CN112055880A

CN112055880A - Radio frequency energy device for delivering combined electrical signals

Info

Publication number: CN112055880A
Application number: CN201980006958.2A
Authority: CN
Inventors: D·C·耶茨; C·R·诺特; K·L·豪泽; F·E·谢尔顿四世; J·L·哈里斯; V·E·小克里格
Original assignee: Ethicon LLC
Current assignee: Ethicon LLC
Priority date: 2018-03-08
Filing date: 2019-02-28
Publication date: 2020-12-08
Also published as: JP2021509599A; JP2024059910A

Abstract

An electrosurgical device may include a controller including a generator; a surgical probe having a distal active electrode in electrical communication with a power terminal of the generator; and a return pad in electrical communication with an electrical return terminal of the generator. The generator may be configured to supply a current from the power supply terminal, wherein the current combines characteristics of the therapeutic electrical signal and characteristics of the excitable tissue stimulation signal. The device may be configured to determine a distance from the electrode to the excitable tissue based, at least in part, on an output signal generated by the sensing device in the pad. The device may also be configured to change one or more characteristics of the treatment signal when the distance from the electrode to the tissue is less than a predetermined value.

Description

Radio frequency energy device for delivering combined electrical signals

Cross Reference to Related Applications

This application claims the benefit of U.S. non-provisional patent application serial No. 16/115,233 entitled "RADIO FREQUENCY ENERGY DEVICE FOR delivery COMBINED ELECTRICAL SIGNAL," filed on 28.8.2018, the disclosure of which is incorporated herein by reference in its entirety.

This patent application claims the priority of U.S. provisional patent application 62/721,995 entitled "control AN ultra simple temporal insertion correction TO a terminal LOCATION", filed on 23.8.2018, ACCORDING TO the provisions of clause 119 (e) of volume 35 of the U.S. code, the disclosure of which is incorporated herein by reference in its entirety.

This patent application claims priority from U.S. provisional patent application 62/721,998 entitled "lateral aware OF ELECTROSURGICAL system" filed 2018, 8, 23, in accordance with the provisions OF clause 119 (e) OF U.S. code 35, volume 35, which is incorporated herein by reference in its entirety.

This patent application claims priority from us provisional patent application 62/721,999 entitled "interim OF ENERGY TO INADVERTENT CAPACITIVE COUPLING" filed on 23.8.8.2018 as specified by title 119 (e) OF american 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 THAT automatic COMBINATION method for use of previous patent application BASED ON ENERGY modification" filed ON 23/8.2018 as specified in title 119 (e) of U.S. code 35, the disclosure of which is incorporated herein by reference in its entirety.

This patent application claims the priority of U.S. provisional patent application 62/721,996 entitled "RADIO FREQUENCY ENERGY DEVICE FOR delay COMBINED ELECTRICAL SIGNALS", filed on 23.8.8.2018, as specified by title 119 (e) of U.S. code, volume 35, which disclosure is incorporated herein by reference in its entirety.

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

This patent application also claims the benefit OF priority from U.S. provisional patent application serial No. 62/640,417 entitled "temparature CONTROL IN ultra sound DEVICE AND CONTROL SYSTEM thermal, filed on 8.3.8.2018 AND U.S. provisional patent application serial No. 62/640,415 entitled" ESTIMATING STATE OF ultra sound END EFFECTOR AND CONTROL SYSTEM thermal, filed on 8.3.2018, the disclosure OF each OF which is incorporated herein by reference IN its entirety, as specified IN clause 119 (e) OF the U.S. code, volume 35.

This patent application also claims us provisional patent application serial number 62/650,898 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH separator ARRAY ELEMENTS" filed on 3, 20.2018, us provisional patent application serial number 62/650,887 entitled "minor powdered SENSING CAPABILITIES" filed on 3, 30.2018, us provisional patent application serial number 62/650,882 entitled "minor implementation MODULE FOR INTERACTIVE minor implementation plan" filed on 3, 30.2018, us provisional patent application serial number 675 entitled "minor adaptation MODULE FOR INTERACTIVE minor adaptation plan form" filed on 3, 30.2018, and us provisional patent application serial number 62/650,877 filed on 3, 30.2018, us provisional patent application serial number SENSING AND entitled "minor adaptation such provisional patent application SENSING AND", each of which disclosures is hereby incorporated by reference in its entirety.

This patent application also claims the benefit of priority from U.S. provisional patent application serial No. 62/611,341 entitled "INTERACTIVE SURGICAL PLATFORM" filed on 28.12.2017, U.S. provisional patent application serial No. 62/611,340 entitled "CLOUD-BASED MEDICAL ANALYTICS" filed on 28.12.2017, and U.S. provisional patent application serial No. 62/611,339 entitled "ROBOT associated minor patent application" filed on 28.12.2017, the disclosures of each of which are incorporated herein by reference in their entirety, as specified in title 119 (e) of U.S. code, volume 35.

Background

In some surgical procedures, a medical professional may employ an electrosurgical device to seal or cut tissue, such as a blood vessel. Such devices achieve medical treatment by passing electrical energy, such as electrical current under Radio Frequency (RF), through the tissue to be treated. Some electrosurgical devices are referred to as bipolar devices because the electrode used to supply electrical energy (the active electrode) and the return electrode are both housed in the same surgical probe. The electrosurgical device may include a generator to generate electrical energy and supply the electrical energy to an active electrode in the surgical probe. A return electrode in the surgical probe can receive current flowing through patient tissue and provide an electrical return path to the generator. Such bipolar devices may provide a short current path through the patient's tissue, and the medical professional may easily determine the tissue that may receive electrical energy from the electrosurgical device.

An alternative device may be referred to as a monopolar device. In such devices, only the active electrode is housed in the surgical probe. The current entering the patient's tissue can be returned to the electrical energy generator via an electrical path through the gurney where the patient is located, or through a specific return electrode pad. In some aspects, the patient may lie on the electrode pad, or the electrode pad may be placed on the patient at a location proximate to the surgical site where the surgical probe is deployed. It can be appreciated that the current path of a patient operating with a monopolar device may not be well characterized as compared to the current path of a patient operating with a bipolar device. As a result, some non-target tissues may be inadvertently cauterized, cut, or otherwise damaged by the monopolar electrosurgical device. Such non-target tissues may include electrically excitable tissues including, but not limited to, ganglia, sensory nerve tissue, motor nerve tissue, and muscle tissue. Such intentional trauma to excitable tissue may cause a patient to experience muscle weakness, pain, numbness, paralysis, and/or other undesirable consequences.

Disclosure of Invention

In one aspect, an electrosurgical device includes a controller having a generator; a surgical probe including a distal active electrode, wherein the active electrode is in electrical communication with a power terminal of the generator; and a return pad in electrical communication with an electrical return terminal of the generator. The generator is configured to be able to supply current from the power supply terminal, and the current supplied by the generator combines characteristics of the therapeutic electrical signal and characteristics of the excitable tissue stimulation signal.

In one aspect of the electrosurgical device, the therapeutic electrical signal is a radio frequency signal having a frequency greater than 200kHz and less than 5 MHz.

In one aspect of the electrosurgical device, the excitable-tissue-stimulating signal is an AC signal having a frequency of less than 200 kHz.

In one aspect of the electrosurgical device, the electrical current supplied by the generator includes at least one alternating therapeutic electrical signal and at least one alternating excitable tissue stimulation signal.

In one aspect of the electrosurgical device, the current supplied by the generator has a therapeutic electrical signal amplitude modulated by the excitable-tissue stimulation signal.

In one aspect of the electrosurgical device, the current supplied by the generator comprises a therapeutic electrical signal dc-offset by the excitable-tissue stimulation signal.

In one aspect of the electrosurgical device, the return pad further comprises at least one sensing device having a sensing device output, and the sensing device is configured to be capable of determining stimulation of the excitable tissue by the excitable tissue stimulation signal.

In one aspect of the electrosurgical device, the controller is configured to receive the sensing device output.

In one aspect of the electrosurgical device, the controller includes a processor and at least one memory component in data communication with the processor, wherein the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to determine a distance of the active electrode from the excitable tissue based, at least in part, on the sensor output received by the controller.

In one aspect of the electrosurgical device, the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to change a value of at least one characteristic of the therapeutic electrical signal when the active electrode is less than a predetermined value away from the excitable tissue.

In one aspect, an electrosurgical system includes a processor and a memory coupled to the processor, wherein the memory is configured to store instructions executable by the processor to cause the generator to combine one or more characteristics of a therapeutic signal with one or more characteristics of an excitable tissue stimulation signal to form a combined signal, cause the generator to transmit the combined signal into tissue of a patient through an active electrode in physical contact with the patient, and receive a sensing device output signal from a sensing device disposed within a return pad in physical contact with the patient.

In one aspect of the electrosurgical system, the memory is configured to further store instructions executable by the processor to determine a distance from the active electrode to the excitable tissue based, at least in part, on the sensing device output signal.

In one aspect of the electrosurgical system, the memory is configured to further store instructions executable by the processor to cause the controller to change one or more characteristics of the treatment signal when a distance from the active electrode to the excitable tissue is less than a predetermined value.

In one aspect of the electrosurgical system, the instructions executable by the processor to cause the generator to combine one or more characteristics of the treatment signal with one or more characteristics of the excitable tissue stimulation signal to form a combined signal include instructions executable by the processor to cause the generator to alternate the treatment signal and the excitable tissue stimulation signal.

In one aspect of the electrosurgical system, the instructions executable by the processor to cause the generator to combine one or more characteristics of the therapeutic signal with one or more characteristics of the excitable tissue stimulation signal to form a combined signal include instructions executable by the processor to cause the generator to modulate an amplitude of the therapeutic signal with an amplitude of the excitable tissue stimulation signal.

In one aspect of the electrosurgical system, the instructions executable by the processor to cause the generator to combine one or more characteristics of the therapeutic signal with one or more characteristics of the excitable tissue stimulation signal to form a combined signal include instructions executable by the processor to cause the generator to offset a DC value of the therapeutic signal by an amplitude of the excitable tissue stimulation signal.

In one aspect, an electrosurgical system includes a control circuit configured to control an electrical output of a generator, wherein the electrical output includes one or more characteristics of a therapy signal and one or more characteristics of an excitable-tissue stimulation signal; receiving a sensing device signal from at least one sensing device configured to measure an activity of excitable tissue of a patient; determining a distance between a location of an active electrode and a location of at least one sensing device, the active electrode configured to transmit an electrical output of a generator into patient tissue; and altering the electrical output of the generator with at least one characteristic of the therapy signal when a distance between a location of the active electrode configured to transmit the electrical output of the generator into the patient tissue and a location of the at least one sensing device is less than a predetermined value.

In one aspect of the electrosurgical system, the control circuitry configured to change the electrical output of the generator with the at least one characteristic of the therapy signal when a distance between a location of the active electrode configured to transmit the electrical output of the generator into the patient tissue and a location of the at least one sensing device is less than a predetermined value includes the control circuitry configured to minimize the at least one characteristic of the therapy signal.

In one aspect, a non-transitory computer readable medium stores computer readable instructions that, when executed, cause a machine to control an electrical output of a generator, wherein the electrical output includes one or more characteristics of a therapy signal and one or more characteristics of an excitable tissue stimulation signal; receiving a sensing device signal from at least one sensing device configured to measure an activity of excitable tissue of a patient; determining a distance between a location of an active electrode and a location of at least one sensing device, the active electrode configured to transmit an electrical output of a generator into patient tissue; and altering the electrical output of the generator with at least one characteristic of the therapy signal when a distance between a location of the active electrode configured to transmit the electrical output of the generator into the patient tissue and a location of the at least one sensing device is less than a predetermined value.

Drawings

The features of the various aspects are set out with particularity in the appended claims. The various aspects (relating to the surgical tissues and methods) and further objects and advantages thereof, however, 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 according to at least one aspect of the present disclosure.

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

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

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

Fig. 6 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 procedures to a cloud in accordance with at least one aspect of the present disclosure.

Fig. 7 is a computer-implemented interactive surgical system according to at least one aspect of the present disclosure.

Fig. 8 illustrates a surgical hub including a plurality of modules coupled to a modular control tower according to at least one aspect of the present disclosure.

Fig. 9 illustrates one aspect of a Universal Serial Bus (USB) hub device in accordance with at least one aspect of the present disclosure.

Fig. 10 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. 11 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. 12 illustrates sequential logic circuitry configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.

Fig. 13 is a system configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, according to at least one aspect of the present disclosure.

Fig. 14 illustrates an example of a generator in accordance with at least one aspect of the present disclosure.

Fig. 15 is a surgical system including a generator and various surgical instruments that may be used therewith according to at least one aspect of the present disclosure.

Fig. 16 is an illustration of the surgical system of fig. 15 in accordance with at least one aspect of the present disclosure.

Fig. 17 is a structural view of a generator architecture according to at least one aspect of the present disclosure.

Fig. 18A-18C are functional views of a generator architecture according to at least one aspect of the present disclosure.

Fig. 19A-19B are structural and functional aspects of a generator according to at least one aspect of the present disclosure.

Fig. 20 is a schematic diagram of a control circuit according to at least one aspect of the present disclosure.

Fig. 21 illustrates a generator circuit divided into a plurality of stages according to at least one aspect of the present disclosure.

Fig. 22 illustrates a generator circuit divided into a plurality of stages, wherein a first stage circuit is common to a second stage circuit, in accordance with at least one aspect of the present disclosure.

Fig. 23 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. 24 is a schematic diagram of a transformer coupled to the RF drive circuit shown in fig. 15, in accordance with at least one aspect of the present disclosure.

Fig. 25 is a schematic diagram of a circuit including separate power sources for the high power energy/driver circuit and the low power circuit, according to at least one aspect of the present disclosure.

Fig. 26 illustrates a control circuit that allows a dual generator system to switch between RF generator and ultrasonic generator energy modalities of a surgical instrument according to at least one aspect of the present disclosure.

Fig. 27 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. 28 illustrates one aspect of a Direct Digital Synthesis (DDS) circuit configured to generate a plurality of wave shapes for use in electrical signal waveforms in a surgical instrument, in accordance with at least one aspect of the present disclosure.

Fig. 29 illustrates one cycle of a discrete-time digital electrical signal according to at least one aspect of the present disclosure in terms of an analog waveform (shown superimposed over a discrete-time digital electrical signal waveform for comparison purposes), in accordance with at least one aspect of the present disclosure.

Fig. 30 depicts a surgical procedure using an electrosurgical system, according to at least one aspect of the present disclosure.

Fig. 31 illustrates a block diagram of the electrosurgical system used in fig. 30, in accordance with at least one aspect of the present disclosure.

Fig. 32 illustrates a return pad of the electrosurgical system of fig. 30 including a plurality of electrodes in accordance with at least one aspect of the present disclosure.

Fig. 33 illustrates an array of sensing devices in the return pad depicted in fig. 31 in accordance with at least one aspect of the present disclosure.

Fig. 34 is a graphical representation of therapeutic RF signals that may be used in an electrosurgical system in accordance with at least one aspect of the present disclosure.

Fig. 35 is a graphical representation of a neurostimulation signal that may be incorporated into an electrosurgical system according to at least one aspect of the present disclosure.

Fig. 36A-36C are graphical representations of signals used by an electrosurgical system that may incorporate features of both the therapeutic RF signal of fig. 34 and the neurostimulation signal of fig. 35, according to at least one aspect of the present disclosure.

Fig. 37 summarizes methods that may enable such control of an intelligent electrosurgical device in accordance with at least one aspect of the present disclosure.

Fig. 38 is a timeline depicting situational awareness of a surgical hub, according to at least one aspect of the present disclosure.

Description

The applicant of the present patent application owns the following U.S. patent applications filed on 28.8.2018, the disclosures of which are incorporated herein by reference in their entirety:

U.S. patent application Ser. No. END8536USNP2/180107-2 entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";

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

U.S. patent application Ser. No. END8563USNP1/180139-1 entitled "CONTROL AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION";

U.S. patent application Ser. No. END8563USNP2/180139-2 entitled "CONTROL ACTIVITION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE";

U.S. patent application publication number END8563USNP3/180139-3 entitled "DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM";

U.S. patent application Ser. No. END8563USNP4/180139-4 entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT";

U.S. patent application publication No. END8563USNP5/180139-5 entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR";

U.S. patent application publication No. END8564USNP1/180140-1 entitled "STATATIONAL AWARENESS OF ELECTROTRROSURGICAL SYSTEMS";

U.S. patent application publication number END8564USNP2/180140-2 entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT";

U.S. patent application publication No. END8564USNP3/180140-3 entitled "DETECTION OF END EFFECTOR IMMERSION IN LIQUID";

U.S. patent application publication No. END8565USNP1/180142-1 entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING";

U.S. patent application publication No. END8565USNP2/180142-2 entitled "INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP";

U.S. patent application publication No. END8566USNP1/180143-1 entitled "BIPOLAR COMMUNICATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY"; and

U.S. patent application publication number END8573USNP1/180145-1 entitled "ACTIVATION OF ENERGY DEVICES".

The applicant of the present patent application owns the following U.S. patent applications filed on 23.8.8.2018, the disclosures of which are incorporated herein by reference in their entirety:

U.S. provisional patent application 62/721,995 entitled "control AN ultra minor exact centering TO a TISSUE LOCATION";

U.S. provisional patent application 62/721,998 entitled "STATATIONAL AWARENESS OF ELECTROTROSURGICAL SYSTEMS";

U.S. provisional patent application 62/721,999 entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING";

U.S. provisional patent application 62/721,994 entitled "BIPOLAR COMMUNICATION DEVICE THAT AUTOMATICALLY ADJUTS PRESSURE BASED ON ENERGY MODALITY"; and

U.S. provisional patent application 62/721,996 entitled "RADIO FREQUENCY ENERGY DEVICE FOR delayed combination ELECTRICAL SIGNALS".

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

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

U.S. provisional patent application 62/692,748, entitled "SMART ENERGY ARCHITURE"; and

us provisional patent application 62/692,768, entitled "SMART ENERGY DEVICES".

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

U.S. patent application Ser. No.16/024,090 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS";

U.S. patent application Ser. No.16/024,057 entitled "control A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";

U.S. patent application Ser. No.16/024,067 entitled "SYSTEM FOR ADJUSE END EFFECTOR PARAMETERS BASED ON PERIORATIVE INFORMATION";

U.S. patent application Ser. No.16/024,075 entitled "SAFETY SYSTEMS FOR SMART POWER SURGICAL STAPLING";

U.S. patent application Ser. No.16/024,083 entitled "SAFETY SYSTEMS FOR SMART POWER SURGICAL STAPLING";

U.S. patent application Ser. No.16/024,094 entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES";

U.S. patent application Ser. No.16/024,138 entitled "SYSTEM FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE";

U.S. patent application Ser. No. 16/024,150 entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES";

U.S. patent application Ser. No. 16/024,160 entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY";

U.S. patent application Ser. No. 16/024,124 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";

U.S. patent application Ser. No. 16/024,132 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT";

U.S. patent application Ser. No. 16/024,141 entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY";

U.S. patent application Ser. No. 16/024,162 entitled "SURGICAL SYSTEMS WITH PRIORIZED DATA TRANSMISSION CAPABILITIES";

U.S. patent application Ser. No. 16/024,066 entitled "SURGICAL EVACUTION SENSING AND MOTOR CONTROL";

U.S. patent application Ser. No. 16/024,096 entitled "SURGICAL EVACUTION SENSOR ARRANGEMENTS";

U.S. patent application Ser. No. 16/024,116, entitled "SURGICAL EVACUATION FLOW PATHS";

U.S. patent application Ser. No. 16/024,149 entitled "SURGICAL EVACUTION SENSING AND GENERATOR CONTROL";

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

U.S. patent application Ser. No. 16/024,245 entitled "COMMUNICATION OF SMOKE EVACUTION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUTION MODULE FOR INTERACTIVE SURGICAL PLATFORM";

U.S. patent application Ser. No. 16/024,258 entitled "SMOKE EVACUTION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM";

U.S. patent application Ser. No. 16/024,265 entitled "SURGICAL EVACUTION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUTION DEVICE"; and

U.S. patent application Ser. No. 16/024,273, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS".

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

U.S. provisional patent application Ser. No. 62/691,228, entitled "A Method of using a reformed fluid circuits with multiple sensors with electronic devices";

U.S. provisional patent application Ser. No. 62/691,227 entitled "controlling a scientific recording to sent closure parameters";

U.S. provisional patent application Ser. No. 62/691,230 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";

U.S. provisional patent application Ser. No. 62/691,219, entitled "SURGICAL EVACUTION SENSING AND MOTOR CONTROL";

U.S. provisional patent application Ser. No. 62/691,257 entitled "COMMUNICATION OF SMOKE EVACUTION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUTION MODULE FOR INTERACTIVE SURGICAL PLATFORM";

U.S. provisional patent application Ser. No. 62/691,262 entitled "SURGICAL EVACUTION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUTION DEVICE"; and

U.S. provisional patent application Ser. No. 62/691,251, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS;

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

U.S. provisional patent application Ser. No. 62/659,900 entitled "METHOD OF HUB COMMUNICATION";

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

us provisional patent application 62/650,898 filed on 30.3.2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH seperable ARRAY ELEMENTS";

U.S. provisional patent application serial No. 62/650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIIES";

U.S. patent application Ser. No. 62/650,882 entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; and

U.S. patent application Ser. No. 62/650,877, entitled "SURGICAL SMOKE EVACUTION SENSING AND CONTROL".

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

U.S. patent application Ser. No. 15/940,641 entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";

U.S. patent application Ser. No. 15/940,648 entitled "INTERACTIVE SURGICAL SYSTEMS WITH Conditionon HANDLING OF DEVICES AND DATA CAPABILITIES";

U.S. patent application Ser. No. 15/940,656 entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";

U.S. patent application Ser. No. 15/940,666 entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS";

U.S. patent application Ser. No. 15/940,670 entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS";

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

U.S. patent application Ser. No. 15/940,632 entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORD AND CREATE ANONYMIZED RECORD";

U.S. patent application Ser. No. 15/940,640 entitled "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS";

U.S. patent application Ser. No. 15/940,645 entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";

U.S. patent application Ser. No. 15/940,649 entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";

U.S. patent application Ser. No. 15/940,654 entitled "SURGICAL HUB SITUATIONAL AWARENESS";

U.S. patent application Ser. No. 15/940,663 entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";

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

U.S. patent application Ser. No. 15/940,671 entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEEATER";

U.S. patent application Ser. No. 15/940,686 entitled "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 DISPLAYS";

U.S. patent application Ser. No. 15/940,629 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";

U.S. patent application Ser. No. 15/940,704 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";

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

U.S. patent application Ser. No. 15/940,742 entitled "DUAL CMOS ARRAY IMAGING";

U.S. patent application Ser. No. 15/940,636 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR basic DEVICES";

U.S. patent application Ser. No. 15/940,653 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS";

U.S. patent application Ser. No. 15/940,660 entitled "CLOOUD-BASED MEDICAL ANALYTICS FOR CUTOSTOMIZATION AND RECOMMENDATION TO A USER";

U.S. patent application Ser. No. 15/940,679 entitled "CLOOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVORS OF LARGER DATA SET";

U.S. patent application Ser. No. 15/940,694 entitled "CLOOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVULALIZATION OF INSTRUMENTS FUNCTION";

U.S. patent application Ser. No. 15/940,634 entitled "CLOOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";

U.S. patent application Ser. No. 15/940,706 entitled "DATA HANDLING AND PRIORITION IN A CLOUD ANALYTICS NETWORK";

and

U.S. patent application Ser. No. 15/940,675 entitled "CLOOUD INTERFACE FOR COUPLED SURGICAL DEVICES";

U.S. patent application Ser. No. 15/940,627 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";

U.S. patent application Ser. No. 15/940,637 entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";

U.S. patent application Ser. No. 15/940,642 entitled "CONTROL FOR ROBOT-ASSISTED SURGICAL PLATFORMS";

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

U.S. patent application Ser. No. 15/940,680 entitled "CONTROL FOR ROBOT-ASSISTED SURGICAL PLATFORMS";

U.S. patent application Ser. No. 15/940,683 entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";

U.S. patent application Ser. No. 15/940,690 entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and

U.S. patent application Ser. No. 15/940,711, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".

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

U.S. provisional patent application serial No. 62/649,302 entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED notification CAPABILITIES";

U.S. provisional patent application Ser. No. 62/649,294 entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORD AND CREATE ANONYMIZED RECORD";

U.S. patent application Ser. No. 62/649,300 entitled "SURGICAL HUB SITUATIONAL AWARENESS";

U.S. provisional patent application serial No. 62/649,309, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEEATER";

U.S. patent application Ser. No. 62/649,310 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";

U.S. provisional patent application Ser. No. 62/649291 entitled "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 UPDATES FOR basic DEVICES";

U.S. provisional patent application Ser. No. 62/649,333 entitled "CLOOUD-BASED MEDICAL ANALYTICS FOR CURSTOMIZATION AND RECOMMENDITIONS TO A USER";

U.S. provisional patent application Ser. No. 62/649,327 entitled "CLOOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";

U.S. provisional patent application Ser. No. 62/649,315 entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK";

U.S. patent application Ser. No. 62/649,313 entitled "CLOOUD INTERFACE FOR COUPLED SURGICAL DEVICES";

U.S. patent application Ser. No. 62/649,320 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";

U.S. provisional patent application Ser. No. 62/649,307 entitled "AUTOMATIC TOOL ADJUSTMENT FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and

united states provisional patent application Serial No. 62/649,323, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".

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

U.S. provisional patent application Ser. No. 62/640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR"; and

U.S. provisional patent application Ser. No. 62/640,415 entitled "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 2017, 12, 28, the disclosure of each of which is incorporated herein by reference in its entirety:

U.S. provisional patent application serial No. 62/611,341, provisional patent application serial No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM";

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

U.S. patent application Ser. No. 62/611,339 entitled "ROBOT ASSISTED SURGICAL PLATFORM";

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

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

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

Fig. 2 depicts an example of a surgical system 102 for performing a surgical procedure on a patient lying on a surgical table 114 in a surgical suite 116. The robotic system 110 is used as part of the surgical system 102 during surgery. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. As the surgeon views the surgical site through the surgeon's console 120, the patient side cart 117 can manipulate at least one removably coupled surgical tool 118 through a minimally invasive incision in the patient. An image of the surgical site may be obtained by the medical imaging device 124, which may be manipulated by the patient side cart 120 to orient the imaging device 124. The robot hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.

Other types of robotic systems may be readily adapted for use with the surgical system 102. Various examples of robotic systems and SURGICAL tools suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,339 entitled "ROBOT ASSISTED SURGICAL tool" filed on 28.12.2017, 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 with the present disclosure are described in U.S. provisional patent application serial No. 62/611,340 entitled "CLOUD-BASED MEDICAL ANALYTICS," filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.

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

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

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

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

In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophago-duodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-nephroscopes, sigmoidoscopes, thoracoscopes, and intrauterine scopes. Some aspects of spectral and multispectral Imaging are described in more detail under the heading "Advanced Imaging Acquisition Module" of U.S. provisional patent application serial No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.

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

In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays that are strategically arranged relative to the sterile field, as shown in fig. 2. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" of U.S. provisional patent application serial No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.

As shown in fig. 2, a main display 119 is positioned in the sterile field to be visible to the operator at the surgical table 114. Further, the visualization tower 111 is positioned outside the sterile field. Visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. Visualization system 108, guided by hub 106, is configured to utilize

displays

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

non-sterile display

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

non-sterile display

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

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

non-sterile display

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

Referring to fig. 2, a surgical instrument 112 is used in surgery as part of the surgical system 102. Hub 106 is also configured to coordinate the flow of information to the display of surgical instrument 112. For example, U.S. provisional patent application serial No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic inputs or feedback entered by non-sterile operators at visualization tower 111 may be routed by hub 106 to surgical instrument display 115 within the sterile field, where the inputs or feedback may be viewed by the operator of surgical instrument 112. Exemplary Surgical instruments suitable for use in the Surgical system 102 are described under the heading "Surgical Instrument Hardware" of U.S. provisional patent application serial No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed on 28.12.2017, 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 handheld intelligent surgical instrument 112. Hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In certain aspects, as shown in fig. 3, hub 106 further includes a smoke evacuation module 126 and/or a suction/irrigation module 128.

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

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

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

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

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

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

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

Referring to fig. 3-5, aspects of the present disclosure are presented as a hub modular housing 136 that allows for modular integration of the generator module 140, the smoke evacuation module 126, and the suction/irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the

modules

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

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

modules

140, 126, 128 and interactive communications therebetween.

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

modules

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

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

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

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

In one aspect, the

modules

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

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

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

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

Various IMAGE PROCESSORs AND imaging devices suitable for use in the present disclosure are described in U.S. patent No. 7,995,045 entitled "COMBINED SBI AND associated IMAGE PROCESSOR" published on 9.8.2011, which is incorporated by reference herein in its entirety. Further, U.S. patent 7,982,776 entitled "MOTION ARTIFACT REMOVAL MOTION ARTIFACT AND METHOD," published 7/19/2011, which is incorporated by reference herein 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 "CONTROL MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPATUS" published on 12/15.2011 and U.S. patent application publication 2014/0243597 entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE" published on 8/28.2014, each of which is incorporated herein by reference in its entirety.

Fig. 6 illustrates a surgical data network 201 including a 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 specially equipped for surgical operations to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, modular communication hub 203 includes a network hub 207 and/or a network switch 209 that communicate with network routers. Modular communication hub 203 may also be coupled to local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured to be passive, intelligent, or switched. The passive surgical data network acts as a conduit for data, enabling it to be transferred from one device (or segment) to another device (or segment) as well as cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuring each port in the hub 207 or network switch 209. The intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

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

It should be understood that surgical data network 201 may be expanded by interconnecting multiple hubs 207 and/or multiple network switches 209 with multiple network routers 211. The modular communication hub 203 may be contained in a modular control tower configured to house a plurality of devices 1a-1n/2a-2 m. Local computer system 210 may also be contained in a modular control tower. The modular communication hub 203 is connected to a display 212 to display images obtained by some of the devices 1a-1n/2a-2m, for example, during surgery. In various aspects, the devices 1a-1n/2a-2m may include, for example, various modules such as non-contact sensor modules in an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction/irrigation module 128, a communication module 130, a processor module 132, a memory 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 network hub(s), network switch (es), and network router(s) 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 network switch may collect data in real time and transmit the data into the cloud computer for data processing and manipulation. It should be appreciated that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term "cloud" may be used as a metaphor for "internet," although the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to a "type of internet-based computing" in which different services (such as servers, memory, and applications) are delivered to modular communication hub 203 and/or computer system 210 located in a surgical room (e.g., a fixed, mobile, temporary, or live operating room or space) and devices connected to modular communication hub 203 and/or computer system 210 over the internet. The cloud infrastructure may be maintained by a cloud service provider. In this case, the cloud service provider may be an entity that coordinates the use and control of the devices 1a-1n/2a-2m located in one or more operating rooms. Cloud computing services can perform a large amount of computing based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware enables multiple devices or connections to connect to a computer in communication with the cloud computing resources and memory.

Applying cloud computer data processing techniques to the data collected by the devices 1a-1n/2a-2m, the surgical data network provides improved surgical 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 disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes localization and edge confirmation of tissues and phenotypes. At least some of the devices 1a-1n/2a-2m may be employed to identify anatomical structures of the body using various sensors integrated with the imaging devices and techniques, such as overlaying images captured by multiple imaging devices. The data (including image data) collected by the devices 1a-1n/2a-2m may be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. Such data analysis may further employ outcome analysis processing, and use of standardized methods may provide beneficial feedback to confirm or suggest modification of the behavior of the surgical treatment and surgeon.

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

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

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

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

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

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

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

Fig. 7 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. 8, the modular control tower 236 includes a modular communication hub 203 coupled to the computer system 210. As shown in the example of fig. 7, the modular control tower 236 is coupled to an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke ejector module 226, a suction/irrigation module 228, a communication module 230, a processor module 232, a storage array 234, a smart device/instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via modular control tower 236. Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. The devices/instruments 235, visualization system 208, etc. may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 may be coupled to the hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device/instrument display, and/or other visualization system 208. The hub display may also combine the image and the overlay image to display data received from devices connected to the modular control tower.

Fig. 8 shows the surgical hub 206 including a plurality of modules coupled to a modular control tower 236. The modular control tower 236 includes a modular communication hub 203 (e.g., a network connectivity device) and a computer system 210 to provide, for example, local processing, visualization, and imaging. As shown in fig. 8, the modular communication hubs 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) connectable to the modular communication hubs 203 and transmit data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in fig. 8, each of the network hubs/switches in modular communication hub 203 includes three downstream ports and one upstream port. The upstream hub/switch is connected to the processor to provide a communication connection with the cloud computing resources and the local display 217. Communication with the cloud 204 may be through a wired or wireless communication channel.

The surgical hub 206 employs the non-contact sensor module 242 to measure dimensions of the operating room and uses ultrasound or laser type non-contact measurement devices to generate a map of the operating room. An ultrasound-based non-contact sensor module scans an Operating Room by emitting a burst of ultrasound waves and receiving echoes as they bounce off the enclosure of the Operating Room, as described under the heading "Surgical Hub Spatial aware with Operating Room" in U.S. provisional patent application serial No. 62/611,341 entitled "INTERACTIVE SURGICAL PLATFORM," filed on 28.12.2017, 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 emitting laser pulses, receiving laser pulses bouncing off the enclosure of the operating room, and comparing the phase of the emitted pulses to the received pulses to determine the size of the operating room and adjust the bluetooth paired distance limit.

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

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

Software internal Read Only Memory (ROM), 2KB Electrically Erasable Programmable Read Only Memory (EEPROM), and/or one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, the details of which can be seen in the product data sheet.

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

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

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

It is to be appreciated that the computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in suitable operating environments. Such software includes an operating system. An operating system, which may be stored on disk storage, is used to control and allocate resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored in system memory or on disk storage. It is to be appreciated that the various devices 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 input device(s) 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 interface port(s). The interface port(s) include, for example, a serial port, a parallel port, a game port, and a USB. The output device(s) use the same type of port as the input device(s). Thus, for example, a USB port may be used to provide input to a computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (such as monitors, displays, speakers, and printers) that require special adapters among other output devices.

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

In various aspects, the computer system 210, imaging module 238, and/or visualization system 208 of fig. 8, and/or the processor module 232 of fig. 7-8 may include an image processor, an image processing engine, a media processor, or any dedicated Digital Signal Processor (DSP) for processing digital images. The image processor may employ parallel computing with single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a series of tasks. The image processor may be a system on a chip having a multi-core processor architecture.

Communication connection(s) refers to the hardware/software used to interface the network to the bus. While a communication connection is shown for exemplary clarity within the 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. 9 illustrates a functional block diagram of one aspect of a USB hub 300 device in accordance with at least one aspect of the present disclosure. In the illustrated aspect, the USB hub device 300 employs a TUSB2036 integrated circuit hub from Texas Instruments. The USB hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream

USB transceiver ports

304, 306, 308 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP0) input paired with a differential data positive (DM0) input. The three downstream

USB transceiver ports

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

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

USB transceiver ports

304, 306, 308. The downstream

USB transceiver ports

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

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

USB transceiver ports

304, 306, 308 through

port logic circuits

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

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

USB transceiver ports

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

Surgical instrument hardware control

Fig. 10 illustrates a 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., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuitry 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement the various processes described herein. The processor 502 may be any of a variety of single-core or multi-core processors known in the art. The memory circuit 504 may include volatile storage media and non-volatile storage media. Processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to be able to receive instructions from the memory circuit 504 of the present disclosure. Fig. 11 illustrates a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool, in accordance with an aspect of the present disclosure. The combinational logic circuit 510 may be configured to enable the various processes described herein. The combinational logic circuit 510 may include a finite state machine including combinational logic 512, the combinational logic 512 configured to receive data associated with a surgical instrument or tool at input 514, process the data through the combinational logic 512 and provide output 516.

Fig. 12 illustrates a sequential logic circuit 520 configured to control various aspects of a surgical instrument or tool, according to one aspect of the present disclosure. Sequential logic circuitry 520 or combinational logic 522 may be configured to implement the various processes described herein. Sequential logic circuit 520 may comprise a finite state machine. Sequential logic circuitry 520 may include, for example, combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store the current state of the finite state machine. In some cases, sequential logic circuit 520 may be synchronous or asynchronous. The combinational logic 522 is configured to receive data associated with a surgical instrument or tool from inputs 526, process the data through the combinational logic 522, and provide outputs 528. In other aspects, a circuit may comprise a combination of a processor (e.g., processor 502, fig. 10) and a finite state machine to implement various processes herein. In other embodiments, the finite state machine may include a combination of combinational logic circuitry (e.g., combinational logic circuitry 510, FIG. 11) and sequential logic circuitry 520.

Generator hardware

Fig. 13 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, according to at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute one or more adaptive ultrasonic blade control algorithms. In another aspect, device/instrument 235 is configured to execute an adaptive ultrasonic blade control algorithm. In another aspect, device/instrument 235 and device/instrument 235 are both configured to execute an adaptive ultrasonic blade control algorithm.

The generator module 240 may include a patient isolation stage in communication with a non-isolation stage via a power transformer. The secondary winding of the power transformer is contained in an isolation stage and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define a drive signal output for delivering drive signals to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-functional surgical instruments including ultrasonic energy modes and RF energy modes that can be delivered separately or simultaneously. In particular, the drive signal output may output an ultrasonic drive signal (e.g., a 420V Root Mean Square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to fig. 14-19B.

The generator module 240 or the device/instrument 235, or both, are coupled to a modular control tower 236 that is connected to a plurality of operating room devices, such as smart surgical instruments, robots, and other computerized devices located in the operating room, as described with reference to, for example, fig. 6-9.

Fig. 14 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. 13. The generator 900 is configured to deliver a plurality of energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals for delivering energy to the surgical instrument independently or simultaneously. The RF signal and the ultrasound signal may be provided separately or in combination, and may be provided simultaneously. As described above, at least one generator output may deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.) through a single port, and these signals may be delivered separately or simultaneously to the end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory coupled to the processor 902, which memory is not shown for clarity of the present disclosure. Digital information associated with the waveform is provided to a waveform generator 904, which waveform generator 904 includes one or more DAC circuits to convert a digital input to an analog output. The analog output is fed to an amplifier 1106 for signal conditioning and amplification. The regulated and amplified output of amplifier 906 is coupled to power transformer 908. The signal is coupled to the secondary side of the patient isolation side through a power transformer 908. A first signal of a first ENERGY modality is provided to the surgical instrument between terminals labeled ENERGY1 and RETURN. The second signal of the second ENERGY modality is coupled across capacitor 910 and provided to the surgical instrument between terminals labeled ENERGY2 and RETURN. It will be appreciated that more than two energy modes may be output, and thus the subscript "n" may be used to specify that up to n ENERGYn terminals may be provided, where n is a positive integer greater than 1. It should also be understood that up to "n" return paths RETURNn may be provided without departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminals labeled ENERGY1 and RETURN path to measure the output voltage therebetween. A second voltage sensing circuit 924 is coupled across the terminals labeled ENERGY2 and RETURN path to measure the output voltage therebetween. As shown, a current sensing circuit 914 is placed in series with the RETURN leg on the secondary side of the power transformer 908 to measure the output current of either energy mode. If a different return path is provided for each energy modality, a separate current sensing circuit should be provided in each return branch. The outputs of the first 912 and second 924 voltage sensing circuits are provided to

respective isolation transformers

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

isolation transformers

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

In one aspect, the impedance may be determined by the processor 902 by dividing the output of a first voltage sensing circuit 912 coupled across terminals labeled ENERGY1/RETURN or a second voltage sensing circuit 924 coupled across terminals labeled ENERGY2/RETURN by the output of a current sensing circuit 914 disposed in series with the RETURN leg of the secondary side of the power transformer 908. The outputs of the first 912 and second 924 voltage sensing circuits are provided to separate

isolation transformers

916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 for use in calculating the impedance. For example, the first ENERGY modality ENERGY1 may be ultrasonic ENERGY and the second ENERGY modality ENERGY2 may be RF ENERGY. However, in addition to ultrasound and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and/or reversible electroporation and/or microwave energy, among others. Also, while the example shown in fig. 21 illustrates that a single RETURN path RETURN may be provided for two or more energy modalities, in other aspects multiple RETURN paths RETURN may be provided for each energy modality enerrgyn. Thus, as described herein, the ultrasound transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914, and the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.

As shown in fig. 14, the generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to the end effector in the form of one or more energy modalities (such as ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy with a higher voltage and lower current to drive an ultrasound transducer, with a lower voltage and higher current to drive an RF electrode for sealing tissue, or with a coagulation waveform for using monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of the generator 900 will preferably be between the outputs labeled ENERGY1 and RETURN as shown in fig. 14. In one example, the connection of the RF bipolar electrode to the output of generator 900 will preferably be between the outputs labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection would be to an active electrode (e.g., a pencil or other surgical probe) at the output of ENERGY2 and a suitable RETURN pad connected to the RETURN output.

Additional details are disclosed in U.S. patent application publication 2017/0086914 entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," published 3, 30, 2017, which is incorporated herein by reference in its entirety.

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

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

As used herein, a system-on-chip or system-on-chip (SoC or SoC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all of the devices of a computer or other electronic system. It may contain digital, analog, mixed signal, and often radio frequency functions-all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a Graphics Processing Unit (GPU), Wi-Fi modules, or coprocessors. The SoC may or may not contain 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 devices. Microcontrollers may include one or more Core Processing Units (CPUs) as well as memory and programmable input/output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory or OTP ROM as well as a small amount of RAM are often included on the chip. In contrast to microprocessors used in personal computers or other general-purpose applications composed of various discrete chips, microcontrollers may be used in embedded applications.

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

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

Internal Read Only Memory (ROM) in software, Electrically Erasable Programmable Read Only Memory (EEPROM) in 2KB, one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features readily available.

In one example, the processor may include a safety controller that includes two series based controllers, such as TMS570 and RM4x also available from Texas Instruments under the trade name Hercules ARM Cortex R4. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, etc., to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

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

Fig. 15 illustrates one form of a surgical system 1000 including a generator 1100 and various

surgical instruments

1104, 1106, 1108 that may be used therewith, wherein the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunctional surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument. The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 15, the generator 1100 is shown separate from the

surgical instruments

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

surgical instruments

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

The generator 1100 is configured to drive a plurality of

surgical instruments

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

buttons

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

Toggle buttons

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

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

clamp arms

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

clamp arms

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

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

switch buttons

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

toggle buttons

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

hand pieces

1105, 1107, 1109 may be replaced with robotically controlled instruments. Thus, the term handpiece should not be limited to this context.

The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 15, the generator 1100 is shown separate from the

surgical instruments

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

surgical instruments

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

In various aspects, the generator 1100 may include several separate functional elements, such as modules and/or blocks, as shown in the illustrations of the surgical system 1000 of fig. 16, 15. Different functional elements or modules may be configured to drive different kinds of

surgical devices

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

surgical devices

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

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

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

The generator 1100 may include an input device 2150 located on, for example, a front panel of the console of the generator 1100 (fig. 18B). Input device 2150 may include any suitable device that generates signals suitable for programming the operation of generator 1100. In operation, a user may program or otherwise control the operation of generator 1100 using input device 2150. The input device 2150 can include any suitable device that generates signals that can be used by the generator (e.g., by one or more processors included in the generator) to control the operation of the generator 1100 (e.g., the operation of the ultrasound generator module and/or the electrosurgical/RF generator module). In various aspects, the input device 2150 includes one or more of the following: buttons, switches, thumbwheels, keyboards, keypads, touch screen monitors, pointing devices, remote connections to general purpose or special purpose computers. In other aspects, the input device 2150 can comprise, 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 may set or program various operating parameters of the generator, such as, for example, the current (I), voltage (V), frequency (f), and/or period (T) of one or more drive signals generated by the ultrasound generator module and/or the electrosurgical/RF generator module.

The generator 1100 may also include an input device 2140 located, for example, on the front panel of the generator 1100 console (fig. 18B). Output devices 2140 include one or more devices for providing sensory feedback to a user. Such devices may include, for example, visual feedback devices (e.g., LCD display screens, LED indicators), audio feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., haptic actuators).

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

In one aspect, the ultrasonic generator driver module and the electrosurgical/RF driver module 1110 (fig. 15) can include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may include various executable modules such as software, programs, data, drivers, Application Program Interfaces (APIs), and so forth. The firmware may be stored in a non-volatile memory (NVM), such as a bit-mask read-only memory (ROM) or flash memory. In various implementations, storing firmware in ROM may protect flash memory. NVM may include other types of memory including, for example, programmable rom (prom), erasable programmable rom (eprom), electrically erasable programmable rom (eeprom), or battery backed Random Access Memory (RAM) (such as dynamic RAM (dram), double data rate dram (ddram), and/or synchronous dram (sdram)).

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

devices

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

devices

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

apparatus

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

end effectors

1122, 1124, 1125).

Fig. 17 is a simplified block diagram of an aspect of a generator 1100 that provides inductorless tuning, among other benefits, as described above. Fig. 18A-18C illustrate an architecture of the generator 1100 of fig. 17, according to one aspect. Referring to fig. 17, generator 1100 may include a patient isolation stage 1520 in communication with a non-isolation stage 1540 via a power transformer 1560. Secondary winding 1580 of power transformer 1560 is included in isolation stage 1520 and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define

drive signal outputs

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

signal outputs

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

signal outputs

1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to electrosurgical device 1106, with output 1060b corresponding to a center tap of power transformer 1560. Non-isolated stage 1540 may include a power amplifier 1620 having an output connected to primary winding 1640 of power transformer 1560. In certain aspects, the power amplifier 1620 may comprise a push-pull amplifier, for example. The non-isolation stage 1540 may also include a programmable logic device 1660, the programmable logic device 1660 being configured to supply a digital output to a digital-to-analog converter (DAC)1680, which digital-to-analog converter 1680 in turn supplies a corresponding analog signal to the input of the power amplifier 1620. In certain aspects, the programmable logic device 1660 may comprise a Field Programmable Gate Array (FPGA), for example. As a result of controlling the input of power amplifier 1620 via DAC 1680, programmable logic device 1660 may thus control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signals present at

drive signal outputs

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

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

In certain aspects and as discussed in more detail in connection with fig. 19A-19B, programmable logic device 1660, in conjunction with processor 1740, can implement a Direct Digital Synthesizer (DDS) control scheme to control the waveform shape, frequency, and/or amplitude of the drive signals output by generator 1100. In one aspect, for example, the programmable logic device 1660 may implement the DDS control algorithm 2680 (fig. 14A) by 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 for ultrasound applications where an ultrasound transducer, such as ultrasound transducer 1120, may be driven by a purely sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the total distortion of the dynamic branch current may correspondingly minimize or reduce adverse resonance effects. Because the waveform shape of the drive signal output by generator 1100 is affected by various sources of distortion present in the output drive circuitry (e.g., power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal may be input into an algorithm, such as an error control algorithm implemented by processor 1740, that compensates for the distortion by pre-distorting or modifying the waveform samples stored in the LUT, as appropriate, on a dynamic ongoing basis (e.g., in real time). In one form, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated dynamic branch current and the desired current waveform shape, where the error may be determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed by the drive circuit, can cause the dynamic branch drive signal to have a desired waveform shape (e.g., sinusoidal shape) to optimally drive the ultrasound transducer. Thus, in such aspects, when distortion effects are taken into account, the LUT waveform samples will therefore not represent the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately produce the desired waveform shape of the dynamic branch drive signal.

Non-isolation stage 1540 may further include

ADCs

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

respective isolation transformers

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

ADCs

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

ADCs

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

ADCs

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

ADCs

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

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

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

evaluating the fourier transform at sinusoidal frequencies yields:

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

high speed ADC

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

Wherein

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

is the phase at t-0.

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

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

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

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

In certain aspects, processor 1740 (fig. 17, 18A) and processor 1900 (fig. 17, 18B) may determine and monitor an operational state of generator 1100. With respect to processor 1740, the operational state of generator 1100 may, for example, indicate to processor 1740 which control and/or diagnostic processes are being implemented. For processor 1900, the operational state of generator 1100 may, for example, indicate which elements of a user interface (e.g., display screen, sound) are presented to the user.

Processors

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

Non-isolated stage 1540 may also include controller 1960 (fig. 17, 18B) for monitoring input device 2150 (e.g., capacitive touch sensor, capacitive touch screen for turning generator 1100 on and off). In certain aspects, the controller 1960 can include at least one processor and/or other controller device in communication with the processor 1900. In one aspect, for example, the controller 1960 can include a processor (e.g., a Mega 1688 bit controller available from Atmel corporation) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, the controller 1960 can include a touchscreen controller (e.g., a QT5480 touchscreen controller available from Atmel corporation (Atemel)) to control and manage the acquisition of touch data from a capacitive touchscreen.

In certain aspects, the controller 1960 may continue to receive operating power (e.g., via a line from a power source of the generator 1100, such as the power source 2110 (fig. 17) discussed below) when the generator 1100 is in a "power off state. In this way, controller 1960 may continue to monitor input device 2150 (e.g., a capacitive touch sensor located on the front panel of generator 1100) for turning generator 1100 on and off. When the generator 1100 is in the "power off" state, if activation of the user "on/off input device 2150 is detected, the controller 1960 can wake up the power source (e.g., enable operation of one or more DC/DC voltage converters 2130 (fig. 17) of the power source 2110). Controller 1960 may thus begin a sequence that transitions generator 1100 to a "power on" state. Conversely, when generator 1100 is in a "power on" state, if activation of "on/off input device 2150 is detected, controller 1960 may begin a sequence that transitions generator 1100 to a" power off "state. In certain aspects, for example, controller 1960 may report activation of "on/off input device 2150 to processor 1900, which in turn implements the desired sequence of processes to transition generator 1100 to a" power off "state. In such aspects, the controller 1960 may not have the independent ability to remove power from the generator 1100 after the "power off" state has been established.

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

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

stages

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

In one aspect, the instrument interface circuit 1980 may include a programmable logic device 2000 (e.g., an FPGA) in communication with the signal conditioning circuit 2020 (fig. 17 and 18C). The signal conditioning circuit 2020 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the programmable logic circuit 2000 to generate a bipolar interrogation signal having the same frequency. For example, the interrogation signal may be generated using a bipolar current source fed by a differential amplifier. The interrogation signal may be sent to the surgical device control circuit (e.g., by using a conductive pair in a cable connecting the generator 1100 to the surgical device) and monitored to determine the state or configuration of the control circuit. For example, the control circuit may include a plurality of switches, resistors, and/or diodes to modify one or more characteristics (e.g., amplitude, correction) of the interrogation signal such that the state or configuration of the control circuit may be uniquely discerned based on the one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may include an ADC for generating samples of a voltage signal that appears in the input of the control circuit as a result of an interrogation signal passing through the control circuit. Programmable logic device 2000 (or a device of non-isolation stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.

In one aspect, the instrument interface circuit 1980 may include a first data circuit interface 2040 to enable the exchange of information between the programmable logic device 2000 (or other element of the instrument interface circuit 1980) and a first data circuit disposed in or otherwise associated with the surgical device. In certain aspects, for example, the first data circuit 2060 may be provided in a cable integrally attached to the surgical device handpiece or provided in an adapter for interfacing a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit may include a non-volatile storage device, such as an electrically erasable programmable read-only memory (EEPROM) device. In certain aspects and referring again to fig. 17, the first data circuit interface 2040 may be implemented separately from the programmable logic device 2000 and include suitable circuitry (e.g., discrete logic devices, processors) to enable communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 may be integral to the logic device 2000.

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

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

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

instruments

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

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

In certain aspects, the isolation stage 1520 may include at least one blocking capacitor 2960-1 (fig. 18C) connected to the drive signal output 1600b to prevent DC current from flowing to the patient. For example, the signal blocking capacitor may be required to comply with medical regulations or standards. While relatively few errors occur in single capacitor designs, such errors can have undesirable consequences. In one aspect, a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1, wherein current leakage from a point between the blocking capacitors 2960-1, 2960-2 is detected by, for example, the ADC 2980 for sampling the voltage induced by the leakage current. The sample may be received by programmable logic device 2000, for example. Based on the change in leakage current (as indicated by the voltage samples in the aspect of FIG. 17), the generator 1100 may determine when at least one of the blocking capacitors 2960-1, 2960-2 fails. Thus, the aspect of fig. 17 provides benefits over a single capacitor design with a single point of failure.

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

Fig. 19A-19B illustrate certain functional and structural aspects of an aspect of the generator 1100. Feedback indicative of the current and voltage output from the secondary winding 1580 of power transformer 1560 is received by

ADCs

1780, 1800, respectively. As shown,

ADCs

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

ADC

1780, 1800. Current and voltage feedback samples from

ADCs

1780, 1800 may be individually buffered and then multiplexed or interleaved into a single data stream within block 2120 of programmable logic device 1660. In the aspect of fig. 19A-19B, programmable logic device 1660 comprises an FPGA.

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

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

At block 2220 of the predistortion algorithm, the current through the dynamic branch of the ultrasound transducer is determined. The ultrasonic transducer static capacitance C can be based on, for example, current and voltage feedback samples stored at memory locations 2180 (which, when properly scaled, can represent Ig and Vg in the model of FIG. 25 discussed above), the ultrasonic transducer static capacitance C₀And a known value of the drive frequency, using kirchhoff's current law to determine the dynamic branch current. Dynamic branch current samples for each set of stored current and voltage feedback samples associated with LUT samples may be determined.

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

Each value of the sample amplitude error determined at block 2240 is transmitted to the LUT of the programmable logic device 1660 (shown at block 2280 in fig. 19A) along with an indication of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and optionally, the previously received value of the sample amplitude error for the same LUT address), the LUT 2280 (or other control block of the programmable logic device 1660) can predistort or modify the value of the LUT sample stored at the LUT address such that the sample amplitude error is reduced or minimized. It will be appreciated that such predistortion or modification of each LUT sample in an iterative manner over the entire LUT address range will result in the waveform shape of the generator's output current matching or conforming to the desired current waveform shape represented by the samples of waveform shape LUT 2260.

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

At block 2340 (fig. 19B), a Root Mean Square (RMS) calculation may be applied to current feedback samples representing a sample size of the drive signal for an integer cycle to generate a measurement I representing the drive signal output current_rms。

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

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

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

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

In certain aspects, the amount I determined at

blocks

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

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

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

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

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

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

At block 2560 (fig. 19A) of the phase control algorithm, a frequency output for controlling the frequency of the drive signal is determined based on the value of the phase error determined at block 2520 and the impedance magnitude determined at block 2420. The value of the frequency output may be continuously adjusted by the block 2560 and transmitted to the DDS control block 2680 (discussed below) in order to maintain the impedance phase determined at block 2500 at a phase set point (e.g., zero phase error). In certain aspects, the impedance phase may be adjusted to a 0 ° phase setpoint. In this way, any harmonic distortion will be centered around the peak of the voltage waveform, thereby enhancing the accuracy of the phase impedance determination.

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

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

Block 2680 (fig. 19A) may implement a DDS control algorithm for controlling the drive signal by retrieving LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm may be a digitally controlled oscillator (NCO) algorithm for generating samples of a waveform at a fixed clock rate using a point (memory location) -skip technique. The NCO algorithm may implement a phase accumulator or frequency-to-phase converter that is used as an address pointer for retrieving LUT samples from the LUT 2280. In one aspect, the phase accumulator may be a D step, modulus N phase accumulator, where D is a positive integer representing the frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D ═ 1 may cause the phase accumulator to sequentially point to each address of LUT2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. When D >1, the phase accumulator may skip addresses in LUT2280, 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 an input of DAC1680, which DAC1680 in turn supplies a corresponding analog signal to an input of power amplifier 1620.

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

In some aspects, the circuitry may be used to drive the ultrasound transducer and the RF electrode interchangeably, and if driven simultaneously, filtering circuitry may be provided to select the ultrasound waveform or the RF waveform. Such filtering TECHNIQUES are described in commonly owned U.S. patent publication US-2017-0086910-A1 entitled "TECHNIQUES FOR COMMUNICED GENERATOR," which is incorporated by reference herein in its entirety.

Fig. 20 is a schematic diagram of a control circuit 3200, such as control circuit 3212, according to at least one aspect of the present disclosure. The control circuit 3200 is located within the housing of the battery assembly. The battery assembly is an energy source for the various local power sources 3215. The control circuit includes a main processor 3214, the main processor 3214 being coupled to various downstream circuits via an interface host (interface master)3218 by, for example, the outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. In one aspect, the interface host 3218 is a universal serial interface, such as I²And C, serial interface. The main processor 3214 is further configured to drive a switch 3224 through a general purpose input/output (GPIO)3220, a display 3226 through a GPIO 3222 (e.g.,and an LCD display) 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.

The main processor 3214 includes a memory for storing a table of digitized drive signals or waveforms that are transmitted to, for example, circuitry that may be used to drive an ultrasonic transducer. In other aspects, the main processor 3214 may generate and transmit a digital waveform to the circuit, or may store the digital waveform for later transmission to the circuit. The main processor 3214 may also provide RF drive through the output terminals SCL-B, SDA-B, and may provide various sensors (e.g., Hall effect sensors, magneto-rheological fluid (MRF) sensors, etc.) through the output terminals SCL-C, SDA-C. In one aspect, the main processor 3214 is configured to sense the presence of the ultrasound drive circuitry and/or RF drive circuitry to enable appropriate software and user interface functionality.

In one aspect, primary processor 3214 may be, for example, LM4F230H5QR, available from Texas Instruments, inc (Texas Instruments). In at least one example, LM4F230H5QR, Texas Instruments (Texas Instruments), is an ARM Cortex-M4F processor core that includes: 256KB of on-chip memory of single cycle flash or other non-volatile memory (up to 40MHZ), prefetch buffers to improve performance by over 40MHz, 32KB of single cycle Serial Random Access Memory (SRAM), Stellaris loaded

Software internal Read Only Memory (ROM), 2KB of Electrically Erasable Programmable Read Only Memory (EEPROM), one or more Pulse Width Modulation (PWM) modules, one or more quadrature encoder inputs (QED analog, one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, and other features readily available.

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

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

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

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

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

In another aspect, the present disclosure provides a surgical instrument comprising: a battery assembly comprising 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 the load; wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to the handle assembly.

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

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

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

Fig. 21 illustrates a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406 in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3400 divided into a plurality of stages. For example, the surgical instrument of the surgical system 1000 can include a generator circuit 3400 divided into at least two circuits: first and

second stage circuits

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

Turning now to fig. 21, the generator circuit 3400 is divided into a plurality of stages located in a plurality of modular assemblies of a surgical instrument (such as the surgical instruments of the surgical system 1000 described herein). In one aspect, the control stage circuitry 3402 may be located in the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is a control circuit 3200 as described in connection with fig. 20. The control circuit 3200 includes a processor 3214 that includes internal memory 3217 (fig. 21) (e.g., volatile and non-volatile memory), and is electrically coupled to a 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. 27 and 28 to generate the digital waveform 4300 (fig. 29). Returning to fig. 21, the digital waveform 4300 may be configured to drive an ultrasound transducer, high frequency (e.g., RF) electrodes, or a combination thereof, either independently or simultaneously. If driven simultaneously, a filter circuit 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 "TECHNIQUES FOR COMMUNICED GENERATOR," which is incorporated by reference herein in its entirety.

The first stage circuitry 3404 (e.g., first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, and first stage transducer drive circuit 3424) is located in the handle assembly 3412 of the surgical instrument. Control circuit 3200 provides the RF drive signal to first stage RF drive circuit 3422 via output SCL-B, SDA-B of control circuit 3200. The first stage RF driver circuit 3422 is described in detail in connection with fig. 23. The control circuit 3200 provides sensor drive signals to the first level sensor drive circuit 3424 via the output SCL-C, SDA-C of the control circuit 3200. Generally, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section to drive the second stage circuit 3406. The output of the first stage 3404 is provided to the input 3406 of the second stage.

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

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

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

Fig. 22 illustrates a generator circuit 3500 divided into a plurality of stages, wherein a first stage circuit 3504 is common to a second stage circuit 3506, in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3500 divided into a plurality of stages. For example, the surgical instrument of the surgical system 1000 may include a generator circuit 3500 divided into at least two circuits: a first stage amplifier circuit 3504 and a second stage amplifier circuit 3506 that enable high frequency (RF) energy operation only, ultrasonic energy operation only, and/or a combination of RF energy and ultrasonic energy operation. The modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 integrally formed with the modular shaft assembly 3514. As previously discussed throughout this specification in connection with the surgical instruments of the surgical system 1000, the battery assembly 3510 and the shaft assembly 3514 are configured to be mechanically and electrically connected to the handle assembly 3512. The end effector assembly is configured to mechanically and electrically connect the shaft assembly 3514.

As shown in the example of fig. 22, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes the previously described control circuit 3200. A handle assembly 3512 connected to a battery assembly 3510 includes a common first stage drive circuit 3420. As previously described, the first stage drive circuit 3420 is configured to drive ultrasound, high frequency (RF) current, and sensor loads. The output of common first stage drive circuit 3420 may drive any of second stage circuits 3506, such as second stage ultrasonic drive circuit 3430, second stage high frequency (RF) current drive circuit 3432, and/or second stage sensor drive circuit 3434. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 detects which second stage circuit 3506 is located in the shaft assembly 3514. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 determines which of the second stage circuits 3506 (e.g., the second stage ultrasonic drive circuit 3430, the second stage RF drive circuit 3432, and/or the second stage sensor drive circuit 3434) is located in the shaft assembly 3514. This information is provided to the control circuit 3200 located in the handle assembly 3512 in order to provide the appropriate digital waveform 4300 (fig. 29) to the second stage circuit 3506 to drive an appropriate load, such as an ultrasonic, RF or sensor. It is to be understood that the identification circuit can be included in various components 3516 in the third stage circuit 3508, such as the ultrasonic transducer 1120, the electrodes 3074a, 3074b, or the sensor 3440. Therefore, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

Fig. 23 is a schematic diagram of one aspect of a circuit 3600 configured to drive high frequency current (RF) in accordance with at least one aspect of the present disclosure. Circuit 3600 includes analog multiplexer 3680. Analog multiplexer 3680 multiplexes the various signals from upstream channels SCL-A, SDA-A such as RF, battery, and power control circuitry. A current sensor 3682 is coupled in series with the return or ground branch of the power source circuit to measure the current provided by the power source. A Field Effect Transistor (FET) temperature sensor 3684 provides ambient temperature. Pulse Width Modulation (PWM) watchdog timer 3688 automatically generates a system reset if the main program ignores maintenance on it periodically. Which is set to auto-reset circuit 3600 when it stalls or freezes due to a software or hardware failure. It should be understood that circuit 3600 may be configured for driving RF electrodes or for driving ultrasound transducer 1120, for example, as described in connection with fig. 29. Thus, referring back now to fig. 23, circuit 3600 may be used to interchangeably drive an ultrasound electrode and an RF electrode.

Drive circuit 3686 provides a Left RF energy output and a Right RF energy output. Digital signals representing signal waveforms are provided from a control circuit, such as control circuit 3200 (fig. 20), to SCL-A, SDA-a inputs of analog multiplexer 3680. A digital-to-analog converter 3690(DAC) converts the digital input to an analog output to drive a PWM circuit 3692 coupled to an oscillator 3694. PWM circuit 3692 provides a first gate drive circuit 3696a coupled to a first transistor output stage 3698a to drive a first RF + (Left) energy output. The PWM circuit 3692 also provides a second gate drive circuit 3696b coupled to the second transistor output stage 3698b to drive a second RF- (Right) energy output. Voltage sensor 3699 is coupled between the RF Left/RF output terminals to measure the output voltage. The driver circuit 3686, the first and

second driver circuits

3696a, 3696b, and the first and second

transistor output stages

3698a, 3698b define a first stage amplifier circuit. In operation, the control circuit 3200 (fig. 20) generates the digital waveform 4300 (fig. 29) using circuitry such as Direct Digital Synthesis (DDS) circuits 4100, 4200 (fig. 27 and 28). DAC 3690 receives the digital waveform 4300 and converts it to an analog waveform that is received and amplified by the first stage amplifier circuit.

Fig. 24 is a schematic diagram of a transformer 3700 coupled to the circuit 3600 shown in fig. 23, 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 barrier capacitor 3706 and a second barrier 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 second secondary RF drive circuit 3774 b. The positive output of the second stage RF drive circuit 3774a 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 1:50₁:n₂。

Fig. 25 is a schematic diagram of a circuit 3800 that includes separate power sources for the high power energy/driver circuit and the low power circuit, in accordance with at least one aspect of the present disclosure. 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 to the circuit 3800 through a switch 3818, and a secondary battery pack including a secondary battery 3820, the secondary battery 3820 being connected to the circuit through a switch 3823 when the power source 3812 is inserted into the battery assembly. The secondary battery 3820 is a drop-resistant battery having a device 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 sag of the

primary batteries

3815, 3817. This ensures that the surgery is initially easy to introduce into a fully charged unit in a sterile field.

Primary batteries

3815, 3817 may be used to directly power the motor control circuitry 3826 and the energy circuitry 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 secondary NiMH batteries 3820 with dedicated energy cells 3820 to control the handle electronic circuitry 3830 from the

dedicated energy cells

3815, 3817 to run motor control circuitry 3826 and energy circuitry 3832. In this case, when the

primary batteries

3815, 3817 involved in driving the energy circuit 3832 and/or the motor control circuit 3826 are dropped, the circuit 3810 is pulled from the secondary battery 3820 involved in driving the handle electronic circuit 3830. In one various 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 the motor control circuit related to the drive electronics circuit).

Additionally, a gamma friendly charging circuit may be provided that includes a switch mode power supply 3827 that uses diodes and vacuum tube devices to minimize voltage sag at predetermined levels. The switch mode power supply 3827 may be eliminated with the inclusion of a separate minimum drop voltage for the NiMH voltage (3 NiMH cells). In addition, a modular system may be provided in which the radiation-hardening devices are located in the modules such that the modules may be sterilized by radiation sterilization. Other non-radiation hardened devices may be included in other modular devices and connections made between modular devices such that the device portions operate together as if the devices were located together on the same circuit board. A diode and vacuum tube based switch mode power supply 3827 allows for sterilizable electronics within a disposable primary battery pack if only two NiMH cells are desired.

Turning now to fig. 26, there is shown 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. The surgical instrument is configured to perform a surgical coagulation/cutting process on living tissue using both ultrasonic vibration and a high-frequency current, and to perform a surgical coagulation process on the living tissue using the high-frequency current.

Fig. 26 shows a control circuit 3900 that allows the dual generator system to switch between RF generator circuit 3902 and ultrasonic generator circuit 3920 energy modalities of a surgical instrument of the surgical system 1000. In one aspect, a current threshold in the 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 at least one aspect, the visual indicator 3912 or light located on the surgical instrument of the surgical system 1000 can 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. Thus, the phototransistor 3914 may be configured to detect a transition from an on state to an off state and dissociate the RF energy, as shown in the control circuit 3900 shown in fig. 26. Thus, 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 are kept off.

Referring to fig. 26, in one aspect, a method of managing the RF generator circuit 3902 and the ultrasonic generator circuit 3920 is provided. The RF generator circuit 3902 and/or the ultrasonic generator circuit 3920 can 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-function 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 open, 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 sensing step-up transformer 3904 will illuminate when the tissue impedance is low. Light from the visual indicator 3912 provides a logic signal to maintain the ultrasonic generator circuit 3920 in the 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 the off state. The logic signal generated by this transition turns off the relay 3908, thereby turning off the RF generator circuit 3902 and turning on the ultrasonic generator circuit 3920 to complete the coagulation and cutting cycle.

Still referring to fig. 26, in one aspect, a dual generator circuit configuration employs a battery 3901 powered on-board RF generator circuit 3902 for one modality, and a second on-board ultrasonic generator circuit 3920 that may be on-board, for example, to a handle assembly 1109, a battery assembly, a shaft assembly 1129, a nozzle, and/or an ultrasonic transducer/RF generator assembly 1120 of the multifunctional electrosurgical instrument 1108. The ultrasonic generator circuit 3920 is also battery 3901 operational. 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 the dual RF generator circuit 3902/ultrasonic generator circuit 3920 as part of the handle assembly 1109 may eliminate the need for complex wiring. The RF generator circuit 3902/ultrasonic generator circuit 3920 can be configured to provide the full capabilities of existing generators while simultaneously utilizing the capabilities of a 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 state, instrument operating parameters (such as jaw closure, force, etc.), and algorithms for managing tissue processing. Various combinations of this integration may be implemented to provide appropriate levels 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 3906b), 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 3906 b. In one aspect, the first winding 3910a and the return electrode 3906b are connected to the negative pole of the bipolar RF generator circuit 3902. The other pole of the bipolar RF generator circuit 3902 is connected to the active electrode 3906a through a switch contact 3909 of the relay 3908, or any suitable electromagnetic switching device that includes an armature that is moved by an electromagnet 3936 to operate the switch contact 3909. When the electromagnet 3936 is energized, the switch contact 3909 is closed, and when the electromagnet 3936 is de-energized, the switch contact 3909 is opened. When the switch contacts are closed, RF current flows through conductive tissue (not shown) located between

electrodes

3906a, 3906 b. It should be appreciated that in one aspect, the active electrode 3906a is connected to the anode 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 the surgical instrument 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, an NE-2 type neon bulb.

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

A first current flows through the first winding 3910a as a function of the impedance of the tissue located between the active electrode 3906a and the return electrode 3906b, thereby providing a first voltage across the first winding 3910a of the step-up transformer 3904. The boosted second voltage is induced on the second winding 3910b of the boost transformer 3904. A secondary voltage appears across resistor R2 and energizes visual indicator 3912 when the current through the tissue is greater than a predetermined threshold, causing the neon bulb to light up. It should be understood that the circuit and device values are exemplary and not limiting. When the switch contact 3909 of the relay 3908 is closed, current flows through the tissue and turns on the 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. Therefore, the output of the and gate 3932 is low and the transistor 3934 is turned off to prevent current from flowing through the windings of the electromagnet 3936. When the electromagnet 3936 is in the de-energized state, the switch contacts 3909 of the relay 3908 remain open and prevent current from flowing through the

electrodes

3906a, 3906 b. The logic low output of the first inverter 3928 is also applied to the second inverter 3930, 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 goes low to turn off the ultrasonic generator circuit 3920, and the Q output goes high and is applied to the other input of the and gate 3932.

When the user presses the energy switch 3926 on the instrument handle to apply energy to the tissue between the

electrodes

3906a, 3906b, the energy switch 3926 is closed and applies a logic low at the input of the first inverter 3928, which first inverter 3928 applies a logic high to the other input of the and gate 3932, causing the output of the and gate 3932 to go high and turn on the transistor 3934. In the on state, the transistor 3934 conducts and sinks current through the windings of the electromagnet 3936 to energize the electromagnet 3936 and close the switch contact 3909 of the relay 3908. As described above, when the switch contact 3909 is closed, current can flow through the

electrodes

3906a, 3906b and the first winding 3910a of the step-up transformer 3904 when tissue is located between the

electrodes

3906a, 3906 b.

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, the tissue impedance is low and the magnitude of the current through the tissue and the first winding 3910a is high. Therefore, the voltage applied across the second winding 3910b is high enough to turn on the visual indicator 3912. The light emitted by the visual indicator 3912 turns on the phototransistor 3914, which pulls the input of the inverter 3916 low and changes the output of the inverter 3916High. The high input of CLK applied to flip-flop 3918 does not affect the Q OR of flip-flop 3918

Output, and Q output remains low, and

the output remains high. Thus, when 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 multifunctional electrosurgical instrument are not activated.

When the tissue between

electrodes

3906a, 3906b dries out, 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 drops 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 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 as a logic high to the Q output and to

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

electrodes

3906a, 3906 a. Which is simultaneously or near simultaneously turned on by the ultrasonic generator circuit 3920,

the output flip-flop 3918 goes low and causes the output of the and gate 3932 to go low and turn off the transistor 3934, thereby de-energizing the electromagnet 3936 and opening the switch contact 3909 of the relay 3908 to cut off the current flowing through the

electrodes

3906a, 3906 b.

When the switch contact 3909 of the relay 3908 is open, there is no current flowing through the

electrodes

3906a, 3906b, the tissue, and the first winding 3910a of the step-up transformer 3904. Therefore, no voltage is generated across the second winding 3910b and no current flows through the visual indicator 3912.

The Q output of the trigger 3918 and when the user squeezes the energy switch 3926 on the instrument handle to hold the energy switch 3926 closed

The output remains the same. Thus, when no current flows from the bipolar RF generator circuit 3902 through the

electrodes

3906a, 3906b, the ultrasonic blade 3924 remains activated and continues to cut tissue between the jaws of the end effector. When the user releases the energy switch 3926 on the instrument handle, the energy switch 3926 opens 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, causing the Q output to go low and turn off the ultrasonic generator circuit 3920. At the same time as this is done,

The output goes high and the circuit is now in the 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 the tissue between the

electrodes

3906a, 3906b, and repeat the cycle of applying RF energy and ultrasonic energy to the tissue as described above.

In one aspect, the ultrasonic or high frequency current generator of the surgical system 1000 may be configured to digitally generate the electrical signal waveform such that it is desirable to digitize the waveform using a predetermined number of phase points stored in a look-up table. The phase points may be stored in tables defined in memory, a Field Programmable Gate Array (FPGA), or any suitable non-volatile memory. Fig. 27 illustrates one aspect of the basic architecture of a digital synthesis circuit, such as a Direct Digital Synthesis (DDS) circuit 4100, configured to be capable of generating multiple wave shapes of electrical signal waveforms. The generator software and digital controls may command the FPGA to scan for addresses in a lookup table 4104, which lookup table 4104 in turn provides varying digital input values to the DAC circuit 4108 feeding the power amplifier. The addresses may be scanned according to the frequency of interest. Various types of waveforms can be generated using this lookup table 4104, which can be fed simultaneously into tissue or transducers, RF electrodes, multiple transducers, multiple RF electrodes, or a combination of RF and ultrasonic instruments. Further, multiple lookup tables 4104 representing multiple wave shapes can be created, stored, and applied to the tissue from the generator.

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

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

As digital technology is widely used in instruments and communication systems, digital control methods for generating multiple frequencies from a reference frequency source have evolved and are referred to as direct digital synthesis. The infrastructure is shown in fig. 27. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic device of the generator circuit and to a memory circuit located in the generator circuit of the surgical system 1000. The DDS circuit 4100 includes an address counter 4102, a lookup table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. Stable clock f_cIs received by an address counter 4102, and register 4106 drives a Programmable Read Only Memory (PROM) that stores one or more integer cycles of a sine wave (or other arbitrary waveform) in a lookup table 4104. As the address counter 4102 steps through memory locations, the values stored in the lookup table 4104 are written to a register 4106, which register 4106 is coupled to a DAC circuit 4108. The corresponding digital amplitude of the signal at the memory location of the lookup table 4104 drives the DAC circuit 4108, which DAC circuit 4108 in turn generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The phase noise being substantially the reference clock f _cPhase noise of (2). The first analog output signal 4110 output from the DAC circuit 4108 is filtered by a filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the generator circuitAnd (6) outputting. The second analog output signal having a frequency f_{Output of}。

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

The DDS circuit 4100 may include a plurality of lookup tables 4104, wherein the lookup tables 4104 store waveforms represented by a predetermined number of samples, wherein the samples define a predetermined shape of the waveform. Accordingly, multiple waveforms having unique shapes may be stored in multiple lookup tables 4104 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4100 may create multiple waveform-shaped look-up tables 4104 and switch between different wave shapes stored in the individual look-up tables 4104 based on desired tissue effects and/or tissue feedback during the tissue treatment process (e.g., based on "on-the-fly" or virtual real-time of user or sensor input). Thus, switching between waveforms may be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4104 can store electrical signal waveforms shaped to maximize the power delivered into the tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the lookup table 4104 can store waveforms synchronized in a manner that maximizes power delivery for the multi-function surgical instrument of the surgical system 1000 when delivering the RF drive signal and the ultrasonic drive signal. In other aspects, the lookup table 4104 can store electrical signal waveforms to drive ultrasound energy and RF therapy energy, and/or sub-therapy energy, simultaneously while maintaining ultrasound frequency lock. The customized waveforms and their tissue effects specific to the different instruments may be stored in non-volatile memory of the generator circuit or in non-volatile memory (e.g., EEPROM) of the surgical system 1000 and extracted when the multifunctional surgical instrument is connected to the generator circuit. An example of an exponentially decaying sinusoid as used in many high crest factor "coag" waveforms is shown in fig. 29.

A more flexible and efficient implementation of the DDS circuit 4100 employs a digital circuit known as a digitally controlled oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit, such as DDS circuit 4200, is shown in fig. 28. In this simplified block diagram, the DDS circuit 4200 is coupled to a processor, controller, or logic device of the generator and connected to a memory circuit located in the generator or in any of the surgical instruments of the surgical system 1000. The DDS circuit 4200 includes a load register 4202, a parallel delta phase register 4204, an adder circuit 4216, a phase register 4208, a look-up table 4210 (phase to amplitude converter), a DAC circuit 4212, and a filter 4214. The adder circuit 4216 and phase register 4208 form part of the phase accumulator 4206. Clock frequency f_cIs applied to the phase register 4208 and the DAC circuit 4212. The load register 4202 receives the signal f designating the output frequency as the reference clock frequency_cFractional tuning words of (a). The output of load register 4202 is provided to parallel delta phase register 4204 as a tuning word M.

DDS circuit 4200 includes generating a clock frequency f_cThe sampling clock, the phase accumulator 4206, and the look-up table 4210 (e.g., phase-to-amplitude converter). Each clock cycle f _cThe contents of phase accumulator 4206 are updated once. When the time of the phase accumulator 4206 is updated, the number M stored in the parallel delta phase register 4204 is added to the number in the phase register 4208 by the adder circuit 4216. Assume that the number in the parallel delta phase register 4204 is 00 … 01 and the initial content of the phase accumulator 4206 is 00 … 00. Phase accumulator 4206 updates 00 … 01 every clock cycle. If the phase accumulator 4206 is 32 bits wide, 232 clock cycles (over 40 hundred million) are required before the phase accumulator 4206 returns to 00 … 00 and the cycle is repeatedAnd (4) a ring.

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

In one aspect, the electrical signal waveform may be digitized as 1024(210) phase points, but the wave shape may be digitized as any suitable number of 2n phase points in the range of 256(28) to 281,474,976,710,656(248), where n is a positive integer, as shown in table 1. The electrical signal waveform can be represented as A_n(θ_n) With normalized amplitude A at point n_nBy the phase angle theta of a phase point called point n_nAnd (4) showing. The number of discrete phase points, n, determines the tuning resolution of the DDS circuit 4200 (as well as the DDS circuit 4100 shown in fig. 21).

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

TABLE 1

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

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

Referring back to fig. 21, for n-32 and M-1, the phase accumulator 4206 steps through 232 possible outputs before it overflows and restarts. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M is 2, the phase register 1708 "flips" twice as fast and the output frequency is doubled. This can be summarized as follows.

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

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

For n-32, the resolution is greater than forty parts per billion. In one aspect of the DDS circuit 4200, not all bits from the phase accumulator 4206 are passed to the lookup table 4210, but are truncated leaving only the first 13 to 15 Most Significant Bits (MSBs), for example. This reduces the size of the look-up table 4210 and does not affect the frequency resolution. Phase truncation adds only a small but acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by current, voltage, or power at a predetermined frequency. Additionally, where any of the surgical instruments of the surgical system 1000 includes an ultrasound device, the electrical signal waveform may be configured to drive at least two vibration modes of the ultrasound transducer of at least one of the surgical instruments. Accordingly, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, wherein the electrical signal waveform is characterized by a predetermined waveform shape stored in the look-up table 4210 (or look-up table 4104 of fig. 27). Further, the electrical signal waveform may be a combination of two or more wave shapes. The lookup table 4210 may include information associated with a plurality of waveform shapes. In one aspect or example, the look-up table 4210 may be generated by the DDS circuit 4200 and may be referred to as a direct digital synthesis table. The DDS works by first storing a large number of repeating waveforms in on-board memory. The cycles of the waveform (sine, triangle, square, arbitrary) may be represented by a predetermined number of phase points as shown in table 1 and stored into memory. Once the waveform is stored in memory, it can be generated at a very precise frequency. The direct digital synthesis table may be stored in a non-volatile memory of the generator circuit and/or may be implemented with FPGA circuitry in the generator circuit. The lookup table 4210 may be addressed by any suitable technique that facilitates classification of waveform shapes. According to one aspect, the look-up table 4210 is addressed according to the frequency of the electrical signal waveform. Additionally, information associated with the plurality of waveform shapes may be stored in memory as digital information or as part of the lookup table 4210.

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

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

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

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

The DDS circuit 4200 may include a plurality of lookup tables 4104, where the lookup tables 4210 store waveforms represented by a predetermined number of phase points (which may also be referred to as samples), where the phase points define a predetermined shape of the waveform. Accordingly, multiple waveforms having unique shapes may be stored in multiple look-up tables 4210 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4200 may create multiple waveform-shaped look-up tables 4210 and switch between different wave shapes stored in different look-up tables 4210 based on desired tissue effects and/or tissue feedback during a tissue treatment process (e.g., "on-the-fly" or virtual real-time based on user or sensor input). Thus, switching between waveforms may be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4210 may store an electrical signal waveform shaped to maximize the power delivered into the tissue per cycle (i.e., a trapezoidal or square wave). In other aspects, the look-up table 4210 may store waveform shapes that are synchronized in such a way that they maximize power delivery by either of the surgical instruments of the surgical system 1000 when delivering the RF signal and the ultrasonic drive signal. In other aspects, the lookup table 4210 may store electrical signal waveforms to drive the ultrasound energy and the RF therapy energy, and/or sub-therapy energy simultaneously, while maintaining ultrasound lock. Generally, the output wave shape may be in the form of a sine wave, cosine wave, pulse wave, square wave, or the like. However, more complex and customized waveforms specific to different instruments and their tissue effects may be stored in non-volatile memory of the generator circuit or non-volatile memory (e.g., EEPROM) of the surgical instrument and extracted upon connecting the surgical instrument to the generator circuit. One example of a custom wave shape is an exponentially decaying sinusoid as used in many high crest factor "coag" waveforms, as shown in fig. 23.

Fig. 29 illustrates one cycle of a discrete-time digital electrical signal waveform 4300 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison) of an analog waveform 4304, in accordance with at least one aspect of the present disclosure. The horizontal axis represents time (t), while the vertical axis represents digital phase points. The digital electrical signal waveform 4300 is a digital discrete-time version of, for example, a desired analog waveform 4304. A digital electrical signal waveform 4300 is generated by storing an amplitude phase point 4302, the amplitude phase point 4302 representing one cycle or period T_oPer clock cycle T_clkThe amplitude of (d). Digital electrical signal waveform 4300 is passed through any suitable digital processing circuitry for one period T_oThe above is generated. The amplitude phase points are digital words stored in a memory circuit. In the examples shown in fig. 27, 28, the digital word is a six-bit word capable of storing amplitude phase points at a resolution of 26 bits or 64 bits. It should be understood that the examples shown in fig. 27, 28 are for exemplary purposes, and that in actual implementations, the resolution may be higher. In a cycle T_oThe digital amplitude phase points 4302 above are stored in memory as a string in look-up tables 4104, 4210, as described in connection with, for example, fig. 27, 28. To generate an analog version of analog waveform 4304, clock cycle T from memory _clkFrom 0 to T_oThe amplitude phase points 4302 are read in turn and converted by

DAC circuits

4108, 4212, also described in connection with fig. 27, 28. Can be obtained by mixing digital electric signal wavesThe amplitude phase point 4302 of the shape 4300 goes from 0 to T_oReading as many cycles or periods as possible is repeated to generate additional cycles. A smoothed analog version of the analog waveform 4304 is achieved by filtering the output of the

DAC circuits

4108, 4212 with filters 4112, 4214 (fig. 27 and 28). The filtered analog output signals 4114, 4222 (fig. 27 and 28) are applied to the input of the power amplifier.

Advanced RF energy device including neural stimulation signals with therapeutic waveforms

As disclosed above, in some surgical procedures, a medical professional may employ an electrosurgical device to seal or cut tissue, such as a blood vessel. Such devices achieve medical treatment by passing electrical energy, such as electrical current under Radio Frequency (RF), through the tissue to be treated. Some electrosurgical devices are referred to as bipolar devices because the electrode used to supply electrical energy (the active electrode) and the return electrode are both housed in the same surgical probe. It should be understood that the surgical probe may comprise a handpiece or robotically controlled instrument or a combination thereof.

An alternative device may be referred to as a monopolar device. In such devices, only the active electrode is housed in the surgical probe. The current entering the patient's tissue can be returned to the electrical energy generator via an electrical path through the gurney where the patient is located, or through a specific return electrode pad. In some aspects, the patient may lie on the electrode pad, or the electrode pad may be placed on the patient at a location proximate to the surgical site where the surgical probe is deployed. It can be appreciated that the current path of a patient operating with a monopolar device may not be well characterized as compared to the current path of a patient operating with a bipolar device. As a result, some non-target tissues may be inadvertently cauterized, cut, or otherwise damaged by the monopolar electrosurgical device. Such intentional trauma to excitable tissue may cause a patient to experience muscle weakness, pain, numbness, paralysis, and/or other undesirable consequences.

Accordingly, it is desirable for monopolar electrosurgical devices to include features to determine whether the device is close enough to excitable tissue to cause an accidental injury. Such features may be used by one or more subsystems of the electrosurgical device as a basis for informing a medical professional of the proximity of such tissue to the monopolar electrode. In addition, one or more subsystems of the intelligent electrosurgical device may use such features to reduce or eliminate the amount of therapeutic energy delivered to tissue believed to be proximate to non-target excitable tissue. In some intelligent medical devices that combine electrosurgical (RF) and ultrasound therapy modes, the feature of determining whether the device is close enough to excitable tissue to cause an accidental injury may cause the device to switch to ultrasound mode when the device is operating in electrosurgical (RF) mode.

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

Fig. 30 illustrates a typical monopolar electrosurgical system 136000. The electrosurgical system 136000 may include a controller 136010, a generator 136012, an electrosurgical instrument 136015, and a return pad 136020 including one or more return electrodes. Generally, the generator 136012 may supply electrical signals to the electrosurgical instrument 136015 along the first conductive electrical path 136017, and may receive return signals from one or more return electrodes along the second conductive electrical path 136023. Fig. 30 depicts an example of a care professional 136025 treating a patient 136027 using an electrosurgical instrument 136015, such as an active monopolar electrode.

Fig. 31 is a schematic block diagram of the patient and electronic components depicted in fig. 30. The generator 136012 may be a separate component from the controller 136010, or the controller 136010 may include an electrical generator 136012. The controller 136010 may control the operation of the generator 136012, including controlling its electrical output. As disclosed below, the controller 136010 may control one or more output waveforms of the generator 136012, including controlling various characteristics of the output signal of the generator 136012, including amplitude characteristics, frequency characteristics, and phase characteristics. The controller 136010 may also receive signals from any number of additional components including, but not limited to, manually controlled actuators (switches, push buttons, sliders, etc.), sensors, or data signals transmitted by any number of communication devices, computers, intelligent surgical devices, and imaging systems. The controller 136010 may be comprised of any one or more types of computer processor devices, one or more memory components (static and/or dynamic memory components), and communication components configured to transmit and/or receive data signals (analog or digital), as may be required for the functions of the controller. The memory component of the controller 136010 may contain one or more instructions that when read by one or more computer processor devices may direct the operation of the controller. Examples of such instructions and their expected results are disclosed below.

Electrical energy may be supplied by the generator 136012 and received by a surgical instrument 136015, such as an active monopolar electrode. In some aspects, the active electrode may be in electrical communication with a power terminal of the generator 136012 to receive electrical energy. In some aspects, the surgical instrument 136015 may receive an electrical signal over the first electrically conductive path 136017, such as a wire or other wiring.

During surgery, patient 136027 may lie supine on return pad 136020. The return pad 136020 may be in electrical communication with the generator 136012 via electrical return terminals, and electrical energy supplied by an electrosurgical instrument 136015 (such as an active electrode) into the patient 136027 may be returned to the generator 136012 through the return pad 136020. In some aspects, the return pad 136020 can be in electrical communication with an electrical return terminal through a second conductive electrical path 136023, such as a wire or other wiring.

In some aspects, the generator 136012 may supply alternating current at radio frequency levels to the electrosurgical instrument 136015. In some alternative aspects, the electrosurgical instrument 136015 may also incorporate features for an ultrasound therapy mode, and the generator 136012 may also be configured to generate power to drive one or more ultrasound therapy components. An electrosurgical instrument 136015, which typically includes an electrode tip (i.e., an active electrode) positionable at target tissue of patient 136027, receives the alternating current from generator 136012 and delivers the alternating current to the target tissue via the electrode tip. The alternating current received by the electrode tip may come from the generator 136012 via the first conductive electrical path 136017. An alternating current is received at the target tissue, and electrical resistance from the tissue generates heat that provides a desired effect (e.g., sealing and/or cutting) at the surgical site. The ac electricity received at the target tissue is conducted through the patient's body and ultimately received by one or more return electrodes of return pad 136020. The alternating current received by the return pad 136020 can be conducted back to the generator via the second conductive electrical path 136023 to complete the closed path followed by the alternating current. The one or more return electrodes are configured to carry the amount of current introduced by the electrode tip. The return pad 136020 may be attached to the patient's body or may be separated from the patient's body by a small distance (i.e., capacitive coupling). The alternating current received by the one or more return electrodes is passed back to the generator 136012 to complete the closed path followed by the alternating current.

For the electrosurgical system 136000 that utilizes capacitive coupling to complete the current path between the patient's body and the return electrode, the patient's body effectively acts as a first capacitive plate of a capacitor and the return electrode pad effectively acts as a second capacitive plate of the capacitor.

In some aspects, the return pad 136020 may include a single return electrode incorporating an array of multiple sensing devices. In some alternative aspects, the return pad 136020 can include an array of return electrodes, where an array of sensing devices can be incorporated into the array of return electrodes. In one non-limiting example, return pad 136020 may include multiple return electrodes, where each of the return electrodes includes a sensing device.

By incorporating an array of sensing devices into the return electrode pad 136020, the sensing devices can be used to detect neural control signals applied to the patient or movement of anatomical features of the patient caused by the application of neural control signals. The sensing devices may include, but are not limited to, one or more pressure sensors, one or more accelerometers, or a combination thereof. In some non-limiting aspects, the sensing device may be configured to output a signal indicative of the detected neural control signal and/or the detected movement of the patient anatomical feature. Using Coulomb's law and the respective positions of the active electrodes, the patient's body, and the sensing device, the detected neural control signals and/or the movement of anatomical features of the patient can be analyzed to determine the location of the nerves within the patient.

In some aspects, as shown, for example, in fig. 32, return pad 136120 can include a plurality of electrodes 136125 that can be capacitively coupled to a patient's body and collectively configured to carry an amount of current that is introduced into the patient's body by an electrosurgical instrument. For this capacitive coupling, the patient's body effectively acts as one plate of a capacitor, and the multiple electrodes 136125 of the return pad 136120 collectively effectively act together as the other plate of the capacitor. A more detailed description of capacitive coupling can be found, for example, in U.S. patent No.6,214,000 entitled "CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE" published on

month

4 and 10 of 2001 and U.S. patent No.6,582,424 entitled "CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE" published on month 6 and 24 of 2003, each of which is incorporated by reference herein in its entirety.

Fig. 31 illustrates a plurality of electrodes 136125a-136125d of the return pad of fig. 30 in accordance with at least one aspect of the present disclosure. Although four electrodes 136215a-136215d are shown in fig. 31, it should be understood that return pad 136120 may include any number of electrodes 136125. For example, according to various aspects, the return pad 136120 can include two electrodes, eight electrodes, sixteen electrodes, or any number of electrodes that can be fabricated in the return pad 136120. It should be appreciated that the number of electrodes may be even or odd. Additionally, although individual electrodes 136125a-136125d are shown in FIG. 31 as being substantially rectangular, it should be understood that individual electrodes may have any suitable shape.

Electrodes 136125a-136125d of return pad 136120 may be used as return electrodes for the electrosurgical systems of fig. 30 and 31, and may also be considered segmented electrodes, as electrodes 136125a-136125d may be selectively detachable from the patient's body and/or the generator. In some aspects, the electrodes 136125a-136125d of the return pad 136120 can be coupled together to effectively act as one large electrode. For example, according to various aspects, each of the electrodes 136125a-136125d of the return pad 136120 can be connected to an input of the switching device 136135 by a respective conductive member 136130a-136130d, as shown in fig. 32. When the switch device 136135 is in the open position, as shown in fig. 32, the respective electrodes 136125a-136125d of the return pad 136120 are disengaged from each other and from the patient's body and/or generator. In contrast, when the switching device 136135 is in the closed position, the respective electrodes 136125a-136125d of the return pad 136120 are coupled together to effectively act as a single large electrode. It may be appreciated that different combinations of electrodes 136125a-136125d may be coupled together by switching device 136135 to form any one or more sets of electrodes. For example, if the patient is positioned in a supine position on return pad 136120 with the patient's head proximate to switch device 136135,

electrodes

136125a and 136125c may be coupled together and

electrodes

136125b and 136125d may be coupled together to sense current flowing through the lower and upper bodies, respectively. Alternatively, if the patient is disposed on return pad 136120 in a supine position with the patient's head proximate to switch 136135,

electrodes

136125a and 136125b may be coupled together and

electrodes

136125c and 136125d may be coupled together to sense current flowing through the right and left side bodies, respectively.

The switching device 136135 may be controlled by a processing circuit (e.g., a processing circuit of a generator of an electrosurgical system, a processing circuit of a hub of an electrosurgical system, etc.). The processing circuitry is not shown in fig. 32 for simplicity. According to various aspects, the switch device 136135 may be incorporated into the return pad 136120. According to other aspects, the switching device 136135 may be incorporated into the second electrically conductive electrical path of the electrosurgical system of fig. 30 and 31. The return pad 136120 may also include a plurality of sensing devices.

Fig. 33 illustrates an array of sensing devices 136140a-136140d of return pads in accordance with at least one aspect of the present disclosure. According to various aspects, the number of sensing devices 36140a-36140d may correspond to the number of electrodes 36125a-36125d such that there is one sensing device per electrode (e.g., sensing device 36140a having electrode 136125a, sensing device 36140b having electrode 136125b, sensing device 36140c having electrode 136125c, and sensing device 36140d having electrode 136125 d). Each sensing device 36140a-36140d may be mounted to or integrated with a corresponding electrode 136125a-136125d, respectively. However, while the number of sensing devices 36140a-36140d associated with corresponding electrodes 136125a-136125d may correspond to the number of electrodes, it should be understood that the return pad may include any number of sensing devices. For example, for aspects of a return pad that includes sixteen electrodes, the return pad may include only four or eight sensing devices. Although sensing devices 136140a-136140d are shown in FIG. 33 as centered on corresponding electrodes 136125a-136125d, respectively, it should be understood that sensing devices 136140a-136140d may be positioned on any portion of corresponding electrodes 136125a-136125 d. It will also be appreciated that the location of a particular sensing device on a particular electrode is independent of the location of any other sensing device on its respective electrode.

The sensing devices 136140a-136140d are configured to be able to detect unipolar neural control signals applied to the patient and/or movement of anatomical features of the patient (e.g., muscle twitches) caused by the application of the neural control signals. The monopolar neural control signal may be applied by the surgical instrument of the electrosurgical system of fig. 30 and 31, or may be applied by a different surgical instrument coupled to a different generator. Each sensing device 136140a-136140d may include, for example, a pressure sensor, an accelerometer, or a combination thereof, and is configured to output a signal indicative of the detected neural control signal and/or the detected movement of the patient's anatomical features. In some non-limiting examples, the sensing device consisting of a pressure sensor may include, for example, a piezoresistive strain gauge, a capacitive pressure sensor, an electromagnetic pressure sensor, and/or a piezoelectric pressure sensor, alone or in combination. In some non-limiting examples, the sensing device consisting of an accelerometer may include, for example, a mechanical accelerometer, a capacitive accelerometer, a piezoelectric accelerometer, an electromagnetic accelerometer, and/or a micro-electromechanical system (MEMS) accelerometer, alone or in combination. The respective output signals of the respective sensing devices 136140a-136140d may be in the form of analog signals and/or digital signals.

Using coulomb's law and the respective locations of the active electrodes of the surgical instrument, the patient's body, and the respective sensing devices, the respective output signals of the sensing devices 136140a-136140d of interest can be analyzed to determine the location of nerves within the patient's body, which are indicative of detected movement of the patient's neural control signals and/or anatomical features of the patient. Coulomb's law states that E ═ K (Q/r)²) Where E is the threshold current required to stimulate the nerve at the nerve, K is a constant, Q is the minimum current from the nerve stimulating electrode, and r is the distance from the nerve. The further away the nerve stimulating electrode is from the nerve (r increases), the proportionally greater the current required to stimulate the nerve. Thus, the amount of stimulation of the excitable tissue measured by the sensing devices 136150a-136150d may be related to the distance of the neurostimulation electrodes to the excitable tissue under constant current stimulation. In some aspects, the output signals of the sensing devices 136140a-136140d may also depend on the distance of the excitable tissue from the sensing devices 136140a-136140 d. It may be appreciated that the plurality of sensing devices 136140a-136140d may be used to triangulate the position of the electrically stimulated excitable tissue based on the geometry and position of the plurality of sensing devices 136140a-136140 d. Thus, the distance from the nerve stimulation electrode to the nerve can be estimated using constant current stimulation. Alternatively, current stimulation consisting of different amounts of current may be used to improve the determination of the location of excitable tissue by triangulation methods associated with multiple sensing devices 136140a-136140 d. Generally, the respective intensity of the output signal of the respective sensing device is indicative of how close or how far the respective sensing device is from the stimulated nerve of the patient.

According to various aspects, the analysis of the respective output signals of the respective sensing devices may be performed by the processing circuitry of the generator of the electrosurgical system of fig. 30 and 31, by the processing circuitry of the nerve monitoring system separate from the generator of its electrosurgical system, by the processing circuitry of the hub of the electrosurgical system, and so forth. The analysis may be performed in real time or near real time. According to various aspects, the respective output signals are used as inputs to a unipolar neural stimulation algorithm executed by the processing circuit.

As shown in fig. 33, according to various aspects, output signals of respective sensing devices 136140a-136140d may be input into a multiple-input-single-output switching device 136137 (e.g., a multiplexer) via respective conductive members 136142a-136142d, respectively. By controlling the select signals S0, S1 to the multiple-input-single-output switching device 136137, the multiple-input-single-output switching device 136137 may be controlled so as to output only one of the output signals of the respective sensing devices 136140a-136140d at a time for the above analysis. As one non-limiting example, referring to fig. 33, by setting the select signals S0, S1 to 0,0, the output signal from the sensing device 136140c may be output by the multiple-input-single-output switching device 136137 for analysis by applicable processing circuitry. In another non-limiting example, with the select signals S0, S1 set to 0,1, the output signal from the sensing device 136140a may be output by the multiple-input-single-output switching device 136137 for analysis by applicable processing circuitry. Similarly, by setting the select signals S0, S1 to 1,0, the output signal from the sensing device 136140d may be output by the multiple-input-single-output switching device 136137 for analysis by applicable processing circuitry. And it is extended that by setting the select signals S0, S1 to 1,1, the output signal from the sensing device 136140b can be output by the multiple-input-single-output switching device 136137 for analysis by applicable processing circuitry.

The selection signals S0, S1 may be provided to the multiple-input-single-output switching device 136137 by processing circuitry (such as, by way of non-limiting example, processing circuitry of a generator of the electrosurgical system of fig. 30 and 31, processing circuitry of a nerve monitoring system separate from the generator of the electrosurgical system), by processing circuitry of a hub of the electrosurgical system, and so forth. The processing circuitry is not shown in fig. 33 for simplicity. By providing the various selection signals at a sufficiently fast rate, the output signals of the respective sensing devices 136125a-136125d can be effectively scanned at a rate that allows all of the output signals of the respective sensing devices 136125a-13612d to be analyzed in time to determine the location of the stimulated nerve.

According to various aspects, a multiple-input-single-output switching device 136137 may be incorporated into the return pad. According to other aspects, the multiple-input-single-output switching device 136137 may be incorporated into the second conductive electrical path 136023 of the electrosurgical system 136000 of fig. 30.

Control of the multiple-input-single-output switching device 136137 as disclosed in FIG. 33 may be conducted in the context of a four-input-one-output switching device corresponding to the four sensing devices 136140a-136140d depicted in FIG. 33. It should be understood that for aspects in which there are more than four sensing devices (e.g., sixteen sensing devices), the output signals of the more than four sensing devices may be used as inputs to a multiple-input, single-output switching device having more than two select signals (e.g., S0, S1, S2, and S3).

For aspects in which the output signals of the sensing devices (e.g., 136140a-136140d) are analog signals, the output of the multiple-input-single-output switching device 136137 may be converted to corresponding digital signals by an analog-to-digital converter 136145 prior to analysis of the output signals being performed by suitable processing circuitry.

Returning to fig. 30, according to various aspects, detection of movement of the neural control signals and/or anatomical features of the patient may be performed by the sensing device when electrodes 136125a-136125d of return pad 136120 are coupled to one another or when electrodes 136125a-136125d are decoupled from one another. For example, with respect to performing detection when the respective electrodes 136125a-136125d of return pad 136120 are decoupled from one another after positioning the patient on the surgical table but before beginning a surgical procedure, return pad 136120 can be placed in a "sensing mode" by controlling switching device 136135 to decouple the respective electrodes 136125a-136125d of return pad 136120 from one another. When the respective electrodes 136125a-136125d are decoupled from one another, the nerve and/or nerve bundle can be stimulated with an electrosurgical instrument as described above, and the respective output signals of the sensing devices of the return pad 136120 can be analyzed as described above to identify the location of the nerve, nerve bundle, and/or nerve junction associated therewith. The location of the nerve, nerve bundle, and/or nerve junction may be input into a unipolar nerve stimulation algorithm curve. Once the location of the nerve, nerve bundle, and/or nerve junction is input into the unipolar nerve stimulation algorithm curve, the location of the nerve, nerve bundle, and/or nerve junction may be effectively isolated from capacitive operation of the electrodes of return pad 136120. The location of the nerve, nerve bundle, and/or nerve junction may be used as a sensing node of a monopolar nerve stimulation algorithm curve to inform the surgeon when the surgeon is approaching the nerve and/or nerve bundle while performing a tissue cutting procedure. According to various aspects, the surgeon may be notified of the nearby location of the nerve and/or nerve bundle via an audible warning, a visual warning, a tactile (such as a vibratory) warning, or the like.

Returning to fig. 31, with respect to performing a detection when the respective electrodes of the return pad 136015 are coupled to one another, according to various aspects, the generator 136012 of the electrosurgical system may generate a high frequency waveform (alternating current at radio frequencies) that may be modulated on a carrier wave having a frequency low enough to stimulate the nerves of the patient. This modulation may allow for sensing movement of the neural control signals and/or anatomical features while capacitively coupling the respective electrodes of return pad 136020 with patient's body 136027. By applying a particular waveform to the patient 136027 and sensing a particular response, there is a high degree of confidence that the movement of the anatomical feature may be associated with the applied waveform rather than due to random patient motion. Modulation may be adjusted over time to stimulate different nerve sizes. According to various aspects, the amplitude of the modulation may change over time so as to allow the applicable processing circuitry to determine the distance of the nerve and/or nerve bundle from the signal without having to constantly stimulate the nerve and/or nerve bundle.

The electrical energy applied to the tissue by the surgical probe of the electrosurgical device may be in the form of Radio Frequency (RF) energy, which may be in the frequency range described in EN 60601-2-2:2009+ a11:2011, definition 201.3.218 — high frequency. For example, frequencies in monopolar RF applications are typically limited to less than 5 MHz. Monopolar applications typically use frequencies above 200kHz to avoid unwanted stimulation of nerves and muscles due to the use of low frequency currents. Bipolar techniques may use lower frequencies if the risk analysis shows that the likelihood of neuromuscular stimulation has been mitigated to an acceptable level. Typically, frequencies above 5MHz are not used to minimize the problems associated with high frequency leakage currents. However, higher frequencies may be used in the case of bipolar technology. It is generally considered that 10mA is the lower threshold for tissue thermal effects.

It can be appreciated that the electrosurgical device can utilize the response of excitable tissue to electrical frequencies below 200kHz in order to determine whether such excitable tissue is close enough to the end effector of the electrosurgical device to be potentially damaged. Fig. 34 illustrates an RF signal 136210 that may be used in an electrosurgical device to cut or cauterize tissue. Such RF signals 136210 may be referred to as treatment signals because they have frequencies that may affect treatment results such as cauterizing or cutting tissue. For exemplary purposes only, the x-axis may represent time, with each divisor representing 10 microseconds, and the y-axis (amplitude) having an arbitrary value. Thus, the RF signal 136210 shown in FIG. 34 may have a frequency of about 1 MHz. It should be appreciated that the RF therapy signal may have any frequency, amplitude, and/or phase characteristics sufficient to achieve a therapeutic application, such as sealing, cauterizing, ablating, or cutting tissue.

Fig. 35 depicts a signal 136220 that may be used to stimulate excitable tissue, such as a nerve or muscle. Also, for illustrative purposes only, the signal 136220 depicted in FIG. 35 may extend over approximately 20 microseconds and, if repeated, would constitute a waveform having a frequency of approximately 50 kHz. Such electrical signals 136220 may be referred to as stimulation signals because they have a frequency that can stimulate excitable tissue, such as nerve or muscle tissue. It should be understood that the waveform of the stimulation signal may differ in any respect (such as duration, frequency, or amplitude) from the signal 136220 presented in fig. 35. In general, stimulation signal 136220 may have any suitable waveform or amplitude while having a frequency within a range capable of stimulating such excitable tissue. As shown, the depiction in fig. 34 and 35 is merely exemplary. In an alternative example, the therapeutic RF signal may have a frequency of about 330kHz, and the waveform stimulating excitable tissue may have a frequency of about 2 kHz.

It should be understood that the intelligent electrosurgical device may be configured to emit a therapeutic signal or a stimulation signal or a combination thereof. Fig. 36A-36C present examples of combinations of treatment signals and stimulation signals. The generator may supply an output current that is made up of any number or combination of characteristics of the therapy signal and characteristics of the tissue stimulation signal. Non-limiting examples of characteristics of the therapy signal may include therapy signal frequency, therapy signal amplitude, and therapy signal phase. Non-limiting examples of characteristics of the tissue stimulation signal may include stimulation signal frequency, stimulation signal amplitude, and stimulation signal phase. It can be appreciated that the treatment signal can be characterized by any number of frequencies, phases, and amplitudes. Additionally, it can be appreciated that the tissue stimulation signal can be characterized by any number of frequencies, phases, and amplitudes. In some aspects, the controller may be configured to control the generator to provide an electrical output comprised of one or more combinations of characteristics of the treatment signal and characteristics of the tissue stimulation signal.

Fig. 36A depicts a non-limiting example of a first combined signal 136230 comprised of a first therapy signal 136212a, a stimulation signal 136222, and a second therapy signal 136212 b. As shown, one or more stimulation signals (such as signal 136220, fig. 35) may be alternated with one or more treatment signals (such as signal 136210, fig. 34). It should be understood that the length of time that one or more treatment signals (such as 136212a, 136212b) are applied may be arbitrary and may depend on the length of time that a medical professional may wish to apply it. It should also be understood that the stimulation signal 136222 may be transmitted at any time during the application of the treatment signal. It should also be understood that one or more zero amplitude signals may be interspersed between the one or more therapy signals and the one or more stimulation signals. The plurality of stimulation signals may be transmitted continuously before the transmission of the subsequent treatment signal.

Fig. 36B presents a non-limiting example of a second combined signal 136240 of a therapy signal and a stimulation signal. In fig. 36B, the stimulation signal (136220 depicted in fig. 35) can be used to modulate the amplitude of the therapy signal (136210 depicted in fig. 34). In some aspects, stimulation signal 136220 may be applied directly to an amplitude modulation circuit to modulate the amplitude of therapy signal 136210. In an alternative aspect, the stimulation signal 136220 may be offset and scaled before being used to modulate the amplitude of the therapy signal 136210. For example, stimulation signal 136220 in fig. 35 may be offset by +4.5V and the resulting signal may be scaled by 4.5V such that the amplitude of therapy signal 136210 is modulated by a positive-valued modulation signal that may range in value from about 0.1V to about 2V. It can be readily appreciated that any simple transformation of stimulation signal 136220 can be used to modulate the amplitude of therapy signal 136210. It can be appreciated that the amplitude of therapy signal 136210 can be modulated by stimulation signal 136220 at any time or any number of times during the application of the therapy signal. The amplitude of therapy signal 136210 may be modulated in the same manner during multiple modulation cycles. Alternatively, each amplitude modulation may be different according to the shifting and/or scaling transform of stimulation signal 136220.

Fig. 36C presents a non-limiting example of a third combined signal 136250 of a therapy signal and a stimulation signal. In fig. 36C, the stimulation signal (136220 depicted in fig. 35) can be used as a DC offset for the treatment signal (136210 depicted in fig. 34). It will be appreciated that the stimulation signal 136220 may also be altered according to any offset or scaling transformation before being applied as a DC offset to the treatment signal 136210. It can be appreciated that the DC offset based on the stimulation signal 136220 can be applied to the therapy signal 136210 at any time, and can be applied multiple times during the application of the therapy signal 136210. The DC offset applied to treatment signal 136210 may be the same over the course of multiple offset application periods. Alternatively, each DC offset of therapy signal 136210 may be different according to the offset and/or scaling transform of the stimulation signal.

It should be understood that the combination of stimulation signals and therapy signals is not limited to the examples disclosed above and depicted in fig. 36A-36C. The stimulation signal may be combined with the treatment signal in the same manner throughout the electrosurgical procedure. Alternatively, the stimulation signal may be combined with the therapy signal in any of a number of different ways throughout the electrosurgical procedure. In some aspects, the stimulation signal may be combined with the treatment signal based on selections made by the health care professional during the electrosurgical procedure. For example, the surgical probe may include one or more controls to allow an operator of the electrosurgical device to select a combination mode of stimulation signals and treatment signals. The surgical probe may also include one or more controls to allow an operator of the electrosurgical device to select when a stimulation signal may be applied. In some alternative aspects, the surgical probe may include controls to allow a user to change one or more characteristics of the therapy signal and/or stimulation signal. Non-limiting examples of such signal characteristics may include one or more frequencies, one or more phases, and one or more amplitudes. In some alternative aspects, one or more controls for the stimulation signal and the therapy signal, their respective characteristics, or a combination thereof may be located on a control unit of the electrosurgical device, or may be incorporated in a foot-operated controller.

In some aspects, the intelligent electrosurgical device may include a processor, a memory component, and instructions residing in the memory component for adjusting the treatment signal output based on the distance of the active electrode from the excitable tissue. In some aspects, such processors, memory components, and instructions may form components of a controller. In some aspects, such processors, memory components, and instructions may form components of a generator. In some aspects, such processors, memory components, and instructions may form a separate component of the computer system from the intelligent electrosurgical device.

FIG. 37 summarizes one non-limiting method 136300 in which such control may be implemented. The controller may configure the generator to be capable of combining 136310 the stimulation signal with the therapy signal to form an electrode emission signal. The controller may then cause the electrode to transmit 136320 the emission signal from the active electrode into the patient tissue. The controller may then receive 136330 a signal from a return signal pad in electrical communication with at least a portion of the patient. The signal returned by the return signal pad may include a signal generated by any one or more sensing devices disposed within the return pad. The controller may analyze 136340 the return signal from the return signal pad. It is recognized that the analysis 136340 may include any one or more pre-processing methods, including but not limited to noise filtering, signal extraction, baseline adjustment, or any other method that may allow the controller to identify the return signal from the patient. Based on the return signal or any suitable manipulation of the return signal, the controller may determine 136350 that the excitable tissue has been stimulated by the emitted electrode signal. When the controller has determined 136350 that the excitable tissue has been stimulated by the emitted electrode signal, the controller may determine 136360 the distance of the excitable tissue from the active electrode. The controller may then adjust 136370 the amplitude of the therapy signal when the distance of the excitable tissue from the active electrode is less than a threshold. In some aspects, the threshold may be determined by a user of the electrosurgical system. In some other aspects, the threshold may be based on a plurality of data collected by an electrosurgical system or a hub system of which the electrosurgical system is a part. In some aspects, the threshold may be based on one or more mathematical models, physiological models (such as animal models), or based on data acquired during the performance of an electrosurgical procedure on a patient.

In some further aspects, the intelligent electrosurgical device may include processor-readable instructions within the memory component that, when executed by the processor, may cause a processor associated with the control unit to combine the stimulation signal with the therapy signal. Such instructions may include, but are not limited to: determining the type of stimulation signal (e.g., amplitude, duration, and waveform); determining a type of signal combination (e.g., an alternating, amplitude modulation, DC offset, or other type of combination); determining the timing of the signal combination (i.e., when the therapy signal and the stimulation signal are combined, e.g., periodically, randomly, or at a single time during the therapeutic activity); or determining the type of signal transformation of the stimulation signal prior to combining with the therapy signal.

In some aspects, the intelligent electrosurgical device may include processor-readable instructions stored within the memory component that, when executed by the processor, may cause the processor within the control unit to cause the active monopolar electrode to emit the therapy signal, the combined therapy signal and stimulation signal, or the stimulation signal when in contact with the tissue of the patient. In some aspects, the intelligent electrosurgical device may include processor-readable instructions within the memory component that, when executed by the processor, may cause the processor within the control unit to combine the treatment signal and the stimulation signal to form an electrode emission signal and transmit the emission signal from the active electrode into patient tissue. In some aspects, the intelligent electrosurgical device may include processor-readable instructions within the memory component that, when executed by the processor, may cause the processor within the control unit to receive one or more return signals from the patient, the return signals including a current return emitted from the active monopolar electrode and a current received by the return signal pad. In some aspects, the smart electrosurgical device may include processor-readable instructions within the memory component that, when executed by the processor, may cause the processor within the control unit to receive one or more output signals of one or more sensing devices associated with a return pad in contact with a patient. In some aspects, the smart electrosurgical device may include processor-readable instructions within the memory component that, when executed by the processor, may cause the processor within the control unit to analyze one or more output signals received from one or more sensing devices associated with a return pad in contact with a patient.

In some aspects, the intelligent electrosurgical device may include processor-readable instructions within the memory component that, when executed by the processor, may cause the processor within the control unit to determine that the excitable tissue has been stimulated by the stimulation signal. In some examples, the one or more sensing devices may include an accelerometer associated with the return pad. In one non-limiting example, the output of the accelerometer may reflect the movement of a muscle in contact therewith, which is activated by the stimulation signal. The amount of muscle movement may be caused, at least in part, by the amount of stimulation current received by muscle tissue or nerves energizing the muscle. Because tissue may act as a resistive element that stimulates signal propagation, the amount of muscle activation may be indicative of the distance of the active electrode from the muscle or energy nerve.

In some aspects, the patient may rest on the return pad in a supine position, and the sensor output of the return pad (such as one or more accelerometers) may indicate the amount of muscle movement of the patient's back muscles in contact with the return pad. In an alternative aspect, the return pad can be placed on a muscle or muscle group proximal to the surgical site location, wherein the electrosurgical device can be operated. In some examples, the return pad may be placed on a portion of a superficial abdominal muscle (such as the rectus abdominis) used for abdominal surgery. In some examples, a return pad may be placed on a lateral portion of the abdomen to monitor stimulation of the external oblique or anterior serratus muscles.

In some aspects, the smart electrosurgical device may include processor-readable instructions within the memory component that, when executed by the processor, may cause the processor within the control unit to calculate or determine a distance of the excitable tissue from the distal end of the active electrode based, at least in part, on a return signal or one or more output signals from one or more sensing devices associated with a return pad in contact with the patient. In some aspects, the intelligent electrosurgical device may include processor-readable instructions within the memory component that, when executed by the processor, may cause the processor within the control unit to adjust one or more of the amplitude, frequency, and phase of the treatment signal based at least in part on the distance of the excitable tissue from the distal end of the active electrode. In some aspects, the amplitude, frequency, and/or phase of the therapeutic signal may be adjusted when the excitable tissue is less than a first predetermined value from the active electrode. In some aspects, adjusting the amplitude, frequency, or phase of the treatment signal may cause the electrosurgical system to not emit the treatment signal when the excitable tissue is less than the second predetermined value from the active electrode.

In some further aspects, the active electrode of a surgical probe of an electrosurgical device may be applied only to tissue to determine the distance of excitable tissue from the active electrode. In such applications, a medical professional using the device may operate the device in the stimulation mode only, without applying a therapeutic signal to the active electrode. In the stimulation mode, a user of the device may operate one or more controls configured to tilt characteristics of the stimulation signal to determine conditions under which the excitable tissue is stimulated. For example, a user may operate a control configured to ramp the voltage or current amplitude of the stimulation signal from a low value to a high value. Upon receiving a signal from a sensor (e.g., an accelerometer that senses muscle movement), the electrosurgical device may then calculate an approximate distance from the active electrode to the excitable tissue based, at least in part, on the amplitude of the stimulation signal. In another example, a user may operate a control configured to ramp the frequency of the stimulation signal from a low value to a high value. Upon receiving a signal from a sensor (e.g., an accelerometer that senses muscle movement), the electrosurgical device may then calculate an approximate distance from the active electrode to the excitable tissue based, at least in part, on the frequency of the stimulation signal.

In some aspects, an electrosurgical device or an intelligent electrosurgical device may be incorporated into a surgical hub system. The hub system may incorporate a plurality of handheld medical devices, robotic medical devices, image acquisition devices, image display devices, communication devices, processing devices, networking devices, and other electronic devices that may operate in a coordinated and coordinated manner. In some aspects, the hub may include such devices located within a single surgical suite, within multiple surgical suites, or within any number of computer server locations. The computer memory modules, instructions, and processors disclosed above in the context of control of an intelligent, self-contained electrosurgical device may be suitably distributed among any of the components of the surgical hub system.

In some aspects, additional information that may be collected by components of the surgical hub system may be used to improve operation of the intelligent electrosurgical device. For example, a camera and imaging system directed at the surgical site may provide imaging information that may be used to determine the position of the distal end of the active electrode relative to tissue in the surgical site. The image-based location of the distal end of the active electrode can be used with the return pad sensor output to refine the distance between the active electrode and any excitable tissue within the patient. In some alternative examples, the hub system may include data including anatomical models relating to the location of nerve and muscle tissue. Such model information may also be used with image-based positioning of the active electrode and return pad sensor output to better determine the proximity of the active electrode to known excitable tissue.

While the functions and devices disclosed above may relate only to electrosurgical devices, it will be appreciated that such functions and devices may also be incorporated into multi-mode surgical devices that include functions associated with electrosurgical devices. For example, the multi-mode surgical device may incorporate features associated with the electrosurgical device along with features associated with the ultrasonic surgical device. In addition to the functions disclosed above with respect to altering the properties of the electrosurgical treatment signal, the multi-mode device may also include other functions. For example, the surgical device may use RF energy or ultrasound to achieve a therapeutic effect, such as cutting tissue. In such multi-mode devices, RF energy may initially be applied to the tissue for cutting material, but the multi-mode device may be configured to switch to the ultrasonic mode if the end effector of the multi-mode device is determined to be too close to excitable tissue.

Situation awareness

Referring now to fig. 38, a timeline 5200 depicting situational awareness of a hub (e.g., surgical hub 106 or 206) is shown. The time axis 5200 is illustrative of the surgical procedure and background information that the

surgical hub

106, 206 may derive from the data received from the data source at each step in the surgical procedure. The time axis 5200 depicts typical steps that nurses, surgeons, and other medical personnel will take during a lung segment resection procedure, starting from the establishment of an operating room and ending with the transfer of the patient to a post-operative recovery room.

The situation aware

surgical hub

106, 206 receives data from data sources throughout the surgical procedure, including data generated each time medical personnel utilize a modular device paired with the

surgical hub

106, 206. The

surgical hub

106, 206 may receive this data from the paired modular devices and other data sources, and continually derive inferences about the procedure being performed (i.e., background information) as new data is received, such as which step of the procedure is performed at any given time. The situational awareness system of the

surgical hub

106, 206 can, for example, record data related to the procedure used to generate the report, verify that the medical personnel are taking steps, provide data or prompts that may be related to particular procedure steps (e.g., via a display screen), adjust the modular device based on context (e.g., activate a monitor, adjust a field of view (FOV) of a medical imaging device, or change an energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such actions described above.

As a first step 5202 in this exemplary procedure, the hospital staff retrieves the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the

surgical hub

106, 206 determines that the procedure to be performed is a chest procedure.

In a second step 5204, the staff scans the incoming medical supplies for the procedure. The

surgical hub

106, 206 cross-references the scanned supplies with a list of supplies used in various types of procedures and confirms that the supplied mix corresponds to a chest procedure. In addition, the

surgical hub

106, 206 may also be able to determine that the procedure is not a wedge procedure (because the incoming supplies lack some of the supplies required for a chest wedge procedure, or otherwise do not correspond to a chest wedge procedure).

In a third step 5206, medical personnel scan the patient belt via a scanner communicatively coupled to the

surgical hub hubs

106, 206. The

surgical hub

106, 206 may then confirm the identity of the patient based on the scanned data.

Fourth, the medical staff opens the ancillary equipment 5208. The ancillary equipment utilized may vary depending on the type of surgery and the technique to be used by the surgeon, but in this exemplary case they include smoke ejectors, insufflators, and medical imaging devices. When activated, the auxiliary device as a modular device may be automatically paired with a

surgical hub

106, 206 located in a specific vicinity of the modular device as part of its initialization process. The

surgical hub

106, 206 may then derive contextual information about the surgical procedure by detecting the type of modular device with which it is paired during the pre-operative or initialization phase. In this particular example, the

surgical hub

106, 206 determines that the surgical procedure is a VATS procedure based on the particular combination of paired modular devices. Based on a combination of data from the patient's EMR, a 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 particular procedure that the surgical team will perform. Once the

surgical hub

106, 206 knows what specific procedure is being performed, the

surgical hub

106, 206 may retrieve the steps of the procedure from memory or cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular devices and patient monitoring devices) to infer what steps of the surgical procedure are being performed by the surgical team.

In a fifth step 5210, the staff member attaches EKG electrodes and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with the

surgical hubs

106, 206. When the

surgical hub

106, 206 begins to receive data from the patient monitoring device, the

surgical hub

106, 206 thus confirms that the patient is in the operating room.

Sixth step 5212, the medical personnel induce anesthesia in the patient. The

surgical hub

106, 206 may infer that the patient is under anesthesia based on data from the modular device and/or the patient monitoring device, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Upon completion of the sixth step 5212, the pre-operative portion of the lung segmentation resection procedure is completed and the operative portion begins.

In a seventh step 5214, the patient's lungs being operated on are collapsed (while ventilation is switched to the contralateral lungs). For example, the

surgical hub

106, 206 may infer from the ventilator data that the patient's lungs have collapsed. The

surgical hub

106, 206 may infer that the surgical portion of the procedure has begun because it may compare the detection of the patient's lung collapse to the expected steps of the procedure (which may have been previously visited or retrieved) to determine that collapsing the lung is the surgical step in that particular procedure.

In an eighth step 5216, a medical imaging device (e.g., an endoscope) is inserted and video from the medical imaging device is initiated. The

surgical hub

106, 206 receives medical imaging device data (i.e., video or image data) through its connection to the medical imaging device. After receiving the medical imaging device data, the

surgical hub

106, 206 may determine that a laparoscopic portion of the surgical procedure has begun. In addition, the

surgical hub

106, 206 may determine that the particular procedure being performed is a segmental resection, rather than a leaf resection (note that wedge procedures have been excluded based on the data received by the

surgical hub

106, 206 at the second step 5204 of the procedure). Data from the medical imaging device 124 (fig. 2) may be used to determine contextual information relating to the type of procedure being performed in a number of different ways, including by determining the angle of visualization orientation of the medical imaging device relative to the patient anatomy, monitoring the number of medical imaging devices utilized (i.e., activated and paired with the surgical hub 106, 206), and monitoring the type of visualization devices utilized. For example, one technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's chest above the septum, while one technique for performing a VATS segmental resection places the camera in an anterior intercostal location relative to the segmental cleft. For example, using pattern recognition or machine learning techniques, the situational awareness system may be trained to recognize the positioning of the medical imaging device from a visualization of the patient's anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmental resection utilizes multiple cameras. As another example, one technique for performing a VATS segmental resection utilizes an infrared light source (which may be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental fissures that are not used in a VATS pulmonary resection. By tracking any or all of this data from the medical imaging device, the

surgical hub

106, 206 can thus determine the particular type of surgical procedure being performed and/or the technique being used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step of the procedure. The

surgical hub

106, 206 may infer that the surgeon is dissecting to mobilize the patient's lungs because it receives data from the RF generator or ultrasound generator indicating that the energy instrument is being fired. The

surgical hub

106, 206 may intersect the received data with the retrieved steps of the surgical procedure to determine that the energy instrument fired at that point in the procedure (i.e., after completion of the previously discussed surgical steps) corresponds to an anatomical step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of a robotic surgical system.

In a tenth step 5220, the surgical team continues with the surgical ligation step. The

surgical hub

106, 206 may infer that the surgeon is ligating arteries and veins because it receives data from the surgical stapling and severing instrument indicating that the instrument is being fired. Similar to the previous steps, the

surgical hub

106, 206 may deduce the inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the retrieval steps in the procedure. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, a segmental resection portion of the procedure is performed. The

surgical hub

106, 206 may infer that the surgeon is transecting soft tissue based on data from the surgical stapling and severing instrument, including data from its cartridge. The cartridge data may correspond to, for example, the size or type of staples fired by the instrument. Since different types of staples are used for different types of tissue, the cartridge data can indicate the type of tissue being stapled and/or transected. In this case, the type of staple fired is for soft tissue (or other similar tissue type), which allows the

surgical hub

106, 206 to infer that the segmental resection portion of the procedure is in progress.

In a twelfth step 5224, a node dissection step is performed. The

surgical hub

106, 206 may infer that the surgical team is dissecting a node and performing a leak test based on data received from the generator indicating that the RF or ultrasonic instrument is being fired. For this particular procedure, the RF or ultrasound instruments used after transecting the soft tissue correspond to a nodal dissection step that allows the

surgical hub

106, 206 to make such inferences. It should be noted that the surgeon periodically switches back and forth between the surgical stapling/severing instrument and the surgical energy (i.e., RF or ultrasonic) instrument depending on the particular step in the procedure, as different instruments are better suited to the particular task. Thus, the particular sequence in which the stapling/severing instrument and the surgical energy instrument are used may dictate the steps of the procedure being performed by the surgeon. Further, in some cases, robotic implements may be used for one or more steps in a surgical procedure, and/or hand-held surgical instruments may be used for one or more steps in a surgical procedure. The surgeon(s) may alternate and/or may use the device simultaneously, for example, between a robotic tool and a hand-held surgical instrument. Upon completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure is initiated.

A thirteenth step 5226, reverse the patient's anesthesia. For example, the

surgical hub

106, 206 may infer that the patient is waking up from anesthesia based on, for example, ventilator data (i.e., the patient's breathing rate begins to increase).

Finally, a fourteenth step 5228 is for the medical personnel to remove various patient monitoring devices from the patient. Thus, when the hub loses EKG, BP, and other data from the patient monitoring device, the

surgical hub

106, 206 may infer that the patient is being transferred to a recovery room. As can be seen from the description of this exemplary procedure, the

surgical hub

106, 206 may determine or infer when each step of a given surgical procedure occurs from data received from various data sources communicatively coupled to the

surgical hub

106, 206.

Situational awareness is further described in U.S. provisional patent application serial No. 62/611,341 entitled "INTERACTIVE SURGICAL PLATFORM," filed on 28.12.2017, which is incorporated herein by reference in its entirety. In certain instances, operation of the robotic surgical system (including the various robotic surgical systems disclosed herein) may be controlled by the

hub

106, 206 based on its situational awareness and/or feedback from its devices and/or based on information from the cloud 102.

While several forms have been illustrated and described, it is not the intention of the applicants to restrict or limit the scope of the appended claims to such detail. Numerous modifications, changes, variations, substitutions, combinations, and equivalents of these forms can be made without departing from the scope of the present disclosure, and will occur to those skilled in the art. Further, the structure of each element associated with the described forms may alternatively be described as a means for providing the function performed by the element. In addition, where materials for certain components are disclosed, other materials may also be used. It is, therefore, to be understood that the foregoing detailed description and appended claims are intended to cover all such modifications, combinations and variations as fall within the scope of the disclosed forms of the invention. It is intended that the following claims cover all such modifications, changes, variations, substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of the devices and/or methods via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein, in whole or in part, can be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the electronic circuitry and/or writing the code for the software and or hardware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as one or more program products in a variety of forms, and that an exemplary form of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution.

Instructions for programming logic to perform the various disclosed aspects may be stored within a memory within a system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Further, the instructions may be distributed via a network or by other computer readable media. Thus, a machine-readable medium may include a mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, read-only memories (CD-ROMs), magneto-optical disks, read-only memories (ROMs), Random Access Memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memory, or a tangible, machine-readable storage device for use in transmitting information over the internet via electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

As used in any aspect herein, the term "control circuitry" can refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor that includes one or more separate instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Programmable Logic Arrays (PLAs), Field Programmable Gate Arrays (FPGAs)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry that forms part of a larger system, e.g., an Integrated Circuit (IC), an Application Specific Integrated Circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that implements, at least in part, the methods and/or apparatus described herein, or a microprocessor configured by a computer program that implements, at least in part, the methods and/or apparatus described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion, or some combination thereof.

As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to perform any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction sets, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) in a memory device.

As used in any aspect herein, the terms "device," "system," "module," and the like can refer to a computer-related entity, either hardware, a combination of hardware and software, or software in execution.

An "algorithm," as used in any aspect herein, is a self-consistent sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states which may (but are not necessarily) take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. And are used to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or conditions.

The network may comprise a packet switched network. The communication devices may be capable of communicating with each other using the selected packet switched network communication protocol. One exemplary communication protocol may include an ethernet communication protocol that may allow communication using the transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with the ethernet standard entitled "IEEE 802.3 standard" promulgated by the Institute of Electrical and Electronics Engineers (IEEE) at 12 months 2008 and/or higher versions of this standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an x.25 communication protocol. The x.25 communication protocol may conform to or conform to standards promulgated by the international telecommunication union, telecommunication standardization sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or conform to standards promulgated by the international committee for telephone and telephone negotiations (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard entitled "ATM-MPLS network interworking 2.0" promulgated by the ATM forum at 8 months 2001 and/or higher versions of that standard. Of course, different and/or later-developed connection-oriented network communication protocols are also contemplated herein.

Unless specifically stated otherwise as apparent from the above discussion, it is appreciated that throughout the above disclosure, discussions utilizing terms such as "processing," "computing," "calculating," "determining," "displaying" or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

One or more components may be referred to herein as "configured," "configurable," "operable," "adaptable," "capable," "conformable," "conforming," or the like. Those skilled in the art will recognize that "configured to" may generally encompass components in an active state and/or components in an inactive state and/or components in a standby state unless the context indicates otherwise.

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

Those skilled in the art will recognize that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claims. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); this also applies to the use of definite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Further, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such a construction is intended to have a meaning that one of ordinary skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include, but not be limited to, systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such a construction is intended to have a meaning that one of skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" would include but not be limited to systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). It will also be understood by those within the art that, in general, disjunctive words and/or phrases having two or more alternative terms, whether appearing in the detailed description, claims, or drawings, should be understood to encompass the possibility of including one of the terms, either of the terms, or both terms, unless the context indicates otherwise. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".

Those skilled in the art will appreciate from the appended claims that the operations recited therein may generally be performed in any order. In addition, while the various operational flow diagrams are listed in sequence(s), it should be understood that the various operations may be performed in other sequences than the illustrated sequences, or may be performed concurrently. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, complementary, simultaneous, reverse, or other altered orderings, unless context dictates otherwise. Furthermore, unless the context dictates otherwise, terms like "responsive," "related," or other past adjectives are generally not intended to exclude such variations.

It is worthy to note that any reference to "an aspect," "an example" means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, the appearances of the phrases "in one aspect," "in an example" in various places throughout this specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.

Any patent applications, patents, non-patent publications or other published materials mentioned in this specification and/or listed in any application data sheet are herein incorporated by reference, to the extent that the incorporated materials are not inconsistent herewith. Thus, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

In summary, a number of benefits resulting from employing the concepts described herein have been described. The foregoing detailed description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The form or forms selected and described are to be illustrative of the principles and practical applications to thereby enable one of ordinary skill in the art to utilize the form or forms and various modifications as are suited to the particular use contemplated. The claims as filed herewith are intended to define the full scope.

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

Embodiment 1. an electrosurgical device, comprising: a controller including a generator; a surgical probe comprising a distal active electrode, wherein the active electrode is in electrical communication with a power terminal of the generator; and a return pad in electrical communication with an electrical return terminal of the generator, wherein the generator is configured to supply current from the power supply terminal, and wherein the current supplied by the generator combines characteristics of the therapeutic electrical signal and characteristics of the excitable tissue stimulation signal.

Embodiment 2. the electrosurgical device of embodiment 1, wherein the therapeutic electrical signal is a radio frequency signal having a frequency greater than 200kHz and less than 5 MHz.

Embodiment 3 the electrosurgical device of any one or more of embodiments 1-2, wherein the excitable-tissue-stimulating signal is an AC signal having a frequency of less than 200 kHz.

Embodiment 4 the electrosurgical device of any one or more of embodiments 1-3, wherein the electrical current supplied by the generator includes at least one alternating therapeutic electrical signal and at least one alternating excitable tissue stimulation signal.

Embodiment 5 the electrosurgical device of any one or more of embodiments 1-4, wherein the electrical current supplied by the generator has a therapeutic electrical signal amplitude modulated by the excitable tissue stimulation signal.

Embodiment 6 the electrosurgical device of any one or more of embodiments 1-5, wherein the electrical current supplied by the generator comprises a therapeutic electrical signal dc-offset from the excitable-tissue stimulation signal.

Embodiment 7 the electrosurgical device of any one or more of embodiments 1-6, wherein the return pad further comprises at least one sensing device having a sensing device output, and the sensing device is configured to determine stimulation of the excitable tissue by the excitable tissue stimulation signal.

Embodiment 8 the electrosurgical device of embodiment 7, wherein the controller is configured to receive the sensing device output.

Example 9 the electrosurgical device of example 8, wherein the controller comprises a processor and at least one memory component in data communication with the processor, and wherein the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to determine the distance of the active electrode from the excitable tissue based, at least in part, on the sensor output received by the controller.

Example 10 the electrosurgical device of example 9, wherein the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to change a value of at least one characteristic of the therapeutic electrical signal when the active electrode is less than a predetermined distance from the excitable tissue.

Embodiment 11 an electrosurgical system, comprising: a processor; and a memory coupled to the processor, the memory configured to store instructions executable by the processor to: causing the generator to combine one or more characteristics of the therapy signal with one or more characteristics of the excitable-tissue stimulation signal to form a combined signal; causing the generator to transmit the combined signal into tissue of a patient through an active electrode in physical contact with the patient; and receiving a sensing device output signal from a sensing device disposed within a return pad in physical contact with the patient.

Embodiment 12 the electrosurgical system of embodiment 11, wherein the memory is configured to further store instructions executable by the processor to: determining a distance from the active electrode to the excitable tissue based, at least in part, on the sensing device output signal.

Embodiment 13 the electrosurgical system of embodiment 12, wherein the memory is configured to further store instructions executable by the processor to: causing the controller to change one or more characteristics of the treatment signal when the distance from the active electrode to the excitable tissue is less than a predetermined value.

Embodiment 14 the electrosurgical system of any one or more of embodiments 11-13, wherein the instructions executable by the processor to cause the generator to combine one or more characteristics of the treatment signal with one or more characteristics of the excitable tissue stimulation signal to form a combined signal include instructions executable by the processor to cause the generator to alternate the treatment signal and the excitable tissue stimulation signal.

Embodiment 15 the electrosurgical system of any one or more of embodiments 11-14, wherein the instructions executable by the processor to cause the generator to combine one or more characteristics of the therapeutic signal with one or more characteristics of the excitable tissue stimulation signal to form a combined signal include instructions executable by the processor to cause the generator to modulate an amplitude of the therapeutic signal with an amplitude of the excitable tissue stimulation signal.

Embodiment 16 the electrosurgical system of any one or more of embodiments 11-15, wherein the instructions executable by the processor to cause the generator to combine the one or more characteristics of the treatment signal with the one or more characteristics of the excitable tissue stimulation signal to form the combined signal include instructions executable by the processor to cause the generator to offset a DC value of the treatment signal by an amplitude of the excitable tissue stimulation signal.

Embodiment 17 an electrosurgical system, comprising: a control circuit configured to be capable of: controlling an electrical output of the generator, wherein the electrical output includes one or more characteristics of the therapeutic signal and one or more characteristics of the excitable-tissue stimulation signal; receiving a sensing device signal from at least one sensing device configured to measure an activity of excitable tissue of a patient; determining a distance between a location of an active electrode and a location of the at least one sensing device, the active electrode configured to transmit the electrical output of the generator into patient tissue; and altering the electrical output of the generator with at least one characteristic of the therapy signal when a distance between a location of the active electrode configured to transmit the electrical output of the generator into the patient tissue and a location of the at least one sensing device is less than a predetermined value.

Example 18 the electrosurgical system of example 17, wherein the control circuitry configured to change the electrical output of the generator with the at least one characteristic of the treatment signal when a distance between a location of the active electrode configured to transmit the electrical output of the generator into the patient tissue and a location of the at least one sensing device is less than a predetermined value comprises the control circuitry configured to minimize the at least one characteristic of the treatment signal.

An embodiment 19. a non-transitory computer readable medium storing computer readable instructions that, when executed, cause a machine to: controlling an electrical output of the generator, wherein the electrical output includes one or more characteristics of the therapeutic signal and one or more characteristics of the excitable-tissue stimulation signal; receiving a sensing device signal from at least one sensing device configured to measure an activity of excitable tissue of a patient; determining a distance between a location of an active electrode and a location of the at least one sensing device, the active electrode configured to transmit the electrical output of the generator into patient tissue; and altering the electrical output of the generator with at least one characteristic of the therapy signal when a distance between a location of the active electrode configured to transmit the electrical output of the generator into the patient tissue and a location of the at least one sensing device is less than a predetermined value.

Claims

1. An electrosurgical device, the electrosurgical device comprising:

a controller including a generator;

a surgical probe comprising a distal active electrode, wherein the active electrode is in electrical communication with a power terminal of the generator; and

a return pad in electrical communication with an electrical return terminal of the generator,

wherein the generator is configured to be able to supply current from the power supply terminal, and

wherein the current supplied by the generator combines characteristics of a therapeutic electrical signal and characteristics of an excitable-tissue stimulation signal.

2. The electrosurgical device of claim 1, wherein the therapeutic electrical signal is a radio frequency signal having a frequency greater than 200kHz and less than 5 MHz.

3. The electrosurgical device of claim 1, wherein the excitable-tissue-stimulating signal is an AC signal having a frequency of less than 200 kHz.

4. The electrosurgical device of claim 1, wherein the electrical current supplied by the generator comprises at least one alternating therapeutic electrical signal and at least one alternating excitable-tissue stimulation signal.

5. The electrosurgical device of claim 1, wherein the electrical current supplied by the generator has a therapeutic electrical signal amplitude modulated by the excitable-tissue stimulation signal.

6. The electrosurgical device of claim 1, wherein the current supplied by the generator comprises a therapeutic electrical signal dc-offset by the excitable-tissue stimulation signal.

7. The electrosurgical device of claim 1, wherein the return pad further comprises at least one sensing device having a sensing device output, and the sensing device is configured to determine stimulation of excitable tissue by the excitable tissue stimulation signal.

8. The electrosurgical device of claim 7, wherein the controller is configured to receive the sensing device output.

9. The electrosurgical device of claim 8, wherein the controller comprises a processor and at least one memory component in data communication with the processor, and wherein the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to determine the distance of the active electrode from excitable tissue based, at least in part, on sensor output received by the controller.

10. The electrosurgical device of claim 9, wherein the at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to change a value of at least one characteristic of the therapeutic electrical signal when the active electrode is less than a predetermined value away from excitable tissue.

11. An electrosurgical system, the electrosurgical system comprising:

a processor; and

a memory coupled to the processor, the memory configured to store instructions executable by the processor to:

causing the generator to combine one or more characteristics of the therapy signal with one or more characteristics of the excitable-tissue stimulation signal to form a combined signal;

causing the generator to transmit the combined signal into tissue of a patient through an active electrode in physical contact with the patient; and

receiving a sensing device output signal from a sensing device disposed within a return pad in physical contact with the patient.

12. The electrosurgical system of claim 11, wherein the memory is configured to further store instructions executable by the processor to:

determining a distance from the active electrode to excitable tissue based, at least in part, on the sensing device output signal.

13. The electrosurgical system of claim 12, wherein the memory is configured to further store instructions executable by the processor to:

causing a controller to change one or more characteristics of the therapy signal when the distance from the active electrode to the excitable tissue is less than a predetermined value.

14. The electrosurgical system of claim 11, wherein the instructions executable by the processor to cause a generator to combine one or more characteristics of a therapeutic signal with one or more characteristics of an excitable tissue stimulation signal to form a combined signal comprise instructions executable by the processor to cause the generator to alternate the therapeutic signal and the excitable tissue stimulation signal.

15. The electrosurgical system of claim 11, wherein the instructions executable by the processor to cause a generator to combine one or more characteristics of a therapeutic signal with one or more characteristics of an excitable-tissue stimulation signal to form a combined signal comprise instructions executable by the processor to cause the generator to modulate an amplitude of the therapeutic signal with an amplitude of the excitable-tissue stimulation signal.

16. The electrosurgical system of claim 11, wherein the instructions executable by the processor to cause a generator to combine one or more characteristics of a therapeutic signal with one or more characteristics of an excitable tissue stimulation signal to form a combined signal comprise instructions executable by the processor to cause the generator to offset a DC value of the therapeutic signal by an amplitude of the excitable tissue stimulation signal.

17. An electrosurgical system, the electrosurgical system comprising:

a control circuit configured to be capable of:

controlling an electrical output of the generator, wherein the electrical output comprises one or more characteristics of the therapeutic signal and one or more characteristics of the excitable-tissue stimulation signal;

receiving a sensing device signal from at least one sensing device configured to measure an activity of excitable tissue of a patient;

determining a distance between a location of an active electrode and a location of the at least one sensing device, the active electrode configured to transmit the electrical output of the generator into patient tissue; and

changing the electrical output of the generator with at least one characteristic of the therapy signal when the distance between the position of the active electrode configured to transmit the electrical output of the generator into the patient tissue and the position of the at least one sensing device is less than a predetermined value.

18. The electrosurgical system of claim 17, wherein the control circuitry configured to change the electrical output of the generator with at least one characteristic of the therapy signal when the distance between the location of the active electrode configured to transmit the electrical output of the generator into the patient tissue and the location of the at least one sensing device is less than a predetermined value comprises control circuitry configured to minimize the at least one characteristic of the therapy signal.

19. A non-transitory computer readable medium storing computer readable instructions that, when executed, cause a machine to: