JP7282782B2 - System for detecting proximity of surgical end effector to cancerous tissue - Google Patents

Description

(Cross reference to related applications)
This application was filed June 28, 2018 under 35 U.S.C. No. 62/691,227 of U.S. Provisional Patent Application No. 62/691,227.

This application is filed March 30, 2018 under 35 U.S.C. U.S. Provisional Patent Application No. 62/650,887, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS," U.S. Provisional Patent Application No. 62/650,877, filed March 30, 2018, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SUR GICAL PLATFORM and U.S. Provisional Application No. 62/650,882, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," filed March 30, 2018. Priority benefit of 62/650,898 is claimed.

This application is further filed under 35 U.S.C. U.S. Provisional Application No. 62/640,417, filed March 8, 2018; claim the priority benefit of

119(e), the disclosures of each of which are incorporated herein by reference in their entireties, filed Dec. 28, 2017. Application No. 62/611,341, U.S. Provisional Patent Application No. 62/611,340, filed December 28, 2017, entitled "CLOUD-BASED MEDICAL ANALYTICS," and U.S. Provisional Application No. 62/611,340, entitled "ROBOT ASSISTED SURGICAL PLATFORM," December 2017. It claims the benefit of priority from US Provisional Patent Application No. 62/611,339, filed May 28.

The present disclosure relates to surgical systems.

A surgical instrument is disclosed. A surgical instrument includes an end effector and control circuitry. The end effector includes a first jaw, a second jaw movable relative to the first jaw to grasp tissue therebetween, an anvil, and a staple positionable within the tissue. wherein the staples are deformable by the anvil; and a sensor configured to provide a sensor signal according to a physiological parameter of tissue. A control circuit is coupled to the sensor, the control circuit configured to receive the sensor signal and assess the sensor's proximity to the cancerous tissue based on the sensor signal.

A surgical stapling instrument is disclosed. A surgical stapling instrument includes an end effector and control circuitry. The end effector includes a first jaw, a second jaw movable relative to the first jaw to grasp tissue therebetween, an anvil, and a staple positionable within the tissue. wherein the staples are deformable by the anvil; and a sensor configured to provide a sensor signal according to a physiological parameter indicative of proximity of the sensor to cancerous tissue. . A control circuit is coupled to the sensor, the control circuit configured to receive the sensor signal, determine a value of the physiological parameter based on the sensor signal, and compare the value of the physiological parameter to a predetermined threshold. It is

A surgical instrument is disclosed. A surgical instrument includes an end effector and control circuitry. The end effector includes a first jaw, a second jaw movable relative to the first jaw to grasp tissue therebetween, an anvil, and a staple positionable within the tissue. a staple cartridge, wherein the staples are deformable by the anvil; a sensor assembly configured to provide a sensor signal according to a physiological parameter indicative of proximity of the sensor to cancerous tissue; including. The sensor assembly includes a first sensor on a first side of a longitudinal axis extending through the staple cartridge and a second sensor on a second side of the longitudinal axis. A control circuit is coupled to the sensor assembly, the control circuit receiving a first sensor signal from the first sensor, a second sensor signal from the second sensor, and a first sensor signal. determining a first value of the physiological parameter based on the second sensor signal; determining a second value of the physiological parameter based on the second sensor signal; comparing the first value and the second value to a predetermined threshold is configured to

Features of various aspects are set forth with particularity in the accompanying 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; 1 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 manipulate 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. FIG. 10 is a schematic diagram of a tissue contacting circuit showing completion of the circuit upon tissue contact with a pair of spaced apart contact plates, according to at least one aspect of the present disclosure; 1 is a perspective view of a surgical instrument having an operably coupled interchangeable shaft assembly in accordance with at least one aspect of the present disclosure; FIG. 22 is an exploded view of a portion of the surgical instrument of FIG. 21 according to at least one aspect of the present disclosure; FIG. 3 is an exploded view of a portion of an interchangeable shaft assembly, according to at least one aspect of the present disclosure; FIG. 22 is an exploded view of an end effector of the surgical instrument of FIG. 21 in accordance with at least one aspect of the present disclosure; FIG. 22 is a block diagram of the control circuitry of the surgical instrument of FIG. 21, spanning two drawings, in accordance with at least one aspect of the present disclosure; FIG. 22 is a block diagram of the control circuitry of the surgical instrument of FIG. 21, spanning two drawings, in accordance with at least one aspect of the present disclosure; FIG. 22 is a block diagram of the control circuitry of the surgical instrument of FIG. 21 showing the interfaces between the handle assembly and the power supply assembly and between the handle assembly and the replaceable shaft assembly, according to at least one aspect of the present disclosure; FIG. is. 1 illustrates a tumor surrounded by healthy tissue and a tumor-free clear margin defined within the healthy tissue, according to at least one aspect of the present disclosure; FIG. 10 is a graph showing physiological parameters of tissue plotted against distance from a tumor, in accordance with at least one aspect of the present disclosure; FIG. FIG. 4 is a logic flow diagram of a process showing a control program or logic configuration for evaluating proximity of an end effector of a surgical instrument to cancerous tissue, in accordance with at least one aspect of the present disclosure; FIG. 10 is a logic flow diagram of a process showing a control program or logic configuration for evaluating proximity of an end effector to cancerous tissue, in accordance with at least one aspect of the present disclosure; 1 illustrates an end effector of a surgical instrument, according to at least one aspect of the present disclosure; 1 illustrates a control system for a surgical instrument, according to at least one aspect of the present disclosure; 4 illustrates a proximity index correlating a sensor signal with proximity from an end effector, according to at least one aspect of the present disclosure; FIG. 10 illustrates a logic flow diagram of a process showing a control program or logic configuration for determining the direction in which cancerous tissue is positioned with respect to an end effector, according to at least one aspect of the present disclosure; FIG. 12A illustrates a plan view of an end effector of a surgical instrument, in accordance with at least one aspect of the present disclosure; 3 is a graph showing sensor signals representing physiological parameters of tissue plotted against time in accordance with at least one aspect of the present disclosure; FIG. 12B illustrates a partial view of an end effector of a surgical instrument, according to at least one aspect of the present disclosure; 3 is a graph showing sensor signals representing physiological parameters of tissue plotted against time in accordance with at least one aspect of the present disclosure; FIG. 10 is a logic flow diagram of a process showing a control program or logic configuration for providing instructions to guide an end effector against cancerous tissue, in accordance with at least one aspect of the present disclosure; FIG. 10 is a logic flow diagram of a process showing a control program or logic configuration for providing instructions to guide an end effector against cancerous tissue, in accordance with at least one aspect of the present disclosure; 3 is a graph showing sensor signals representing physiological parameters of tissue plotted against time in accordance with at least one aspect of the present disclosure; error! No array specified. 1 illustrates a glucose sensor, according to at least one aspect of the present disclosure; 43 shows an exploded view of the glucose sensor of FIG. 42. FIG. 4 is a graph showing current plotted against potential, according to at least one aspect of the present disclosure; 4 is a graph showing net current plotted against blood glucose level in accordance with at least one aspect of the present disclosure; 4 is a timeline illustrating surgical 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 June 29, 2018, the entire disclosures of each of which are incorporated herein by reference:
U.S. Patent Application No. ____________, Attorney Docket No. END8542USNP/170755, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS";
U.S. Patent Application No. ____________, Attorney Docket No. END8543USNP/170760, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";
U.S. Patent Application No. ____________, Attorney Docket No. END8543USNP1/170760-1, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOD PERATIVE INFORMATION";
U.S. Patent Application No. ____________, Attorney Docket No. END8543USNP2/170760-2, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING";
U.S. Patent Application No. ____________, Attorney Docket No. END8543USNP3/170760-3, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING";
U.S. Patent Application No. ____________, Attorney Docket No. END8543USNP4/170760-4, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES";
- U.S. Patent Application No. ______________, Attorney Docket No. END8543USNP6/170760-6, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES";
- U.S. Patent Application entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY", Attorney Docket No. END8543USNP7/170760-7;
U.S. Patent Application No. ____________, Attorney Docket No. END8544USNP/170761, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
- U.S. Patent Application No. ____________, Attorney Docket No. END8544USNP1/170761-1, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT";
- U.S. Patent Application No. ____________, Attorney Docket No. END8544USNP2/170761-2, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY";
U.S. Patent Application No. ______________, Attorney Docket No. END8544USNP3/170761-3, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES";
- U.S. Patent Application No. ____________, Attorney Docket No. END8545USNP/170762, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
- U.S. Patent Application No. ____________, Attorney Docket No. END8545USNP1/170762-1, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS";
- U.S. Patent Application No. ____________, Attorney Docket No. END8545USNP2/170762-2, entitled "SURGICAL EVACUATION FLOW PATHS";
- U.S. Patent Application No. ____________, Attorney Docket No. END8545USNP3/170762-3, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL";
- U.S. Patent Application No. ____________, Attorney Docket No. END8545USNP4/170762-4, entitled "SURGICAL EVACUATION SENSING AND DISPLAY";
U.S. Patent Application No. ____________, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; Agent reference number END8546USNP/170763,
- U.S. Patent Application No. ____________, Attorney Docket No. END8546USNP1/170763-1, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM";
- U.S. Patent Application No. ________, Attorney Docket No. E, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION DEVICE" ND8547USNP/170764, and "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS No. ____________, Attorney Docket No. END8548USNP/170765.

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 Patent Open 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 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.

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 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 No. 15/940,634 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"
U.S. Patent Application No. 15/940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; No. 675.

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:
- 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 Serial No. 62/649,323 entitled "ORMS" issue.

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. 62/650,887 entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES";
• US Provisional Patent Application No. 62/650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS."
U.S. Provisional Patent Application No. 62/650,882 entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; Application No. 62/650,898 .

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"; U.S. Provisional Patent Application No. 62/640 entitled EM THEREOFR , 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:
• US 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 systems in detail, it is noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of the parts shown in the accompanying drawings and description. Should. 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.

Aspects of the present disclosure present various surgical instruments that are utilized in cancer treatment to assess proximity to cancerous tissue and/or to guide a user to a safe distance from cancerous tissue. Using various sensors and algorithms to assist in A surgical instrument may be utilized alone or as a component of a computer-implemented interactive surgical system.

Referring to FIG. 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., cloud 104 that may include a remote server 113 coupled to storage device 105). ,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 . One or more of the surgical instruments of the present disclosure may be implemented as a robotic tool for use with a robotic system. 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 removably 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, nasopharyngeal-nephroscopes, 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 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 interfaces for Health Level-7, image archiving and communication systems, and electronic medical records (EMR). 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 the flow of information to the operator in and out of 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 Dec. 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 surgical system 102 are described, for example, in the "Surgical Instrument Hardware" section and the 2017 article entitled "INTERACTIVE SURGICAL PLATFORM", the entire disclosures of which are incorporated herein by reference. No. 62/611,341, filed December 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 monitor 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 radio frequency (RF) energy generator component, and a unipolar RF energy generator component housed within a single unit. include. 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 the 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. and may be configured to facilitate communication.

As described in more detail below, one or more of the monopolar device 146, the bipolar device 147, and the ultrasound device 148 may include, for assessing proximity to cancerous tissue and/or for can be equipped with sensors and algorithms to assist in guiding a safe distance from cancerous tissue.

In one aspect, the hub's modular housing 136 is a modular power and power module with external and wireless communication headers to allow removable attachment of modules 140, 126, 128 and bi-directional communication therebetween. 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 vertical 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 relating 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 hereby incorporated by reference in its entirety for each disclosure.

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 data conduit, allowing data to go from one device (or segment) to another device (or segment) and to cloud computing resources. The intelligent surgical data network includes additional mechanisms that allow traffic to pass through the monitored surgical data network and configure each port within 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 . Although 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 receives data packets from network hub 207 and/or network switch 209 in order to further process and manipulate data collected by any one or all of devices 1a-1n/2a-2m. Create a path 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 transmits 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-bandwidth 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 the 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 . Robotic 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, non-volatile 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, the processor 244 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 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 non-volatile memory. The basic input/output system (BIOS), containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in nonvolatile memory. For example, 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 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, game pads, satellite dishes, scanners, TV tuner cards, digital cameras, digital video cameras, and web cameras. but not limited to these. 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 and 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. Control system 470 includes a microcontroller 461 that includes 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 a motor driver 492 operatively couples the longitudinally movable displacement member to drive the I-beam knife member. Tracking system 480 is configured to determine the position of the longitudinally moveable displacement member. The positional information is provided to processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member, as well as the positions of the firing member, firing bar, and I-beam knife elements. Additional motors may be provided in the tool driver interface to control I-beam firing, obturator tube movement, shaft rotation, and articulation. The display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on display 473 can 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 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, the microcontroller 461 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 configured specifically for IEC61508 and ISO26262 safety limit applications to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

The microcontroller 461 may be programmed to perform various functions such as precision control over the speed and position of the knife and articulation system. 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 other 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. In at least one embodiment, the battery cells may be lithium ion (LI) 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. The driver 492 contains a unique charge pump regulator that provides full (>10V) gate drive until the battery voltage drops to 7V and operates the A3941 with reduced gate drive until the battery voltage drops to 5.5V. A bootstrap capacitor may be used to provide the required battery supply voltage for the N-channel MOSFET. 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 includes controlled motor drive circuitry with position sensor 472 in accordance with at least 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 firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Accordingly, as used herein, the term displacement member refers to any movable member of a surgical instrument, such as a drive member, firing member, firing bar, I-beam, or any element that can be displaced. Used to refer in general. In one aspect, a longitudinally movable drive member is coupled to the firing member, firing bar, and I-beam. Thus, the absolute positioning system can actually track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. 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, firing member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable 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, moveable magnets, and magnetic sensing including Hall effect sensors arranged in a series of lines. A system, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical detection comprising a movable light source and a series of linearly arranged photodiodes or photodetectors. The system may include a fixed light source and an optical detection system including 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 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, firing bar, I-beam, or a combination thereof.

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 displacement of the displacement member from point "a" after one rotation of the sensor element coupled to the displacement member. It is the linear longitudinal distance traveled 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 rotations 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 d1+d2+ . . . 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 to sense magnetic fields include, among others, search 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. A digit-by-digit method and a boulder method to implement concise and efficient algorithms for computing hyperbolic and trigonometric functions, requiring only addition, subtraction, bit-shifting, and table lookup operations. A coordinate rotation digital computer (CORDIC) processor, also known as Volder's algorithm, is provided. Angular position, alarm bits, and magnetic field information are transmitted to microcontroller 461 via a standard serial communication interface, such as a serial peripheral interface (SPI) interface. Position sensor 472 provides 12-bit or 14-bit resolution. Position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

Tracking system 480, 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 configurations such as: 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 member, 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 the machine actuator, drive bar, knife, 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 micro strain gauge, may be used to indicate one or more of the end effectors, such as the amplitude of strain exerted on the anvil during a clamping operation, which may indicate, for example, the closing force applied to the anvil. configured to measure parameters of The measured distortion is converted to a digital signal and provided to processor 462 . Alternatively, or in addition to sensor 474, sensor 476, such as, for example, a load sensor, can measure the closing force applied to the anvil by the closing drive system. For example, a sensor 476, such as a load sensor, can measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sled, which is configured to cam the staple driver upwardly to force the staples into deforming contact with the anvil. The I-beam also includes a sharp cutting edge that can be used to cut tissue as the I-beam is advanced distally by the firing bar. Alternatively, current sensor 478 can be used to measure the current drawn by motor 482 . The force required to advance the firing 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 clamping operation, 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. 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 control circuitry 500 configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure. Control circuitry 500 may be configured to perform 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 the machine instructions to perform various processes described herein. Processor 502 may be any one of numerous single or multi-core processors known in the art. Memory circuit 504 may include volatile and nonvolatile 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 at least one aspect of the present disclosure. Combinatorial logic 510 may be configured to perform 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 at least one aspect of the present disclosure. Sequential logic 520 or combinatorial logic 522 may be configured to perform 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 to perform 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 operable to a firing motor drive assembly 604, which can be configured to transmit firing motion generated by firing motor 602 to an end effector, specifically to displace the I-beam elements. may be connected to In certain examples, the firing motion generated by firing motor 602 may, for example, deploy staples from a staple cartridge into tissue captured by an end effector and/or advance a cutting edge of an I-beam element to The captured tissue may be cut. The I-beam elements can be retracted by reversing the direction of firing motor 602 .

In certain examples, a surgical instrument or tool may include a closure motor 603. Closure motor 603 is specifically configured to displace the closure tube to close the anvil and transmit the closure motion generated by closure motor 603 to the end effector to compress tissue between the anvil and staple cartridge. may be operably coupled with a closure motor drive assembly 605, which may be configured to: The closing motion can 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 the closing motor 603.

In certain examples, a surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The articulation motors 606a, 606b can be operably coupled to corresponding articulation motor drive assemblies 608a, 608b, which can be configured to transmit the articulation motion generated by the articulation motors 606a, 606b to the end effector. . In certain examples, the articulation can, 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 the closure tube and I-beam elements, 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 memories 624 may be coupled to processor 622, for example.

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, for example, a LI 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. A processor 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 include 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, when processor 622 detects, for example, via sensor 630 that switch 614 is in first position 616, processor 622 can use program instructions associated with firing the end effector I-beam, causing processor 622 to can use 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, via sensor 630, Upon detecting that the switch 614 is in the third position 618a or the fourth position 618b, program instructions associated with end effector articulation can be used.

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

In one aspect, the robotic surgical instrument 700, via a plurality of motors 704a-704e, controls the anvil 716 and I-beam 714 (including sharp cutting edges) portions of the end effector 702, removable staple cartridge 718, shaft 740, and A control circuit 710 is provided that is configured to control one or more articulation members 742a, 742b. Position sensor 734 may be configured to provide position feedback of I-beam 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 I-beam 714 determined by position sensor 734 with the output of timer/counter 731; As a result, control circuit 710 can determine the position of I-beam 714 at a particular time (t) relative to a starting position or time (t) when I-beam 714 is at a particular position relative to the starting position. can. Timer/counter 731 may be configured to measure elapsed time, count external events, or time external events.

In one aspect, control circuit 710 may be programmed to control the 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 anvil 716 . Other control programs control the rotation of shaft 740 and articulation members 742a, 742b.

In one aspect, the control circuit 710 can generate a motor setpoint signal. Motor setpoint signals may be provided to various motor controls 708a-708e. The motor controls 708a-708e are 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 include 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 controls 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 translation 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 are mechanically coupled to respective movable mechanical elements such as I-beam 714, anvil 716, shaft 740, articulation 742a, and articulation 742b via corresponding transmissions 706a-706e. good too. 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. Position sensor 734 may sense the position of I-beam 714 . Position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 714 . In some embodiments, position sensor 734 may include an encoder configured to provide a series of pulses to control circuit 710 as I-beam 714 translates distally and proximally. Control circuit 710 may track the pulses to determine the position of I-beam 714 . Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors can provide other signals indicative of I-beam 714 movement. Also, in some embodiments, position sensor 734 may be omitted. If any of motors 704a-704e are stepper motors, control circuit 710 may track the position of I-beam 714 by summing the number and direction of steps that motor 704 is instructed to perform. can. The position sensor 734 may 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 circuitry 710 is configured to drive a firing member, such as the I-beam 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 I-beam 714 . Transmission device 706a includes moveable mechanical elements, such as rotating elements and firing members, for controlling movement of I-beam 714 distally and proximally along the longitudinal axis of end effector 702 . In one aspect, motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. Torque sensor 744 a provides a firing force feedback signal to control circuit 710 . The firing force signal represents the force required to fire or displace I-beam 714 . Position sensor 734 may be configured to provide the position of I-beam 714 or the position of the firing member along the firing stroke 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 the firing member translates distally, I-beam 714 , which has a cutting element positioned at its distal end, advances distally to cut tissue located between staple cartridge 718 and anvil 716 . .

In one aspect, control circuit 710 is configured to drive a closure member, such as anvil 716 of end effector 702 . Control circuit 710 provides motor set points to motor control 708b, which provides drive signals to motor 704b. The output shaft of motor 704b is coupled to torque sensor 744b. Torque sensor 744b is coupled to transmission device 706b which is coupled to anvil 716 . Transmission device 706b includes moveable mechanical elements such as rotating elements and closure members for controlling movement of anvil 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 anvil 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 anvil 716 is positioned opposite staple cartridge 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 closure member to grasp tissue between anvil 716 and staple cartridge 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 setpoints 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 706c includes moveable mechanical elements, such as rotary elements, to control clockwise or counterclockwise rotation of shaft 740 through 360 degrees and beyond. In one aspect, the motor 704c was formed on the proximal end of the proximal closure tube to be operably engaged by a rotating gear assembly operably supported on the tool mounting plate. connected to a rotary transmission assembly including a tubular gear segment attached to the . 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 setpoints 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 device 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 located on the deck of the staple cartridge 718 to determine tissue location using segmented electrodes. Torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and/or articulation forces, among others. Thus, the control circuit 710 determines (1) the 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 staple cartridge 718 has tissue thereon. and (4) can sense load and position on both articulation rods.

In one aspect, the one or more sensors 738 may include strain gauges, such as micro strain gauges, configured to measure the amount of strain in the anvil 716 in its clamped state. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 738 may include a pressure sensor configured to detect pressure created by the presence of compressed tissue between anvil 716 and staple cartridge 718 . Sensor 738 may be configured to detect the impedance of a portion of tissue located between anvil 716 and staple cartridge 718, which may indicate the thickness and/or fullness of tissue located therebetween. indicate.

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 anvil 716 by the closing drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the anvil 716 to detect the closure force exerted by the closure tube on the anvil 716 . The force exerted on anvil 716 may be representative of the tissue compression experienced by tissue portions captured between anvil 716 and staple cartridge 718 . One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closing force applied to anvil 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 . Control circuitry 710 receives real-time sample measurements to provide and analyze time-based information to evaluate the closing force applied to anvil 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 I-beam 714, corresponds to the current drawn by one of motors 704a-704e. The force is converted to a digital signal and provided to control circuit 710 . Control circuitry 710 may be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the I-beam 714 within the end effector 702 at or near a 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 block diagram of a surgical instrument 750 programmed to control distal translation of a displacement member, according to at least one aspect of the present disclosure. In one aspect, surgical instrument 750 is programmed to control distal translation of a displacement member such as I-beam 764 . Surgical instrument 750 includes an anvil 766 , an I-beam 764 (which includes a sharp cutting edge), and an end effector 752 that may include a removable staple cartridge 768 .

The position, movement, displacement and/or translation of a linear displacement member such as closure member 764 may be measured by absolute positioning system, sensor arrangement and position sensor 784 . Because I-beam 764 is coupled to a longitudinally movable drive member, the position of I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using position sensor 784 . Accordingly, in the discussion below, position, displacement, and/or translation of I-beam 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 I-beam 764 . In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or processors to control the displacement member, e.g., I-beam 764, in the manner described. Other suitable processors may be included for execution. In one aspect, timer/counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate the position of I-beam 764 determined by position sensor 784 with the output of timer/counter 781. , so that control circuit 760 can determine the position of I-beam 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 control 758 . Motor control 758 may include one or more circuits configured to provide motor drive signals 774 to motor 754 to drive motor 754 as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774 . In some examples, motor 754 may be a brushless DC electric motor, and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754 . Also, in some embodiments, motor control 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 I-beam 764 via transmission 756 . Transmission 756 may include one or more gears or other coupling components for coupling motor 754 to I-beam 764 . A position sensor 784 may sense the position of the I-beam 764 . Position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 764 . In some embodiments, position sensor 784 may include an encoder configured to provide a series of pulses to control circuit 760 as I-beam 764 translates distally and proximally. Control circuitry 760 may track the pulses to determine the position of I-beam 764 . Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors can provide other signals indicative of I-beam 764 movement. Also, in some embodiments, position sensor 784 may be omitted. If motor 754 is a stepper motor, control circuit 760 can track the position of I-beam 764 by summing the number and direction of steps motor 754 is instructed to perform. The position sensor 784 may 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. . 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 752 . Any other suitable sensor for measuring the parameter may be included. Sensor 788 may include one or more sensors.

The one or more sensors 788 may include strain gauges, such as micro strain gauges, configured to measure the amount of strain in the anvil 766 in its clamped state. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 788 may include a pressure sensor configured to detect pressure created by the presence of compressed tissue between anvil 766 and staple cartridge 768 . Sensor 788 may be configured to detect the impedance of a portion of tissue located between anvil 766 and staple cartridge 768, which may indicate the thickness and/or fullness of tissue located therebetween. indicate.

Sensor 788 may be configured to measure the force exerted against anvil 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 anvil 766 to detect the closure force exerted by the closure tube on the anvil 766 . The force exerted against anvil 766 may be representative of tissue compression experienced by tissue portions captured between anvil 766 and staple cartridge 768 . One or more sensors 788 can be positioned at various interaction points along the closure drive system to detect the closing force applied to anvil 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 anvil 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 I-beam 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 I-beam 764 within the end effector 752 at or near a 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 may 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 I-beam 764 is driven by a gearbox and a brushed DC motor with mechanical connections 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 are directed to a surgical instrument 750 comprising an end effector 752 having motorized surgical stapling and cutting means. For example, motor 754 may drive the displacement member distally and proximally along the longitudinal axis of end effector 752 . End effector 752 may include a pivotable anvil 766 and a staple cartridge 768 positioned opposite anvil 766 when configured for use. A clinician may grasp tissue between anvil 766 and staple cartridge 768 as described herein. When surgical instrument 750 is ready for use, the clinician may provide a firing signal, for example, by pressing a trigger on surgical 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. may As the displacement member translates distally, an I-beam 764 having a cutting element positioned at its distal end can cut tissue between staple cartridge 768 and anvil 766 .

In various embodiments, surgical instrument 750 has control circuitry 760 programmed to control distal translation of a displacement member, eg, I-beam 764, based on one or more tissue conditions. You may prepare. Control circuitry 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. Control circuit 760 may be programmed to select a firing 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 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 surgical 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 at least one aspect of the present disclosure. In one aspect, surgical instrument 790 is programmed to control distal translation of a displacement member such as I-beam 764 . Surgical instrument 790 includes an end effector 792 that can include an anvil 766, an I-beam 764, and a removable staple cartridge 768 that can be replaced with an RF cartridge 796 (shown in dashed lines).

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, position sensor 784 may be implemented as an absolute positioning system, including 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 circuit 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 one aspect, the I-beam 764 may be implemented as a knife member including a knife body operably supporting a tissue cutting blade thereon, with an anvil engaging tab or feature and a passageway engaging feature or foot. may further include: In one aspect, staple cartridge 768 may be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, RF cartridge 796 may be implemented as an RF cartridge. These and other sensor configurations are disclosed in commonly owned U.S. Patent Application Serial No. 15/628,175, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT").

The position, movement, displacement, and/or translation of a linear displacement member such as I-beam 764 can be measured by an absolute positioning system, sensor configuration, and position sensor represented as position sensor 784 . Because I-beam 764 is coupled to a longitudinally movable drive member, the position of I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using position sensor 784 . Accordingly, in the discussion below, position, displacement, and/or translation of I-beam 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 I-beam 764, as described herein. In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or processors to control the displacement member, e.g., I-beam 764, in the manner described. Other suitable processors may be included for execution. In one aspect, timer/counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate the position of I-beam 764 determined by position sensor 784 with the output of timer/counter 781. , so that control circuit 760 can determine the position of I-beam 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 control 758 . Motor control 758 may include one or more circuits configured to provide motor drive signals 774 to motor 754 to drive motor 754 as described herein. In some examples, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774 . In some examples, motor 754 may be a brushless DC electric motor and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754 . Also, in some embodiments, motor control 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 I-beam 764 via transmission 756 . Transmission 756 may include one or more gears or other coupling components for coupling motor 754 to I-beam 764 . A position sensor 784 may sense the position of the I-beam 764 . Position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 764 . In some examples, position sensor 784 may include an encoder configured to provide a series of pulses to control circuit 760 as I-beam 764 translates distally and proximally. Control circuitry 760 may track the pulses to determine the position of I-beam 764 . Other suitable position sensors may be used including, for example, proximity sensors. Other types of position sensors can provide other signals indicative of I-beam 764 movement. Also, in some embodiments, position sensor 784 may be omitted. If motor 754 is a stepper motor, control circuit 760 can track the position of I-beam 764 by summing the number and direction of steps the motor is instructed to take. The position sensor 784 may 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 effectors 792 . Any other suitable sensor for measuring the parameter may be included. Sensor 788 may include one or more sensors.

The one or more sensors 788 may include strain gauges, such as micro strain gauges, configured to measure the amount of strain in the anvil 766 in its clamped state. A strain gauge provides an electrical signal whose amplitude varies with the amount of strain. Sensor 788 may include a pressure sensor configured to detect pressure created by the presence of compressed tissue between anvil 766 and staple cartridge 768 . Sensor 788 may be configured to detect the impedance of a portion of tissue located between anvil 766 and staple cartridge 768, which may indicate the thickness and/or fullness of tissue located therebetween. indicates

Sensor 788 may be configured to measure the force exerted on anvil 766 by the closing drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the anvil 766 to detect the closure force exerted by the closure tube on the anvil 766 . The force exerted against anvil 766 may be representative of tissue compression experienced by tissue portions captured between anvil 766 and staple cartridge 768 . One or more sensors 788 can be positioned at various interaction points along the closure drive system to detect the closing force applied to anvil 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 anvil 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 I-beam 764 corresponds to the current drawn by motor 754 . The force is converted to a digital signal and provided to control circuit 760 .

RF energy source 794 is coupled to end effector 792 and applied to RF cartridge 796 when RF cartridge 796 is loaded into end effector 792 in place of staple cartridge 768 . Control circuitry 760 controls the delivery of RF energy to RF cartridge 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.

21-24 illustrate a motorized cutting and fastening surgical instrument 150010 that may or may not be reused. In the illustrated example, the surgical instrument 150010 includes a housing 150012 that includes a handle assembly 150014 configured to be grasped, manipulated and actuated by a clinician. Housing 150012 is configured for operable attachment to interchangeable shaft assembly 150200 to which end effector 150300 configured to perform one or more surgical tasks or procedures is operably coupled. It is According to the present disclosure, various forms of interchangeable shaft assemblies may be effectively used in conjunction with robotic surgical systems. Accordingly, the term "housing" encloses or operably supports at least one drive system configured to generate and apply at least one control motion that can be used to actuate the interchangeable shaft assembly. , a housing or similar portion of a robotic system. The term "frame" may refer to a portion of a handheld surgical instrument. The term "frame" may also refer to a portion of a robotic surgical instrument and/or a robotic system that may be used to operatively control a surgical instrument. Interchangeable shaft assemblies may be used in various robotic systems disclosed in U.S. Pat. No. 9,072,535, entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STABLE DEPLOYMENT ARRANGEMENTS," which is incorporated herein by reference in its entirety. , devices, components, and methods.

FIG. 21 is a perspective view of a surgical instrument 150010 having an operably coupled interchangeable shaft assembly 150200, according to at least one aspect of the present disclosure. Housing 150012 includes an end effector 150300 that includes a surgical cutting and fastening device configured to operatively support surgical staple cartridge 150304 therein. The housing 150012 may be configured for use in connection with replaceable shaft assemblies that accommodate end effectors adapted to support various sizes and types of staple cartridges. with various shaft lengths, sizes and types. The housing 150012 may be used with a variety of interchangeable shaft assemblies, which are adapted for use in connection with various surgical applications and procedures for end effector configurations. Includes assemblies configured to apply other forms of motion and energy, such as radio frequency (RF) energy, ultrasonic energy, and/or motion. End effectors, shaft assemblies, handles, surgical instruments, and/or surgical instrument systems can utilize any suitable fasteners to fasten tissue. For example, a fastener cartridge with a plurality of fasteners removably stored therein may be removably inserted and/or attached to the end effector of the shaft assembly.

The handle assembly 150014 may include a pair of interconnectable handle housing segments 150016, 150018 interconnected by screws, snap mechanisms, adhesives, or the like. Handle housing segments 150016, 150018 cooperate to form a pistol grip portion 150019 that can be grasped and manipulated by a clinician. The handle assembly 150014 operatively supports a plurality of drive systems configured to generate and apply controlled motion to corresponding portions of interchangeable shaft assemblies operably attached to the handle assembly. It is A display may be provided below cover 150045 .

FIG. 22 is an exploded view of a portion of the surgical instrument 150010 of FIG. 21, according to at least one aspect of the present disclosure. The handle assembly 150014 may include a frame 150020 that operably supports multiple drive systems. Frame 150020 may operatively support a “first” or closing drive system 150030 , which may apply closing and opening motions to interchangeable shaft assembly 150200 . Closure drive system 150030 may include an actuator such as closure trigger 150032 pivotally supported by frame 150020 . Closure trigger 150032 is pivotally coupled to handle assembly 150014 by pivot pin 150033 to allow closure trigger 150032 to be manipulated by a clinician. When the clinician grasps the pistol grip portion 150019 of the handle assembly 150014, the closure trigger 150032 moves from a starting or "unactuated" position to an "actuated" position, more specifically a fully compressed or fully actuated position. can pivot to

The handle assembly 150014 and frame 150020 may operably support a firing drive system 150080 that applies firing motion to corresponding portions of the interchangeable shaft assemblies attached thereto. is configured to Firing drive system 150080 may employ electric motor 150082 located in pistol grip portion 150019 of handle assembly 150014 . Electric motor 150082 may be, for example, a brushed DC motor having a maximum rotational speed of approximately 25,000 RPM. In other configurations, the motor may include a brushless motor, cordless motor, synchronous motor, stepper motor, or any other suitable electric motor. Electric motor 150082 may be powered by power supply 150090 which may include a removable power pack 150092 . A removable power pack 150092 may include a proximal housing portion 150094 configured to attach to a distal housing portion 150096 . Proximal housing portion 150094 and distal housing portion 150096 are configured to operably support a plurality of batteries 150098 therein. Batteries 150098 may each include, for example, LI or other suitable batteries. Distal housing portion 150096 is configured to be removably and operably attached to control circuit board 150100 , which is operably coupled to electric motor 150082 . Several batteries 150098 connected in series can power the surgical instrument 150010 . Power source 150090 may be replaceable and/or rechargeable. A display 150043 located below cover 150045 is electrically coupled to control circuit board 150100 . Cover 150045 may be removed to expose display 150043 .

An electric motor 150082 is in operative association with a rotatable shaft (Fig. not shown). A longitudinally movable drive member 150120 has a rack of drive teeth 150122 formed thereon for meshing engagement with a corresponding drive gear 150086 of the gear reducer assembly 150084 .

In use, the voltage polarity provided by the power supply 150090 may cause the electric motor 150082 to operate in a clockwise direction, whereas the voltage polarity applied by the battery to the electric motor 150082 may cause the electric motor 150082 to operate in a counterclockwise direction. can be flipped to When the electric motor 150082 is rotated in one direction, the longitudinally movable drive member 150120 will be axially driven in the distal direction "DD". When the electric motor 150082 is driven in the opposite rotational direction, the longitudinally movable drive member 150120 will be axially driven in the proximal direction "PD". Handle assembly 150014 may include a switch that may be configured to reverse the polarity applied to electric motor 150082 by power supply 150090 . The handle assembly 150014 may include sensors configured to detect the position of the longitudinally movable drive member 150120 and/or the direction in which the longitudinally movable drive member 150120 is moving.

Actuation of electric motor 150082 may be controlled by firing trigger 150130 pivotally supported on handle assembly 150014 . Firing trigger 150130 may pivot between an unactuated position and an actuated position.

Returning to FIG. 21, replaceable shaft assembly 150200 includes an end effector 150300 including an elongated channel 150302 configured to operatively support surgical staple cartridge 150304 therein. End effector 150300 may include an anvil 150306 pivotally supported relative to elongated channel 150302 . Interchangeable shaft assembly 150200 may include articulation joint 150270 . The configuration and operation of the end effector 150300 and articulation joint 150270 are described in U.S. Patent Application Publication No. 2014/0263541, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," which is incorporated herein by reference in its entirety. . Interchangeable shaft assembly 150200 may include a proximal housing or nozzle 150201 comprised of nozzle portions 150202,150203. Interchangeable shaft assembly 150200 may include a closure tube 150260 extending along shaft axis "SA", which may be utilized to close and/or open anvil 150306 of end effector 150300.

Returning to FIG. 21, in response to actuation of the closure trigger 150032, for example, the closure tube 150260 is moved distally (in the direction " DD") and anvil 150306 is closed. Anvil 150306 is opened by translating closure tube 150260 proximally. In the anvil open position, closure tube 150260 moves to its proximal position.

FIG. 23 is another exploded view of a portion of interchangeable shaft assembly 150200, according to at least one aspect of the present disclosure. Interchangeable shaft assembly 150200 may include a firing member 150220 supported for axial movement within spine 150210 . Firing member 150220 includes an intermediate firing shaft 150222 configured to attach to a distal cutting portion or knife bar 150280 . Firing member 150220 is sometimes referred to as a "second shaft" or "second shaft assembly." Intermediate firing shaft 150222 may include a longitudinal slot 150223 at its distal end configured to receive tab 150284 at proximal end 150282 of knife bar 150280 . Longitudinal slot 150223 and proximal end 150282 may be configured to allow relative movement therebetween and may include slip joint 150286 . Slip joint 150286 allows intermediate firing shaft 150222 of firing member 150220 to articulate end effector 150300 about articulation joint 150270 without moving, or at least substantially not, knife bar 150280. obtain. Once end effector 150300 is properly oriented, intermediate firing shaft 150222 is advanced distally until the proximal sidewall of longitudinal slot 150223 contacts tab 150284 to advance knife bar 150280 and into channel 150302 . A positioned staple cartridge can be fired. Spine 150210 has an elongated opening or window 150213 therein to facilitate assembly and insertion of intermediate firing shaft 150222 into spine 150210 . Once intermediate firing shaft 150222 is inserted, top frame segment 150215 may be engaged with shaft frame 150212 to enclose intermediate firing shaft 150222 and knife bar 150280 therein. The operation of firing member 150220 can be found in US Patent Application Publication No. 2014/0263541. Spine 150210 may be configured to slidably support firing member 150220 and a closure tube 150260 extending around spine 150210 . Spine 150210 may slidably support articulation driver 150230 .

Interchangeable shaft assembly 150200 may include a clutch assembly 150400 configured to selectively and removably couple articulation driver 150230 to firing member 150220 . Clutch assembly 150400 includes a locking collar or locking sleeve 150402 positioned about firing member 150220 in an engaged position in which locking sleeve 150402 couples articulation driver 150230 to firing member 150220 and articulation. Driver 150230 can be rotated between disengaged positions in which driver 150230 is not operably coupled to firing member 150220 . When the locking sleeve 150402 is in its engaged position, distal movement of the firing member 150220 can cause the articulation driver 150230 to move distally, correspondingly moving the firing member 150220 proximally. Movement may cause articulation driver 150230 to move proximally. When locking sleeve 150402 is in its disengaged position, movement of firing member 150220 is not transmitted to articulation driver 150230 such that firing member 150220 can be moved independently of articulation driver 150230 . The nozzle 150201 can be used to operably engage and disengage the articulation drive system and the firing drive system in various manners described in US Patent Application Publication No. 2014/0263541.

The replaceable shaft assembly 150200 can include a slip ring assembly 150600 that, for example, conducts power to and/or from the end effector 150300 and/or extends to the end effector 150300. /or may be configured to communicate signals from the end effector 150300; The slip ring assembly 150600 may include a proximal connector flange 150604 and a distal connector flange 150601 positioned within slots defined in the nozzle portions 150202,150203. The proximal connector flange 150604 can include a first surface and the distal connector flange 150601 can include a second surface positioned adjacent the first surface and movable relative to the first surface. . Distal connector flange 150601 can rotate relative to proximal connector flange 150604 about shaft axis "SA" (FIG. 21). Proximal connector flange 150604 may include a plurality of concentric, or at least substantially concentric, conductors 150602 defined on a first surface thereof. Connector 150607 may be attached to the proximal side of distal connector flange 150601 and may have a plurality of contacts, each contact corresponding to and making electrical contact with one of conductors 150602. ing. Such a configuration allows proximal connector flange 150604 and distal connector flange 150601 to rotate relative to each other while maintaining electrical contact therebetween. The proximal connector flange 150604 can include an electrical connector 150606 that can, for example, allow the conductors 150602 to communicate with the shaft circuit board. In at least one instance, a wire harness including multiple conductors may extend between the electrical connector 150606 and the shaft circuit board. The electrical connector 150606 may extend proximally through a connector opening defined in the chassis mounting flange. US Patent Application Publication No. 2014/0263551 entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" is incorporated herein by reference in its entirety. US Patent Application Publication No. 2014/0263552 entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" is incorporated herein by reference in its entirety. Further details regarding the slip ring assembly 150600 can be found in US Patent Application Publication No. 2014/0263541.

Interchangeable shaft assembly 150200 may include a proximal portion fixedly attached to handle assembly 150014 and a distal portion rotatable about a longitudinal axis. The rotatable distal shaft portion can rotate about the slip ring assembly 150600 relative to the proximal portion. A distal connector flange 150601 of the slip ring assembly 150600 may be positioned within the rotatable distal shaft portion.

24 is an exploded view of one aspect of the end effector 150300 of the surgical instrument 150010 of FIG. 21, in accordance with at least one aspect of the present disclosure. End effector 150300 may include anvil 150306 and surgical staple cartridge 150304 . Anvil 150306 may be coupled to elongated channel 150302 . Apertures 150199 can be defined in elongate channel 150302 to receive pins 150152 extending from anvil 150306 to move anvil 150306 from an open position to a closed position relative to elongate channel 150302 and surgical staple cartridge 150304 . can be pivoted. A firing bar 150172 is configured to longitudinally translate into the end effector 150300 . Firing bar 150172 may be constructed from one solid piece or may comprise laminated material comprising a stack of steel plates. Firing bar 150172 includes an I-beam 150178 and a cutting edge 150182 at its distal end. The distally projecting end of firing bar 150172 is attached to I-beam 150178 to space anvil 150306 from surgical staple cartridge 150304 positioned within elongated channel 150302 when anvil 150306 is in the closed position. can help. I-beam 150178 may include a sharp cutting edge 150182 for cutting tissue while advancing I-beam 150178 distally by firing bar 150172 . In operation, I-beam 150178 may fire surgical staple cartridge 150304 . Surgical staple cartridge 150304 can include a molded cartridge body 150194 that retains a plurality of staples 150191 mounted on staple drivers 150192 within corresponding upwardly opening staple cavities 150195 . Wedge sled 150190 is driven distally by I-beam 150178 to slide over cartridge tray 150196 of surgical staple cartridge 150304 . Wedge sled 150190 cams staple driver 150192 upward to drive staple 150191 out and deform it into contact with anvil 150306 while cutting edge 150182 of I-beam 150178 cuts through the clamped tissue.

I-beam 150178 may include an upper pin 150180 that engages anvil 150306 during firing. I-beam 150178 may include center pin 150184 and bottom foot 150186 for engaging cartridge body 150194 , cartridge tray 150196 and a portion of elongated channel 150302 . When surgical staple cartridge 150304 is disposed within elongated channel 150302, slots 150193 defined within cartridge body 150194, longitudinal slots 150197 defined within cartridge tray 150196, and longitudinal slots 150197 defined within elongated channel 150302. It can be aligned with slot 150189 . In use, I-beam 150178 can slide through aligned longitudinal slots 150193, 150197, and 150189, and bottom foot 150186 of I-beam 150178 slides into slot 150189 as shown in FIG. The central pin 150184 may engage the upper surface of the cartridge tray 150196 along the length of the longitudinal slot 150197, and the upper surface of the cartridge tray 150196 may engage the upper surface of the cartridge tray 150196 along the length of the longitudinal slot 150197. Pin 150180 may engage anvil 150306 . I Beam 150178 may space or limit relative movement between anvil 150306 and surgical staple cartridge 150304 . Firing bar 150172 and I-beam 150178 are retracted proximally, thereby opening anvil 150306 and allowing the two stapled and cut tissue sections to be released.

25A-25B are block diagrams of control circuitry 150700 of surgical instrument 150010 of FIG. 21, spanning two figures, according to at least one aspect of the present disclosure. Referring primarily to FIGS. 25A and 25B, handle assembly 150702 may include motor 150714, which may be controlled by motor driver 150715 and may be used by the firing system of surgical instrument 150010. In various forms, motor 150714 may be a brushed DC drive motor having a maximum rotational speed of approximately 25,000 RPM. In alternative configurations, motor 150714 may include a brushless motor, cordless motor, synchronous motor, stepper motor, or any other suitable electric motor. Motor driver 150715 may include, for example, an H-bridge driver including FET 150719 . Motor 150714 may be powered by power supply assembly 150706 releasably attached to handle assembly 150200 for supplying control power to surgical instrument 150010 . The power assembly 150706 may include a battery, which may include multiple batteries connected in series that may be used as a power source to power the surgical instrument 150010 . Under certain circumstances, the battery cells of power assembly 150706 may be replaceable and/or rechargeable. In at least one example, the battery cells may be LI batteries, which may be separately connectable to power assembly 150706 .

The shaft assembly 150704 can communicate with the safety controller and power management controller 150716 via an interface while the shaft assembly 150704 and the power assembly 150706 are coupled to the handle assembly 150702. Shaft assembly controller 150722 may include For example, the interface may be compliant to allow electrical communication between shaft assembly controller 150722 and power management controller 150716 while shaft assembly 150704 and power supply assembly 150706 are coupled to handle assembly 150702. A first interface portion 150725 that may include one or more electrical connectors for interlocking engagement with a shaft assembly electrical connector and a corresponding power assembly electrical connector for interlocking engagement with a corresponding power assembly electrical connector. A second interface portion 150727 may be included which may include one or more electrical connectors. One or more communication signals can be sent via the interface to send one or more power requirements of the attached replaceable shaft assembly 150704 to the power management controller 150716 . In response, the power management controller may modulate the battery power output of power supply assembly 150706 according to the power requirements of the attached shaft assembly 150704, as described in further detail below. The connector activates after mechanical coupling engagement of handle assembly 150702 to shaft assembly 150704 and/or power assembly 150706 to provide electrical communication between shaft assembly controller 150722 and power management controller 150716. may include a switch that can enable the

The interface may be one or more such controllers between the power management controller 150716 and the shaft assembly controller 150722, for example, by routing communication signals through the main controller 150717 housed in the handle assembly 150702. It can facilitate the transmission of communication signals. Under other circumstances, while shaft assembly 150704 and power supply assembly 150706 are coupled to handle assembly 150702, the interface is between power management controller 150716 and shaft assembly controller 150722 through handle assembly 150702. can facilitate direct line communication between

Main controller 150717 may be any single-core or multi-core processor, such as that known by Texas Instruments under the trade name ARM Cortex. In one aspect, the main controller 150717 has on-chip memory of 256 KB single-cycle flash memory or other non-volatile memory up to 40 MHz, for example, details of which are available in the product datasheet, improving performance beyond 40 MHz. 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2 KB electrically erasable programmable read-only memory (EEPROM), 1 or two or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters with 12 analog input channels (ADC), LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.

The safety controller may be a safety controller platform comprising two controller-based families, such as the TMS570 and RM4x, also known by Texas Instruments as the Hercules ARM Cortex R4. 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.

The power supply assembly 150706 may include power management circuitry, which may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. While the shaft assembly 150704 and power supply assembly 150706 are coupled to the handle assembly 150702, the power management circuitry may be configured to modulate the power output of the battery based on the power requirements of the shaft assembly 150704. The power management controller 150716 can be programmed to control the power modulator 150738 of the power output of the power supply assembly 150706, and the current sensing circuit 150736 monitors the power output of the power supply assembly 150706 to determine the power output of the battery. Feedback can be used to provide power management controller 150716 so that power management controller 150716 can adjust the power output of power supply assembly 150706 to maintain the desired output. Power management controller 150716 and/or shaft assembly controller 150722 may each include one or more processors and/or memory units capable of storing a number of software modules.

Surgical instrument 150010 (FIGS. 21-24) may include output device 150742, which may include a device for providing sensory feedback to the user. Such devices may include, for example, visual feedback devices (e.g. liquid crystal display (LCD) screens, LED indicators), audible feedback devices (e.g. speakers, buzzers) or tactile feedback devices (e.g. tactile actuators). good. Under certain circumstances, the output device 150742 may include a display 150743 that may be included in the handle assembly 150702. Shaft assembly controller 150722 and/or power management controller 150716 may provide feedback to the user of surgical instrument 150010 via output device 150742 . The interface may be configured to connect shaft assembly controller 150722 and/or power management controller 150716 to output device 150742 . Output device 150742 may alternatively be integrated with power supply assembly 150706 . Under such circumstances, while shaft assembly 150704 is coupled to handle assembly 150702, communication between output device 150742 and shaft assembly controller 150722 may be accomplished via the interface.

Control circuitry 150700 includes circuit segments configured to control operation of powered surgical instrument 150010 . The safety controller segment (segment 1) includes a safety controller and a main controller 150717 segment (segment 2). The safety controller and/or main controller 150717 are configured to interact with one or more additional circuit segments such as an acceleration segment, display segment, shaft segment, encoder segment, motor segment, and power segment. there is Each of the circuit segments may be coupled to a safety controller and/or main controller 150717. Main controller 150717 is also coupled to the flash memory. Main controller 150717 also includes a serial communication interface. The main controller 150717 includes multiple inputs coupled, for example, to one or more circuit segments, a battery, and/or multiple switches. The segmentation circuitry may be implemented by any suitable circuitry, such as, for example, a printed circuit board assembly (PCBA) within powered surgical instrument 150010 . The term processor, as used herein, means any microprocessor, processor, controller or controllers, or central processing unit (CPU) of a computer that combines the functions of a single integrated circuit or It should be understood to include other basic computing devices incorporated on several integrated circuits in . Main controller 150717 is a multi-purpose programmable device that accepts digital data as input, processes that data according to instructions stored in memory, and provides results as output. This is an example of sequential digital logic since it has internal memory. Control circuitry 150700 may be configured to perform one or more of the processes described herein.

The acceleration segment (segment 3) comprises an accelerometer. The accelerometer is configured to detect movement or acceleration of the powered surgical instrument 150010 . Input from the accelerometer may be used to transition to and from sleep mode, identify orientation of the powered surgical instrument, and/or identify when the surgical instrument has been dropped. In some examples, the acceleration segment is coupled to the safety controller and/or main controller 150717.

The display segment (segment 4) includes a display connector coupled to the main controller 150717. A display connector couples the main controller 150717 to the display through one or more of the display's integrated circuit drivers. The display's integrated circuit driver may be integrated with the display and/or may be located separately from the display. The display may include any suitable display, such as, for example, an organic light emitting diode (OLED) display, a liquid crystal display (LCD), and/or any other suitable display. In some examples, the display segment is coupled to a safety controller.

Shaft segment (Segment 5) is a control and/or replaceable shaft for replaceable shaft assembly 150200 (FIGS. 21 and 23) coupled to surgical instrument 150010 (FIGS. 21-24). It includes one or more controls for the end effector 150300 coupled to the assembly 150200. The shaft segment includes a shaft connector configured to couple the main controller 150717 to the shaft PCBA. The shaft PCBA includes a low power microcontroller with ferroelectric random access memory (FRAM), articulation switches, shaft release Hall effect switches, and shaft PCBA EEPROM. The Shaft PCBA EEPROM contains one or more parameters, routines and/or programs specific to the replaceable shaft assembly 150200 and/or Shaft PCBA. Shaft PCBA may be coupled to interchangeable shaft assembly 150200 and/or may be integral with surgical instrument 150010 . In some examples, the shaft segment comprises a second shaft EEPROM. The second shaft EEPROM stores a plurality of algorithms, routines, parameters, and/or other data corresponding to one or more shaft assemblies 150200 and/or end effectors 150300 that may be associated with the powered surgical instrument 150010. including.

The position encoder segment (segment 6) comprises one or more magnetic angular rotary position encoders. One or more magnetic rotary position encoders are used to rotate the motor 150714 of the surgical instrument 150010 (FIGS. 21-24), the interchangeable shaft assembly 150200 (FIGS. 21 and 23), and/or the end effector 150300. configured to identify a location; In some examples, a magnetic angular rotary position encoder may be coupled to the safety controller and/or the main controller 150717.

Motor circuit segment (segment 7) includes motor 150714 configured to control movement of powered surgical instrument 150010 (FIGS. 21-24). Motor 150714 is coupled to main microcontroller processor 150717 by an H-bridge driver, which includes one or more H-bridge field effect transistors (FETs) and a motor controller. The H-bridge driver is also coupled to the safety controller. A motor current sensor is connected in series with the motor to measure the current drawn by the motor. The motor current sensor is in signal communication with the main controller 150717 and/or the safety controller. In some examples, the motor 150714 is coupled to a motor electromagnetic interference (EMI) filter.

The motor controller controls a first motor flag and a second motor flag to indicate the status and position of motor 150714 to main controller 150717 . The main controller 150717 provides pulse width modulated (PWM) high, PWM low, direction, sync, and motor reset signals to the motor controllers through buffers. The power segments are configured to provide segment voltages to each of the circuit segments.

The power segment (segment 8) includes a battery coupled to the safety controller, main controller 150717, and additional circuit segments. The batteries are connected to the segmentation circuit by battery connectors and current sensors. A current sensor is configured to measure the total current drawn by the segmentation circuit. In some examples, one or more voltage converters are configured to provide predetermined voltage values to one or more circuit segments. For example, in some examples the segmentation circuit may comprise a 3.3V voltage converter and/or a 5V voltage converter. The boost converter is configured to provide a boost voltage up to a predetermined amount, eg, up to 13V. A boost converter is configured to provide additional voltage and/or current during power intensive operations to prevent brownouts or low power conditions.

Multiple switches are coupled to the safety controller and/or main controller 150717 . The switch may be configured to control operation of surgical instrument 150010 (FIGS. 21-24), control operation of segmentation circuits, and/or indicate status of surgical instrument 150010. FIG. The emergency exit door switch and hall effect switch for emergency exit are configured to indicate the status of the emergency exit door. A plurality of articulation switches, for example, a left articulation left switch, a left articulation right switch, a left articulation center switch, a right articulation left switch, a right articulation right switch, and a right articulation center switch, are interchangeable shafts. It is configured to control articulation of assembly 150200 (FIGS. 21 and 23) and/or end effector 150300 (FIGS. 21 and 24). The left reversing switch and the right reversing switch are connected to the main controller 150717 . Left switches, including a left articulation left switch, a left articulation right switch, a left articulation center switch, and a left flip switch, are connected to the main controller 150717 by left flexible connectors. The right side switches, including the right side articulation left switch, the right side articulation right switch, the right side articulation center switch, and the right side flip switch, are connected to the main controller 150717 by the right side flexible connector. The firing switch, clamp release switch, and shaft engagement switch are linked to main controller 150717 .

Multiple switches may be implemented in any combination using any suitable mechanical, electromechanical, or solid state switches. For example, the switch may be a limit switch operated by movement of the surgical instrument 150010 (FIGS. 21-24) or a component associated with the presence of a subject. Such switches can be used to control various functions associated with surgical instrument 150010 . A limit switch is an electromechanical device consisting of an actuator in mechanical communication with a set of contacts. When an object contacts the actuator, the device manipulates the contact to make or break an electrical connection. Due to their ruggedness, ease of installation, and reliability of operation, limit switches are used in a wide variety of applications and environments. A limit switch can determine the presence, absence, passage, placement, and end of movement of an object. In other implementations, the switch is a solid-state switch that operates under the influence of a magnetic field, such as a Hall effect device, a magnetoresistive (MR) device, a giant magnetoresistive (GMR) device, a magnetometer, among others. may In other implementations, the switch may be a solid-state switch that operates under the influence of light, such as an optical sensor, an infrared sensor, an ultraviolet sensor, among others. Further, the switch may be a solid state device such as a transistor (eg, FET, junction FET, metal oxide semiconductor FET (MOSFET), bipolar, etc.). Other switches may include wireless switches, ultrasonic switches, accelerometers, inertial sensors, among others.

FIG. 26 shows the interface between the handle assembly 150702 and the power assembly 150706 and the interface between the handle assembly 150702 and the interchangeable shaft assembly 150704, according to at least one aspect of the present disclosure; 150700 is another block diagram of the control circuit 150700 of the surgical instrument of FIG. Handle assembly 150702 may include main controller 150717 , shaft assembly connector 150726 and power assembly connector 150730 . The power assembly 150706 may include a power assembly connector 150732, power management circuitry 150734, which may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. Shaft assembly connectors 150726 , 150728 form interface 150727 . While interchangeable shaft assembly 150704 and power supply assembly 150706 are coupled to handle assembly 150702, power management circuitry 150734 modulates the power output of battery 150707 based on the power requirements of interchangeable shaft assembly 150704. can be configured to For example, the power management controller 150716 can be programmed to control the power modulator 150738 of the power output of the power supply assembly 150706, and the current sensing circuit 150736 provides feedback to the power management controller 150716 regarding the power output of the battery 150707. As such, the power management controller 150716 can be used to monitor the power output of the power supply assembly 150706 so that the power management controller 150716 can adjust the power output of the power supply assembly 150706 to maintain the desired output. Shaft assembly 150704 includes shaft processor 150720 coupled to non-volatile memory 150721 and shaft assembly connector 150728 to electrically couple shaft assembly 150704 to handle assembly 150702 . Shaft assembly connectors 150726 , 150728 form interface 150725 . Main controller 150717, shaft processor 150720, and/or power management controller 150716 may be configured to implement one or more of the processes described herein.

Surgical instrument 150010 (FIGS. 21-24) may include an output device 150742 that provides sensory feedback to the user. Such devices may include visual feedback devices (eg, LCD display screens, LED indicators), audible feedback devices (eg, speakers, buzzers) or tactile feedback devices (eg, tactile actuators). Under certain circumstances, the output device 150742 may include a display 150743 that may be included in the handle assembly 150702. Shaft assembly controller 150722 and/or power management controller 150716 may provide feedback to the user of surgical instrument 150010 via output device 150742 . Interface 150727 may be configured to connect shaft assembly controller 150722 and/or power management controller 150716 to output device 150742 . Output device 150742 may be integrated with power assembly 150706 . While interchangeable shaft assembly 150704 is coupled to handle assembly 150702, communication between output device 150742 and shaft assembly controller 150722 may be accomplished via interface 150725.

Cancer Histotoxicity Detection Cancer is a disease at the cellular level involving disturbances in cellular regulatory mechanisms. Tumor cells alter their metabolism to maintain unregulated cell growth and survival, but this transformation leaves them dependent on a constant supply of nutrients and energy. Cancer cells have been shown to undergo characteristic changes in their metabolic program, including increased uptake of glucose. Many cancer cells exhibit increased glycolysis (anaerobic metabolism) leading to decreased glucose and increased lactate in the interstitial fluid environment. Therefore, blood glucose levels in normal tissue are higher than in cancer tissue. Also, due to the increased lactate level in cancer tissue, the pH (potential of hydrogen) of cancer tissue is lower than that of normal tissue.

One common treatment for cancer is to resect cancerous tissue. As shown in FIG. 27, surgical instruments can be used to seal and cut tissue along a perimeter defined in healthy tissue around cancerous tissue. Tissue sealing may be accomplished by application of energy (eg, RF or ultrasound) or by placement of staples into the tissue. With successful treatment, no cancer cells are detected in the outer margin of the removed tissue, referred to as the clear surgical margin.

Using various existing techniques, the surgeon may attempt to visually determine where the tissue grasped by the surgical end effector lies relative to the desired tumor-free margin. Needless to say, such visual determination can be inefficient. Furthermore, unintentionally disturbing cancerous tissue by cutting it can have undesirable consequences. For example, cancer cells removed by this process can migrate through the bloodstream to other healthy tissues, causing, for example, the spread of cancer to other healthy tissues.

Aspects of the present disclosure present various surgical instruments utilized in cancer therapy that assess proximity to cancerous tissue and/or allow a user to assess cancer prior to application of cancer therapy by an end effector. Various sensors and algorithms are used to help guide the safe distance from the tissue.

FIG. 29 is a logic flow diagram of a process 26120 showing a control program or logic configuration for evaluating proximity of an end effector 26000 of a surgical instrument 26010 to cancerous tissue, according to at least one aspect of the present disclosure. In one aspect, process 26120 is performed by control circuit 500 (FIG. 13), as described in more detail below. In another aspect, process 26120 may be performed by combinatorial logic 510 (FIG. 14). In yet another aspect, process 26120 may be performed by sequential logic 520 (FIG. 15).

Process 26120 measures 26123 a physiological parameter of tissue in contact with end effector 26000, the measured physiological parameter being indicative of the proximity of end effector 26000 to cancerous tissue. Process 26120 further alerts the user (26125) and/or disables tissue therapy (26126) if it is determined that the physiological parameter reaches or exceeds a predetermined threshold.

FIG. 30 is a logic flow diagram of a process 26020 showing a control program or logic configuration for evaluating proximity of an end effector 26000 of a surgical instrument 26010 to cancerous tissue, according to at least one aspect of the present disclosure. In one aspect, process 26020 is performed by control circuit 500 (FIG. 13), as described in more detail below. In another aspect, process 26020 may be performed by combinatorial logic 510 (FIG. 14). In yet another aspect, process 26020 may be performed by sequential logic 520 (FIG. 15).

The end effector 26000, as shown in FIGS. 31 and 32, includes a sensor array 26471 configured to generate or provide sensor signals indicative of tissue physiological parameters indicative of the proximity of the end effector to cancerous tissue. . FIG. 32 shows control system 26470 including control circuitry coupled to sensor array 26471 . Control system 26470 is configured to assess proximity of end effector 26000 to cancerous tissue based on sensor signals of sensor array 26471 .

In one aspect, the physiological parameter is blood glucose levels in tissue. Hypoglycemia indicates proximity of the end effector to cancerous tissue.

In another aspect, the physiological parameter is pH level. A low pH level indicates that the end effector is in close proximity to the cancerous tissue.

FIG. 28 is a graph showing tissue physiological parameters (Y-axis) plotted against distance from the tumor (x-axis). In the example of Figure 28, the physiological parameter decreases with increasing proximity to the tumor. Examples of physiological parameters exhibiting such properties include glucose and pH, as described in more detail below. Other examples may involve physiological parameters that increase with increasing proximity to the tumor.

In the example of FIG. 28, the tissue physiological parameter reaches a normal level (N) at a distance (d) from the tumor that defines the tumor-free margin, as shown in FIG. Normal level (N) represents the typical level of a physiological parameter in normal tissue.

Surgical instrument 26010 is similar in many respects to surgical instrument 150010 . For example, end effector 26000 and control system 26470 are similar in many respects to end effector 150300 and control system 470 (FIG. 12), respectively. For the sake of brevity, components of surgical instrument 26010 that are similar to the above-described components of surgical instrument 150010 are not repeated in detail herein.

End effector 26000 includes first jaw 26001 and second jaw 26002 extending from interchangeable shaft assembly 150200 . End effector 26000 further includes an anvil 26009 (FIG. 32) defined within first jaw 26001 and a staple cartridge 26005 defined within second jaw 26002 . At least one of first jaw 26001 and second jaw 26002 transitions end effector 26000 between an open configuration and a closed configuration to grasp tissue between anvil 26009 and staple cartridge 26005. Therefore, it is movable with respect to the other. In operation, tissue treatment with surgical instrument 26010 involves deploying staples into tissue grasped from staple cartridge 26005 by firing member 26011 . The placed staples are deformed by the anvil 26009. FIG.

In various aspects, a surgical instrument according to the present disclosure may include an end effector that treats tissue by applying RF energy or ultrasonic energy to the tissue. In various aspects, surgical instrument 26010 can be a handheld surgical instrument. Alternatively, surgical instrument 26010 may be incorporated into a robotic system as a component of a robotic arm. Further details regarding robotic systems are disclosed in US Provisional Patent Application No. 62/611,339, filed December 28, 2017, which is incorporated herein by reference in its entirety.

Measuring physiological parameters and assessing the proximity of end effector 26000 to cancerous tissue may begin with activation of surgical instrument 26010 and continue as long as surgical instrument 26010 remains in operation. obtain. Alternatively, such activity may be triggered by detecting tissue grasped by the end effector 26000, for example, as described in connection with process 26020. In certain cases, such activity may be triggered upon reaching or approaching a closed configuration.

Process 26020 detects whether tissue is being grasped by surgical end effector 26000 (26021). FIG. 20 shows an example tissue contact circuit that includes a tissue contact or pressure sensor that determines when the jaws of the end effector first contact tissue "T". Contact between the jaws and the tissue "T" is established by establishing contact with a pair of opposing plates "P1, P2" provided on the jaw members to establish an otherwise open sensing circuit "SC". ”.

The contact sensor may also include a sensing force transducer that determines the amount of force applied to the sensor, which can be assumed to be the same as the amount of force applied to tissue "T". Such force applied to tissue can then be translated into an amount of tissue compression. In certain instances, measuring physiological parameters and assessing the proximity of the end effector 26000 to cancerous tissue may be triggered by reaching a predetermined tissue compression threshold.

Force transducers include, but are not limited to, piezoelectric elements, piezoresistive elements, metal film or semiconductor strain gauges, inductive pressure sensors, capacitive pressure sensors, and for driving wiper arms on resistive elements. Piezoelectric pressure transducers using Bourdon tubes, capsules, or bellows may be mentioned. FIG. 20 and additional examples are provided in a U.S. patent issued May 5, 2012, entitled "SURGICAL INSTRUMENT EMPLOYING SENSORS," filed Jun. 27, 2011, the entire disclosure of which is incorporated herein by reference. Further described in 8,181,839.

In certain instances, transitioning the end effector 26000 to the closed configuration may trigger measuring physiological parameters and assessing the proximity of the end effector 26000 to cancerous tissue. A tracking system 480 (FIGS. 12 and 32) configured to determine the position of the longitudinally movable displacement member that transmits the closing motion to the end effector 26000 can be used in detecting the closed configuration. .

Microcontroller 461 may refer to one or more readings from one or more of sensors 472, 474, 476 in performing detection (26021). For example, readings from strain gauge sensors 474, which may be used to measure the force applied to tissue grasped by the end effector 26000, may reflect whether tissue is being grasped by the end effector 26000.

In either case, if tissue is grasped by the end effector 26000 or it is determined 26021 has reached a closed configuration, then based on physiological parameters of the grasped tissue, end The proximity of the effector 26000 may be checked (26023). A sensor array 26471, which includes 'n' sensors (where 'n' is an integer greater than or equal to 1), provides sensor signals to microcontroller 461 according to tissue physiological parameters indicative of the proximity of end effector 26000 to cancerous tissue. can be configured as

If it is determined (26024) that the proximity of the end effector to the cancerous tissue reaches or exceeds a predetermined threshold, alert the surgeon (26025) and/or disable tissue treatment (26026). ) steps can be taken.

Microcontroller 461 may alert the surgeon via display 473, for example. Other audio, tactile, and/or visual means may also be used. Microcontroller 461 may also take steps to prevent tissue sealing. For example, microcontroller 461 may signal motor driver 492 to stop motor 482 .

In various aspects, one or more of processes 26020 and 26120 may be executed by processor 462 to perform one or more of the steps of processes 26020 and 26120, memory 468 executed by program instructions stored within. Microcontroller 461 also uses neural networks, lookup tables, defining functions, and/or functions from cloud-based system 104 (FIG. 1) in performing one or more of the steps of processes 26020 and 26120. Alternatively, real-time input may be used.

In one embodiment, microcontroller 461 correlates sensor signals from sensor array 26471 with values of physiological parameters of the grasped tissue using lookup tables or defining functions that may be stored in memory 468. good too. The lookup table also defines a proximity index for evaluating the proximity of the end effector 26000 to cancerous tissue based on the determined value of the physiological parameter, or more directly based on the received sensor signal. can. FIG. 33 is an exemplary illustration of correlating sensor signal readings (R _1-n ) received by microcontroller 461 from sensor array 26471 with corresponding distances (D _1-n ) between the end effector and cancerous tissue. A typical proximity index of 26030 is shown.

In various instances, measuring physiological parameters of tissue and/or assessing proximity of end effector 26000 to cancerous tissue is triggered by user input. For example, a user interface such as display 473 can be used to receive and transmit user input to microcontroller 461, for example.

In addition to detecting the proximity of the end effector to cancerous tissue, it is desirable to provide a direction to guide the end effector sufficiently away from the cancerous tissue. FIG. 34 is a logic flow diagram of process 26040 showing the control program or logic configuration for guiding end effector 26050 away from cancerous tissue. End effector 26050 is similar in many respects to end effector 26000. For example, surgical instrument 26010 may be equipped with end effector 26050 instead of end effector 26000 .

Process 26040 may be performed alone or in combination with process 26020 or at least a portion thereof. In various aspects, process 26040 is performed by control circuitry of control system 26470 that communicates with sensors 26055 , 26056 on each side 26053 , 26054 of end effector 26050 . Sensors 26055, 26056 are spaced apart and separated by a transverse dissection path defined by a longitudinal axis "L" extending along an elongated channel configured to receive a movable transverse dissection member therein. be. Sensors 26055, 26056 are configured to provide sensor signals corresponding to physiological parameters indicative of the proximity of end effector 26050 to cancerous tissue.

Process 26040 may be performed by program instructions stored in memory 468 that may be executed by processor 462 to implement process 26040 . Microcontroller 461 may also use neural networks, lookup tables, defining functions, and/or real-time inputs from cloud-based system 104 (FIG. 1) in performing process 26040.

Process 26040 includes receiving sensor signals from sensors 26055, 26056 (26041). If it is determined (26042) that the sensor signal represents a value of the physiological parameter equal to or greater than the predetermined threshold, process 26040 allows treatment application to tissue by end effector 26050 (26043). Conversely, if it is determined 26044 that the sensor signal represents a value of the physiological parameter below the predetermined threshold, process 26040 directs the user to move the end effector in any suitable direction. (26045).

Further to the above, if it is determined 26046 that the first sensor signal represents a value of the physiological parameter equal to or greater than the predetermined threshold and the second sensor signal represents a value less than the predetermined threshold, the process 26040 instructs the user to move end effector 26050 in first direction 26061 . Conversely, if it is determined 26048 that the second sensor signal represents a value of the physiological parameter greater than or equal to the predetermined threshold and the first sensor signal represents a value less than the predetermined threshold (26048), process 26040 , instructs the user to move the end effector 26050 in a second direction 26062 opposite the first direction 26061 .

As shown in FIG. 35, longitudinal axis “L” defines first side 26053 and second side 26054 . A first direction 26061 extends away from the longitudinal axis "L" on a first side 26053, while a second direction 26062 extends away from the longitudinal axis "L" on a second side 26054. direction.

FIG. 36 shows the values of tissue physiological parameters (Y-axis) plotted against time (x-axis) for three different positions (Position A, Position B, Position C) of the end effector 26050 relative to cancerous tissue. 26055, 26056 is a graph showing sensor signals from sensors 26055, 26056 representing; A physiological parameter is the blood glucose level in tissues. As noted above, low blood sugar levels indicate proximity to cancerous tissue. Alternatively, the physiological parameter can be pH level. A low pH level indicates proximity to cancerous tissue.

In various embodiments, according to at least one aspect of the present disclosure, an end effector may include sensors that measure two or more physiological parameters indicative of proximity to cancerous tissue. For example, an end effector may include one or more glucose sensors and one or more pH sensors. Sensor signals from different types of sensors can be received by microcontroller 461 and analyzed to assess proximity to cancerous tissue.

At position A, sensor signals 26057, 26058 of sensors 26055, 26056 are greater than or equal to a predetermined threshold "N". Therefore, it can be concluded that the cancerous tissue is far enough away from the end effector 26050. Accordingly, the microcontroller 461 may notify the surgeon that it is safe to treat the tissue grasped by the end effector 26050.

At position C, signals 26057, 26058 of sensors 26055, 26056 are below a predetermined threshold "N". Therefore, it can be concluded that the tumor is on or at least near the transcision path 26052 between the sensors 26055,26056. Thus, prior to application of treatment to tissue, microcontroller 461 instructs the surgeon to release the grasped tissue and reposition end effector 26050 by moving it to the side in either direction. can be directed to

At position B, sensor signal 26057 of sensor 26055 is below predetermined threshold "N" and sensor signal 26058 of sensor 26056 is above predetermined threshold "N". It can therefore be concluded that the tumor has spread to the first side 56053 of the end effector 26050 . Accordingly, the microcontroller 461 instructs the surgeon to release the grasped tissue and reposition it by moving the end effector 26050 in the second direction 26062 before treating the tissue. obtain.

In various embodiments, the sensor signal is directly proportional to the physiological parameter detected by the sensor. However, in other equivalent embodiments, the sensor signal may be inversely proportional to the physiological parameter detected by the sensor. In other such embodiments, the sensor signal decreases with increasing proximity to cancerous tissue. Nevertheless, an inverter can be utilized to invert the received sensor signal.

In various aspects, referring to FIGS. 32, 35 and 36, microcontroller 461 further processes the sensor signals of sensors 26055, 26056 by subtracting one sensor signal from the other sensor signals. The resulting delta can be further analyzed to determine the direction in which the end effector 26050 is moved. As shown in FIG. 36, at positions A and C, the sensor signals nearly cancel each other. However, at position B in FIG. 36, a positive is detected at delta 26059. A delta positive transition indicates that cancerous tissue has spread to the first side 26053 of the end effector 26050 but has not spread to the second side 26054 . Additionally, whether delta 26059 is above or below zero may give an indication as to the desired direction of motion for end effector 26050 .

As shown in the example of FIG. 35, using sensors 26055, 26056, microcontroller 461 can assess the proximity associated with cancer and determine how to steer away from the cancer tissue direction. . In other examples, the sensor array may include more than two sensors. In one example, the sensor array may include, in addition to sensors 26055, 26056, a third sensor on the distal portion of the end effector.

In various aspects, as shown in FIG. 37, the end effector 26070 has six sensors (Sen ₁ -Sen ₆ ), two proximal sensors (Sen ₁ and Sen ₆ ), two inner sensors (Sen ₂ and Sen ₅ ), and two distal sensors (Sen ₃ and Sen ₄ ). The added sensors allow the microcontroller 461, among other things, to more accurately predict the position of the end effector 26070 relative to cancerous tissue.

The end effector 26070 is similar in many respects to the end effectors 26000, 26050. For example, end effector 26070 includes first jaw 26071 and second jaw 26072 . At least one of the first jaw 26071 and the second jaw 26072 is movable relative to the other to grasp tissue therebetween.

Further to the above, end effector 26070 includes an anvil defined within second jaw 26072 and a staple cartridge 26075 defined within first jaw 26071 . To treat tissue grasped by end effector 26070, staples are placed into the grasped tissue from staple cartridge 26075 and deformed by the anvil. To cut tissue, the transsecting member is moved relative to the elongated slot that defines the transsecting path 26073 of the transsecting member. The transverse dissection path 26073 defines two sides 26076 , 26077 of the end effector 26070 .

In addition to the above, sensor array 26080 is similar in many respects to sensor array 26471 . For example, sensor array 26080 may also be coupled to microcontroller 461 . Sensor array 26080 includes six sensors (Sen ₁ -Sen ₆ ) configured to provide sensor signals to microcontroller 461 according to tissue physiological parameters indicative of the proximity of end effector 26070 to cancerous tissue. In other embodiments, sensor array 26080, like sensor array 26471, may include more or less than six sensors.

The sensors of sensor array 26080 are spaced on outer edges 26078 , 26079 of staple cartridge 26075 . In the example of FIG. 37, Sen ₁ , Sen ₂ and Sen ₃ are located on side 26076 and Sen ₄ , Sen ₅ and Sen ₆ are located on side 26077 . In other words, transection path 26052 extends between sensors of sensor array 26080 .

In various embodiments, the difference between the sensor signal and the average of the signals can add insight into the proximity of the tumor. If the signal indicates that the sensor is over the tumor, the difference between that sensor and the other sensors is whether the tumor is along one side (not transected) or across the transcision path (transcision It would add insight as to whether If the difference between the signal and the mean is small, but the mean is high, the entire end effector is on the tumor.

38 and 41 are graphs showing the sensor signals of sensors Sen ₁ -Sen ₆ plotted on the y-axis against time on the x-axis. The sensor signals of sensors Sen ₁ -Sen ₆ measure physiological parameters that change with changing distance from the cancerous tissue. Accordingly, the Sen ₁ -Sen ₆ sensor signals represent tissue physiological parameters indicative of the position of the end effector 26070 relative to the cancerous tissue.

Although the physiological parameters in FIGS. 38 and 41 decrease with increasing proximity to cancerous tissue, the sensor signals of sensors Sen ₁ -Sen ₆ are passed through the inverter. Positions AC in FIG. 38 and positions AE in FIG. 40 each represent a separate position of the end effector 26070 relative to the cancerous tissue.

In the examples of FIGS. 38 and 41, the sensor signal average (AVG) can be calculated by the microcontroller 461 from the following equation.

式中、Ｓｅｎ_１～ｎは、時間（ｔ）におけるセンサ信号値を表し、（ｎ）はセンサの数を表す。

where Sen _1-n represent the sensor signal values at time (t) and (n) represents the number of sensors.

The microcontroller 461 can then determine the proximity of the end effector 26070 to the cancerous tissue using the formula:

式中、（ｎ）はゼロを超える整数であり、（ＡＶＧ）はセンサ信号の平均であり、（ｘ）は所定の閾値である。式が閾値（ｘ）を下回る結果をもたらす場合、図３８及び図４１の位置Ａに示されるように、マイクロコントローラ４６１は、エンドエフェクタ２６０７０による組織治療を認可する。図３８の位置Ｂ～Ｄ及び図４１の位置Ｂ～Ｅでは、式は、所定の閾値（ｘ）を超える結果をもたらし、センサのうちの１つ又は２つ以上が癌組織に近接した範囲内にあることを示す。

where (n) is an integer greater than zero, (AVG) is the average of the sensor signal, and (x) is a predetermined threshold. If the formula yields a result below the threshold (x), microcontroller 461 authorizes tissue treatment by end effector 26070, as shown at position A in FIGS. At positions B-D in FIG. 38 and positions B-E in FIG. 41, the formula yields a result that exceeds a predetermined threshold (x) and one or more of the sensors are within close proximity to cancerous tissue. indicates that it is in

The microcontroller 461 may compare the sensor signal of each of the sensors Sen ₁ -Sen ₆ to the average of the sensor signals (AVG) to assess the proximity of the sensors Sen ₁ -Sen ₆ to the cancerous tissue. The proximity of end effector 26070 to tissue can be inferred from the estimated proximity of sensors Sen ₁ -Sen ₆ to cancer tissue. Sensors providing sensor signals exceeding (AVG) may be identified as sensors positioned within close proximity to cancerous tissue. Other equations can be applied to the sensor signals of sensors Sen ₁ -Sen ₆ to ascertain the proximity of sensors Sen ₁ -Sen ₆ to the cancerous tissue.

In addition to the above, additional information can also be inferred from the spatial relationships of sensors Sen ₁ -Sen ₆ on end effector 26070 . FIG. 39 is a logic flow diagram of process 26090 showing a control program or logic construct that provides instructions for guiding the end effector against cancerous tissue, the instructions being the sensor is in proximity to the cancerous tissue. Based on the spatial relationship of the sensors on the end effector, it reports readings that indicate Process 26090 may be performed by microcontroller 461 based on sensor readings from sensors Sen ₁ -Sen ₆ . Process 26090 includes receiving sensor signals from sensors Sen ₁ -Sen ₆ (26091) and determining which sensors are proximate to cancerous tissue based on the above equations (26092). Additionally, process 26090 includes providing (26092) instructions to guide end effector 26050 away from the cancerous tissue based on the relative positions of the sensors on end effector 26050 proximate the cancerous tissue.

Position C of FIG. 38 and position B of FIG. 41 show an example of implementing process 26090 of FIG. At position C in FIG. 38 and position B in FIG. 41, Sen ₃ and Sen ₄ read above (AVG), while the remaining sensors report readings below (AVG). Additionally, Sen ₃ and Sen ₄ are located on opposite sides 26076 and 26077 at the distal portion of end effector 26070 . Therefore, it can be concluded that the cancerous tissue spreads on the transcision path 26073 and is located mainly in front of the end effector 26070 . In response, the microcontroller 461 instructs the surgeon to release the grasped tissue and move the end effector 26070 backward to reach the tumor-free margin before regrasping the tissue. can be directed to

Position D of FIG. 38 shows another example of implementing process 26090 of FIG. At position D in FIG. 38, Sen ₃ and Sen ₂ read above (AVG), but the remaining sensors report readings below (AVG). Additionally, Sen ₂ and Sen ₃ are positioned on the same side 26076 of the end effector 26070 . Therefore, it can be concluded that cancerous tissue has spread to the side 26076 of the end effector 26070 . Since the readings of sensors Sen ₄ , Sen ₅ , and Sen ₆ located on side 26077 indicate that these sensors are not in close proximity to cancerous tissue, microcontroller 461 instructs the surgeon to: The grasped tissue may be released and the end effector 26070 may be directed to move away from the transcision path 26073 on side 26077 to reach normal tissue on side 26076 .

FIG. 40 is a logic flow diagram of process 26190 showing control programs or logic constructs that provide instructions for guiding the end effector against cancerous tissue, the instructions indicating that the sensor is in proximity to cancerous tissue. based on the spatial relationship of the sensors on the end effector and a comparison of the readings to report readings indicative of Process 26190 may be performed by microcontroller 461 based on sensor readings from sensors Sen ₁ -Sen ₆ . Process 26190 includes receiving sensor signals from sensors Sen ₁ -Sen ₆ (26191) and determining which sensors are proximate to cancerous tissue (26192) based on the equations described above. Additionally, the process 26190 provides instructions to guide the end effector 26070 away from the cancerous tissue based on the relative positions and relative readings of the sensors on the end effector 26070 proximate the cancerous tissue (26193). including.

Location E of FIG. 41 provides an example of performing process 26190. FIG. At position E in FIG. 41, Sen ₁ , Sen ₂ , and Sen ₃ readings are all above (AVG), but the remaining sensors report readings below (AVG). Additionally, Sen ₁ , Sen ₂ , and Sen ₃ are all positioned on side 26076 of end effector 26070 . It can therefore be concluded that cancerous tissue has spread to the side 26076 of the end effector 26070 . In addition, the Sen ₂ reading exceeds the Sen ₁ reading. Also, the Sen ₂ reading exceeds the Sen ₃ reading. Since Sen ₂ is positioned between Sen ₁ and Sen ₃ on the same side 26076, cancerous tissue has spread to side 26076 of end effector 26070 at a position closer to Sen ₂ than to Sen ₁ and Sen ₃ . can be concluded.

In various embodiments, sensors of sensor arrays, such as sensor array 26471 and/or sensor array 26080, are integrated into the staple cartridge and engage contactor plates that transmit power and/or data when assembled with an end effector. can be conducted through the metal portion of the staple cartridge that mates.

In various embodiments, the tissue physiological parameter measured by the sensors of the sensor array according to the present disclosure is pH. As mentioned above, lactate is a by-product of the glycolytic (anaerobic metabolism) process performed by cancerous tissue, resulting in decreased glucose and increased lactate in the interstitial fluid environment.

In various embodiments, the tissue physiological parameter measured by the sensors of the sensor array according to the present disclosure is glucose. As mentioned above, blood glucose levels have been measured to be very low in the tumor microenvironment (0.1-0.4 mM). In normal tissues, blood glucose levels can range from about 3.3-5.5 mM.

In various embodiments, the sensors of the sensor array are Clark-type sensors that can be used to measure blood glucose levels based on oxygen reactions with enzymes, according to the present disclosure. The Clark-type sensor uses an immobilized glucose oxidase-embedded surface to catalyze the oxidation of β-D-glucose to produce gluconic acid and hydrogen peroxide. Hydrogen peroxide is oxidized at a catalytic (usually platinum) anode which induces electron transfer proportional to the number of glucose molecules present.

42 and 43 show an exemplary thick film printed glucose sensor 26200 that can be used with the sensor arrays of the present disclosure. This configuration uses an iridium-doped carbon ink with high specificity for glucose detection that is not masked by other common interfering chemicals (eg, ascorbic acid). Sensor 26200 includes an electrode diameter of approximately 1 mm. In one example, as shown in FIG. 43, sensor 26200 includes Ir-carbon counter electrode 26202 and Ir-carbon working electrode 26203, Ag/AgCl reference electrode 26204, and silver conductive pad 26205. Additionally, sensor 26200 further includes an insulating layer 26206 . Further details of sensor 26200 are provided in Sensors and Actuators B: Chemical, 2007, V125(1), pp. 16-113, Shen J et al. described in the author's scientific publications. As shown in FIGS. 44-45, at an applied potential of 0.2-0.3 V, a response current of approximately 15-20 uA can be observed with an increase of 5 mM glucose.

In various aspects, the sensors of the sensor array can be located on the staple cartridge according to the present disclosure. Adhesive masks can be implanted with sensors in place. In various aspects, the sensor is attached to a ridge on the staple cartridge such that the sensor is positioned higher than the cartridge deck of the staple cartridge to ensure contact with tissue. Adhesive masks can be mass produced, for example, using screen printing techniques on polyester substrates. Conductive pads may be printed at common locations.

In various embodiments, in addition to detecting proximity to cancer tissue, the end effectors of the present disclosure can also be configured to target specific cancer types within specific tissues. Academic publication by Alternberg B and Greulich KO, Genomics 84 (2004) pp. 1014-1020, certain cancers are characterized by overexpression of glycolytic genes, while other cancers are not characterized by overexpression of glycolytic genes. Accordingly, the end effector of the present disclosure can be equipped with a sensor array that has high specificity for cancerous tissue characterized by overexpression of glycolytic genes, such as lung cancer or liver cancer.

In various aspects, the sensor readings of the sensor array are communicated by the surgical instrument to a surgical hub (eg, surgical hub 106, 206) for additional analysis and/or situational awareness, according to the present disclosure. be.

Situational Awareness Situational awareness is the ability of some aspects of a surgical system to determine or infer information related to a surgical procedure from data received from databases and/or instruments. Information may include the type of procedure being performed, the type of tissue being operated on, or the body cavity being treated. Contextual information related to a surgical procedure may allow the surgical system to, for example, control modular devices (e.g., robotic arms and/or robotic surgical tools) connected to it, and provide contextually appropriate information or information during the course of a surgical procedure. The method of providing suggestions to the surgeon can be improved.

Referring now to FIG. 46, a timeline 5200 illustrating situational awareness of a hub, such as 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.

In the 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. In addition, 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 (because it is either not compatible with 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 the surgical procedure to be 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 electrocardiography (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, blood pressure, and other data from the patient monitor. As can be seen from this exemplary procedure description, surgical hubs 106, 206 may 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 Application No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety. In certain instances, 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 the cloud 104. can be controlled by the hub 106, 206 based on the information in the

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

Example 1 - A surgical instrument is disclosed. A surgical instrument includes an end effector and control circuitry. The end effector includes a first jaw, a second jaw movable relative to the first jaw to grasp tissue therebetween, an anvil, and a staple positionable within the tissue. wherein the staples are deformable by the anvil; and a sensor configured to provide a sensor signal according to a physiological parameter of tissue. A control circuit is coupled to the sensor, the control circuit configured to receive the sensor signal and assess the sensor's proximity to the cancerous tissue based on the sensor signal.

Example 2 - The surgical device of Example 1, wherein the control circuit is further configured to generate an alert if the proximity of the sensor to cancerous tissue reaches or exceeds a predetermined threshold. instrument.

Example 3—The A surgical instrument according to any one of the preceding claims.

Embodiment 4—Further comprising a motor configured to cause placement of the staples, wherein the control circuit prevents activation of the motor if the value of the physiological parameter reaches or exceeds a predetermined threshold. The surgical instrument of any one of Examples 1-3, further configured to:

Example 5 - The surgical instrument of any one of Examples 1-4, wherein the physiological parameter is tissue blood glucose level.

Example 6 - The surgical instrument of any one of Examples 1-4, wherein the physiological parameter is tissue pH level.

Example 7 - The surgical instrument of any one of Examples 1-6, wherein the sensor is a Clark-type sensor.

[0040] Example 8 - The surgical instrument of any one of Examples 1-7, wherein the control circuitry is further configured to provide commands to move the end effector in a predetermined direction away from the cancerous tissue.

Example 9 - A surgical stapling instrument is disclosed. A surgical stapling instrument includes an end effector and control circuitry. The end effector includes a first jaw, a second jaw movable relative to the first jaw to grasp tissue therebetween, an anvil, and a staple positionable within the tissue. wherein the staples are deformable by the anvil; and a sensor configured to provide a sensor signal according to a physiological parameter indicative of proximity of the sensor to cancerous tissue. , a sensor, and the like. A control circuit is coupled to the sensor, the control circuit configured to receive the sensor signal, determine a value of the physiological parameter based on the sensor signal, and compare the value of the physiological parameter to a predetermined threshold. It is

[00100] Example 10 - The surgical stapling instrument of Example 9, wherein the control circuit is further configured to generate an alert based on comparing the value of the physiological parameter to a predetermined threshold.

Example 11 - Any of Examples 9 and 10, wherein the control circuit is further configured to prevent deployment of the staples if the value of the physiological parameter reaches or exceeds the predetermined threshold 1. The surgical stapling instrument of claim 1.

Embodiment 12—Further comprising a motor configured to cause staple deployment, wherein the control circuit prevents activation of the motor if the value of the physiological parameter reaches or exceeds a predetermined threshold The surgical stapling instrument of any one of Examples 9-11, further configured to:

Example 13 - The surgical stapling instrument of any one of Examples 9-12, wherein the physiological parameter is tissue blood glucose level.

Example 14 - The surgical stapling instrument of any one of Examples 9-12, wherein the physiological parameter is tissue pH level.

Example 15 - The surgical stapling instrument of any one of Examples 9-14, wherein the sensor is a Clark-type sensor.

Example 16 - The surgical stapling of any one of Examples 9-15, wherein the control circuit is further configured to provide commands to move the end effector in a predetermined direction away from cancerous tissue. instrument.

Example 17 - A surgical instrument is disclosed. A surgical instrument includes an end effector and control circuitry. The end effector includes a first jaw, a second jaw movable relative to the first jaw to grasp tissue therebetween, an anvil, and a staple positionable within the tissue. wherein the staples are deformable by the anvil; a sensor assembly configured to provide a sensor signal according to a physiological parameter indicative of proximity of the sensor to cancerous tissue; including. The sensor assembly includes a first sensor on a first side of a longitudinal axis extending through the staple cartridge and a second sensor on a second side of the longitudinal axis. A control circuit is coupled to the sensor assembly, the control circuit receiving a first sensor signal from the first sensor, a second sensor signal from the second sensor, and a first sensor signal. determining a first value of the physiological parameter based on the second sensor signal; determining a second value of the physiological parameter based on the second sensor signal; comparing the first value and the second value to a predetermined threshold is configured to

Embodiment 18 - The control circuit may provide instructions to move the end effector in a first direction if the first value reaches or exceeds a predetermined threshold value but the second value does not. 18. The surgical instrument of example 17, wherein the first direction extends away from the longitudinal axis on the first side.

Example 19 - The control circuit may provide instructions to move the end effector in a second direction if the second value reaches or exceeds a predetermined threshold value but the first value does not. and the second direction extends away from the longitudinal axis on the second side.

Example 20 - The surgical procedure of example 19, wherein the control circuit is further configured to approve the position of the end effector if the first value and the second value are below a predetermined threshold equipment.

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 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 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 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," "above," and "below" are sometimes used herein with respect to the drawings. Will. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

Those skilled in the art will 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, it will be understood by those of ordinary skill in the art that where any particular number of introduced claim statements is intended, such intent is expressly set forth in the claims, and that in the absence of such statement, such intent does not exist. will be understood. 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.

[Mode of implementation]
(1) A surgical instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter of said tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
and a control circuit configured to assess the proximity of the sensor to cancerous tissue based on the sensor signal.
2. The method of claim 1, wherein the control circuit is further configured to generate an alert when the proximity of the sensor to cancerous tissue reaches or exceeds a predetermined threshold. surgical instruments.
Embodiment 1, wherein the control circuit is further configured to prevent deployment of the staples when the proximity of the sensor to cancerous tissue reaches or exceeds a predetermined threshold. The surgical instrument according to .
(4) further comprising a motor configured to cause deployment of the staples, wherein the control circuit activates the motor when the value of the physiological parameter reaches or exceeds a predetermined threshold; 2. The surgical instrument of embodiment 1, further configured to prevent .
(5) The surgical instrument of claim 1, wherein the physiological parameter is tissue blood glucose level.

(6) The surgical instrument of claim 1, wherein the physiological parameter is tissue pH level.
(7) The surgical instrument of claim 1, wherein the sensor is a Clark-type sensor.
Clause 8. The surgical instrument of Clause 1, wherein the control circuit is further configured to provide commands to move the end effector in a predetermined direction away from the cancerous tissue.
(9) A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter indicative of the sensor's proximity to cancerous tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
determining a value of the physiological parameter based on the sensor signal;
and a control circuit configured to compare the value of the physiological parameter to a predetermined threshold.
Clause 10. The surgical stapling instrument of Clause 9, wherein the control circuit is further configured to generate an alert based on comparing the value of the physiological parameter to a predetermined threshold.

11. Aspect 9, wherein the control circuit is further configured to prevent deployment of the staples when the value of the physiological parameter reaches or exceeds the predetermined threshold. A surgical stapling instrument as described.
(12) further comprising a motor configured to cause deployment of the staples, wherein the control circuit activates the motor when the value of the physiological parameter reaches or exceeds the predetermined threshold; 10. The surgical stapling instrument of embodiment 9, further configured to prevent actuation.
(13) The surgical stapling instrument of Clause 9, wherein the physiological parameter is tissue blood glucose level.
(14) A surgical stapling instrument according to Clause 9, wherein the physiological parameter is tissue pH level.
Clause 15. The surgical stapling instrument of Clause 9, wherein the sensor is a Clark-type sensor.

Clause 16. The surgical stapling instrument of Clause 9, wherein the control circuit is further configured to provide commands to move the end effector in a predetermined direction away from the cancerous tissue.
(17) A surgical instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
A sensor assembly configured to provide a sensor signal according to a physiological parameter indicative of proximity of the sensor to cancerous tissue, the sensor assembly comprising:
a first sensor on a first side of a longitudinal axis extending through the staple cartridge;
an end effector including a sensor assembly including a second sensor on a second side of the longitudinal axis;
A control circuit coupled to the sensor assembly, the control circuit comprising:
receiving a first sensor signal from the first sensor;
receiving a second sensor signal from the second sensor;
determining a first value of the physiological parameter based on the first sensor signal;
determining a second value of the physiological parameter based on the second sensor signal;
and a control circuit configured to compare the first value and the second value to a predetermined threshold.
(18) said control circuit moves said end effector in a first direction when said first value reaches or exceeds said predetermined threshold but said second value does not; 18. The surgical instrument of embodiment 17, further configured to provide commands, wherein the first direction extends away from the longitudinal axis on the first side.
(19) the control circuit moves the end effector in a second direction if the second value reaches or exceeds the predetermined threshold but the first value does not; 19. The surgical instrument of embodiment 18, further configured to provide commands, wherein the second direction extends away from the longitudinal axis on the second side.
20. Embodiment 19, wherein the control circuit is further configured to approve the position of the end effector if the first value and the second value are below the predetermined threshold. The surgical instrument according to .

Claims (17)

A surgical instrument,
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter of said tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
a control circuit configured to assess the proximity of the sensor to cancerous tissue based on the sensor signal ;
A surgical instrument, wherein the control circuit is further configured to generate an alert if the proximity of the sensor to cancerous tissue reaches or exceeds a predetermined threshold. A surgical instrument,
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter of said tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
a control circuit configured to assess the proximity of the sensor to cancerous tissue based on the sensor signal;
The surgical instrument, wherein the control circuit is further configured to prevent deployment of the staples when the proximity of the sensor to cancerous tissue reaches or exceeds a predetermined threshold. A surgical instrument,
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter of said tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
determining a value of the physiological parameter based on the sensor signal;
a control circuit configured to assess the proximity of the sensor to cancerous tissue based on a comparison of the value of the physiological parameter to a predetermined threshold;
The surgical instrument further comprises a motor configured to cause deployment of the staples, and the control circuit controls the motor if the value of the physiological parameter reaches or exceeds a predetermined threshold. surgical instrument further configured to prevent activation of the The surgical instrument of claim 1, wherein the physiological parameter is tissue blood glucose level. The surgical instrument of claim 1, wherein the physiological parameter is tissue pH level. The surgical instrument of claim 1, wherein the sensor is a Clark-type sensor. A surgical instrument,
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter of said tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
a control circuit configured to assess the proximity of the sensor to cancerous tissue based on the sensor signal;
A surgical instrument, wherein the control circuit is further configured to provide commands to move the end effector in a predetermined direction away from the cancerous tissue. A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter indicative of the sensor's proximity to cancerous tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
determining a value of the physiological parameter based on the sensor signal;
a control circuit configured to compare the value of the physiological parameter to a predetermined threshold ;
A surgical stapling instrument, wherein the control circuit is further configured to generate an alert based on comparing the value of the physiological parameter to a predetermined threshold. A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter indicative of the sensor's proximity to cancerous tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
determining a value of the physiological parameter based on the sensor signal;
a control circuit configured to compare the value of the physiological parameter to a predetermined threshold;
The surgical stapling instrument, wherein the control circuit is further configured to prevent deployment of the staples when the value of the physiological parameter reaches or exceeds the predetermined threshold. A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter indicative of the sensor's proximity to cancerous tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
determining a value of the physiological parameter based on the sensor signal;
a control circuit configured to compare the value of the physiological parameter to a predetermined threshold;
The surgical stapling instrument further comprises a motor configured to cause deployment of the staples, and the control circuit controls the , a surgical stapling instrument further configured to prevent activation of said motor. The surgical stapling instrument of Claim 8 , wherein the physiological parameter is tissue blood glucose level. The surgical stapling instrument according to claim 8 , wherein the physiological parameter is tissue pH level. The surgical stapling instrument of Claim 8 , wherein the sensor is a Clark-type sensor. A surgical stapling instrument comprising:
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
an end effector comprising a sensor configured to provide a sensor signal according to a physiological parameter indicative of the sensor's proximity to cancerous tissue;
A control circuit coupled to the sensor, the control circuit comprising:
receiving the sensor signal;
determining a value of the physiological parameter based on the sensor signal;
a control circuit configured to compare the value of the physiological parameter to a predetermined threshold;
A surgical stapling instrument, wherein the control circuit is further configured to provide commands to move the end effector in a predetermined direction away from the cancerous tissue. A surgical instrument,
an end effector,
a first jaw;
a second jaw movable relative to the first jaw to grasp tissue therebetween;
anvil and
a staple cartridge including staples positionable within the tissue, the staples being deformable by the anvil;
A sensor assembly configured to provide a sensor signal according to a physiological parameter indicative of proximity of the sensor to cancerous tissue, the sensor assembly comprising:
a first sensor on a first side of a longitudinal axis extending through the staple cartridge;
an end effector including a sensor assembly including a second sensor on a second side of the longitudinal axis;
A control circuit coupled to the sensor assembly, the control circuit comprising:
receiving a first sensor signal from the first sensor;
receiving a second sensor signal from the second sensor;
determining a first value of the physiological parameter based on the first sensor signal;
determining a second value of the physiological parameter based on the second sensor signal;
and a control circuit configured to compare the first value and the second value to a predetermined threshold. The control circuit provides instructions to move the end effector in a first direction when the first value reaches or exceeds the predetermined threshold, but the second value does not. 16. The surgical instrument of claim 15 , wherein the first direction extends away from the longitudinal axis on the first side. The control circuit provides instructions to move the end effector in a second direction when the second value reaches or exceeds the predetermined threshold, but the first value does not. 17. The surgical instrument of claim 16 , wherein the second direction extends away from the longitudinal axis on the second side.

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