JP7275144B2 - Increasing radio frequency to generate unpadded unipolar loops - Google Patents

Description

(Cross reference to related applications)
This application was filed on Aug. 23, 2018 under 35 U.S.C. No. 62/721,995 of US Provisional Patent Application No. 62/721,995.

This application is filed under 35 U.S.C. Priority is claimed to Application No. 62/721,998.

This application is filed on Aug. 23, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING" under 35 U.S.C. Priority is claimed to US Provisional Patent Application No. 62/721,999.

This application is filed under 35 U.S.C. Priority is claimed to US Provisional Patent Application No. 62/721,994, filed on May 1, 2004.

This application is filed on Aug. 23, 2018 under 35 U.S.C. No. 62/721,996 of US Provisional Patent Application No. 62/721,996.

This application is further filed under 35 U.S.C. U.S. Provisional Patent Application No. 62/692,747, filed on June 20, 2018; Priority is claimed to U.S. Provisional Patent Application No. 62/692,768, filed June 30, 2018.

This application is further filed under 35 U.S.C. U.S. Provisional Patent Application No. 62/650,898, filed on Jan. 1, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," U.S. Provisional Patent Application No. 62/650,887, filed March 30, 2018, entitled "SMOKE EVACUATION MODULE FOR U.S. Provisional Patent Application No. 62/650,882, filed March 30, 2018, entitled "INTERACTIVE SURGICAL PLATFORM" and U.S. Provisional Patent Application No. 62/650,882, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS." Claims priority benefit of 62/650,877.

This application is further subject to U.S. provisional patent application entitled "INTERACTIVE SURGICAL PLATFORM," filed Dec. 28, 2017, under 35 U.S.C. Application No. 62/611,341, U.S. Provisional Patent Application No. 62/611,340, filed Dec. 28, 2017, entitled "CLOUD-BASED MEDICAL ANALYTICS," and U.S. Provisional Patent Application No. 62/611,340, entitled "ROBOT ASSISTED SURGICAL PLATFORM," Dec. 12, 2017. It claims the benefit of priority from US Provisional Patent Application No. 62/611,339, filed May 28.

The present disclosure relates generally and in various aspects to surgical systems that utilize radio frequency (RF) energy in electrosurgery.

Electrosurgical systems typically utilize a generator to supply electrosurgical energy to active electrodes that apply electrosurgical energy (eg, alternating current at high frequency levels) to a surgical site on a patient's body. Surgical instruments may utilize energy to perform various types of surgery, such as tissue cutting or tissue coagulation, as desired. Monopolar electrosurgery involves applying surgical instruments to patient tissue using a single active electrode and completing an electrical circuit through the patient with a patient return electrode. This return electrode is typically connected to a monopolar energy generator. However, capacitive coupling is a constant problem with this system and can cause unwanted burns to initially unknown locations on the patient's body. To minimize or eliminate unintended patient damage, it is desirable to take capacitive coupling into account.

In some aspects, a surgical system is presented. The surgical system includes a monopolar energy generator and a surgical instrument electrically coupled to the monopolar energy generator comprising electrodes and configured to transmit electrosurgical energy through the electrodes to patient tissue at a surgical site. , at least one detection circuit for measuring an amount of conductivity in a return path of electrosurgical energy, determining that the amount of conductivity in the return path is below a predetermined threshold, and supplying electricity to the monopolar generator; at least one detection circuit configured to transmit a signal that increases current leakage in the surgical system by increasing the AC frequency in the surgical energy generation, wherein the monopolar energy generator is , a sensor configured to determine that the monopolar energy circuit is complete by detecting that current leakage reaches a ground terminal within the monopolar energy generator.

In some aspects of the surgical system, the increased current leakage allows the surgical instrument to be used to perform monopolar electrosurgery on a patient.

In some aspects of the surgical system, the monopolar energy generator receives an indication from the sensor that the current leakage has not yet reached a ground terminal within the monopolar energy generator; further comprising a control circuit configured to further increase the .

In some aspects of the surgical system, the control circuit receives a second indication from the sensor that the current leakage has reached a ground terminal within the monopolar energy generator in response to the further increase in the alternating frequency; It is further configured to stop increasing the AC frequency in response to the second indication.

In some aspects of the surgical system, the surgical system provides instructions to isolate any return path pads from the surgical system to minimize conductivity flowing through any of the return path pads. It is further configured as

In some aspects of the surgical system, increasing the frequency includes increasing the frequency to a range of 500 KHz to 4 MHz.

Features of various aspects are set forth with particularity in the appended claims. The various aspects, both as to organization and method of operation, however, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings, which follow.
1 is a block diagram of a computer-implemented interactive surgical system, according to at least one aspect of the present disclosure; FIG. A surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure; FIG. 122 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing in accordance with at least one aspect of the present disclosure; 3 is a perspective view of a combination generator module comprising bipolar, ultrasonic, and monopolar contacts and smoke evacuation components in accordance with at least one aspect of the present disclosure; FIG. 4 illustrates individual power bus attachments for multiple lateral docking ports of a lateral modular housing configured to receive multiple modules, in accordance with at least one aspect of the present disclosure; 1 illustrates a vertical modular housing configured to receive multiple modules, according to at least one aspect of the present disclosure; Cloud modular devices located in one or more operating rooms of a healthcare facility, or any room within a healthcare facility with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure. 1 illustrates a surgical data network with modular communication hubs configured to connect; 1 illustrates a computer-implemented interactive surgical system, according to at least one aspect of the present disclosure; 4 illustrates a surgical hub comprising multiple modules coupled to a modular control tower, according to at least one aspect of the present disclosure; 1 illustrates one aspect of a universal serial bus (USB) network hub device, in accordance with at least one aspect of the present disclosure; 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 1 illustrates a control circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 11 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; FIG. 4 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure; 1 illustrates a surgical instrument or tool comprising multiple motors that can be activated to perform various functions, in accordance with at least one aspect of the present disclosure; 1 is a schematic diagram of a robotic surgical instrument configured to operate a surgical tool described herein, according to at least one aspect of the present disclosure; FIG. FIG. 10 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member, according to at least one aspect of the present disclosure; 1 is a circuit diagram of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure; FIG. A system configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network comprising a modular communication hub, according to at least one aspect of the present disclosure. 1 illustrates one example of a generator, in accordance with at least one aspect of the present disclosure; A surgical system comprising a generator and various surgical instruments usable with the generator, according to at least one aspect of the present disclosure. An end effector according to at least one aspect of the present disclosure. 23 is a diagram of the surgical system of FIG. 22 in accordance with at least one aspect of the present disclosure; FIG. 4 is a model illustrating operating branch currents, in accordance with at least one aspect of the present disclosure; 2 is a structural diagram of a generator architecture, according to at least one aspect of the present disclosure; FIG. FIG. 4 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure; FIG. 4 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure; FIG. 4 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure; 4A-4B are structural and functional aspects of a generator, in accordance with at least one aspect of the present disclosure; 4A-4B are structural and functional aspects of a generator, in accordance with at least one aspect of the present disclosure; FIG. 2 provides a diagram illustrating an exemplary system having means for detecting capacitive coupling, according to at least one aspect of the present disclosure; FIG. FIG. 3 is a logic flow diagram illustrating a control program or logic configuration of an exemplary methodology for limiting capacitive coupling effects in a surgical system disclosed according to at least one aspect of the present disclosure; 4 is a logic flow illustrating a control program or logic configuration of an exemplary methodology that may be executed by a surgical system using monopolar energy generation to determine whether to utilize parasitic capacitive coupling, in accordance with at least one aspect of the present disclosure; It is a diagram. 4 is a timeline illustrating hub situational awareness, in accordance with at least one aspect of the present disclosure;

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

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

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

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

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

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

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

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

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

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

The applicant of this application owns the following US provisional patent applications filed December 28, 2017, the entire disclosures of each of which are incorporated herein by reference:
- U.S. Provisional Patent Application No. U.S. Provisional 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 surgical devices and generators in detail, it is noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts set forth in the accompanying drawings and description. It should be noted. Example embodiments may be practiced with or incorporated in other aspects, variations, and modifications, and may be practiced or carried out in various ways. Further, unless otherwise stated, the terms and expressions used herein have been chosen for the convenience of the reader for the purpose of describing example embodiments and not for purposes of limitation thereof. . Further, one or more of the aspects, implementations of aspects and/or examples described below may be combined with any of the other aspects, implementations of aspects and/or examples described below. It should be understood that one or more can be combined.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In one aspect, the hub modular housing 136 is a modular power and A communications backplane 149 is provided.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices, or other general network nodes, etc., and are typically computers Includes many or all of the elements described for the system. For simplicity, only the memory storage device is shown along with the remote computer(s). Remote computer(s) are logically connected to the computer system through a network interface and then physically connected via a communications connection. The network interface encompasses communication networks such as local area networks (LAN) and wide area networks (WAN). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5, and 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 variations thereof, packet-switched networks, and Digital Subscriber Lines (DSL).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In one aspect, one or more of the motors 704a-704e may comprise brushed DC motors with gearboxes and mechanical connections to the firing, closing, or articulating members. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation connections, closed tubes, and shafts. External influences are unmeasured and unpredictable influences such as friction on tissues, surroundings, and physical systems. Such an external influence is sometimes referred to as a drag acting against one of the electric motors 704a-704e. External influences, such as disturbances, can cause the behavior of a physical system to deviate from the desired behavior of the physical system.

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

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

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

In one aspect, sensor 738 is implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, among others. may be In other implementations, sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, among others. Additionally, the switch may be a solid state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, sensors 738 may include conductorless switches, ultrasonic switches, accelerometers, and inertial sensors, among others.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Generator Hardware Adaptive Ultrasonic Blade Control Algorithm In various aspects, the smart ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to identify tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize the tissue type. Algorithms for detecting the collagen/elasticity ratio of tissue for adjusting the amplitude of the distal tip of the ultrasonic blade are described in the following sections of this disclosure. Various aspects of smart ultrasonic energy devices are described herein, for example, in connection with FIGS. 1-94. Accordingly, the following description of adaptive ultrasonic blade control algorithms should be read in conjunction with FIGS. 1-94 and their associated descriptions.

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

FIG. 20 is a system 800 configured to execute adaptive ultrasonic blade control algorithms within a surgical data network comprising a modular communication hub, according to at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute the adaptive ultrasonic blade control algorithm(s) 802 described herein with reference to FIGS. In another aspect, the device/instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm(s) 804 described herein with reference to FIGS. 53-105. In another aspect, both the device/instrument 235 and the device/instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 described herein with reference to FIGS. be done.

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

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

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

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

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

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

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

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

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

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). is available). It can include digital, analog, mixed signal, and often high frequency functions all on a single substrate. SoCs integrate microcontrollers (or microprocessors) with modern peripherals such as graphics processing units (GPUs), Wi-Fi modules, or co-processors. The SoC may or may not include embedded memory.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Evaluating the Fourier transform at the frequency of the sinusoid gives

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

式中、φは位相角であり、ｆは周波数であり、ｔは時間であり、φ_０は、ｔ＝０における位相である。

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

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

Other techniques for determining the phase difference between voltage and current signals include monitoring Lissajous figures and images; methods such as the three voltmeter method, the crossed coil method, the vector voltmeter method and the vector impedance method; Phase Measurement, Peter O'Shea, 2000 CRC Press LLC, <http://www. engnetbase. com>.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Capacitive Coupling and Limiting Its Effects Aspects of the present disclosure are presented for surgical instruments with improved device capabilities to reduce undesirable operational side effects. Specifically, the surgical instrument may include means for limiting capacitive coupling to improve monopolar isolation for use independently or in conjunction with another advanced energy modality. Capacitive coupling generally occurs when there is a transfer of energy between nodes induced by an electric field. Capacitive coupling can occur when two or more electrosurgical instruments are used in or around a patient during surgery. In some cases, capacitive coupling may be desirable because additional devices can be inductively powered by capacitive coupling, but inadvertent occurrence of capacitive coupling during surgery or around the patient is generally very May have harmful consequences. Parasitic or accidental capacitive coupling can occur in unknown or unpredictable locations and cause energy to be applied to unintended areas. If the patient is under anesthesia and unable to make any response, parasitic capacitive coupling can burn the patient without the surgeon even knowing it has occurred. Therefore, it is desirable to limit parasitic or inadvertent capacitive coupling in surgical instruments, typically during surgery.

In some aspects, a system that includes a surgical instrument and a generator can be configured to interrupt transmission of energy from the generator to the surgical instrument when capacitive coupling is detected. One or more safety fuses, sensors, controls, and/or algorithms may be in place to automatically trigger shutdown of the generator in these scenarios. An alert, including an audible signal, vibration, and visual message, may be issued to notify the surgical team that the generator has been shut off due to detection of capacitive coupling.

In some aspects, the system includes means for detecting that a capacitive coupling event has occurred. For example, an algorithm involving inputs from one or more sensors to monitor events in the environment of the system may apply situational awareness and other programmatic means to allow capacitive coupling to occur elsewhere in the system. can conclude that they are and react accordingly. A system with situational awareness may be configured such that the system predicts possible scenarios based on current environmental and system data and determines that the current situation follows a pattern that produces a predictable next step. means that As an example, the system can apply situational awareness in the context of processing capacitive coupling events by recalling surgical examples of similar situations in which various sensor data are detected. Sensor data may indicate current increases at two specific locations along the closed-loop electrosurgical system, which, based on previous data from surgeries in similar situations, may indicate an imminent capacitive coupling event. This indicates that the

In some aspects, the surgical instrument may be modified in structure to limit the occurrence of capacitive coupling or otherwise reduce collateral damage caused by capacitive coupling. For example, additional insulation strategically placed within or around the surgical instrument can help limit the occurrence of capacitive coupling. In other cases, the end effector of the surgical instrument may include modified structures that reduce the generation of current displacement, such as by rounding the tip of the end effector or shaping the blade of the end effector, among other things. may be made to behave more like a unipolar blade while still operating as a bipolar device.

In some aspects, the system may include passive means for mitigating or limiting the effects of capacitive coupling. For example, the system may include leads capable of shunting energy to neutral nodes through conductive passive components. Generally, any and all of these aspects are combined or included within a single system to address the challenges posed by multiple electrical components prone to capacitive coupling during surgery on a patient. good too.

FIG. 29 provides a diagram illustrating an exemplary system 134000 having means for detecting capacitive coupling, in accordance with at least one aspect of the present disclosure. System 134000 is surgical instrument 134008 . includes a unipolar ESU generator 134002 electrically coupled to the . Surgical instruments 134008 are used to perform surgery on a patient, and patient tissue 134016 is shown representing the surgical site of the patient on which surgery is being performed. Surgical instrument 134008 may include means for applying electrosurgical or ultrasonic energy to the end effector and may optionally include a blade and/or a pair of jaws for grasping or clamping tissue. The energy delivered by the ESU generator 134002 may pass through the end effector to the patient via any of a variety of possible components of the end effector. At least a portion of the patient has a return path pad 134014, such as, for example, a Smart Megasoft Pad™, configured to divert excess energy away from the patient when the surgical instrument 134008 touches the patient to apply electrosurgical energy. may be placed on top.

Due to the multiple power sources in the vicinity of the patient, parasitic capacitive coupling is constantly present and poses a constant risk of harm to the patient during surgery. Since the patient cannot be expected to show any reaction during surgery, the patient may end up being burned in unintended locations if an unknown or unforeseen capacitive coupling occurs. In general, energy anomalies such as capacitive coupling should be minimized or otherwise corrected to improve patient safety. Multiple smart sensors or monitors such as CT1 (134006), CT2 (134010), and CT3 (134012) smart sensors are integrated into the electrosurgical system as indicators to limit the occurrence of capacitive coupling or other types of energy anomalies. may be used to determine if excess or inductive energy is being dumped outside of one or more power sources. As shown in FIG. 29, smart sensors CT1 (134006), CT2 (134010), and CT3 (134012) are placed at locations where energy is likely to be released inductively. The sensor or monitor may be configured to detect capacitance, and when placed at strategic locations within the system, the capacitance reading indicates that capacitive leakage has occurred near the sensor or monitor. can mean that there is The presence of capacitive leakage in close proximity to a sensor or monitor that is providing a positive can conclude. Other sensors may be used, such as capacitive leak monitors or detectors. These sensors may be configured to provide warnings such as lighting up or emitting noise or sending a signal to an eventual display monitor. Additionally, the unipolar ESU 134002 may be configured to automatically trigger a cutoff of energy generation to stop any further capacitive coupling from occurring.

In some aspects, as another solution to reduce capacitive coupling, a neutral electrode 134004 may be included in the unipolar ESU 1340002, e.g. may be electrically coupled. When the electrosurgical instrument 134008 touches the patient, the patient touches the return path pad 134014, and the pad is conductively connected to the neutral electrode 134004, energy can reach the neutral node 134004 conductively. Thus, energy can be diverted from the monopolar ESU 134002 or surgical instrument 134008 to the neutral node 134004, thereby reducing the occurrence of capacitive coupling.

In some aspects, a cloud analytics system communicatively coupled to a unipolar ESU, such as through a medical hub, is configured to use situational awareness that can help predict when capacitive coupling may occur during surgery. may be The cloud analytics system and/or the medical hub can utilize capacitive coupling algorithms to monitor the generation of energy flowing through the surgical system and integrate previous data regarding the energy state within the system for treatment of similar situations. Based on this, it can be concluded that capacitive coupling may occur if no further action is taken. For example, during a surgery involving a prescribed method regarding the method and amount of power of surgical instruments to be used during a particular step of surgery, the cloud analytics module may pull from the same previous surgery to determine the capacity after that particular step of surgery. It can be noted that binding is more likely to occur. During monitoring of surgical steps, the cloud analysis system can generate capacitive coupling when the same or very similar energy profiles occur during or immediately prior to a step that would be expected to induce capacitive coupling. A warning can be issued to indicate that The surgeon may be given the option to reduce the peak voltage on the surgical instrument 134008 or cut off the power generation by the unipolar ESU 134002, or the cloud analytics module will automatically let the medical hub take these measures. may This can eliminate the possibility of capacitive coupling before it can occur, or at least limit any unintended effects caused by the momentary onset of capacitive coupling.

In some aspects, the surgical instrument shown in FIG. 29 may include structural means to reduce or prevent capacitive coupling. For example, insulation in the shaft of the surgical instrument 134008 can reduce the generation of inductance. In other cases, the monopolar wire connecting the monopolar ESU 134002 to the surgical instrument 134008 may be shielded. As another example, interrupting plastic elements can be intermittently present within the shaft to prevent capacitive coupling from being transmitted over long distances within the shaft. Other insulator-type elements may be used to achieve a similar effect. In some aspects, the monopolar wires electrically connecting the surgical instrument 134008 to the generator 134002 may also be shielded to reduce the occurrence of capacitive coupling.

In some aspects, the structure of the end effector may be modified to reduce capacitive coupling effects as the end effector contacts the patient. As an example, the jaws of an end effector may be designed such that only one side of each jaw is dedicated to delivering energy, thereby causing the end effector to behave like a monopolar blade while still actually functioning. typically structured as a bipolar device. In one example of this, the end or tip of the end effector may be shaped like a duckbill with rounded ends to reduce any voltage peaks that may result from sharp ends. Energy within the end effector may still be directed to areas or points along the duckbill end, but the duckbill end may dampen the dispersion of any excess energy. As another example, the blade may be structured with an upstanding upper blade element that is slightly thicker on one side and thinner on the other side so as to have a triangular cross-sectional area. This allows any energy delivered to the blade to be focused to a point, which can help the surgical instrument behave like a monopolar blade while still being a bipolar device. In this way, the energy will not become dispersed, making the surgical instrument more susceptible to capacitive coupling. As a final example, the jaws of a surgical instrument may have electrodes positioned inside the end effector, with the outer portion of the end effector acting like a shield to avoid capacitive coupling. can. Although the electrodes are still positioned to make good contact with the patient's tissue during surgery, one or more edges of the end effector prevent the energy from dispersing beyond the focused surgical field. can be shielded.

FIG. 30 is a logic flow diagram 134100 illustrating a control program or logic configuration of an exemplary methodology for limiting capacitive coupling effects in a surgical system disclosed according to some aspects. Exemplary methodologies may be consistent with the above description of some enumerated means for limiting or mitigating the effects of capacitive coupling during surgery using one or more surgical instruments.

As shown, and consistent with the examples above, methodology 134100 can begin with a surgical system configured to monitor (134102) energy generation. For example, multiple sensors may be strategically placed at potential weak points that are more prone to leaking energy that can cause capacitive coupling. These sensors may be configured to send alerts when energy anomalies occur.

Subsequently, sensors or other detection means detect voltage anomalies, such as voltage peaks or voltage spikes, at one or more locations along the surgical system that would not normally be expected to produce such energy. (134104) can. The system may be configured to conclude that these scenarios may cause parasitic capacitive coupling and, without any warning, may burn the patient without the surgical team's knowledge. As a result, a warning or message may be sent indicating the danger of energy anomalies and capacitive coupling occurring.

In some embodiments, situational awareness may also be used to predict when capacitive coupling is more likely during the normal course of surgery (134106). Situational awareness can be used to reference past surgeries of similar type or situation to identify what variables may be present when capacitive coupling is determined to have occurred. If there are certain steps in the procedure that are more prone to capacitive coupling, the system may specifically monitor sensors at these times and/or take proactive measures to reduce the occurrence of capacitive coupling. , can predict these situations.

Based on the above methodology 134100 performed by the surgical system, if capacitive coupling is detected or believed to be imminent, measures taken to reduce, eliminate, or mitigate the effects of capacitive coupling include: Some aspects may include automatically shutting off energy generation (134108) in a monopolar energy generator. Note that some loss in surgery may occur momentarily once this block is effective, but prevention of unintended injury to the patient will be paramount in any case. Surgery can continue as planned after a brief interruption.

By measuring the output energy relative to the input energy, using parasitic leakage to improve pad contact, or turning off the power, the amount of current the generator produces is known and the energy output is measured.

Increasing Frequency in the Presence of Capacitive Coupling In some aspects, the presence of parasitic capacitive coupling can be exploited to effect energy coagulation or energy ablation. In certain instances, it may be desirable to increase the energy production of the electrosurgical instrument to drive a monopolar circuit through the patient's body to ground. There can be numerous instances in which a unipolar circuit is completed via conductivity drawn by a conductive return pad (see FIG. 29) such as the Smart Megasoft Pad 134014®, but in some cases the pad is defective. or worn out so that the conductivity of the pads 134014 is not sufficient to draw the current of the electrosurgical instrument (eg, 134008) through the patient's body. In such cases, the current may effectively act like a short circuit through the patient's body, lacking sufficient ground for the energy to be transferred. This may render electrosurgery ineffective because the energy delivered by the surgical instrument 134008 does not pass through the patient's tissue and thus does not heat the tissue as intended. A similar situation can occur if there is no return pad at all. That is, without a conductive return pad, such as the Smart Megasoft Pad 134014®, to provide a wide conductive return path, there may not be an effective ground connected to the patient. This can also lead to the patient acting as a short circuit when energy from the surgical instrument is applied to the patient.

To accommodate these situations, in some embodiments, the monopolar energy generation is increased to very high frequencies, such as 500 Khz to 3.4 Mhz, to take advantage of parasitic patient leakage for padless electrosurgery. (or electrosurgery with poor conductivity in the pad) can be performed. Increasing the AC frequency will increase the parasitic leakage current. The stronger leakage current can then traverse the patient's body radially more efficiently. After arriving through the patient's body, the capacitively coupled leakage current is consequently more efficiently radially coupled to ground, effectively driving the current radially into another body that serves as the ground. obtain. For example, if the AC frequency is high enough, current leakage can reach the ground terminal of a monopolar generator. This helps eliminate the patient's short-circuit effect, thereby allowing energy coagulation to occur. Therefore, in situations where there are systems with no pads or pads with poor conductivity, it may be desirable to increase the current leakage to complete a unipolar circuit with the higher leakage return available. There is That is, in some cases the return path may be formed by radiative current leakage caused by capacitive coupling. The energy of the surgical instrument may be increased to very high frequencies to ensure that the radiative return path reaches the ground plane.

In some cases, the low-conductivity return pad may be intentionally connected to earth ground or to the table or nearest supporting surface, while the return connector of the generator is likewise connected to earth ground. good too. This allows the circuit to be diverted to flow through a radioactive return path, rather than having any energy attempts back to the generator through the low-conductivity return pad, which could burn the patient. be.

Note that if a system with pads exists and the pads provide sufficient conductivity under the patient, a typical monopolar circuit driving current through the body to the return pad may be the preferred method. . In these cases, it may be useful to build an isolation barrier to an externally connected power source such as the energy generator 134002 (see FIG. 29). Alternatively, a battery-powered instrument may be a more ideal system for reducing leakage currents that would help isolate the energy path through the conductive return pads.

In some aspects, a surgical system may include a detection circuit configured to determine capabilities of a return path pad. The detection circuit then provides information as to whether it is better to use radiative current leakage to complete the circuit rather than relying on low-conductivity return-path pads or simply trying not to rely on pads at all. may provide. A detection circuit can measure the amount of conductivity in the return path pad. If the conductivity measurement meets a predetermined threshold, the system can determine that the return path pad can be used to perform surgery and provide a monopolar energy return path. If the conductivity is below the threshold, the detection circuitry should significantly increase the frequency of the monopolar energy, such as in a processor or monopolar generator in the surgical hub, and eliminate the return path pad from consideration. Or at least it may be configured to send a signal to the system that it should be quarantined. Increasing the frequency will complete a unipolar circuit by creating a radiative return path.

In some aspects, the monopolar generator has one or more sensors coupled to one or more sensors configured to determine whether a current leakage reaches the ground terminal of the monopolar generator. More than one control circuit may be included. A closed feedback loop system that can automatically adjust the frequency to create a sufficient return path based on high leakage currents using a sensor combined with a detection circuit and a control circuit for the unipolar generator. may be generated. For example, the detection circuit can determine whether the return path pad has sufficient conductivity. Otherwise, the control circuit of the unipolar generator can generate energy to increase the AC frequency. A sensor in the unipolar generator may continuously monitor whether any radiative current leakage reaches the ground terminal of the unipolar generator based on the increased frequency. The control circuit may gradually increase the frequency until radiative current leakage is detected reaching the ground terminal. Therefore, the surgical system may rely on a predetermined frequency threshold to determine whether there is no return path pad or insufficient conductivity in the pad, or use a closed feedback system to A sufficiently high frequency may be found that can create a return path through radiative coupling.

FIG. 31 is a logic flow diagram 134200 showing a control program or logic configuration of an exemplary methodology that may be executed by a surgical system utilizing monopolar energy generation to determine whether to utilize parasitic capacitive coupling. Consistent with the discussion above, a detection circuit as part of a surgical system may be configured to measure (134202) the level of conductivity in the return path of a monopolar electrosurgical setup. A return path may be specified by itself through a conductive pad such as a Soft Megasoft Pad® or other return path conductive pad. In some cases, the conductivity within the pad may provide low conductivity. In other cases, pads may not be present as part of the surgical setup. This may cause the patient's body to act as a short circuit for the monopolar circuit, which would reduce or eliminate the effectiveness of attempting to apply monopolar energy to the patient's surgical site.

The detection circuit may determine (134204) that the measured conductivity is below a predetermined threshold, which means that the level of conductivity in the return path is sufficiently low to prevent completion of a unipolar circuit. indicate. As a result, the surgical system may cause the generator to increase current leakage (134206) by increasing the frequency of the alternating current in the monopolar generator. Surgical systems may alternatively utilize radioactive current leakage to create a return path. As the frequency increases, the current leakage also increases, thereby increasing the reach of the radiative current leakage reaching the ground plane, completing the circuit. Thus, by increasing the frequency, low conductivity return path pads, or even no pads at all, can be reversed. In some cases, an increase in leakage may be determined based on a closed feedback sensor system that adjusts the frequency until it is determined that radioactive current leakage has reached the ground terminal at the monopolar generator.

In some aspects, the surgical system may also provide instructions to insulate (134208) any of the return path pads and to attach the return connector of the monopolar generator to earth ground. good. These measures can be taken to eliminate other alternative return paths that could inadvertently cause burns to unwanted locations on the patient.

Situational Awareness Referring now to FIG. 32, a timeline 5200 illustrating the situational awareness of a hub, eg, surgical hub 106 or 206, is shown. Timeline 5200 is an exemplary surgical procedure and contextual information that surgical hubs 106, 206 can derive from data received from data sources at each step of the surgical procedure. Timeline 5200 is taken by nurses, surgeons, and other medical personnel during the course of a segmentectomy surgery, beginning with setting up the operating room and ending with transferring the patient to the post-operative recovery room. A typical process that might be followed is shown.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Situational awareness is further described in US 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, operation of a robotic surgical system, including, for example, various robotic surgical systems disclosed herein, is based on its situational awareness and/or feedback from its components and/or from cloud 102. can be controlled by the hub 106, 206 based on the information in the

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

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

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

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

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

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

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). is available). It can include digital, analog, mixed signal, and often high frequency functions all on a single substrate. SoCs integrate microcontrollers (or microprocessors) with modern peripherals such as graphics processing units (GPUs), Wi-Fi modules, or co-processors. The SoC may or may not include embedded memory.

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

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

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

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

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

As used in any aspect of this specification, the terms “component,” “system,” “module,” etc. may be implemented in either hardware, a combination of hardware and software, software, or software in execution. It can refer to some computer-related entity.

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

The network may include packet switched networks. The communication devices can communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include the Ethernet communication protocol, which may use Transmission Control Protocol/Internet Protocol (TCP/IP) to enable communication. The Ethernet protocol conforms to or is compatible with the Ethernet standard entitled "IEEE 802.3 Standard" published December 2008 by the Institute of Electrical and Electronics Engineers (IEEE) and/or later versions of this standard. possible. Alternatively or additionally, the communication device may V.25 communication protocol can be used to communicate with each other. X. The V.25 communication protocol may conform to or be compatible with standards promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices can communicate with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or be compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be able to communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published in August 2001 by the ATM Forum under the title "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, terms such as "process", "calculate", "calculate", "determine", "display", etc. are used throughout the foregoing disclosure as is apparent from the foregoing disclosure. Discussions using the term refer to data represented as physical (electronic) quantities in computer system registers and memory as physical quantities in computer system memory or registers or in any such information storage, transmission, or display device. It will be understood to refer to the actions and processes of a computer system or similar electronic computing device that manipulates and transforms other data that may be similarly represented.

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

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

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

Those skilled in the art will appreciate that the terms used herein generally, and particularly in the appended claims (e.g., the appended claim text), are generally intended as "open" terms. (e.g., the term "including" is to be interpreted as "including but not limited to"; the term "having" is to be interpreted as "including but not limited to"); should be interpreted as "having at least" and the term "includes" should be interpreted as "includes but is not limited to" should be done, etc.). Moreover, where a particular number is intended in an introduced claim recitation, such intent is expressly recited in the claim; and in the absence of such a statement, such intent does not exist. will be understood by those skilled in the art. For example, as an aid to understanding, the following appended claims use the introductory phrases "at least one" and "one or more" to introduce claim recitations. may be included to However, the use of such phrases when introducing claim recitations by the indefinite article "a" or "an" may be used even if the introductory phrases "one or more" or "at least one" are used within the same claim. and any particular claim containing such an introduced claim recitation is limited to the claim containing only one such recitation, even if the indefinite articles "a" or "an" are included. (e.g., "a" and/or "an" should generally be construed to mean "at least one" or "one or more ). the same holds true where the definite article is used to introduce claim recitations.

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

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

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

Any patent applications, patents, non-patent publications, or other disclosure material referenced herein and/or listed in any application data sheet is, to the extent the material incorporated herein, is not inconsistent with this specification. , incorporated herein by reference. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting statements incorporated herein by reference. Any content, or portion thereof, that is inconsistent with the current definitions, opinions, or other disclosures set forth herein, is hereby incorporated by reference, but the reference content and the current disclosure are hereby incorporated by reference. References shall be made only to the extent that there is no inconsistency between

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

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

Example 1. A surgical system electrically coupled to a monopolar energy generator and a monopolar energy generator comprising an electrode and configured to transmit electrosurgical energy through the electrode to tissue of a patient at a surgical site. an instrument and at least one detection circuit for measuring an amount of conductivity in a return path of electrosurgical energy and determining that the amount of conductivity in the return path is below a predetermined threshold; at least one detection circuit configured to transmit a signal that increases current leakage in the surgical system by increasing the alternating frequency in the electrosurgical energy generation to the monopolar energy generator; A surgical system comprising a sensor configured to determine that a monopolar energy circuit is complete by detecting that current leakage reaches a ground terminal within the monopolar energy generator.

Example 2. The surgical system of Example 1, wherein the increased current leakage allows the surgical instrument to be used to perform monopolar electrosurgery on a patient.

Example 3. The monopolar energy generator is configured to receive an indication from the sensor that the current leakage has not yet reached a ground terminal within the monopolar energy generator and, in response to the indication, further increase the AC frequency. 3. The surgical system of example 1 or 2, further comprising control circuitry.

Example 4. the control circuit, in response to the further increase in the AC frequency, receiving a second indication from the sensor that the current leakage has reached the ground terminal within the monopolar energy generator; in response to the second indication, 4. The surgical system of Example 3, further configured to stop increasing the AC frequency.

Example 5. The surgical system is further configured to provide instructions to isolate any return path pads from the surgical system to minimize conductivity flowing through any of the return path pads. A surgical system according to any one of Examples 1-4.

Example 6. The surgical system of any one of Examples 1-5, wherein increasing the frequency comprises increasing the frequency to a range of 500 KHz to 4 MHz.

Example 7. A surgical system monopolar energy generator coupled to a surgical instrument configured to transmit electrosurgical energy to patient tissue at a surgical site, the energy generator generating monopolar electrosurgical energy. a power supply, a complete circuit sensor, a control circuit, and a ground terminal, wherein the control circuit determines that the amount of conductivity in the return path of monopolar electrosurgical energy is below a predetermined threshold. A signal is received from the detection circuit and, in response to the signal, is configured to increase the current leakage by increasing the AC frequency in the power supply, the complete circuit sensor indicating that the current leakage has reached the ground terminal. A monopolar energy generator configured to determine completion of a monopolar energy circuit by detecting.

Example 8. 8. The monopolar energy generator of example 7, wherein the increased current leakage allows the surgical instrument to be used to perform monopolar electrosurgery on a patient.

Example 9. Embodiment 7 or 8, wherein the control circuit is further configured to receive an indication from the complete circuit sensor that the current leakage has not yet reached the ground terminal and, in response to the indication, further increase the AC frequency. A monopolar energy generator as described in .

Example 10. the control circuit, in response to the further increase in the AC frequency, receiving a second indication from the sensor that the current leakage has reached the ground terminal within the monopolar energy generator; in response to the second indication, 10. The monopolar energy generator of example 9 further configured to stop increasing the alternating frequency.

Example 11. The method of Examples 7-10, further configured to provide instructions to isolate any of the return-path pads from the surgical system to minimize conductivity flowing through any of the return-path pads. A monopolar energy generator according to any one of the preceding claims.

Example 12. A monopolar energy generator according to any one of examples 7-10, wherein increasing the frequency comprises increasing the frequency to a range of 500 KHz to 4 MHz.

Example 13. A closed loop method for a surgical system, the surgical system comprising a monopolar energy generator, a surgical instrument coupled to the energy generator, and a detection circuit communicatively coupled to the energy generator, the method comprising: generating electrosurgical energy to the surgical instrument by the energy generator; transmitting the electrosurgical energy to the tissue of the patient at the surgical site through the electrodes at the surgical site; measuring an amount of conductivity in the energy return path; determining, by the detection circuit, that the amount of conductivity in the return path is below a predetermined threshold; sending a signal to the monopolar energy generator that increases current leakage in the surgical system by increasing the alternating frequency at the energy generation; determining that the monopolar energy circuit is complete by detecting reaching a ground terminal in the vessel.

Example 14. 14. The method of Example 13, wherein increasing current leakage enables the surgical instrument to be used to perform monopolar electrosurgery on a patient.

Example 15. Example 13, further comprising receiving an indication from the sensor that the current leakage has not yet reached a ground terminal within the monopolar energy generator; and further increasing the AC frequency in response to the indication. Or the method according to 14.

Example 16. receiving a second indication from the sensor that the current leakage has reached the ground terminal within the monopolar energy generator in response to the further increase in the AC frequency; 16. The method of example 15, further comprising ceasing to increase the .

Example 17. 17. Any of Examples 13-16, further comprising providing instructions to isolate any return-path pads from the surgical system to minimize conductivity flowing through any of the return-path pads. The method described in 1.

Example 18. The method of any one of Examples 13-17, wherein increasing the frequency comprises increasing the frequency to a range of 500 KHz to 4 MHz.

[Mode of implementation]
(1) A surgical system comprising:
a monopolar energy generator;
a surgical instrument electrically coupled to the monopolar energy generator comprising electrodes and configured to transmit electrosurgical energy through the electrodes to tissue of a patient at a surgical site;
at least one detection circuit,
measuring the amount of conductivity in the electrosurgical energy return path;
determining that the amount of conductivity in the return path is below a predetermined threshold;
at least one detection circuit configured to send a signal to the monopolar generator to increase current leakage in the surgical system by increasing the alternating frequency in the electrosurgical energy generation; prepared,
The monopolar energy generator comprises a sensor configured to determine that a monopolar energy circuit is complete by detecting that the current leakage reaches a ground terminal within the monopolar energy generator. surgical system.
Clause 2. The surgical system of clause 1, wherein increasing the current leakage allows the surgical instrument to be used to perform monopolar electrosurgery on the patient.
(3) the monopolar energy generator,
receiving an indication from the sensor that the current leakage has not yet reached the ground terminal in the monopolar energy generator;
2. The surgical system of embodiment 1, further comprising a control circuit configured to further increase the alternating frequency in response to the instruction.
(4) the control circuit,
receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to the further increase in the alternating frequency;
4. The surgical system of embodiment 3, further configured to stop increasing the alternating frequency in response to the second indication.
(5) further wherein the surgical system provides instructions to isolate any of the return-path pads from the surgical system to minimize conductivity flowing through any of the return-path pads; 2. The surgical system of embodiment 1, wherein the surgical system is configured.

Clause 6. The surgical system of Clause 1, wherein increasing the frequency comprises increasing the frequency to a range of 500 KHz to 4 MHz.
(7) a monopolar energy generator of a surgical system coupled to a surgical instrument configured to deliver electrosurgical energy to tissue of a patient at a surgical site, said energy generator comprising:
a power source configured to generate monopolar electrosurgical energy;
a complete circuit sensor;
a control circuit;
a ground terminal;
The control circuit
receiving a signal from a detection circuit that the amount of conductivity in the return path of the monopolar electrosurgical energy is below a predetermined threshold;
configured to cause the power supply to increase current leakage by increasing the AC frequency in response to the signal;
The monopolar energy generator, wherein the completion circuit sensor is configured to determine that the monopolar energy circuit is complete by detecting that the current leakage reaches the ground terminal.
Clause 8. The monopolar energy generator of Clause 7, wherein increasing the current leakage allows the surgical instrument to be used to perform monopolar electrosurgery on the patient.
(9) the control circuit,
receiving an indication from the complete circuit sensor that the current leakage has not yet reached the ground terminal;
8. The monopolar energy generator of embodiment 7, further configured to further increase the alternating frequency in response to the indication.
(10) The control circuit
receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to the further increase in the alternating frequency;
10. The monopolar energy generator of embodiment 9 further configured to stop increasing the alternating frequency in response to the second indication.

(11) further configured to provide instructions to isolate any of the return-path pads from the surgical system to minimize conductivity flowing through any of the return-path pads; 8. A monopolar energy generator according to embodiment 7.
Clause 12. The monopolar energy generator of Clause 7, wherein increasing the frequency comprises increasing the frequency to a range of 500 KHz to 4 MHz.
(13) A closed loop method of a surgical system, wherein said surgical system comprises a monopolar energy generator, a surgical instrument coupled to said energy generator, and a detection circuit communicatively coupled to said energy generator. and, wherein the method includes:
generating electrosurgical energy to the surgical instrument with the energy generator;
transmitting electrosurgical energy through electrodes to tissue of a patient at a surgical site by the surgical instrument;
measuring, with the detection circuitry, the amount of conductivity in the return path of the electrosurgical energy;
determining, by the detection circuit, that the amount of conductivity in the return path is below a predetermined threshold;
sending, by the detection circuit, a signal to the monopolar energy generator that causes the energy generator to increase current leakage in the surgical system by increasing an alternating frequency in the electrosurgical energy generation;
determining, with a sensor in the monopolar energy generator, that a monopolar energy circuit is complete by detecting that the current leakage reaches a ground terminal in the monopolar energy generator; Method.
Aspect 14. The method of aspect 13, wherein increasing the current leakage enables the surgical instrument to be used to perform monopolar electrosurgery on the patient.
(15) receiving an indication from the sensor that the current leakage has not yet reached the ground terminal within the monopolar energy generator;
14. The method of embodiment 13, further comprising, in response to said indication, further increasing said alternating frequency.

(16) receiving a second indication from the sensor that the current leakage has reached the ground terminal within the monopolar energy generator in response to the further increase in the AC frequency;
16. The method of embodiment 15, further comprising, in response to the second indication, stopping increasing the alternating frequency.
Embodiment 13 further comprising providing instructions to isolate any of said return-path pads from said surgical system to minimize conductivity flowing through any of said return-path pads. The method described in .
18. The method of claim 13, wherein increasing the frequency comprises increasing the frequency to a range of 500 KHz to 4 MHz.

Claims (12)

A surgical system,
a monopolar energy generator;
a surgical instrument electrically coupled to the monopolar energy generator comprising electrodes and configured to transmit electrosurgical energy through the electrodes to tissue of a patient at a surgical site;
at least one detection circuit,
measuring the amount of conductivity in the electrosurgical energy return path;
determining that the amount of conductivity in the return path is below a predetermined threshold;
at least one detection circuit configured to send a signal to the monopolar energy generator to increase current leakage in the surgical system by increasing the alternating frequency in the electrosurgical energy generation; with
The monopolar energy generator comprises a sensor configured to determine that a monopolar energy circuit is complete by detecting that the current leakage reaches a ground terminal within the monopolar energy generator. surgical system. The surgical system of claim 1, wherein increasing the current leakage allows the surgical instrument to be used to perform monopolar electrosurgery on the patient. the monopolar energy generator comprising:
receiving an indication from the sensor that the current leakage has not yet reached the ground terminal in the monopolar energy generator;
The surgical system of claim 1, further comprising a control circuit configured to further increase the AC frequency in response to the indication. The control circuit
receiving a second indication from the sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to the further increase in the alternating frequency;
4. The surgical system of claim 3, further configured to stop increasing the AC frequency in response to the second instruction. The surgical system is further configured to provide instructions to isolate any of the return-path pads from the surgical system to minimize conductivity flowing through any of the return-path pads. 2. The surgical system of claim 1, wherein the surgical system comprises: The surgical system of claim 1, wherein increasing the AC frequency comprises increasing the AC frequency to a range of 500 KHz to 4 MHz. A surgical system monopolar energy generator coupled to a surgical instrument configured to deliver electrosurgical energy to patient tissue at a surgical site, the monopolar energy generator comprising:
a power source configured to generate monopolar electrosurgical energy;
a complete circuit sensor;
a control circuit;
a ground terminal;
The control circuit
receiving a signal from a detection circuit that the amount of conductivity in the return path of the monopolar electrosurgical energy is below a predetermined threshold;
configured to cause the power supply to increase current leakage by increasing the AC frequency in response to the signal;
The monopolar energy generator, wherein the completion circuit sensor is configured to determine that the monopolar energy circuit is complete by detecting that the current leakage reaches the ground terminal. 8. The monopolar energy generator of claim 7, wherein increasing the current leakage allows the surgical instrument to be used to perform monopolar electrosurgery on the patient. The control circuit
receiving an indication from the complete circuit sensor that the current leakage has not yet reached the ground terminal;
8. The monopolar energy generator of claim 7, further configured to further increase the AC frequency in response to the indication. The control circuit
receiving a second indication from the complete circuit sensor that the current leakage has reached the ground terminal in the monopolar energy generator in response to the further increase in the AC frequency;
10. The monopolar energy generator of claim 9, further configured to stop increasing the AC frequency in response to the second indication. 8. Further configured to provide instructions to isolate any of the return-path pads from the surgical system to minimize conductivity flowing through any of the return-path pads. A monopolar energy generator as described in . 8. The monopolar energy generator of claim 7, wherein increasing the alternating frequency comprises increasing the alternating frequency to a range of 500 KHz to 4 MHz.

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