Surgical instrument having a flexible electrode
The flexible electrode assembly for surgical instruments addresses premature failure and tissue adhesion issues by using insulating layers to reduce deformation and enhance sensing capabilities.
Patent Information
- Application Number
- JP2023206026
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-06-29
- Filing Date
- 2023-12-06
- Publication Date
- 2025-07-08
- Estimated Expiration
- 2038-10-23
AI Technical Summary
Surgical instrument electrodes are prone to premature failure due to bending or deformation, and their large surface area causes unwanted tissue adhesion and limits sensing capabilities.
A flexible electrode assembly for surgical instruments, featuring insulating layers between therapeutic and sensing electrodes, allowing them to contact tissue while reducing deformation and providing sensing capabilities.
The flexible electrode assembly minimizes premature failure and tissue adhesion, while enabling effective tissue parameter determination.
Smart Images

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Abstract
Description
Technical Field
[0001] (Cross - Reference to Related Applications) This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 691,230, filed Jun. 28, 2018, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE", the entire disclosure of which is incorporated herein by reference. This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 691,228, filed Jun. 28, 2018, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES", the entire disclosure of which is incorporated herein by reference.
[0002] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 650,887, filed Mar. 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES", U.S. Provisional Patent Application No. 62 / 650,877, filed Mar. 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS", U.S. Provisional Patent Application No. 62 / 650,882, filed Mar. 30, 2018, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM", and U.S. Provisional Patent Application No. 62 / 650,898, filed Mar. 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", the entire disclosures of each of which are incorporated herein by reference.
[0003] This application further claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 640,417, filed Mar. 8, 2018, entitled “TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR,” and U.S. Provisional Patent Application No. 62 / 640,415, filed Mar. 8, 2018, entitled “ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,” the entire disclosures of each of which are incorporated herein by reference.
[0004] This application further claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 611,341, filed Dec. 28, 2017, entitled “INTERACTIVE SURGICAL PLATFORM,” U.S. Provisional Patent Application No. 62 / 611,340, filed Dec. 28, 2017, entitled “CLOUD-BASED MEDICAL ANALYTICS,” and U.S. Provisional Patent Application No. 62 / 611,339, filed Dec. 28, 2017, entitled “ROBOT ASSISTED SURGICAL PLATFORM,” the entire disclosures of each of which are incorporated herein by reference.
[0005] This application discloses inventions related to surgical systems, surgical instruments, and flexible circuits generally and in various aspects. BACKGROUND OF THE INVENTION
[0006] Surgical instruments include components that need to move in various directions and / or be subjected to various forces. For example, the shaft rotates, articulates, experiences different tensions, the jaw opens and closes and pivots, experiences unwanted flexure or deformation, and the cutting member axially moves in the distal and proximal directions and experiences different resistive forces.
[0007] The surgical instrument may also include additional components such as electrodes, sensing devices, processing circuits, motors, and wiring and / or wiring traces, some of which may be located within various parts of the surgical instrument. For example, the sensing device and / or processing circuit 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 an electrical circuit of the surgical instrument, and some of such electrical circuits are also required to move in various directions and / or may be subject to various forces.
[0008] In many cases, the jaw electrodes of various surgical instruments are rigid and are used as therapeutic electrodes that apply electrosurgical energy to the tissue positioned between the jaws, collectively occupy substantially the entire width of the jaws, and may experience bending or deformation as the jaws open and close. In a surgical instrument that includes a knife that traverses a slot defined by the jaws, a first electrode may be positioned on a first side (e.g., the right hand side) of the slot, and a second electrode may be positioned on a second side (e.g., the left hand side) of the slot.
[0009] Due to their rigid nature, unwanted 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 that contacts the tissue positioned between the jaws. When the electrodes deliver high frequency (RF) energy to the tissue, the large surface area of the electrodes can contribute to unwanted tissue adhesion. In addition, the large surface area of the electrodes leaves little room for sensing and / or measuring devices to contact the tissue positioned between the jaws.
[0010] In conventional electrical circuits within surgical instruments, portions of the electrical circuit that are required to move in various directions and / or are subject to various forces tend to become detached or separated from their connections to the surgical instrument and / or fail at a higher rate than desired. SUMMARY OF THE INVENTION MEANS FOR SOLVING THE PROBLEM
[0011] A flexible electrode for a surgical instrument is disclosed. The flexible electrode includes a high-frequency energy source, a sensing electrode, and a therapeutic electrode connectable to an insulating layer. The insulating layer is positioned between the therapeutic electrode and the sensing electrode. The therapeutic electrode and the sensing electrode are configured to contact tissue positioned between a first jaw and a second jaw of the surgical instrument.
[0012] A flexible electrode assembly for a surgical instrument is disclosed. The flexible electrode assembly includes first and second therapeutic electrodes connectable to a high-frequency energy source and first and second sensing electrodes configured to assist in determining parameters associated with tissue positioned between a first jaw and a second jaw of the surgical instrument. The flexible electrode assembly further includes a first insulating layer positioned between the first therapeutic electrode and the first sensing electrode and a second insulating layer positioned between the second therapeutic electrode and the second sensing electrode, and the first and second therapeutic electrodes and the first and second sensing electrodes are configured to contact the tissue.
[0013] 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 therapeutic electrode and a sensing electrode. The therapeutic electrode is positioned between the first insulating layer and the second insulating layer and is connectable to a high-frequency energy source. The sensing electrode is positioned between the second insulating layer and the third insulating layer and is configured to assist in determining parameters associated with tissue positioned between a first jaw and a second jaw of the surgical instrument, and the therapeutic electrode and the sensing electrode are configured to contact the tissue. BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The features of the various aspects are set forth in detail in the appended claims. However, the various aspects, both as to their construction and method of operation, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings.
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DETAILED DESCRIPTION OF THE INVENTION
[0015] The applicant of the present application owns the following US patent applications filed on June 29, 2018, the entire disclosures of each of which are incorporated herein by reference. · U.S. Patent Application No. __________, Attorney Docket No. END8542USNP / 170755, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", · U.S. Patent Application No. __________, Attorney Docket No. END8543USNP / 170760, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS" · U.S. Patent Application No. __________, Attorney Docket No. END8543USNP1 / 170760-1, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION" · U.S. Patent Application No. __________, Attorney Docket No. END8543USNP2 / 170760-2, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING" · U.S. Patent Application No. __________, Attorney Docket No. END8543USNP3 / 170760-3, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING" · U.S. Patent Application No. __________, Attorney Docket No. END8543USNP4 / 170760-4, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES" · U.S. Patent Application No. __________, Attorney Docket No. END8543USNP5 / 170760-5, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE" · U.S. Patent Application No. __________, Attorney Docket No. END8543USNP6 / 170760-6, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES" · U.S. Patent Application No. __________, Attorney Docket No. END8543USNP7 / 170760-7, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY" · U.S. Patent Application No. __________, Attorney Docket No. END8544USNP1 / 170761-1, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT" · U.S. Patent Application No. __________, Attorney Docket No. END8544USNP2 / 170761-2, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY" · U.S. Patent Application No. __________, Attorney Docket No. END8544USNP3 / 170761-3, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES" · U.S. Patent Application No. __________, Attorney Docket No. END8545USNP / 170762, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL" · U.S. Patent Application No. __________, Attorney Docket No. END8545USNP1 / 170762-1, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS" · U.S. Patent Application No. __________, Attorney Docket No. END8545USNP2 / 170762-2, entitled "SURGICAL EVACUATION FLOW PATHS" · U.S. Patent Application No. __________, Attorney Docket No. END8545USNP3 / 170762-3, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL" · U.S. Patent Application No. __________, Attorney Docket No. END8545USNP4 / 170762-4, entitled "SURGICAL EVACUATION SENSING AND DISPLAY" · U.S. Patent Application No. __________, Attorney Docket No. END8546USNP / 170763, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM" · U.S. Patent Application No. __________, Attorney Docket No. END8546USNP1 / 170763-1, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM" · U.S. Patent Application No. __________, Attorney Docket No. END8547USNP / 170764, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE", and · U.S. Patent Application No. __________, Attorney Docket No. END8548USNP / 170765, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS".
[0016] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on June 28, 2018, the entire disclosure of each of which is incorporated herein by reference. · U.S. Provisional Patent Application No. 62 / 691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES" · U.S. Provisional Patent Application No. 62 / 691,227 entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS", · U.S. Provisional Patent Application No. 62 / 691,230 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE", · U.S. Provisional Patent Application No. 62 / 691,219 entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL", · U.S. Provisional Patent Application No. 62 / 691,257 entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM", · U.S. Provisional Patent Application No. 62 / 691,262 entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE, and · U.S. Provisional Patent Application No. 62 / 691,251 entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS".
[0017] The applicant of the present application owns the following U.S. patent applications filed on March 29, 2018, the entire disclosure of each of which is incorporated herein by reference. · 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" · U.S. Patent Application No. 15 / 940,640 entitled "Communication Hub and Storage Device for Storing Parameters and Status of a Surgical Device to be Shared with Cloud Based Analytics Systems" · U.S. Patent Application No. 15 / 940,645 entitled "Self Describing Data Packets Generated at an Issuing Instrument" · U.S. Patent Application No. 15 / 940,649 entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME", · U.S. Patent Application No. 15 / 940,654 entitled "SURGICAL HUB SITUATIONAL AWARENESS", · U.S. Patent Application No. 15 / 940,663 entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING", · U.S. Patent Application No. 15 / 940,668 entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA", · U.S. Patent Application No. 15 / 940,671 entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER", · U.S. Patent Application No. 15 / 940,686 entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE", · U.S. Patent Application No. 15 / 940,700 entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS", · U.S. Patent Application No. 15 / 940,629 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS", · U.S. Patent Application No. 15 / 940,704 entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT", · U.S. Patent Application No. 15 / 940,722 entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY", and · U.S. Patent Application No. 15 / 940,742 entitled "DUAL CMOS ARRAY IMAGING".
[0018] The applicant of this application owns the following U.S. patent applications filed on March 29, 2018, the entire disclosure of each of which is incorporated herein by reference. · U.S. Patent Application No. 15 / 940,636 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES", · U.S. Patent Application No. 15 / 940,653 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS", · U.S. Patent Application No. 15 / 940,660 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER", · U.S. Patent Application No. 15 / 940,679 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET", · U.S. Patent Application No. 15 / 940,694 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION", · U.S. Patent Application No. 15 / 940,634 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES", · U.S. Patent Application No. 15 / 940,706 entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK", and · U.S. Patent Application No. 15 / 940,675, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES".
[0019] The applicant of this application owns the following U.S. patent applications filed on March 29, 2018, the entire disclosure of each of which is incorporated herein by reference. · 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", and · U.S. Patent Application No. 15 / 940,711, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".
[0020] The applicant of the present application owns the following U.S. provisional patent applications filed on March 28, 2018, the entire disclosure of each of which is incorporated herein by reference. · U.S. Provisional Patent Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES", · U.S. Provisional Patent Application No. 62 / 649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD", · U.S. Provisional Patent Application No. 62 / 649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS", · U.S. Provisional Patent Application No. 62 / 649,309, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER", · U.S. Provisional Patent Application No. 62 / 649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS", · U.S. Provisional Patent Application No. 62 / 649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT", · U.S. Provisional Patent Application No. 62 / 649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES", · U.S. Provisional Patent Application No. 62 / 649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER", · U.S. Provisional Patent Application No. 62 / 649,327 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES", · U.S. Provisional Patent Application No. 62 / 649,315 entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK", · U.S. Provisional Patent Application No. 62 / 649,313 entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES", · U.S. Provisional Patent Application No. 62 / 649,320 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", · U.S. Provisional Patent Application No. 62 / 649,307 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", and · U.S. Provisional Patent Application No. 62 / 649,323 entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".
[0021] The applicant of the present application owns the following U.S. provisional patent applications filed on April 19, 2018, the entire disclosure of each of which is incorporated herein by reference. · U.S. Provisional Patent Application No. 62 / 659,900 entitled "METHOD OF HUB COMMUNICATION".
[0022] The applicant of the present application owns the following U.S. provisional patent applications filed on March 30, 2018, the entire disclosure of each of which is incorporated herein by reference. · 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 · U.S. Provisional Patent Application No. 62 / 650,898 entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS".
[0023] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on March 8, 2018, the entire disclosure of each of which is incorporated herein by reference. · U.S. Provisional Patent Application No. 62 / 640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR", and · U.S. Provisional Patent Application No. 62 / 640,415 entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREOFR".
[0024] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on December 28, 2017, the entire disclosure of each of which is incorporated herein by reference. · 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".
[0025] At least some of the figures and descriptions of the present invention are simplified to show elements relevant to a clear understanding of the present disclosure. However, it should be understood that for the purpose of clarity, excluding other elements understood by those skilled in the art may form part of the present invention. However, since such elements are well known in the art and do not facilitate a better understanding of the present invention, an explanation of such elements is not provided in this specification.
[0026] In the following "Detailed Description of the Invention", reference is made to the accompanying drawings which form a part of this specification. In the figures, generally, like symbols and reference numerals indicate like elements throughout the plurality of figures unless the context otherwise indicates. The exemplary embodiments described in the "Detailed Description of the Invention", "Drawings", and "Claims" are not intended to be limiting. Other embodiments can be used and other changes can be made without departing from the scope of the technology described herein.
[0027] The following description of specific embodiments of the present technology should not be used for the purpose of limiting its scope. Other embodiments, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated in practicing the present technology by way of example. As will be understood, the technologies described herein are all capable of other different and apparent modes without departing from the technology. Therefore, the drawings and description should be regarded as being of an illustrative nature rather than a limiting nature.
[0028] It is further understood that any one or more of the teachings, expressions, aspects, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, aspects, embodiments, examples, etc. described herein. Therefore, the teachings, expressions, aspects, embodiments, examples, etc. described below should not be considered in isolation from each other. Various suitable ways of combining the teachings of this specification will be readily apparent to those skilled in the art in view of the teachings of this specification. Such modifications and variations are intended to be included within the scope of the "claims".
[0029] Before detailing various aspects of the surgical system, surgical instruments, flexible circuits, and flexible electrode assemblies, it should be noted that the various aspects disclosed herein are not limited to the details of the structure and arrangement of the components illustrated in the accompanying drawings and description in their use or application. Rather, the disclosed aspects can be positioned as, or incorporated into, other aspects, embodiments, variations, and modifications thereof and can be implemented or carried out in various ways. Accordingly, the aspects of the surgical system, surgical instruments, flexible circuits, and flexible electrode assemblies disclosed herein are exemplary in nature and are not intended to limit their scope or application. Further, unless otherwise specified, the terms and expressions used herein are selected for the purpose of describing aspects for the convenience of the reader and are not intended to limit their scope. Further, it should be understood that any one or more of the disclosed aspects, expressions of aspects, and / or their examples can be combined with any one or more of the other disclosed aspects, expressions of aspects, and / or their examples without limitation.
[0030] Also, in the following description, terms such as inner, outer, upward, downward, higher, lower, left, right, inner surface, outer surface, etc. should be understood as terms used for convenience and should not be construed as limiting terms. The terms used in this specification are not limiting as long as the devices described in this specification, or parts thereof, can be installed or used in other orientations. Various aspects will be described in more detail with reference to the drawings.
[0031] As described in more detail below, aspects of the present invention may be implemented by a computing device and / or a computer program stored on a computer-readable medium. The computer-readable medium may include a disk, a device, and / or a propagated signal.
[0032] Referring to FIG. 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 that communicates with cloud 104 that may include a remote server 113. In one embodiment, 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. 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 greater than or equal to 1.
[0033] 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 an operating room 116. A robotic system 110 is used as part of the surgical system 102 in the surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient-side cart 120 (surgical robot), and a surgical robot hub 122. The patient-side cart 120 can operate at least one removably coupled surgical tool 117 while the surgeon views the surgical site through the surgeon's console 118 during minimally invasive incision of the patient's body. An image of the surgical site can be obtained by a medical imaging device 124, and the medical imaging device 124 can be operated by the patient-side cart 120 to orient the imaging device 124. The robot hub 122 can be used to process an image of the surgical site for subsequent display to the surgeon via the surgeon's console 118.
[0034] Other types of robotic systems can be easily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed on Dec. 28, 2017, the entire disclosure of which is incorporated herein by reference.
[0035] Various examples of cloud-based analytics implemented by the cloud 104 and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed on Dec. 28, 2017, the entire disclosure of which is incorporated herein by reference.
[0036] In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.
[0037] The optical components of the imaging device 124 may include one or more illumination light sources and / or one or more lenses. One or more illumination light sources may be directed to illuminate a portion of the surgical field. One or more image sensors may be capable of receiving light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.
[0038] One or more illumination light sources may be configured to emit electromagnetic energy within the visible spectrum and the invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or emission spectrum, is a portion of the electromagnetic spectrum that is visible to the human eye (i.e., detectable by the human eye) and may be referred to as visible light, or simply light. A typical human eye responds to wavelengths of approximately 380 nm to approximately 750 nm in air.
[0039] The invisible spectrum (i.e., non-emission spectrum) is a portion of the electromagnetic spectrum that is located below and above the visible spectrum (i.e., wavelengths less than approximately 380 nm and greater than approximately 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than approximately 750 nm are longer than the red visible spectrum and become invisible infrared (IR), microwaves, and radio electromagnetic radiation. Wavelengths less than approximately 380 nm are shorter than the violet spectrum and become invisible ultraviolet, X-rays, and gamma ray electromagnetic radiation.
[0040] In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.
[0041] In one aspect, the imaging device uses multispectral monitoring to distinguish topography from the underlying structure. A multispectral image captures image data within a specific wavelength range across the electromagnetic spectrum. The wavelengths can be separated by a filter or by using an instrument sensitive to light from specific wavelengths, such as frequencies beyond the visible light range, e.g., IR and ultraviolet light. Spectral imaging methods 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 methods is described in detail in the "Advanced Imaging Acquisition Module" section of 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. Multispectral monitoring can be a useful tool for repositioning the surgical field to perform one or more of the above-described tests on the treated tissue after a surgical procedure has been completed.
[0042] It is self-evident that strict sterilization of the operating room and surgical instruments is required in any surgical procedure. The strict hygiene and sterilization conditions required in the "surgical theater", i.e., the operating room or treatment room, require the highest level of sterility for 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. It will be understood that the sterile field can be considered a specific area, such as within a tray or on a sterile towel, that is considered free of microorganisms, or the sterile field can be considered the area immediately surrounding the patient prepared for the surgical procedure. The sterile field can include properly attired and scrubbed team members, as well as all supplies and fixtures within that area.
[0043] In various aspects, the visualization system 108 includes, as shown in FIG. 2, one or more imaging sensors strategically positioned with respect to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. The various components of the visualization system 108 are described in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62 / 611,341, filed Dec. 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference.
[0044] As shown in FIG. 2, the primary display 119 is positioned within the sterile field so as to be visible to the operator located on the operating table 114. Additionally, the visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 that face away from each other. The visualization system 108, which is directed by the surgical hub 106, is configured to utilize the displays 107, 109, and 119 to coordinate the flow of information to the operators inside and outside of the sterile field. For example, the surgical hub 106 can cause the visualization system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the non-sterile display 107 or 109 while maintaining a live video of the surgical site on the primary display 119. The snapshot on the non-sterile display 107 or 109 can, for example, enable a non-sterile operator to perform diagnostic steps related to the surgical procedure.
[0045] In one aspect, the surgical hub 106 is also configured to send diagnostic inputs 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 area, where it can be viewed by a sterile operator located at the operating table. In one embodiment, the input may be in the form of a modification to a snapshot displayed on a non-sterile display 107 or 109 that can be sent by the surgical hub 106 to the primary display 119.
[0046] Referring to FIG. 2, the surgical instrument 112 is being used as part of the surgical system 102 in a surgical procedure. The surgical hub 106 is also configured to regulate the flow of information to the display of the surgical instrument 112. For example, see U.S. Provisional Patent Application No. 62 / 611,341, filed Dec. 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM", the entire disclosure of which is incorporated herein by reference. Diagnostic inputs or feedback entered by a non-sterile operator at the location of the visualization tower 111 can be sent by the surgical hub 106 within the sterile field to a surgical instrument display 115, where the operator of the surgical instrument 112 can view the diagnostic inputs or feedback. Exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in the section entitled "Surgical Instrument Hardware" and in U.S. Provisional Patent Application No. 62 / 611,341, filed Dec. 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM", the entire disclosure of which is incorporated herein by reference.
[0047] Referring now to FIG. 3, the surgical hub 106 is shown in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The surgical hub 106 includes a surgical hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In certain aspects, as shown in FIG. 3, the surgical hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128.
[0048] During a surgical procedure, the application of energy to tissue for sealing and / or cutting generally involves smoke evacuation, suction of excess fluid, and / or irrigation of the tissue. Fluid, power, and / or data lines from different sources often become entangled during a surgical procedure. Valuable time can be lost in addressing this problem during a surgical procedure. To untangle the lines, it may be necessary to unplug 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, reducing the frequency of such line entanglements.
[0049] Aspects of the present disclosure present a surgical hub for use in a surgical procedure 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. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combination generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.
[0050] In one aspect, the fluid line is a first fluid line and a second fluid line extends from a remote surgical site to a suction and perfusion module slidably receivable within the surgical hub housing. In one aspect, the surgical hub housing includes a fluid interface.
[0051] Certain surgical procedures may require the application of two or more energy types to tissue. One energy type may be more beneficial for cutting tissue, while a different energy type may be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue, while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the modular housing 136 of the surgical hub is configured to house various generators and facilitate bidirectional communication between them. One advantage of the modular housing 136 of the surgical hub is that it allows for the quick removal and / or replacement of various modules.
[0052] Aspects of the present disclosure present a modular surgical housing for use in a surgical procedure involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking station including a first docking port that includes first data and power contacts, wherein the first energy generator module is slidably movable to engage electrically with the power and data contacts, and wherein the first energy generator module is also slidably movable to disengage from the electrical engagement with the first power and data contacts.
[0053] In addition to the above, the modular surgical housing further includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port that includes second data and power contacts, wherein the second energy generator module is slidably movable to engage electrically with the power and data contacts, and wherein the second energy generator module is also slidably movable to disengage from the electrical engagement with the second power and data contacts.
[0054] Furthermore, the modular surgical housing further includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.
[0055] Referring to FIGS. 3-7, aspects of the present disclosure are presented regarding a modular housing 136 of a surgical hub that enables modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The modular housing 136 of the surgical hub further facilitates bidirectional communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 may be a generator module comprising integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit 139 slidably insertable into the modular housing 136 of the surgical hub. As shown in FIG. 5, the generator module 140 may be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the modular housing 136 of the surgical hub. The modular housing 136 of the surgical hub may be configured to facilitate the insertion of multiple generators and bidirectional communication between the generators docked to the modular housing 136 of the surgical hub such that the multiple generators function as a single generator.
[0056] In one aspect, the modular housing 136 of the surgical hub includes a modular power and communication backplane 149 comprising external and wireless communication headers to enable removable attachment of the modules 140, 126, 128 and bidirectional communication between them.
[0057] 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 modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and a combination generator module 145 slidably receivable in the docking station 151 of the surgical hub housing 136. A docking port 152 having power and data contacts on the rear side of the combination generator module 145 is configured to engage corresponding power and data contacts of the docking station 151 of the modular housing 136 of the hub when the combination generator module 145 is slid into position within the corresponding docking station 151 of the modular housing 136 of the surgical hub. In one aspect, the combination generator module 145 includes, as shown in FIG. 5, bipolar, ultrasonic, and monopolar modules, and a smoke evacuation module integrated with a single housing unit 139.
[0058] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that conveys captured smoke and / or fluid away from the surgical site, for example, to the smoke evacuation module 126. The vacuum suction generated from the smoke evacuation module 126 can draw smoke into the opening of the utility conduit at the surgical site. The utility conduit connected to the fluid line may be in the form of a flexible tube that terminates at the smoke evacuation module 126. The utility conduit and the fluid line define a fluid path extending towards the smoke evacuation module 126 received within the surgical hub housing 136.
[0059] In various aspects, the aspiration / perfusion module 128 is connected to a surgical tool that includes an aspiration fluid line and a suction fluid line. In one embodiment, the aspiration and suction fluid lines are in the form of flexible tubes extending from the surgical site towards the aspiration / perfusion module 128. One or more drive systems may be configured to cause perfusion and aspiration of fluid to and from the surgical site.
[0060] In one aspect, the surgical tool includes a shaft having an end effector at its distal end, at least one energy treatment section 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 extends through the shaft. Similarly, the irrigation tube can extend through the shaft and can have an inlet port proximate to the energy delivery device. The energy delivery device is configured to deliver ultrasonic and / or RF energy to the surgical site and is coupled to the generator module 140 by a cable that first extends through the shaft.
[0061] The irrigation tube can be in fluid communication with a fluid source, and the suction tube can be in fluid communication with a vacuum source. The fluid source and / or the vacuum source can be housed within the aspiration / irrigation module 128. In one embodiment, the fluid source and / or the vacuum source can be housed within the surgical hub housing 136 separately from the aspiration / irrigation module 128. In such an embodiment, the fluid interface can be configured to connect the aspiration / irrigation module 128 to the fluid source and / or the vacuum source.
[0062] In one aspect, the corresponding docking stations on the modular housings of the modules 140, 126, 128 and / or the surgical hub can include an alignment mechanism configured to align the docking ports of the modules and engage these corresponding components within the docking station of the modular housing 136 of the surgical hub. For example, as shown in FIG. 4, the combination generator module 145 includes side brackets 155 configured to slidably engage corresponding brackets 156 of the corresponding docking station 151 of the modular housing 136 of the surgical hub. The brackets cooperate to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the modular housing 136 of the surgical hub.
[0063] In some embodiments, the drawers 151 of the modular housing 136 of the surgical hub are the same size or substantially the same size, and the modules are sized to be received within the drawers 151. For example, the side brackets 155 and / or 156 may be larger or smaller depending on the size of the module. In other embodiments, the drawers 151 are different sizes and are each designed to accommodate a specific module.
[0064] Further, to avoid inserting a module into a drawer with mismatched contacts, the contacts of a specific module may be keyed to engage the contacts of a specific drawer.
[0065] As shown in FIG. 4, the docking port 150 of one drawer 151 is connected via a communication link 157 to the docking port 150 of another drawer 151 to facilitate two-way communication between the modules housed within the modular housing 136 of the surgical hub. Alternatively or additionally, the docking ports 150 of the modular housing 136 of the surgical hub may facilitate wireless two-way communication between the modules housed within the modular housing 136 of the surgical hub. For example, any suitable wireless communication such as Air Titan - Bluetooth may be used.
[0066] FIG. 6 shows the individual power bus attachments of the plurality of lateral docking ports of a lateral modular housing 160 configured to receive a plurality of modules of a surgical hub 206. The lateral modular housing 160 is configured to receive and interconnect the modules 161 laterally. The modules 161 are slidably inserted into a docking station 162 of the lateral modular housing 160 that includes a backplane for interconnecting the modules 161. As shown in FIG. 6, the modules 161 are arranged laterally within the lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically within a vertical modular housing.
[0067] FIG. 7 shows a vertical modular housing 164 configured to receive a plurality of modules 165 of a surgical hub 106. The modules 165 are slidably inserted into a docking station or drawer 167 of the vertical modular housing 164 that includes a backplane for interconnecting the modules 165. The drawer 167 of the vertical modular housing 164 is arranged vertically, but in certain cases, the vertical modular housing 164 may include a laterally arranged drawer. Further, the modules 165 can interact with each other via the docking ports of the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of the modules 165. Additionally, the vertical modular housing 164 includes a master module 178 that houses a plurality of sub-modules slidably received within the master module 178.
[0068] In various aspects, the imaging module 138 includes a built-in video processor and a modular light source and is adapted to be used with various imaging devices. In one aspect, the imaging device is configured 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 according to 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 imaging a scanned beam. Similarly, the light source module can be configured to deliver white light or different light according to the surgical procedure.
[0069] 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. Temporarily losing the view of the surgical field can result in undesirable outcomes. The modular imaging device of the present disclosure is configured to allow for the replacement of a light source module or a camera module midstream during a surgical procedure without the need to remove the imaging device from the surgical field.
[0070] In one aspect, the imaging device comprises a tubular housing that includes a plurality of channels. The first channel is configured to slidably receive a camera module that can be configured to snap-fit engage with the first channel. The second channel is configured to slidably receive a light source module that can be configured to snap-fit engage 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 screw engagement may be employed instead of the snap-fit engagement.
[0071] In various examples, a plurality of imaging devices are positioned at various locations within the surgical field to provide a plurality of fields of view. The imaging module 138 can be configured to switch between the imaging devices to provide an optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from different imaging devices.
[0072] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Patent No. 7,995,045, issued August 9, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which is hereby incorporated by reference in its entirety. Further, U.S. Patent No. 7,982,776, issued July 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is hereby incorporated by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems may be integrated with the imaging module 138. Further, U.S. Patent Application Publication No. 2011 / 0306840, published December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS," and U.S. Patent Application Publication No. 2014 / 0243597, published August 28, 2014, entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE," are hereby incorporated by reference in their entireties, respectively.
[0073] FIG. 8 shows a surgical data network 201 comprising a modular communication hub 203 configured to connect a modular device disposed in one or more operating rooms of a medical facility or any room within a medical facility equipped with specialized equipment for surgical procedures to a cloud-based system (e.g., cloud 204 (FIG. 9) that may include a remote server 213 connected to a storage device 205). In one aspect, the modular communication hub 203 comprises a network hub 207 and / or a network switch 209 that communicates with a network router. The modular communication hub 203 can further be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network functions as a conduit for data, enabling data to go from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network enables traffic to be monitored through the surgical data network being monitored and includes additional mechanisms that 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. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.
[0074] The modular devices 1a to 1n arranged in the operating room may be connected to the modular communication hub 203. The network hub 207 and / or the network switch 209 may be connected to the network router 211 to connect the devices 1a to 1n to the cloud 204 or the local computer system 210. The data associated with the devices 1a to 1n may be transferred via the router to a cloud-based computer for remote data processing and operation. The data associated with the devices 1a to 1n may also be transferred to the local computer system 210 for local data processing and operation. The modular devices 2a to 2m located in the same operating room may also be connected to the network switch 209. The network switch 209 may be connected to the network hub 207 and / or the network router 211 to connect the devices 2a to 2m to the cloud 204. The data associated with the devices 2a to 2m may be transferred via the network router 211 to the cloud 204 for data processing and operation. The data associated with the devices 2a to 2m may also be transferred to the local computer system 210 for local data processing and operation.
[0075] It will be appreciated that the surgical data network 201 can be extended by interconnecting a plurality of network hubs 207 and / or a plurality of network switches 209 with a plurality of network routers 211. The modular communication hub 203 can be housed within a modular control tower configured to receive a plurality of devices 1a-1n / 2a-2m. The 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, for example, during a surgical procedure. In various embodiments, the devices 1a-1n / 2a-2m can include, among other modular devices connectable to the modular communication hub 203 of the surgical data network 201, for example, an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and / or a non-contact sensor module, and the like.
[0076] In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(es), and network router(s) that connect the devices 1a - 1n / 2a - 2m to the cloud. Any one or all of the devices 1a - 1n / 2a - 2m connected to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and operation. It will be understood that cloud computing relies on shared computing resources rather than having a local server or personal device to handle software applications. The term "cloud" can be used as a metaphor for the "Internet", but this term is not so limited. Thus, the term "cloud computing" can be used herein to refer to "a type of Internet - based computing", in which case various services such as servers, storage, and applications are delivered to a modular communication hub 203 and / or a computer system 210 located at the surgical site (e.g., a fixed, mobile, temporary, or on - site operating room or space) and to devices connected to the modular communication hub 203 and / or the computer system 210 via the Internet. The cloud infrastructure can be maintained by a cloud service provider. In this context, the cloud service provider can be an entity that coordinates the use and control of the devices 1a - 1n / 2a - 2m located in one or more operating rooms. Cloud computing services can perform a number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The surgical hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.
[0077] By applying cloud computer data processing techniques to the data collected by devices 1a to 1n / 2a to 2m, the surgical data network provides improvements in surgical outcomes, cost reduction, and patient satisfaction. After tissue sealing and cutting procedures, at least some of devices 1a to 1n / 2a to 2m can be used to observe the state of the tissue to evaluate leakage or perfusion of the sealed tissue. At least some of devices 1a to 1n / 2a to 2m can be used to examine data including images of samples of body tissue for diagnostic purposes using cloud-based computing to identify medical conditions such as the effects of disease. This includes tissue and phenotype localization and margin confirmation. At least some of devices 1a to 1n / 2a to 2m can be used to identify the anatomical structure of the body using techniques such as various sensors integrated with the imaging device and overlaying images captured by multiple imaging devices. The data collected by devices 1a to 1n / 2a to 2m, including image data, may be transferred to cloud 204 or local computer system 210 or both for data processing and operations including image processing and manipulation. The data can be analyzed to improve the results of surgical procedures by determining whether further treatments such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and precision robotics can be performed on tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processing, and using a standardized approach can provide useful feedback either to confirm surgical treatment and surgeon behavior or to propose modifications to surgical treatment and surgeon behavior.
[0078] In one implementation, the operating room devices 1a to 1n may be connected to the modular communication hub 203 via a wired channel or a wireless channel according to the configuration of the devices 1a to 1n with respect to the network hub. The network hub 207 may be implemented as a local network broadcast device that functions on the physical layer of the Open Systems Interconnection (OSI) model in one aspect. The network hub provides connectivity to the devices 1a to 1n located within the same operating room network. The network hub 207 collects data in packet form and transmits them to the router in half-duplex mode. The network hub 207 does not store any Media Access Control / Internet Protocol (MAC / IP) for transferring device data. Only one of the devices 1a to 1n can transmit data at a time via the network hub 207. The network hub 207 has no routing table or intelligence regarding the destination of the information and broadcasts all network data across each connection and to the remote server 213 (Figure 9) on the cloud 204. The network hub 207 can detect basic network errors such as collisions, but broadcasting all information to multiple ports can pose a security risk and cause a bottleneck.
[0079] In another implementation, the operating room devices 2a to 2m may be connected to the network switch 209 via a wired channel or a wireless channel. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a to 2m located within the same operating room to the network. The network switch 209 transmits data in the form of frames to the network router 211 and functions in full-duplex mode. Multiple devices 2a to 2m can transmit data simultaneously via the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a to 2m for transferring data.
[0080] The network hub 207 and / or the network switch 209 are connected to the network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of the data collected by any one or all of the devices 1a - 1n / 2a - 2m. The network router 211 may be used, for example, to connect two or more different networks located at different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 transmits data in packet form to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to transfer data.
[0081] In one embodiment, the network hub 207 may be implemented as a USB hub that enables connecting multiple USB devices to a host computer. The USB hub can expand a single USB port into several tiers to increase the number of ports available for connecting devices to the host system computer. The network hub 207 can include wired or wireless capabilities for receiving information via a wired or wireless channel. In one aspect, a wireless USB short-range high-bandwidth wireless communication protocol may be used for communication between the devices 1a - 1n and the devices 2a - 2m located within the operating room.
[0082] In other embodiments, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard to exchange data over short distances from fixed and mobile devices (using short-wavelength UHF radio waves in the 2.4 - 2.485 GHz ISM band) and to construct a personal area network (PAN). In other aspects, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via a number of wireless or wired communication standards or protocols including, but not limited to, Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, Long-Term Evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as well as any other wireless and wired protocols designated for 3G, 4G, 5G, and beyond. The computing module may include a plurality of communication modules. For example, a first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO.
[0083] The modular communication hub 203 can function as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handle a data type known as a frame. The frame carries data generated by the devices 1a-1n / 2a-2m. When the frame is received by the modular communication hub 203, the frame is amplified and transmitted to the network router 211, which transfers this data to cloud computing resources by using a number of wireless or wired communication standards or protocols described herein.
[0084] The modular communication hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. Since the modular communication hub 203 is generally easy to install, configure, and maintain, the modular communication hub 203 is a good option for network-connecting the operating room devices 1a~1n / 2a~2m.
[0085] FIG. 9 shows a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar to the computer-implemented interactive surgical system 100 in many respects. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar to the 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 a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to a plurality of operating room devices such as, for example, intelligent surgical instruments, robots, and other computerized devices located within the operating room. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210. 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 module 228, a communication module 230, a processor module 232, a storage array 234, a smart device / instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via the modular control tower 236. A robot hub 222 may also be connected to the modular control tower 236 and cloud computing resources. Among other things, the device / instrument 235, visualization system 208 may be coupled to the modular control tower 236 via the wired or wireless communication standards or protocols described herein. The modular control tower 236 may be coupled to a surgical hub display 215 (e.g., a monitor, screen) to display and overlay images received from the imaging module, device / instrument display, and / or other visualization system 208. The surgical hub display may also display data received from devices connected to the modular control tower along with the images and overlaid images.
[0086] FIG. 10 shows a surgical hub 206 comprising a plurality of modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communication hub 203, such as a network connection device, and a computer system 210 for providing, for example, local processing, visualization, and imaging. As shown in FIG. 10, the modular communication hub 203 is connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs / switches within the modular communication hub 203 includes three downstream ports and one upstream port. The upstream network hub / switch is connected to a processor to provide a communication connection to cloud computing resources and a local display 217. Communication to the cloud 204 can be via either a wired or wireless communication channel.
[0087] The surgical hub 206 uses a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the surgical site using either an ultrasonic or laser-based non-contact measurement device. As described in the section "Surgical Hub Spatial Awareness Within an Operating Room" of U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is hereby incorporated by reference in its entirety, the ultrasonic-based non-contact sensor module scans the operating room by transmitting ultrasonic bursts and receiving the echoes when the ultrasonic bursts are reflected off the outer walls of the operating room, where the sensor module is configured to determine the size of the operating room and adjust the distance limit for Bluetooth pairing. The laser-based non-contact sensor module scans the operating room, for example, by transmitting laser light pulses, receiving the laser light pulses reflected off the outer walls of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the Bluetooth pairing distance limit.
[0088] The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled via a system bus to a communication module 247, a storage 248, a memory 249, a non-volatile memory 250, and an input / output interface 251. The system bus may use any of various bus architectures including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus, such as a 9-bit bus, an Industry Standard Architecture (ISA), a Micro Channel Architecture (MSA), an Extended ISA (EISA), an Intelligent Drive Electronics (IDE), a VESA Local Bus (VLB), a Peripheral Component Interconnect (PCI), a Universal Serial Bus (USB), an Advanced Graphics Port (AGP), a Personal Computer Memory Card International Association Bus (PCMCIA), a Small Computer System Interface (SCSI), or any other proprietary bus, but is not limited thereto.
[0089] The processor 244 may be any single-core or multi-core processor, such as those known by the trade name of ARM Cortex from Texas Instruments. In one aspect, the processor may include, for example, on-chip memory of 256 KB single-cycle flash memory or other non-volatile memory up to 40 MHz, the details of which are available in the product datasheet, a prefetch buffer for improving performance beyond 40 MHz, 32 KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare (registered trademark) software, 2 KB electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, such as the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.
[0090] In one aspect, the processor 244 may include a safety controller that includes two controller families such as TMS570 and RM4x, also known by the trade name of Hercules ARM Cortex R4 from Texas Instruments. The safety controller may be configured specifically for safety-critical applications of IEC61508 and ISO26262, among others, to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory options.
[0091] System memories include volatile memory and non-volatile memory. The basic input / output system (BIOS), which contains basic routines for transferring information between elements within a computer system during startup and the like, is stored in non-volatile memory. For example, non-volatile memories can include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM) that functions as an external cache memory. Further, RAM is available in many forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), synchlink DRAM (SLDRAM), and direct rambus RAM (DRRAM).
[0092] Computer system 210 also includes removable / non-removable volatile / non-volatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. Additionally, disk storage can include the storage media, either independently or in combination with other storage media such as optical disk drives including, but not limited to, compact disk ROM devices (CD-ROM), compact disk recordable drives (CD-R drives), compact disk rewritable drives (CD-RW drives), or digital versatile disk ROM drives (DVD-ROM). A removable or non-removable interface may be used to facilitate connection of the disk storage device to the system bus.
[0093] It should be understood that computer system 210 includes software that functions as a medium between a user and basic computer resources, which are described in a suitable operating environment. Such software includes an operating system. The operating system, which can be stored on disk storage, functions to control and allocate the resources of the computer system. System applications utilize the resource management by the operating system via 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.
[0094] The user inputs commands or information into the computer system 210 via an input device (s) connected to the I / O interface 251. Examples of input devices include, but are not limited to, pointing devices such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, gamepad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, webcam, etc. These and other input devices are connected to the processor through the system bus via an interface port (s). Examples of interface port (s) include, for example, serial port, parallel port, game port, 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 the computer system and output information from the computer system to the output device. Output adapters are provided, especially among output devices that require special adapters, to indicate the presence of some output devices such as monitors, displays, speakers, and printers. Examples of output adapters include, but are not limited to, video and sound cards that provide connection means between the output device and the system bus. Note that other devices and / or systems of devices, such as remote computer (s), provide both input and output functions.
[0095] The computer system 210 can operate in a networked environment that uses a logical connection to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) can be a personal computer, server, router, network PC, workstation, microprocessor-based device, peer device, or other common network node, and typically includes many or all of the elements described with respect to the computer system. For simplicity, only a memory storage device is shown along with the remote computer(s). The remote computer(s) is logically connected to the computer system via a network interface and subsequently physically connected via a communication connection. The network interface includes communication networks such as local area networks (LANs) and wide area networks (WANs). Examples of LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, etc. Examples of WAN technologies include circuit-switched networks such as point-to-point links, Integrated Services Digital Network (ISDN) and its variants, packet-switched networks, and Digital Subscriber Line (DSL), but are not limited thereto.
[0096] 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 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) used for processing digital images. The image processor can use parallel computing using single instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine can perform various tasks. The image processor may be a system-on-chip with a multi-core processor architecture.
[0097] A communication connection (plural available) refers to the hardware / software used to connect a network interface to a bus. For clarity of illustration, the communication connection is shown inside the computer system, but the communication connection may be external to the computer system 210. For illustrative purposes only, the hardware / software required for connection to a network interface includes modems such as ordinary telephone-grade modems, cable modems, and DSL modems, ISDN adapters, and internal and external technologies such as Ethernet cards.
[0098] FIG. 11 shows a functional block diagram of one aspect of a USB network hub 300 device according to at least one aspect of the present disclosure. In the illustrated aspect, the USB network hub device 300 employs a TUSB2036 integrated circuit hub manufactured by Texas Instruments. The USB network hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 that comply with the USB 2.0 standard. The upstream USB transceiver port 302 is a differential route data port that includes a differential data plus (DP0) input paired with a differential data minus (DM0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports in which each port includes a differential data plus (DP1 - DP3) output paired with a differential data minus (DM1 - DM3) output.
[0099] 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 transceiver ports 304, 306, 308 support both high-speed and low-speed devices by automatically setting the throughput rate according to the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus power mode or self-power mode and includes surgical hub power logic 312 for managing power.
[0100] The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocols described in Chapter 8 of the USB specification. The SIE 310 typically understands signaling up to the transaction level. Functions it handles can include packet recognition, transaction rearrangement, detection / generation of SOP, EOP, RESET, and RESUME signals, clock / data separation, non-return-to-zero inverted (NRZI) data encoding / decoding and bit stuffing, CRC generation and checking (for tokens and data), packet ID (PID) generation, and checking / decoding, and / or serial / parallel / parallel / serial conversion. The SIE 310 receives a clock input 314 and is connected to the suspend / resume logic, frame timer 316 circuitry, and surgical hub repeater circuitry 318 to control communication between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 via port logic circuits 320, 322, 324. The SIE 310 is connected to a command decoder 326 via interface logic for controlling commands from a serial EEPROM via a serial EEPROM interface 330.
[0101] In various aspects, the USB network hub 300 can connect up to 127 functions configured within a maximum of six logical layers (tiers) to a single computer. Further, the USB network hub 300 can be connected to all peripheral devices using four standardized wire cables that provide both communication and power distribution. The power configurations are bus power mode and self-power mode. The USB network hub 300 may be configured to support four modes of power management of a bus-powered hub with either individual port power management or linked port power management, and a self-powered hub with either individual port power management or linked port power management. In one aspect, using a USB cable and the 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 are exposed for connecting USB-compatible devices, and so on.
[0102] FIG. 12 shows a logic diagram of a control system 470 for a surgical instrument or tool according to one or more aspects of the present disclosure. The system 470 includes a control circuit. The control circuit includes a microcontroller 461 having a processor 462 and a memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482 driven by a motor driver 492 is operably coupled to a longitudinally movable displacement member to drive an I-beam knife element. A 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 can be programmed or configured to determine the position of the longitudinally movable drive member and the positions of the firing member, the firing bar, and the I-beam knife element. Additional motors may be provided to the tool driver interface to control the firing of the I-beam, the movement of the closure tube, the rotation of the shaft, and the articulation movement. A display 473 may display various operating conditions of the instrument and include a touch screen function for data input. The information displayed on the display 473 can be overlaid with an image acquired via an endoscopic imaging module.
[0103] In one aspect, the microcontroller 461 may be any single-core or multi-core processor, such as those known by the trade name of ARM Cortex made by Texas Instruments. In one aspect, the main microcontroller 461 may be, for example, an on-chip memory of up to 40 MHz 256 KB single-cycle flash memory or other non-volatile memory, the details of which are available in the product datasheet, a prefetch buffer for improving performance beyond 40 MHz, 32 KB single-cycle SRAM, an internal ROM with StellarisWare® software, 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and / or one or more 12-bit ADCs including 12 analog input channels, such as the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.
[0104] In one aspect, the microcontroller 461 may include a safety controller including two controller families such as TMS570 and RM4x, also known by the trade name of Hercules ARM Cortex R4 made by Texas Instruments. The safety controller may be configured specifically for safety-critical applications of IEC61508 and ISO26262, among others, to provide a high-level integrated safety mechanism while offering scalable performance, connectivity, and memory options.
[0105] The microcontroller 461 may be programmed to perform various functions, such as precise control over the speed and position of the knife and articulation movement system. In one aspect, the microcontroller 461 includes a processor 462 and a memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and a mechanical coupling to the articulation movement or knife system. In one aspect, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily replaced for use in the tracking system 480 with an absolute positioning system. A detailed description of the absolute positioning system is described in U.S. Patent Application Publication No. 2017 / 0296213, published Oct. 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT", which is hereby incorporated by reference in its entirety.
[0106] The microcontroller 461 may be programmed to provide accurate control over the speed and position of the displacement member and the articulation movement system. The microcontroller 461 may be configured to calculate a response within the software of the microcontroller 461. The calculated response is compared with the measured response of the actual system to obtain an "observed" response, which is used for the determination of the actual feedback. The observed response is a suitably adjusted value that balances the smooth and continuous nature of the response by simulation and the response by measurement, which can detect external influences on the system.
[0107] In one aspect, the motor 482 may be controlled by a motor driver 492 and may be used by a surgical instrument or tool firing system. In various forms, the motor 482 may be, for example, a brushed DC drive motor having a maximum rotational speed of about 25,000 RPM. In other configurations, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may comprise, for example, an H-bridge driver including field effect transistors (FETs). The motor 482 may be powered by a power supply assembly removably attached to the handle assembly or tool housing to supply control power to the surgical instrument or tool. The power supply assembly may include a battery including a number of battery cells connected in series that may be used as a power source to power the 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 cells may be lithium ion batteries that may be connectable to and separable from the power supply assembly.
[0108] The motor driver 492 may be the A3941 available from Allegro Microsystems, Inc. The A3941 motor 492 is a full-bridge controller for use with an external N-channel power metal oxide semiconductor field effect transistor (MOSFET) designed specifically for inductive loads such as brushed DC motors. The driver 492 includes an inherent charge pump regulator that provides full (>10V) gate drive to battery voltages down to 7V, enabling the A3941 to operate with a reduced gate drive down to 5.5V. A bootstrap capacitor may be used to provide the above battery supply voltage required for the N-channel MOSFET. The internal charge pump for high-side drive enables DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay modes using diodes or synchronous rectification. In the slow decay mode, current recirculation is possible by either the high-side FET or the low-side FET. The power FETs are protected from shoot-through by a register-adjustable dead time. The integrated diagnostics indicate low voltage, overtemperature, and power bridge anomalies and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers can be easily substituted for use in the tracking system 480 with an absolute positioning system.
[0109] The tracking system 480 comprises a controlled motor drive circuit configuration with a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for an 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 having a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reduction assembly. In other aspects, the displacement member may represent a firing member adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Accordingly, as used herein, the term displacement member is used to generally refer to any movable member of a surgical instrument, such as a drive member, a firing member, a firing bar, an I-beam, or any element that can be displaced. In one aspect, the longitudinally movable drive member is coupled to the firing member, the firing bar, and the I-beam. Thus, the absolute positioning system can, in effect, 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. Thus, the longitudinally movable drive member, the firing member, the firing bar, or the I-beam, or combinations thereof, may be coupled to any suitable displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor. The linear displacement sensor may include a linear variable differential transformer (LVDT), a differential variable reluctance transducer (DVRT), a slide potentiometer, a magnetic sensing system including a movable magnet and a series of Hall effect sensors disposed in a line, a magnetic sensing system including a fixed magnet and a series of Hall effect sensors disposed on a series of movable lines, an optical detection system including a movable light source and a series of photodiodes or photodetectors disposed in a line, an optical detection system including a fixed light source and a series of photodiodes or photodetectors disposed on a series of movable lines, or any combination thereof.
[0110] The electric motor 482 may include a rotary shaft operably coupled to a gear assembly that is mounted in meshing engagement with a set of drive teeth or a rack on the displacement member. The sensor element may be operably coupled to the gear assembly such that one revolution of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gear ring and sensor mechanism can be connected to the linear actuator by a rack and pinion mechanism or to a rotary actuator by a spur gear or other connection. The power supply supplies power to the absolute positioning system, and the output indicator can display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member having a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reduction assembly. The displacement member represents a longitudinally movable firing member, firing bar, I-beam, or combination thereof.
[0111] One revolution of the sensor element associated with the position sensor 472 corresponds to a longitudinal linear displacement d1 of the displacement member, where d1 is the linear distance in the longitudinal direction that the displacement member moves from point "a" to point "b" after the sensor element coupled to the displacement member has made one revolution. The sensor mechanism may be connected via a reduction of the gear that results in the position sensor 472 completing more than one revolution for the full stroke of the displacement member. The position sensor 472 can complete multiple revolutions for the full stroke of the displacement member.
[0112] To provide a unique position signal for more than two rotations of the position sensor 472, a series of switches (where n is an integer greater than 1) may be used either alone or in combination with a gear reduction. The state of the switches is fed back to the microcontroller 461, which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1 + d2 +... dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor mechanism may comprise an analog rotational sensor such as a magnetic sensor, a potentiometer, etc., or an array of analog Hall effect elements, which outputs a unique combination of position signals or values.
[0113] The position sensor 472 may comprise any number of magnetic sensing elements, such as a magnetic sensor classified, for example, based on whether it measures the total magnetic field or a vector component of the magnetic field. The technologies used to produce both types of magnetic sensors involve many aspects of physics and electronics. Technologies used for magnetic field sensing include, among others, search coils, flux gates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetic impedance, magnetostrictive / piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magneto-optics, and microelectromechanical system-based magnetic sensors.
[0114] In one aspect, the position sensor 472 of the tracking system 480 comprising an absolute positioning system comprises a magnetic rotary absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 472 cooperates with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low-voltage and low-power component and includes four Hall effect elements in the area of the position sensor 472 located above the magnet. Further, a high-resolution ADC and a smart power management controller are provided on the chip. A coordinate rotation digital computer (CORDIC) processor, also known as the digit-by-digit method and Volder's algorithm, is provided to implement a concise and efficient algorithm for calculating hyperbolic and trigonometric functions that only requires addition, subtraction, bit shifting, and table reference operations. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 via a standard serial communication interface such as a serial peripheral interface (SPI) interface. The position sensor 472 provides a resolution of 12 bits or 14 bits. The position sensor 472 may be an AS5055 chip provided in a small QFN16-pin 4×4×0.85 mm package.
[0115] Tracking system 480 with an absolute positioning system may include and / or be programmed to implement a feedback controller such as a PID, a state feedback, and an adaptive controller. A power supply converts a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by the position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, other sensor(s) may include sensor configurations such as those described in U.S. Patent No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM", which is hereby incorporated by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM", which is hereby incorporated by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT", which is hereby incorporated by reference in its entirety. In a digital signal processing system, the 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. The absolute positioning system may include a comparison and combination circuit to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, and inductive resistance to predict how the state and output of the physical system will be based on knowing the input.
[0116] The absolute positioning system provides the absolute position of the displacement member upon power-up of the instrument without having to retract or advance the displacement member to a reset position (zero or home), as may be required by conventional rotary encoders that count the number of steps the motor 482 has simply traveled forward or backward to estimate the position of device actuators, drive bars, knives, etc.
[0117] For example, a sensor 474, such as a strain gauge or a micro strain gauge, is configured to measure one or more parameters of the end effector, such as the amplitude of the strain exerted on the anvil during a clamping operation, which can indicate, for example, the closing force applied to the anvil. The measured strain is converted into a digital signal and provided to the processor 462. Instead of, or in addition to, the sensor 474, a sensor 476, such as a load cell, for example, can measure the closing force applied to the anvil by the closing drive system. For example, a sensor 476, such as a load cell, 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 thread, which is configured to cam the staple driver upward to eject staples and bring them into deformation contact with the anvil. The I-beam also includes a sharp cutting edge that can be used to cut tissue when the I-beam is advanced distally by a firing bar. Alternatively, a current sensor 478 can be used to measure the current draw by the motor 482. The force required to advance the firing member can correspond, for example, to the current drawn by the motor 482. The measured force is converted into a digital signal and provided to the processor 462.
[0118] In one form, a strain gauge sensor 474 can be used to measure the force applied to tissue by an end effector. To measure the force exerted by the end effector on the tissue being treated, a strain gauge can be coupled to the end effector. A system for measuring the force applied to tissue grasped by an end effector includes, for example, a strain gauge sensor 474 such as a micro strain gauge configured to measure one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain exerted on the jaw members of the end effector during a clamping operation, which can indicate compression of the tissue. The measured strain is converted to a digital signal and provided to a processor 462 of a microcontroller 461. A load sensor 476 can measure, for example, the force used to operate a knife element to cut tissue captured between an anvil and a staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. The measurements of the magnetic field sensor can also be converted to a digital signal and provided to the processor 462.
[0119] The measurements of tissue compression, tissue thickness, and / or the force required to close the end effector on the tissue, respectively measured by sensors 474, 476, can be used by the microcontroller 461 to characterize corresponding values of a selected position of the firing member and / or the velocity of the firing member. In one example, the memory 468 can store techniques, equations, and / or look-up tables that can be used by the microcontroller 461 during evaluation.
[0120] The control system 470 of the surgical instrument or tool may also include a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 8-11.
[0121] FIG. 13 shows a control circuit 500 configured to control aspects of a surgical instrument or tool. The control circuit 500 can be configured to implement the various processes described herein. The control circuit 500 can comprise a microcontroller comprising one or more processors 502 (e.g., a microprocessor, a microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions for implementing the various processes described herein. The processor 502 can be any one of a number of single- or multi-core processors known in the art. The memory circuit 504 can include volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present disclosure.
[0122] FIG. 14 shows a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool. The combinational logic circuit 510 can be configured to implement the various processes described herein. The combinational logic circuit 510 can include a finite state machine including combinational logic 512 configured to receive data associated with a surgical instrument or tool at an input 514, process the data by the combinational logic 512, and provide an output 516.
[0123] FIG. 15 shows a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool. The sequential logic circuit 520 or combinatorial logic 522 can be configured to implement the various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 can store the current state of the finite state machine. In a particular example, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data by the combinatorial logic 522, and provide an output 528. In other aspects, the circuit may include a combination of a processor (e.g., processor 502 of FIG. 13) and a finite state machine that implements the various processes herein. In other aspects, the finite state machine can include a combination of a combinatorial logic circuit (e.g., combinatorial logic circuit 510 of FIG. 14) and the sequential logic circuit 520.
[0124] FIG. 16 shows a surgical instrument or tool having a plurality of motors that can be activated to perform various functions. In a particular example, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In a particular example, the plurality of motors of the robotic surgical instrument 600 can be individually activated to cause firing motion, closing motion, and / or articulation motion at an end effector. The firing motion, closing motion, and / or articulation motion can be transmitted to the end effector, for example, via a shaft assembly.
[0125] In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604 configured to transmit the firing motion generated by the firing motor 602 to the end effector, specifically to displace an I-beam element. In certain examples, the firing motion generated by the firing motor 602 may deploy, for example, staples from a staple cartridge into tissue captured by the end effector and / or advance the cutting edge of the I-beam element to cut the captured tissue. The I-beam element may be retracted by reversing the direction of the firing motor 602.
[0126] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 configured to transmit the closure motion generated by the motor 603 to the end effector, specifically to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. By the closure motion, for example, the end effector can transition from an open configuration to an approaching configuration to capture tissue. The end effector may be transitioned to an open position by reversing the direction of the motor 603.
[0127] In certain examples, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The articulation motors 606a, 606b may be operably coupled to corresponding articulation motor drive assemblies 608a, 608b configured to transmit the articulation motion generated by the articulation motors 606a, 606b to the end effector. In certain examples, by the articulation motion, for example, the end effector can articulate with respect to the shaft.
[0128] As described above, a surgical instrument or tool may include a plurality of motors configured to perform various independent functions. In certain examples, a plurality of motors of a surgical instrument or tool can be activated independently or separately to perform one or more functions while other motors remain stopped. For example, the joint movement motors 606a, 606b can be activated to move the end effector in joint movement while the firing motor 602 remains stopped. Alternatively, the firing motor 602 can be activated to fire a plurality of staples and / or advance the blade tip while the joint movement motors 606 are stopped. Further, the closure motor 603 may be activated simultaneously with the firing motor 602 to advance the closure tube and the I-beam element distally, as will be described in more detail below.
[0129] In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with a plurality of motors of the surgical instrument or tool. In certain examples, the common control module 610 can correspond to one of a plurality of motors at a time. For example, the common control module 610 may be individually connectable and separable with respect to a plurality of motors of a robotic surgical instrument. In certain examples, a plurality of motors of a surgical instrument or tool may share one or more common control modules such as the common control module 610. In certain examples, a plurality of motors of a surgical instrument or tool can engage with the common control module 610 independently and selectively. In certain examples, the common control module 610 can selectively switch from cooperation with one of a plurality of motors of a surgical instrument or tool to cooperation with another of the plurality of motors of the surgical instrument or tool.
[0130] In at least one example, a common control module 610 can selectively switch between an operable engagement with the articulation motors 606a, 606b and an operable engagement with either the firing motor 602 or the closure motor 603. In at least one embodiment, as shown in FIG. 16, a switch 614 can move or transition between multiple positions and / or states. For example, in a first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602, and in a second position 617, the switch 614 may electrically couple the common control module 610 to the closure motor 603. In a third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606a, and in a fourth position 618b, the switch 614 may electrically couple the common control module 610 to the second articulation motor 606b. In a particular example, a separate common control module 610 may be electrically coupled to the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b simultaneously. In a particular example, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.
[0131] Each of the motors 602, 603, 606a, 606b may include a torque sensor for measuring the output torque on the motor shaft. The force on the end effector may be sensed by any conventional method, such as by a force sensor outside of the jaw or by a torque sensor of the motor that actuates the jaw.
[0132] 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. The motor driver 626 may modulate the power transmitted from the power supply 628 to a motor connected to the common control module 610 based on an input from, for example, a microcontroller 620 (the "controller"). In certain examples, as described above, for example, while the motor is connected to the common control module 610, the current drawn by the motor can be determined using the microcontroller 620.
[0133] In certain examples, the microcontroller 620 may include a microprocessor 622 (the "processor") and one or more non-transitory computer-readable media or memory units 624 (the "memory"). In certain examples, the memory 624 can store various program instructions that, when executed, can cause the processor 622 to perform the multiple functions and / or calculations described herein. In certain examples, one or more of the memory units 624 may be connected to the processor 622, for example.
[0134] In certain examples, the power supply 628 may be used to supply power to, for example, the microcontroller 620. In certain examples, the power supply 628 may include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In certain examples, the battery pack may be configured to be removably attached to the handle to supply power to the surgical instrument 600. A number of battery cells connected in series may be used as the power supply 628. In certain examples, the power supply 628 may be, for example, replaceable and / or rechargeable.
[0135] In various examples, the processor 622 can control the motor driver 626 to control the position, rotational direction, and / or speed of a motor coupled to the common control module 610. In a particular example, the processor 622 can signal the motor driver 626 to stop and / or disable a motor coupled to the common control module 610. As used herein, the term "processor" is to be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a central processing unit (CPU) of a computer on one integrated circuit or, at most, a few integrated circuits. A processor is a multipurpose programmable device that accepts digital data as input, processes that data in accordance with instructions stored in memory, and provides results as output. Since this has internal memory, it is an example of sequential digital logic. A processor operates on numbers and symbols represented in binary notation.
[0136] In one example, the processor 622 may be any single-core or multi-core processor, such as those known by the trade name of ARM Cortex made by Texas Instruments. In a specific example, the microcontroller 620 may be, for example, LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the LM4F230H5QR of Texas Instruments is, among other characteristics readily available in the product datasheet, an on-chip memory of 256KB single-cycle flash memory or other NVM with a maximum of 40MHz, a prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle SRAM, an internal ROM equipped with StellarisWare (registered trademark) software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs, and one or more 12-bit ADCs with 12 analog input channels, which is an ARM Cortex-M4F processor core. Other microcontrollers may be easily substituted for use with the module 4410. Therefore, the present disclosure should not be limited to this context.
[0137] In a specific example, the memory 624 may include program instructions for controlling the motors of the surgical instrument 600 that can be connected to the common control module 610, respectively. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606a, 606b. Such program instructions can cause the processor 622 to control the firing function, the closing function, and the articulation function according to the input from the algorithm or control program of the surgical instrument or tool.
[0138] In certain examples, one or more mechanisms and / or sensors, such as sensor 630, can be used to alert processor 622 of program instructions to be used in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions related to the firing, closing, and articulation of the end effector. In certain examples, sensor 630 may comprise a position sensor that can be used, for example, to sense the position of switch 614. Thus, processor 622 can use the program instructions associated with the firing of the I-beam of the end effector when it detects, via sensor 630, that switch 614 is in the first position 616, and processor 622 can use the program instructions associated with the closing of the anvil when it detects, via sensor 630, that switch 614 is in the second position 617, and processor 622 can use the program instructions associated with the articulation of the end effector when it detects, via sensor 630, that switch 614 is in the third position 618a or the fourth position 618b.
[0139] FIG. 17 is a circuit diagram of a robotic surgical instrument 700 configured to operate a surgical tool as described herein, according to one aspect of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control the distal / proximal translation of a displacement member, the distal / proximal displacement of a closure tube, the rotation of a shaft, and the articulation using any of a single or multiple articulation drive linkages. In one aspect, the surgical instrument 700 may be programmed or configured to individually control a firing member, a closure member, a shaft member, and / or one or more articulation members. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, closure member, shaft member, and / or one or more articulation members.
[0140] In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control, via a plurality of motors 704a - 704e, the anvil 716 and the I-beam 714 (including the sharp cutting edge) portion of the end effector 702, the removable staple cartridge 718, the shaft 740, and one or more articulating members 742a, 742b. A position sensor 734 may be configured to provide position feedback of the I-beam 714 to the control circuit 710. Other sensors 738 may be configured to provide feedback to the control circuit 710. A timer / counter 731 provides timing and count information to the 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. The motors 704a - 704e can be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.
[0141] In one aspect, the control circuit 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause one or more processors to perform one or more tasks. 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 determined by the position sensor 734 with the output of the timer / counter 731, such that the control circuit 710 can determine the position of the I-beam 714 at a particular time (t) relative to the start position or time (t) when the I-beam 714 is at a particular position relative to the start position. The timer / counter 731 may be configured to measure an elapsed time, count external events, or measure the time of external events.
[0142] In one aspect, the control circuit 710 may be programmed to control the function of the end effector 702 based on one or more tissue states. The control circuit 710 may be programmed to sense a tissue state, such as thickness, either directly or indirectly as described herein. The control circuit 710 may be programmed to select a firing control program or a closure control program based on the tissue state. The firing control program can describe the distal movement of the displacement member. Various firing control programs can be selected to better handle various tissue states. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a slower speed and / or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a faster speed and / or with higher power. The closure control program can control the closure force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and the articulating movement members 742a, 742b.
[0143] In one aspect, the control circuit 710 may generate a motor setpoint signal. The motor setpoint signal may be provided to various motor controllers 708a - 708e. The motor controllers 708a - 708e may include one or more circuits configured to provide motor drive signals to motors 704a - 704e to drive the motors 704a - 704e as described herein. In some embodiments, the motors 704a - 704e may be brushed DC electric motors. For example, the speed of the 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 their respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a - 704e. Also, in some embodiments, the motor controllers 708a - 708e may be omitted, and the control circuit 710 may directly generate the motor drive signals.
[0144] In one aspect, the control circuit 710 may first operate each of the motors 704a - 704e in an open - loop configuration during a first open - loop portion of the stroke of the displacement member. 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 firing control program in a closed - loop configuration. Examples of the response of the instrument may include 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 total pulse width of the motor drive signal, and the like. After the open - loop portion, the control circuit 710 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 710 may modulate one of the 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.
[0145] In one aspect, motors 704a - 704e can receive power from an energy source 712. The energy source 712 may be a main AC power source, a battery, a supercapacitor, or a DC power source driven by any other suitable energy source. Motors 704a - 704e may be 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 transmission devices 706a - 706e. Transmission devices 706a - 706e may include one or more gears or other connection components for connecting motors 704a - 704e to the movable mechanical elements. A position sensor 734 can sense the position of the I - beam 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicating the position of the I - beam 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to a control circuit 710 as the I - beam 714 translates in the distal and proximal directions. The control circuit 710 may track the pulses to determine the position of the I - beam 714. Other suitable position sensors, such as proximity sensors, may be used. Other types of position sensors may provide other signals indicating the movement of the I - beam 714. Also, in some embodiments, the position sensor 734 may be omitted. If any of the motors 704a - 704e is a stepper motor, the control circuit 710 can track the position of the I - beam 714 by summing the number and direction of steps instructed for the motor 704 to execute. The position sensor 734 may be located within the end - effector 702 or any other part of the instrument. Each output of motors 704a - 704e includes a torque sensor 744a - 744e for sensing force and has an encoder for sensing the rotation of the drive shaft.
[0146] In one aspect, the control circuit 710 is configured to drive a firing member such as the I-beam 714 portion of the end effector 702. The control circuit 710 provides a motor setpoint to the motor control unit 708a, and the motor control unit 708a provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to the torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a that is coupled to the I-beam 714. The transmission 706a includes movable mechanical elements such as a rotating element and a firing member for controlling the movement of the I-beam 714 in the distal and proximal directions along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set including a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to fire or displace the I-beam 714. The position sensor 734 may be configured to provide the control circuit 710 with the position of the I-beam 714 or the position of the firing member along the firing stroke as a feedback signal. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor control unit 708a. In response to the firing signal, the motor 704a can drive the firing member in the distal direction along the longitudinal axis of the end effector 702 from a proximal stroke start position to a stroke end position distal to the stroke start position. As the firing member translates distally, the I-beam 714, which includes a cutting element positioned at the distal end, advances distally to cut tissue positioned between the staple cartridge 718 and the anvil 716.
[0147] In one aspect, the control circuit 710 is configured to drive a closing member such as the anvil 716 portion of the end effector 702. The control circuit 710 provides a motor setpoint to a motor control unit 708b that provides a drive signal to the motor 704b. The output shaft of the motor 704b is coupled to a torque sensor 744b. The torque sensor 744b is coupled to a transmission device 706b coupled to the anvil 716. The transmission device 706b includes movable mechanical elements such as a rotating element and a closing member for controlling the movement of the anvil 716 from an open position and a closed position. In one aspect, the motor 704b is coupled to a closing gear assembly that includes a closing reduction gear set supported in meshing engagement with a closing spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal represents the closing force applied to the anvil 716. A position sensor 734 may be configured to provide the control circuit 710 with a feedback signal of the position of the closing member. An additional sensor 738 within the end effector 702 can provide the closing force feedback signal to the control circuit 710. The pivotable anvil 716 is positioned on the opposite side of the staple cartridge 718. When ready for use, the control circuit 710 can provide a closing signal to the motor control unit 708b. In response to the closing signal, the motor 704b advances the closing member to grip tissue between the anvil 716 and the staple cartridge 718.
[0148] In one aspect, the control circuit 710 is configured to rotate a shaft member, such as shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor setpoint to a motor control unit 708c that provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission device 706c coupled to the shaft 740. The transmission device 706c includes a movable mechanical element, such as a rotating element, to control the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is coupled to a rotational transmission device assembly including a tubular gear segment formed on (or attached to) the proximal end of the proximal closure tube so as to be operably engaged by a rotational gear assembly operably supported on the tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. A position sensor 734 may be configured to provide the position of the closure member to the control circuit 710 as a feedback signal. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.
[0149] In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides motor setpoints to a motor control unit 708d that provides drive signals to a motor 704d. The output shaft of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission 706d that is coupled to an articulation member 742a. The transmission 706d includes movable mechanical elements such as articulation elements for controlling the ±65° articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut that is rotatably supported on the proximal end portion of the distal spine portion and is rotatably driven by an articulation gear assembly on the proximal end portion of the distal spine portion. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the control circuit 710 with the articulation position of the end effector 702.
[0150] In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members, or links 742a, 742b. These articulation members 742a, 742b are driven by individual disks on a robotic interface (rack) that is driven by two motors 704d, 704e. When an individual firing motor 704a is provided, each of the articulation links 742a, 742b can be driven antagonistically with respect to the other links to provide a holding resistance movement and load to the head when the head is not moving and to provide articulation when the head is articulating. The articulation members 742a, 742b are attached to the head at a fixed radius as the head rotates. Thus, as the head rotates, the mechanical efficiency of the push-pull link changes. This change in mechanical efficiency can be more pronounced in the drive systems of other articulation links.
[0151] In one aspect, one or more of the motors 704a-704e may comprise a brushed DC motor with a gearbox and a mechanical connection to a firing member, a closure member, or an articulating member. As another example, the electric motors 704a-704e operate movable mechanical elements such as displacement members, articulation joints, closure tubes, and shafts. External influences are unmeasured and unpredictable influences such as those of tissue, ambient bodies, and friction on the physical system. Such external influences may be referred to as a drag acting against one of the electric motors 704a-704e. External influences such as drag may cause the operation of the physical system to deviate from the desired operation of the physical system.
[0152] In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may comprise a magnetic rotary absolute positioning system implemented as the AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 734 may provide an absolute positioning system in association with the control circuit 710. The position may be located above the magnet and may include a plurality of Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the Volder algorithm, which implements a concise and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition, subtraction, bit shifting, and table reference operations.
[0153] In one aspect, the control circuit 710 may communicate with one or more sensors 738. The sensors 738 may be positioned on the end effector 702 and 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. The sensors 738 may include inductive sensors such as magnetic sensors, magnetic field sensors, strain gauges, load cells, pressure sensors, force sensors, torque sensors, eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 702. The sensors 738 may include one or more sensors. The sensors 738 may be located on the deck of the staple cartridge 718 to determine the position of tissue using segmented electrodes. The torque sensors 744a - 744e may be configured to sense forces such as, among other things, firing force, closing force, and / or articulation force. Thus, the control circuit 710 can sense (1) the closing load experienced by the distal closing tube and its position, (2) the firing member in the rack and its position, (3) which portion of the staple cartridge 718 has tissue thereon, and (4) the load and position on both articulation rods.
[0154] In one aspect, one or more sensors 738 may include strain gauges such as micro - strain gauges configured to measure the magnitude of strain in the anvil 716 during the clamped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensors 738 may include pressure sensors configured to detect the pressure generated by the presence of tissue compressed between the anvil 716 and the staple cartridge 718. The sensors 738 may be configured to detect the impedance of the tissue portion located between the anvil 716 and the staple cartridge 718, and this impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0155] In one aspect, the sensor 738 may be implemented as, among other things, one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers. In other implementations, the sensor 738 may be implemented as, among other things, solid state switches that operate under the influence of light, such as optical sensors, IR sensors, ultraviolet sensors. Further, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include, among other things, conductor-free switches, ultrasonic switches, accelerometers, and inertial sensors.
[0156] In one aspect, the sensor 738 may be configured to measure the force exerted on the anvil 716 by the closure drive system. For example, one or more sensors 738 may be positioned at the point of interaction between the closure tube and the anvil 716 to detect the closure force applied to the anvil 716 by the closure tube. The force exerted on the anvil 716 may represent the tissue compression experienced by the tissue portion captured between the anvil 716 and the staple cartridge 718. One or more sensors 738 may be positioned at various points of interaction along the closure drive system to detect the closure force applied to the anvil 716 by the closure drive system. One or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. The control circuit 710 receives real-time sample measurements, provides and analyzes time-based information, and evaluates in real time the closure force applied to the anvil 716.
[0157] In one aspect, a 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 motors 704a - 704e. The force is converted into a digital signal and provided to control circuit 710. Control circuit 710 can be configured to simulate the response of the actual system of the instrument with the controller's software. The displacement member can be actuated to move the I - beam 714 within end - effector 702 at or near a target velocity. Robotic surgical instrument 700 can include a feedback controller, which can be any one of, for example, but not limited to, a PID, state - feedback, linear - quadratic (LQR), and / or adaptive controller. Robotic surgical instrument 700 can include a power source for converting a signal from the feedback controller into a physical input such as, for example, case voltage, PWM voltage, frequency - modulated voltage, current, torque, and / or force. Further details are disclosed in U.S. Patent Application No. 15 / 636,829, filed on June 29, 2017, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT", which is hereby incorporated by reference in its entirety.
[0158] FIG. 18 shows a block diagram of a surgical instrument 750 programmed to control the distal translation of a displacement member, according to one aspect of the present disclosure. In one aspect, surgical instrument 750 is programmed to control the distal translation of a displacement member, such as I - beam 764. Surgical instrument 750 includes an end - effector 752 that can include an anvil 766, an I - beam 764 (including a sharp cutting edge), and a removable staple cartridge 768.
[0159] The position, movement, displacement, and / or translation of a linear displacement member, such as the closure member 764, can be measured by an absolute positioning system, a sensor configuration, and a position sensor 784. Since the I-beam 764 is connected to a longitudinally movable drive member, the position of the I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and / or translation of the I-beam 764 can be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control the translation of a displacement member, such as the I-beam 764. In some embodiments, the control circuit 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions to cause a displacement member, such as the I-beam 764, to be controlled in the manner described. In one aspect, a timer / counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuit 760 to correlate the position of the I-beam 764 determined by the position sensor 784 with the output of the timer / counter 781, such that the control circuit 760 can determine the position of the I-beam 764 at a particular time (t) relative to the starting position. The timer / counter 781 may be configured to measure an elapsed time, count external events, or measure the time of external events.
[0160] The control circuit 760 may generate a motor setpoint signal 772. The motor setpoint signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to drive the motor 754 by providing a motor drive signal 774 to the motor 754 as described herein. In some embodiments, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor, and the motor drive signal 774 may include a PWM signal provided to one or more stator windings of the motor 754. Also, in some embodiments, the motor controller 758 may be omitted, and the control circuit 760 may directly generate the motor drive signal 774.
[0161] Motor 754 may receive power from an energy source 762. The energy source 762 may be a battery, a supercapacitor, or any other suitable energy source, or may include it. Motor 754 may be mechanically coupled to the I-beam 764 via a transmission device 756. The transmission device 756 may include one or more gears or other coupling components for coupling the motor 754 to the I-beam 764. A position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or may include any type of sensor capable of generating position data indicating the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the I-beam 764 translates in the distal and proximal directions. The control circuit 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors, such as proximity sensors, may be used. Other types of position sensors may provide other signals indicative of the movement of the I-beam 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuit 760 may track the position of the I-beam 764 by summing the number and direction of steps instructed for the motor 754 to execute. The position sensor 784 may be located within the end effector 752 or any other part of the instrument.
[0162] The control circuit 760 may communicate with one or more sensors 788. The sensors 788 are positioned on the end effector 752 and may be 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. The sensors 788 may include inductive sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 752. The sensors 788 may include one or more sensors.
[0163] One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the anvil 766 during the clamping state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of tissue compressed between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of the tissue portion located between the anvil 766 and the staple cartridge 768, and this impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0164] The sensor 788 may be configured to measure the force exerted on the anvil 766 by a closing drive system. For example, one or more sensors 788 may be located at the interaction point between the closing tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closing tube. The force exerted on the anvil 766 may represent the tissue compression experienced by the tissue portion captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closing drive system to detect the closing force applied to the anvil 766 by the closing drive system. One or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during the clamping operation. The control circuit 760 receives the real-time sample measurements, provides and analyzes the time-based information, and evaluates the closing force applied to the anvil 766 in real time.
[0165] A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current drawn by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.
[0166] The control circuit 760 can be configured to simulate the response of the actual system of the instrument with the controller's software. The displacement member can be actuated to move the I-beam 764 within the end effector 752 at or near the target speed. The surgical instrument 750 can include a feedback controller, which can be any one of any feedback controllers, such as, but not limited to, PID, state feedback, LQR, and / or adaptive controllers. The surgical instrument 750 can include a power source for converting the signal from the feedback controller into a physical input such as, for example, case voltage, PWM voltage, frequency modulation voltage, current, torque, and / or force.
[0167] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or I-beam 764 by a brushed DC motor with a gearbox and mechanical connections to the articulation and / or knife system. Another example is an electric motor 754 of a replaceable shaft assembly that operates, for example, the displacement member and articulation driver. External influences are unmeasured and unpredictable influences such as tissue, ambient bodies, and friction on the physical system. Such external influences may be referred to as disturbances that act against the electric motor 754. External influences such as disturbances may cause the operation of the physical system to deviate from the desired operation of the physical system.
[0168] Various exemplary aspects are directed to a surgical instrument 750 comprising an end effector 752 having motor-driven surgical stapling and cutting means. For example, a motor 754 may drive a displacement member in distal and proximal directions along the longitudinal axis of the end effector 752. The end effector 752 may include a pivotable anvil 766 and, when configured for use, a staple cartridge 768 positioned on the opposite side of the anvil 766. A clinician may grasp tissue between the anvil 766 and the staple cartridge 768 as described herein. When the instrument 750 is ready for use, the clinician can provide a firing signal, for example, by pressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member in a distal direction along the longitudinal axis of the end effector 752 from a proximal stroke start position to a stroke end position distal of the stroke start position. As the displacement member translates distally, an I-beam 764 having a cutting element positioned at its distal end can cut tissue between the staple cartridge 768 and the anvil 766.
[0169] In various embodiments, the surgical instrument 750 may comprise a control circuit 760 programmed to control the distal translation of a displacement member, such as the I-beam 764, based on one or more tissue states. The control circuit 760 may be programmed to sense a tissue state, such as thickness, either directly or indirectly as described herein. The control circuit 760 may be programmed to select a firing control program based on the tissue state. The firing control program may describe the distal movement of the displacement member. Various firing control programs can be selected to better handle various tissue states. For example, if thicker tissue is present, the 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, the control circuit 760 may be programmed to translate the displacement member at a faster speed and / or with more power.
[0170] In some embodiments, the control circuit 760 may first operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's stroke. Based on the response of the instrument 750 during the open-loop portion of the stroke, the control circuit 760 may select a firing control program. Examples of the response of the instrument may include the translational distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to the motor 754 during the open-loop portion, the total pulse width of the motor drive signal, and the like. After the open-loop portion, the 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 are disclosed in U.S. Patent Application No. 15 / 720,852, filed on September 29, 2017, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT", which is hereby incorporated by reference in its entirety.
[0171] FIG. 19 is a schematic view of a surgical instrument 790 configured to control various functions, according to at least one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control the distal translation of a displacement member, such as an I-beam 764. The surgical instrument 790 includes an end effector 792 that may include an anvil 766, an I-beam 764, and a detachable staple cartridge 768 that can be exchanged with an RF cartridge 796 (shown in dashed lines).
[0172] In one aspect, the sensor 788 may be implemented, among other things, as a limit switch, an electromechanical device, a solid state switch, a Hall effect device, an MR device, a GMR device, or a magnetometer. In other implementations, the sensor 638 may be, among other things, a solid state switch that operates under the influence of light, such as an optical sensor, an IR sensor, or an ultraviolet sensor. Further, the switch may be a solid state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 788 may include, among other things, a conductor-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.
[0173] In one aspect, the position sensor 784 may be implemented as an absolute positioning system including a magnetic rotary absolute positioning system implemented as the AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 784 may provide an absolute positioning system in association with the control circuit 760. The position may be located above the magnet and may include a plurality of Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the Volder algorithm, which implements a concise and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition, subtraction, bit shifting, and table reference operations.
[0174] In one aspect, the I-beam 764 may be implemented as a knife member that includes a knife body that operably supports a tissue cutting blade thereon, and may further include an anvil engagement tab or feature and a passage engagement feature or foot. In one aspect, the staple cartridge 768 may be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, the RF cartridge 796 may be implemented as an RF cartridge. These, and other sensor configurations, are described in U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, of the same assignee, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT", which is hereby incorporated by reference in its entirety.
[0175] The position, movement, displacement, and / or translation of a linear displacement member, such as the I-beam 764, can be measured by an absolute positioning system, a sensor configuration, and a position sensor represented as the position sensor 784. Since the I-beam 764 is connected to a drive member that is movable in the longitudinal direction, the position of the I-beam 764 can be determined by measuring the position of the drive member that is movable in the longitudinal direction using the position sensor 784. Therefore, in the following description, the position, displacement, and / or translation of the I-beam 764 can be achieved by the position sensor 784 described herein. As described herein, the control circuit 760 may be programmed to control the translation of a displacement member, such as the I-beam 764. In some embodiments, the control circuit 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions to cause a displacement member, such as the I-beam 764, to be controlled in the described manner. In one aspect, the timer / counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuit 760 to correlate the position of the I-beam 764 determined by the position sensor 784 with the output of the timer / counter 781, such that the control circuit 760 can determine the position of the I-beam 764 at a particular time (t) relative to the starting position. The timer / counter 781 may be configured to measure an elapsed time, count external events, or measure the time of external events.
[0176] The control circuit 760 may generate a motor setpoint signal 772. The motor setpoint signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to drive the motor 754 by providing a motor drive signal 774 to the motor 754 as described herein. In some embodiments, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor, and the motor drive signal 774 may include a PWM signal provided to one or more stator windings of the motor 754. Also, in some embodiments, the motor controller 758 may be omitted, and the control circuit 760 may directly generate the motor drive signal 774.
[0177] The motor 754 may receive power from an energy source 762. The energy source 762 may be, or may include, a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via a transmission device 756. The transmission device 756 may include one or more gears or other coupling components for coupling the motor 754 to the I-beam 764. A position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be, or may include, any type of sensor capable of generating position data indicative of the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to a control circuit 760 as the I-beam 764 translates in the distal and proximal directions. The control circuit 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors, such as proximity sensors, may be used. Other types of position sensors may provide other signals indicative of the movement of the I-beam 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuit 760 may track the position of the I-beam 764 by totaling the number and direction of steps the motor is instructed to perform. The position sensor 784 may be located within the end effector 792 or any other part of the instrument.
[0178] The control circuit 760 may communicate with one or more sensors 788. The sensors 788 are positioned on the end effector 792 and may be adapted to operate with the surgical instrument 790 to measure various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may include inductive sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 792. The sensors 788 may include one or more sensors.
[0179] One or more sensors 788 may include strain gauges, such as micro strain gauges, configured to measure the magnitude of strain in anvil 766 during the clamping state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of tissue compressed between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of a tissue portion located between the anvil 766 and the staple cartridge 768, and this impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0180] The sensor 788 may be configured to measure the force exerted on the anvil 766 by a closing drive system. For example, one or more sensors 788 may be located at the interaction point between the closing tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closing tube. The force exerted on the anvil 766 may represent the tissue compression experienced by the tissue portion captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be arranged at various interaction points along the closing drive system to detect the closing force applied to the anvil 766 by the closing drive system. One or more sensors 788 may be sampled in real time by a processor of the control circuit 760 during the clamping operation. The control circuit 760 receives real-time sample measurements, provides and analyzes time-based information, and evaluates in real time the closing force applied to the anvil 766.
[0181] A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the I-beam 764 corresponds to the current drawn by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.
[0182] The RF energy source 794 is coupled to the end effector 792 and is applied to the RF cartridge 796 when the RF cartridge 796 is loaded onto the end effector 792 in place of the staple cartridge 768. The control circuit 760 controls the delivery of RF energy to the RF cartridge 796.
[0183] Further details are disclosed in U.S. Patent Application No. 15 / 636,096, filed June 28, 2017, entitled "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME", which is incorporated herein by reference in its entirety.
[0184] FIG. 20 is a simplified block diagram of a generator 800 configured to provide inductance-less tuning, among other advantages. Additional details of the generator 800 are described in U.S. Patent No. 9,060,775, issued June 23, 2015, entitled "SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES", which is incorporated herein by reference in its entirety. The generator 800 may include a patient isolation stage 802 that communicates 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 may include a tap configuration (e.g., a center tap or non-center tap configuration) for defining drive signal outputs 810a, 810b, 810c for delivering drive signals to various surgical instruments such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-functional surgical instruments including ultrasonic and RF energy modes that can be delivered alone or simultaneously. Specifically, the drive signal outputs 810a, 810c may output an ultrasonic drive signal (e.g., a 420V root mean square (RMS) drive signal) to an ultrasonic surgical instrument, and the drive signal outputs 810b, 810c may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to an RF electrosurgical instrument by the drive signal output 810b corresponding to the center tap of the power transformer 806.
[0185] In certain embodiments, the ultrasonic and electrosurgical drive signals may be provided simultaneously to separate surgical instruments and / or to a single surgical instrument, such as a multifunctional surgical instrument having the ability to deliver both ultrasonic energy and electrosurgical energy to tissue. The electrosurgical signal provided to either a dedicated electrosurgical instrument and / or a combined multifunctional ultrasonic / electrosurgical instrument is either a therapeutic or sub-therapeutic level signal, and the sub-therapeutic signal can be understood to be used, for example, to monitor tissue or instrument conditions and provide feedback to the generator. For example, ultrasonic and RF signals can be delivered separately or simultaneously from a generator having 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 ultrasonic energy and electrosurgical RF energy to deliver a combined energy to a multifunctional ultrasonic / electrosurgical instrument. Bipolar electrodes can be disposed on one or both jaws of the end effector. One jaw may be driven by ultrasonic energy in addition to electrosurgical RF energy acting simultaneously. The ultrasonic energy may be used to incise tissue, and the electrosurgical RF energy may be used for vessel sealing.
[0186] The non-insulated stage 804 may include a power amplifier 812 having an output connected to the primary winding 814 of the power transformer 806. In certain forms, the power amplifier 812 may include a push-pull amplifier. For example, the non-insulated stage 804 may further include a logic device 816 for supplying a digital output to a digital-to-analog converter (DAC) circuit 818, and the digital-to-analog converter (DAC) circuit 818 then supplies a corresponding analog signal to the input of the power amplifier 812. In certain forms, the logic device 816 may include, among a number of logic circuits, for example, a programmable gate array (PGA), a field programmable gate array (FPGA), a programmable logic device (PLD). Thus, the logic device 816 can control any of many parameters (e.g., frequency, waveform, waveform amplitude) of the drive signals that appear at the drive signal output portions 810a, 810b, 810c by controlling the input of the power amplifier 812 via the DAC circuit 818. In certain embodiments, as described below, the logic device 816, together with a processor (e.g., the DSP described below), can implement many DSP-based and / or other control algorithms to control the parameters of the drive signals output by the generator 800.
[0187] Power may be supplied to the power rail of the power amplifier 812 by a switch mode regulator 820, such as a power conversion device. In certain forms, the switch mode regulator 820 may include, for example, an adjustable buck regulator. The non-isolated stage 804 may further include a first processor 822, which in one form may include, for example, a DSP processor such as the Analog Devices ADSP-21469 SHARC DSP available from Analog Devices (Norwood, MA), although in various forms any suitable processor may be used. In a particular form, the DSP processor 822 may control the operation of the switch-mode regulator 820 in response to voltage feedback data received by the DSP processor 822 from the power amplifier 812 via the ADC circuit 824. In one form, for example, the DSP processor 822 may receive, as an input via the ADC circuit 824, the waveform envelope of a signal (e.g., an RF signal) amplified by the power amplifier 812. The DSP processor 822 may then control the switch-mode regulator 820 (e.g., the PWM output) such that the rail voltage supplied to the power amplifier 812 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the power amplifier 812 based on the waveform envelope, the efficiency of the power amplifier 812 can be significantly improved over a fixed rail voltage amplifier scheme.
[0188] In a particular form, the logic device 816, together with the DSP processor 822, may implement a digital synthesis circuit such as a direct digital synthesizer control scheme to control the waveform shape, frequency, and / or amplitude of the drive signal output by the generator 800. In one form, for example, the logic device 816 may implement a DDS control algorithm by calling waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT that can be embedded within an FPGA. This control algorithm is particularly useful in ultrasonic applications where an ultrasonic transducer, such as an ultrasonic converter, can be driven by a clear sine wave current at its resonant frequency. Since other frequencies can excite parasitic resonances, minimizing or reducing the total distortion of the operating branch current can correspondingly minimize or reduce unwanted resonance effects. Since the waveform of the drive signal output by the generator 800 is affected by various distortion sources (e.g., power transformer 806, power amplifier 812) present within the output drive circuit, voltage and current feedback data based on the drive signal may be input into an algorithm such as an error control algorithm implemented by the DSP processor 822, which dynamically, on a progressive basis (e.g., in real time), compensates for the distortion by suitably pre-distorting or modifying the waveform samples stored in the LUT. In one form, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated operating branch current and the desired current waveform, the error being determined for each sample. In this way, when the pre-distorted LUT samples are processed by the drive circuit, they can produce an operating branch drive signal having a desired waveform shape (e.g., a sine wave) to optimally drive the ultrasonic transducer. In such a form, the LUT waveform samples thus represent not the desired waveform of the drive signal, but rather the waveform necessary to ultimately generate the desired waveform of the operating branch drive signal when considering the distortion effects.
[0189] The non-insulated stage 804 may further include a first ADC circuit 826 and a second ADC circuit 828 connected 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. In a particular form, the ADC circuits 826, 828 may be configured to sample at high speed (e.g., 80 megasamples per second (MSPS)) to enable oversampling of the drive signal. In one form, for example, the sampling speed of the ADC circuits 826, 828 may enable oversampling of approximately 200x (depending on frequency) of the drive signal. In a particular form, the sampling operation of the ADC circuits 826, 828 may be performed by a single ADC circuit that receives input voltage and current signals via a bidirectional multiplexer. The use of high-speed sampling in the form of the generator 800 can enable, among other things, the calculation of complex currents flowing through the operating branches (which can be used in a particular form to implement the DDS-based waveform shaping described above), accurate digital filtering of the sampled signals, and the calculation of actual power consumption with high precision. The voltage and current feedback data output by the ADC circuits 826, 828 may be received and processed by the logic device 816 (e.g., first-in-first-out (FIFO) buffer, multiplexer, etc.) and stored in the data memory for subsequent reading, for example, by the DSP processor 822. As described above, the voltage and current feedback data can be used as input to an algorithm to pre-distort or correct the LUT waveform samples on a dynamic and progressive basis. In a particular form, this may require that the stored voltage and current feedback data pairs are indexed based on or otherwise related to the corresponding LUT samples output by the logic device 816 when a voltage and current feedback data pair is obtained. The synchronization of the LUT samples with the voltage and current feedback data by this method contributes to the accurate timing and stability of the pre-distortion algorithm.
[0190] In certain embodiments, the feedback data of voltage and current may be used to control the frequency and / or amplitude (e.g., current amplitude) of the drive signal. For example, in one embodiment, the feedback data of voltage and current may be used to determine the impedance phase. Subsequently, the frequency of the drive signal may be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set value (e.g., 0°), thereby minimizing or reducing the influence of harmonic distortion and correspondingly improving the measurement accuracy of the impedance phase. The determination of the phase impedance and the frequency control signal may be implemented, for example, in the DSP processor 822, and the frequency control signal is supplied as an input to the DDS control algorithm implemented by the logic device 816.
[0191] In another embodiment, for example, the feedback data of current may be monitored to maintain the current amplitude of the drive signal at the current amplitude set point. The current amplitude set value may be directly specified or may be indirectly determined based on the specified voltage amplitude and power set value. In certain embodiments, the control of the current amplitude may be implemented by a control algorithm, such as a proportional-integral-derivative (PID) control algorithm within the DSP processor 822. To suitably control the current amplitude of the drive signal, the variables controlled by the control algorithm may include, for example, the scaling of the LUT waveform samples stored in the logic device 816 and / or the full-scale output voltage of the DAC circuit 818 via the DAC circuit 834 (which supplies an input to the power amplifier 812).
[0192] The non-insulated stage 804 may further include a second processor 836, among other things, to provide user interface (UI) functionality. In one form, the UI processor 836 may include, for example, an Atmel AT91SAM9263 processor having an ARM 926EJ-S core, available from Atmel Corporation (San Jose, California). Examples of UI functions supported by the UI processor 836 may include auditory and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with a foot switch, communication with an input device (e.g., a touch screen display), and communication with an output device (e.g., a speaker). The UI processor 836 may communicate with the DSP processor 822 and the logic device 816 (e.g., an SPI bus). The UI processor 836 may primarily support UI functionality, but in certain forms, the UI processor 836 may also cooperate with the DSP processor 822 to achieve risk mitigation. For example, the UI processor 836 may be programmed to monitor various aspects of user input and / or other inputs (e.g., touch screen input, foot switch input, temperature sensor input), and may disable the drive output of the generator 800 when an incorrect state is detected.
[0193] In certain embodiments, both the DSP processor 822 and the UI processor 836 may, for example, determine and monitor the operating state of the generator 800. With respect to the DSP processor 822, the operating state of the generator 800 may represent, for example, which control and / or diagnostic processes are implemented by the DSP processor 822. With respect to the UI processor 836, the operating state of the generator 800 may represent, for example, which elements of the UI (e.g., display screen, sound) are provided to the user. The DSP processor 822 and the UI processor 836 may each separately maintain the current operating state of the generator 800 and recognize and evaluate possible transitions from the current operating state. The DSP processor 822 may function as the master in this relationship and determine when a transition between operating states occurs. The UI processor 836 may recognize valid transitions between operating states and also confirm whether a particular transition is appropriate. For example, when the DSP processor 822 instructs the UI processor 836 to transition to a particular state, the UI processor 836 may confirm that the requested transition is valid. If the requested transition between states is determined to be invalid by the UI processor 836, the UI processor 836 may put the generator 800 into a fault mode.
[0194] The non-insulating stage 804 may further include a controller 838 for monitoring the input device (e.g., a capacitive touch sensor, a capacitive touch screen used to turn the generator 800 on and off). In certain embodiments, the controller 838 may include at least one processor and / or another controller device that communicates with the UI processor 836. In one embodiment, for example, the controller 838 may include 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. In one embodiment, the controller 838 may include a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) for controlling and managing the acquisition of touch data from a capacitive touch screen.
[0195] In certain embodiments, when the generator 800 is in the "power off" state, the controller 838 may continue to receive operating power (e.g., via a line from the power supply of the generator 800 such as the power supply 854 described below). In this way, the controller 838 may continue to monitor an input device (e.g., a capacitive touch sensor located on the front panel of the generator 800) for turning the generator 800 on / off. When the generator 800 is in the power off state, the controller 838 may activate the power supply (e.g., enable the operation of one or more DC / DC voltage transformers 856 of the power supply 854) if activation of the "on / off" input device by the user is detected. Accordingly, the controller 838 may initiate a sequence to transition the generator 800 to the "power on" state. Conversely, if activation of the "on / off" input device is detected when the generator 800 is in the power on state, the controller 838 may initiate a sequence to transition the generator 800 to the power off state. For example, in certain embodiments, the controller 838 may report activation of the "on / off" input device to the UI processor 836, and the UI processor 836 may then implement the process sequence necessary to transition the generator 800 to the power off state. In such embodiments, the controller 838 may not need to have an independent ability to remove power from the generator 800 after the power on state of the generator 800 is established.
[0196] In certain embodiments, the controller 838 may cause the generator 800 to provide audible or other sensory feedback to warn the user that a power on or power off sequence has been initiated. Such warnings may be provided at the start of the power on or power off sequence and prior to the start of other processes associated with the sequence.
[0197] In a particular form, the isolation stage 802 may include an instrument interface circuit 840 to provide a communication interface between, for example, a control circuit of a surgical instrument (e.g., a control circuit including a handpiece switch) and components of the non-isolation stage 804 such as, for example, a logic device 816, a DSP processor 822, and / or a UI processor 836. The instrument interface circuit 840 can exchange information with components of the non-isolation stage 804 via a communication link that maintains a suitable degree of electrical insulation between the isolation stage 802 and the non-isolation stage 804, such as, for example, an IR-based communication link. For example, a low-dropout voltage regulator powered by an isolation transformer driven from the non-isolation stage 804 can be used to supply power to the instrument interface circuit 840.
[0198] In one form, the instrument interface circuit 840 may include a logic circuit 842 (e.g., a logic circuit, a programmable logic circuit, a PGA, an FPGA, a PLD) that communicates with a signal conditioning circuit 844. The signal conditioning circuit 844 may be configured to receive a periodic signal (e.g., a 2 kHz square wave) from the logic device 842 to generate a bipolar call signal having the same frequency. The call signal can be generated using, for example, a bipolar current source supplied by a differential amplifier. The call signal may be 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. The control circuit may include a number of switches, resistors, and / or diodes, and one or more characteristics of the call signal (e.g., amplitude, rectification) may be modified so that the state or configuration of the control circuit can be individually identified based on one or more characteristics. For example, in one form, the signal conditioning circuit 844 may include an ADC circuit to generate samples of a voltage signal that appears across an input of the control circuit resulting from the path through which the call signal passes. The logic circuit 842 (or a component of the non-isolation stage 804) can then determine the state or configuration of the control circuit based on the ADC circuit samples.
[0199] In one form, the instrument interface circuit 840 may include a first data circuit interface (DCI) 846 to enable information exchange between the logic circuit 842 (or other elements of the instrument interface circuit 840) and a first data circuit disposed within or otherwise associated with the surgical instrument. In a particular form, for example, the first data circuit may be disposed within a cable integrally attached to the surgical instrument handpiece or within an adapter to associate a particular surgical instrument type or model with the generator 800. The first data circuit may be implemented in any suitable manner and may communicate with the generator, for example, according to any suitable protocol including those described herein with respect to the first data circuit. In a particular form, the first data circuit may include a non-volatile memory device such as an EEPROM device. In a particular form, the first data circuit interface 846 may be implemented separately from the logic circuit 842 and may include suitable circuitry (e.g., a separate logic device, processor) to enable communication between the logic circuit 842 and the first data circuit. In other forms, the first data circuit interface 846 may be integral with the logic circuit 842.
[0200] In certain embodiments, the first data circuit may store information regarding a particular surgical instrument to which the first data circuit is associated. Such information can include, for example, a model number, a serial number, the number of operations in which the surgical instrument has been used, and / or any other type of information. This information is read out by the instrument interface circuit 840 (e.g., by the logic circuit 842) and transmitted to the components of the non-insulated stage 804 (e.g., the logic device 816, the DSP processor 822, and / or the UI processor 836) for provision to the user via an output device and / or for control of the function or operation of the generator 800. Additionally, any type of information may be transmitted to the first data circuit (e.g., using the logic circuit 842) for internal storage via the first data circuit interface 846. Such information may include, for example, the most recent number of surgeries in which the surgical instrument has been used and / or the date and / or time of its use.
[0201] As described above, the surgical instrument may be removable from the handpiece (e.g., a multi-functional surgical instrument may be removable from the handpiece) to facilitate instrument compatibility and / or disposability. In such cases, conventional generators may be limited in their ability to recognize the particular instrument configuration being used and optimize the control and diagnostic processes accordingly. However, to address this issue, adding a readable data circuit to the surgical instrument is problematic from a compatibility perspective. For example, designing the surgical instrument to maintain backward compatibility with generators lacking the necessary data reading functionality may not be practical due to, for example, different signal schemes, design complexity, and cost. The instrument embodiments discussed herein address these concerns by economically using data circuits that may be implemented in existing surgical instruments and minimizing design changes to maintain compatibility between the surgical instrument and the latest generator platforms.
[0202] In addition, the form of the generator 800 may enable communication with an instrument-based data circuit. For example, the generator 800 may be configured to communicate with a second data circuit housed within an instrument (e.g., a multi-functional surgical instrument). In some forms, the second data circuit may be implemented in many ways similar to those of the first data circuit described herein. The instrument interface circuit 840 may include a second data circuit interface 848 that enables this communication. In one form, the 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 generally be any circuit for transmitting and / or receiving data. In one form, for example, the second data circuit may store information regarding a particular surgical instrument to which the second data circuit is associated. Such information may include, for example, a model number, a serial number, the number of operations in which the surgical instrument has been used, and / or any other type of information.
[0203] In some forms, the second data circuit may store information regarding the electrical and / or ultrasonic characteristics of an associated ultrasonic transducer, end effector, or ultrasonic drive system. For example, the first data circuit may indicate a burn-in frequency slope as described herein. Additionally or alternatively, any type of information may be transmitted to the second data circuit (e.g., using logic circuit 842) for internal storage via the second data circuit interface 848. Such information may include, for example, the most recent number of operations in which the instrument has been used, and / or the date and / or time of its use. In certain forms, the second data circuit may transmit data obtained by one or more sensors (e.g., an instrument-based temperature sensor). In specific forms, the second data circuit may receive data from the generator 800 and provide an indication (e.g., a light-emitting diode indication or other visual indication) to the user based on the received data.
[0204] In certain forms, the second data circuit and the second data circuit interface 848 may be configured such that communication between the logic circuit 842 and the second data circuit can be effected without the need for the provision of additional conductors (e.g., dedicated conductors of a cable connecting the handpiece to the generator 800) for this purpose. In one form, for example, one of the conductors being used may utilize an existing cable wiring implemented one-wire bus communication scheme to transmit a calling signal from the signal conditioning circuit 844 to a control circuit within the handpiece, to communicate information with the second data circuit. In this way, design changes or modifications to the surgical instrument that might otherwise be required are minimized or reduced. Further, since different types of communication implemented on a common physical channel can be frequency band separated, the presence of the second data circuit is "invisible" to a generator that does not have the necessary data reading capabilities, and thus enables backward compatibility of the surgical instrument.
[0205] In certain forms, the insulation stage 802 may include at least one blocking capacitor 850-1 connected to the drive signal output section 810b so as not to pass DC current to the patient. A single blocking capacitor may be required, for example, to comply with medical regulations or standards. Failures in a single capacitor design are relatively rare, but nonetheless such failures can result in negative consequences. In one form, a second blocking capacitor 850-2 may be provided in series with the blocking capacitor 850-1, and leakage from the point between the blocking capacitors 850-1 and 850-2 is monitored by an ADC circuit 852, for example, to sample the voltage induced by the leakage current. The sample may be received, for example, by the logic circuit 842. The generator 800 can determine the point in time when at least one of the blocking capacitors 850-1, 850-2 has failed, based on a change in the leakage current (as indicated by the voltage sample), thus providing an advantage over a single capacitor design having a single point of failure.
[0206] In certain forms, the non-insulated stage 804 may include a power source 854 for delivering DC power at a suitable voltage and current. The power source may include, for example, a 400W power source for delivering a 48VDC system voltage. The power source 854 may further include one or more DC / DC voltage converters 856 for receiving the output of the power source and generating a DC output at the voltage and current required by various components of the generator 800. As described above in connection with the controller 838, one or more of the DC / DC voltage converters 856 may receive an input from the controller 838 when the activation of a user “on / off” input device is detected by the controller 838, enabling the operation or activation of the DC / DC voltage converter 856.
[0207] FIG. 21 shows an example of a generator 900 that is one form of the generator 800 (FIG. 20). The generator 900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides an RF signal and an ultrasonic signal for delivering energy to the surgical instrument either alone or simultaneously. The RF signal and the ultrasonic signal may be provided alone, in combination, or simultaneously. As described above, at least one generator output may deliver multiple energy modalities (e.g., among others, ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy) through a single port, and these signals may be delivered to the end effector individually or simultaneously to treat tissue.
[0208] The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to generate various signal waveforms based on information (not shown for clarity of disclosure) stored in a memory coupled to the processor 902. Digital information related to the waveform is provided to the waveform generator 904 including one or more DAC circuits to convert a digital input to an analog output. The analog output is supplied to an amplifier 906 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled across the power transformer 908 to a secondary side on the patient isolation side. The first signal of the first energy modality is provided between terminals labeled ENERGY1 and RETURN of the surgical instrument. The second signal of the second energy modality is coupled across a capacitor 910 and provided between terminals labeled ENERGY2 and RETURN of the surgical instrument. More than two energy modalities may be output, and thus the subscript "n" can be used to indicate that up to n ENERGYn terminals may be provided, where n is understood to be a positive integer greater than 1. It will also be understood that up to "n" return paths (RETURNn) may be provided without departing from the scope of the present disclosure.
[0209] The first voltage sensing circuit 912 is connected across the terminals labeled ENERGY1 and RETURN path and measures the output voltage therebetween. The second voltage sensing circuit 924 is connected across the terminals labeled ENERGY2 and RETURN path and measures the output voltage therebetween. The current sensing circuit 914 is disposed in series with the RETURN section on the secondary side of the illustrated power transformer 908 to measure the output current of any energy modality. If different return paths are provided for each energy modality, separate current sensing circuits must be provided at each return section. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to the corresponding isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side (non-patient isolation side) of the power transformer 908 are provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and calculation. The feedback information of the output voltage and output current can be used to adjust the output voltage and current provided to the surgical instrument and to calculate the output impedance among several parameters. The input / output communication between the processor 902 and the patient isolation circuit is provided through the interface circuit 920. The sensors may also communicate electrically with the processor 902 via the interface circuit 920.
[0210] In one aspect, the impedance can be determined by a processor 902 by dividing the output of either a first voltage sensing circuit 912 connected across terminals labeled ENERGY1 / RETURN or a second voltage sensing circuit 924 connected across terminals labeled ENERGY2 / RETURN by the output of a current sensing circuit 914 arranged in series with the RETURN section on the secondary side of a power transformer 908. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to individual isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sensing measurements from the ADC circuit 926 are provided to the processor 902 to calculate the impedance. As an example, the first energy modality ENERGY1 may be ultrasonic energy, and the second energy modality ENERGY2 may be RF energy. Nevertheless, in addition to the ultrasonic energy modality and the bipolar or monopolar RF energy modality, other energy modalities include, among others, irreversible and / or reversible electroporation and / or microwave energy. Also, the example illustrated in FIG. 21 shows that a single return path RETURN can be provided for two or more energy modalities, but in other aspects, multiple return paths RETURNn may be provided for respective energy modalities ENERGYn. Thus, as described herein, the impedance of the ultrasonic transducer may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914, and the impedance of the tissue may be measured by dividing the output of the second voltage sensing circuit 924 by the current sensing circuit 914.
[0211] As shown in FIG. 21, a generator 900 including at least one output port can have a single output and include a power transformer 908 having a plurality of taps to provide power to an end effector in the form of one or more energy modalities, such as, for example, among others, ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, depending on the type of tissue treatment to be performed. For example, generator 900 can deliver energy at a high voltage and low current to drive an ultrasonic transducer, at a low voltage and high current to drive an RF electrode for tissue sealing, or in a coagulation waveform for spot coagulation, using either a monopolar or bipolar RF electrosurgical electrode. The output waveform from generator 900 can be induced, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of generator 900 will preferably be located between the output labeled ENERGY1 and RETURN, as shown in FIG. 21. In one embodiment, the connection of the RF bipolar electrode to the output of generator 900 will preferably be located between the output labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection will be an active electrode (e.g., a pencil-type or other probe) to a suitable return pad connected to the ENERGY2 output and the RETURN output.
[0212] Further details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published Mar. 30, 2017, entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS", which is incorporated herein by reference in its entirety.
[0213] FIG. 22 shows a surgical instrument 29000 according to at least one aspect of the present disclosure. In the aspect 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. Although FIG. 22 shows the surgical instrument 29000 as having a bendable shaft assembly 29004, it will be understood that according to other aspects, the surgical instrument 29000 may include a shaft assembly having a joint instead of a bendable portion.
[0214] FIG. 23 shows a shaft assembly 29005 of a surgical instrument 29000 according to at least one other aspect of the present disclosure. As shown in FIG. 23, the shaft assembly 29005 includes a joint 29010 and is coupled to an end effector 29006 that includes a first jaw 29012 and a second jaw 29014, and at least one of the first and second jaws 29012, 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 the end effector 29006 is shown as including a staple cartridge 29016, it will be understood that according to other aspects, the end effector 29006 may include electrodes instead of or in addition to the staple cartridge 29016.
[0215] FIG. 24 shows the flexible circuit 29008 of the surgical instrument 29000 of FIG. 22. The flexible circuit 29008 is present within the handle 29002, the shaft assembly 29004 / 29005, and the end effector 29006, and includes a processing device 29018, a logic element 29020, conductive traces 29022, and conductive pads 29024. Although only one processing device 29018 and one logic element 29020 are shown in FIG. 23, it will be understood that the flexible circuit 29008 may include any number of processing devices 29018 and / or logic elements 29020. The conductive pads 29024 are configured to connect to other components of the 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. The conductive traces 29022 carry signals from sensors, signals traveling to and from the processing device 29018, signals traveling to and from the logic element 29020, signals traveling to and from the control circuit, signals to the motors, etc. Although not shown for simplicity, the flexible circuit 29008 may also include a substrate, one or two or more insulating layers, and an overlay. The processing device 29018, the logic element 29020, etc. may be mounted on the substrate, and the conductive traces 29022 and the conductive pads 29024 may be patterned on / across the substrate. One or two or more insulating layers electrically insulate the conductive traces from each other. The overlay covers the insulating layer and / or the processing device 29018, the logic element 29020, the conductive traces 29022, and the conductive pads 29024. The flexible circuit 29008 may be single-sided, double-sided, or multi-layered as shown in FIG. 24. The conductive traces 29022 and the conductive pads 29024 may include copper, gold, tin, and / or other suitable conductive materials.
[0216] According to various aspects, to insulate conductive traces 29022 from the high-frequency energy delivered by surgical instrument 29000, flexible circuit 29008 includes an electromagnetic shield (e.g., a guard trace or guard ring) that blocks high-frequency electromagnetic radiation and / or minimizes signal crosstalk between the various conductive traces 29022. The electromagnetic shield need not be included throughout flexible circuit 29008. For example, according to various aspects, the electromagnetic shield may be positioned only at selected locations of flexible circuit 29008 to protect conductive traces 29022 from unwanted effects or signals caused by an external high-frequency generator or magnet. For the sake of brevity, the electromagnetic shield is not shown in FIG. 24.
[0217] Flexible circuit 29008 includes both a rigid portion 29026 and a flexible portion 29028. Thus, flexible circuit 29008 may sometimes be referred to as a rigid-flex circuit. Rigid portion 29026 may be reinforced and is configured not to bend / flex to any significant degree. Rigid portion 29026 includes portions of conductive traces 29022 and may also include, for example, one or more processing devices 29018, one or more integrated circuits, one or more logic elements 29020, and / or conductive pads 29024 as shown in FIG. 24. The actual positioning of devices such as non-chip gates and other logic elements 29020 allows for local low-level decision-making (e.g., distributed processing) with respect to the actuator of surgical instrument 29000.
[0218] According to various aspects, the first rigid portion 29026 of the flexible circuit 29008 proximal to the articulation joint 29010 of the shaft assembly 29005 includes an interlock mechanism 29030 configured to snap into a recess 29032 defined by a first channel retainer 29034 (see FIG. 25), and the second rigid portion 29026 of the flexible circuit 29008 distal to the articulation joint 29010 of the shaft assembly 29005 includes an interlock mechanism configured to snap into a recess defined by a second channel retainer. The interlock mechanism of the second rigid portion, the second channel retainer, and its recess are not shown in FIG. 24 for simplicity, but in addition to positioning (proximal to distal with respect to the articulation joint), the interlock mechanism of the second rigid portion may be similar or identical to the interlock mechanism 29030 of the first rigid portion 29026, the second channel retainer may be similar or identical to the first channel retainer 29034, and the recess of the second channel retainer may be similar or identical to the recess 29032 of the first channel retainer 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 the rigid portion 29026 and the channel retainer 29034 enables the flexible circuit 29008 to be attached to the surgical instrument 29000 and prevents the flexible circuit 29008 from "coming out of position" when the surgical instrument 29000 needs to be moved in various directions and / or when the flexible circuit 29008 is subjected to various forces.
[0219] The flexible portion 29028 is configured to bend and fold as needed. For example, in the case of the flexible portion 29028 aligned with the active bending portion of the shaft assembly 20004 of the surgical instrument 29000 or the articulating portion of the shaft assembly 29005, the flexible portion 29028 also needs to be similarly foldable to prevent unwanted stress applied to the flexible portion 29028 and / or failure of the flexible portion 29028. Similarly, if the flexible portion 29028 needs to be stepped across a mechanical component of the surgical instrument 29000 (e.g., the articulating rod of the surgical instrument), the flexible portion 29028 of the flexible circuit 29008 enables this (see, for example, 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 bend more in one direction than in other directions, thereby preventing damage to the flexible circuit 29008 due to the load.
[0220] 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 folded in certain potentially high stress regions (e.g., within the active bending portion of the shaft assembly 29004 as shown in FIG. 22 or within the joint 29010 of the shaft assembly 29005) to enhance operability, strength, and / or resistance to failure.
[0221] According to various aspects, the respective cross-sections of the conductive traces 29022 can vary throughout the flexible circuit 29008 even if the conductive traces 29022 still have the same or substantially similar current-carrying capacity. The respective height (h) or thickness of the conductive traces 29022 can be changed, and / or the respective width (w) of the conductive traces 29022 can also be changed. For example, for a given conductive trace 29022 present in both the rigid portion 29026 and the 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, and the width (W) of the conductive trace 29022 may be greater in the flexible portion 29028 than in the rigid portion 29026. The combination of a lower height and a greater width in the flexible portion 29028 enables the conductive trace 29022 to enhance its resistance to the high stresses introduced by movements such as articulation and / or joint closure movements. The length L shown in FIG. 24 represents the length of the articulating portion of the shaft assembly 29005 with respect to the conductive trace 29022 aligned with the joint 29010.
[0222] FIG. 26 shows a cross-sectional view of the flexible circuit 29008 along line A-A of FIG. 24, according to at least one aspect of the present disclosure. The portion of the flexible circuit 29008 along line A-A is distal to the bent portion of the shaft assembly 29004 / the joint 29010 of the shaft assembly 29005 and can be considered as the rigid portion 29026. As shown in FIGS. 24 and 26, the flexible circuit 29008 is not separated along line A-A, and the corresponding conductive traces 29022 in this portion of the flexible circuit 29008 have a height h a and a width W a and.
[0223] FIG. 27 shows a cross-section of the flexible circuit 29008 along line B-B of FIG. 24 according to at least one aspect of the present disclosure. The portion of the flexible circuit 29008 along line B-B is proximal to the bent portion of the shaft assembly 29004 / the joint 29010 of the shaft assembly 29005 and can be regarded as the flexible portion 29028. As shown in FIGS. 24 and 27, the flexible circuit 29008 defines a separation or opening 29036 along line B-B, and the corresponding conductive trace 29022 in this portion of the flexible circuit 29008 has a height h b and a width W b .
[0224] By comparing FIGS. 26 and 27, the height (h a ) of the corresponding portion of the conductive trace 29022 along line A-A (the portion of the conductive trace 29022 within the rigid portion 29026) is greater than the height (h b ) of the corresponding portion of the conductive trace 29022 along line B-B (the portion of the conductive trace 29022 within the flexible portion 29028). Similarly, the width (W a ) of the corresponding portion of the conductive trace 29022 along line A-A (the portion of the conductive trace 29022 within the rigid portion 29026) is smaller than the width (W b ) of the corresponding portion of the conductive trace 29022 along line B-B (the portion of the conductive trace 29022 within the flexible portion 29028). In other words, as shown in FIG. 26, h a >h b and W a <W b .
[0225] In an aspect of the surgical instrument 29000 that includes the articulation joint 29010 within the shaft assembly 29005, for the portion of the flexible circuit 29008 that passes through the articulation joint 29010 (flexible portion 29028 of the flexible circuit 29008), the portion of the corresponding conductive trace 29022 is shorter / thinner and wider than the portion of the corresponding conductive trace 29022 within the rigid portion 29026 that is distally adjacent to the flexible portion 29028. Conventional wires within this region typically must be reinforced with strain relief, but the conductive traces 29022 of the flexible circuit 29008 within this region are made shorter / thinner and wider such that the conductive traces 29022 of this flexible portion 29028 can have the same current-carrying capacity as those within the rigid portion 29026 while enhancing 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, whereby it will be understood that the flexible circuit 29008 can be bent up to 90° (or more) with respect to the longitudinal axis 29038 of the shaft assembly 29005 and / or the surgical instrument 29000. Similar functionality can be achieved for a 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. Thus, it can be understood that the flexible circuit 29008 includes an element (e.g., conductive trace 29022) having a variable cross-section that is aligned with a joint 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).
[0226] As shown in FIG. 22, for the portion of the flexible circuit 29008 that passes through the bendable portion of the shaft assembly 29004 (or through the articulation joint 29010 of the shaft assembly 29005), the flexible circuit 29008 may be folded on each side of the separation or opening 29040 in the same manner as shown in FIG. 22. The folding on each side of the separation or opening 29040 and the flexibility of the conductive trace 29022 allow the wider portion of the conductive trace 29022 of the flexible portion 29028 to fit within the limited area available within the articulation joint 29010 of the shaft assembly 29005.
[0227] According to various aspects, the flexible circuit 29008 may include a twist or strain relief portion 29042 incorporated into the flexible circuit 29008. As shown in FIG. 22, according to various aspects, the twist or strain relief portion 29042 may be positioned between a rigid portion 29026 that includes an interlock mechanism 29030 and a flexible portion 29028 that passes through the articulation joint 29010 of the shaft assembly 29005. The twist or strain relief portion 29042 allows the flexible circuit 29008 to be first attached to the first channel retainer 29034 (along a first plane along the length of the shaft assembly 29005 proximal to the articulation joint 29010) and then twisted approximately 90° with respect to the first plane to allow articulation about an axis perpendicular to the first plane. The twist or strain relief portion 29042 is configured to safely relieve the strain imposed on the flexible circuit 29008.
[0228] 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 can remain properly positioned within the surgical instrument 29000 and reflect the movement of the active bending portion of the shaft assembly 29004 or the articulation joint 29010 of the shaft assembly 29005 of the surgical instrument 29000. Such a combination provides a flexible circuit 29008 that is more resistant to failure than is typical for surgical instruments 29000.
[0229] Figure 28 shows an exploded view of the flexible electrode 29100 of the surgical instrument 29000 of FIG. 22, according to at least one aspect of the present disclosure. According to various aspects, the flexible electrode 29100 can be incorporated into the flexible circuit 29008 of FIG. 22 or can be electrically coupled to at least the flexible circuit 29008. Although not shown for clarity, it will be understood that the flexible electrode 29100 can be coupled to an electrosurgical generator and can receive electrosurgical energy (alternating current at RF levels) supplied by the electrosurgical generator.
[0230] The flexible electrode 29100 can 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. The treatment electrode 29102 and the sensing electrode 29104 can include copper, gold, tin, or any other suitable material for conducting electricity.
[0231] The treatment electrode 29102 can have a rectangular shape and is configured to deliver RF energy to tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. According to various aspects, the treatment electrode 29102 can have a thickness in the range of about 0.003 inches.
[0232] The sensing electrode 29104 is configured to assist in determining one or more parameters associated with tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. For example, the sensing electrode 29104 may be configured to assist in determining the impedance of tissue positioned between the first jaw 29012 and the second jaw 29014 of the 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 may then determine the impedance of the tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. An example of such a sensing electrode is described in U.S. Patent No. 5,817,093 to the same assignee, entitled "IMPEDANCE FEEDBACK MONITOR WITH QUERY ELECTRODE FOR ELECTROSURGICAL INSTRUMENT", issued Oct. 6, 1998, the entire contents of which are incorporated herein by reference. The sensing electrode 29104 may continuously sense even when RF energy is being delivered to the tissue by the treatment electrode 29102 to weld the tissue. According to various aspects, the sensing electrode 29104 may have a thickness similar or identical to the thickness of the treatment electrode 29102 (e.g., within the range of about 0.003 inches).
[0233] According to various aspects, the 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 the current passing through the tissue, the sensing electrode 29104 may pass the sensed "value" to the processing circuitry of the surgical instrument 29000, and then the processing circuitry may utilize the sensed "value" to determine the electrical continuity of the tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. The processing circuitry may then utilize the determined electrical continuity of the tissue to help determine tissue contraction. When the sensing electrode 29104 is utilized in relation to the treatment electrode 29102, since the sensing electrode 29104 is at a higher pressure than the treatment electrode 29102, it may be possible to detect the approach to the transition temperature point associated with tissue welding. By utilizing the sensing capabilities of the sensing electrode 29104, the sensed "value" may be passed to the processing circuitry of the surgical instrument 29000, and the processing circuitry may then utilize the sensed "value" to identify impedance events before a temperature transition point / inflection point occurs within the low pressure zone of the tissue.
[0234] The sensing electrode 29104 may have a pattern shape that overlaps the treatment electrode 29102 and may have the same overall length and width as the treatment electrode 29102, but due to its pattern shape, does not completely cover the treatment electrode 29102. As shown in FIG. 28, according to various aspects, the sensing electrode 29104 may be patterned as a modified "E shape" having a plurality of rectangular fingers 29106. When the sensing electrode 29104 overlaps the treatment electrode 29102, the spaces 29108 between the plurality of rectangular fingers 29106 of the modified E shape of the sensing electrode 29104 are aligned with the portions of the treatment electrode 29102 that remain uncovered. According to other aspects, the pattern shape of the sensing electrode 29104 may be a modified E shape having a plurality of triangular fingers or fingers of other shapes.
[0235] The flexible electrode 29100 also includes a first insulating layer 29110 positioned between the therapeutic electrode 29102 and the 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 having a plurality of rectangular fingers 29112), is aligned with the sensing electrode 29104, and electrically insulates the sensing electrode 29104 from the therapeutic 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 therapeutic electrode 29102, the space 29114 between the plurality of rectangular fingers 29112 of the first insulating layer 29110 in the modified E-shape is aligned with the portion of the therapeutic electrode 29102 that remains uncovered and is aligned with the space 29108 between the plurality of rectangular fingers 29106 of the sensing electrode 29104 in the modified E-shape. According to other aspects, the plurality of rectangular fingers 29112 of the first insulating layer 29110 in the modified E-shape can be slightly wider than the plurality of rectangular fingers 29106 of the sensing electrode 29104 in the modified E-shape (see FIGS. 29 and 30), such that the space 29114 can be slightly narrower than the space 29108. According to various aspects, the first insulating layer 29110 has a thickness in the range of about 0.001 inches to 0.0003 inches. The first insulating layer 29110 can include any suitable non-conductive material and can have a higher flexibility than either the therapeutic electrode 29102 or the sensing electrode 29104.
[0236] The flexible electrode 29100 also includes a second insulating layer 29116 positioned to cover the surface of the therapeutic electrode 29102 that is opposite to the surface of the therapeutic electrode 29102 that is partially covered by the first insulating layer 29110 and the sensing electrode 29104. The second insulating layer 29116 can have a rectangular shape having the same overall length and width as the therapeutic electrode 29102. According to various aspects, the second insulating layer 29116 can have a thickness in the range of about 0.0001 inches to 0.003 inches. The second insulating layer 29116 can include any suitable non-conductive material and can have a higher flexibility than either the therapeutic electrode 29102 or the sensing electrode 29104.
[0237] For clarity, only one flexible electrode 29100 is shown in FIG. 28, but it will be understood that the surgical instrument 29000 can include at least two of the flexible electrodes 29100 (e.g., one on each side of the knife slot of the end effector 29006 of the surgical instrument 29000). Additionally, when the flexible electrode 29100 includes a plurality of components and a plurality of layers, it will be understood that the flexible electrode 29100 can be regarded as a flexible electrode assembly and / or a multi-layer flexible electrode.
[0238] FIGS. 29 and 30 show plan views of a flexible electrode assembly 29200 according to at least one aspect of the present disclosure. The flexible electrode assembly 29200 includes two of the flexible electrodes 29100 of FIG. 28, with a first electrode 29100a of the flexible electrodes positioned on the left side of the knife slot 29202 of the end effector 29006 of the surgical instrument 29000, and a second electrode 29100b of the flexible electrodes positioned on the right side of the knife slot 29202. With respect to the plan views shown in FIGS. 29 and 30, the sense electrodes 29104a and 29104b are positioned over and partially cover the treatment electrodes 29102a and 29102b.
[0239] The surfaces of the corresponding sense electrodes 29104a, 29104b that can be in direct contact with tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000 are shown in dark color in FIG. 29. The dark surfaces in FIG. 29 can be regarded as a sense electrode pattern. As described above, the sense electrodes 29104 can help determine the impedance of tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. When the sense electrodes 29104 are utilized in relation to the treatment electrodes 29102, since the sense electrodes 29104 are at a higher pressure than the treatment electrodes 29102, it may be possible to detect the approach to the transition temperature point associated with tissue welding. By utilizing the measuring capabilities of the sense electrodes 29104, impedance events can be identified before an inflection point occurs in the low-pressure zone of the tissue. Additionally, the sense electrodes 29014 can also enable the measurement of tissue contraction when electrical continuity is measured thereby. By using the sense electrodes 29104 to measure continuity rather than impedance, the measured parameter can indicate tissue contraction rather than water expelled from the tissue. Further, both the impedance and continuity of the tissue can be measured using the sense electrodes 29104. According to various aspects, the sense electrodes 29104 can also be used as a conductive gap spacer to control the minimum gap between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000.
[0240] The concave, discontinuous portions on the surfaces of the corresponding treatment electrodes 29102a, 29102b that can come into direct contact with tissue positioned between the jaws of the surgical instrument 29000 are shown in dark color in FIG. 30. The dark-colored surfaces in FIG. 30 can be regarded as treatment electrode patterns. Due to the concave, segmented, discontinuous nature of the surfaces of the treatment electrodes 29102a, 29102b that can come into direct contact with tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000, the treatment electrodes 29102 can reduce any undesirable tissue adhesion when the treatment electrodes 29102 are energized. According to various aspects, a given concave, discontinuous portion of the treatment electrode 29102 between two adjacent rectangular fingers 29106 of the sense electrode 29104 can be greater in the longitudinal direction by an amount in the range of about 0.005” to 0.0008” than the “length” of one of the rectangular fingers 29106. In other words, the surface area of a given concave, discontinuous portion of the treatment electrode 29102 between two adjacent rectangular fingers 29106 of the sense electrode 29104 can be greater than the surface area of one of the rectangular fingers 29106 of the sense electrode 29104. According to various aspects, at least one of the concave, segmented, discontinuous portions on the surface of the treatment electrode 29102 can be positioned in an offset or opposed electrode configuration, can be connected to a current return path, and can be connected therefrom to an electrosurgical generator.
[0241] In view of the above, it will be appreciated that the flexible electrode assembly 29200 is a multi-level flexible electrode and can measure one or more parameters associated with the surgical instrument 29000 and / or tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000, and can also cauterize the tissue.
[0242] FIG. 31 shows an exploded view of the flexible electrode 29300 of the surgical instrument 29000 of FIG. 22 according to 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, but differs in that the flexible electrode 29300 of FIG. 31 further includes a third insulating layer 29302 positioned to partially cover the surface of the sensing electrode 29104 that is opposite to the surface of the sensing electrode 29104 covered by the first insulating layer 29110. The third insulating layer 29302 has the same overall length as the sensing electrode 29104, the first insulating layer 29110, and / or the treatment electrode 29102, but has a width smaller than the width of the sensing electrode 29104, the first insulating layer 29110, the treatment electrode 29102, and / or the second insulating layer 29116, and may have a rectangular shape. For example, according to various aspects, the third insulating layer 29302 may have a width that covers all of the sensing electrode 29104 except for the rectangular finger portions 29106. According to other aspects, the third insulating layer 29302 may have a width that does not cover the rectangular finger portions 29106 and only partially covers the remaining portion of the sensing electrode 29104. According to various aspects, the third insulating layer 29302 may have a thickness in the range of about 0.0001 inches to 0.003 inches. The third insulating layer 29302 may include any suitable non-conductive material and may have a higher flexibility than either the treatment electrode 29102 or the sensing electrode 29104.
[0243] FIG. 32 shows an end view of the flexible electrode 29400 of the surgical instrument 29000 of FIG. 22, according to 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 (with respect to FIG. 32), the second insulating layer 29116 extends beyond the left and right sides of the therapeutic electrode 29102, and the third insulating layer 29302 extends beyond one of the sides of the sensing electrode 29104. Additionally, the flexible electrode 29400 of FIG. 32 also includes an insulating material 29402 that covers one of the sides of the therapeutic electrode 29102 and one of the sides of the sensing electrode 29102 and collectively connects the first, second, and third insulating layers 29110, 29116, 29302. The insulating material 29402 may be similar or identical to the material of the first, second, and / or third insulating layers 29110, 29116, 29302 and may have a higher flexibility than either the therapeutic electrode 29102 or the sensing electrode 29104. Further, the flexible electrode 29400 of FIG. 32 may be a layered composite structure that includes portions of the sensing electrode 29104 and / or the therapeutic electrode 29102 embedded within a laminated structure that allows multiple portions of the sensing electrode 29104 and / or the therapeutic electrode 29102 to contact tissue positioned between the jaws of the surgical instrument 29000.
[0244] FIG. 33 shows a top perspective view of the flexible electrode 29500 of the surgical instrument 29000 of FIG. 22, according to at least one other aspect of the present disclosure. As shown in FIG. 33, the flexible electrode 29500 further includes additional insulating material 29504 that covers the side of the sensing electrode 29104 that is opposite the side covered by the insulating material 29402. The additional insulating material 29504 may be similar or identical to the material of the insulating material 29402 and the materials of the first, second, and / or third insulating layers 29110, 29116, 29302. The additional insulating material 29504 may have a higher flexibility than either the therapeutic electrode 29102 or the sensing electrode 29104. As shown in FIG. 33, the long, thin portion 29506 of the therapeutic electrode 29104 is not covered and may come into direct contact with tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000. The limited surface area of the long, thin, uncovered portion 29506 of the therapeutic electrode 29104 may reduce any undesirable tissue adhesion. Similarly, the discontinuous portions of the therapeutic electrode 29102 that are not covered by the first insulating member 29110 and / or the sensing electrode 29104 may also come into direct contact with tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000 and may further reduce any undesirable tissue adhesion.
[0245] As described 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 terminal contact configuration may enable the flexible circuit 29008 to be readily attached to or connected to other connections and / or circuits within the surgical instrument 29000. The terminal contact configuration may provide strain relief to the flexible circuit 29008, which may reduce damage to the portion of the flexible circuit 29008 adjacent the connection. The terminal contact configuration may also maintain the connection in a watertight manner. According to various aspects, the terminal contact configuration may 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 against fluid and may provide strain relief to the portion of the flexible circuit 29008 adjacent the ZIF connector.
[0246] By incorporating the treatment electrode 29102 and the sensing electrode 29104 into the flexible electrode, the flexible electrode may apply RF energy to tissue positioned between the first jaw 29012 and the second jaw 29014 of the surgical instrument 29000 while also measuring parameters associated with the tissue and / or the surgical instrument 29000. In the configuration described above, even when the treatment electrode 29102 applies RF energy to the tissue for welding, the sensing electrode 29104 may continuously sense the parameters. Additionally, 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 a small surface area in contact with the tissue and thus is less likely to contribute to undesirable tissue adhesion. Further, due to the inherent flexibility of the flexible electrode, the treatment electrode 29102 is less likely to experience early failure due to undesirable bending or deformation compared to electrodes typically associated with surgical instruments.
Example
[0247] Various aspects of the subject matter described herein are illustrated in the following numbered examples.
[0248] Example 1 - A flexible electrode for a surgical instrument is disclosed. The flexible electrode includes a high-frequency energy source, a sensing electrode, and a treatment electrode connectable to an insulating layer. The 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 a first jaw and a second jaw of the surgical instrument.
[0249] Example 2 - The flexible electrode according to Example 1, wherein the treatment electrode includes a rectangular shape.
[0250] Example 3 - The flexible electrode according to any one of Examples 1 and 2, wherein the sensing electrode overlaps the treatment electrode.
[0251] Example 4 - The flexible electrode according to any one of Examples 1 to 3, wherein the sensing electrode includes a pattern shape including a rectangular portion and a plurality of finger portions extending from the rectangular portion.
[0252] Example 5 - The flexible electrode according to any one of Examples 1 to 4, wherein the sensing electrode is configured to assist in determining at least one of the impedance of tissue positioned between a first jaw and a second jaw of the surgical instrument, the electrical continuity of the tissue, and the temperature transition point within the tissue.
[0253] Example 6 - The flexible electrode according to any one of Examples 1, 2, 4, and 5, wherein the insulating layer overlaps the treatment sensing electrode.
[0254] Example 7 - The flexible electrode according to any one of Examples 1 to 6, wherein the insulating layer includes a rectangular portion and a plurality of finger portions extending from the rectangular portion.
[0255] Example 8 - The flexible electrode according to any one of Examples 1 to 7, wherein the insulating layer coincides with the sensing electrode.
[0256] Example 9 - The flexible electrode according to any one of Examples 1 to 8, wherein the flexibility of the insulating layer exceeds the flexibility of the treatment electrode and the flexibility of the sensing electrode.
[0257] Example 10 - The flexible electrode according to any one of Examples 1 to 9, further comprising a second insulating layer, wherein the treatment layer is positioned between the insulating layer and the second insulating (instulative) layer.
[0258] Example 11 - The flexible electrode according to Example 10, further comprising a third insulating layer, wherein the sensing electrode is positioned between the insulating layer and the third insulating layer.
[0259] Example 12 - A flexible electrode assembly for a surgical instrument is disclosed. The flexible electrode assembly includes first and second treatment electrodes connectable to a high frequency energy source, and first and second sensing electrodes configured to assist in determining parameters associated with tissue positioned between a first jaw and a second jaw of the surgical instrument. The flexible electrode assembly further includes a first insulating layer positioned between the first treatment electrode and the first sensing electrode, and a second insulating layer positioned between the second treatment electrode and the second sensing electrode, and the first and second treatment electrodes and the first and second sensing electrodes are configured to contact the tissue.
[0260] Example 13 - The flexible electrode assembly according to Example 12, wherein 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, and the second treatment electrode, the second sensing electrode, and the first insulating layer are positioned on an opposite side of the knife slot.
[0261] Example 14 - The flexible electrode assembly according to any one of Examples 12 and 13, wherein the first and second sensing electrodes are configured to assist in determining at least one of impedance of tissue positioned between a first jaw and a second jaw of the surgical instrument, electrical continuity of the tissue, and a temperature transition point within the tissue.
[0262] The flexible electrode assembly according to any one of Examples 12 to 14, wherein each of the first and second sensing electrodes includes a pattern shape including a rectangular portion and a plurality of finger portions extending from the rectangular portion.
[0263] The flexible electrode assembly according to any one of Examples 12 to 15, wherein each of the first and second insulating layers includes a pattern shape including a rectangular portion and a plurality of finger portions extending from the rectangular portion.
[0264] The flexible electrode assembly according to any one of Examples 12 to 16, wherein the flexibility of the first and second insulating layers exceeds the flexibility of the first and second therapeutic electrodes and the flexibility of the first and second sensing electrodes.
[0265] The flexible electrode assembly according to any one of Examples 12 to 17, wherein 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.
[0266] 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 therapeutic electrode and a sensing electrode. The therapeutic electrode is positioned between the first insulating layer and the second insulating layer, and the therapeutic electrode is connectable to a high-frequency energy source. The sensing electrode is positioned between the second insulating layer and the third insulating layer, and the sensing electrode is configured to assist in determining a parameter associated with tissue positioned between a first jaw and a second jaw of the surgical instrument, and the therapeutic electrode and the sensing electrode are configured to contact the tissue.
[0267] The multi-level electrode according to Example 19, wherein the sensing electrode is configured to assist in determining at least one of impedance of tissue positioned between a first jaw and a second jaw of the surgical instrument, electrical continuity of the tissue, and a temperature transition point within the tissue.
[0268] Although several forms have been illustrated and described, it is not the intention of the applicant to limit or restrict the appended "claims" to such a detailed description. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these forms can be implemented and would be contemplated by those skilled in the art without departing from the scope of the present disclosure. Further, the structure of each element related to the forms described can alternatively be described as a means for providing the function performed by that element. Also, although materials are disclosed with respect to certain components, other materials may be used. Accordingly, it should be understood that the foregoing description and the appended claims are intended to cover all such modifications, combinations, and variations as being within the scope of the disclosed forms. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.
[0269] The above detailed description has described various forms of apparatuses and / or processes using block diagrams, flowcharts, and / or examples. As long as such block diagrams, flowcharts, and / or examples include one or two or more functions and / or operations, each function and / or operation included in such block diagrams, flowcharts, and / or examples can be implemented individually and / or collectively by various hardware, software, firmware, or virtually any combination thereof, which will be understood by those skilled in the art. Those skilled in the art will understand that all or part of some aspects of the forms disclosed herein can be equivalently realized on an integrated circuit as one or two or more computer programs operating on one or more computers (e.g., as one or two or more programs operating on one or more computer systems), as one or two or more programs operating on one or two or more processors (e.g., as one or two or more programs operating on one or two or more microprocessors), as firmware, or as virtually any combination thereof, and that designing circuits and / or writing software and / or firmware code are within the scope of the skills of those skilled in the art in view of the present disclosure. Further, as will be understood by those skilled in the art, the mechanisms of the subject matter described herein can be distributed as one or two or more program products in various forms, and the specific forms of the subject matter described herein are used regardless of the specific type of signal carrier medium used for actual distribution.
[0270] Instructions used to program logic to execute various disclosed aspects may be stored in system memory such as DRAM, cache, flash memory, or other storage. Further, the instructions may be distributed via a network or by other computer-readable media. Thus, machine-readable media can include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but are not limited to floppy disks, optical disks, CD-ROMs, and magneto-optical disks, ROM, RAM, EPROM, EEPROM, magnetic or optical cards, flash memory, or tangible machine-readable storage used to transmit information via the Internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, IR signals, digital signals, etc.). Thus, non-transitory computer-readable media can include any type of tangible machine-readable media suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
[0271] As used throughout this description, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, technologies, communication channels, etc. that can communicate data through the use of modulated electromagnetic radiation via a non-solid medium. This term does not mean that the associated devices do not include any wired components, but in some aspects, they may not be present. The communication module may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, LTE, Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, derivatives of these Ethernet, as well as 3G, 4G, 5G, and any other wireless and wired protocols designated for later generations. The computing module may include a plurality of communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.
[0272] When used in any aspect of this specification, the term "control circuit" can refer to, for example, a hardwired circuit, a programmable circuit (e.g., a computer processor, processing unit, processor, microcontroller, microcontroller unit, controller, DSP, PLD, programmable logic array (PLA), or FPGA that includes one or more individual instruction processing cores), a state machine circuit, firmware that stores instructions executed by a programmable circuit, and any combination thereof. The control circuit can be embodied, collectively or individually, as part of a larger system, such as an integrated circuit (IC), an application specific integrated circuit (ASIC), a system on chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, a "control circuit" can include, but is not limited 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, an electrical circuit forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that at least partially executes the processes and / or devices described herein, or a microprocessor configured by a computer program that at least partially executes the processes and / or devices described herein), an electrical circuit forming a memory device (e.g., in the form of a random access memory), and / or an electrical circuit forming a communication device (e.g., a modem, a communication switch, or an opto-electrical facility). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form or some combination thereof.
[0273] As used herein, a processor or processing unit is an electronic circuit that executes operations on some external data source, typically memory or some other data stream. This term is used herein to refer to the central processor (central processing unit) within a system or computer system (especially a SoC) that combines many dedicated "processors".
[0274] As used herein, a SoC or system-on-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 functions, all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with state-of-the-art peripherals such as a graphics processing unit (GPU), Wi-Fi module, or coprocessor. A SoC may or may not include on-chip memory.
[0275] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU of a microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to a SoC, which may include a microcontroller as one of its components. A microcontroller can accommodate memory and programmable input / output peripherals along with one or two or more core processing units (CPUs). Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM, and a small amount of RAM are also often included on the chip. A microcontroller can be employed for embedded applications, as opposed to microprocessors used in personal computers or other general-purpose applications composed of various individual chips.
[0276] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. It may also be the link between two parts of a computer or controller on an external device that manages the operation of the device (and connections to the device).
[0277] Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those known by the trade name of ARM Cortex from Texas Instruments. In one aspect, the processor may be, for example, a 256KB single-cycle flash memory or other NVM up to 40MHz, the details of which are available in the product datasheet, a prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle SRAM, an internal ROM with StellarisWare® software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI analogs, or one or more 12-bit ADCs with 12 analog input channels, such as the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.
[0278] In one aspect, the processor may include a safety controller that includes two controller families such as TMS570 and RM4x, also known by the trade name of Hercules ARM Cortex R4 from Texas Instruments. The safety controller may be configured specifically for safety-critical applications of IEC61508 and ISO26262, among others, to provide a high degree of integrated safety mechanisms while offering scalable performance, connectivity, and memory options.
[0279] When used in any aspect of this specification, the term "logic" may refer to an application, software, firmware, and / or circuitry configured to perform any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. The firmware may be embodied as code, instructions, or instruction sets within a memory device, and / or hard-coded (e.g., non-volatile) data.
[0280] When used in any aspect of this specification, terms such as "component", "system", "module", etc. may refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution.
[0281] When used in any aspect of this specification, "algorithm" refers to a self-collision-free sequence of steps leading to a desired result, and "step" refers to an operation of a physical quantity and / or logical state that is not necessarily required but can be in the form of an electrical or magnetic signal capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, etc. These and similar terms may be associated with appropriate physical quantities and are merely convenient labels applied to these quantities and / or states.
[0282] Examples of the network may include a packet-switching network. The communication devices can communicate with each other using a selected packet-switching network communication protocol. As an example of a communication protocol, an Ethernet communication protocol that enables communication using the Transmission Control Protocol / Internet Protocol (TCP / IP) may be included. The Ethernet protocol may comply with or be compatible with the Ethernet standard titled "IEEE 802.3 Standard" issued by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and / or later versions of this standard. Alternatively or additionally, the communication devices can communicate with each other using the X.25 communication protocol. The X.25 communication protocol may comply with or be compatible with the standard published by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices can communicate with each other using the frame relay communication protocol. The frame relay communication protocol may comply with or be compatible with the standards published by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be able to communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may comply with or be compatible with the ATM standard published by the ATM Forum under the title "ATM-MPLS Network Interworking 2.0" in August 2001 and / or later versions of this standard. Naturally, different and / or later-developed connection-oriented network communication protocols are equally contemplated herein.
[0283] Unless otherwise expressly defined, as will be apparent from the foregoing disclosure, throughout the foregoing disclosure, discussions using terms such as "process", "calculate", "compute", "determine", "display", etc. refer to the operation and processing of a computer system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities in the registers and memories of the computer system into other data similarly represented as physical quantities in the memories or registers of the computer system or in such information storage, transmission, or display devices.
[0284] One or more components may be referred to herein as "configured to", "configurable to", "operable / operative to", "adapted / adaptable", "able to", "conformable / conformed to", etc. Those skilled in the art will understand that "configured to" generally may include components in an active state and / or components in a non-active state and / or components in a standby state, unless the context requires otherwise.
[0285] The terms "proximal" and "distal" are used herein with reference to a clinician who operates the handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located farther from the clinician. It will be further understood that, for convenience and clarity, spatial terms such as "vertical", "horizontal", "up", "down", "left", and "right" may be used herein with respect to the drawings. However, the surgical instrument is used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[0286] The modular device includes a module receivable within a surgical hub (e.g., as described in connection with FIGS. 3 and 9), and a surgical device or instrument connectable to various modules to connect or pair with a corresponding surgical hub. Examples of 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. The control algorithm can be executed on the modular device itself, on the surgical hub to which a particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors within, on, or connected to the modular device). This data can be related to the patient during surgery (e.g., tissue characteristics or infusion pressure) or to the modular device itself (e.g., the speed of a advancing knife, motor current, or energy level). For example, the control algorithm of 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.
[0287] Those skilled in the art will generally understand that the terms used herein, and particularly those used in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be construed as "including but not limited to", the term "having" should be construed as "having at least", the term "includes" should be construed as "includes but is not limited to", etc.). Further, where a particular number is intended in an introduced claim recitation, such intention will be clearly recited in the claim, and those skilled in the art will understand that where such a recitation is absent, no such intention exists. For example, by way of illustration, the following appended claims may include introductory phrases such as "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed as suggesting that any particular claim that includes such an introduced claim recitation, even where the introductory phrases "one or more" or "at least one" and the indefinite article "a" or "an" are included within the same claim, is limited to a claim that includes only one such recited matter (e.g., "a" and / or "an" should generally be construed to mean "at least one" or "one or more"). The same holds true when introducing a claim recitation using a definite article.
[0288] Moreover, even when a specific number is specified in the introduced claim description, those skilled in the art will recognize that such description should typically be interpreted to mean at least the recited number (for example, when there is a mere description of "two descriptions" without other modifiers, generally it means at least two descriptions, or two or more descriptions). Further, when a notation similar to "at least one of A, B, and C, etc." is used, generally such syntax is intended in the sense that those skilled in the art will understand the notation (for example, "a system having at least one of A, B, and C" includes, without limitation, a system having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C, etc.). When a notation similar to "at least one of A, B, or C, etc." is used, generally such syntax is intended in the sense that those skilled in the art will understand the notation (for example, "a system having at least one of A, B, or C" includes, without limitation, a system having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C, etc.). Moreover, typically, any disjunctive word and / or phrase representing two or more alternative terms should be understood to be intended to include one of those terms, any of those terms, or both of those terms, whether in the specification, in the claims, or in the drawings, unless the context requires otherwise. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B".
[0289] Regarding the appended claims, those skilled in the art will understand that the recited operations herein can generally be performed in any order. Also, although flowcharts of various operations are shown in a sequence(s), it should be understood that the various operations may be performed in an order other than that shown, or may be performed simultaneously. Examples of such alternative orderings may include, without interpretation to other meanings in context, repetition, interleaving, interruption, reordering, incremental, preparatory, additional, simultaneous, reverse, or other different orderings. Further, terms such as "in response to", "associated with", or other past tense adjectives are not generally intended to exclude such variations, except where the context dictates otherwise.
[0290] It is particularly worth noting that any reference to "one aspect", "aspect", "exemplification", "an exemplification", etc. means that the particular mechanism, structure, or characteristic described in relation to that aspect is included in at least one aspect. Thus, the phrases "in one aspect", "in an aspect", "in an exemplification", and "in an exemplification" that appear in various places throughout this specification do not necessarily all refer to the same aspect. Further, a particular feature, structure, or characteristic can be combined in any suitable manner in one or more aspects.
[0291] Any patent application, patent, non-patent publication, or other disclosure material referenced herein and / or listed in any application data sheet is incorporated herein by reference to the extent that the incorporated material is not inconsistent with this specification. As such, and to the extent necessary, the disclosure clearly set forth herein shall supersede any conflicting description incorporated herein by reference. Any content, or portions thereof, that are inconsistent with the current definitions, views, or other disclosure set forth herein shall be incorporated herein by reference, but only to the extent that no conflict arises between the reference content and the current disclosure content.
[0292] In summary, many benefits resulting from using the concepts described herein have been described. The above description in one or more forms is presented for purposes of illustration and explanation. It is not intended to be exhaustive or to limit to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. One or more forms are selected and described to illustrate the principles and practical applications, so that those skilled in the art can utilize the various forms with various modifications as suitable for the particular uses contemplated. The claims presented with this specification are intended to define the overall scope.
[0293] 〔Embodiment〕 (1) A flexible electrode for a surgical instrument, wherein the flexible electrode comprises a therapeutic electrode connectable to a high-frequency energy source, a sensing electrode, and an insulating layer positioned between the therapeutic electrode and the sensing electrode, wherein the therapeutic electrode and the sensing electrode are configured to contact tissue positioned between a first jaw and a second jaw of the surgical instrument. (2) The flexible electrode according to Embodiment 1, wherein the therapeutic electrode includes a rectangular shape. (3) The flexible electrode according to Embodiment 1, wherein the sensing electrode overlaps the therapeutic electrode. (4) The flexible electrode according to Embodiment 1, wherein the sensing electrode includes a pattern shape including a rectangular portion and a plurality of finger portions extending from the rectangular portion. (5) The sensing electrode is configured to assist in determining at least one of the impedance of the tissue positioned between the first jaw and the second jaw of the surgical instrument, the electrical continuity of the tissue, and the temperature transition point within the tissue.
[0294] (6) The flexible electrode according to Embodiment 1, wherein the insulating layer overlaps the therapeutic electrode. (7) The flexible electrode according to Embodiment 1, wherein the insulating layer includes a rectangular portion and a plurality of finger portions extending from the rectangular portion. (8) The flexible electrode according to Embodiment 1, wherein the insulating layer coincides with the sensing electrode. (9) The flexibility of the insulating layer is greater than the flexibility of the treatment electrode and greater than the flexibility of the sensing electrode. The flexible electrode according to Embodiment 1. (10) The flexible electrode according to Embodiment 1, further comprising a second insulating layer, wherein the treatment electrode is positioned between the insulating layer and the second insulating layer.
[0295] (11) The flexible electrode according to Embodiment 10, further comprising a third insulating layer, 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 high-frequency energy source, and first and second sensing electrodes configured to assist in determining parameters associated with tissue positioned between a first jaw and a second jaw of the surgical instrument, and a first insulating layer positioned between the first treatment electrode and the first sensing electrode, and a second insulating layer positioned between the second treatment electrode and the second sensing electrode, wherein the first and second treatment electrodes and the first and second sensing electrodes are configured to contact the tissue. The flexible electrode assembly. (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, The flexible electrode assembly according to Embodiment 12, wherein the second treatment electrode, the second sensing electrode, and the first insulating layer are positioned on the opposite side of the knife slot. (14) The first and second sensing electrodes are The impedance of the tissue positioned between the first jaw and the second jaw of the surgical instrument, the electrical continuity of the tissue, the flexible electrode assembly according to embodiment 12, configured to assist in determining at least one of the temperature transition points within the tissue. (15) The flexible electrode assembly according to embodiment 12, wherein each of the first and second sensing electrodes includes a pattern shape including a rectangular portion and a plurality of finger portions extending from the rectangular portion.
[0296] (16) The flexible electrode assembly 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 finger portions extending from the rectangular portion. (17) The flexibility of the first and second insulating layers exceeds the flexibility of the first and second therapeutic electrodes and the flexibility of the first and second sensing electrodes, of the flexible electrode assembly according to embodiment 12. (18) The flexible electrode assembly according to embodiment 12, wherein 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. (19) A multi-level flexible electrode of a surgical instrument, the multi-level 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 high-frequency energy source, and a sensing electrode positioned between the second insulating layer and the third insulating layer, the sensing electrode being configured to assist in determining a parameter associated with tissue positioned between a first jaw and a second jaw of the surgical instrument, the therapeutic electrode and the sensing electrode being configured to contact the tissue, the multi-level flexible electrode. (20) The sensing electrode the impedance of the tissue positioned between the first jaw and the second jaw of the surgical instrument, the electrical continuity of the tissue, a multi-level flexible electrode according to Embodiment 19, configured to assist in determining at least one of a temperature transition point within the tissue.
Claims
1. A flexible electrode for a surgical instrument, wherein the flexible electrode comprises: A treatment electrode connectable to a high-frequency energy source; A sensing electrode overlapping the treatment electrode; An insulating layer overlapping the treatment electrode and positioned between the treatment electrode and the sensing electrode, wherein the treatment electrode and the sensing electrode are configured to contact tissue positioned between a first jaw and a second jaw of the surgical instrument, and are disposed at least on the first jaw, and the treatment electrode is positioned between the sensing electrode and the first jaw; The sensing electrode includes a pattern shape including a rectangular portion and a plurality of finger portions extending from the rectangular portion; The treatment electrode has a rectangular shape and is configured to face the tissue from a space between adjacent finger portions of the sensing electrode. A flexible electrode.
2. The sensing electrode is configured to assist in determining at least one of: The impedance of the tissue positioned between the first jaw and the second jaw of the surgical instrument; The electrical continuity of the tissue; The temperature transition point within the tissue. The flexible electrode according to claim 1.
3. The insulating layer includes a rectangular portion and a plurality of finger portions extending from the rectangular portion of the insulating layer. The flexible electrode according to claim 1.
4. The insulating layer coincides with the sensing electrode. The flexible electrode according to claim 1.
5. The flexibility of the insulating layer is Greater than the flexibility of the treatment electrode; Greater than the flexibility of the sensing electrode. The flexible electrode according to claim 1.
6. Further comprising a second insulating layer, wherein the treatment electrode is positioned between the insulating layer and the second insulating layer. The flexible electrode according to claim 1.
7. Further comprising a third insulating layer, wherein the sensing electrode is positioned between the insulating layer and the third insulating layer. The flexible electrode according to claim 6.
8. A flexible electrode assembly for a surgical instrument, wherein the flexible electrode assembly comprises: A flexible electrode according to 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 second treatment electrode connectable to the high-frequency energy source; A second sensing electrode configured to assist in determining a parameter associated with the tissue positioned between the first jaw and the second jaw of the surgical instrument. A second insulating layer positioned between the second therapeutic electrode and the second sensing electrode, the flexible electrode assembly comprising the second therapeutic electrode and the second sensing electrode being configured to contact the tissue. **Claim 9** The first therapeutic electrode, the first sensing electrode, and the first insulating layer are positioned on a first side of the knife slot of the surgical instrument. The flexible electrode assembly according to claim 8, wherein the second therapeutic electrode, the second sensing electrode, and the second insulating layer are positioned on the opposite side of the knife slot. **Claim 10** The first and second sensing electrodes are configured to assist in determining at least one of the impedance of the tissue positioned between the first jaw and the second jaw of the surgical instrument, the electrical continuity of the tissue, and the temperature transition point within the tissue. The flexible electrode assembly according to claim 8. **Claim 11** The flexible electrode assembly according to claim 8, wherein the second sensing electrode includes a pattern shape including a rectangular portion and a plurality of finger portions extending from the rectangular portion. **Claim 12** The flexible electrode assembly according to claim 8, wherein each of the first and second insulating layers includes a pattern shape including a rectangular portion and a plurality of finger portions extending from the rectangular portion. **Claim 13** The flexibility of the first and second insulating layers is greater than the flexibility of the first and second therapeutic electrodes and the flexibility of the first and second sensing electrodes. The flexible electrode assembly according to claim 8. **Claim 14** The flexible electrode assembly according to claim 8, wherein 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. **Claim 15** The flexible electrode assembly according to claim 8, wherein the second therapeutic electrode and the second sensing electrode are disposed at least on the first jaw, and the second therapeutic electrode is positioned between the second sensing electrode and the first jaw. **Claim 16** The therapeutic electrode defines a first layer, the sensing electrode defines a second layer, and the insulating layer is positioned between the first layer and the second layer. The flexible electrode according to claim 1, wherein the first layer is positioned between the second layer and the first jo. **Claim 17** A surgical instrument comprising: the flexible electrode according to claim 1; and the first jo and the second jo.
Citation Information
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