JP7783320B2 - Radiofrequency energy device for delivering composite electrical signals - Patent Application 20070122997 - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. Provisional Patent Application No. 16/115,233, filed August 28, 2018, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS," the entire disclosure of which is incorporated herein by reference.

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

This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/721,998, filed August 23, 2018, entitled "Situational Awareness of Electrical Systems," the entire disclosure of which is incorporated herein by reference.

This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/721,999, filed August 23, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIIVE COUPLING," the entire disclosure of which is incorporated herein by reference.

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

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

This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/692,747, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE," filed June 30, 2018; U.S. Provisional Patent Application No. 62/692,748, entitled "SMART ENERGY ARCHITECTURE," filed June 30, 2018; and U.S. Provisional Patent Application No. 62/692,768, entitled "SMART ENERGY DEVICES," filed June 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.

This application further claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," and U.S. Provisional Patent Application No. 62/640,415, filed March 8, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR," the disclosures of each of which are incorporated herein by reference in their entirety.

This application further discloses, under 35 U.S.C. § 119(e), U.S. Provisional Patent Application No. 62/650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," and U.S. Provisional Patent Application No. 62/650,887, filed March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," the disclosures of each of which are incorporated herein by reference in their entirety. This application claims the benefit of priority to U.S. Provisional Patent Application No. 62/650,882, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS," and U.S. Provisional Patent Application No. 62/650,877, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS."

This application further claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017; U.S. Provisional Patent Application No. 62/611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017; and U.S. Provisional Patent Application No. 62/611,339, entitled "ROBOT-ASSISTED SURGICAL PLATFORM," filed December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety.

In some surgical procedures, medical professionals may use electrosurgical devices to seal or cut tissue, such as blood vessels. Such devices perform medical treatment by passing electrical energy, such as radio frequency (RF) current, through the tissue being treated. Some electrosurgical devices are referred to as bipolar devices because both the electrode that generates the electrical energy (the active electrode) and the return electrode are housed within the same surgical probe. Electrosurgical devices may include a generator for generating and delivering electrical energy to the active electrode within the surgical probe. A return electrode within the surgical probe may receive the current flowing through the patient's tissue and provide an electrical return path for the generator. Such bipolar devices can provide a short current path through the patient's tissue, allowing medical professionals to easily determine the tissue that can receive electrical energy from the electrosurgical device.

Alternative devices include those referred to as monopolar devices. In such devices, only the active electrode is contained within the surgical probe. Current entering the patient's tissue may return to the electrical energy generator via an electrical pathway through a gurney on which the patient lies or through a specific return electrode pad. In some variations, the patient may lie on the electrode pad. Alternatively, the electrode pad may be positioned on the patient near the surgical site where the surgical probe is deployed. The current path through a patient undergoing treatment using a monopolar device may be less easily identified than the current path through a patient undergoing treatment using a bipolar device. As a result, with monopolar electrosurgical devices, some non-target tissue may be unintentionally cauterized, cut, or otherwise damaged. Such non-target tissue may include electrically excitable tissue, including, but not limited to, nerve ganglia, sensory nerve tissue, motor nerve tissue, and muscle tissue. Such unintentional damage to excitable tissue may result in muscle weakness, pain, paralysis, and/or other undesirable conditions in the patient.

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

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

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

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

In one aspect of the electrosurgical device, the current delivered by the electrical generator includes a therapeutic electrical signal amplitude modulated by an excitatory tissue stimulation signal.

In one aspect of the electrosurgical device, the current delivered by the electrical generator includes a therapeutic electrical signal DC offset by an excitatory tissue stimulation signal.

In one aspect of the electrosurgical device, the return pad further includes at least one sensing device having a sensing device output, the sensing device configured to determine stimulation of 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, the at least one memory component storing 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, at least one memory component stores one or more instructions that, when executed by the processor, cause the processor to change the value of at least one characteristic of the therapeutic electrical signal when the distance of the active electrode from the excitable tissue is less than a predetermined value.

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

In one aspect of the electrosurgical system, the memory is further configured to store instructions executable by the processor, the instructions being 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 further configured to store instructions executable by the processor, the instructions being executable by the processor to cause the controller to modify one or more characteristics of the therapeutic signal when the 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 electrical 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 electrical generator to alternate between the therapeutic signal and the excitable tissue stimulation signal.

In one aspect of the electrosurgical system, the instructions executable by the processor to cause the electrical 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 electrical generator to modulate the amplitude of the therapeutic signal by the amplitude of the excitable tissue stimulation signal.

In one aspect of the electrosurgical system, the instructions executable by the processor to cause the electrical 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 electrical generator to offset a DC value of the therapeutic signal by the amplitude of the excitable tissue stimulation signal.

In one aspect, the electrosurgical system includes a control circuit configured to control the electrical output of the electrical generator, including one or more characteristics of the therapeutic signal and one or more characteristics of the excitable tissue stimulation signal; receive a sensing device signal from at least one sensing device configured to measure activity of the patient's excitable tissue; determine a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into the patient tissue and a location of the at least one sensing device; and modify the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the location of the active electrode configured to transmit the electrical output of the electrical 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 circuit configured to modify the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the location of the active electrode configured to transmit the electrical output of the electrical generator into patient tissue and the location of the at least one sensing device is less than a predetermined value includes a control circuit configured to minimize at least one characteristic of the therapeutic signal.

In one aspect, a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to control the electrical output of an electrical generator, including one or more characteristics of a therapeutic signal and one or more characteristics of an excitable tissue stimulation signal; receive a sensing device signal from at least one sensing device configured to measure activity of excitable tissue in a patient; determine a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into the patient tissue and a location of the at least one sensing device; and modify the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the location of the active electrode configured to transmit the electrical output of the electrical generator into the patient tissue and a location of the at least one sensing device is less than a predetermined value.

While the features of the various aspects are set forth with particularity in the appended claims, the various aspects, both as to organization and method of operation, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings in which:
FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. 1 is a surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. FIG. 12 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing, in accordance with at least one aspect of the present disclosure. FIG. 1 is a perspective view of a combination generator module including bipolar, ultrasonic, and monopolar contacts and smoke evacuation components in accordance with at least one aspect of the present disclosure. 1 illustrates a surgical data network comprising a modular communications hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped with specialized facilities for surgical procedures, to a cloud, in accordance with at least one aspect of the present disclosure. 1 illustrates a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure. 1 illustrates a surgical hub comprising multiple modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure. 1 illustrates one aspect of a Universal Serial Bus (USB) network hub device in accordance with at least one aspect of the present disclosure. 1 illustrates a control circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 is a system configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communications hub in accordance with at least one aspect of the present disclosure. 1 illustrates an example of a generator in accordance with at least one aspect of the present disclosure. In accordance with at least one aspect of the present disclosure, a surgical system includes a generator and various surgical instruments usable with the generator. FIG. 16 is a diagram of the surgical system of FIG. 15 in accordance with at least one aspect of the present disclosure. FIG. 1 is a structural diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 1 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 1 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 1 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. 1 illustrates structural and functional aspects of a generator according to at least one aspect of the present disclosure. 1 illustrates structural and functional aspects of a generator according to at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of a control circuit according to at least one aspect of the present disclosure. 1 illustrates a generator circuit divided into multiple stages in accordance with at least one aspect of the present disclosure. 1 illustrates a generator circuit divided into multiple stages, where the first stage circuit is common with the second stage circuit, in accordance with at least one aspect of the present disclosure. FIG. 1 is a circuit diagram of one embodiment of a drive circuit configured to drive radio frequency (RF) current, in accordance with at least one embodiment of the present disclosure. FIG. 16 is a circuit 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. 1 is a circuit diagram of a circuit with separate power supplies for a high-power energy/drive circuit and a low-power circuit, in accordance with at least one aspect of the present disclosure. 1 illustrates a control circuit that enables a dual generator system to switch between RF generator energy modalities and ultrasonic generator energy modalities for a surgical instrument according to at least one aspect of the present disclosure. 1 illustrates one aspect of a basic architecture of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms for an electrical signal waveform for use in a surgical instrument, in accordance with at least one aspect of the present disclosure. 1 illustrates one aspect of a direct digital synthesis (DDS) circuit configured to generate a plurality of waveforms of an electrical signal waveform for use in a surgical instrument, in accordance with at least one aspect of the present disclosure. 1 illustrates one cycle of a discrete-time digital electrical signal waveform (shown superimposed on the discrete-time digital electrical signal waveform for comparison purposes) of an analog waveform according to at least one aspect of the present disclosure. 1 illustrates a surgical procedure using an electrosurgical system according to at least one aspect of the present disclosure. FIG. 31 is a block diagram of the surgical system used in FIG. 30 in accordance with at least one aspect of the present disclosure. 31 illustrates a return pad of the surgical system of FIG. 30 including multiple electrodes, in accordance with at least one aspect of the present disclosure. 32 illustrates an array of sensing devices within the return pad shown in FIG. 31 in accordance with at least one aspect of the present disclosure. 10 graphically illustrates a therapeutic RF signal that may be used in an electrosurgical system in accordance with at least one aspect of the present disclosure. 10 graphically illustrates a nerve stimulation signal that may be incorporated into an electrosurgical system in accordance with at least one aspect of the present disclosure. 36 graphically illustrates a signal used by an electrosurgical system that may incorporate features of both the therapeutic RF signal of FIG. 34 and the neural stimulation signal of FIG. 35 in accordance with at least one aspect of the present disclosure. 36 graphically illustrates a signal used by an electrosurgical system that may incorporate features of both the therapeutic RF signal of FIG. 34 and the neural stimulation signal of FIG. 35 in accordance with at least one aspect of the present disclosure. 36 graphically illustrates a signal used by an electrosurgical system that may incorporate features of both the therapeutic RF signal of FIG. 34 and the neural stimulation signal of FIG. 35 in accordance with at least one aspect of the present disclosure. The manner in which such control of a smart electrosurgical device may be achieved according to at least one aspect of the present disclosure is summarized. 10 is a timeline illustrating situational awareness of a surgical hub, in accordance with at least one aspect of the present disclosure.

The applicant of the present application owns the following U.S. patent applications, filed August 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. Patent Application Serial No. END8536USNP2/180107-2, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";
U.S. Patent Application Serial No. END8560USNP2/180106-2, entitled "TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";
U.S. Patent Application Serial No. END8563USNP1/180139-1, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION";
U.S. Patent Application Serial No. END8563USNP2/180139-2, entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE";
U.S. Patent Application Serial No. END8563USNP3/180139-3, entitled "DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM";
U.S. Patent Application Serial No. END8563USNP4/180139-4, entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT";
U.S. Patent Application Serial No. END8563USNP5/180139-5, entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR";
U.S. Patent Application Serial No. END8564USNP1/180140-1, entitled "Situational Awareness of Electrical Systems";
U.S. Patent Application Serial No. END8564USNP2/180140-2, entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT";
U.S. Patent Application Serial No. END8564USNP3/180140-3, entitled "DETECTION OF END EFFECTOR IMMERSION IN LIQUID";
U.S. Patent Application Serial No. END8565USNP1/180142-1, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIIVE COUPLING";
U.S. Patent Application Serial No. END8565USNP2/180142-2, entitled "Increasing Radio Frequency to Create a Pad-Less Monopolar Loop";
- U.S. Patent Application Serial No. END8566USNP1/180143-1 entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY", and - U.S. Patent Application Serial No. END8573USNP1/180145-1 entitled "ACTIVATION OF ENERGY DEVICES".

The applicant of the present application owns the following U.S. patent applications, filed August 23, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. Provisional Patent Application No. 62/721,995, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION";
U.S. Provisional Patent Application No. 62/721,998, entitled "Situational Awareness of Electrical Systems";
U.S. Provisional Patent Application No. 62/721,999, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIIVE COUPLING";
U.S. Provisional Patent Application No. 62/721,994, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY," and U.S. Provisional Patent Application No. 62/721,996, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS."

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

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

U.S. Patent Application No. 16/024,090, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS";
U.S. Patent Application No. 16/024,057, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";
U.S. Patent Application No. 16/024,067, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION";
U.S. Patent Application No. 16/024,075, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING";
U.S. Patent Application No. 16/024,083, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING";
U.S. Patent Application No. 16/024,094, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES";
U.S. Patent Application No. 16/024,138, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE";
U.S. Patent Application No. 16/024,150, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES";
U.S. Patent Application No. 16/024,160, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY";
U.S. Patent Application No. 16/024,124, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
U.S. Patent Application No. 16/024,132, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT";
U.S. Patent Application No. 16/024,141, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY";
U.S. Patent Application No. 16/024,162, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES";
U.S. Patent Application No. 16/024,066, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
U.S. Patent Application No. 16/024,096, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS";
U.S. Patent Application No. 16/024,116, entitled "SURGICAL EVACUATION FLOW PATHS";
U.S. Patent Application No. 16/024,149, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL";
U.S. Patent Application No. 16/024,180, entitled "SURGICAL EVACUATION SENSING AND DISPLAY";
U.S. Patent Application No. 16/024,245, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM";
U.S. Patent Application No. 16/024,258, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM";
U.S. patent application Ser. No. 16/024,265, entitled "SURGICAL EVACATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACATION 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 application owns the following U.S. provisional patent applications, filed June 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. Provisional Patent Application No. 62/691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES";
U.S. Provisional Patent Application No. 62/691,227, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";
U.S. Provisional Patent Application No. 62/691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
U.S. Provisional Patent Application No. 62/691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
U.S. Provisional Patent Application No. 62/691,257, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM";
U.S. Provisional Patent Application No. 62/691,262, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE," and U.S. Provisional Patent Application No. 62/691,251, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS."

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

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

The applicant of the present application owns the following U.S. patent applications, filed March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. Patent Application No. 15/940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. Patent Application No. 15/940,648, entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES";
U.S. Patent Application No. 15/940,656, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";
U.S. Patent Application No. 15/940,666, entitled "SPATIAL AWARENESS OF SURGICAL HUB IN OPERATING ROOMS";
U.S. Patent Application No. 15/940,670, entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBs";
U.S. Patent Application No. 15/940,677, entitled "SURGICAL HUB CONTROL ARRANGEMENTS";
U.S. Patent Application No. 15/940,632, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
U.S. Patent Application 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 No. 15/940,645, entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
U.S. Patent Application No. 15/940,649, entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
- U.S. Patent Application No. 15/940,654, entitled "SURGICAL HUB SITUATIONAL AWARENESS";
- U.S. Patent Application No. 15/940,663, entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
U.S. Patent Application No. 15/940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
U.S. Patent Application No. 15/940,671, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
U.S. Patent Application No. 15/940,686, entitled "Display of Alignment of Staple Cartridge to Prior Linear Staple Line";
U.S. Patent Application No. 15/940,700, entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
U.S. Patent Application No. 15/940,629, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. Patent Application No. 15/940,704, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
U.S. patent application Ser. No. 15/940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIONITY," and U.S. patent application Ser. No. 15/940,742, entitled "DUAL CMOS ARRAY IMAGING."
U.S. Patent Application No. 15/940,636, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. Patent Application No. 15/940,653, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBs";
U.S. Patent Application No. 15/940,660, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. Patent Application No. 15/940,679, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGE DATA SET";
U.S. Patent Application No. 15/940,694, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION";
U.S. Patent Application No. 15/940,634, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. patent application Ser. No. 15/940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK," and U.S. patent application Ser. No. 15/940,675, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES."
U.S. Patent Application No. 15/940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,642, entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,676, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,680, entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application No. 15/940,683, entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. patent application 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 application owns the following U.S. provisional patent applications, filed March 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. Provisional Patent Application No. 62/649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. Provisional Patent Application No. 62/649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
- U.S. Provisional Patent Application No. 62/649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS";
U.S. Provisional Patent Application No. 62/649,309, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
- U.S. Provisional Patent Application No. 62/649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. Provisional Patent Application No. 62/649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
U.S. Provisional Patent Application No. 62/649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
U.S. Provisional Patent Application No. 62/649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. Provisional Patent Application No. 62/649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. Provisional Patent Application No. 62/649,315, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK";
U.S. Provisional Patent Application No. 62/649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES";
U.S. Provisional Patent Application No. 62/649,320, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Provisional Patent Application No. 62/649,307, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and U.S. Provisional Patent Application No. 62/649,323, entitled "SENSING ARRANGMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS."

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

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

Before describing various aspects of the surgical device and generator in detail, it should be noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. The illustrative embodiments may be embodied in or incorporated into other aspects, variations, and modifications, and may be practiced or carried out in various ways. Moreover, unless otherwise specified, the terms and phrases used herein have been chosen for the convenience of the reader for the purpose of describing the illustrative embodiments, and not for the purpose of limiting them. Furthermore, it should be understood that one or more of the aspects, embodiment(s) of aspects, and/or embodiments described below can be combined with any one or more of the other aspects, embodiment(s) of aspects, and/or embodiments described below.

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

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

FIG. 2 shows an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 in a surgical operating room 116. A robotic system 110 is used as part of the surgical system 102 in the surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 during minimally invasive incisions in the patient's body while the surgeon views the surgical site via the surgeon's console 118. Images of the surgical site can be obtained by a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 can be used to process the images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.

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

Various examples of cloud-based analytics performed by the cloud 104 and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62/611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.

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

The optical components of the imaging device 124 may include one or more illumination sources and/or one or more lenses. The one or more illumination sources may be directed to illuminate a portion 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.

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

The invisible spectrum (i.e., non-radiative spectrum) is the portion of the electromagnetic spectrum located below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths above about 750 nm are longer than the red visible spectrum, which constitutes invisible infrared (IR), microwave, and radio frequency electromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, which constitutes 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 with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes. Some aspects of spectral and multispectral imaging are described in detail in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.

It is self-evident that any surgical procedure requires rigorous sterilization of the operating room and surgical instruments. The strict sanitation and sterility conditions required in the "surgical theater," i.e., operating room or procedure room, require the utmost sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It will be understood that the sterile field may be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field may be considered the area immediately surrounding the patient as he or she is prepared for the surgical procedure. The sterile field may include cleaned team members in appropriate clothing, as well as all equipment and fixtures within the area.

In various aspects, the visualization system 108 includes one or more imaging sensors strategically positioned relative to the sterile field, as shown in FIG. 2, one or more image processing units, one or more storage arrays, and one or more displays. In one aspect, the visualization system 108 includes HL7, PACS, and EMR interfaces. The various components of the visualization system 108 are described in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.

As shown in FIG. 2 , primary display 119 is positioned within the sterile field so as to be visible to an operator positioned at operating table 114. In addition, visualization tower 111 is positioned outside the sterile field. Visualization tower 111 includes first non-sterile display 107 and second non-sterile display 109 facing away from each other. Visualization system 108, guided by hub 106, is configured to coordinate information flow to operators inside and outside the sterile field using displays 107, 109, and 119. For example, hub 106 can cause visualization system 108 to maintain a live video of the surgical site on primary display 119 while displaying snapshots of the surgical site captured by imager 124 on non-sterile displays 107 or 109. The snapshots on non-sterile displays 107 or 109 can, for example, enable a non-sterile operator to perform diagnostic steps related to the surgical procedure.

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

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

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

During a surgical procedure, the application of energy to tissue for sealing and/or cutting is commonly accompanied by smoke evacuation, aspiration of excess fluid, and/or irrigation of tissue. Fluid, power, and/or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular housing 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of such line tangling.

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

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

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

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

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

Furthermore, 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.

With reference to Figures 3-5, aspects of the present disclosure are presented relating to a hub modular housing 136 that allows for modular integration of a generator module 140, a smoke evacuation module 126, and a suction/irrigation module 128. The hub modular housing 136 further facilitates bidirectional communication between the modules 140, 126, and 128. As shown in Figure 5, the generator module 140 may be a generator module comprising integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit 139 that is slidably insertable into the hub modular housing 136. As shown in Figure 5, the generator module 140 may be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules that interact via the hub modular housing 136. The hub modular housing 136 may be configured to facilitate insertion of multiple generators and bidirectional communication between the generators docked in the hub modular housing 136 so that the multiple generators function as a single generator.

In one aspect, the hub's modular housing 136 includes a modular power and communication backplane 149 with external and wireless communication headers to enable removable attachment of and bidirectional communication between modules 140, 126, and 128.

In one aspect, the hub modular housing 136 includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and a combination generator module 145 slidably receiveable in the docking station 151 of the surgical hub housing 136. A docking port 152 having power and data contacts on the rear side of the combination 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 modular housing 136 when the combination generator module 145 is slid into position within the corresponding docking station 151 of the hub modular housing 136. In one aspect, the combination generator module 145 includes bipolar, ultrasound, and monopolar modules and a smoke evacuation module integrated with a single housing unit 139, as shown in FIG. 5.

In various aspects, the smoke evacuation module 126 includes fluid lines 154 that transport captured/collected smoke and/or fluid away from the surgical site, for example, to the smoke evacuation module 126. Vacuum suction generated from the smoke evacuation module 126 can draw the smoke into openings in utility conduits at the surgical site. Utility conduits connected to the fluid lines may be in the form of flexible tubing that terminates at the smoke evacuation module 126. The utility conduits and fluid lines define a fluid pathway extending toward the smoke evacuation module 126, which is received within the hub housing 136.

In various aspects, the smoke evacuation module 126 includes fluid lines 154 that transport captured/collected smoke and/or fluid away from the surgical site, for example, to the smoke evacuation module 126. Vacuum suction generated from the smoke evacuation module 126 can draw the smoke into openings in utility conduits at the surgical site. Utility conduits connected to the fluid lines may be in the form of flexible tubing that terminates at the smoke evacuation module 126. The utility conduits and fluid lines define a fluid pathway that extends toward the smoke evacuation module 126, which is received within the hub housing 136.

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

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

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

In some aspects, the drawers 151 of the hub's modular housing 136 are the same or substantially the same size, and the modules are sized to be received within the drawers 151. For example, 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 different sizes, each designed to accommodate a specific module.

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

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

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

FIG. 6 illustrates a surgical data network 201 comprising a modular communications hub 203 configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped for surgical procedures, 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, the modular communications hub 203 comprises a network hub 207 and/or a network switch 209 in communication with a network router. The modular communications hub 203 can further be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to travel from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features that allow traffic to pass through the monitored surgical data network, configuring each port in the network hub 207 or network switch 209. An intelligent surgical data network can be referred to as a manageable hub or switch. A 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. A network hub 207 and/or a network switch 209 may be coupled to a network router 211 to connect devices 1a-1n to the cloud 204 or a local computer system 210. Data associated with devices 1a-1n may be transferred via the router to a cloud-based computer for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to the network switch 209. The network switch 209 may be coupled to the network hub 207 and/or a network router 211 to connect devices 2a-2m to the cloud 204. Data associated with devices 2a-2n may be transferred via the network router 211 to the cloud 204 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to the local computer system 210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and/or multiple network switches 209 with multiple network routers 211. The modular communications hub 203 may be housed within a modular control tower configured to receive multiple devices 1a-1n/2a-2m. A local computer system 210 may also be housed in the modular control tower. The modular communications hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n/2a-2m, for example, during a surgical procedure. In various aspects, devices 1a-1n/2a-2m may include various modules such as 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 communications module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and/or a non-contact sensor module, among other modular devices that may be connected to a modular communications 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 devices 1a-1n/2a-2m to the cloud. Any one or all of devices 1a-1n/2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. While the term "cloud" may be used as a metaphor for the "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to a type of internet-based computing in which various services, such as servers, storage, and applications, are delivered to the modular communications hub 203 and/or computer system 210 located at the surgical site (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and/or computer system 210 via the internet. The cloud infrastructure may be maintained by a cloud service provider. In this context, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n/2a-2m located in one or more operating rooms. The cloud computing service may perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware allows multiple devices or connections to connect to the computer, which communicates with cloud computing resources and storage.

By applying cloud computer data processing technology to data collected by devices 1a-1n/2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of devices 1a-1n/2a-2m can be used to observe tissue status and evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. Using cloud-based computing, at least some of devices 1a-1n/2a-2m can be used to diagnostically examine data, including images of bodily tissue samples, to identify pathologies, such as the effects of disease. This includes tissue and phenotypic localization and margin confirmation. At least some of devices 1a-1n/2a-2m can be used to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by devices 1a-1n/2a-2m, including image data, can be transferred to the cloud 204 or a local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. Data can be analyzed to improve surgical outcomes by determining whether further treatments, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and precision robotics, can be performed on tissue-specific sites and conditions. Such data analysis may also employ prognostic analysis processes, and using a standardized approach can provide valuable feedback to either confirm or suggest modifications to surgical treatments and surgeon performance.

In one implementation, operating room devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. The network hub 207 may, in one embodiment, be implemented as a local network broadcast device operating on the physical layer of the Open Systems Interconnection (OSI) model. The network hub provides connectivity to devices 1a-1n located within the same operating room network. The network hub 207 collects data in the form of packets and sends them to a router in half-duplex mode. The network hub 207 does not store any media access control/internet protocol (MAC/IP) protocols for transporting device data. Only one of the devices 1a-1n can transmit data through the network hub 207 at a time. The network hub 207 does not have a routing table or intelligence regarding where to send the information; it broadcasts all network data across each connection and to a remote server 213 (Figure 9) on the cloud 204. While the network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose a security risk and cause bottlenecks.

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

The network hub 207 and/or the network switch 209 are coupled to a network router 211 for connection to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and/or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n/2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 transmits data in the form of packets to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.

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

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

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

The modular communications hub 203 may be used as a standalone device or may be connected to compatible network hubs and network switches to form a larger network. Because the modular communications hub 203 is generally easy to install, configure, and maintain, the modular communications hub 203 is a good choice for networking operating room devices 1a-1n/2a-2m.

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 that communicates 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 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the 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 illustrated in the FIG. 7 embodiment, 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 evacuation module 226, a suction/irrigation module 228, a communications module 230, a processor module 232, a storage array 234, optionally a smart device/instrument 235 coupled to a display 237, and a non-contact sensor module 242. Operating room equipment is coupled to cloud computing resources and data storage via modular control tower 236. Robotic hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices/instruments 235, visualization system 208, among other devices, may be coupled to modular control tower 236 via wired or wireless communication standards or protocols described herein. Modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from the imaging module, device/instrument display, and/or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with images and overlay images.

FIG. 8 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for providing local processing, visualization, and imaging. As shown in FIG. 8, the modular communications hubs 203 can be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communications hub 203 and transfer 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 the modular communications hub 203 includes three downstream ports and one upstream port. The upstream network hub/switch is connected to a processor to provide communications connectivity to cloud computing resources and a local display 217. Communications to the cloud 204 can occur via either wired or wireless communication channels.

The surgical hub 206 uses a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the surgical site using either an ultrasound or laser-based non-contact measurement device. As described in the section entitled "Surgical Hub Spatial Awareness Within an Operating Room" of U.S. Provisional Patent Application No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety, the ultrasound-based non-contact sensor module is configured to scan the operating room by transmitting bursts of ultrasound and receiving echoes as the bursts reflect off the exterior walls of the operating room, whereby the sensor module determines the size of the operating room and adjusts the distance limit for Bluetooth pairing. The laser-based non-contact sensor module scans the operating room, for example, by transmitting laser light pulses, receiving laser light pulses that reflect off the exterior walls of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the Bluetooth pairing distance limit.

The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled to a communications module 247, storage 248, memory 249, non-volatile memory 250, and input/output interface 251 via a system bus. The system bus may be any of several types of bus structures, including a memory bus or memory controller, a peripheral bus or external bus, and/or a local bus, using any of a variety of bus architectures, including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), MicroChannel Architecture (MSA), Enhanced 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 proprietary bus.

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

In one aspect, the processor 244 may include a safety controller, including two controller families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

System memory includes both volatile and nonvolatile memory. The basic input/output system (BIOS), containing the basic routines to transfer information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. Furthermore, RAM is available in many forms, including static RAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), SyncLink DRAM (SLDRAM), and direct RAM (DRRAM).

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

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

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

The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices, or other common network nodes, and typically include many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown along with the remote computer(s). The remote computer(s) are logically connected to the computer system through a network interface, which is then physically connected via a communications connection. Network interfaces encompass communications 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-switched networks such as Integrated Services Digital Networks (ISDN) and its variants, packet-switched networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 8, the imaging module 238 of FIGS. 7 and 8, and/or the visualization system 208, and/or the processor module 232 may include an image processor, an image processing engine, a media processor, or any specialized digital signal processor (DSP) used to process digital images. The image processor may use parallel computing using 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 variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

The communications connection(s) refer to the hardware/software used to connect the network interface to the bus. While the communications connections are shown internal to the computer system for clarity of illustration, the communications connections may also be external to computer system 210. By way of example only, the hardware/software required to connect to the network interface may include 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 embodiment of a USB network hub 300 device in accordance with at least one aspect of the present disclosure. In the illustrated embodiment, the USB network hub device 300 employs a Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that conforms to the USB 2.0 standard and provides an upstream USB transmit/receive port 302 and up to three downstream USB transmit/receive ports 304, 306, and 308. The upstream USB transmit/receive port 302 is a differential routed data port that includes a differential data minus (DM0) input paired with a differential data plus (DP0) input. The three downstream USB transmit/receive ports 304, 306, and 308 are differential data ports, each including a differential data plus (DP1-DP3) output paired with a differential data minus (DM1-DM3) output.

The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller, eliminating the need for firmware programming. A fully compliant USB transceiver is integrated into the circuitry of the upstream USB transmit/receive port 302 and all downstream USB transmit/receive ports 304, 306, and 308. The downstream USB transmit/receive ports 304, 306, and 308 support both full-speed and low-speed devices by automatically setting the slew rate depending on the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered or self-powered mode and includes hub power logic 312 for managing power.

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

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

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 can be configured to implement various processes described herein. The control circuit 500 can comprise a microcontroller including one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute the machine instructions to implement the various processes described herein. The processor 502 can be any one of a number of single- or multi-core processors known in the art. The memory circuit 504 can include volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured 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 according to one aspect of the present disclosure. The combinational logic 510 can be configured to implement the various processes described herein. The combinational logic 510 may include a finite state machine including 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 an output 516.

FIG. 12 illustrates a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. The sequential logic circuit 520 or combinatorial logic 522 can be configured to implement the various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 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 can store the current state of the finite state machine. In certain examples, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data through the combinatorial logic 522, and provide an output 528. In other aspects, the circuitry may include a combination of a processor (e.g., processor 502 of FIG. 10) and a finite state machine that implements the various processes described herein. In other aspects, the finite state machine may include a combination of combinational logic (e.g., combinational logic 510 of FIG. 11) and sequential logic 520.

13 is a system 800 configured to execute adaptive ultrasonic blade control algorithms within a surgical data network with a modular communications hub, in accordance with at least one aspect of the present disclosure. In one aspect, 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 adaptive ultrasonic blade control algorithms. In another aspect, both device/instrument 235 and device/instrument 235 are configured to execute adaptive ultrasonic blade control algorithms described herein.

The generator module 240 may include a patient-isolated stage that communicates with the non-isolated stage via a power transformer. The secondary winding of the power transformer is housed within the isolated stage and may include a tap configuration (e.g., center-tapped or non-center-tapped) to define a drive signal output for delivering drive signals to various surgical instruments, such as ultrasonic surgical instruments, RF electrosurgical instruments, and multifunction surgical instruments including ultrasonic and RF energy modes that can be delivered singly or simultaneously. Specifically, the drive signal output can output an ultrasonic drive signal (e.g., a 420 V root-mean-square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output can output an RF electrosurgical drive signal (e.g., a 100 V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to Figures 14-19B.

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

FIG. 14 illustrates an example of a generator 900, a form of generator configured to couple with an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network comprising the modular communications hub shown in FIG. 13 . The generator 900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals, either alone or simultaneously, for delivering energy to the surgical instrument. The RF and ultrasonic signals may be provided alone, in combination, or simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, among others) through a single port, which can be delivered individually or simultaneously to an 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 (not shown for clarity of disclosure) coupled to the processor 902. Digital information related to the waveforms is provided to the waveform generator 904, which includes one or more DAC circuits for converting the digital input to an analog output. The analog output is supplied to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled across the power transformer 908 to a secondary side on the patient-isolated side. A first signal of a first energy modality is provided to the surgical instrument between terminals labeled ENERGY1 and RETURN. A second signal of a second energy modality is coupled across a capacitor 910 and provided to the surgical instrument between terminals labeled ENERGY2 and RETURN. It will be understood that more than two energy modalities may be output, and thus the subscript "n" may be used to indicate that up to n ENERGYn terminals may be provided, where n is a positive integer greater than 1. It will also be understood that up to "n" return paths (RETURNn) may be provided without departing from the scope of this disclosure.

A first voltage sense circuit 912 is coupled across the terminals labeled ENERGY1 and RETURN PATH and measures the output voltage therebetween. A second voltage sense circuit 924 is coupled across the terminals labeled ENERGY2 and RETURN PATH and measures the output voltage therebetween. A current sense circuit 914 is disposed in series with the RETURN section of the secondary side of the illustrated power transformer 908 to measure the output current of either energy modality. If different return paths are provided for each energy modality, a separate current sense circuit must be provided in each return section. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to corresponding isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side (non-patient-isolated side) of the power transformer 908 are 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 calculations. Output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument and to calculate output impedance, among other parameters. Input/output communication between the processor 902 and the patient-isolated circuitry is provided through an interface circuit 920. Sensors may also be in electrical communication with the processor 902 via the interface circuit 920.

In one aspect, impedance may be determined by the processor 902 by dividing the output of a first voltage sensing circuit 912 coupled across the terminals labeled ENERGY1/RETURN or a second voltage sensing circuit 924 coupled across the terminals labeled ENERGY2/RETURN by the output of a current sensing circuit 914 disposed in series with the RETURN section of the secondary side of the power transformer 908. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 916. Digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 to calculate the impedance. By way of example, the first energy modality ENERGY1 may be ultrasound energy and the second energy modality ENERGY2 may be RF energy. Nevertheless, in addition to ultrasound energy modalities and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and/or reversible electroporation and/or microwave energy, among others. Also, while the example illustrated in FIG. 21 shows that a single return path (RETURN) may be provided to two or more energy modalities, in other aspects, multiple return paths RETURNn may be provided to each energy modality ENERGYn. Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914, and the impedance of the tissue may be measured by dividing the output of the second voltage sensing circuit 924 by the current sensing circuit 914.

As shown in FIG. 14 , a generator 900 including at least one output port may include a power transformer 908 with a single output and multiple taps to provide power to an 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, among others, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy at high voltage and low current to drive an ultrasonic transducer, at low voltage and high current to drive an RF electrode for tissue sealing, or in a coagulation waveform for spot coagulation, using either monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 may be directed, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the generator 900 output would preferably be located between the outputs labeled ENERGY1 and RETURN shown in FIG. 14 . In one example, the connection to the output of the RF bipolar electrode generator 900 would preferably be located between the output labeled ENERGY2 and the output labeled RETURN. In the case of a monopolar output, the preferred connection would be the active electrode (e.g., a pencil or other surgical probe) to suitable return pads connected to the ENERGY2 and RETURN outputs.

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

As used throughout this description, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that may communicate data through the use of modulated electromagnetic radiation over a non-solid medium. This term does not imply that the associated devices do not include any wires, although in some aspects they may not be present. 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 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and beyond. The computing module may include multiple communication modules. For example, a first communication module may be dedicated to short-range wireless communications such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to long-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.

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

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

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

As used herein, the term controller or microcontroller may refer to a standalone IC or chip device that interfaces with a peripheral device. It may also refer to the link between two parts: a computer or controller on an external device that manages the operation of (and connections with) that device.

Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those known by the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including, for example, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance beyond 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product data sheet.

In one aspect, the processor may include a safety controller, including two controller families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

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

FIG. 15 illustrates one form of a surgical system 1000 including a generator 1100 and various surgical instruments 1104, 1106, 1108 usable therewith, where the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunction surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument. The generator 1100 is configurable for use with a variety of surgical instruments. According to various forms, the generator 1100 may be configurable for use with a variety of different surgical devices, including, for example, the ultrasonic surgical instrument 1104, the RF electrosurgical instrument 1106, and the multifunction surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. While the generator 1100 is shown separate from the surgical instruments 1104, 1106, and 1108 in the configuration of FIG. 15 , in one configuration the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, and 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. The input device 1110 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.

The generator 1100 is configured to drive multiple surgical instruments 1104, 1106, and 1108. The first surgical instrument is an ultrasonic surgical instrument 1104, which 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 acoustically coupled to the ultrasonic transducer 1120 and a clamp arm 1140. The handpiece 1105 includes a trigger 1143 for actuating the clamp arm 1140 and a combination of toggle buttons 1134a, 1134b, and 1134c for energizing and driving the ultrasonic blade 1128 or other functions. The toggle buttons 1134a, 1134b, and 1134c can be configured to energize the ultrasonic transducer 1120 using the 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 handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in clamp arms 1142a, 1142b and back through the conductor portion of the shaft 1127. The electrodes are coupled to and energized by a bipolar energy source within the generator 1100. The handpiece 1107 includes a trigger 1145 for operating the clamp arms 1142a, 1142b and an energy button 1135 for actuating an energy switch to energize the electrodes in the end effector 1124.

The generator 1100 is also configured to drive a multifunction surgical instrument 1108. The multifunction surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 that operates the clamp arm 1146 and a combination of toggle buttons 1137a, 1137b, and 1137c for energizing and driving the ultrasonic blade 1149 or other functions. The toggle buttons 1137a, 1137b, and 1137c can be configured to energize the ultrasonic transducer 1120 using the generator 1100, and also to energize the ultrasonic blade 1149 using a bipolar energy source housed within the generator 1100. It will be appreciated that handpieces 1105, 1107, and 1109 may be replaced with robotically controlled instruments; therefore, the term handpiece should not be limited in this context.

The generator 1100 is configurable for use with a variety of surgical instruments. According to various configurations, the generator 1100 may be configurable for use with a variety of different surgical devices, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunction surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. In the configuration of FIG. 15 , the generator 1100 is shown separate from the surgical instruments 1104, 1106, and 1108; however, in other configurations, the generator 1100 may be integrally formed with any one of the surgical instruments 1104, 1106, and 1108 to form an integrated surgical system. As mentioned above, the generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. The input device 1110 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. The generator 1100 may also include one or more output devices 1112. Further aspects of generators for digitally generating electrical signal waveforms and surgical instruments are described in U.S. Patent Application Publication No. 2017-0086914-A1, the entirety of which is incorporated herein by reference.

In various aspects, the generator 1100 may include several separate functional elements, such as the modules and/or blocks shown in FIG. 16, which is a schematic representation of the surgical system 1000 of FIG. 15. The various functional elements or modules may be configured to drive various types of surgical devices 1104, 1106, 1108. For example, an ultrasonic generator module may drive an ultrasonic device, such as the ultrasonic device 1104. An electrosurgical/RF generator module may drive the electrosurgical device 1106. The modules may generate corresponding drive signals to drive the surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and/or the electrosurgical/RF generator module may each be integrally formed with the generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100. (The modules are shown in phantom to illustrate this option.) Also, in some variations, the electrosurgical/RF generator module may be integrally formed with the ultrasonic generator module, or vice versa.

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

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

The generator 1100 may include an input device 2150 (FIG. 18B) located, for example, on a front panel of the console of the generator 1100. The input device 2150 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. During operation, a user may use the input device 2150 to program or otherwise control the operation of the generator 1100. The input device 2150 may include any suitable device that generates signals that can be used by the generator (e.g., by one or more processors housed within the generator) to control the operation of the generator 1100 (e.g., the operation of the ultrasonic 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, touchscreen monitors, pointing devices, and a remote connection to a general-purpose or dedicated computer. In other aspects, the input device 2150 may include a suitable user interface, such as, for example, one or more user interface screens displayed on a touchscreen monitor. Thus, the input device 2150 allows a user to set or program various operating parameters of the generator, such as, for example, the current (I), voltage (V), frequency (f), and/or duration (T) of the drive signal or signals generated by the ultrasonic generator module and/or the electrosurgical/RF generator module.

The generator 1100 may also include an output device 2140 (FIG. 18B) located, for example, on the front panel of the generator 1100 console. The output device 2140 includes one or more devices for providing sensory feedback to the user. Such devices may include, for example, visual feedback devices (e.g., LCD display screen, LED indicators), audible feedback devices (e.g., speaker, buzzer), or tactile feedback devices (e.g., tactile actuators).

While particular modules and/or blocks of generator 1100 may be described as examples, it will be understood that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the aspects. Furthermore, while various aspects may be described in terms of modules and/or blocks for ease of explanation, such modules and/or blocks may be implemented by one or more hardware components, e.g., a processor, a digital signal processor (DSP), a programmable logic device (PLD), an application-specific integrated circuit (ASIC), circuits, registers, and/or software components, e.g., programs, subroutines, logic, and/or combinations of hardware and software components.

In one aspect, the ultrasonic generator drive module and electrosurgical/RF drive module 1110 (FIG. 15) may include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may comprise various executable modules such as software, programs, data, drivers, application program interfaces (APIs), etc. The firmware may be stored in nonvolatile memory (NVM), such as bit-masked read-only memory (ROM) or flash memory. In various implementations, storing the firmware in ROM may preserve flash memory. The NVM may include other types of memory, including, for example, programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or battery-backed random access memory (RAM), such as dynamic RAM (DRAM), double data rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).

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

FIG. 17 is a simplified block diagram of one embodiment of a generator 1100 for providing, among other advantages, the inductorless regulation described above. FIGS. 18A-18C illustrate the architecture of the generator 1100 of FIG. 17 according to one embodiment. Referring to FIG. 17, the generator 1100 may include a patient-isolated stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of the power transformer 1560 is included in the isolated 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 various surgical devices, such as the ultrasonic surgical device 1104 and the electrosurgical device 1106. In particular, 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, where output 1600b corresponds to the 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, power amplifier 1620 may include, for example, a push-pull amplifier. Non-isolated stage 1540 may further include programmable logic 1660 for providing a digital output to a digital-to-analog converter (DAC) 1680, which in turn provides a corresponding analog signal to the input of power amplifier 1620. In certain aspects, programmable logic 1660 may include, for example, a field programmable gate array (FPGA). Programmable logic 1660 may control the input of power amplifier 1620 via DAC 1680, thereby controlling any of a number of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signals appearing at drive signal outputs 1600a, 1600b, 1600c. In certain aspects, and as described below, programmable logic 1660, in conjunction with a processor (e.g., processor 1740, described below), may execute a number of digital signal processing (DSP)-based and/or other control algorithms to control parameters of the drive signals output by generator 1100.

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

In certain aspects, and as described in further detail in connection with FIGS. 19A-19B, the programmable logic 1660, in conjunction with the processor 1740, may implement a direct digital synthesizer (DDS) control scheme to control the waveform shape, frequency, and/or amplitude of the drive signal output by the generator 1100. In one aspect, for example, the programmable logic 1660 may execute a DDS control algorithm 2680 (FIG. 14A) by recalling waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT, which may be embedded in an FPGA. This control algorithm is particularly useful in ultrasound applications where an ultrasonic transducer, such as the ultrasonic transducer 1120, may be driven by a well-defined sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the overall distortion of the operating branch current can correspondingly minimize or reduce undesirable resonant effects. Because the waveform shape of the drive signal output by generator 1100 may be affected by various distortion sources present in the output drive circuitry (e.g., power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal can be input to an algorithm, such as an error control algorithm executed by processor 1740, which compensates for the distortion by appropriately pre-distorting or modifying the waveform samples stored in the LUT on a dynamic, ongoing basis (e.g., in real time). In one aspect, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated motional branch current and the desired current waveform shape, with the error determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed by the drive circuitry, may yield a motional branch drive signal having a desired waveform shape (e.g., a sinusoidal wave) for optimally driving the ultrasonic transducer. Thus, in such an aspect, the LUT waveform samples do not represent the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately generate the motional branch drive signal of the desired waveform, taking distortion effects into account.

The non-isolated stage 1540 may further include ADCs 1780 and 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820 and 1840 for sampling the voltage and current, respectively, of the drive signal output by the generator 1100. In certain aspects, the ADCs 1780 and 1800 may be configured to sample at a high speed (e.g., 80 Msps) to enable oversampling of the drive signal. In one aspect, for example, the sampling rate of the ADCs 1780 and 1800 may enable oversampling of the drive signal by approximately 200 times (depending on the drive frequency). In certain aspects, the sampling operation of the ADCs 1780 and 1800 may be performed by a single ADC that receives the input voltage and current signals via a bidirectional multiplexer. The use of high-speed sampling in aspects of generator 1100 can enable, among other things, calculation of complex currents flowing in the motional branch (which may be used in certain aspects to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and highly accurate calculation of actual power consumption. The voltage and current feedback data output by ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering, multiplexing) by programmable logic 1660 and stored in data memory for subsequent retrieval, e.g., by processor 1740. As noted above, the voltage and current feedback data may be used as input to algorithms for pre-distorting or modifying LUT waveform samples on a dynamic and ongoing basis. In certain aspects, this may require each stored voltage and current feedback data pair to be indexed or otherwise associated with the corresponding LUT sample output by programmable logic 1660 as the voltage and current feedback data pair is acquired. Synchronizing the LUT samples with the voltage and current feedback data in this manner contributes to the precise timing and stability of the predistortion algorithm.

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

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

Evaluating the Fourier transform at the frequency of the sine wave gives:

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

where φ is the phase angle, f is the frequency, t is the time, and φ ₀ is the phase at t=0.

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

Other techniques for determining the phase difference between voltage and current signals include Lissajous figures and image monitoring, as well as methods such as the three-voltmeter method, cross-coil method, vector voltmeter, and vector impedance method. Additionally, other techniques include the use of phase standards, phase-locked loops, and other techniques, as described in *Phase Measurement*, Peter O'Shea, 2000 CRC Press LLC, http://www.engnetbase.com, which is incorporated herein by reference.

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

The non-isolated stage 1540 may further include a processor 1900 to provide, among other things, user interface (UI) functionality. In one aspect, the processor 1900 may include, for example, an Atmel AT91 SAM9263 processor with an ARM 926EJ-S core, available from Atmel Corporation (San Jose, Calif.). Examples of UI functionality 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 a footswitch 1430, communication with an input device 2150 (e.g., a touchscreen display), and communication with an output device 2140 (e.g., a speaker). The processor 1900 may communicate with the processor 1740 and the programmable logic (e.g., via a serial peripheral interface (SPI) bus). While processor 1900 may primarily support UI functions, it may also cooperate with processor 1740 in certain aspects to provide hazard mitigation. For example, processor 1900 may be programmed to monitor various aspects of user input and/or other input (e.g., touchscreen input 2150, footswitch 1430 input, temperature sensor input 2160) and may disable the drive output of generator 1100 if an erroneous condition is detected.

In certain aspects, both processor 1740 (FIGS. 17, 18A) and processor 1900 (FIGS. 17, 18B) can determine and monitor the operating state of generator 1100. In the case of processor 1740, the operating state of generator 1100 can determine, for example, which control and/or diagnostic processes are executed by processor 1740. In the case of processor 1900, the operating state of generator 1100 can determine, for example, which elements of the user interface (e.g., display screen, sound) are presented to the user. Processors 1740, 1900 separately maintain the current operating state of generator 1100 and recognize and evaluate possible transitions from the current operating state. Processor 1740 acts as a master in this relationship and can determine when transitions between operating states occur. Processor 1900 can recognize valid transitions between operating states and can verify that a particular transition is appropriate. For example, when processor 1740 commands processor 1900 to transition to a particular state, processor 1900 can verify that the requested transition is valid. If the requested transition between states is determined by processor 1900 to be invalid, processor 1900 can place generator 1100 in a failure mode.

The non-isolated stage 1540 may further include a controller 1960 (FIGS. 17, 18B) for monitoring the input device 2150 (e.g., a capacitive touch sensor, a capacitive touch screen used to turn the generator 1100 on and off). In certain aspects, the controller 1960 may comprise at least one processor and/or other controller device in communication with the processor 1900. In one aspect, for example, the controller 1960 may comprise a processor (e.g., a Mega168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, the controller 1960 may comprise a touchscreen controller (e.g., a QT5480 touchscreen controller available from Atmel) for controlling and managing the acquisition of touch data from the capacitive touchscreen.

In certain aspects, when the generator 1100 is in the "power off" state, 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) described below). In this manner, the controller 1960 may continue to monitor an input device 2150 (e.g., a capacitive touch sensor located on the front panel of the generator 1100) for turning the generator 1100 on and off. When the generator 1100 is in the "power off" state, the controller 1960 may activate the power source (e.g., enable operation of one or more DC/DC voltage converters 2130 (FIG. 17) of the power source 2110) upon detecting user activation of the "on/off" input device 2150. As a result, the controller 1960 may initiate a sequence to transition the generator 1100 to the "power on" state. Conversely, if activation of the "on/off" input device 2150 is detected while the generator 1100 is in the "power on" state, the controller 1960 may initiate a sequence to transition the generator 1100 to the "power off" state. In certain aspects, for example, the controller 1960 may report activation of the "on/off" input device 2150 to the processor 1900, which then executes the processing sequence necessary to transition the generator 1100 to the "power off" state. In such aspects, the controller 1960 may not have the independent ability to cause the removal of power from the generator 1100 after its "power on" state has been established.

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

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

In one aspect, the instrument interface circuit 1980 can include a programmable logic 2000 (e.g., an FPGA) in communication with a signal conditioning circuit 2020 (FIGS. 17 and 18C). The signal conditioning circuit 2020 can be configured to receive a periodic signal (e.g., a 2 kHz square wave) from the programmable logic 2000 and generate a bipolar interrogation signal having the same frequency. The interrogation signal can be generated, for example, using a bipolar current source fed by a differential amplifier. The interrogation signal can be communicated to a 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 can include a number of switches, resistors, and/or diodes to modify one or more characteristics (e.g., amplitude, rectification) of the interrogation signal such that the state or configuration of the control circuit is individually identifiable based on the one or more characteristics. For example, in one aspect, the signal conditioning circuit 2020 may include an ADC for generating samples of the voltage signal appearing across the input of the control circuit caused by the interrogation signal passing through it. The programmable logic 2000 (or a component of the non-isolated 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 can include a first data circuit interface 2040 that enables the exchange of information between the programmable logic 2000 (or other elements of the instrument interface circuit 1980) and a first data circuit disposed within or otherwise associated with the surgical device. In certain aspects, for example, the first data circuit 2060 can be disposed in a cable integrally attached to a surgical device handpiece or in an adapter for interfacing a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit can include non-volatile storage, such as an electrically erasable programmable read-only memory (EEPROM) device. In certain aspects, and again referring to FIG. 17 , the first data circuit interface 2040 can be implemented separately from the programmable logic 2000 and can include suitable circuitry (e.g., discrete logic, processor) that enables communication between the programmable logic 2000 and the first data circuit. In other embodiments, the first data circuit interface 2040 may be integral with the programmable logic device 2000.

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

As noted above, surgical instruments may be detachable from the handpiece to facilitate instrument interchangeability and/or disposability (e.g., instrument 1106 may be detachable from handpiece 1107). In such cases, known generators may be limited in their ability to recognize the particular instrument configuration being used and correspondingly optimize their control and diagnostic processes. However, adding readable data circuitry to the surgical instrument to address this issue presents compatibility challenges. For example, designing a surgical instrument to be backward compatible with generators lacking the necessary data read functionality may be impractical due to, for example, different signaling schemes, design complexity, and expense. Other aspects of the instrument address these concerns by economically using data circuitry that can be implemented in existing surgical instruments and minimizing design changes to maintain compatibility of the surgical instrument with modern generator platforms.

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

In certain aspects, the second data circuit and second data circuit interface 2100 can be configured to enable communication between the programmable logic 2000 and the second data circuit without the need to provide additional conductors for this purpose (e.g., dedicated conductors in the cable connecting the handpiece to the generator 1100). In one aspect, information can be conveyed to and from the second data circuit using a one-wire bus communication scheme implemented on existing cable wiring, e.g., one of the conductors used transmits an interrogation signal from the signal conditioning circuit 2020 to the control circuitry in the handpiece. In this manner, surgical device design changes or modifications that might otherwise be required are minimized or reduced. Furthermore, because various types of communications can be conducted over a common physical channel (either with or without frequency band separation), the presence of the second data circuit is "invisible" to generators that do not have the necessary data reading capabilities, thus enabling backward compatibility of surgical device instruments.

In certain embodiments, the isolation stage 1520 can include at least one blocking capacitor 2960-1 (FIG. 18C) connected to the drive signal output 1600b to prevent DC current from passing through the patient. A single blocking capacitor may be required, for example, to comply with medical regulations or standards. While failure in a single capacitor design is relatively rare, such failure may still have negative consequences. In one embodiment, a second blocking capacitor 2960-2 can be provided in series with the blocking capacitor 2960-1 to monitor current leakage from a point between the blocking capacitors 2960-1, 2960-2, for example, by an ADC 2980 sampling the voltage induced by the leakage current. The samples can be received, for example, by the programmable logic 2000. Based on changes in the leakage current (represented by voltage samples in the embodiment of FIG. 17), the generator 1100 can determine when at least one of the blocking capacitors 2960-1, 2960-2 has failed. Thus, the embodiment of FIG. 17 can provide benefits over single-capacitor designs with a single point of failure.

In certain aspects, the non-isolated stage 1540 may include a power supply 2110 for outputting DC power at a suitable voltage and current. The power supply may, for example, comprise a 400 W power supply for outputting a 48 VDC system voltage. As described above, the power supply 2110 may further include one or more DC/DC voltage converters 2130 for receiving the output of the power supply and generating a DC output at the voltage and current required by the various components of the generator 1100. As described above in connection with the controller 1960, one or more of the DC/DC voltage converters 2130 may receive input from the controller 1960 when activation of an "on/off" input device 2150 by a user is detected by the controller 1960, allowing operation or activation of the DC/DC voltage converters 2130.

19A-19B illustrate certain functional and structural aspects of one embodiment of generator 1100. Feedback indicative of the current and voltage output from secondary winding 1580 of power transformer 1560 is received by ADCs 1780 and 1800, respectively. As shown, ADCs 1780 and 1800 may be implemented as two-channel ADCs and may sample the feedback signal at a high speed (e.g., 80 Msps) to allow oversampling of the drive signal (e.g., approximately 200x oversampling). The current and voltage feedback signals may be appropriately conditioned (e.g., amplified, filtered) in the analog domain prior to processing by ADCs 1780 and 1800. The current and voltage feedback samples from ADCs 1780 and 1800 may be individually buffered and then multiplexed or interleaved into a single data stream within block 2120 of programmable logic 1660. In the embodiment of Figures 19A-19B, the programmable logic 1660 comprises an FPGA.

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

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

In block 2220 of the pre-distortion algorithm, the current through the motional branch of the ultrasonic transducer is determined. The motional branch current may be determined using Kirchhoff's current law, for example, based on the current and voltage feedback samples stored in memory location 2180 (which, when appropriately scaled, may represent Ig and Vg of the model of FIG. 25 above), the value of the ultrasonic transducer capacitance _C0 (measured or known a priori), and the known value of the drive frequency. For each set of stored current and voltage feedback samples associated with a LUT sample, the motional branch current sample may be determined.

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

Each value of sample amplitude error determined in block 2240 can be communicated to the LUT of programmable logic 1660 (shown in block 2280 of FIG. 19A ) along with an index of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and, optionally, a previously received sample amplitude error value for the same LUT address), LUT 2280 (or other control block of programmable logic 1660) can pre-distort or modify the value of the LUT sample stored at the LUT address, thereby reducing or minimizing the sample amplitude error. It will be appreciated that such pre-distortion or modification of each LUT sample in an iterative manner across the entire range of LUT addresses causes the waveform shape of the generator's output current to match or adapt to the desired current waveform shape represented by the samples of waveform shape LUT 2260.

Current and voltage amplitude measurements, power measurements, and impedance measurements may be determined in block 2300 of processor 1740 based on the current and voltage feedback samples stored in memory location 2180. Prior to determining these values, the feedback samples may be appropriately scaled and, in certain aspects, processed through a suitable filter 2320 to remove, for example, noise and induced harmonic components caused by the data acquisition process. The filtered voltage and current samples may therefore substantially represent the fundamental frequency of the generator's drive output signal. In certain aspects, filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain. Such an aspect may employ a fast Fourier transform (FFT) of the output drive signal current and voltage signals. In certain aspects, the resulting frequency spectrum may be used to provide additional generator functions. In one aspect, for example, the ratio of second and/or third harmonic components 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 a sample size of current feedback samples representing an integer number of cycles of the drive signal to generate a measurement I _rms that represents the drive signal output current.

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

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

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

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

In certain aspects, the values _Irms , _Vrms , _Pr , _Pa , and _Zm determined in blocks 2340, 2360, 2380, 2400, and 2420 may be used by the generator 1100 to implement any of a number of control and/or diagnostic processes. In certain aspects, any of these values may be communicated to a user through a suitable communications interface (e.g., a USB interface), for example, via an output device 2140 integral with or connected to the generator 1100. The various diagnostic processes may include, but are not limited to, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock failure, overvoltage condition, overcurrent condition, overpower condition, voltage sense failure, current sense failure, audible indicator failure, visual indicator failure, short circuit condition, power supply failure, or blocking capacitor failure.

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

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

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

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

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

In block 2560 (FIG. 19A) of the phase control algorithm, a frequency output is determined for controlling the frequency of the drive signal based on the value of the phase error determined in block 2520 and the magnitude of the impedance determined in block 2420. The frequency output value may be continuously adjusted by block 2560 and forwarded to DDS control block 2680 (described below) to maintain the impedance phase determined in block 2500 at a phase setpoint (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 is centered around the top of the voltage waveform, improving the accuracy of the phase impedance determination.

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

In aspects where drive signal voltage is the controlled variable, the current demand _Id may be indirectly specified based on the current required to maintain the desired voltage set point 2620B ( _Vsp ) given the magnitude of the load impedance _Zm measured in block 2420 (e.g., _Id = _Vsp / _Zm ). Similarly, in aspects where drive signal power is the controlled variable, the current demand _Id may be indirectly specified based on the current required to maintain the desired power set point 2620C ( _Psp ) given the voltage _Vrms measured in block 2360 (e.g., _Id = _Psp / _Vrms ).

Block 2680 (FIG. 19A) can implement a DDS control algorithm to control the drive signal by recalling LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm can be a numerically controlled oscillator (NCO) algorithm for generating waveform samples at a fixed clock rate using a point (memory location) skip technique. The NCO algorithm can implement a phase accumulator or frequency-to-phase converter that serves as an address pointer for recalling LUT samples from LUT 2280. In one aspect, the phase accumulator can be a D-step size, modulo-N phase accumulator, where D is a positive integer representing a frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D=1 can cause the phase accumulator to sequentially address all of LUT 2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. If D>1, the phase accumulator may skip addresses in LUT 2280, resulting in a waveform output having a higher frequency. This allows the frequency of the waveform generated by the DDS control algorithm to be controlled by appropriately varying the frequency control value. In certain aspects, the frequency control value may be determined based on the output of the phase control algorithm implemented in block 2440. The output of block 2680 may provide the input of DAC 1680, which in turn provides a corresponding analog signal to the input of power amplifier 1620.

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

In some aspects, electrical circuitry can be used to interchangeably drive both the ultrasound transducer and the RF electrode. Filtering circuitry can be provided to select either the ultrasound waveform or the RF waveform when driven simultaneously. Such filtering techniques are described in commonly owned U.S. Patent Publication No. 2017-0086910-A1, entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated herein by reference in its entirety.

FIG. 20 is a circuit diagram of a control circuit 3200, such as control circuit 3212, in accordance with at least one aspect of the present disclosure. Control circuit 3200 is located within the housing of a battery assembly. The battery assembly is the energy source for various local power sources 3215. The control circuit comprises a main processor 3214 coupled to various downstream circuits via an interface master 3218, e.g., by outputs SCL-A and SDA-A, SCL-B and SDA-B, and SCL-C and SDA-C. In one aspect, interface master 3218 is a general purpose serial interface, such as an ^I2C serial interface. Main processor 3214 is also configured to drive switches 3224 via general purpose input/output (GPIO) 3220, a display 3226 (e.g., and LCD display), and various indicators 3228 via GPIO 3222. A watchdog processor 3216 is provided to control main processor 3214. A switch 3230 is provided in series with the battery 3211 to activate the control circuit 3212 when the battery assembly is inserted into the handle assembly of the surgical instrument.

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

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

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

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

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

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

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

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

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

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

FIG. 21 illustrates a generator circuit 3400 split into a first stage circuit 3404 and a second stage circuit 3406, according to at least one aspect of the present disclosure. In one aspect, the surgical instruments of the surgical system 1000 described herein may include a generator circuit 3400 split into multiple stages. For example, the surgical instruments of the surgical system 1000 may include a generator circuit 3400 split into at least two circuits, namely, a first stage circuit 3404 and a second stage circuit 3406 of amplification that enable operation with RF energy only, ultrasonic energy only, and/or a combination of RF and ultrasonic energy. The combination modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within the handle assembly 3412 and a modular second stage circuit 3406 integral with the modular shaft assembly 3414. As discussed above throughout this description in connection with the surgical instruments of the surgical system 1000, the battery assembly 3410 and shaft assembly 3414 are configured to be in mechanical and electrical communication with the handle assembly 3412. The end effector assembly is configured to be in mechanical and electrical communication with the shaft assembly 3414.

21, the generator circuit 3400 is divided into multiple stages located within multiple modular assemblies of a surgical instrument, such as the surgical instrument of the surgical system 1000 described herein. In one aspect, the control stage circuit 3402 may be located within the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is the control circuit 3200 described in connection with FIG. 20. The control circuit 3200 comprises a processor 3214 including internal memory 3217 (FIG. 21) (e.g., volatile and non-volatile memory) and is in electrical communication with a battery 3211. The battery 3211 provides power to the first stage circuit 3404, the second stage circuit 3406, and the third stage circuit 3408, respectively. As mentioned above, the control circuit 3200 generates the digital waveform 4300 (FIG. 29) using the circuits and techniques described in connection with FIGS. 27 and 28. Referring again to FIG. 21 , the digital waveform 4300 can be configured to drive an ultrasound transducer, a radio frequency (e.g., RF) electrode, or a combination thereof, either individually or simultaneously. If driven simultaneously, a filter circuit may be provided within the corresponding first stage circuit 3404 to select either the ultrasound waveform or the RF waveform. Such filtering techniques are described in commonly owned U.S. Patent Application No. 2017-0086910-A1, entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated herein by reference in its entirety.

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

The control circuit 3200 is configured to detect which modules are plugged into the control circuit 3200. For example, the control circuit 3200 is configured to detect whether the first stage ultrasonic drive circuit 3420, the first stage RF drive circuit 3422, or the first stage sensor drive circuit 3424 located in the handle assembly 3412 is connected to the battery assembly 3410. Similarly, each first stage circuit 3404 can detect which second stage circuit 3406 is connected to it, and that information is returned to the control circuit 3200 to determine the type of signal waveform to generate. Similarly, each second stage circuit 3406 can detect which third stage circuit 3408 or component is connected to it, and that information is returned 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 within the shaft assembly 3414 of the surgical instrument. The first stage ultrasonic drive circuitry 3420 provides a signal to the second stage ultrasonic drive circuitry 3430 via outputs US Left/US Right. In addition to a transformer, the second stage ultrasonic drive circuitry 3430 may further include filters, amplifiers, and signal conditioning circuitry. The first stage radio frequency (RF) current drive circuitry 3422 provides a signal to the second stage RF drive circuitry 3432 via outputs RF Left/RF Right. In addition to a transformer and blocking capacitors, the second stage RF drive circuitry 3432 may further include filters, amplifiers, and signal conditioning circuitry. The first stage sensor drive circuitry 3424 provides a signal to the second stage sensor drive circuitry 3434 via outputs Sensor 1/Sensor 2. The second stage sensor driver circuit 3434 may include filters, amplifiers, and signal conditioning circuitry depending on the type of sensor. 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 ultrasonic transducer 1120, RF electrodes 3074a, 3074b, and sensor 3440) may be located within various assemblies 3416 of the surgical instrument. In one aspect, the second stage ultrasonic drive circuit 3430 provides a drive signal to the piezoelectric stack of the ultrasonic transducer 1120. In one aspect, the ultrasonic transducer 1120 is located within the ultrasonic transducer assembly of the surgical instrument. However, in other aspects, the ultrasonic transducer 1120 may be located within the handle assembly 3412, shaft assembly 3414, or end effector. In one aspect, the second stage RF drive circuit 3432 provides a drive signal to the RF electrodes 3074a, 3074b, which are located generally within the end effector portion of the surgical instrument. In one aspect, the second stage sensor drive circuit 3434 provides a drive signal to various sensors 3440 located throughout the surgical instrument.

22 illustrates a generator circuit 3500 split into multiple stages, with a first stage circuit 3504 common to a second stage circuit 3506, in accordance with at least one aspect of the present disclosure. In one aspect, a surgical instrument of a surgical system 1000 described herein may include a generator circuit 3500 split into multiple stages. For example, a surgical instrument of a surgical system 1000 may include a generator circuit 3500 split into at least two circuits, a first stage circuit 3504 and a second stage circuit 3506 of amplification that enable operation with radio frequency (RF) energy only, ultrasonic energy only, and/or a combination of RF and ultrasonic energy. A combination modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 integral with the modular shaft assembly 3514. As discussed above throughout this description in connection with the surgical instruments of the surgical system 1000, the battery assembly 3510 and shaft assembly 3514 are configured to be in mechanical and electrical communication with the handle assembly 3512. The end effector assembly is configured to be in mechanical and electrical communication with the shaft assembly 3514.

As shown in the embodiment of FIG. 22 , the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes the control circuit 3200 described above. The handle assembly 3512 that connects to the battery assembly 3510 includes a common first stage drive circuit 3420. As described above, the first stage drive circuit 3420 is configured to drive ultrasonic, radio frequency (RF) current, and sensor loads. The output of the common first stage drive circuit 3420 can drive any one of the second stage circuits 3506, such as the second stage ultrasonic drive circuit 3430, the second stage radio frequency (RF) current drive circuit 3432, and/or the second stage sensor drive circuit 3434. The common first stage drive circuit 3420 detects which second stage circuit 3506 is located within the shaft assembly 3514 when the shaft assembly 3514 is connected to the handle assembly 3512. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 determines which one of the second stage circuits 3506 (e.g., second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and/or second stage sensor drive circuit 3434) is located within the shaft assembly 3514. This information is provided to the control circuit 3200 located within the handle assembly 3512 to supply the appropriate digital waveform 4300 ( FIG. 29 ) to the second stage circuit 3506 to drive the appropriate load (e.g., ultrasonic, RF, or sensor). It will be appreciated that identification circuitry may be included in the various assemblies 3516 within the third stage circuit 3508, such as the ultrasonic transducer 1120, electrodes 3074 a, 3074 b, or sensor 3440. Thus, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

23 is a circuit diagram of one embodiment of an electrical circuit 3600 configured to drive radio frequency (RF) current, in accordance with at least one embodiment of the present disclosure. The electrical circuit 3600 includes an analog multiplexer 3680. The analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A, such as RF, battery, and power control circuits. A current sensor 3682 is coupled in series with the return or ground section of the power supply circuit and measures the current supplied by the power supply. A field-effect transistor (FET) temperature sensor 3684 provides ambient temperature. A pulse-width modulation (PWM) watchdog timer 3688 automatically generates a system reset if the main program neglects to provide a periodic system reset. This is provided to automatically reset the electrical circuit 3600 if it hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 3600 may be configured to drive RF electrodes or to drive the ultrasonic transducer 1120, for example, as described with respect to FIG. 29. Thus, referring again now to FIG. 23, the electrical circuit 3600 may be used to alternately drive both ultrasonic and RF electrodes.

Driver circuit 3686 provides left and right RF energy outputs. Digital signals representing signal waveforms are provided to the SCL-A and SDA-A inputs of analog multiplexer 3680 from a control circuit, such as control circuit 3200 (FIG. 20). A digital-to-analog converter 3690 (DAC) converts the digital input to an analog output to drive a PWM circuit 3692 coupled to an oscillator 3694. PWM circuit 3692 provides a first signal to a first gate drive circuit 3696a coupled to a first transistor output stage 3698a to drive the first RF+ (left) energy output. PWM circuit 3692 also provides a second signal to a second gate drive circuit 3696b coupled to a second transistor output stage 3698b to drive the second RF (right) energy output. A voltage sensor 3699 is coupled between the RF Left/RF Output terminals to measure the output voltage. The driver circuit 3686, the first and second driver circuits 3696a and 3696b, and the first and second transistor output stages 3698a and 3698b define a first stage amplifier circuit. In operation, the control circuit 3200 (FIG. 20) generates a digital waveform 4300 (FIG. 29) using circuitry such as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 27 and 28). The DAC 3690 receives the digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

24 is a circuit diagram of a transformer 3700 coupled to the electrical circuit 3600 shown in FIG. 23 , in accordance with at least one embodiment of the present disclosure. The RF+/RF input terminal (primary winding) of the transformer 3700 is electrically coupled to the RF+/RF output terminal of the electrical circuit 3600. One side of the secondary winding is coupled in series with a first blocking capacitor 3706 and a second blocking capacitor 3708. The second blocking capacitor is coupled to the positive terminal of a second stage RF drive circuit 3774 a. The other side of the secondary winding is coupled to the negative terminal of a second stage RF drive circuit 3774 b. The positive output of the second stage RF drive circuit 3774 a is coupled to the ultrasonic blade, and the negative ground terminal of the second stage RF drive circuit 3774 b is coupled to the outer tube. In one embodiment, the transformer has an _n1 : _n2 ratio of 1:50.

FIG. 25 is a circuit diagram of a circuit 3800 with separate power supplies for the high-power energy/drive circuitry and the low-power circuitry, in accordance with at least one aspect of the present disclosure. The power supply 3812 includes a primary battery pack including a first primary battery 3815 and a second primary battery 3817 (e.g., Li-ion batteries) that are connected to the circuit 3800 by a switch 3818 when the power supply 3812 is inserted into the battery assembly, and a secondary battery pack including a secondary battery 3820 that is connected to the circuit by a switch 3823. The secondary battery 3820 is an anti-sag battery with components that are resistant to gamma or other radiation sterilization. For example, a switch-mode power supply 3827 and optional charging circuitry within the battery assembly can be incorporated to enable the secondary battery 3820 to reduce voltage sags in the primary batteries 3815, 3817. This ensures fully charged cells at the start of surgery for easy introduction into the sterile field. Primary batteries 3815, 3817 can be used to directly power the motor control circuit 3826 and the energy circuit 3832. The motor control circuit 3826 is configured to control a motor, such as motor 3829. The power supply/battery pack 3812 may comprise a dual-type battery assembly including primary Li-ion batteries 3815, 3817 and a secondary NiMH battery 3820, with a dedicated energy cell 3820 for controlling the handle electronics circuit 3830 from the dedicated energy cell 3815, 3817 for running the motor control circuit 3826 and the energy circuit 3832. In this case, if the primary batteries 3815, 3817 involved in driving the energy circuit 3832 and/or the motor control circuit 3826 drop low, the circuit 3810 will draw from the secondary battery 3820 involved in driving the handle electronics circuit 3830. In one various aspect, the circuit 3810 may include a one-way diode that does not allow current to flow in the opposite direction (e.g., from the battery responsible for powering the energy and/or motor control circuitry to the battery responsible for powering the electronics circuitry).

Additionally, a gamma-friendly charging circuit can be provided that includes a switch-mode power supply 3827 that uses diode and vacuum tube components to minimize voltage sag at a predetermined level. By including a minimum sag voltage that is a division of the NiMH voltage (three NiMH cells), the switch-mode power supply 3827 can be eliminated. Furthermore, a modular system can be provided in which radiation-hardened components are located within a module, making the module sterilizable by radiation sterilization. Other non-radiation-hardened components can be included with other modular components and connections made between modular components, allowing the components to operate together as if they were located together on the same circuit board. When only two NiMH cells are desired, a switch-mode power supply 3827 based on diodes and vacuum tubes allows for sterilizable electronics within a disposable primary battery pack.

Referring now to FIG. 26, there is shown a control circuit 3900 for operating an RF generator circuit 3902 powered by a battery 3901 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 procedure on living tissue using both ultrasonic vibrations and high frequency current, and to perform a surgical coagulation procedure on living tissue using high frequency current.

FIG. 26 illustrates a control circuit 3900 that enables a dual generator system to switch between the energy modalities of the RF generator circuit 3902 and the ultrasonic generator circuit 3920 for a surgical instrument of the surgical system 1000. In one aspect, a current threshold in the RF signal is detected. When tissue impedance is low, high frequency current through the tissue is high when RF energy is used as the tissue treatment source. According to at least one aspect, a visual indicator 3912 or light located on the surgical instrument of the surgical system 1000 may be configured to be in an ON state during this high current period. When the current falls below the threshold, the visual indicator 3912 is in an OFF state. Thus, the phototransistor 3914 can be configured to detect the transition from an ON state to an OFF state and release the RF energy, as shown in the control circuit 3900 illustrated in FIG. 26. Thus, when the energy button is released and the energy switch 3926 is opened, the control circuit 3900 is reset, and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 are held in an OFF state.

26 , in one aspect, a method of managing an RF generator circuit 3902 and an ultrasonic generator circuit 3920 is provided. The RF generator circuit 3902 and/or the ultrasonic generator circuit 3920 may be located, for example, within the handle assembly 1109, the ultrasonic transducer/RF generator assembly 1120, the battery assembly, the shaft assembly 1129, and/or the nozzle of the multifunction electrosurgical instrument 1108. The control circuit 3900 is held in a reset state when the energy switch 3926 is off (e.g., open). 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 depressed 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 is illuminated while tissue impedance is low. The light from the visual indicator 3912 provides a logic signal to maintain the ultrasonic generator circuit 3920 in an off state. Once the tissue impedance increases above a threshold and the radio frequency current through the tissue decreases below the threshold, the visual indicator 3912 turns off and the light transitions to an off state. This transition generates a logic signal that turns off the relay 3908, thereby turning off the RF generator circuit 3902 and turning on the ultrasonic generator circuit 3920, completing the coagulation and cutting cycle.

Continuing with reference to FIG. 26 , in one aspect, a dual generator circuit configuration employs, for one modality, an on-board RF generator circuit 3902 powered by a battery 3901 and a second on-board ultrasonic generator circuit 3920 that may be on-board, for example, within the handle assembly 1109, battery assembly, shaft assembly 1129, nozzle, and/or ultrasonic transducer/RF generator assembly 1120 of the multifunction electrosurgical instrument 1108. The ultrasonic generator circuit 3920 is also powered by the battery 3901. In various aspects, the RF generator circuit 3902 and the ultrasonic generator circuit 3920 may be integral or separable components of the handle assembly 1109. According to various aspects, having the dual RF/ultrasonic generator circuits 3902, 3920 as part of the handle assembly 1109 may eliminate the need for complex wiring. The RF/ultrasonic generator circuits 3902, 3920 may be configured to provide the full capabilities of existing generators while simultaneously utilizing the capabilities of a cordless generator system.

Either type of system can have separate controls for the modalities that do not communicate with each other. The surgeon activates RF and ultrasound separately and at will. Another approach is to provide a fully integrated communication scheme that shares buttons, tissue status, instrument actuation parameters (e.g., jaw closure, force, etc.), and algorithms for managing tissue manipulation. Various combinations of this integration can be implemented to provide the appropriate level of functionality and performance.

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

The visual indicator 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 as well as other electrosurgical systems and tools, such as those described herein. A first winding 3910a of the step-up transformer 3904 is connected in series with the return electrode 3906b, and a second winding 3910b of the step-up transformer 3904 is connected in series with resistor R2 and the visual indicator 3912, which may comprise, for example, an NE-2 type neon bulb.

In operation, when the switch contact 3909 of the relay 3908 is open, the active electrode 3906a is isolated from the positive terminal 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. As a result, the visual indicator 3912 is not energized and does not illuminate. When the switch contact 3909 of the relay 3908 is closed, the active electrode 3906a is connected to the positive terminal of the bipolar RF generator circuit 3902, thereby allowing 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, for example, 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, providing a first voltage across the first winding 3910a of the step-up transformer 3904. A boosted second voltage is induced across the second winding 3910b of the step-up transformer 3904. A secondary voltage appears across resistor R2, energizing the visual indicator 3912 and illuminating the neon bulb when the current through the tissue is greater than a predetermined threshold. It will be understood that the circuit and component values are exemplary and not limiting. When the switch contact 3909 of the relay 3908 closes, current flows through the tissue and the visual indicator 3912 is turned on.

Referring 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 off, preventing current from flowing through the winding of the electromagnet 3936. When the electromagnet 3936 is de-energized, the switch contact 3909 of the relay 3908 remains open, preventing current from flowing through the electrodes 3906a and 3906b. 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, turning off the ultrasonic generator circuit 3920.

The output goes high and is applied to the other input of AND gate 3932 .

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

As mentioned above, the magnitude of the current flowing through electrodes 3906a, 3906b depends on the impedance of the tissue located between electrodes 3906a and 3906b. Initially, the tissue impedance is low and the magnitude of the current through the tissue and first winding 3910a is high. Therefore, the voltage applied to second winding 3910b is high enough to turn on visual indicator 3912. Light emitted by visual indicator 3912 turns on phototransistor 3914, which pulls the input of inverter 3916 low and the output of inverter 3916 high. A high input applied to CLK of flip-flop 3918 causes Q or

The output is unaffected and the Q output remains low.

The output remains high, therefore 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 multifunction electrosurgical instrument are not activated.

As the tissue between electrodes 3906a and 3906b dries due to heat generated by the current flowing through the tissue, the tissue impedance increases and the current therethrough decreases. As the current through first winding 3910a decreases, the voltage across second winding 3910b also decreases, and when the voltage falls below the minimum threshold required to operate visual indicator 3912, visual indicator 3912 and phototransistor 3914 turn off. When phototransistor 3914 turns 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, driving a logic high to the Q output and a logic low to the CLK input of flip-flop 3918.

A logic high at the Q output turns on the ultrasonic generator circuit 3920, activating the ultrasonic transducer 3922 and ultrasonic blade 3924 to begin cutting the tissue located between the electrodes 3906a and 3906b. At or about the same time that the ultrasonic generator circuit 3920 turns on, the flip-flop 3918

The output goes low, causing the output of AND gate 3932 to go low, turning off transistor 3934, thereby de-energizing electromagnet 3936 and opening switch contacts 3909 of relay 3908 to interrupt the flow of current through electrodes 3906a, 3906b.

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

While the user holds the energy switch 3926 on the instrument handle to keep it closed, the Q and Q of the flip-flop 3918 are

The state of the output remains the same. Thus, while no current is flowing 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 in the instrument handle, the energy switch 3926 opens, causing the output of the first inverter 3928 to go low and the output of the second inverter 3930 to go high, resetting the flip-flop 3918 and driving the Q output low to turn off the ultrasonic generator circuit 3920. At the same time,

The output goes high, whereupon the circuit is in the off state and ready for the user to activate the energy switch 3926 on the instrument handle, closing the energy switch 3926 and applying current to the tissue located between electrodes 3906a and 3906b, and repeating the cycle of applying RF energy to the tissue and ultrasonic energy to the tissue as described above.

In one aspect, the ultrasonic or radio frequency current generator of the surgical system 1000 can be configured to digitally generate the electrical signal waveform, desirably using a predetermined number of phase points stored in a lookup table to digitize the waveform. The phase points may be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 27 illustrates one aspect of a basic architecture for a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit 4100, configured to generate multiple waveforms for the electrical signal waveform. The generator software and digital control can instruct the FPGA to scan addresses in the lookup table 4104, which in turn provides various digital input values to the DAC circuit 4108 that feeds the power amplifier. The addresses may be scanned according to the desired frequency. Using such a lookup table 4104 allows for the generation of various types of waveforms that can be delivered into tissue, or into a transducer, an RF electrode, multiple transducers simultaneously, multiple RF electrodes simultaneously, or a combination of RF and ultrasonic instruments. Additionally, multiple lookup tables 4104 representing multiple waveforms can be created, stored, and applied to tissue from the generator.

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

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

With the widespread use of digital technology in instrumentation and communication systems, a digitally controlled method for generating multiple frequencies from a reference frequency has evolved, known as direct digital synthesis. The basic architecture is shown in Figure 27. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic of the generator circuit and to a memory circuit located within the generator circuit of the surgical system 1000. The DDS circuit 4100 comprises an address counter 4102, a look-up table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. A stable clock f _c is received by the address counter 4102, and the register 4106 drives a programmable read-only memory (PROM) that stores one or more integer numbers of cycles of a sine wave (or any other waveform) in the look-up table 4104. As the address counter 4102 steps through the memory locations, the values stored in the lookup table 4104 are written to a register 4106 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 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 is essentially that of the reference clock f _c . The first analog output signal 4110 output from the DAC circuit 4108 is filtered by a filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal has a frequency f _out .

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

The DDS circuit 4100 may include multiple lookup tables 4104, each storing waveforms represented by a predetermined number of samples, which define a predetermined waveform shape. Thus, multiple waveforms with unique shapes can be stored in the multiple lookup tables 4104 to provide various tissue treatments based on instrument settings or tissue feedback. Example waveforms include RF electrical signal waveforms with high crest factors for superficial tissue coagulation, RF electrical signal waveforms with low crest factors for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. In one aspect, the DDS circuit 4100 can create multiple waveform lookup tables 4104 and switch between various waveforms stored in the individual lookup tables 4104 during a tissue treatment procedure (e.g., "on the fly" or in substantial real time based on user or sensor input) based on the desired tissue effect and/or tissue feedback. Thus, switching between waveforms can be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4104 can store an electrical signal waveform (i.e., a trapezoidal or square wave) configured to maximize the power delivered into tissue per cycle. In other aspects, the lookup table 4104 can store synchronized waveforms that maximize power delivery by the multifunction surgical instrument of the surgical system 1000 while delivering RF and ultrasonic drive signals. In still other aspects, the lookup table 4104 can store electrical signal waveforms that simultaneously drive ultrasonic and RF therapeutic and/or sub-therapeutic energy while maintaining ultrasonic frequency lock. Custom waveforms specific to various instruments and their tissue effects can be stored in the generator circuit's non-volatile memory or in the surgical system 1000's non-volatile memory (e.g., EEPROM) and fetched upon connecting a multifunction surgical instrument to the generator circuit. An example of an exponentially decaying sinusoidal waveform, as used for many high crest factor "coagulation" waveforms, is shown in FIG. 29.

A more flexible and efficient implementation of the DDS circuit 4100 uses a digital circuit called a numerically controlled oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit, such as DDS circuit 4200, is shown in FIG. 28. In this simplified block diagram, the DDS circuit 4200 is coupled to the processor, controller, or logic of the generator and to memory circuitry located either in the generator or in the surgical instrument of the surgical system 1000. The DDS circuit 4200 comprises a load register 4202, a parallel delta phase register 4204, a summer circuit 4216, a phase register 4208, a look-up table 4210 (phase-to-amplitude converter), a DAC circuit 4212, and a filter 4214. The summer circuit 4216 and the phase register 4208 form part of a phase accumulator 4206. A clock frequency f _c is applied to the phase register 4208 and the DAC circuit 4212. Load register 4202 receives an adjustment word that specifies the output frequency as a fraction of the reference clock frequency signal f _c The output of load register 4202, along with adjustment word M, is provided to parallel delta phase register 4204.

DDS circuit 4200 includes a sample clock generating a clock frequency f _c , a phase accumulator 4206, and a look-up table 4210 (e.g., a phase-to-amplitude converter). The contents of phase accumulator 4206 are updated once every clock cycle f _c . When phase accumulator 4206 is updated, a digital number M stored in parallel delta phase register 4204 is added to the number in phase register 4208 by adder circuit 4216. Assume the number in parallel delta phase register 4204 is 00...01 and the initial contents of phase accumulator 4206 are 00...00. Phase accumulator 4206 is updated to 00...01 every clock cycle. If phase accumulator 4206 is 32-bit wide, then when phase accumulator 4206 is 00...00, the digital number M is added to the number in phase register 4208 by adder circuit 4216. It takes 232 clock cycles (over 4 billion) to wrap around to 00 and then the cycle repeats.

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

In one aspect, the electrical signal waveform may be digitized into 1024 (210) phase points, although the waveform that may be digitized may be any suitable number of 2n phase points ranging from 256 (28) to 281,474,976,710,656 (248), where n is a positive integer as shown in Table 1. The electrical signal waveform may be represented as A _n (θ _n ), where the normalized amplitude A _n at point n is represented by the phase angle θ _n and is referred to as the phase point at point n. The number of distinct phase points n determines the adjustment resolution of DDS circuit 4200 (and DDS circuit 4100 shown in FIG. 21 ).

Table 1 specifies the electrical signal waveform digitized into multiple phase points.

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

Referring again to FIG. 21, when n=32 and M=1, the phase accumulator 4206 steps through 232 possible outputs before overflowing and restarting. The corresponding output wave frequency is equal to the input clock frequency divided by 232. When M=2, the phase register 1708 "rolls over" twice as fast, doubling the output frequency. This can be generalized as follows:

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

The above equation is known as the DDS "tuning equation." The system's frequency resolution is:

Note that with n=32, the resolution is greater than a fraction in 4 billion. In one aspect of DDS circuit 4200, not all bits outside of phase accumulator 4206 are passed to lookup table 4210, but are truncated, leaving, for example, only the first 13-15 most significant bits (MSBs). This reduces the size of lookup table 4210 and does not affect the frequency resolution. The 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. Furthermore, if the surgical instruments of the surgical system 1000 include ultrasonic components, the electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Thus, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, the electrical signal waveform characterized by a predetermined waveform stored in the lookup table 4210 (or the lookup table 4104 of FIG. 27). Note that the electrical signal waveform may be a combination of two or more waveforms. The lookup table 4210 may contain information related to multiple waveforms. In one aspect or embodiment, the lookup table 4210 may be generated by the DDS circuit 4200 and may be referred to as a direct digital synthesis table. The DDS operates by first storing a large, repeating waveform in on-board memory. A cycle of a waveform (sine, triangle, square, or any) may be represented by a predetermined number of phase points and stored in memory, as shown in Table 1. Once the waveform is stored in memory, it can be generated at very precise frequencies. The direct digital synthesis table may be stored in non-volatile memory of the generator circuitry and/or implemented with FPGA circuitry within the generator circuitry. The lookup table 4210 may be addressed by any suitable technique convenient for categorizing waveforms. According to one aspect, the lookup table 4210 is addressed according to the frequency of the electrical signal waveform. Additionally, information related to multiple waveforms may be stored as digital information in memory or as part of the lookup table 4210.

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

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

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

In addition to traditional sine/cosine waveforms, the generator circuit may be configured to generate waveform(s) (i.e., trapezoidal or square waves) that maximize power to the tissue per cycle. If the generator circuit includes a circuit topology that allows for simultaneous driving of RF and ultrasonic signals, the generator circuit can provide waveform(s) that are synchronized to maximize power delivered to the load and maintain ultrasonic frequency lock when simultaneously driving RF and ultrasonic signals. Furthermore, custom waveforms specific to an instrument and its tissue effect can be stored in non-volatile memory (NVM) or in the instrument's EEPROM and fetched upon connecting any one of the surgical instruments of the surgical system 1000 to the generator circuit.

The DDS circuit 4200 may include multiple lookup tables 4210, each storing waveforms represented by a predetermined number of phase points (sometimes called samples), which define the shape of a given waveform. Thus, multiple waveforms with unique shapes can be stored in the multiple lookup tables 4210 to provide various tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include RF electrical signal waveforms with high crest factors for superficial tissue coagulation, RF electrical signal waveforms with low crest factors for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. In one aspect, the DDS circuit 4200 can create multiple waveform lookup tables 4210 and switch between the various waveforms stored in the various lookup tables 4210 during a tissue treatment procedure (e.g., "on the fly" or in substantial real time based on user or sensor input) based on the desired tissue effect and/or tissue feedback. Thus, switching between waveforms can be based, for example, on tissue impedance and other factors. In other aspects, the lookup table 4210 can store an electrical signal waveform (i.e., a trapezoidal wave or a square wave) that is shaped to maximize the power delivered into tissue per cycle. In other aspects, the lookup table 4210 can store synchronized waveforms that maximize power delivery by any one of the surgical instruments of the surgical system 1000 when delivering RF and ultrasonic drive signals. In still other aspects, the lookup table 4210 can store electrical signal waveforms that simultaneously drive ultrasonic and RF therapeutic and/or sub-therapeutic energy while maintaining ultrasonic frequency lock. In general, the output waveforms may be in the form of sine waves, cosine waves, pulse waves, square waves, etc. Nevertheless, more complex custom waveforms specific to different instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory (e.g., EEPROM) of the surgical instrument and can be fetched upon connection of the surgical instrument to the generator circuit. An example of a custom waveform is an exponentially decaying sinusoidal waveform, as used in many high crest factor "coagulation" waveforms, as shown in Figure 23.

FIG. 29 illustrates one cycle of a discrete-time digital electrical signal waveform 4300 (shown superimposed on a discrete-time digital electrical signal waveform 4300 for comparison purposes) according to at least one aspect of the present disclosure of an analog waveform 4304. The horizontal axis represents time (t) and the vertical axis represents digital phase points. The digital electrical signal waveform 4300 is, for example, a digital, discrete-time version of the desired analog waveform 4304. The digital electrical signal waveform 4300 is generated by storing amplitude phase points 4302, which represent the amplitude per clock _cycle T _over one cycle or period T. The digital electrical signal waveform 4300 is generated over one period _T by any suitable digital processing circuitry. The amplitude phase points are digital words stored in a memory circuit. In the examples shown in FIGS. 27 and 28, the digital words are 6-bit words capable of storing amplitude phase points with 26 or 64 bits of resolution. It will be understood that the examples shown in Figures 27 and 28 are for illustrative purposes, and that in an actual implementation the resolution may be much higher. The digital magnitude phase points 4302 over one cycle _To are stored in memory as a string of string words in lookup tables 4104, 4210, for example, as described with respect to Figures 27 and 28. The magnitude phase points 4302 are read sequentially from 0 to To every clock cycle _Tclk and converted by DAC circuitry 4108, 4212 to generate an analog version of the analog waveform 4304, also as described with respect to Figures 27 and _28. Additional cycles can be generated by repeatedly reading the magnitude phase points 4302 of the digital electrical signal waveform 4300 from 0 to _To for as many cycles or periods as may be desired. A smooth analog version of the analog waveform 4304 is achieved by filtering the output of the DAC circuit 4108, 4212 by a filter 4112, 4214 (FIGS. 27 and 28). The filtered analog output signal 4114, 4222 (FIGS. 27 and 28) is applied to the input of the power amplifier.

Advanced RF Energy Devices Including Nerve Stimulation Signals with Therapeutic Waveforms As mentioned above, in some surgical procedures, medical professionals may use electrosurgical devices to seal or cut tissue, such as blood vessels. Such devices perform medical treatment by passing electrical energy, such as radio frequency (RF) current, through the tissue being treated. Some electrosurgical devices are referred to as bipolar devices because both the electrode that generates the electrical energy (the active electrode) and the return electrode are housed within the same surgical probe. It will be understood that the surgical probe may include a handpiece or a robotic control instrument, or a combination thereof.

Alternative devices include those referred to as monopolar devices. In such devices, only the active electrode is contained within the surgical probe. Current entering the patient's tissue may return to the electrical energy generator via an electrical pathway through a gurney on which the patient lies or through a specific return electrode pad. In some variations, the patient may recline on the electrode pad. Alternatively, the electrode pad may be positioned on the patient near the surgical site where the surgical probe is deployed. The current path through a patient undergoing treatment using a monopolar device may be less easily identified than the current path through a patient undergoing treatment using a bipolar device. As a result, with monopolar electrosurgical devices, some non-target tissue may be unintentionally cauterized, cut, or otherwise damaged. Such unintentional damage to excitable tissue may result in muscle weakness, pain, numbness, paralysis, and/or other undesirable conditions in the patient.

Therefore, it is desirable for monopolar electrosurgical devices to incorporate features for determining whether the device is in close enough proximity to excitable tissue to cause unintended damage. Such features may be used by one or more subsystems of the electrosurgical device as criteria for notifying a medical professional that such tissue is in close proximity to the monopolar electrode. Additionally, such features may be used by one or more subsystems of an intelligent electrosurgical device to reduce or eliminate the amount of treatment energy delivered to tissue deemed to be in close proximity to non-target excitable tissue. In some intelligent medical devices that combine ultrasonic treatment modes with electrosurgery (RF), a feature for determining close enough proximity to cause unintended damage may cause the device to switch to ultrasonic mode when the device is operating in electrosurgical (RF) mode.

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

Figure 30 shows 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. Typically, the generator 136012 may supply an electrical signal to the electrosurgical instrument 136015 along a first conductive electrical pathway 136017 and may receive a return signal from one or more return electrodes along a second conductive electrical pathway 136023. Figure 30 shows an example of a medical 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 electrical components shown in FIG. 30. The generator 136012 may be a separate component from the controller 136010, or the controller 136010 may include the electrical generator 136012. The controller 136010 may perform operational control of the generator 136012, including controlling the electrical output of the generator 136012. As disclosed below, the controller 136010 may perform one or more output waveform controls of the electrical generator 136012, including control of various characteristics, including amplitude, frequency, and phase characteristics, of the output signal of the electrical generator 136012. The controller 136010 may further receive signals from any number of additional components, including, but not limited to, manual control actuators (switches, push buttons, slides, and the like), sensors, or may receive data signals transmitted by any number of communication devices, computers, smart surgical device sensors, 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), depending on the controller functionality required. The memory components of the controller 136010 may contain one or more instructions that, when read by the one or more computer processor devices, may direct the operation of the controller. Examples of such instructions and their intended results are disclosed below.

Electrical energy may be supplied by the electrical generator 136012 and received by the 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 electrical generator 136012 to receive the electrical energy. In some aspects, the surgical instrument 136015 may receive the electrical signal via a first conductive electrical pathway 136017, such as a wire or other cable.

During the procedure, the patient 136027 may lie supine on the return pad 136020. The return pad 136020 may be in electrical communication with the electrical generator 136012 via an electrical return terminal, and electrical energy delivered into the patient 136027 by an electrosurgical instrument 136015, such as an active electrode, may be returned to the electrical generator 136012 through the return pad 136020. In some aspects, the return pad 136020 may be in electrical communication with the electrical return terminal via a second electrically conductive electrical pathway 136023, such as a wire or other cable.

In some aspects, the generator 136012 may supply alternating current at high frequency levels to the electrosurgical instrument 136015. In some alternative aspects, the electrosurgical instrument 136015 may also incorporate features for an ultrasonic treatment mode, and the generator 136012 may also be configured to generate power to drive one or more ultrasonic treatment components. The electrosurgical instrument 136015, which typically includes an electrode tip (i.e., active electrode) that may be placed on target tissue of the patient 136027, receives alternating current from the generator 136012 and delivers the alternating current to the target tissue via the electrode tip. The alternating current received by the electrode tip may be transmitted from the generator 136012 via a first conductive electrical pathway 136017. The alternating current is received by the target tissue, and resistance from the tissue generates heat that produces the desired effect (e.g., sealing and/or cutting) at the surgical site. The alternating current received at the target tissue is conducted through the patient's body and ultimately received by one or more return electrodes of the return pad 136020. The alternating current received by the return pad 136020 may be returned to the generator via a second conductive electrical pathway 136023, completing a closed circuit through which the alternating current flows. 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 spaced some distance from the patient's body (i.e., capacitively coupled). The alternating current received by the one or more return electrodes may be returned to the generator 136012, completing a closed circuit through which the alternating current flows.

In electrosurgical system 136000, which utilizes capacitive coupling to complete the current path between the patient's body and the return electrode, the patient's body effectively acts as the first capacitive plate of a capacitor, and the return electrode pad effectively acts as the 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 may include an array of return electrodes, and an array of sensing devices may be incorporated into the array of return electrodes. In one non-limiting example, the return pad 136020 may include multiple return electrodes, each including a sensing device.

By incorporating an array of sensing devices into the return electrode pad 136020, the sensing devices can be used to detect either the neurocontrol signals applied to the patient or the movement of the patient's anatomical features resulting from the application of the neurocontrol signals. The sensing devices can 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 devices can be configured to output signals indicative of the detected neurocontrol signals and/or the detected movement of the patient's anatomical features. Utilizing Coulomb's law and the respective positions of the active electrode, the patient's body, and the sensing devices, the detected neurocontrol signals and/or the movement of the patient's anatomical features can be analyzed to determine the location of the nerve within the patient's body.

In some aspects, as shown in FIG. 32 , for example, the return pad 136120 may include a plurality of electrodes 136125 that may be capacitively coupled to the patient's body and collectively configured to carry the amount of current introduced into the patient's body by the electrosurgical instrument. With this capacitive coupling, the patient's body effectively acts as one plate of a capacitor, and the plurality of electrodes 136125 of the return pad 136120 collectively act as the other plate of the capacitor. A more detailed description of capacitive coupling can be found, for example, in U.S. Pat. No. 6,214,000, issued April 10, 2001, entitled "CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE," and U.S. Pat. No. 6,582,424, issued June 24, 2003, entitled "CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE," the contents of which are incorporated herein by reference in their entireties.

31 illustrates multiple electrodes 136125a-d of the return pad of FIG. 30 in accordance with at least one aspect of the present disclosure. While four electrodes 136125a-d are illustrated in FIG. 31, it will be understood that the return pad 136120 may include any number of electrodes 136125. For example, according to various aspects, the return pad 136120 may include two electrodes, eight electrodes, sixteen electrodes, or any number of electrodes that may be fabricated within the return pad 136120. It will be understood that the number of electrodes may be an even integer or an odd integer. Additionally, while the individual electrodes 136125a-d are illustrated in FIG. 31 as being substantially rectangular, it will be understood that the individual electrodes may be any suitable shape.

The electrodes 136125a-d of the return pad 136120 may function as return electrodes for the electrosurgical system of FIGS. 30 and 31 . Furthermore, the electrodes 136125a-d may be selectively isolated from the patient's body and/or the generator and may therefore be considered segmented electrodes. In some aspects, the electrodes 136125a-d of the return pad 136120 may be coupled to one another to effectively act as one large electrode. For example, according to various aspects, each of the electrodes 136125a-d of the return pad 136120 may be connected to an input of the switching device 136135 by a respective conductive member 136130a-d, as shown in FIG. 32 . When the switching device 136135 is in the open position, as shown in FIG. 32 , the respective electrodes 136125a-d of the return pad 136120 are isolated from one another from the patient's body and/or the generator. On the other hand, when the switching device 136135 is in the closed position, the electrodes 136125a-d of the return pad 136120 are coupled together to effectively act as a single large electrode. It will be appreciated that the electrodes 136125a-d may be coupled together in different combinations by the switching device 136135 to form any one or more electrode groups. For example, if a patient lies supine on the return pad 136120 with the patient's head positioned adjacent to electrodes 136125a and 136125c of the switching device 136135, electrodes 136125b and 136125d may be coupled together to sense current flowing through the lower torso and upper torso, respectively. Alternatively, if the patient lies supine on the return pad 136120 and the patient's head is positioned adjacent to electrodes 136125a and 136125b of the switching device 136135, electrodes 136125c and 136125d may be coupled to each other, thereby sensing current flowing through the lower torso and upper torso, respectively.

The switching device 136135 can be controlled by a processing circuit (e.g., a processing circuit of a generator of an electrosurgical system, a hub of an electrosurgical system, etc.). For simplicity, the processing circuit is not shown in FIG. 32. According to various aspects, the switching device 136135 can be incorporated into the return pad 136120. According to other aspects, the switching device 136135 can be incorporated into the second conductive electrical pathway of the electrosurgical system of FIGS. 30 and 31. The return pad 136120 can also include multiple sensing devices.

33 illustrates an array of sensing devices 136140a-d on a return pad, according to at least one aspect of the present disclosure. According to various aspects, the number of sensing devices 36140a-d may correspond to the number of electrodes 36125a-d, such that one sensing device is provided for each electrode (e.g., sensing device 36140a with electrode 136125a, sensing device 36140b with electrode 136125b, sensing device 36140c with electrode 136125c, and sensing device 36140d with electrode 136125d). Each sensing device 36140a-d may be attached to or integrated with a corresponding electrode 136125a-d, respectively. However, it will be understood that while the number of sensing devices 36140a-d associated with corresponding electrodes 136125a-d may correspond to the number of electrodes, the return pad may include any number of sensing devices. For example, in an embodiment of a return pad including 16 electrodes, the return pad may include only four or eight sensing devices. While the sensing devices 136140a-d are shown in FIG. 33 as being centered on their respective corresponding electrodes 136125a-d, it will be understood that the sensing devices 136140a-d may be located on any portion of the corresponding electrodes 136125a-d. It will be further understood that the location of a particular sensing device on a particular electrode is independent of the location of any other sensing devices on the respective electrode.

The sensing devices 136140a-d are configured to detect monopolar neural control signals applied to the patient and/or movement of a patient's anatomical feature (e.g., muscle contraction) resulting from the application of the neural control signals. The monopolar neural control signals may be applied by a surgical instrument of the electrosurgical system of FIGS. 30 and 31 . Alternatively, the monopolar neural control signals may be applied by different surgical instruments coupled to different generators. Each sensing device 136140a-d 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 a signal indicative of the detected movement of the patient's anatomical feature. In some non-limiting examples, sensing devices comprising pressure sensors may include, for example, piezoresistive strain gauges, capacitive pressure sensors, electromagnetic pressure sensors, and/or piezoelectric pressure sensors, alone or in combination. In some non-limiting examples, the sensing devices comprising accelerometers may include, for example, mechanical accelerometers, capacitive accelerometers, piezoelectric accelerometers, electromagnetic accelerometers, and/or microelectromechanical systems (MEMS) accelerometers, alone or in combination. The output signal of each of the sensing devices 136140a-d may be in the form of an analog signal and/or a digital signal.

Using Coulomb's law and the respective positions of the surgical instrument's active electrode, the patient's body, and each sensing device, the output signal of each sensing device 136140a-d, indicative of detected neural control signals and/or movement of the patient's anatomical features, can be analyzed to determine the location of the nerve within the patient's body. Coulomb's law is E=K(Q/ ^r² ), where E is the threshold current required for neural stimulation at the nerve, K is a constant, Q is the minimum current from the neural stimulation electrode, and r is the distance from the nerve. The current required to stimulate the nerve increases in proportion to the distance from the neural stimulation electrode to the nerve (as r increases). Therefore, the amount of stimulation of the excitable tissue measured by the sensing devices 136140a-d can be related to the distance of the neural stimulation electrode to the excitable tissue during constant current stimulation. In some aspects, the output signal of the sensing devices 136140a-d can also depend on the distance of the excitable tissue from the sensing devices 136140a-d. It will be appreciated that multiple sensing devices 136140a-d can be used to triangulate the location of electrically stimulable excitable tissue based on the geometry and location of the multiple sensing devices 136140a-d. Thus, constant current stimulation can be utilized to estimate the distance from the neural stimulation electrode to the nerve. Alternatively, current stimulation comprised of varying amounts of current can be used to improve the location of excitable tissue via triangulation associated with the multiple sensing devices 136140a-d. Generally, the respective strengths of the output signals of each sensing device indicate how close or far the respective sensing device is from the patient's stimulated nerve.

According to various aspects, analysis of each output signal of each sensing device can be performed by processing circuitry of a neuromonitoring system separate from the generator of the electrosurgical system, such as by processing circuitry of an electrosurgical system hub, by processing circuitry of the generator of the electrosurgical system of FIGS. 30 and 31 . The analysis can be performed in real time or near real time. According to various aspects, each output signal serves as an input to a monopolar nerve stimulation algorithm executed by the processing circuitry.

According to various aspects, as shown in FIG. 33 , the output signals of each of the sensing devices 136140a-d can be input to a multiple-input, single-output switching device 136137 (e.g., a multiplexer) via respective conductive members 136142a-d. By controlling the select signals S0, S1 to the multiple-input, single-output switching device 136137, the multiple-input, single-output switching device 136137 can be controlled to output only one of the output signals of each of the sensing devices 136140a-d for analysis as described above. As a non-limiting example, with reference to FIG. 33 , setting the select signals S0, S1 to 0, 0 can cause the output signal from sensing device 136140c to be output by the multiple-input, single-output switching device 136137 for analysis by applicable processing circuitry. As another non-limiting example, by setting select signals S0 and S1 to 0 and 1, the output signal from detector device 136140a can be output by multiple-input, single-output switching device 136137 for analysis by applicable processing circuitry. Similarly, by setting select signals S0 and S1 to 1 and 0, the output signal from detector device 136140d can be output by multiple-input, single-output switching device 136137 for analysis by applicable processing circuitry. As a further extension, by setting select signals S0 and S1 to 1 and 1, the output signal from detector device 136140b can be output by multiple-input, single-output switching device 136137 for analysis by applicable processing circuitry.

The selection signals S0 and S1 may be provided to the multiple-input, single-output switching device 136137 by, by way of non-limiting example, a processing circuit such as the processing circuit of the generator of the electrosurgical system of FIGS. 30 and 31 , by a processing circuit of a nerve monitoring system separate from the generator of the electrosurgical system, by a processing circuit of a hub of the electrosurgical system, or the like. For simplicity, the processing circuit is not shown in FIG. 33 . By providing the various selection signals at a sufficiently high rate, the output signals of each of the sensing devices 136125a-d can be effectively scanned at a rate that allows for timely analysis of all of the output signals of each of the sensing devices 136125a-d to determine the location of the stimulated nerve.

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

The control of the multiple-input, single-output switching device 136137 disclosed in FIG. 33 may be in accordance with a four-input, single-output switching device corresponding to the four detector devices 136140a-d shown in FIG. 33. It should be understood that in embodiments where there are more than four detector devices (e.g., 16 detector devices), the output signals of the more than four detector devices may serve as inputs to a multiple-input, single-output switching device having more than two select signals (e.g., S0, S1, S2, and S3).

In embodiments where the detection device output signal (e.g., 136140a-d) is an analog signal, the output of the multiple-input single-output switching device 136137 may be converted to a corresponding digital signal by an analog-to-digital converter 136145 prior to analysis of the output signal by applicable processing circuitry.

Returning to FIG. 30 , in various aspects, detection of the patient's neural control signals and/or anatomical feature movement by the sensing device can be performed while the electrodes 136125a-d of the return pad 136120 are coupled to one another, or while the electrodes 136125a-d are not coupled to one another. For example, if detection is to be performed after positioning the patient on the operating table and before the start of a surgical procedure when the respective electrodes 136125a-d of the return pad 136120 are not coupled to one another, the return pad 136120 can be placed in a “sensing mode” by controlling the switching device 136135 to decouple the respective electrodes 136125a-d of the return pad 136120 from one another. While the respective electrodes 136125a-d are not coupled to one another, nerves and/or nerve bundles can be stimulated with the electrosurgical instrument described above, and the output signals of each of the sensing devices of the return pad 136120 can be analyzed as described above to identify the location of the associated nerve, nerve bundle, and/or nerve plexus. The location of the nerve, nerve bundle, and/or nerve plexus may be input into a monopolar nerve stimulation algorithm profile. When the location of the nerve, nerve bundle, and/or nerve plexus is input into a monopolar nerve stimulation algorithm profile, the location of the nerve, nerve bundle, and/or nerve plexus may be effectively isolated from the capacitive operation of the electrodes of the return pad 136120. The location of the nerve, nerve bundle, and/or nerve plexus may be used as a sensing node in the monopolar nerve stimulation algorithm profile to notify the surgeon when the surgeon approaches the nerve and/or nerve bundle while performing a tissue cutting procedure. According to various aspects, the location of the nearby nerve and/or nerve bundle may be communicated to the surgeon via an audio alert, a visual alert, a tactile (e.g., vibration) alert, etc.

Returning to FIG. 31 , according to various aspects, when sensing is performed with the electrodes of the return pad 136015 coupled together, the generator 136012 of the electrosurgical system may generate a high-frequency waveform (alternating current at high frequency) that may be modulated onto a carrier wave having a frequency low enough to stimulate the patient's nerve. This modulation may enable sensing of neural control signals and/or anatomical feature movement simultaneously with capacitive coupling of the electrodes of the return pad 136020 with the patient's body 136027. By applying a specific waveform to the patient 136027 and sensing a specific response, movement of the anatomical feature can be correlated with the applied waveform and not due to random patient movement, providing increased confidence. The modulation can be adjusted over time to stimulate different nerve sizes. According to various aspects, the amplitude of the modulation can be varied over time to allow applicable processing circuitry to determine the distance of the signal to the nerve and/or nerve bundle without the need to constantly stimulate the nerve and/or nerve bundle.

The electrical energy applied 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 below 5 MHz. Frequencies above 200 kHz may typically be used in monopolar applications to avoid unnecessary nerve and muscle stimulation resulting from the use of low-frequency currents. Lower frequencies may be used in bipolar applications if a risk analysis indicates that the potential for neuromuscular stimulation has been mitigated to an acceptable level. Typically, frequencies above 5 MHz are not used to minimize problems associated with high-frequency leakage currents. However, higher frequencies may be used with bipolar techniques. 10 mA is generally recognized as the lower threshold for thermal effects on tissue.

It should be understood that an electrosurgical device may utilize the response of excitable tissue to electrical frequencies below 200 kHz to determine whether such excitable tissue is sufficiently close to the end effector of the electrosurgical device. FIG. 34 illustrates an RF signal 136210 that may be used in an electrosurgical device to cut or cauterize tissue. Such an RF signal 136210 may be referred to as a therapeutic signal because it has a frequency that may produce a therapeutic result, such as cauterizing or cutting tissue. For illustrative purposes only, the x-axis may represent time, with each division representing 10 μsec, and the y-axis (amplitude) may have any value. Thus, the RF signal 136210 illustrated in FIG. 34 may have a frequency of approximately 1 MHz. It should be understood that an RF therapeutic signal may have any frequency, amplitude, and/or phase characteristics sufficient for therapeutic applications, such as sealing, cauterizing, ablation, or cutting of tissue.

FIG. 35 illustrates a signal 136220 that may be used to stimulate excitable tissue, such as nerve or muscle. Again, for illustrative purposes only, the signal 136220 illustrated in FIG. 35 may last approximately 20 microseconds and, when repeated, constitute a waveform having a frequency of approximately 50 kHz. Such an electrical signal 136220 may be referred to as a stimulation signal because it has 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 from the signal 136220 presented in FIG. 35 in any aspect, such as duration, frequency, or amplitude. In general, the stimulation signal 136220 may have any suitable waveform or amplitude, so long as it has a frequency within a range that can stimulate such excitable tissue. As noted above, such waveforms illustrated in FIGS. 34 and 35 are merely exemplary. In one alternative example, the therapeutic RF signal may have a frequency of approximately 330 kHz, and the waveform that stimulates the excitable tissue may have a frequency of approximately 2 kHz.

It should be understood that the intelligent electrosurgical device can be configured to emit either a therapeutic signal, a stimulation signal, or a combination thereof. FIGS. 36A-36C show example combinations of therapeutic and stimulation signals. The electrical generator may provide an output current comprised of any number or combination of characteristics of the therapeutic signal and the tissue stimulation signal. Non-limiting examples of characteristics of the therapeutic signal may include a therapeutic signal frequency, a therapeutic signal amplitude, and a therapeutic signal phase. Non-limiting examples of characteristics of the tissue stimulation signal may include a tissue stimulation signal frequency, a tissue stimulation signal amplitude, and a tissue stimulation signal phase. It should be understood that the therapeutic signal may be characterized by any number of frequencies, phases, and amplitudes. It should also be understood that the neural stimulation signal may be characterized by any number of frequencies, phases, and amplitudes. In some aspects, the controller may be configured to control the electrical generator to provide an electrical output including one or more combinations of characteristics of the therapeutic signal and the tissue stimulation signal.

FIG. 36A shows a non-limiting example of a first combination signal 136230 including a first therapeutic signal 136212a, a stimulation signal 136222, and a second therapeutic signal 136212b. As shown, one or more stimulation signals (such as signal 136220 of FIG. 35) may alternate with one or more therapeutic signals (such as signal 136210 of FIG. 34). It should be understood that the length of time for which one or more therapeutic signals (e.g., 136212a, b, etc.) are applied may be any length of time and may depend on the length of application time desired by a medical professional. It should also be understood that the stimulation signal 136222 may be transmitted at any time during the application of the therapeutic signals. Furthermore, it should be understood that one or more zero amplitude signals may be interspersed between one or more therapeutic signals and one or more stimulation signals. Multiple stimulation signals may be transmitted consecutively before a subsequent therapeutic signal is transmitted.

FIG. 36B shows a non-limiting example of a second combined therapeutic and stimulation signal 136240. In FIG. 36B, a stimulation signal (136220 shown in FIG. 35) can be used to modulate the amplitude of a therapeutic signal (136210 shown in FIG. 34). In some aspects, the stimulation signal 136220 can be applied directly to an amplitude modulation circuit to modulate the amplitude of the therapeutic signal 136210. In alternative aspects, the stimulation signal 136220 can be offset and scaled before being used to adjust the amplitude of the therapeutic signal 136210. As an example, the stimulation signal 136220 of FIG. 35 can be offset by +4.5 V and the resulting signal can be scaled by 4.5 V so that the amplitude of the therapeutic signal 136210 is modulated by a positive modulation signal that can range in value from about 0.1 V to about 2 V. It will be readily apparent that any simple transformation of the stimulation signal 136220 may be used to adjust the amplitude of the therapeutic signal 136210. It will be appreciated that the amplitude of the therapeutic signal 136210 may be modulated by the stimulation signal 136220 at any time or any number of times during application of the therapeutic signal. The amplitude of the therapeutic signal 136210 may be similarly modulated over the course of multiple periods of modulation. Alternatively, each amplitude modulation may differ according to an offset and/or scaling transformation of the stimulation signal 136220.

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

It should be understood that the combination of the stimulation signal with the therapeutic signal is not limited to the example disclosed above and shown in FIGS. 36A-36C. The stimulation signal may be combined with the therapeutic signal in the same manner throughout the electrosurgical procedure. Alternatively, the stimulation signal may be combined with the therapeutic signal in any of a number of different ways throughout the electrosurgical procedure. In some aspects, the stimulation signal may be combined with the therapeutic signal based on the selection of a medical professional during the electrosurgical procedure. For example, a surgical probe may include one or more controls that allow an operator of the electrosurgical device to select a mode of combination with the therapeutic signal. The surgical probe may also include one or more controls that allow an operator of the electrosurgical device to select the timing at which the stimulation signal may be applied. In some alternative aspects, a surgical probe may include controls to allow a user to vary one or more characteristics of the therapeutic signal and/or the 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, control of one or more of the stimulation and therapeutic signals, their respective characteristics, or combinations thereof may be provided on the controls of the electrosurgical device or may be incorporated into the foot-operated controller.

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

FIG. 37 summarizes one non-limiting method 136300 by which such control may be achieved. The controller may configure the generator to combine the stimulation signal with the therapeutic signal to form an electrode-generated signal 136310. The controller may then cause the electrodes to transmit the electrode-generated signal from the active electrode to the patient tissue 136320. The controller may then receive a signal from a return signal pad in electrical communication with at least a portion of the patient 136330. 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 the return signal from the return signal pad 136340. It should be understood 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 enable 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 that excitable tissue has been stimulated by the emitted electrode signal 136350. When the controller determines 136350 that 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 therapeutic signal when the distance of the excitable tissue from the active electrode is less than a threshold value. In some aspects, the threshold value may be determined by a user of the electrosurgical system. In some other aspects, the threshold value may be based on a plurality of data acquired by the electrosurgical system or a hub system of which the electrosurgical system is a part. In some aspects, the threshold value may be based on one or more mathematical models, physiological models (such as animal models), or data acquired during an electrosurgical procedure on a patient.

In some further aspects, the smart electrosurgical device may include processor-readable instructions within a memory component that, when executed by the processor, cause the processor associated with the controller to combine the stimulation signal with the therapeutic signal. Such instructions may include, without limitation, determining the type of stimulation signal (e.g., amplitude, duration, and waveform), the type of signal combination (e.g., alternating, amplitude modulated, DC offset, or other types of combinations), the timing of the signal combination (i.e., when the therapeutic signal and stimulation signal are combined, e.g., periodically, randomly, or at a single time during a therapeutic procedure), or the type of signal transformation of the stimulation signal before being combined with the therapeutic signal.

In some aspects, a smart electrosurgical device may include processor-readable instructions stored in a memory component that, when executed by a processor in a controller, can cause the processor to emit a therapeutic signal, a combined therapeutic and stimulation signal, or a stimulation signal from an active monopolar electrode in response to contact with patient tissue. In some aspects, a smart electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor in a controller, can cause the processor to combine the therapeutic signal and the stimulation signal to generate an electrode-emitted signal and transmit the transmit signal from the active electrode into patient tissue. In some aspects, a smart electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor in a controller, can cause the processor to receive one or more return signals from the patient, the return signals including currents emitted by the active electrode and received by the return signal pads. In some aspects, a smart electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor in a controller, can cause the processor to receive one or more output signals of one or more sensing devices associated with return pads that have contacted the patient. In some aspects, the smart electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor in the controller, may cause the processor to analyze one or more output signals of one or more sensing devices associated with return pads that have contacted the patient.

In some aspects, the smart electrosurgical device may include processor-readable instructions in a memory component that, when executed by a processor in the controller, may cause the processor to determine that irritable tissue has been stimulated by the stimulation signal. In some embodiments, 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 movement of a muscle in contact therewith and activated by the stimulation signal. The amount of muscle movement may be determined, at least in part, from the amount of stimulation current received by either the muscle tissue or the muscle-damping nerve. Because tissue may act as a resistive element to the propagation of the stimulation signal, the amount of muscle activation may indicate the distance of the active electrode from either the muscle or the muscle-damping nerve.

In some embodiments, the patient may lie supine on the return pad, 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 spine in contact with the return pad. In alternative embodiments, the return pad may be placed over a muscle or muscle group proximate to the location of the surgical site to operate the electrosurgical device. In some examples, the return pad may be placed over a portion of the superficial abdominal muscle (e.g., the rectus abdominis) for abdominal surgery. In some examples, the return pad may be placed on the side of the abdomen to monitor stimulation of the external oblique or serratus anterior muscles.

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

In some additional aspects, the active electrode of the surgical probe of the electrosurgical device may be applied to tissue solely to determine the distance from the active electrode to the excitable tissue. In such use, a medical professional using the device may operate it solely in stimulation mode, without applying a therapeutic signal to the active electrode. In stimulation mode, a user of the device may operate one or more controls configured to vary characteristics of the stimulation signal to determine the state under which the excitable tissue is stimulated. For example, the user may operate a control configured to vary the voltage or current amplitude of the stimulation signal from a low value to a high value. If a signal is received from a sensor (e.g., an accelerometer sensing muscle movement), the electrosurgical device may 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, the user may operate a control configured to vary the frequency of the stimulation signal from a low value to a high value. If a signal is received from a sensor (e.g., an accelerometer sensing muscle movement), the electrosurgical device may 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, the electrosurgical device or smart electrosurgical device may be incorporated into a surgical hub system. The hub system may incorporate multiple handheld medical devices, robotic medical devices, imaging devices, image display devices, communication devices, processing devices, networking devices, and other electronic devices that may operate in a cooperative and collaborative manner. In some aspects, the hub may include such devices located in an operating room(s) or in any number of computer server rooms. Computer memory modules, instructions, and processors may be distributed among any of the components of the surgical hub system as appropriate for control of the smart standalone electrosurgical device.

In some aspects, additional information that may be acquired by components of the surgical hub system may be used to improve the operation of the smart electrosurgical device. For example, a camera and imaging system aimed at the surgical site may provide imaging information that may be used to identify the location of the distal end of the active electrode relative to tissue at the surgical site. Image-based identification of the distal end of the active electrode may be used in conjunction 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 related to the location of nerve and muscle tissue. Such model information may also be used in conjunction with the image-based location of the active electrode and the return pad sensor output to better determine the proximity of the active electrode to known excitable tissue.

While the features and devices disclosed above may relate solely to electrosurgical devices, it should be understood that such features and devices may also be incorporated into a multimode surgical device that includes features associated with electrosurgical devices. For example, a multimode surgical device may incorporate features associated with electrosurgical devices along with features associated with ultrasonic surgical devices. In addition to the functionality described above with respect to modifying the characteristics of the electrosurgical treatment signal, a multimode device may include other functionality. For example, a surgical device may use either RF energy or ultrasound for a therapeutic effect, such as cutting tissue. In such a multimode device, RF energy may be applied to tissue primarily for the purpose of cutting material, but the multimode device may be configured to switch to ultrasonic mode if the end effector of the multimode device is determined to be too close to excitable tissue.

38, there is shown a timeline 5200 illustrating the situational awareness of a hub, such as surgical hub 106 or 206. The timeline 5200 illustrates an exemplary surgical procedure and the contextual information that the surgical hub 106, 206 can derive from data received from data sources at each step of the surgical procedure. The timeline 5200 illustrates typical steps that may be taken by nurses, surgeons, and other medical personnel during the course of a lung segmentectomy surgery, beginning with setting up the operating room and concluding with transporting the patient to a post-operative recovery room.

The context-aware surgical hub 106, 206 receives data from data sources throughout the course of a surgical procedure, including data generated each time medical personnel use a modular device paired with the surgical hub 106, 206. The surgical hub 106, 206 receives this data from the paired modular device and other data sources and can continuously derive inferences (i.e., context information) about the ongoing procedure as new data is received, such as which step of the procedure is being performed at any given time. The context-aware system of the surgical hub 106, 206 can, for example, record data about the procedure to generate a report, verify steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be relevant to a particular procedure step, adjust the modular device based on the context (e.g., activate a monitor, adjust the field of view (FOV) of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and any other such actions described above.

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

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

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

In a fourth step 5208, the medical staff turns on the auxiliary devices. The auxiliary devices utilized may vary according to the type of surgical procedure and the technology used by the surgeon, but in this exemplary case, they include a smoke evacuator, an aspirator, and a medical imaging device. Once activated, the auxiliary device, which is a modular device, may automatically pair with the surgical hub 106, 206 located within a specific proximity of the modular device as part of its initialization process. The surgical hub 106, 206 may then derive contextual information regarding the surgical procedure by detecting the type of modular device paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the types of modular devices connected to the hub, the surgical hub 106, 206 may roughly deduce the specific procedure the surgical team will be performing. Once the surgical hub 106, 206 knows what particular procedure is being performed, it can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources (e.g., modular devices and patient monitors) to deduce which steps of the surgical procedure the surgical team is performing.

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

In a sixth step 5212, medical personnel induce anesthesia in the patient. The surgical hub 106, 206 can estimate that the patient is under anesthesia based on data from the modular devices and/or patient monitoring devices, 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 segmentectomy surgery is complete and the operative portion begins.

In a seventh step 5214, the patient's lung being operated on is collapsed (while ventilation is switched to the contralateral lung). The surgical hub 106, 206 can, for example, infer that the patient's lung has been collapsed from ventilator data. The surgical hub 106, 206 can compare the detection of the patient's lung being collapsed to the expected steps of the procedure (which may be accessed or retrieved in advance) and therefore infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung is the first surgical step in this particular procedure.

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

In a ninth step 5218, the surgical team begins the dissection step of the procedure. Because the surgical hub 106, 206 receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired, it can infer that the surgeon is in the process of dissecting and separating the patient's lungs. The surgical hub 106, 206 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the steps of the procedure described above have been completed) corresponds to the dissection step. In a particular example, the energy instrument may be an energy tool attached to a robotic arm of a robotic surgical system.

In a tenth step 5220, the surgical team proceeds to the ligation step of the procedure. Because the surgical hub 106, 206 receives data from the surgical stapling and severing instrument indicating that the instrument is being fired, it can infer that the surgeon is ligating the arteries and veins. As with the previous step, the surgical hub 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the step in the retrieved process. In a specific example, the surgical instrument may be a surgical tool attached to a robotic arm of a robotic surgical system.

In an eleventh step 5222, the segmental resection portion of the procedure is performed. The surgical hub 106, 206 can infer that the surgeon is transecting parenchymal tissue based on data from the surgical stapling and severing instrument, including data from its cartridge. The cartridge data can correspond, for example, to the size or type of staples fired by the instrument. Because different types of staples are utilized 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 staples fired is utilized for parenchymal tissue (or other similar tissue type), thereby enabling the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is being performed.

Next, at twelfth step 5224, a node dissection step is performed. Based on data received from the generator indicating that an RF or ultrasonic instrument is being fired, the surgical hub 106, 206 can infer that the surgical team is dissecting nodes and performing a leak test. For this particular procedure, the RF or ultrasonic instrument used after the parenchymal tissue is transected corresponds to the node dissection step, which enables the surgical hub 106, 206 to make this inference. Note that, because different instruments are better suited for specific tasks, the surgeon will periodically alternate between a surgical stapling/severing instrument and a surgical energy (i.e., RF or ultrasonic) instrument depending on the particular step during the procedure. Thus, the particular sequence in which the stapling/severing instrument and the surgical energy instrument are used can indicate which step of the procedure the surgeon is performing. Furthermore, in certain instances, a robotic tool may be used for one or more steps during the surgical procedure, and/or a handheld surgical instrument may be used for one or more steps during the surgical procedure. The surgeon(s) can, for example, alternate between the robotic tool and the handheld surgical instrument and/or can use the devices simultaneously, for example. Once the twelfth step 5224 is completed, the incision is closed and the post-operative portion of the procedure begins.

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

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

Situational awareness is further described in U.S. Provisional Patent Application No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety. In certain examples, the operation of a robotic surgical system, including, for example, the various robotic surgical systems disclosed herein, may be controlled by the hub 106, 206 based on its situational awareness and/or feedback from its components and/or based on information from the cloud 102.

While several embodiments have been illustrated and described, it is not the applicant's intention to restrict or limit the scope of the appended claims to such details. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these embodiments may be implemented and will occur to those skilled in the art without departing from the scope of the present disclosure. Moreover, the structure of each element associated with the described embodiments can alternatively be described as a means for providing the function performed by that element. Also, while materials are disclosed with respect to particular components, other materials may be used. It is therefore to be understood that the above description and the appended claims are intended to cover all such modifications, combinations, and variations as fall within the scope of the disclosed embodiments. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various aspects of devices and/or processes via the use of block diagrams, flowcharts, and/or examples. To the extent that such block diagrams, flowcharts, and/or examples include one or more functions and/or operations, those skilled in the art will understand that each function and/or operation included in such block diagrams, flowcharts, and/or examples can be individually and/or collectively implemented by a variety of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will understand that all or a portion of some aspects of the embodiments disclosed herein can be equivalently implemented on an integrated circuit, 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 virtually any combination thereof, and that designing circuitry and/or writing software and/or firmware code is within the skill of those skilled in the art in light of this disclosure. Furthermore, those skilled in the art will appreciate that the subject matter described herein may be distributed as one or more program products in a variety of forms, and that the particular form of the subject matter described herein will be used regardless of the particular type of signal-bearing medium used to actually effect the distribution.

The instructions used to program logic to implement various disclosed aspects may be stored in system memory, such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Additionally, the instructions may be distributed over a network or by other computer-readable media. Thus, machine-readable media may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including, but not limited to, floppy diskettes, optical disks, compact 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 tangible machine-readable storage used to transmit information over the Internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Accordingly, non-transitory computer-readable media includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

As used in any aspect of this specification, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, a processing unit, a processor, a microcontroller, a microcontroller unit, a controller, a digital signal processor (DSP), a programmable logic device (PLD), a programmable logic array (PLA), or a field programmable gate array (FPGA)), a state machine circuit, firmware that stores instructions executed by the programmable circuitry, and any combination thereof. Control circuitry may be embodied, collectively or individually, as circuits that form part of a larger system, such as, for example, 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, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application-specific integrated circuit, electrical circuitry forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that at least partially executes the processes and/or apparatus described herein, or a microprocessor configured by a computer program that at least partially executes the processes and/or apparatus described herein), electrical circuitry forming a memory device (e.g., a form of random access memory), and/or electrical circuitry forming a communications device (e.g., a modem, a communications switch, or an optical-to-electrical facility). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.

As used in any aspect of this specification, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to perform any of the aforementioned operations. 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 in a memory device, and/or hard-coded (e.g., non-volatile) data.

When used in any aspect of this specification, the terms "component," "system," "module," etc. may refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution.

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

The network may include a packet-switched network. The communication devices may communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include an Ethernet communication protocol, which may enable communication using 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," published December 2008, by the Institute of Electrical and Electronics Engineers (IEEE), and/or later versions of this standard. Alternatively or additionally, the communication devices may communicate with each other using the X.25 communication protocol. The T.25 communication protocol may conform to or be compatible with standards promulgated by the International Telecommunication Union-Telecommunication Standards Sector (ITU-T). Alternatively or additionally, the communication devices may communicate with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or be compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be 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 published by the ATM Forum in August 2001, entitled "ATM-MPLS Network Interworking 2.0," and/or later versions of this standard. Of course, different and/or later-developed connection-oriented network communication protocols are equally contemplated herein.

Unless expressly specified otherwise, as will be apparent from the foregoing disclosure, discussions throughout the foregoing disclosure using terms such as "processing," "calculating," "computing," "determining," and "displaying" will be understood to refer to the operations and processing of a computer system or similar electronic computing device that manipulates and converts data represented as physical (electronic) quantities in the computer system's registers and memory into other data similarly represented as physical quantities in the computer system's memory or registers or such information storage, transmission, or display devices.

One or more components may be referred to herein as being "configured to," "configurable to," "operable/operative to," "adapted/adaptable," "able to," "conformable/conformed to," etc. Those skilled in the art will understand that "configured to" may generally encompass active components and/or inactive components and/or standby components, unless the context requires otherwise.

The terms "proximal" and "distal" are used herein with reference to a clinician manipulating the 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 understood that for convenience and clarity, spatial terms such as "vertical," "horizontal," "above," and "below" may be used herein with respect to the drawings. However, surgical instruments 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 understand that the terms used herein generally, and in the appended claims in particular (e.g., the body 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.). Furthermore, those skilled in the art will understand that where a specific number is intended in an introduced claim recitation, such intention will be clearly stated in the claim; and, in the absence of such a statement, no such intention exists. For example, as an aid to understanding, the appended claims below may include the introductory phrases "at least one" and "one or more" to introduce the claim recitation. However, the use of such phrases should not be construed as suggesting that when a claim is introduced by the indefinite article "a" or "an," any particular claim containing such introduced claim language is limited to claims containing only one such recitation, even if the same claim contains both an introductory phrase such as "one or more" or "at least one" and the indefinite article "a" or "an" (e.g., "a" and/or "an" should normally be construed to mean "at least one" or "one or more"). The same applies when a definite article is used to introduce a claim.

Furthermore, even when a specific number is explicitly stated in an introduced claim, those skilled in the art will recognize that such a statement should typically be interpreted to mean at least the recited number (e.g., a statement simply stating "two items" without other modifiers generally means at least two items, or more than two items). Furthermore, when a term similar to "at least one of A, B, and C, etc." is used, such syntax is generally intended to mean what a person skilled in the art would understand the term (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and/or all of A, B, and C, etc.). When notation similar to "at least one of A, B, or C, etc." is used, such syntax is generally intended in the sense that one of ordinary skill in the art would understand the notation (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and/or all of A, B, and C, etc.). Furthermore, one of ordinary skill in the art will understand that any disjunctive word and/or phrase typically representing two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of those terms, either of those terms, or both of those terms, unless the context requires otherwise. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B."

With respect to the appended claims, those skilled in the art will understand that the recited actions herein generally may be performed in any order. Additionally, while flow diagrams of various actions are shown in sequence(s), it should be understood that the various actions may occur in orders other than those illustrated, or may occur simultaneously. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, additional, simultaneous, reverse, or other different orderings, unless the context requires otherwise. Furthermore, terms such as "responsive to," "related to," or other past-tense adjectives are generally not intended to exclude such variations, unless the context requires otherwise.

It is worth noting that any reference to "one embodiment," "embodiment," "exemplary," "one example," etc. means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment," "in an embodiment," "exemplary," and "in one example" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

Any patent application, patent, non-patent publication, or other disclosure material referenced herein and/or listed in any Application Data Sheet is incorporated herein by reference to the extent the incorporated material is not inconsistent with this specification. As such, and to the extent necessary, the disclosure material expressly set forth herein shall supersede any conflicting statements incorporated herein by reference. Any content, or portions thereof, that conflicts with current definitions, opinions, or other disclosure material set forth herein shall be incorporated herein by reference, but only to the extent that there is no conflict between the referenced content and the current disclosure material.

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

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

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

Example 2. The electrosurgical device described in Example 1, wherein the therapeutic electrical signal is a high-frequency signal having a frequency greater than 200 kHz and less than 5 MHz.

Example 3. The electrosurgical device of Example 1 or 2, wherein the excitatory tissue stimulation signal is an AC signal having a frequency of less than 200 kHz.

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

Example 5. The electrosurgical device of any one or more of Examples 1-4, wherein the current supplied by the electrical generator includes a therapeutic electrical signal amplitude modulated by the excitatory tissue stimulation signal.

Example 6. The electrosurgical device of any one or more of Examples 1-5, wherein the current supplied by the electrical generator includes a therapeutic electrical signal DC offset by the excitatory tissue stimulation signal.

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

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

Example 9. The electrosurgical device of Example 8, wherein the controller includes a processor and at least one memory component in data communication with the processor, the at least one memory component storing one or more instructions that, when executed by the processor, cause the processor to determine a distance of the active electrode from 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 the value of at least one characteristic of the therapeutic electrical signal when the distance of the active electrode from excitable tissue is less than a predetermined value.

Example 11. An electrosurgical system comprising: a processor; and a memory coupled to the processor and configured to store instructions executable by the processor, the instructions being executable by the processor to cause an electrical generator to combine one or more characteristics of a therapeutic signal with one or more characteristics of an excitatory tissue stimulation signal to form a combined signal; cause the electrical generator to transmit the combined signal into the patient's tissue via an active electrode in physical contact with the patient; and receive a sensing device output signal from a sensing device disposed in a return pad in physical contact with the patient.

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

Example 13. The electrosurgical system of Example 12, wherein the memory is further configured to store instructions executable by the processor, the instructions being executable by the processor to cause the controller to modify one or more characteristics of the therapeutic signal when the distance from the active electrode to the excitable tissue is less than a predetermined value.

Example 14. The electrosurgical system of any one or more of Examples 11-13, wherein the instructions executable by the processor to cause the electrical 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 include instructions executable by the processor to cause the electrical generator to alternate between the therapeutic signal and the excitable tissue stimulation signal.

Example 15. An electrosurgical system according to any one or more of Examples 11-14, wherein the instructions executable by the processor to cause the electrical 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 include instructions executable by the processor to cause the electrical generator to modulate the amplitude of the therapeutic signal by the amplitude of the excitable tissue stimulation signal.

Example 16. An electrosurgical system according to any one or more of Examples 11 to 15, wherein the instructions executable by the processor to cause the electrical 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 include instructions executable by the processor to cause the electrical generator to offset a DC value of the therapeutic signal by an amplitude of the excitable tissue stimulation signal.

Example 17. An electrosurgical system comprising: a control circuit configured to control the electrical output of an electrical generator, the electrical output including one or more characteristics of a therapeutic signal and one or more characteristics of an excitable tissue stimulation signal; receive a sensing device signal from at least one sensing device configured to measure activity of excitable tissue of a patient; determine a distance between a position of an active electrode configured to transmit the electrical output of the electrical generator into patient tissue and a position of the at least one sensing device; and modify the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the position of the active electrode configured to transmit the electrical output of the electrical generator into patient tissue and the position of the at least one sensing device is less than a predetermined value.

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

Example 19. A non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause the machine to control the electrical output of an electrical generator, including one or more characteristics of a therapeutic signal and one or more characteristics of an excitable tissue stimulation signal; receive sensing device signals from at least one sensing device configured to measure activity of excitable tissue in a patient; determine a distance between a location of an active electrode configured to deliver the electrical output of the electrical generator into patient tissue and a location of the at least one sensing device; and modify the electrical output of the electrical generator in at least one characteristic of the therapeutic signal if the distance between the location of the active electrode configured to deliver the electrical output of the electrical generator into patient tissue and the location of the at least one sensing device is less than a predetermined value.

[Embodiment]
(1) An electrosurgical device comprising:
a controller comprising an electrical generator;
a surgical probe including a distal active electrode, the active electrode being in electrical communication with a power terminal of the electrical generator;
a return pad in electrical communication with the electrical return terminal of the electrical generator;
the electrical generator is configured to provide electrical current from the power supply terminals;
An electrosurgical device, wherein the electrical current delivered by the electrical generator combines characteristics of a therapeutic electrical signal and characteristics of an excitatory tissue stimulation signal.
(2) The electrosurgical device according to claim 1, wherein the therapeutic electrical signal is a high-frequency signal having a frequency greater than 200 kHz and less than 5 MHz.
(3) The electrosurgical device according to claim 1, wherein the excitatory tissue stimulation 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 electrical generator includes at least one alternating current therapeutic electrical signal and at least one alternating current excitatory tissue stimulation signal.
5. The electrosurgical device of claim 1, wherein the current supplied by the electrical generator comprises a therapeutic electrical signal amplitude modulated by the excitatory tissue stimulation signal.

6. The electrosurgical device of claim 1, wherein the current supplied by the electrical generator comprises a therapeutic electrical signal DC offset by the excitatory 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, the sensing device configured to determine stimulation of excitable tissue by the excitable tissue stimulation signal.
8. The electrosurgical device according to claim 7, wherein the controller is configured to receive the sensing device output.
9. The electrosurgical device of claim 8, wherein the controller includes a processor and at least one memory component in data communication with the processor, the at least one memory component storing one or more instructions that, when executed by the processor, cause the processor to determine a distance of the active electrode from excitable tissue based at least in part on the 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 modify a value of at least one characteristic of the therapeutic electrical signal when the distance of the active electrode from excitable tissue is less than a predetermined value.

(11) An electrosurgical system comprising:
a processor;
a memory coupled to the processor and configured to store instructions executable by the processor, the instructions comprising:
causing the electrical generator to combine one or more characteristics of the therapeutic signal with one or more characteristics of the excitatory tissue stimulation signal to form a combined signal;
causing the electrical generator to transmit the composite signal into tissue of the patient via an active electrode in physical contact with the patient;
An electrosurgical system executable by the processor to receive a detector output signal from a detector disposed in a return pad in physical contact with the patient.
(12) The memory is further configured to store instructions executable by the processor, the instructions including:
12. The electrosurgical system of claim 11, wherein the electrosurgical system is executable by the processor to determine a distance from the active electrode to excitable tissue based at least in part on the sensing device output signal.
(13) The memory is further configured to store instructions executable by the processor, the instructions including:
13. The electrosurgical system of claim 12, wherein the electrosurgical system is executable by the processor to cause the controller to modify one or more characteristics of the therapeutic 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 an electrical 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 include instructions executable by the processor to cause the electrical generator to alternate between 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 an electrical 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 include instructions executable by the processor to cause the electrical 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 an electrical 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 include instructions executable by the processor to cause the electrical generator to offset a DC value of the therapeutic signal by an amplitude of the excitable tissue stimulation signal.
(17) An electrosurgical system comprising:
a control circuit, the control circuit comprising:
controlling the electrical output of the electrical generator, including one or more characteristics of the therapeutic signal and one or more characteristics of the excitatory tissue stimulation signal;
receiving a sensing device signal from at least one sensing device configured to measure excitable tissue activity in the patient;
determining a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into patient tissue and a location of the at least one sensing device;
1. An electrosurgical system configured to modify the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the location of the active electrode configured to transmit the electrical output of the electrical generator into the patient tissue and the location 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 modify the electrical output of the electrical generator in at least one characteristic of the therapeutic signal when the distance between the location of the active electrode configured to transmit the electrical output of the electrical 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 therapeutic signal.
(19) A non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to:
controlling the electrical output of the electrical generator, including one or more characteristics of the therapeutic signal and one or more characteristics of the excitatory tissue stimulation signal;
receiving a sensing device signal from at least one sensing device configured to measure excitable tissue activity of the patient;
determining a distance between a location of an active electrode configured to transmit the electrical output of the electrical generator into patient tissue and a location of the at least one sensing device;
12. A non-transitory computer-readable medium that causes the electrical output of the electrical generator to be altered in at least one characteristic of the therapeutic signal when the distance between the location of the active electrode configured to transmit the electrical output of the electrical generator into the patient tissue and the location of the at least one sensing device is less than a predetermined value.

Claims (20)

In the surgical hub,
1. A surgical data network comprising a modular communications hub, the modular communications hub comprising:
A router,
network modules communicatively coupled to the router, each of the network modules comprising a network hub and a network switch communicatively coupled to the network hub;
a surgical data network comprising:
a computer system communicatively coupled to the modular communications hub, the computer system comprising:
a processor communicatively coupled to the network module;
A network interface;
a communication module;
a volatile memory;
a non-volatile memory;
an interface module;
a computer system comprising:
Equipped with
the network module is a primary network module;
the modular communications hub further comprising a secondary network module communicatively coupled to the primary network module;
The surgical hub , wherein each said secondary network module comprises a secondary network hub and a secondary network switch communicatively coupled to said secondary network hub. The surgical hub of claim 1 , wherein each secondary network module is configured to communicatively couple to a plurality of modular surgical devices located in a surgical operating room. 3. The surgical hub of claim 2, wherein the surgical modular device is selected from an imaging device coupled to an endoscope, a generator coupled to an ultrasonic surgical instrument, a smoke evacuation device, a suction/irrigation device, a communication device, a processor, a storage array, a smart device/instrument, and a non-contact sensor. the secondary network hub is configured to communicatively couple to a plurality of first surgical modular devices located in a surgical operating room;
The surgical hub of claim 1 , wherein the secondary network switch is configured to communicatively couple with a second plurality of modular surgical devices located in the surgical operating room. The surgical hub of claim 4, further comprising a display communicatively coupled to the secondary network hub and the secondary network switch. The surgical hub of claim 1, wherein the router is communicatively coupled to a cloud-based system including a remote server and a storage device coupled to the remote server. The modular communications hub is communicatively coupled to a plurality of modular surgical devices disposed in a surgical operating room , and data relating to the modular surgical devices is transmitted from the modular surgical devices to:
via the router, the cloud-based system for remote data processing and manipulation;
The surgical hub of claim 6, wherein the surgical hub is capable of transmitting data to the computer system for local data processing and manipulation. each said network hub is configured to transmit data in the form of packets to said router and to operate in half-duplex mode;
The surgical hub of claim 1 , wherein each said network switch is configured to transmit data in the form of frames to said router and to operate in full duplex mode. The surgical hub of claim 1, further comprising a display communicatively coupled to the interface module. In the surgical hub,
1. A surgical data network comprising a modular communications hub, the modular communications hub comprising:
A router,
a primary network module communicatively coupled to the router, the primary network module comprising a primary network hub and a primary network switch in communication with the primary network hub;
secondary network modules communicatively coupled to the primary network modules, each secondary network module comprising a secondary network hub and a secondary network switch in communication with the secondary network hub;
a surgical data network comprising:
a computer system communicatively coupled to the modular communications hub, the computer system comprising:
a processor communicatively coupled to the primary network module;
A network interface;
a communication module;
a volatile memory;
a non-volatile memory;
an interface module;
A surgical hub comprising: The surgical hub of claim 10 , wherein each secondary network module is configured to communicatively couple to a plurality of modular surgical devices located in a surgical operating room. the secondary network hub is configured to communicatively couple to a plurality of first surgical modular devices located in a surgical operating room;
The surgical hub of claim 10 , wherein the secondary network switch is configured to communicatively couple with a second plurality of modular surgical devices located in the surgical suite. The surgical hub of claim 10, further comprising a display communicatively coupled to the secondary network hub and the secondary network switch. The surgical hub of claim 10, wherein the router is communicatively coupled to a cloud-based system including a remote server and a storage device coupled to the remote server. The modular communications hub is communicatively coupled to a plurality of modular surgical devices disposed in a surgical operating room , and data relating to the modular surgical devices is transmitted from the modular surgical devices to:
via the router, the cloud-based system for remote data processing and manipulation;
The surgical hub of claim 14, wherein the surgical hub is capable of transmitting data to the computer system for local data processing and manipulation. the primary network hub and the secondary network hub are configured to transmit data in the form of packets to the router and to operate in half-duplex mode;
The surgical hub of claim 10, wherein the primary network switch and the secondary network switch are configured to transmit data to the router in the form of frames and to operate in a full-duplex mode. The surgical hub of claim 10, further comprising a display communicatively coupled to the interface module. In a surgical system,
The display and
a surgical hub communicatively coupled to the display;
the surgical hub comprising:
1. A surgical data network comprising a modular communications hub, the modular communications hub comprising:
A router,
a primary network module communicatively coupled to the router, the primary network module comprising a primary network hub and a primary network switch in communication with the primary network hub;
a secondary network module communicatively coupled to the primary network module and to a plurality of surgical modular devices located in a surgical operating room, the secondary network module comprising a secondary network hub and a secondary network switch in communication with the secondary network hub;
a surgical data network comprising:
a computer system communicatively coupled to the modular communications hub, the computer system comprising:
a processor communicatively coupled to the primary network module;
A network interface;
a communication module;
a volatile memory;
a non-volatile memory;
an interface module;
a computer system comprising:
A surgical system comprising: The router is communicatively coupled to a cloud-based system, and data relating to the surgical modular device is transmitted from the surgical modular device through the modular communications hub to:
via the router, the cloud-based system for remote data processing and manipulation;
The surgical system of claim 18, wherein the surgical system is capable of transmitting data to the computer system for local data processing and manipulation. the primary network hub and the secondary network hub are configured to transmit data in the form of packets to the router and to operate in half-duplex mode;
The surgical system of claim 18, wherein the primary network switch and the secondary network switch are configured to transmit data in frames to the router and to operate in a full-duplex mode.