JP2024023560A - Surgical instrument having flexible electrode - Google Patents

Abstract

To disclose a flexible electrode of a surgical instrument.SOLUTION: A flexible electrode includes a therapeutic electrode, a sensing electrode and an insulative layer. The therapeutic electrode is couplable to a source of radiofrequency energy. The insulative layer is positioned between the therapeutic electrode and the sensing electrode. The therapeutic electrode and the sensing electrode are configured to contact a tissue positioned between first and second jaws of the surgical instrument.SELECTED DRAWING: Figure 28

Description

(Cross reference to related applications)
This application is a United States Provisional Application filed June 28, 2018, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE," the entire disclosure of which is incorporated herein by reference under 35 U.S.C. 119(e). Claims priority to patent application no. 62/691,230. This application is filed under 35 U.S.C. 119(e), the entire disclosure of which is incorporated herein by reference. June 2018 titled “S” Claims priority to U.S. Provisional Patent Application No. 62/691,228, filed May 28th.

This application is filed under 35 U.S.C. U.S. Provisional Patent Application No. 62/650,887, entitled “SURGICAL SMOKE EVACUATION SENSING AND CONTROLS,” filed March 30, 2018, “SMOKE EVACUATION MODULE FO R INTERACTIVE SURGICAL PLATFORM ” and U.S. Provisional Patent Application No. 62/650,882, filed March 30, 2018, entitled “CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS.” No. 62/650,898 claims priority.

This application is further filed under 35 U.S.C. 119(e) in a March 2018 application entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," each of which is incorporated herein by reference in its entirety. U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, and U.S. Provisional Patent Application No. 62/640,41, filed March 8, 2018, entitled “ESTIMATION STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.” No. 5 claim priority interest.

This application further relates to a United States provisional patent filed December 28, 2017 entitled "INTERACTIVE SURGICAL PLATFORM," each disclosure of which is hereby incorporated by reference in its entirety under 35 U.S.C. 119(e). Applications 62/611, 341, and "CLOUD -BASED MEDICAL Analytics" Applications on December 28, 2017, US temporary patent application No. 62/611, 340, and "Robot ASSISTED SURGICALP 2017 1217 entitled "LATFORM" Claims priority benefit of U.S. Provisional Patent Application No. 62/611,339, filed on May 28th.

This application discloses inventions that relate generally and in various aspects to surgical systems, surgical instruments, and flexible circuits.

Surgical instruments include components that are required to move in different directions and/or are subjected to different forces. For example, the shaft rotates, articulates, experiences different tensions, the jaws pivot open and close, experiences undesirable bending or deformation, and the cutting member moves axially in distal and proximal directions. , experience different resistance forces.

The surgical instrument may also include additional components such as electrodes, sensing devices, processing circuitry, motors, and wiring and/or wiring traces, some of which may be located within various portions of the surgical instrument. obtain. For example, the sensing device and/or processing circuitry may be located within the end effector of the surgical instrument, within the shaft assembly of the surgical instrument, and/or within the handle assembly of the surgical instrument. Such additional components may form electrical circuits of the surgical instrument, and portions of such electrical circuits may also be required to move in different directions and/or apply different forces. There is a possibility that you will receive it.

The jaw electrodes of various surgical instruments are often rigid, apply electrosurgical energy to tissue positioned between the jaws, collectively occupy nearly the entire width of the jaws, and flex or flex as the jaws open and close. Used as a therapeutic electrode that can undergo deformation. In a surgical instrument that includes a knife that traverses a slot defined by a jaw, a first electrode may be positioned on a first side of the slot (e.g., the right-hand side) and a second electrode may be positioned on a second side of the slot. (e.g., the left-hand side).

Due to their rigid nature, undesired bending or deformation of the electrodes can lead to premature failure. Also, by collectively occupying substantially the entire width of the jaws, the electrodes have a relatively large surface area for contacting tissue positioned between the jaws. When an electrode delivers radio frequency (RF) energy to tissue, the large surface area of the electrode can contribute to undesirable tissue adhesion. Additionally, the large surface area of the electrodes leaves little space for the sensing and/or measuring device to contact the tissue positioned between the jaws.

In conventional electrical circuits within surgical instruments, portions of the electrical circuit that are required to move in different directions and/or are subjected to different forces may become disconnected or separated from their connection to the surgical instrument. , and/or tend to fail at a higher rate than desired.

A flexible electrode for a surgical instrument is disclosed. The flexible electrode includes a radiofrequency energy source, a sensing electrode, and a therapeutic electrode connectable to the insulating layer. An insulating layer is positioned between the treatment electrode and the sensing electrode. The treatment electrode and the sensing electrode are configured to contact tissue positioned between the first and second jaws of the surgical instrument.

A flexible electrode assembly for a surgical instrument is disclosed. a flexible electrode assembly associated with first and second treatment electrodes connectable to a source of radiofrequency energy and tissue positioned between first and second jaws of the surgical instrument; first and second sensing electrodes configured to assist in determining the parameter. A flexible electrode assembly includes a first insulating layer positioned between the first treatment electrode and the first sensing electrode, and a first insulation layer positioned between the second treatment electrode and the second sensing electrode. the first and second treatment electrodes and the first and second sensing electrodes are configured to contact tissue.

A multi-level flexible electrode for a surgical instrument is disclosed. The multi-level flexible electrode includes first, second, and third insulating layers. The multi-level flexible electrode further includes a treatment electrode and a sensing electrode. A treatment electrode is positioned between the first insulating layer and the second insulating layer, and the treatment electrode is connectable to a radio frequency energy source. A sensing electrode is positioned between the second insulating layer and the third insulating layer, the sensing electrode being associated with tissue positioned between the first jaw and the second jaw of the surgical instrument. the treatment electrode and the sensing electrode are configured to contact the tissue.

The features of various aspects are set forth in detail in the appended claims. However, various aspects of both the mechanism and the method of operation, together with further objects and advantages thereof, can best be understood by reference to the following description, taken in conjunction with the accompanying drawings, in which: FIG.
1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure. FIG. 1 is a surgical system used to perform a surgical procedure within an operating room in accordance with at least one aspect of the present disclosure. 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. 1 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing, in accordance with at least one aspect of the present disclosure; FIG. 1 is a perspective view of a combination generator module with bipolar, ultrasonic, and monopolar contacts and smoke evacuation components in accordance with at least one aspect of the present disclosure; FIG. FIG. 6 illustrates individual power bus attachments of a plurality of lateral docking ports of a lateral modular housing configured to receive a plurality of modules in accordance with at least one aspect of the present disclosure. 2 illustrates a vertical modular housing configured to receive a plurality of modules in accordance with at least one aspect of the present disclosure. A modular device located in one or more operating rooms of a medical facility, or any room within a medical facility with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure, can be placed in the cloud. 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. 3 illustrates a surgical hub with multiple modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure; FIG. 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 surgical instrument or tool control system in accordance with at least one aspect of the present disclosure. 1 illustrates a control circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 2 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 3 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of a robotic surgical instrument configured to manipulate the surgical tools described herein, according to at least one aspect of the present disclosure. FIG. 3 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure. 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. 1 is a simplified block diagram of a generator configured to provide inductorless tuning, among other advantages, in accordance with at least one aspect of the present disclosure. FIG. 21 illustrates an example of a generator that is a form of the generator of FIG. 20, in accordance with at least one aspect of the present disclosure. 1 illustrates a surgical instrument according to at least one aspect of the present disclosure. 23 illustrates a shaft assembly of the surgical instrument of FIG. 22 in accordance with at least one other aspect of the present disclosure; FIG. 23 illustrates a flexible circuit of the surgical instrument of FIG. 22 in accordance with at least one aspect of the present disclosure. 23 illustrates a channel holder of the surgical instrument of FIG. 22, according to at least one aspect of the present disclosure. FIG. 25 illustrates a cross-sectional view of a flexible circuit along line AA of FIG. 24, in accordance with at least one aspect of the present disclosure. FIG. 25 illustrates a cross-sectional view of a flexible circuit along line BB of FIG. 24, in accordance with at least one aspect of the present disclosure. FIG. 23 illustrates an exploded view of the flexible electrode of the surgical instrument of FIG. 22, in accordance with at least one aspect of the present disclosure. FIG. 23 illustrates a top view of a flexible electrode of the surgical instrument of FIG. 22, according to at least one aspect of the present disclosure. FIG. 23 illustrates a top view of a flexible electrode of the surgical instrument of FIG. 22, according to at least one aspect of the present disclosure. FIG. 23 illustrates an exploded view of the flexible electrode of the surgical instrument of FIG. 22, in accordance with at least one other aspect of the present disclosure. FIG. 23 illustrates an end view of a flexible electrode of the surgical instrument of FIG. 22, according to at least one other aspect of the present disclosure. FIG. 23 illustrates a top perspective view of a flexible electrode of the surgical instrument of FIG. 22, according to at least one other aspect of the present disclosure. FIG.

The applicant of this application owns the following United States patent applications filed June 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
- U.S. Patent Application No. _____, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," Attorney Docket No. END8542USNP/170755;
- U.S. Patent Application No. _____, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS," Attorney Docket No. END8543USNP/170760;
- U.S. Patent Application No. ``SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION,'' Attorney Docket No. END8543USNP1/1707 60-1,
- U.S. Patent Application No. _____, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLINING," Attorney Docket No. END8543USNP2/170760-2;
- U.S. Patent Application No. _____, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING," Attorney Docket No. END8543USNP3/170760-3;
- U.S. Patent Application No. _____, entitled “SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES,” Attorney Docket No. END8543USNP4/170760 -4,
- U.S. Patent Application No. _____, entitled “SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE,” Attorney Docket No. END8543USNP5/170760-5 ,
- United States Patent Application No. _____, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES," Attorney Docket No. END8543USNP6/170760-6;
- U.S. Patent Application No. _____, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY," Attorney Docket No. END8543USNP7/170760-7;
- U.S. Patent Application No. _____, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT," Attorney Docket No. END8544USNP1/170761-1;
- U.S. Patent Application No. _____, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY," Attorney Docket No. END8544USNP2/170761-2;
- U.S. Patent Application No. _____, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES," Attorney Docket No. END8544USNP3/170761-3;
- U.S. Patent Application No. _____, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL," Attorney Docket No. END8545USNP/170762;
- United States Patent Application No. _____, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS," Attorney Docket No. END8545USNP1/170762-1;
- U.S. Patent Application No. _____, entitled "SURGICAL EVACUATION FLOW PATHS," Attorney Docket No. END8545USNP2/170762-2;
- U.S. Patent Application No. _____, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL," Attorney Docket No. END8545USNP3/170762-3;
- United States Patent Application No. _____, entitled "SURGICAL EVACUATION SENSING AND DISPLAY," Attorney Docket No. END8545USNP4/170762-4;
・“COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL P LATFORM,” United States Patent Application No. _____, Attorney Docket No. END8546USNP/170763;
- U.S. Patent Application No. ``SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM,'' Attorney Docket No. EN D8546USNP1/170763-1,
・“SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE” U.S. Patent Application No. _____, Attorney Docket No. END8547USNP/170764, entitled ``DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS'' ”, United States Patent Application No. _____, Attorney Docket No. END8548USNP/170765.

The applicant of this application owns the following United States Provisional Patent Applications filed June 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
- U.S. Provisional Patent Application No. 62/691,228 entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES,"
- U.S. Provisional Patent Application No. 62/691,227 entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";
- U.S. Provisional Patent Application No. 62/691,230 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
- U.S. Provisional Patent Application No. 62/691,219 entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
・“COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL P U.S. Provisional Patent Application No. 62/691,257 entitled ``LATFORM'';
・“SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE” U.S. Provisional Patent Application No. 62/691,262 entitled ``DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS''; Provisional Patent Application No. 62/691,251.

The applicant of this application owns the following United States patent applications filed March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
- U.S. Patent Application No. 15/940,641 entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
- U.S. Patent Application No. 15/940,648 entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES";
- U.S. Patent Application No. 15/940,656 entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";
- U.S. Patent Application No. 15/940,666 entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS";
- U.S. Patent Application No. 15/940,670 entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS";
- U.S. Patent Application No. 15/940,677 entitled "SURGICAL HUB CONTROL ARRANGEMENTS";
- U.S. Patent Application No. 15/940,632 entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
・“COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUDS BASED U.S. Patent Application No. 15/940,640 entitled ``ANALYTICS SYSTEMS'';
- U.S. Patent Application No. 15/940,645 entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
- U.S. Patent Application No. 15/940,649 entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
- U.S. Patent Application No. 15/940,654 entitled "SURGICAL HUB SITUATIONAL AWARENESS";
- U.S. Patent Application No. 15/940,663 entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
- U.S. Patent Application No. 15/940,668 entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
- U.S. Patent Application No. 15/940,671 entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER";
- U.S. Patent Application No. 15/940,686 entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE";
- U.S. Patent Application No. 15/940,700 entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
- U.S. Patent Application No. 15/940,629 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
- U.S. Patent Application No. 15/940,704 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT";
U.S. Patent Application No. 15/940,722 entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY" U.S. Patent Application No. 15/940,742 entitled ``UAL CMOS ARRAY IMAGING''.

The applicant of this application owns the following United States patent applications filed March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
- U.S. Patent Application No. 15/940,636 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
- U.S. Patent Application No. 15/940,653 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS";
- U.S. Patent Application No. 15/940,660 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER,"
・“CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGE DATA SE U.S. patent application Ser. No. 15/940,679, entitled
- U.S. Patent Application No. 15/940,694 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION" No.,
- 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,'' and ``CLOUD INTERFACE FOR COUPLED SURGIC.'' US patent application Ser. No. 15/940,675 entitled ``AL DEVICES''.

The applicant of this application owns the following United States patent applications filed March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
- U.S. Patent Application No. 15/940,627 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,637 entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,642 entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,676 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,680 entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,683 entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application No. 15/940,690 entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" No. 15/940,711 entitled "SURGICAL PLATFORMS."

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

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

The applicant of this application owns the following United States Provisional Patent Applications filed March 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
- U.S. Provisional Patent Application No. 62/650,887 entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES";
- U.S. 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," and - "CAPACITIVE COUPLED RETURN PATH PAD WITH US Provisional Patent Application No. 62/650,898 entitled “SEPARABLE ARRAY ELEMENTS” .

The applicant of this application owns the following United States Provisional Patent Applications filed March 8, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
・U.S. Provisional Patent Application No. 62/640,417 entitled “TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR,” and ・“ESTIMATING STATE OF ULTRASON U.S. Provisional Patent Application No. 62/640 entitled “IC END EFFECTOR AND CONTROL SYSTEM THEREOFR” , No. 415.

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

At least some of the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the disclosure; however, for purposes of clarity, other features as would be understood by those skilled in the art are provided. It is to be understood that excluding elements may form part of the invention. However, a description of such elements is not provided herein because such elements are well known in the art and they do not facilitate a better understanding of the invention.

In the following Detailed Description, reference is made to the accompanying drawings, which form a part of this specification. In the figures, like symbols and reference numbers generally indicate similar elements throughout the figures, unless the context dictates otherwise. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other aspects may be used and other changes may be made without departing from the scope of the technology described herein.

The following descriptions of specific embodiments of the present technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the present technology will be apparent to those skilled in the art from the following description, which is, by way of illustration, one of the best modes contemplated for carrying out the technology. It will be. As will be appreciated, the technology described herein is capable of other different and obvious embodiments without departing from the technology. Accordingly, the drawings and description are to be regarded in an illustrative rather than a restrictive nature.

Any one or more of the teachings, representations, aspects, embodiments, examples, etc. described herein can be substituted with any other teachings, representations, aspects, embodiments, examples, etc. described herein. It is further understood that any one or more of the following may be combined. Accordingly, the teachings, representations, aspects, embodiments, examples, etc. described below should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

Before describing in detail various aspects of surgical systems, surgical instruments, flexible circuits, and flexible electrode assemblies, various aspects disclosed herein will be discussed in detail below in their application or use. It is to be noted that there is no limitation to the details of construction and arrangement of parts illustrated in the drawings and description. Rather, the disclosed aspects can be positioned as or incorporated into other aspects, embodiments, variations, and modifications thereof, and may be practiced or carried out in various ways. Accordingly, the aspects of surgical systems, surgical instruments, flexible circuits, and flexible electrode assemblies disclosed herein are exemplary in nature and are not intended to limit the scope or application thereof. It's not what I intend. Furthermore, unless otherwise stated, the terms and expressions used herein are selected for the purpose of describing the embodiments for the convenience of the reader and are not intended to limit the scope thereof. do not have. Additionally, any one or more of the disclosed aspects, expressions of aspects, and/or examples thereof may be used without limitation to any other disclosed aspects, expressions of aspects, and/or examples thereof. It should be understood that any one or more of the above may be combined.

In addition, in the following explanation, terms such as inside, outside, upward, downward, above, below, left, right, inner surface, and outer surface should be understood to be used for convenience, and should not be interpreted as limiting. It should not be construed as a term. The terminology used herein is not limiting, provided that the apparatus described herein, or portions thereof, may be mounted or used in other orientations. Various aspects will now be described in more detail with reference to the drawings.

As described in more detail below, aspects of the invention may be implemented by a computing device and/or a computer program stored on a computer-readable medium. Computer readable media may include disks, devices, and/or propagated signals.

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., a cloud 104 that may include a remote server 113 coupled to a storage device 105). ,including. Each surgical system 102 includes at least one surgical hub 106 that communicates with a cloud 104 that may include remote servers 113. In one example, as shown in FIG. 1, surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112 configured to communicate with each other and/or with hub 106. and, including. In some aspects, 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 more.

FIG. 3 shows an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 within a surgical operating room 116. Robotic system 110 is used as part of surgical system 102 in a surgical procedure. Robotic system 110 includes a surgeon's console 118, a patient 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 a minimally invasive dissection of the patient's body. . Images of the surgical site may be obtained by medical imaging device 124, which may be manipulated by patient cart 120 to orient imaging device 124. Robotic hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via surgeon's console 118.

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

Various examples of cloud-based analytics performed by cloud 104 and suitable for use with this disclosure are described in “CLOUD-BASED MEDICAL,” filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. 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.

Optical components of imager 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 reflected or refracted light from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.

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

The invisible spectrum (ie, the non-emissive spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (ie, wavelengths less than about 380 nm and greater than about 750 nm). 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 wireless electromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, and these constitute invisible ultraviolet, X-ray, and gamma 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, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes). , endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlying structure. Multispectral images capture image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to light from specific wavelengths, including frequencies beyond the visible light range, such as IR and ultraviolet light. Spectral imaging can enable the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging techniques is described in "Advanced Imaging" in U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. Acquisition Module” section. Multispectral monitoring can be a useful tool to reposition 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 a "surgical theater", ie, operating room or treatment room, require maximum sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize anything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. A sterile field may be considered a specific area that is considered free of microorganisms, such as in a tray or on a sterile towel, or a sterile field may be considered the area immediately surrounding a patient prepared for a surgical procedure. It will be understood that what can be done. A sterile field may include cleaned team members wearing appropriate clothing and all equipment and fixtures within the area.

In various aspects, visualization system 108 includes one or more imaging sensors strategically positioned 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, visualization system 108 includes HL7, PACS, and EMR interfaces. Various components of visualization system 108 are described in U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is explained in the section "Advanced Imaging Acquisition Module".

As shown in FIG. 2, primary display 119 is positioned within the sterile field so that it is visible to an operator positioned at operating table 114. Additionally, visualization tower 111 is located outside the sterile field. Visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. A visualization system 108 guided by the surgical hub 106 is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators within and outside the sterile field. For example, surgical 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 live video of the surgical site on primary display 119. can be done. A snapshot on a non-sterile display 107 or 109 may, for example, allow a non-sterile operator to perform diagnostic steps associated with a surgical procedure.

In one aspect, the surgical hub 106 transmits diagnostic input or feedback entered by a non-sterile operator located at the visualization tower 111 within the sterile field to a primary display 119 within the sterile field, which is located at the operating table. It is also configured so that it can be viewed by the sterilization operator. In one example, the input may be in the form of a modification to a snapshot displayed on non-sterile display 107 or 109 that may be sent by surgical 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. Surgical hub 106 is also configured to coordinate information flow to the display of surgical instrument 112. See, for example, U.S. Provisional Patent Application No. 62/611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 location may be sent by the surgical hub 106 within the sterile field to the surgical instrument display 115, where the operator of the surgical instrument 112 inputs the diagnostic input. Or you can see the feedback. For exemplary surgical instruments suitable for use with surgical system 102, see, for example, the section entitled "Surgical Instrument Hardware" and the 2017 publication entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference. It is described in US Provisional Patent Application No. 62/611,341, filed December 28th.

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

During a surgical procedure, applying energy to tissue for sealing and/or cutting typically involves evacuation of smoke, suction of excess fluid, and/or irrigation of the tissue. Fluid, power, and/or data lines from different sources often become intertwined during surgical procedures. Valuable time may be lost addressing this problem during the surgical procedure. Disentangling the lines may require removing the lines from their corresponding modules, which may require resetting the modules. The modular housing 136 of the surgical hub provides a unified environment for managing power, data, and fluid lines and reduces 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 surgical hub housing and a combination generator module slidably receivable within a docking station of the surgical hub housing. The docking station includes data and power contacts. A combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combination generator module also includes 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 expel fluid 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 the second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received within the surgical hub housing. In one aspect, the surgical 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 ultrasound generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the modular housing 136 of the surgical hub is configured to house various generators and facilitate bi-directional communication therebetween. One of the advantages of the surgical 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. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue and a first docking port that includes a first data and power contact. a first docking station including a first energy generator module, the first energy generator module being slidably movable into electrical engagement with the power and data contacts; The first power and data contact is slidably movable out of electrical engagement with the first power and data contact.

In addition to the above, the modular surgical housing includes a second energy generator module configured to generate a second energy for applying to tissue that is different than the first energy; a second docking station with a second docking port including data and power contacts of the second energy generator module, the second energy generator module being slidably moved into electrical engagement with the power and data contacts. and the second energy generator module is slidably movable out of electrical engagement with the second power and data contacts.

Additionally, the modular surgical housing 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. It further includes a communication bus to and from the port.

3-7, aspects of the present disclosure relate to a modular housing 136 of a surgical hub that allows for modular integration of a generator module 140, a smoke evacuation module 126, and an aspiration/irrigation module 128. is presented. The surgical hub's modular housing 136 further facilitates bi-directional communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 includes an integrated monopolar, bipolar, and a generator module comprising ultrasound components. As shown in FIG. 5, generator module 140 may be configured to connect to monopolar device 146, bipolar device 147, and ultrasound device 148. Alternatively, the generator module 140 may include a series of monopolar, bipolar, and/or ultrasound generator modules that interact through the modular housing 136 of the surgical hub. The surgical hub modular housing 136 allows for the insertion of multiple generators and generators docked into the surgical hub modular housing 136 such that the multiple generators function as a single generator. and may be configured to facilitate two-way communication between.

In one aspect, the modular housing 136 of the surgical hub includes external and wireless communication headers to allow for removable attachment of the modules 140, 126, 128 and bi-directional communication therebetween. Includes power and communications backplane 149.

In one aspect, the modular housing 136 of the surgical hub includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140, 126, 128. . FIG. 4 shows a partial perspective view of the surgical hub housing 136 and the combination generator module 145 slidably receivable in the docking station 151 of the surgical hub housing 136. A docking port 152 with power and data contacts on the rear side of the combination generator module 145 allows the combination generator module 145 to be slid into position within a corresponding docking station 151 of the modular housing 136 of the surgical hub. and a corresponding docking port 150 configured to engage the power and data contacts of a corresponding docking station 151 of the hub's 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 conveys captured/recovered smoke and/or fluid away from the surgical site, e.g., to the smoke evacuation module 126. The vacuum suction generated from the smoke evacuation module 126 can draw smoke into the utility conduit opening at the surgical site. The utility conduit connected to the fluid line may be in the form of a flexible tube that terminates in the smoke evacuation module 126. The utility conduits and fluid lines define a fluid path extending toward the smoke evacuation module 126 received within the surgical hub housing 136.

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

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

The irrigation tube can be in fluid communication with a fluid source and the suction tube can be in fluid communication with a vacuum source. A fluid source and/or a vacuum source may be housed within the aspiration/irrigation module 128. In one example, the fluid source and/or vacuum source may be housed within the surgical hub housing 136 separately from the suction/irrigation module 128. In such embodiments, the fluidic 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 modular housing 136 of the surgical hub align the docking ports of the modules to the modular housing of the surgical hub. The 136 docking stations may include alignment mechanisms configured to engage these corresponding components within the 136 docking stations. For example, as shown in FIG. 4, the combination generator module 145 has a side configured to slidably engage a corresponding bracket 156 of a corresponding docking station 151 of the modular housing 136 of the surgical hub. includes a bracket 155. The brackets cooperate to direct the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the modular housing 136 of the surgical hub.

In some aspects, the drawers 151 of the surgical 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, the drawers 151 are of different sizes, each designed to accommodate a particular module.

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

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

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

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

In various aspects, the imaging module 138 includes a built-in video processor and a modular light source, and is adapted for use with a variety of imaging devices. In one aspect, the imaging device is constructed with 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 to a 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 scanned beam imaging. Similarly, the light source module can be configured to deliver white light or different lights 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 a different light source. Temporary loss of vision of the surgical field can have undesirable consequences. The modular imaging device of the present disclosure is configured to allow replacement of the light source module or camera module midstream during a surgical procedure without the need to remove the imaging device from the surgical field.

In one aspect, an imaging device includes a tubular housing that includes a plurality of channels. The first channel is configured to slidably receive a camera module that can be configured for snap-fit engagement with the first channel. The second channel is configured to slidably receive a light source module that can be configured to snap-fit into engagement with the second channel. In another example, the camera module and/or the light source module can be rotated to a final position 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 can be configured to switch between imaging devices to provide optimal viewing. In various aspects, imaging module 138 can be configured to integrate images from different imaging devices.

Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Pat. No. 7,995,045. Additionally, 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, provides a method for removing motion artifacts from image data. It describes various systems for doing so. Such a system may be integrated with imaging module 138. Further, U.S. Patent Application Publication No. 2011/0306840, published December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS" and "SYSTEM FOR PERFORM ING A MINIMALLY INVASIVE SURGICAL PROCEDURE” August 28, 2014 Published US Patent Application Publication No. 2014/0243597 are each incorporated herein by reference in their entirety.

FIG. 8 shows how a cloud-based system (e.g. storage A surgical data network 201 is shown with a modular communications hub 203 configured to connect to a cloud 204 (FIG. 9), which may include a remote server 213 coupled to a device 205. In one aspect, modular communications hub 203 includes a network hub 207 and/or a network switch 209 that communicates with a network router. Modular communication hub 203 may further be coupled to local computer system 210 to provide local computer processing and data manipulation. Surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to go from one device (or segment) to another 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 the 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 1a-1n located in the operating room may be coupled to a modular communication hub 203. Network hub 207 and/or network switch 209 can be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with devices 1a-1n may be transferred via a router to a cloud-based computer 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 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 can 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-2m may be transferred via network router 211 to cloud 204 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 communications hub 203 may be housed within a modular control tower configured to receive a plurality of devices 1a-1n/2a-2m. Local computer system 210 may also be housed in the modular control tower. The modular communication hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n/2a-2m, eg, during a surgical procedure. In various aspects, the devices 1a-1n/2a-2m include, for example, an imaging module 138 coupled to an endoscope, among other modular devices that may be connected to the modular communications hub 203 of the surgical data network 201. , 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 Alternatively, various modules such as a non-contact sensor module may be mentioned.

In one aspect, surgical data network 201 includes a combination of network hub(s), network switch(es), and network router(s) that connect devices 1a-1n/2a-2m to the cloud. May include. 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 a local server or personal device. Although the term "cloud" may be used as a metaphor for "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which various services such as servers, storage, and applications are provided at the surgical site. (e.g., a fixed, mobile, temporary, or on-site operating room or space) and via the Internet to a modular communication hub 203 and/or computer system 210 located in a fixed, mobile, temporary, or on-site operating room or space. and delivered to devices connected to system 210. 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 within 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 within the operating room. Surgical 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 the data collected by the devices 1a-1n/2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. After the tissue sealing and cutting procedure, at least some of the devices 1a-1n/2a-2m can be used to observe the state of the tissue and assess leakage or perfusion of the sealed tissue. . At least one of the devices 1a-1n/2a-2m is configured to use cloud-based computing to examine data including images of samples of body tissue for diagnostic purposes to identify medical conditions such as disease effects. Several can be used. This includes tissue and phenotypic localization and margin confirmation. Devices 1a-1n/2a for identifying body anatomy using various sensors integrated with the imaging device and techniques such as overlaying images captured by multiple imaging devices. ~2m 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. . Data can be used to improve surgical procedures by determining whether further treatments can be performed, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics to tissue-specific sites and conditions. Results can be analyzed to improve. Such data analysis may further employ prognostic analysis processing, using a standardized approach to confirm surgical treatment and surgeon behavior or suggest modifications to surgical treatment and surgeon behavior. You can provide helpful feedback for any of them.

In one implementation, the operating room devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n to the network hub. Network hub 207, in one aspect, may be implemented as a local network broadcast device that functions on 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 data in the form of packets and sends them in half-duplex mode to the router. 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 via network hub 207 at a time. Network hub 207 has no routing table or intelligence as to where to send the information and broadcasts all network data across each connection and to remote server 213 (FIG. 9) on cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can be a security risk and cause bottlenecks.

In another implementation, operating room devices 2a-2m may be connected to network switch 209 via wired or wireless channels. Network switch 209 functions within the data link layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a to 2m located in the same operating room to a network. Network switch 209 sends data in the form of frames to network router 211 and functions in full duplex mode. Multiple devices 2a-2m can transmit data simultaneously via 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. The network router 211 sends data packets received from the network hub 207 and/or network switch 211 to the cloud for further processing and manipulation of the data collected by any one or all of the devices 1a-1n/2a-2m. Create a route to send to a base computer resource. Network router 211 is used to connect two or more different networks located at different locations, such as, for example, different networks located in different operating rooms of the same medical facility or different operating rooms of different medical facilities. Good too. Network router 211 sends data in the form of packets to cloud 204 and functions in full duplex mode. Multiple devices can transmit data at the same time. Network router 211 uses 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 extend a single USB port into several tiers so that more ports are available for connecting the device to a host system computer. Network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short range high bandwidth wireless communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located within the operating room.

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

The modular communication hub 203 can serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handles a data type known as a frame. The frames carry data generated by devices 1a-1n/2a-2m. Once the frame is received by modular communication hub 203, the frame is amplified and sent to network router 211, which can transmit the frame to network router 211 using any of the numerous wireless or wired communication standards or protocols described herein. Transfer this data to cloud computing resources.

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

FIG. 9 shows a computer-implemented interactive surgical system 200. Computer-implemented interactive surgical system 200 is similar to computer-implemented interactive surgical system 100 in many respects. For example, computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar to surgical system 102 in many respects. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204 that may include remote servers 213. In one aspect, computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to a plurality of operating room equipment, such as, for example, intelligent surgical instruments, robots, and other computerized equipment located within the operating room. . As shown in FIG. 10, modular control tower 236 includes modular communication hub 203 coupled to computer system 210. As shown in FIG. As illustrated in the embodiment of FIG. 9, the modular control tower 236 includes an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke evacuation module 226, a suction/irrigation Coupled to module 228 , communication module 230 , processor module 232 , storage array 234 , smart device/appliance 235 optionally coupled to display 237 , and contactless sensor module 242 . Operating room equipment is coupled to cloud computing resources and data storage via a modular control tower 236. Robot hub 222 may also be connected to a modular control tower 236 and cloud computing resources. Among others, devices/appliances 235, visualization system 208 may be coupled to modular control tower 236 via wired or wireless communication standards or protocols described herein. Modular control tower 236 is coupled to surgical 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. Good too. The surgical 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 with multiple modules coupled to modular control tower 236. FIG. Modular control tower 236 includes a modular communication hub 203, such as a network connection device, and a computer system 210, for example, to provide local processing, visualization, and imaging. As shown in FIG. 10, the modular communications hubs 203 are connected in a layered configuration to expand the number of modules (e.g., devices) that can be connected to the modular communications hubs 203 to transmit data associated with the modules. The information may 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 connectivity to cloud computing resources and local display 217. Communication to cloud 204 can occur via either wired or wireless communication channels.

Surgical hub 206 uses non-contact sensor modules 242 to measure dimensions of the operating room and generates a map of the surgical site using either ultrasound or laser-type non-contact measurement devices. ``Surgical Hub Spatial Awareness With an Operat'' in U.S. Provisional Patent Application No. 62/611,341, filed December 28, 2017, entitled ``INTERACTIVE SURGICAL PLATFORM'', which is incorporated herein by reference in its entirety. ing Room” The ultrasound-based non-contact sensor module scans the operating room by transmitting bursts of ultrasound waves and receiving echoes when the bursts of ultrasound reflect off the exterior walls of the operating room, as described in section where the sensor module is configured to determine the size of the operating room and adjust the distance limit for Bluetooth pairing. A laser-based non-contact sensor module, for example, transmits laser light pulses, receives laser light pulses that reflect off the exterior walls of an operating room, and compares the phase of the transmitted pulses with the received pulses to determine the location of the operating room. Scan the operating room by determining size and adjusting Bluetooth pairing distance limits.

Computer system 210 includes a processor 244 and a 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. System buses include 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 bus including, but not limited to, USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association Bus (PCMCIA), Small Computer System 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 bus or external bus, and/or a local bus, using a variety of bus architectures.

Processor 244 may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex from Texas Instruments. In one aspect, the processor includes on-chip memory, e.g., 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, details of which are available in the product data sheet, to improve performance above 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 LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including a converter (ADC).

In one aspect, processor 244 may include a safety controller that includes two controller family families, such as the TMS570 and RM4x, also known by the Hercules ARM Cortex R4 trade names from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety limit applications, among other things, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

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

Computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage can be defined as a storage medium, independently or in the form of a compact disk ROM device (CD-ROM), a compact disk recordable drive (CD-R drive), a compact disk rewritable drive (CD-RW drive), or in combination with other storage media, including, but not limited to, optical disk drives such as digital versatile disk ROM drives (DVD-ROMs). 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 underlying 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 resources of a computer system. 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 understood that the various components described herein can be implemented with various operating systems or combinations of operating systems.

A user enters commands or information into computer system 210 through input device(s) coupled to I/O interface 251 . Input devices include 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 and other input devices connect to the processor through the system bus through interface port(s). Interface port(s) include, for example, serial ports, parallel ports, game ports, and USB. The output device(s) use some of the same types of ports as the input device(s). Thus, for example, a USB port may be used to provide input to a computer system and output information from the computer system to an output device. Output adapters are provided to indicate that there are several 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 connection between an output device and a 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 a personal computer, server, router, network PC, workstation, microprocessor-based device, peer device, or other common network node, and typically includes a computer Contains many or all of the elements described with respect to the system. For simplicity, only the memory storage device is shown along with the remote computer(s). The remote computer(s) are logically connected to the computer system via a network interface and then physically connected via a communication connection. Network interfaces encompass communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber optic distributed data interface (FDDI), copper wire distributed data interface (CDDI), Ethernet/IEEE802.3, Token Ring/IEEE802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Network (ISDN) and its variants, 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 for processing. Image processors can use parallel computing using single instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) techniques to increase speed and efficiency. Digital image processing engines can perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

Communication connection(s) refers to the hardware/software used to connect the network interface to the bus. Although the communication connections are shown internal to the computer system for clarity of illustration, the communication connections may be external to the computer system 210. For illustrative purposes only, the hardware/software required to connect to a 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. Can be 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 Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308, compliant with 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 and 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 transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transmit and receive ports 304, 306, 308 support both the highest speed and lower speed devices by automatically setting the slew rate depending on the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered or self-powered mode and includes surgical hub power logic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310 (SIE). SIE 310 is the front end for 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, SOP, EOP, RESET, and RESUME signal detection/generation, 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-to-parallel/parallel-to-serial conversion may be mentioned. The SIE 310 receives a clock input 314 and provides suspend/resume logic as well as to control communication between the upstream USB transceiver port 302 and the downstream USB transceiver port 304, 306, 308 via port logic 320, 322, 324. It is coupled to a frame timer 316 circuit and a surgical hub repeater circuit 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, USB network hub 300 can connect up to 127 functions organized in six logical layers to a single computer. Additionally, the USB network hub 300 can be connected 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. The USB network hub 300 has four types of power management: bus-powered hubs with either individual port power management or ganged port power management, and self-powered hubs with either individual port power management or ganged port power management. may be configured to support two modes. In one aspect, using a USB cable, a USB network hub 300, the upstream USB transceiver port 302 is plugged into a USB host controller and the downstream USB transceiver ports 304, 306, 308 connect USB compatible devices. In other words, they are exposed for the sake of others.

FIG. 12 depicts a logic diagram of a surgical instrument or tool control system 470 in accordance with one or more aspects of the present disclosure. System 470 includes control circuitry. The control circuit includes a microcontroller 461 with a processor 462 and a 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 operably couples the longitudinally movable displacement member to drive the I-beam knife element. Tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to a processor 462 that may be programmed or configured to determine the position of the longitudinally movable drive member, as well as the position of the firing member, firing bar, and I-beam knife element. Additional motors may be provided at the tool driver interface to control I-beam firing, closure tube movement, shaft rotation, and articulation. Display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on display 473 may be overlaid with images acquired via the endoscopic imaging module.

In one aspect, microcontroller 461 may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex from Texas Instruments. In one aspect, the main microcontroller 461 has on-chip memory, e.g., 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, the details of which are available in the product data sheet, improving performance above 40 MHz. 32 KB single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB 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 Hercules ARM Cortex R4 trade names from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety limit applications, among other things, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

Microcontroller 461 may be programmed to perform various functions, such as precision control over the speed and position of the knife and articulation system. In one aspect, microcontroller 461 includes a processor 462 and memory 468. Electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical connection to an articulation or knife system. In one aspect, motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system. A detailed description of absolute positioning systems is provided in U.S. Patent Application Publication No. 2, published October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety. 017/ No. 0296213.

Microcontroller 461 may be programmed to provide precise control over the speed and position of the displacement member and articulation system. Microcontroller 461 may be configured to calculate the response within microcontroller 461 software. The calculated response is compared to 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 suitable calibrated 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 a surgical instrument or tool firing system. In various forms, motor 482 may be a brushed DC drive motor having a maximum rotational speed of approximately 25,000 RPM, for example. In other configurations, motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. Motor driver 492 may include, for example, an H-bridge driver including a field effect transistor (FET). Motor 482 may be powered by a power supply assembly releasably mounted to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery that may include a number of 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 supply assembly may be replaceable and/or rechargeable. In at least one example, the battery cell may be a lithium ion battery that may be connectable to and separable from the power supply assembly.

Motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 motor 492 is a full bridge controller for use with external N-channel power metal oxide semiconductor field effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. Driver 492 includes an inherent charge pump regulator that provides full (>10V) gate drive to battery voltages up to 7V and allows the A3941 to operate with reduced gate drive down to 5.5V. do. A bootstrap capacitor may be used to provide the battery supply voltage required for the N-channel MOSFET. An internal charge pump for high-side drive allows DC (100% duty cycle) operation. A 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 both the high-side FET and the low-side FET. The power FET is protected from shoot-through by a register-adjustable dead time. Integrated diagnostics indicate low voltage, overtemperature, and power bridge abnormalities and can be configured to protect the power MOSFET under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system.

Tracking system 480 includes controlled motor drive circuitry that includes a position sensor 472 according to one aspect of the present disclosure. A position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for mating engagement with a corresponding drive gear of a 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 members represent firing bars or I-beams, 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, movable magnets, and a series of linear displacement sensors. a magnetic sensing system including a Hall effect sensor disposed, a fixed magnet and a Hall effect sensor disposed in a series of movable straight lines, a movable light source and a set of movable straight lines; The optical detection system may include a photodiode or photodetector, a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof. .

The electric motor 482 may include a rotary shaft operatively associated with a gear assembly mounted in mating engagement with a set of drive teeth or racks 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 a linear actuator by a rack and pinion mechanism or to a rotary actuator by a spur gear or other connection. A power supply can power the absolute positioning system and an output indicator can display an output of the absolute positioning system. The displacement member represents a longitudinally movable drive member with a rack of drive teeth formed thereon for mating 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 position sensor 472 corresponds to a 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 longitudinal straight line 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 rotations for a full stroke of the displacement member.

A series of switches (where n is an integer greater than 1) can be used alone or in combination with a gear reduction to provide unique position signals for more than one revolution 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 a unique location 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 rotation 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 include any number of magnetic sensing elements, such as, for example, magnetic sensors classified based on whether they measure the total field or vector components of the magnetic field. The technology used to produce both types of magnetic sensors involves many aspects of physics and electronics. Techniques used to sense magnetic fields include, inter alia, search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetic impedance. , magnetostrictive/piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magneto-optics, and microelectromechanical systems-based magnetic sensors.

In one aspect, position sensor 472 of tracking system with absolute positioning system 480 comprises a magnetic rotational absolute positioning system. Position sensor 472 may be implemented as an AS5055EQFT single chip magnetic rotary position sensor available from Austria Microsystems, AG. Position sensor 472 works with microcontroller 461 to provide an absolute positioning system. Position sensor 472 is a low voltage, low power component and includes four Hall effect elements in the area of position sensor 472 located above the magnet. Additionally, a high resolution ADC and smart power management controller are provided on-chip. The digit-by-digit method and Boulder method are used to implement concise and efficient algorithms for computing hyperbolic and trigonometric functions that require 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 with 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) include U.S. Pat. , 345,481, and 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. U.S. Patent filed June 20, 2017 entitled “TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT,” incorporated herein by reference. Described in Application No. 15/628,175 Sensor configurations such as objects may be mentioned. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. Absolute positioning systems use comparison and combination circuits to combine the calculated response with the measured response, using algorithms such as weighted averaging and theoretical control loops to drive the calculated response towards the measured response. can be provided. The calculated response of a physical system takes into account properties such as mass, inertia, viscous friction, induced drag, etc. in order to predict what the state and output of the physical system will be by knowing the inputs.

Absolute positioning systems reset the displacement member to a position, such as may be required with conventional rotary encoders, where the motor 482 simply counts the number of steps forward or backward it has taken to estimate the position of a device actuator, drive bar, knife, etc. Provides the absolute position of the displacement member upon power-up of the instrument without retracting or advancing (to zero or home).

A sensor 474, such as a strain gauge or microstrain gauge, may be indicative of one or more of the end effectors, such as the amplitude of strain exerted on the anvil during a clamping operation, which may, for example, indicate 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. Instead of or in addition to sensor 474, a sensor 476, such as a load sensor, can measure the closing force applied to the anvil by the closure 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 a surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sled, and the wedge-shaped sled is configured to cam the staple driver upwardly to force the staple into deforming contact with the anvil. The I-beam also includes sharp cutting edges 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 draw by motor 482. The force required to advance the firing member may correspond to the electrical current drawn by motor 482, for example. The measured force is converted to a digital signal and provided to processor 462.

In one form, strain gauge sensor 474 can be used to measure the force applied to 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 force applied to tissue grasped by an end effector includes, for example, a strain gauge sensor 474, such as a microstrain gauge configured to measure one or more parameters of the end effector. Equipped with. In one aspect, strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the end effector jaw member during a clamping operation, which can be indicative of tissue compression. The measured distortion is converted to a digital signal and provided to the processor 462 of the microcontroller 461. Load sensor 476 can measure the force used to manipulate 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 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 the force required to close the end effector on the tissue, as measured by sensors 474, 476, respectively, are determined based on the selected position of the firing member and/or or 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 during evaluation.

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

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

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

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

FIG. 16 shows a surgical instrument or tool with multiple motors that can be activated to perform various functions. In particular 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 to perform a second function. A fourth 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, closing, and/or articulating motions at the end effector. The firing motion, closing motion, and/or articulation motion can be transmitted to the end effector via the shaft assembly, for example.

In certain examples, a surgical instrument system or tool may include a firing motor 602. Firing motor 602 is operably coupled to a firing motor drive assembly 604 that can be configured to transmit firing motion generated by firing motor 602 to an end effector, specifically to displace the I-beam element. May be connected. In certain examples, the firing motion generated by firing motor 602 may, for example, deploy staples from a staple cartridge into tissue acquired by an end effector and/or advance a cutting edge of an I-beam element. , the captured tissue may be cut. The I-beam element may be retracted by reversing the direction of firing motor 602.

In certain examples, the surgical instrument or tool may include a closure motor 603. Closure motor 603 is configured to specifically displace the closure tube to close the anvil and transmit the closure motion generated by motor 603 to the end effector to compress tissue between the anvil and the staple cartridge. may be operably coupled with a closure motor drive assembly 605, which may be configured. The closing motion may, for example, transition the end effector from an open configuration to an approximation configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of motor 603.

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

As mentioned above, a surgical instrument or tool may include multiple motors that may be configured to perform a variety of independent functions. In certain instances, multiple motors of a surgical instrument or tool may be activated independently or separately to perform one or more functions while other motors remain stopped. It 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 stopped. Additionally, closure motor 603 may be activated simultaneously with firing motor 602 to advance the closure tube and I-beam element distally, as described in more 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, the 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 a 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 selectively switches from cooperating with one of the plurality of motors of the surgical instrument or tool to cooperating with another of the plurality of motors of the surgical instrument or tool. Can be switched.

In at least one example, common control module 610 selects between operative engagement with articulation motors 606a, 606b and operative engagement with either firing motor 602 or closure motor 603. can be switched. In at least one embodiment, as shown in FIG. 16, switch 614 can be moved or transitioned 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. The switch 614 may electrically couple the common control module 610 with the first articulation motor 606a, and in the third position 618a, the switch 614 may electrically couple the common control module 610 with the first articulation motor 606a, and in the fourth position 618a. At 618b, switch 614 may electrically couple common control module 610 with second articulation motor 606b. In particular examples, a separate common control module 610 may be electrically coupled to firing motor 602, closure 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 to measure the output torque on the motor's shaft. The force on the end effector may be sensed in any conventional manner, such as by a force sensor on the outside of the jaw or by a torque sensor on the motor actuating the jaw.

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

In certain examples, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In certain examples, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform multiple functions and/or calculations described herein. can. In particular examples, one or more of memory units 624 may be coupled to processor 622, for example.

In certain examples, power supply 628 may be used to power microcontroller 620, for example. In certain examples, power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power the surgical instrument 600. A number of battery cells connected in series may be used as the 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 driver 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 driver 626 to stop and/or disable motors coupled to common control module 610. The term "processor" as used herein refers to any suitable microprocessor, microcontroller, or computer central processing unit (CPU) that combines the functionality of one or up to several integrated circuits. It should be understood to include other basic computing devices integrated above. A processor is a versatile 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. Processors operate with numbers and symbols that are represented in a binary system.

In one example, processor 622 may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex from Texas Instruments. In a particular example, microcontroller 620 may be a LM 4F230H5QR available from Texas Instruments, for example. In at least one embodiment, Texas Instruments' LM4F230H5QR supports up to 40 MHz of 256 KB of single-cycle flash memory or other NVM on-chip memory, with performance exceeding 40 MHz, among other features readily available in the product data sheet. Prefetch buffer for improved performance, 32 KB single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, 12 An ARM Cortex-M4F processor core that includes one or more 12-bit ADCs with analog input channels. Other microcontrollers may be easily substituted for use with module 4410. Therefore, the present disclosure should not be limited to this context.

In certain examples, memory 624 may include program instructions for controlling each motor of surgical instrument 600 that is connectable to common control module 610. For example, memory 624 may include program instructions for controlling firing motor 602, closure motor 603, and articulation motors 606a, 606b. Such program instructions may cause processor 622 to control firing, closure, and articulation functions in accordance with input from a surgical instrument or tool algorithm or control program.

In certain 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 configuration. For example, sensor 630 can alert processor 622 to use program instructions related to firing, closing, and articulating the end effector. In certain examples, sensor 630 may include a position sensor that can be used to sense the position of switch 614, for example. Accordingly, processor 622 may use program instructions associated with firing an I-beam of an end effector upon detecting, for example, via sensor 630 that switch 614 is in first position 616; may use program instructions associated with closing the anvil upon detecting that switch 614 is in second position 617, e.g., via sensor 630; Upon detecting that the switch 614 is in the third position 618a or the fourth position 618b, program instructions associated with articulation of the end effector may be used.

FIG. 17 is a circuit diagram of a robotic surgical instrument 700 configured to manipulate the surgical tools described herein, according to one aspect of the present disclosure. Robotic surgical instrument 700 uses either single or multiple articulation drive connections to achieve distal/proximal translation of the displacement member, distal/proximal displacement of the obturator canal, 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 motor-driven firing member, a closure member, a shaft member, and/or one or more articulating members.

In one aspect, the robotic surgical instrument 700 connects, via a plurality of motors 704a-704e, the anvil 716 and I-beam 714 (including sharp cutting edges) portions of the end effector 702, the removable staple cartridge 718, the shaft 740, and a control circuit 710 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 704a-704e, 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, control circuit 710 includes one or more microcontrollers, microprocessors, or other suitable devices for executing instructions that cause the processor or processors to perform one or more tasks. It may also include a processor. In one aspect, the timer/counter 731 provides an output signal, such as an elapsed time or a digital count, to the control circuit 710 to correlate the position of the I-beam 714 as determined by the position sensor 734 with the output of the timer/counter 731; As a result, the control circuit 710 can determine the position of the I-beam 714 at a particular time (t) relative to the starting position or time (t) when the 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 functionality of end effector 702 based on one or more tissue conditions. Control circuit 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 closure control program based on tissue conditions. The firing control program can describe distal movement of the displacement member. Different fire control programs can be selected to better handle different tissue conditions. For example, if thicker tissue is present, control circuit 710 may be programmed to translate the displacement member at a slower speed and/or with less power. If thinner tissue is present, control circuit 710 may be programmed to translate the displacement member at higher speeds and/or with higher power. A closure control program may control the closure force applied to the tissue by anvil 716. Other control programs control the rotation of shaft 740 and articulation members 742a, 742b.

In one aspect, control circuit 710 may generate a motor set point signal. Motor setpoint signals may be provided to various motor controllers 708a-708e. Motor controllers 708a-708e include one or more circuits configured to provide motor drive signals to motors 704a-704e to drive motors 704a-704e, as described herein. It's okay. 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, the motors 704a-704e may be brushless DC electric motors, and each motor drive signal is a PWM signal provided to one or more stator windings of the motors 704a-704e. It may also include a signal. Also, in some embodiments, motor controllers 708a-708e may be omitted and 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 during a first open-loop portion of the displacement member stroke. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a 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 Examples include the sum of pulse widths of drive signals. After the open loop portion, control circuit 710 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during a closed-loop portion of a stroke, control circuit 710 modulates one of motors 704a-704e in a closed-loop manner based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. You may let them.

In one aspect, motors 704a-704e can receive power from energy source 712. Energy source 712 may be a DC power source powered by a mains AC power source, a battery, a supercapacitor, or any other suitable energy source. Motors 704a-704e are mechanically coupled to individual movable mechanical elements such as I-beam 714, anvil 716, shaft 740, articulation section 742a, and articulation section 742b via corresponding transmissions 706a-706e. may be done. Transmission devices 706a-706e may include one or more gears or other coupling components for coupling motors 704a-704e to a movable mechanical element. 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 examples, position sensor 734 may include an encoder configured to provide a series of pulses to control circuit 710 as I-beam 714 is translated 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 may provide other signals indicative of I-beam 714 movement. Also, in some embodiments, position sensor 734 may be omitted. If any of the motors 704a-704e are stepper motors, the control circuit 710 may track the position of the I-beam 714 by summing the number and direction of steps that the motors 704 are instructed to perform. can. Position sensor 734 may be located within end effector 702 or any other portion of the instrument. The output of each motor 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.

In one aspect, control circuit 710 is configured to drive a firing member, such as an I-beam 714 portion of end effector 702. Control circuit 710 provides motor settings to motor controller 708a, and motor controller 708a provides drive signals to motor 704a. The output shaft of motor 704a is coupled to torque sensor 744a. Torque sensor 744a is coupled to transmission 706a coupled to I-beam 714. Transmission device 706a includes movable mechanical elements, such as a rotational element and a firing member, 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 744a 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 to control circuitry 710 as a feedback signal. End effector 702 may include an additional sensor 738 configured to provide a feedback signal to control circuit 710. When ready for use, control circuit 710 can provide a firing 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 start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. be able to. As the firing member is translated distally, I-beam 714 with a cutting element positioned at the 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 an anvil 716 portion of end effector 702. Control circuit 710 provides motor settings to motor controller 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 coupled to anvil 716. Transmission device 706b includes movable mechanical elements such as a rotating element and a closing member to control movement of anvil 716 from open and closed positions. In one aspect, motor 704b is coupled to a closure gear assembly that includes a closure reduction gear set supported in meshing engagement with a closure spur gear. Torque sensor 744b provides a closing force feedback signal to control circuit 710. The closure force feedback signal represents the closure 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 within end effector 702 can provide a closure force feedback signal to control circuit 710. Pivotable anvil 716 is positioned on the opposite side of 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 704b advances the 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 settings to motor controller 708c, which provides drive signals to motor 704c. The output shaft of motor 704c is coupled to torque sensor 744c. Torque sensor 744c is coupled to transmission device 706c coupled to shaft 740. Transmission device 706c includes a movable mechanical element, such as a rotating element, to control clockwise or counterclockwise rotation of shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is formed on (or attached to) the proximal end of the proximal closure tube such that it is operably engaged by a rotating gear assembly operably supported on the tool mounting plate. attached) to a rotational transmission assembly including a tubular gear segment. Torque sensor 744c provides a torque feedback signal to control circuit 710. The rotational force feedback signal represents 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 circuitry 710.

In one aspect, control circuit 710 is configured to articulate end effector 702. Control circuit 710 provides motor settings to motor controller 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 device 706d coupled to articulation member 742a. Transmission device 706d includes a movable mechanical element, such as an articulation element for controlling the ±65° articulation of end effector 702. In one aspect, the motor 704d is coupled to an articulation nut rotatably pivoted on a proximal end portion of the distal spine portion and articulated on a proximal end portion of the distal spine portion. Rotatably driven by a motion gear assembly. Torque sensor 744d provides a joint force feedback signal to control circuit 710. The joint force feedback signal represents the joint force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.

In another aspect, the articulation feature of the robotic surgical system 700 may include two articulation members or connections 742a, 742b. These articulating members 742a, 742b are driven by separate disks on a robot interface (rack) driven by two motors 704d, 704e. A separate firing motor 704a is provided to provide resistive holding motion and load to the head when the head is not in motion, and to provide articulation motion when the head is articulating. Each of the articulation connections 742a, 742b may be driven competitively with respect to the other connection. Articulating 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 with other articulating joint drive systems.

In one aspect, the one or more motors 704a-704e may include a brushed DC motor with a gearbox and a mechanical connection to a firing member, closure member, or articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation connections, closure tubes, and shafts. External influences are unmeasured and unpredictable influences such as friction on tissues, surrounding bodies, and physical systems. Such an external influence may be 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 its desired behavior.

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

In one aspect, control circuit 710 may communicate with one or more sensors 738. A sensor 738 is positioned on the end effector 702 and is adapted to operate with the robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. It's okay. Sensor 738 may be one of a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or the end effector 702 or any other suitable sensor for measuring more than one parameter. Sensor 738 may include one or more sensors. A sensor 738 may be located on the deck of 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, control circuit 710 determines (1) the closure load experienced by the distal closure tube and its location, (2) the firing member in the rack and its location, (3) which portion of staple cartridge 718 has tissue thereon. and (4) can sense the load and position on both articulating rods.

In one aspect, one or more sensors 738 may include strain gauges, such as microstrain gauges, configured to measure the amount of strain in anvil 716 during the clamped condition. Strain gauges provide electrical signals whose amplitude varies with the magnitude of strain. Sensor 738 may include a pressure sensor configured to detect pressure generated 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 impedance may be determined by the thickness and/or fullness of tissue located therebetween. shows.

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 done. In other implementations, the sensor 738 may be implemented as a solid state switch that operates under the influence of light, such as a light 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 conductor-free 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 closure drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and anvil 716 to detect the closure force applied to the anvil 716 by the closure tube. The force exerted on anvil 716 may be representative of tissue compression experienced by a portion of tissue 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 closure forces applied to the anvil 716 by the closure drive system. One or more sensors 738 may be sampled in real time during clamping operations by a processor of control circuit 710. Control circuit 710 receives real-time sample measurements to provide and analyze time-based information and evaluates the closure force applied to anvil 716 in real-time.

In one aspect, current sensor 736 can be used to measure the current drawn by each of 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 the motors 704a-704e. The force is converted to a digital signal and provided to control circuit 710. Control circuit 710 may be configured to simulate the instrument's actual system response in the controller's software. The displacement member can be actuated to move the I-beam 714 within the end effector 702 at or near a target velocity. Robotic surgical instrument 700 may include a feedback controller, which may include any feedback controller, including, but not limited to, PID, state feedback, linear quadratic (LQR), and/or adaptive controllers. It may be any one of the following. Robotic surgical instrument 700 can include a power source for converting signals from a feedback controller into physical inputs such as, for example, case voltages, PWM voltages, frequency modulated voltages, currents, torques, and/or forces. . Further details are disclosed in U.S. Patent Application No. 15/636,829, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT," filed June 29, 2017, which is incorporated herein by reference in its entirety. has been done.

FIG. 18 depicts a block diagram of a surgical instrument 750 programmed to control distal translation of a displacement member, according to one aspect of the present disclosure. In one aspect, surgical instrument 750 is programmed to control distal translation of a displacement member, such as I-beam 764. Surgical instrument 750 includes an anvil 766, an I-beam 764 (including 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 an 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 may be determined by measuring the position of the longitudinally movable drive member using position sensor 784. Accordingly, in the following discussion, the position, displacement, and/or translation of I-beam 764 may be accomplished by position sensor 784 as described herein. Control circuit 760 may be programmed to control translation of a displacement member, such as I-beam 764. In some embodiments, control circuit 760 provides instructions for one or more microcontrollers, microprocessors, or processors to control a displacement member, e.g., I-beam 764, in the manner described. Other suitable processors may also 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 as determined by position sensor 784 with the output of timer/counter 781. , so that control circuit 760 may 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 set point signal 772 may be provided to motor controller 758. Motor controller 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 controller 758 may be omitted and control circuit 760 may directly generate motor drive signal 774.

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 device 756 may include one or more gears or other coupling components to couple motor 754 to I-beam 764. Position sensor 784 may sense the position of 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 is translated distally and proximally. Control circuit 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 may 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 that motor 754 is instructed to perform. Position sensor 784 may be located within end effector 752 or any other portion of the instrument.

Control circuit 760 may communicate with one or more sensors 788. A sensor 788 is positioned on the end effector 752 and is adapted to operate with the surgical instrument 750 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Good too. The sensor 788 may be a magnetic sensor, a magnetic field sensor, an inductive sensor such as a strain gauge, a pressure sensor, a force sensor, an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or one or more of the end effector 752. Any other suitable sensors for measuring parameters may also be included. Sensor 788 may include one or more sensors.

One or more sensors 788 may include strain gauges, such as microstrain gauges, configured to measure the amount of strain in anvil 766 during the clamped condition. Strain gauges provide electrical signals whose amplitude varies with the magnitude 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 impedance may be determined by the thickness and/or fullness of the tissue located therebetween. shows.

Sensor 788 may be configured to measure the force exerted on 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 anvil 766 to detect the closure force applied to the anvil 766 by the closure tube. The force exerted on anvil 766 may be representative of tissue compression experienced by a portion of tissue captured between anvil 766 and staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect closure forces 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. Control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluates the closure force applied to anvil 766 in real-time.

A current sensor 786 can be used to measure the current drawn by 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.

Control circuit 760 may be configured to simulate the instrument's actual system response in the controller's 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 can include a feedback controller, for example, any one of any feedback controllers including, but not limited to, PID, status feedback, LQR, and/or adaptive controllers. It may be one. Surgical instrument 750 can include a power source for converting signals from the feedback controller into physical inputs such as, for example, case voltages, PWM voltages, frequency modulated voltages, currents, torques, and/or forces.

The actual drive system for the surgical instrument 750 is a brushed DC motor with a gearbox and a mechanical connection to the articulation and/or knife system to drive the displacement member, cutting member, or I-beam 764. It is composed of Another example is an electric motor 754 that operates an exchangeable shaft assembly, such as a displacement member and an articulation driver. External influences are unmeasured and unpredictable influences such as friction on tissues, surrounding bodies, and physical systems. Such external influences may be referred to as disturbances acting against the electric motor 754. External influences, such as disturbances, can cause the behavior of a physical system to deviate from its desired behavior.

Various exemplary aspects are directed to a surgical instrument 750 that includes an end effector 752 having a motor-driven 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, when configured for use, a staple cartridge 768 positioned on the opposite side of anvil 766. A clinician may grasp tissue between anvil 766 and staple cartridge 768, as described herein. When instrument 750 is ready for use, the clinician can provide a firing signal, for example by pressing a trigger on 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 start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. It's okay. As the displacement member is translated distally, I-beam 764 with a cutting element positioned at the distal end can cut tissue between staple cartridge 768 and anvil 766.

In various embodiments, surgical instrument 750 includes control circuitry 760 programmed to control distal translation of a displacement member, such as, for example, I-beam 764, based on one or more tissue conditions. You may prepare. Control circuit 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 conditions. The firing control program can describe distal movement of the displacement member. Different fire control programs can be selected to better handle different tissue conditions. For example, if thicker tissue is present, control circuit 760 may be programmed to translate the displacement member at a slower speed and/or with less power. If thinner tissue is present, control circuit 760 may be programmed to translate the displacement member at higher speeds and/or with 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 displacement member stroke. Based on the response of instrument 750 during the open loop portion of the stroke, control circuit 760 may select a firing control program. The response of the instrument includes the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to motor 754 during the open-loop portion, and the sum of the pulse widths of the motor drive signals. etc. may be mentioned. After the open loop portion, control circuit 760 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 760 may modulate the motor 754 in a closed-loop manner based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. Further details may be found in U.S. patent application Ser. has been disclosed.

FIG. 19 is a schematic illustration of a surgical instrument 790 configured to control various functions in accordance with 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 may 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 phantom).

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, the sensor 638 may be a solid state switch that operates under the influence of light, such as a light 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 788 may include conductor-free 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 magnetic rotational absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotational position sensor available from Austria Microsystems, AG. Position sensor 784 may cooperate with control circuitry 760 to provide an absolute positioning system. The position is located above the magnet and is provided to implement a concise and efficient algorithm for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. It may include multiple Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and Boulder algorithm.

In one aspect, the I-beam 764 may be implemented as a knife member that includes a knife body operably supporting a tissue cutting blade thereon, an anvil-engaging tab or feature, and a passageway-engaging feature or foot. It may further contain. 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 described in TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INST, filed June 20, 2017, which is incorporated herein by reference in its entirety. Identical entitled ``RUMENT'' No. 15/628,175 in proprietorship.

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, a sensor arrangement, and a 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 may be determined by measuring the position of the longitudinally movable drive member using position sensor 784. Accordingly, in the following discussion, the position, displacement, and/or translation of I-beam 764 may be accomplished by position sensor 784 as described herein. As described herein, control circuit 760 may be programmed to control translation of a displacement member, such as I-beam 764. In some embodiments, control circuit 760 provides instructions for one or more microcontrollers, microprocessors, or processors to control a displacement member, e.g., I-beam 764, in the manner described. Other suitable processors may also 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 as determined by position sensor 784 with the output of timer/counter 781. , so that control circuit 760 may 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 set point signal 772 may be provided to motor controller 758. Motor controller 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 controller 758 may be omitted and control circuit 760 may directly generate motor drive signal 774.

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 device 756 may include one or more gears or other coupling components to couple motor 754 to I-beam 764. Position sensor 784 may sense the position of 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 is translated distally and proximally. Control circuit 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 may 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 perform. Position sensor 784 may be located within end effector 792 or any other portion of the instrument.

Control circuit 760 may communicate with one or more sensors 788. Sensor 788 may be positioned on end effector 792 and adapted to operate with surgical instrument 790 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. . Sensors 788 may include one or more of the following: 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 sensors for measuring parameters may also be included. Sensor 788 may include one or more sensors.

One or more sensors 788 may include strain gauges, such as microstrain gauges, configured to measure the amount of strain in anvil 766 during the clamped condition. Strain gauges provide electrical signals whose amplitude varies with the magnitude of strain. Sensor 788 may include a pressure sensor configured to detect pressure generated 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 impedance may be determined by the thickness and/or fullness of the tissue located therebetween. shows.

Sensor 788 may be configured to measure the force exerted on 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 anvil 766 to detect the closure force applied to the anvil 766 by the closure tube. The force exerted on anvil 766 may be representative of tissue compression experienced by a portion of tissue captured between anvil 766 and staple cartridge 768. One or more sensors 788 can be placed at various interaction points along the closure drive system to detect the closure force applied to the 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. Control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluates the closure force applied to anvil 766 in real-time.

A current sensor 786 can be used to measure the current drawn by 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.

An 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 circuit 760 controls the delivery of RF energy to RF cartridge 796.

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

FIG. 20 is a simplified block diagram of a generator 800 configured to provide inductorless tuning, among other advantages. Additional details of generator 800 may be found in U.S. Pat. Are listed. Generator 800 may include a patient isolation stage 802 in communication with a non-isolated stage 804 via a power transformer 806. The secondary winding 808 of the power transformer 806 is housed within the isolation stage 802 and is capable of carrying multiple energy sources, including, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and ultrasonic and RF energy modes that can be delivered singly or simultaneously. A tap configuration (e.g., a center tap or non-center tap configuration) may be included to define drive signal outputs 810a, 810b, 810c for delivering drive signals to various surgical instruments, such as functional surgical instruments. good. Specifically, drive signal output portions 810a, 810c may output an ultrasonic drive signal (e.g., a 420V root mean square (RMS) drive signal) to an ultrasonic surgical instrument, and drive signal output portion 810b , 810c may output an RF electrosurgical drive signal (eg, a 100V RMS drive signal) to the RF electrosurgical instrument with a drive signal output 810b corresponding to the center tap of power transformer 806.

In certain forms, the ultrasound and electrosurgical drive signals are applied to separate surgical instruments and/or to a multifunctional surgical instrument that has the ability to deliver both ultrasound energy and electrosurgical energy to tissue. may be provided simultaneously on a single surgical instrument such as. The electrosurgical signal provided to either a dedicated electrosurgical instrument and/or a combined multifunctional ultrasound/electrosurgical instrument may be either a therapeutic or subtherapeutic level signal; It will be appreciated that the sub-quantitative signal may be used, for example, to monitor tissue or instrument status and provide feedback to the generator. For example, ultrasound and RF signals may be delivered separately or simultaneously from a generator with a single output port to provide a desired output signal to a surgical instrument, as discussed in more detail below. . Thus, the generator can combine ultrasound energy and electrosurgical RF energy to deliver combined energy to a multifunctional ultrasound/electrosurgical instrument. Bipolar electrodes can be placed on one or both jaws of the end effector. One jaw may be driven by ultrasound energy in addition to electrosurgical RF energy, working simultaneously. Ultrasonic energy may be used to dissect tissue and electrosurgical RF energy may be used for vessel sealing.

Non-isolated stage 804 may include a power amplifier 812 having an output connected to a primary winding 814 of power transformer 806. In certain forms, power amplifier 812 may include a push-pull amplifier. For example, the non-isolated stage 804 may further include a logic device 816 for providing a digital output to a digital-to-analog converter (DAC) circuit 818, which then provides a corresponding An analog signal is provided to the input of power amplifier 812. In certain forms, logic device 816 may include, for example, a programmable gate array (PGA), a field programmable gate array (FPGA), a programmable logic device (PLD), among other logic circuits. Accordingly, by controlling the input of power amplifier 812 via DAC circuit 818, logic device 816 determines many parameters (e.g., frequency, waveform, amplitude) can be controlled. In certain aspects, as described below, logic device 816 may implement a number of DSP-based and/or other control algorithms in conjunction with a processor (e.g., a DSP, as described below) to generate information by generator 800. The parameters of the output drive signal can be controlled.

Power may be provided to the power rail of power amplifier 812 by a switch mode regulator 820, such as a power conversion device. In certain forms, switch mode regulator 820 may include, for example, an adjustable buck regulator. The non-isolated stage 804 may further include a first processor 822, in one form, such as, for example, an Analog Devices ADSP-21469 SHARC DSP available from Analog Devices (Norwood, Mass.). Any suitable processor may be used in various forms, although a DSP processor may be included. In certain forms, DSP processor 822 may control operation of switch-mode regulator 820 in response to voltage feedback data that DSP processor 822 receives from power amplifier 812 via ADC circuit 824 . In one form, for example, DSP processor 822 may receive as input the waveform envelope of the signal (eg, RF signal) amplified by power amplifier 812 via ADC circuit 824 . DSP processor 822 may then control switch-mode regulator 820 (eg, a PWM output) such that the rail voltage provided to power amplifier 812 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of power amplifier 812 based on the waveform envelope, the efficiency of power amplifier 812 may be significantly improved relative to fixed rail voltage amplifier schemes.

In certain forms, logic device 816, along with DSP processor 822, implements digital synthesis circuitry, such as a direct digital synthesizer control scheme, to control the waveform shape, frequency, and/or amplitude of the drive signal output by generator 800. You may. In one form, for example, logic 816 implements the DDS control algorithm by invoking waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT that may be embedded within an FPGA. May be implemented. This control algorithm is particularly useful in ultrasound applications where an ultrasound transducer, such as an ultrasound transducer, may be driven by a well-defined sinusoidal current at its resonant frequency. Since other frequencies may excite parasitic resonances, minimizing or reducing the total distortion of the operational branch currents may correspondingly minimize or reduce undesirable resonance effects. The waveform of the drive signal output by generator 800 is influenced by various distortion sources present within the output drive circuit (e.g., power transformer 806, power amplifier 812), so that voltage and current feedback based on the drive signal is required. The data may be input to an algorithm such as an error control algorithm implemented by DSP processor 822, which preferably processes waveform samples stored in a LUT on a dynamic, as-is-progress basis (e.g., real-time). Compensate for distortion by pre-distorting or modifying. In one form, the amount or degree of predistortion applied to the LUT samples may be based on the error between the calculated operating branch current and the desired current waveform, where the error is determined on a sample-by-sample basis. In this way, the pre-distorted LUT sample, when processed by the drive circuit, generates a working branch drive signal with the desired waveform shape (e.g. a sine wave) in order to optimally drive the ultrasound transducer. can occur. In such a form, the LUT waveform samples therefore do not represent the desired waveform of the drive signal, but are necessary to ultimately generate the desired waveform of the operational branch drive signal, when distortion effects are taken into account. represents a waveform.

The non-isolated stage 804 includes a first one coupled to the output of the power transformer 806 via corresponding isolation transformers 830, 832 to sample the voltage and current of the drive signal output by the generator 800, respectively. may further include an ADC circuit 826 and a second ADC circuit 828. In certain forms, the ADC circuits 826, 828 may be configured to sample at a high rate (eg, 80 megasamples per second (MSPS)) to enable oversampling of the drive signal. In one form, for example, the sampling rate of the ADC circuits 826, 828 may allow approximately 200x (by frequency) oversampling of the drive signal. In certain forms, the sampling operations of ADC circuits 826, 828 may be performed by a single ADC circuit that receives input voltage and current signals through a bidirectional multiplexer. The use of high-speed sampling in the form of generator 800 is useful for, among other things, the calculation of complex currents flowing through the operating branches (which may be used in certain forms to implement the DDS-based waveform shape control described above). ), may enable precise digital filtering of the sampled signal and calculation of real power consumption with high accuracy. Voltage and current feedback data output by ADC circuits 826, 828 may be received and processed by logic device 816 (e.g., first-come-first-served (FIFO) buffers, multiplexers, etc.) and subsequently processed by, e.g., DSP processor 822. may be stored in a data memory for reading. As described above, voltage and current feedback data may be used as input to an algorithm to predistort or modify LUT waveform samples on a dynamic and progressive basis. In a particular form, this is based on or otherwise related to the corresponding LUT samples output by logic device 816 when voltage and current feedback data pairs are obtained. voltage and current feedback data pairs may need to be indexed. Synchronization of LUT samples with voltage and current feedback data in this manner contributes to accurate timing and stability of the predistortion algorithm.

In certain forms, voltage and current feedback data may be used to control the frequency and/or amplitude (eg, current amplitude) of the drive signal. For example, in one form, voltage and current feedback data may be used to determine impedance phase. Subsequently, the frequency of the drive signal is controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase setpoint (e.g., 0°), thereby minimizing the effects of harmonic distortion. or reduced, and the accuracy of the impedance phase measurement can be correspondingly improved. Determination of phase impedance and frequency control signals may be implemented, for example, in DSP processor 822, with the frequency control signals provided as inputs to a DDS control algorithm implemented by logic unit 816.

In another form, for example, current feedback data may be monitored to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude setting may be specified directly or determined indirectly based on the specified voltage amplitude and power setting. In certain forms, control of current amplitude may be implemented by a control algorithm, such as a proportional-integral-derivative (PID) control algorithm within DSP processor 822, for example. Variables controlled by the control algorithm include, for example, scaling of LUT waveform samples stored in logic device 816 and/or DAC circuit 818 via DAC circuit 834 to suitably control the current amplitude of the drive signal. (which provides the input to power amplifier 812).

Non-isolated stage 804 may further include a second processor 836 to provide user interface (UI) functionality, among other things. In one form, UI processor 836 may include, for example, an Atmel AT91SAM9263 processor with an ARM 926EJ-S core, available from Atmel Corporation (San Jose, California). Examples of UI functions supported by the UI processor 836 include audible and visual user feedback, communication with peripheral devices (e.g., via a universal serial bus (USB) interface), communication with footswitches, and input. Communication with devices (eg, touch screen displays) as well as output devices (eg, speakers) may be included. UI processor 836 may communicate with DSP processor 822 and logic device 816 (eg, an SPI bus). Although UI processor 836 may primarily support UI functionality, in certain forms UI processor 836 may also cooperate with DSP processor 822 to provide risk mitigation. For example, the UI processor 836 may be programmed to monitor various aspects of user input and/or other input (e.g., touch screen input, footswitch input, temperature sensor input) and detect erroneous conditions. When detected, the drive output of generator 800 may be disabled.

In certain forms, both DSP processor 822 and UI processor 836 may determine and monitor the operational status of generator 800, for example. With respect to DSP processor 822, the operational state of generator 800 may represent, for example, which control and/or diagnostic processes are implemented by DSP processor 822. With respect to the UI processor 836, the operational state of the generator 800 may represent, for example, which elements of the UI (eg, display screen, sounds) are provided to the user. DSP processor 822 and UI processor 836 may each separately maintain the current operating state of generator 800 and recognize and evaluate possible transitions from the current operating state. DSP processor 822 may act as a master in this relationship and determine when transitions between operating states occur. UI processor 836 may recognize valid transitions between operating states and may verify that a particular transition is appropriate. For example, when DSP processor 822 commands UI processor 836 to transition to a particular state, UI processor 836 may verify that the requested transition is valid. If the required transition between states is determined to be invalid by UI processor 836, UI processor 836 may place generator 800 into a failure mode.

The non-isolated stage 804 may further include a controller 838 for monitoring input devices (e.g., a capacitive touch sensor, a capacitive touch screen used to turn the generator 800 on and off). . In certain forms, controller 838 may include at least one processor and/or other controller device in communication with UI processor 836. In one form, for example, controller 838 includes a processor (e.g., a Meg168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. ) may also be included. In one form, controller 838 may include a touch screen controller (eg, a QT5480 touch screen controller available from Atmel) to control and manage the acquisition of touch data from a capacitive touch screen.

In certain forms, when generator 800 is in a “power off” state, controller 838 continues to receive operating power (e.g., via a line from a power source of generator 800, such as power source 854, described below). It's okay. In this manner, controller 838 may continue to monitor an input device (eg, a capacitive touch sensor located on the front panel of generator 800) for turning generator 800 on and off. When generator 800 is in a powered off state, controller 838 may activate a power supply (e.g., one or two of power supplies 854) if activation of an "on/off" input device by the user is detected. enabling operation of one or more DC/DC voltage transformers 856). Accordingly, controller 838 may initiate a sequence to transition generator 800 to a "power on" state. Conversely, if activation of an "on/off" input device is detected while generator 800 is in a powered-on state, controller 838 initiates a sequence to transition generator 800 to a powered-off state. Good too. For example, in certain forms, controller 838 may report activation of an "on/off" input device to UI processor 836, which then Implement the required process sequence. In such a configuration, the controller 838 may not have an independent ability to remove power from the generator 800 after the power-on state of the generator 800 is established.

In certain forms, controller 838 may cause generator 800 to provide audible or other sensory feedback to alert the user that a power-on or power-off sequence has begun. Such warnings may be provided at the beginning of a power-on or power-off sequence and before the start of other processes associated with the sequence.

In certain forms, the isolation stage 802 can be used to separate control circuits of the surgical instrument (e.g., control circuitry including handpiece switches) and non-isolated stages, such as, for example, the logic device 816, the DSP processor 822, and/or the UI processor 836. Instrument interface circuitry 840 may be included to provide a communication interface between components of 804 . Instrument interface circuit 840 communicates with components of non-isolated stage 804 via a communication link that maintains a suitable degree of electrical isolation between isolated stage 802 and non-isolated stage 804, such as an IR-based communication link. can exchange information with. For example, a low dropout voltage regulator powered by an isolation transformer driven from non-isolated stage 804 can be used to power instrument interface circuit 840.

In one form, instrument interface circuit 840 may include logic circuit 842 (eg, logic circuit, programmable logic circuit, PGA, FPGA, PLD) in communication with signal conditioning circuit 844. Signal conditioning circuit 844 may be configured to receive a periodic signal (eg, a 2 kHz square wave) from logic device 842 to generate bipolar interrogation signals having the same frequency. The interrogation signal can be generated using, for example, a bipolar current source provided by a differential amplifier. The interrogation signal is communicated to the surgical instrument control circuit (e.g., using a conductive pair in a cable connecting the generator 800 to the surgical instrument) and monitored to determine the state or configuration of the control circuit. It's okay. The control circuit may include a number of switches, resistors, and/or diodes, and may include an interrogation signal such that the state or configuration of the control circuit is individually identifiable based on one or more characteristics. One or more characteristics (eg, amplitude, rectification) of the signal may be modified. For example, in one form, the signal conditioning circuit 844 may include an ADC circuit to generate a sample of the voltage signal appearing across the input of the control circuit resulting from the path taken by the interrogation signal. Logic circuit 842 (or a component of non-isolated stage 804) may then determine the state or configuration of the control circuit based on the ADC circuit samples.

In one form, the instrument interface circuit 840 includes a first data circuit interface (DCI) 846 and a logic circuit 842 (or other elements of the instrument interface circuit 840) disposed within the surgical instrument. or an otherwise associated first data circuit. In certain configurations, for example, the first data circuit is located within a cable integrally attached to the surgical instrument handpiece or within an adapter to interface a particular surgical instrument type or model with the generator 800. It may be placed in The first data circuit may be implemented in any suitable manner, e.g., in communication with the generator according to any suitable protocol, including those described herein with respect to the first data circuit. Good too. In certain forms, the first data circuit may include a non-volatile storage device, such as an EEPROM device. In certain forms, first data circuit interface 846 may be implemented separately from logic circuit 842 and include suitable circuitry (e.g., separate logic device, processor) to interface logic circuit 842 and first data circuit interface 846 . may enable communication between the data circuit and the data circuit. In other forms, first data circuit interface 846 may be integral to logic circuit 842.

In certain forms, the first data circuit may store information regarding a particular surgical instrument with which the first data circuit is associated. Such information may include, for example, a model number, serial number, number of operations in which the surgical instrument was used, and/or any other type of information. This information may be read by instrument interface circuitry 840 (e.g., by logic circuitry 842) and provided to a user via an output device and/or for control of functionality or operation of generator 800. It may be communicated to components of isolation stage 804 (eg, logic device 816, DSP processor 822, and/or UI processor 836). Additionally, any type of information may be communicated to the first data circuit (eg, using logic circuit 842) for internal storage via first data circuit interface 846. Such information may include, for example, the most recent number of surgeries in which the surgical instrument was used and/or the date and/or time of its use.

As mentioned above, surgical instruments may be removable from the handpiece to facilitate interchangeability and/or disposability of the instruments (e.g., multifunctional surgical instruments may be removable from the handpiece). could be). In such cases, conventional generators may have limited ability to recognize the particular instrument configuration being used and optimize control and diagnostic processes accordingly. However, adding readable data circuitry to surgical instruments to address this problem is problematic from a compatibility standpoint. For example, it may be impractical to design a surgical instrument to be backward compatible with a generator that lacks the necessary data reading functionality, e.g. due to different signaling schemes, design complexity and expense. be. The instrument configurations discussed herein are designed to economically use data circuitry that may be implemented on existing surgical instruments and maintain compatibility of surgical instruments with modern generator platforms. Address these concerns by minimizing changes.

Additionally, the configuration of generator 800 may enable communication with instrument-based data circuitry. For example, generator 800 may be configured to communicate with a second data circuit housed within an instrument (eg, a multifunction surgical instrument). In some forms, the second data circuit may be implemented much like that of the first data circuit described herein. Instrument interface circuit 840 may include a second data circuit interface 848 to enable this communication. In one form, second data circuit interface 848 may include a tri-state digital interface, although other interfaces may also be used. In certain forms, the second data circuit may be any circuit for transmitting and/or receiving data in general. In one form, for example, the second data circuit may store information regarding the particular surgical instrument with which the second data circuit is associated. Such information may include, for example, a model number, serial number, number of operations in which the surgical instrument was used, and/or any other type of information.

In some forms, the second data circuit may store information regarding electrical and/or ultrasound characteristics of an associated ultrasound transducer, end effector, or ultrasound drive system. For example, the first data circuit may exhibit a burn-in frequency slope as described herein. Additionally or alternatively, any type of information may be communicated to the second data circuit (e.g., using logic circuit 842) for internal storage via second data circuit interface 848. may be done. Such information may include, for example, the most recent number of operations in which the instrument was used, and/or the date and/or time of its use. In certain forms, the second data circuit may transmit data acquired by one or more sensors (eg, an instrument-based temperature sensor). In certain forms, the second data circuit may receive data from the generator 800 and provide an indicator (eg, a light emitting diode indicator or other visible indicator) to a user based on the received data.

In certain forms, the second data circuit and the second data circuit interface 848 provide that communication between the logic circuit 842 and the second data circuit includes additional conductors for this purpose (e.g., a hand piece). The generator 800 may be configured such that it can be provided without requiring the provision of a dedicated conductor (of a cable connecting the generator 800 to the generator 800). In one form, a one-wire bus communication scheme is implemented over existing cabling, e.g., one of the conductors used transmits an interrogation signal from signal conditioning circuit 844 to control circuitry within the handpiece. can be used to communicate information to and from a second data circuit. In this way, design changes or modifications to the surgical instrument that may otherwise be required are minimized or reduced. Furthermore, the presence of the second data circuit is "invisible" to generators that do not have the necessary data reading capabilities, since different types of communications carried out on a common physical channel can be separated in frequency bands. , thus allowing backward compatibility of surgical instruments.

In certain forms, isolation stage 802 may include at least one blocking capacitor 850-1 connected to drive signal output 810b to prevent DC current from passing through the patient. A single blocking capacitor may be required, for example, to comply with medical regulations or standards. Although failures in single capacitor designs are relatively rare, such failures can still have negative consequences. In one form, a second blocking capacitor 850-2 may be provided in series with blocking capacitor 850-1 such that current leakage from a point between blocking capacitors 850-1 and 850-2 is caused by leakage, e.g. It is monitored by an ADC circuit 852 to sample the voltage induced by the current. The samples may be received by logic circuit 842, for example. Generator 800 may determine, based on changes in leakage current (as indicated by the voltage samples), when at least one of blocking capacitors 850-1, 850-2 has failed, and may do so. This provides advantages over a single capacitor design with a single point of failure.

In certain forms, non-isolated stage 804 may include a power source 854 for delivering DC power at a suitable voltage and current. The power supply may include, for example, a 400W power supply to deliver a 48VDC system voltage. Power supply 854 includes one or more DC/DC voltage converters 856 for receiving the output of the power supply and producing DC output at the voltages and currents required by the various components of generator 800. It may further contain. As described above in connection with controller 838 , one or more of DC/DC voltage converters 856 are activated by controller 838 when activation of an "on/off" input device by a user is detected by controller 838 . Inputs may be received from 838 to enable operation or activation of DC/DC voltage converter 856.

FIG. 21 shows an example of a generator 900, which is one form of generator 800 (FIG. 20). Generator 900 is configured to deliver multiple energy modalities to a surgical instrument. Generator 900 provides RF and ultrasound signals, either alone or simultaneously, for delivering energy to a surgical instrument. The RF signal and ultrasound signal may be provided alone, in combination, or simultaneously. As mentioned above, at least one generator output can transmit multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave, among others) through a single port. These signals can be delivered to the end effector individually or simultaneously to treat tissue.

Generator 900 includes a processor 902 coupled to a waveform generator 904. Processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory coupled to processor 902 (not shown for clarity of disclosure). Digital information related to the waveform is provided to a waveform generator 904 that includes one or more DAC circuits to convert digital inputs to analog outputs. The analog output is provided to amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of amplifier 906 is coupled to power transformer 908. The signal is coupled across power transformer 908 to the secondary side on the patient isolation side. A first signal of a first energy modality is provided between terminals labeled ENERGY ₁ and RETURN of the surgical instrument. A second signal of a second energy modality is coupled across capacitor 910 and provided between terminals labeled ENERGY ₂ and RETURN of the surgical instrument. More than two energy modalities may be output, so the subscript "n" can be used to indicate that up to n ENERGYn terminals may be provided, where n is greater than one. It will be understood that it is a positive integer. It will also be appreciated that up to "n" return paths (RETURNn) may be provided without departing from the scope of this disclosure.

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

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

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

Further details may be found in TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INST, which is incorporated herein by reference in its entirety. U.S. Patent Application Publication No. 2017/0086914 published March 30, 2017 entitled “RUMENTS” Disclosed in the issue.

FIG. 22 illustrates a surgical instrument 29000 in accordance with at least one aspect of the present disclosure. In the embodiment shown in FIG. 22, the surgical instrument includes a handle 29002, a bendable shaft assembly 29004, an end effector 29006, a motor (not visible through the outer surface of the handle 29002), and a flexible circuit 29008. including. Although surgical instrument 29000 is shown in FIG. 22 as having a collapsible shaft assembly 29004, according to other aspects, surgical instrument 29000 has an articulating joint in place of a collapsible portion. It will be appreciated that a shaft assembly may be included.

FIG. 23 illustrates a shaft assembly 29005 of a surgical instrument 29000 in accordance with at least one other aspect of the present disclosure. As shown in FIG. 23, the shaft assembly 29005 includes an articulation joint 29010 and is coupled to an end effector 29006 that includes a first jaw 29012 and a second jaw 29014; At least one of the jaws 29014 is configured to pivot between an open position and a closed position to clamp tissue between the first jaw 29012 and the second jaw 29014. Although end effector 29006 is shown as including staple cartridge 29016, it will be appreciated that according to other aspects, end effector 29006 may include electrodes instead of or in addition to staple cartridge 29016.

FIG. 24 shows flexible circuit 29008 of surgical instrument 29000 of FIG. 22. FIG. Flexible circuit 2900 resides within handle 29002, shaft assembly 29004/29005, and end effector 29006, and includes processing unit 29018, logic element 29020, conductive traces 29022, and conductive pads 29024. Although only one processing unit 29018 and one logic element 29020 are shown in FIG. 23, it will be appreciated that the flexible circuit 29008 may include any number of processing units 29018 and/or logic elements 29020. . Conductive pads 29024 may be connected to other components of surgical instrument 29000 such as sensing devices, motors (see conductive pads A and B in FIG. 24), and slip rings (see conductive pads C and D in FIG. 24) as described above. Configured to connect to a component. Conductive traces 29022 carry signals from sensors, signals to and from processing unit 29018, signals to and from logic element 29020, signals to and from control circuitry, signals to motors, etc. Although not shown for simplicity, flexible circuit 29008 may also include a substrate, one or more insulating layers, and an overlay. Processing devices 29018, logic elements 29020, etc. may be mounted on the substrate, and conductive traces 29022 and conductive pads 29024 may be patterned on/across the substrate. One or more insulating layers electrically isolate the conductive traces from each other. The overlay covers the insulating layer and/or processing device 29018, logic elements 29020, conductive traces 29022, and conductive pads 29024. Flexible circuit 29008 may be single-sided, double-sided, or multilayered as shown in FIG. 24. Conductive traces 29022 and conductive pads 29024 may include copper, gold, tin, and/or other suitable conductive materials.

According to various aspects, to insulate the conductive traces 29022 from high frequency energy delivered by the surgical instrument 29000, the flexible circuit 29008 blocks high frequency electromagnetic radiation and/or connects the various conductive traces 29022 between the various conductive traces 29022. including electromagnetic shielding (e.g., guard traces or guard rings) to minimize signal crosstalk. Electromagnetic shielding does not need to be included throughout the flexible circuit 29008. For example, according to various aspects, electromagnetic shielding is positioned only at selected locations of the flexible circuit 29008 to prevent conductive traces from receiving undesirable effects or signals caused by external high frequency generators or magnets. 29022 can be protected. For simplicity, electromagnetic shielding is not shown in FIG. 24.

Flexible circuit 29008 includes both a rigid (resid) portion 29026 and a flexible (flex) portion 29028. Therefore, flexible circuit 29008 is sometimes referred to as a rigid-flex circuit. Rigid portion 29026 may be reinforced and configured not to buckle/bend to any significant degree. Rigid portion 29026 includes portions of conductive traces 29022 and also includes, for example, one or more processing devices 29018, one or more integrated circuits, one or two as shown in FIG. The above logic elements 29020 and/or conductive pads 29024 may be included. The actual positioning of devices such as non-chip gates and other logic elements 29020 enables low-level decision making (eg, distributed processing) local to the actuators of the surgical instrument 29000.

According to various aspects, the first rigid portion 29026 of the flexible circuit 29008 proximal to the articulating joint 29010 of the shaft assembly 29005 snaps into the recess 29032 defined by the first channel retainer 29034. A second rigid portion 29026 of the flexible circuit 29008 distal to the articulation joint 29010 of the shaft assembly 29005 includes an interlocking mechanism 29030 configured to be engaged (see FIG. 25). an interlocking mechanism configured to snap fit within a recess defined by a channel retainer of the channel retainer. The interlocking mechanism of the second rigid portion, the second channel retainer, and its recess are not shown in FIG. 24 for simplicity, except for the positioning (proximal vs. distal to the articulating joint). Also, the interlocking mechanism of the second rigid portion 29026 may be similar or identical to the interlocking mechanism 29030 of the first rigid portion 29026, and the second channel retainer may be similar to or identical to the interlocking mechanism 29030 of the first rigid portion 29034. It will be appreciated that the recesses of the second channel holder may be similar or identical to the recesses 29032 of the first channel holder 29034. The first and second channel retainers 29034 are fixed within the surgical instrument 29000 and do not move relative to the surgical instrument 29000. The snap-fit connection between rigid portion 29026 and channel retainer 29034 allows flexible circuit 29008 to be attached to surgical instrument 29000 when surgical instrument 29000 needs to be moved in various directions. and/or prevent the flexible circuit 29008 from "rolling out" of position when the flexible circuit 29008 is subjected to various forces.

Flexible portion 29028 is configured to flex and fold as desired. For example, in the case of a flexible portion 29028 aligned with an active bending portion of shaft assembly 20004 or an articulating portion of shaft assembly 29005 of surgical instrument 29000, flexible portion 29028 is also added to flexible portion 29028. It also needs to be bendable to prevent undesirable stress and/or failure of the flexible portion 29028. Similarly, if the flexible portion 29028 is required to be stepped across a mechanical component of the surgical instrument 29000 (e.g., an articulating rod of the surgical instrument), the flexible portion of the flexible circuit 29008 29028 makes this possible (see, eg, FIG. 23). When a force, twist, or deformation is applied to the flexible circuit 29008, the flexible portion 29028 allows the flexible circuit 29008 to flex more in one direction than the other, thereby damage to the flexible circuit 29008 due to

The flexible portion 29028 includes a portion of the conductive trace 29022 and may be stepped across one or more mechanical components, as described above, and/or to improve maneuverability, strength, and/or or folded in potentially high stress areas (e.g., within the active bending portion of shaft assembly 29004 as shown in FIG. 22 or within articulation joint 29010 of shaft assembly 29005) to increase resistance to failure. It can be done.

According to various aspects, the cross-section of each of the conductive traces 29022 may vary throughout the flexible circuit 29008 even though the conductive traces 29022 still have the same or substantially similar current carrying capacity. The height (h) or thickness of each of the conductive traces 29022 may be varied, and/or the width (w) of each of the conductive traces 29022 may also be varied. For example, for a given conductive trace 29022 that exists in both a rigid portion 29026 and a flexible portion 29028, the height (h) of the conductive trace 29022 may be greater in the rigid portion 29026 than in the flexible portion 29028. Often, the width (W) of conductive trace 29022 may be greater in flexible portion 29028 than in rigid portion 29026. The combination of lower height and greater width in flexible portion 29028 allows conductive trace 29022 to be more resistant to high stresses introduced by movements such as articulation and/or jaw closure movements. . The length L shown in FIG. 24 represents the length of the articulating portion of shaft assembly 29005 relative to conductive trace 29022 aligned with articulation joint 29010.

FIG. 26 illustrates a cross-sectional view of flexible circuit 29008 along line AA of FIG. 24, in accordance with at least one aspect of the present disclosure. The portion of flexible circuit 29008 along line AA is distal to the bending portion of shaft assembly 29004/articulating joint 29010 of shaft assembly 29005 and may be considered a rigid portion 29026. As shown in FIGS. 24 and 26, the flexible circuit 29008 is not separated along line AA, and the corresponding conductive traces 29022 in this portion of the flexible circuit 29008 have heights h _a and It has a width W _a .

FIG. 27 illustrates a cross-section of flexible circuit 29008 along line BB of FIG. 24, in accordance with at least one aspect of the present disclosure. The portion of flexible circuit 29008 along line BB is proximal to the bending portion of shaft assembly 29004/articulation joint 29010 of shaft assembly 29005 and may be considered flexible portion 29028. As shown in FIGS. 24 and 27, flexible circuit 29008 defines a separation or opening 29036 along line BB, and a corresponding conductive trace 29022 in this portion of flexible circuit 29008 , has a height h _b and a width W _b .

By comparing FIGS. 26 and 27, the height (h _a ) of the corresponding portion of conductive trace 29022 along line AA (the portion of conductive trace 29022 within rigid portion 29026) is equal to line B-B. (the portion of conductive trace 29022 within flexible portion 29028) is greater than the height (h _b ) of the corresponding portion of conductive trace 29022 along . Similarly, the width (W a ) of the portion of the corresponding conductive trace 29022 along the line AA (the portion of the conductive trace 29022 within the rigid portion 29026) is the width (W _a ) of the corresponding conductive trace 29022 along the line BB. It is also clear that the width (W b ) of the portion (the portion of the conductive trace 29022 within the flexible portion 29028) is smaller than the width (W _b ). In other words, as shown in FIG. 26, h _a > h _b and W _a < W _b .

In embodiments of the surgical instrument 29000 that include an articulation joint 29010 within the shaft assembly 29005, for the portion of the flexible circuit 29008 that passes through the articulation joint 29010 (the flexible portion 29028 of the flexible circuit 29008), a corresponding Portions of conductive trace 29022 are shorter/thinner and wider than corresponding portions of conductive trace 29022 in rigid portion 29026 distally adjacent to flexible portion 29028. The conductive traces 29022 of the flexible circuit 29008 in this region are They are made shorter/thinner and wider so that they can have the same current carrying capacity as those in the rigid portion 29026 while increasing their flexibility. In view of the above, the flexible portion 29028 of the flexible circuit 29008 may be aligned with the pivot axis of the articulation joint 29010 of the shaft assembly 29005 such that the flexible circuit 29008 and/or can be bent up to 90 degrees (or more) relative to the longitudinal axis 29038 of the surgical instrument 29000. Similar functionality may be realized for the portion of the flexible circuit 29008 that passes through the pivot joint of the end effector 29006 and/or the first and/or second jaws 29012, 29014 of the surgical instrument 29000. . As such, the flexible circuit 29008 has a variable cross-section that is aligned with the joints of the surgical instrument 29000 (e.g., the articulation joint 29010 of the shaft assembly 29005 and/or the pivot joint of the end effector 29006). elements (eg, conductive traces 29022).

As shown in FIG. 22, for the portion of flexible circuit 29008 that passes through the bendable portion of shaft assembly 29004 (or passes through articulation joint 29010 of shaft assembly 29005), flexible circuit 29008 Similar to the method shown in FIG. 22, each side of the separation or opening 29040 may be folded. The folding on each side of the separation or opening 29040 and the flexibility of the conductive trace 29022 allows a wider portion of the conductive trace 29022 of the flexible portion 29028 to be utilized within the articulation joint 29010 of the shaft assembly 29005 It allows us to fit within a restricted area.

According to various aspects, flexible circuit 29008 can include a torsion or strain relief portion 29042 incorporated into flexible circuit 29008. As shown in FIG. 22, according to various aspects, the torsion or strain relief portion 29042 includes a rigid portion 29026 that includes an interlock mechanism 29030 and a flexible portion 29028 that passes through an articulation joint 29010 of the shaft assembly 29005. can be positioned between. The torsion or strain relief portion 29042 initially attaches the flexible circuit 29008 to the first channel retainer 29034 (along a first plane along the length of the shaft assembly 29005 proximal to the articulating joint 29010). ) and then twisted about 90° relative to the first plane to allow articulation about an axis perpendicular to the first plane. Torsion or strain relief portion 29042 is configured to safely relieve strain imposed on flexible circuit 29008.

By incorporating both the rigid portion 29026 and the flexible portion 29028 into the flexible circuit 29008 of the surgical instrument 29000, the flexible circuit 29008 remains properly positioned within the surgical instrument 29000 and allows the 29000 or the articulation joint 29010 of the shaft assembly 29005. Such a combination provides a flexible circuit 29008 that is more resistant to failure than that typically associated with surgical instrument 29000.

FIG. 28 illustrates an exploded view of flexible electrode 29100 of surgical instrument 29000 of FIG. 22, in accordance with at least one aspect of the present disclosure. According to various aspects, the flexible electrode 29100 can be incorporated into, or at least electrically coupled to, the flexible circuit 29008 of FIG. 22. Although not shown for clarity, the flexible electrode 29100 may be coupled to an electrosurgical generator and may receive electrosurgical energy (RF level alternating current) provided by the electrosurgical generator. That will be understood.

The flexible electrode 29100 may be positioned on the first or second jaw 29012, 29014 of the end effector 29006 of the surgical instrument 29000 and includes a treatment electrode 29102 and a sensing electrode 29104. Treatment electrode 29102 and sensing electrode 29104 may include copper, gold, tin, or any other suitable material for conducting electricity.

Treatment electrode 29102 may have a rectangular shape and is configured to deliver RF energy to tissue positioned between first jaw 29012 and second jaw 29014 of surgical instrument 29000. According to various aspects, the treatment electrode 29102 can have a thickness in the range of about 0.003 inches.

Sensing electrode 29104 is configured to assist in determining one or more parameters associated with tissue positioned between first jaw 29012 and second jaw 29014 of surgical instrument 29000. has been done. For example, sensing electrode 29104 may be configured to help determine the impedance of tissue positioned between first jaw 29012 and second jaw 29014 of surgical instrument 29000. By sensing the amplitude, frequency, phase shift, etc. of the current passing through the tissue, the sensing electrode 29104 may pass the sensed "value" to the processing circuitry of the surgical instrument 29000, which in turn The impedance of tissue positioned between first jaw 29012 and second jaw 29014 of instrument 29000 may be determined. An example of such a sensing electrode may be found in the U.S. Pat. It is described in Patent No. 5,817,093. Sensing electrode 29104 may continuously sense even as RF energy is being delivered to the tissue by treatment electrode 29102 to weld the tissue. According to various aspects, the sensing electrode 29104 can have a thickness similar to or the same as the thickness of the treatment electrode 29102 (eg, within about 0.003 inches).

According to various aspects, sensing electrode 29104 may also be configured to help determine tissue contraction and/or temperature transition points within tissue. For example, by sensing the amplitude, frequency, phase shift, etc. of electrical current passing through tissue, the sensing electrode 29104 may pass the sensed "value" to the processing circuitry of the surgical instrument 29000, which then The sensed “value” may be utilized to determine electrical continuity of tissue positioned between first jaw 29012 and second jaw 29014 of surgical instrument 29000. The processing circuitry may then utilize the determined tissue electrical continuity to assist in determining tissue contraction. Sensing electrode 29104, when utilized in conjunction with treatment electrode 29102, detects proximity to a transition temperature point associated with tissue welding because sensing electrode 29104 is at a higher pressure than treatment electrode 29102. can be made possible. By utilizing the sensing capabilities of the sensing electrode 29104, the sensed "value" can be passed to the processing circuitry of the surgical instrument 29000, which then utilizes the sensed "value" to Impedance events can be identified before temperature transition/inflection points occur within the low pressure zone.

The sensing electrode 29104 may have a patterned shape that overlaps the treatment electrode 29102 and has the same overall length and width as the treatment electrode 29102, but does not completely cover the treatment electrode 29102 due to its patterned shape. As shown in FIG. 28, according to various aspects, the sensing electrode 29104 can be patterned as a modified “E-shape” having multiple rectangular fingers 29106. When the sensing electrode 29104 overlaps the treatment electrode 29102, the spaces 29108 between the modified E-shaped rectangular fingers 29106 of the sensing electrode 29104 are the portions of the treatment electrode 29102 that remain uncovered. It is aligned with. According to other aspects, the pattern shape of the sensing electrode 29104 can be a modified E-shape with multiple triangular fingers or other shaped fingers.

Flexible electrode 29100 also includes a first insulating layer 29110 positioned between treatment electrode 29102 and sensing electrode 29104. The first insulating layer 29110 can be patterned in the same manner as the sensing electrode 29104 (e.g., a modified E-shape with a plurality of rectangular fingers 29112) and is aligned with and aligned with the sensing electrode 29104. 29104 is electrically isolated from treatment electrode 29102. According to various aspects, the first insulating layer 29110 coincides with the sensing electrode 29104. According to various aspects, when the first insulating layer 29110 overlaps the treatment electrode 29102, the spaces 29114 between the plurality of rectangular fingers 29112 of the modified E-shaped first insulating layer 29110 are covered. It is aligned with the portion of the treatment electrode 29102 that remains empty and is aligned with the spaces 29108 between the rectangular fingers 29106 of the modified E-shaped sensing electrode 29104. According to other aspects, the rectangular fingers 29112 of the modified E-shaped first insulating layer 29110 are slightly smaller than the rectangular fingers 29106 of the modified E-shaped sensing electrode 29104. It may be wide (see FIGS. 29 and 30), such that space 29114 may be slightly narrower than space 29108. According to various embodiments, first insulating layer 29110 has a thickness ranging from about 0.001 inch to 0.0003 inch. First insulating layer 29110 may include any suitable non-conductive material and may have greater flexibility than either therapeutic electricity 29102 or sensing electrodes 29104.

Flexible electrode 29100 was also positioned to cover a surface of treatment electrode 29102 opposite a surface of treatment electrode 29102 that was partially covered by first insulating layer 29110 and sensing electrode 29104. A second insulating layer 29116 is included. The second insulating layer 29116 can have a rectangular shape with the same overall length and width as the treatment electrode 29102. According to various aspects, second insulating layer 29116 can have a thickness ranging from about 0.0001 inch to 0.003 inch. Second insulating layer 29116 may include any suitable non-conductive material and may have greater flexibility than either therapeutic electricity 29102 or sensing electrodes 29104.

Although only one flexible electrode 29100 is shown in FIG. 28 for clarity, the surgical instrument 29000 includes at least two of the flexible electrodes 29100 (e.g., It is understood that the effector 29006 may include one on the left side of the knife slot and one on the right side of the knife slot). Additionally, it will be appreciated that when flexible electrode 29100 includes multiple components and multiple layers, flexible electrode 29100 may be considered a flexible electrode assembly and/or a multilayer flexible electrode. .

29 and 30 illustrate top views of a flexible electrode assembly 29200 according to at least one aspect of the present disclosure. Flexible electrode assembly 29200 includes two of the flexible electrodes 29100 of FIG. The second one of the flexible electrodes 29100b is located on the right side of the knife slot 29202. With respect to the top views shown in FIGS. 29 and 30, sensing electrodes 29104a and 29104b are positioned over and partially cover treatment electrodes 29102a and 29102b.

The surfaces of corresponding sensing electrodes 29104a, 29104b that may be in direct contact with tissue positioned between first jaw 29012 and second jaw 29014 of surgical instrument 29000 are shown in dark color in FIG. 29. The dark surface in FIG. 29 can be considered the sensing electrode pattern. As mentioned above, sensing electrode 29104 can help determine the impedance of tissue positioned between first jaw 29012 and second jaw 29014 of surgical instrument 29000. Sensing electrode 29104, when utilized in conjunction with treatment electrode 29102, detects proximity to a transition temperature point associated with tissue welding because sensing electrode 29104 is at a higher pressure than treatment electrode 29102. can be made possible. By utilizing the measurement capabilities of sensing electrodes 29104, impedance events can be identified before inflection points occur in low pressure zones of the tissue. In addition, sensing electrodes 29014 may also allow measurement of tissue contraction if electrical continuity is measured by them. By using sensing electrode 29104 to measure continuity rather than impedance, the measured parameter may be indicative of tissue contraction rather than water expelled from the tissue. Additionally, sensing electrodes 29104 may be utilized to measure both tissue impedance and continuity. According to various aspects, sensing electrode 29104 may also be used as a conductive gap spacer to control the minimum gap between first jaw 29012 and second jaw 29014 of surgical instrument 29000.

Concave, discontinuous portions of the surfaces of the corresponding treatment electrodes 29102a, 29102b that may be in direct contact with tissue positioned between the jaws of the surgical instrument 29000 are shown in dark color in FIG. 30. The dark surface in FIG. 30 may be considered a therapeutic electrode pattern. Due to the concave segmented and discontinuous nature of the surfaces of the treatment electrodes 29102a, 29102b that may be in direct contact with tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. , the treatment electrode 29102 may reduce any undesirable tissue adhesion when the treatment electrode 29102 is energized. According to various aspects, a given concave discontinuous portion of the treatment electrode 29102 between two adjacent rectangular-shaped fingers 29106 of the sensing electrode 29104 is one of the rectangular-shaped fingers 29106. longitudinally by a range of about 0.005'' to 0.0008''. In other words, the surface area of a given concave discontinuous portion of the treatment electrode 29102 between two adjacent rectangular shaped fingers 29106 of the sensing electrode 29104 is may be larger than the surface area of one of them. According to various aspects, at least one of the concave segmented non-continuous portions of the surface of the treatment electrode 29102 can be positioned in an offset or opposing electrode configuration and coupled to a current return path. from which it can be connected to an electrosurgical generator.

In view of the above, flexible electrode assembly 29200 is a multi-level flexible electrode that can be used to control one or more parameters associated with surgical instrument 29000 and/or the first jaw of surgical instrument 29000. It will be appreciated that tissue positioned between 29012 and second jaw 29014 may be measured and tissue may be ablated.

FIG. 31 illustrates an exploded view of flexible electrode 29300 of surgical instrument 29000 of FIG. 22, in accordance with at least one other aspect of the present disclosure. The flexible electrode 29300 of FIG. 31 is similar to the flexible electrode 29100 of FIG. 28, except that the flexible electrode 29300 of FIG. It differs in that it further includes a third insulating layer 29302 positioned to partially cover the opposite surface of the sensing electrode 29104. The third insulation layer 29302 has the same overall length as the sensing electrode 29104, the first insulation layer 29110, and/or the treatment electrode 29102, but the third insulation layer 29302 has the same overall length as the sensing electrode 29104, the first insulation layer 29110, the treatment electrode 29102, and /or may have a rectangular shape with a width smaller than the width of the second insulating layer 29116. For example, according to various aspects, third insulating layer 29302 can have a width that covers all sensing electrodes 29104 except for rectangular shaped fingers 29106. According to other aspects, the third insulating layer 29302 may have a width that does not cover the rectangular shaped fingers 29106 and only partially covers the remaining portions of the sensing electrodes 29104. According to various aspects, third insulating layer 29302 can have a thickness ranging from about 0.0001 inch to 0.003 inch. Third insulating layer 29302 may include any suitable non-conductive material and may have greater flexibility than either therapeutic electricity 29102 or sensing electrodes 29104.

FIG. 32 illustrates an end view of flexible electrode 29400 of surgical instrument 29000 of FIG. 22, in accordance with at least one other aspect of the present disclosure. The flexible electrode 29400 of FIG. 32 is similar to, but different from, the flexible electrode of FIG. 31. In the flexible electrode 29400 of FIG. 32, the first insulating layer 29110 extends beyond the left and right sides of the sensing electrode 29104 (relative to FIG. 32), and the second insulating layer 29116 extends beyond the treatment electrode Extending beyond the left and right sides of 29102, third insulating layer 29302 extends beyond one of the sides of sensing electrode 29104. In addition, the flexible electrode 29400 of FIG. 32 also covers one of the sides of the treatment electrode 29102 and one of the sides of the sensing electrode 29102, and includes Includes an insulating material 29402 connecting layers 29110, 29116, 29302 together. The insulating material 29402 may be similar or the same as the material of the first, second, and/or third insulating layer 29110, 29116, 29302, and has a higher temperature than either the treatment electrode 29102 or the sensing electrode 29104. It can be flexible. Additionally, the flexible electrode 29400 of FIG. 32 has a laminated structure that allows multiple portions of the sensing electrode 29104 and/or the treatment electrode 29102 to contact tissue positioned between the jaws of the surgical instrument 29000. It can be a layered composite structure that includes portions of the sensing electrode 29104 and/or treatment electrode 29102 embedded within the structure.

FIG. 33 illustrates a top perspective view of flexible electrode 29500 of surgical instrument 29000 of FIG. 22, in accordance with at least one other aspect of the present disclosure. As shown in FIG. 33, flexible electrode 29500 further includes additional insulating material 29504 covering the side of sensing electrode 29104 that is opposite the side covered by insulating material 29402. The additional insulating material 29504 may be similar or the same as the material of the insulating material 29402 and the first, second, and/or third insulating layers 29110, 29116, 29302. The additional insulating material 29504 may have greater flexibility than either the treatment electrode 29102 or the sensing electrode 29104. As shown in FIG. 33, the long thin portion 29506 of the treatment electrode 29104 is uncovered and in direct contact with tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. It is possible. The limited surface area of the long, thin, uncovered portion 29506 of the treatment electrode 29104 may reduce any unwanted tissue adhesion. Similarly, the discontinuous portion of the treatment electrode 29102 that is not covered by the first insulating member 29110 and/or the sensing electrode 29104 also extends between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. may be in direct contact with tissue located therein, further reducing any undesirable tissue adhesion.

As mentioned above, one or more of the flexible electrodes 29100, 29200, 29300, 29400, 29500 may form part of the flexible circuit 29008 of the surgical instrument 29000. According to various aspects, the termination contact configuration may allow flexible circuit 29008 to be easily attached to or connected to other connections and/or circuits within surgical instrument 29000. The termination contact configuration may provide strain relief to the flexible circuit 29008, and the strain relief may reduce damage to portions of the flexible circuit 29008 adjacent the connection. The termination contact configuration may also maintain the connection watertight. According to various aspects, the termination contact configuration can be a zero insertion force (ZIF) connector that electrically connects the flexible circuit 29008 to other connections and/or circuits within the surgical instrument 29000. Such a ZIF connector may include a self-sealing connection to fluids and provide strain relief to the portion of the flexible circuit 29008 adjacent the ZIF connector.

By incorporating the treatment electrode 29102 and the sensing electrode 29104 into a flexible electrode, the flexible electrode transmits RF radiation to tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. While energy may be applied, parameters associated with the tissue and/or surgical instrument 29000 may also be measured. In the configuration described above, the sensing electrode 29104 may continuously sense the parameter even as the treatment electrode 29102 applies RF energy to the tissue to cause welding. In addition, due to the partial overlap of the "contact surface" of the treatment electrode 29102 by the sensing electrode 29104 and/or the first insulating layer 29110, the treatment electrode 29102 has less surface area in contact with tissue, which is desirable. Not likely to contribute to tissue adhesion. Furthermore, due to the inherent flexibility of flexible electrodes, the therapeutic electrode 29102 may be more likely to experience premature failure due to undesired bending or deformation than electrodes typically associated with surgical instruments. is low.

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

Example 1 - A flexible electrode for a surgical instrument is disclosed. The flexible electrode includes a radiofrequency energy source, a sensing electrode, and a therapeutic electrode connectable to the insulating layer. An insulating layer is positioned between the treatment electrode and the sensing electrode. The treatment electrode and the sensing electrode are configured to contact tissue positioned between the first and second jaws of the surgical instrument.

Example 2 - The flexible electrode of Example 1, wherein the therapeutic electrode comprises a rectangular shape.

Example 3 - A flexible electrode according to any one of Examples 1 and 2, wherein the sensing electrode overlaps the treatment electrode.

Example 4 - The flexible electrode of any one of Examples 1-3, wherein the sensing electrode includes a patterned shape that includes a rectangular portion and a plurality of fingers extending from the rectangular portion.

Example 5 - Sensing electrodes detect the impedance of tissue positioned between first and second jaws of a surgical instrument, electrical continuity of the tissue, and temperature transition points within the tissue. The flexible electrode according to any one of Examples 1-4, configured to assist in determining at least one of the following:

Example 6 - The flexible electrode of any one of Examples 1, 2, 4, and 5, wherein the insulating layer overlies the therapeutic sensing electrode.

Example 7 - The flexible electrode of any one of Examples 1-6, wherein the insulating layer includes a rectangular portion and a plurality of fingers extending from the rectangular portion.

Example 8 - A flexible electrode according to any one of Examples 1 to 7, wherein the insulating layer is coincident with the sensing electrode.

Example 9 - A flexible electrode according to any one of Examples 1-8, wherein the flexibility of the insulating layer exceeds the flexibility of the treatment electrode and the flexibility of the sensing electrode.

Example 10 - The method according to any one of Examples 1 to 9, further comprising a second insulative layer, and wherein the therapeutic layer is positioned between the insulating layer and the second insulative layer. Flexible electrode.

Example 11 - The flexible electrode of Example 10, further comprising a third insulating layer, and wherein the sensing electrode is positioned between the insulating layer and the third insulating layer.

Example 12 - A flexible electrode assembly for a surgical instrument is disclosed. a flexible electrode assembly associated with first and second treatment electrodes connectable to a source of radiofrequency energy and tissue positioned between first and second jaws of the surgical instrument; first and second sensing electrodes configured to assist in determining the parameter. A flexible electrode assembly includes a first insulating layer positioned between the first treatment electrode and the first sensing electrode, and a first insulation layer positioned between the second treatment electrode and the second sensing electrode. the first and second treatment electrodes and the first and second sensing electrodes are configured to contact tissue.

Example 13 - A first treatment electrode, a first sensing electrode, and a first insulating layer are positioned on a first side of a knife slot of a surgical instrument, and a second treatment electrode, a second The flexible electrode assembly of Example 12, wherein the sensing electrode and the first insulating layer are positioned on opposite sides of the knife slot.

Example 14 - First and second sensing electrodes detect the impedance of tissue, the electrical continuity of the tissue, and the 14. The flexible electrode assembly of any one of Examples 12 and 13, configured to assist in determining at least one of a temperature transition point.

Example 15 - Any one of Examples 12-14, wherein each of the first and second sensing electrodes includes a pattern shape that includes a rectangular portion and a plurality of fingers extending from the rectangular portion. The described flexible electrode assembly.

Example 16 - Any one of Examples 12-15, wherein each of the first and second insulating layers includes a pattern shape that includes a rectangular portion and a plurality of fingers extending from the rectangular portion. The described flexible electrode assembly.

Example 17 - The flexibility of the first and second insulating layers exceeds the flexibility of the first and second treatment electrodes and the flexibility of the first and second sensing electrodes. 17. The flexible electrode assembly of any one of Examples 12-16, wherein

Example 18 - Examples 12-17 wherein the first and second sensing electrodes form a conductive gap spacer configured to control the minimum gap between the first and second jaws. A flexible electrode assembly according to any one of .

Example 19 - A multi-level flexible electrode for a surgical instrument is disclosed. The multi-level flexible electrode includes first, second, and third insulating layers. The multi-level flexible electrode further includes a treatment electrode and a sensing electrode. A treatment electrode is positioned between the first insulating layer and the second insulating layer, and the treatment electrode is connectable to a radio frequency energy source. A sensing electrode is positioned between the second insulating layer and the third insulating layer, the sensing electrode being associated with tissue positioned between the first jaw and the second jaw of the surgical instrument. the treatment electrode and the sensing electrode are configured to contact the tissue.

Example 20 - Sensing electrodes detect the impedance of tissue, electrical continuity of the tissue, and temperature transition points within the tissue positioned between the first and second jaws of a surgical instrument. The multilevel electrode of Example 19, configured to assist in determining at least one of the following:

While several embodiments have been illustrated and described, it is not the intention of the applicant to limit or limit the scope of the appended claims to such details. Numerous modifications, variations, changes, permutations, combinations and equivalents of these forms may be implemented and will occur to those skilled in the art without departing from the scope of this disclosure. Furthermore, the structure of each element in connection with the described form may alternatively be described as a means for providing the functionality performed by that element. Also, although materials are disclosed for particular components, other materials may be used. It is therefore intended that the foregoing description and appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed forms. I want you to understand. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

The detailed description above has described various forms of apparatus and/or processes using block diagrams, flowcharts, and/or example embodiments. To the extent such block diagrams, flowcharts, and/or examples include one or more features and/or operations, each feature and/or operation included in such block diagrams, flowcharts, and/or examples Those skilled in the art will appreciate that the/or operations may be implemented individually and/or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will appreciate that all or a portion of some aspects of the forms disclosed herein can be implemented as one or more computer programs running on one or more computers (e.g., one as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g. (as one or more programs running on a microprocessor), as firmware, or on an integrated circuit as virtually any combination thereof; , and/or software and/or firmware code is within the skill of those skilled in the art in light of this disclosure. Additionally, those skilled in the art will appreciate that the features of the subject matter described herein can be distributed as one or more program products in a variety of formats; The specific forms of the subject matter described are employed without regard to the particular type of signal-bearing medium used to actually effectuate the distribution.

The instructions used to program the logic to perform the various disclosed aspects may be stored in memory within the system, such as 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 may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including floppy diskettes, optical disks, CD-ROMs, and magneto-optical disks. , ROM, RAM, EPROM, EEPROM, magnetic or optical card, flash memory, or via electrical, optical, acoustic, or other forms of propagating signals (e.g., carrier waves, IR signals, digital signals, etc.) It is not limited to tangible machine-readable storage used for transmitting information over the Internet. Thus, non-transitory computer-readable media includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).

As used throughout this description, the term "wireless" and its derivatives describe any circuit, device, system, method, technique, communication channel, etc. that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. may be used for This term does not imply that the associated equipment does not include any wires, although in some aspects they may not be present. Communication modules include Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, LTE, Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, of numerous wireless or wired communications standards or protocols, including but not limited to Bluetooth, their Ethernet derivatives, as well as any other wireless and wired protocols designated as 3G, 4G, 5G, and beyond. You may implement any of them. A computing module may include multiple communication modules. For example, the first communication module may be dedicated to short-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to short-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to short-range wireless communications such as It may also be used exclusively for long-distance wireless communications.

As used in any aspect herein, the term "control circuit" refers to, for example, hard-wired circuits, programmable circuits (e.g., computer processors containing one or more individual instruction processing cores, processing units, , a processor, a microcontroller, a microcontroller unit, a controller, a DSP, a PLD, a programmable logic array (PLA), or an FPGA), a state machine circuit, firmware that stores instructions to be executed by a programmable circuit, and any combination thereof. can point. Control circuits may be used, collectively or individually, in, for example, integrated circuits (ICs), application specific integrated circuits (ASICs), systems on chips (SoCs), desktop computers, laptop computers, tablet computers, servers, smartphones, etc. , may be implemented as a circuit that forms part of a larger system. Accordingly, as used herein, "control circuit" refers to an electrical circuit having at least one individual 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 at least partially executes a process and/or device described herein, or a process described herein) and/or electrical circuits forming memory devices (e.g. in the form of random access memory), and/or communication devices (e.g. Examples include, but are not limited to, electrical circuits forming a modem, communications switch, or opto-electrical equipment. Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form or some combination thereof.

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

As used herein, an SoC or system on a chip (SOC) is an IC that integrates all the components of a computer or other electronic system. This can include digital, analog, mixed signal, and often high frequency functionality, all on a single substrate. SoCs integrate microcontrollers (or microprocessors) with modern peripherals such as graphics processing units (GPUs), Wi-Fi modules, or coprocessors. The SoC may or may not include built-in memory.

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

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

Any processor or microcontroller described herein may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex from Texas Instruments. In one aspect, the processor includes, for example, 256 KB of single cycle flash memory or other NVM up to 40 MHz, the details of which are available in the product data sheet, a prefetch buffer to improve performance above 40 MHz, 32 KB of single Has cycle SRAM, internal ROM with StellarisWare® software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI analog, or 12 analog input channels It may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments that includes one or more 12-bit ADCs.

In one aspect, the processor may include a safety controller that includes two controller family families, such as TMS570 and RM4x, also known by the Hercules ARM Cortex R4 trade names from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety limit applications, among other things, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options. good.

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

As used in any aspect herein, the terms "component," "system," "module," etc. refer to either hardware, a combination of hardware and software, software, or running software. Can refer to some computer-related entity.

As used in any aspect herein, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result; a "step" may include, but does not require, storage, transfer, combination, Refers to the manipulation of physical quantities and/or logical states, which can take the form of electrical or magnetic signals, which can be compared and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities or are simply convenient labels applied to these quantities and/or conditions.

The network may include a packet switched network. The communication devices can communicate with each other using a selected packet-switched network communication protocol. One example communication protocol may include the Ethernet communication protocol, which may enable communication using Transmission Control Protocol/Internet Protocol (TCP/IP). The Ethernet protocol conforms to the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) under the title "IEEE 802.3 Standard," published December 2008, and/or any later version of this standard, or Can be compatible. Alternatively or additionally, the communication device is configured to support X. can communicate with each other using the X.25 communication protocol. X. The T.25 communication protocols 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 may communicate with each other using a frame relay communication protocol. The Frame Relay communication protocol is a protocol developed by the Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute (AN SI) or may be compatible with the standards promulgated by SI. Alternatively or additionally, the transceivers may be capable of communicating with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communications protocol shall comply with or be compatible with the ATM standard published by the ATM Forum in August 2001 under the title "ATM-MPLS Network Interworking 2.0" and/or with later versions of this standard. obtain. Of course, different and/or later developed connection-oriented network communication protocols are equally contemplated herein.

Unless explicitly stated otherwise, it is clear from the foregoing disclosure that throughout the foregoing disclosure, terms such as "process", "calculate", "calculate", "determine", "display", etc. Discussion of the use of the term refers to data that is represented as a physical (electronic) quantity in the registers and memory of a computer system, and It will be understood to refer to the operations and processes of a computer system or similar electronic computing device that manipulate and convert other data into similarly represented data.

One or more components are herein defined as "configured to," "configurable to," "operable/as such." "operable/operative to", "adapted/adaptable", "able to", "conformable/conformed" may be referred to as "to)". Those skilled in the art will understand that "configured to" generally refers to components in an active state and/or components in an inactive state and/or components in a standby state, unless the context requires otherwise. It will be understood that elements can be included.

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 part closest to the clinician, and the term "distal" refers to the part located away from the clinician. For convenience and clarity, spatial terms such as "vertical," "horizontal," "above," "below," "left," and "right" may be used herein with reference to the drawings. will be better understood. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.

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

Those skilled in the art will generally understand that the terms used herein, and particularly in the appended claims (e.g., the text of the appended claims), are generally intended as "open" terms. (For example, the term "including" should be interpreted as "including but not limited to," and the term "having" should 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.). Further, if a specific number is intended in an introduced claim recitation, such intent will be clearly stated in the claim, and if no such statement is made, no such intent exists. will be understood by those skilled in the art. For example, as an aid to understanding, the following appended claims incorporate the introductory phrases "at least one" and "one or more" into claim statements. may be included in order to However, the use of such phrases does not apply when the claim is introduced by the indefinite article "a" or "an," even if the introductory phrase "one or more" or "at least one" appears within the same claim. and the indefinite articles "a" or "an," any particular claim containing such an introduced claim statement is limited to a claim containing only one such statement. (e.g., "a" and/or "an" should generally be construed to mean "at least one" or "one or more") ). The same applies when introducing claim statements using definite articles.

Furthermore, even if a particular number is specified in an introduced claim statement, such statement is typically to be construed to mean at least the recited number. , as will be recognized by those skilled in the art (e.g., a mere statement of "two entries" without any other modifiers generally means at least two entries, or two or more entries). (meaning a matter). Further, when a notation similar to "at least one of A, B, and C, etc." is used, such construction is generally intended in the sense that a person 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 and/or all of A, B, and C, etc.). When a notation similar to "at least one of A, B, or C, etc." is used, such construction is generally intended in the sense that a person 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, B, and C, etc.). Further, typically any disjunctive words and/or phrases expressing two or more alternative terms are used in the specification unless the context requires otherwise. It is understood that the possibility is intended to include one, either, or both of these terms, whether in the claims or in the drawings. Those skilled in the art will understand that this should be the case. For example, the phrase "A or B" will typically be understood to include the possibilities "A" or "B" or "A and B."

With reference to the appended claims, those skilled in the art will appreciate that the acts recited herein may generally be performed in any order. Additionally, while flow diagrams of various operations are shown in sequence(s), it is understood that the various operations may be performed in an order other than that illustrated, or may be performed simultaneously. It should be. Examples of such alternative orderings include overlapping, interleaving, interpolating, reordering, incremental, preliminary, additional, simultaneous, reverse, or other different orderings, unless the context requires otherwise. May include. Additionally, terms such as "responsive to," "relating to," or other past tense adjectives generally exclude such variations unless the context requires otherwise. It's not intended.

Any reference to "an aspect," "an aspect," "an example," "an example," etc. refers to the fact that the particular feature, structure, or characteristic described in connection with that aspect is included in at least one aspect. The meaning of this is worth noting. Thus, the phrases "in one aspect," "in an aspect," "in an example," and "in one example" appearing in various places throughout this specification do not necessarily all refer to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or other disclosure material referenced herein and/or listed in any application data sheet is incorporated by reference herein to the extent that the incorporated material is not inconsistent with this specification. , incorporated herein by reference. As such, and to the extent necessary, disclosure expressly set forth herein shall supersede any conflicting disclosure herein incorporated by reference. Any content, or portion thereof, that is inconsistent with current definitions, views, or other disclosures set forth herein shall be incorporated herein by reference, but the references and current disclosures shall be incorporated herein by reference. shall be referred to only to the extent that there is no conflict between them.

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

[Mode of implementation]
(1) A flexible electrode for a surgical instrument, the flexible electrode comprising:
a therapeutic electrode connectable to a radiofrequency energy source;
a sensing electrode;
an insulating layer positioned between the treatment electrode and the sensing electrode, the treatment electrode and the sensing electrode being positioned between a first jaw and a second jaw of the surgical instrument. A flexible electrode configured to contact positioned tissue.
(2) The flexible electrode according to embodiment 1, wherein the treatment electrode includes a rectangular shape.
(3) The flexible electrode of embodiment 1, wherein the sensing electrode overlaps the treatment electrode.
(4) The flexible electrode of embodiment 1, wherein the sensing electrode includes a pattern shape that includes a rectangular portion and a plurality of fingers extending from the rectangular portion.
(5) The sensing electrode is
an impedance of the tissue positioned between the first and second jaws of the surgical instrument;
electrical continuity of the tissue;
2. The flexible electrode of embodiment 1, configured to assist in determining at least one of: a temperature transition point within the tissue.

(6) The flexible electrode according to embodiment 1, wherein the insulating layer overlaps the treatment electrode.
(7) The flexible electrode according to embodiment 1, wherein the insulating layer includes a rectangular portion and a plurality of fingers extending from the rectangular portion.
(8) The flexible electrode of embodiment 1, wherein the insulating layer is coincident with the sensing electrode.
(9) The flexibility of the insulating layer is
flexibility of the treatment electrode;
The flexible electrode of embodiment 1, wherein the flexibility of the sensing electrode exceeds.
(10) The flexible electrode of embodiment 1, further comprising a second insulating layer, wherein the treatment electrode is positioned between the insulating layer and the second insulating layer.

11. The flexible electrode of embodiment 10, further comprising a third insulating layer, and wherein the sensing electrode is positioned between the insulating layer and the third insulating layer.
(12) A flexible electrode assembly for a surgical instrument, the flexible electrode assembly comprising:
first and second treatment electrodes connectable to a source of radiofrequency energy;
first and second sensing electrodes configured to assist in determining a parameter associated with tissue positioned between the first and second jaws of the surgical instrument;
a first insulating layer positioned between the first treatment electrode and the first sensing electrode;
a second insulating layer positioned between the second treatment electrode and the second sensing electrode, the first and second treatment electrodes and the first and second sensing electrodes; A flexible electrode assembly, wherein the electrode is configured to contact the tissue.
(13) the first treatment electrode, the first sensing electrode, and the first insulating layer are positioned on a first side of a knife slot of the surgical instrument;
13. The flexible electrode assembly of embodiment 12, wherein the second treatment electrode, the second sensing electrode, and the first insulating layer are positioned on opposite sides of the knife slot.
(14) The first and second sensing electrodes are
an impedance of the tissue positioned between the first and second jaws of the surgical instrument;
electrical continuity of the tissue;
13. The flexible electrode assembly of embodiment 12, configured to assist in determining at least one of: a temperature transition point within the tissue.
(15) The flexible electrode of embodiment 12, wherein each of the first and second sensing electrodes includes a pattern shape that includes a rectangular portion and a plurality of fingers extending from the rectangular portion. assembly.

(16) The flexible electrode according to embodiment 12, wherein each of the first and second insulating layers includes a pattern shape including a rectangular portion and a plurality of fingers extending from the rectangular portion. assembly.
(17) The flexibility of the first and second insulating layers is
flexibility of the first and second treatment electrodes;
13. The flexible electrode assembly of embodiment 12, wherein the flexibility of the first and second sensing electrodes exceeds.
Embodiment 12: The first and second sensing electrodes form a conductive gap spacer configured to control a minimum gap between the first and second jaws. A flexible electrode assembly as described in .
(19) A multilevel flexible electrode for a surgical instrument, the multilevel flexible electrode comprising:
first, second, and third insulating layers;
a therapeutic electrode positioned between the first insulating layer and the second insulating layer, the therapeutic electrode being connectable to a radio frequency energy source;
a sensing electrode positioned between the second insulating layer and the third insulating layer, the sensing electrode being positioned between the first and second jaws of the surgical instrument. a multi-level flexible electrode configured to assist in determining a parameter associated with positioned tissue, wherein the treatment electrode and the sensing electrode are configured to contact the tissue; .
(20) The sensing electrode is
an impedance of the tissue positioned between the first and second jaws of the surgical instrument;
electrical continuity of the tissue;
20. The multi-level flexible electrode of embodiment 19, configured to assist in determining at least one of: a temperature transition point within the tissue.

Claims (22)

A flexible electrode for a surgical instrument, the flexible electrode comprising:
a therapeutic electrode connectable to a radiofrequency energy source;
a sensing electrode;
an insulating layer positioned between the treatment electrode and the sensing electrode, the treatment electrode and the sensing electrode being positioned between a first jaw and a second jaw of the surgical instrument. a flexible electrode configured to contact positioned tissue and disposed on at least the first jaw, the treatment electrode being positioned between the sensing electrode and the first jaw; sex electrode. The flexible electrode of claim 1, wherein the treatment electrode includes a rectangular shape. The flexible electrode of claim 1, wherein the sensing electrode overlaps the treatment electrode. 2. The flexible electrode of claim 1, wherein the sensing electrode includes a pattern shape that includes a rectangular portion and a plurality of fingers extending from the rectangular portion. The sensing electrode is
an impedance of the tissue positioned between the first and second jaws of the surgical instrument;
electrical continuity of the tissue;
2. The flexible electrode of claim 1, configured to assist in determining at least one of: a temperature transition point within the tissue. The flexible electrode of claim 1, wherein the insulating layer overlies the treatment electrode. The flexible electrode of claim 1, wherein the insulating layer includes a rectangular portion and a plurality of fingers extending from the rectangular portion. The flexible electrode of claim 1, wherein the insulating layer is coincident with the sensing electrode. The flexibility of the insulating layer is
flexibility of the treatment electrode;
The flexible electrode of claim 1, wherein the flexibility of the sensing electrode exceeds. 2. The flexible electrode of claim 1, further comprising a second insulating layer, the therapeutic electrode being positioned between the insulating layer and the second insulating layer. 11. The flexible electrode of claim 10, further comprising a third insulating layer, wherein the sensing electrode is positioned between the insulating layer and the third insulating layer. A flexible electrode assembly for a surgical instrument, the flexible electrode assembly comprising:
2. The flexible electrode of claim 1, wherein the treatment electrode is a first treatment electrode, the sensing electrode is a first sensing electrode, and the insulating layer is a first insulating layer. A flexible electrode,
a second treatment electrode connectable to the radiofrequency energy source;
a second sensing electrode configured to assist in determining a parameter associated with the tissue positioned between the first and second jaws of the surgical instrument;
a second insulating layer positioned between the second treatment electrode and the second sensing electrode, the second treatment electrode and the second sensing electrode being in contact with the tissue. a flexible electrode assembly configured to make contact; the first treatment electrode, the first sensing electrode, and the first insulating layer are positioned on a first side of a knife slot of the surgical instrument;
13. The flexible electrode assembly of claim 12, wherein the second treatment electrode, the second sensing electrode, and the second insulating layer are positioned on opposite sides of the knife slot. The first and second sensing electrodes are
an impedance of the tissue positioned between the first and second jaws of the surgical instrument;
electrical continuity of the tissue;
13. The flexible electrode assembly of claim 12, configured to assist in determining at least one of: a temperature transition point within the tissue. 13. The flexible electrode assembly of claim 12, wherein each of the first and second sensing electrodes includes a pattern shape that includes a rectangular portion and a plurality of fingers extending from the rectangular portion. 13. The flexible electrode assembly of claim 12, wherein each of the first and second insulating layers includes a pattern shape that includes a rectangular portion and a plurality of fingers extending from the rectangular portion. The flexibility of the first and second insulating layers is
flexibility of the first and second treatment electrodes;
13. The flexible electrode assembly of claim 12, wherein the flexibility of the first and second sensing electrodes exceeds. 13. The first and second sensing electrodes form a conductive gap spacer configured to control a minimum gap between the first jaw and the second jaw. Flexible electrode assembly. The second treatment electrode and the second sensing electrode are disposed on at least the first jaw, and the second treatment electrode is located between the second sensing electrode and the first jaw. 13. The flexible electrode assembly of claim 12, wherein the flexible electrode assembly is positioned between. the treatment electrode defines a first layer, the sensing electrode defines a second layer,
the insulating layer is positioned between the first layer and the second layer;
The flexible electrode of claim 1, wherein the first layer is positioned between the second layer and the first jaw. 5. The flexible electrode of claim 4, wherein the treatment electrode has a rectangular shape and is configured to face the tissue from a space between adjacent fingers of the sensing electrode. A surgical instrument,
A flexible electrode according to claim 1;
A surgical instrument comprising the first jaw and the second jaw.

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