, wherein the closed configuration corresponds to a predetermined distance traveled by the drive member from a starting position.

12. The surgical instrument of claim 6, wherein the closed configuration corresponds to a maximum compression applied to the tissue by the clamping arm.

13. The surgical instrument of any one of claims 1-12, further comprising:

a Radio Frequency (RF) component configured to deliver RF energy to the clamped tissue,

wherein the ultrasound transducer is configured to deliver ultrasound energy to the clamped tissue, and

wherein the control circuitry is further configured to operate the ultrasound transducer in a non-therapeutic diagnostic mode while operating the Radio Frequency (RF) component in a therapeutic mode to treat the clamped tissue.

14. The surgical instrument of claim 13, wherein the non-therapeutic diagnostic mode comprises determining at least one temperature of clamped tissue.

15. The surgical instrument of claim 14, wherein the temperature of the clamped tissue is inferred based on a phase angle Φ between a voltage Vg (t) signal and a current Ig (t) signal applied to the ultrasonic transducer.

16. The surgical instrument of claim 13, wherein the treatment mode comprises applying RF energy to seal clamped tissue.

17. The surgical instrument of claim 13, wherein the Radio Frequency (RF) component comprises an RF electrode.

18. The surgical instrument of claim 17, further comprising a generator configured to drive the ultrasonic transducer and the RF electrode.