Communication hub and storage device for storing parameters and status of surgical devices for sharing with cloud-based analysis systems

Abstract

The present invention discloses various surgical hubs. The surgical hub includes: a storage device; a processor coupled to the storage device; and a memory coupled to the processor. The memory stores instructions executable by the processor to perform the following operations: receiving data from a surgical instrument coupled to the surgical hub; and determining a rate at which the data is transmitted from the surgical hub to a cloud-based telemedicine analysis network based on available storage capacity of the storage device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application Serial No. 62 / 649,294, filed on March 28, 2018, entitled DATA STRIPPINGMETHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD, the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application also claims the benefit of priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application Serial No. 62 / 611,341, filed on December 28, 2017, entitled INTERACTIVE SURGICAL PLATFORM, U.S. Provisional Patent Application Serial No. 62 / 611,340, filed on December 28, 2017, entitled CLOUD-BASED MEDICAL ANALYTICS, and U.S. Provisional Patent Application Serial No. 62 / 611,339, filed on December 28, 2017, entitled ROBOT ASSISTED SURGICAL PLATFORM, the disclosure of each of which is incorporated herein by reference in its entirety. Background Art

[0004] The present disclosure relates to various surgical systems. Surgical procedures are typically performed in operating theaters or rooms in medical facilities, such as, for example, hospitals. A sterile field is typically created around the patient. The sterile field may include appropriately dressed scrubbed team members, as well as all furniture and fixtures in the area. Various surgical devices and systems are utilized when performing surgical procedures. Summary of the invention

[0005] In one general aspect, a surgical hub is provided. The surgical hub includes: a storage device; a processor coupled to the storage device; and a memory coupled to the processor. The memory stores instructions executable by the processor to: receive data from a surgical instrument coupled to the surgical hub; and determine a rate at which the data is transmitted from the surgical hub to a cloud-based telemedicine analysis network based on available storage capacity of the storage device.

[0006] In another general aspect, another surgical hub and method of transmitting data is provided. The method transmits data from a surgical hub to a cloud-based telemedicine analysis network. The surgical hub includes a storage device, a processor coupled to the storage device, and a memory coupled to the processor. The memory stores instructions executable by the processor. The method includes: receiving, by the processor, data from a surgical instrument coupled to the surgical hub; and determining, by the processor, a rate at which the data is transmitted from the surgical hub to the cloud-based telemedicine analysis network based on available storage capacity of the storage device coupled to the surgical hub.

[0007] In another general aspect, a computer readable medium is provided. The computer readable medium is a non-transitory computer readable medium and stores computer readable instructions that, when executed, cause a machine to: receive data from a surgical instrument coupled to the surgical hub; and determine a rate at which to transmit the data from the surgical hub to a cloud-based telemedicine analysis network based on available storage capacity of the storage device. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The features of the various aspects are particularly described in the appended claims. However, the various aspects (relating to surgical organizations and methods) and further objects and advantages thereof may best be understood by reference to the following description taken in conjunction with the following drawings.

[0009] Figure 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure.

[0010] Figure 2 A surgical system for performing a surgical procedure in an operating room according to at least one aspect of the present disclosure.

[0011] Figure 3 A surgical hub is paired with a visualization system, a robotic system, and a smart instrument according to at least one aspect of the present disclosure.

[0012] Figure 4 A partial perspective view of a surgical hub housing and a combination generator module slidably received in a drawer of the surgical hub housing according to at least one aspect of the present disclosure.

[0013] Figure 5 is a perspective view of a combination generator module having bipolar, ultrasonic and monopolar contacts and a smoke evacuation device according to at least one aspect of the present disclosure.

[0014] Figure 6A single power bus attachment for multiple lateral docking ports of a lateral modular housing configured to accommodate multiple modules is shown in accordance with at least one aspect of the present disclosure.

[0015] Figure 7 A vertical modular housing configured to accommodate a plurality of modules according to at least one aspect of the present disclosure is shown.

[0016] Figure 8 A surgical data network including a modular communication hub configured to enable connecting modular devices located in one or more operating rooms of a medical facility or any room in a medical facility dedicated to surgical operations to a cloud is shown in accordance with at least one aspect of the present disclosure.

[0017] Fig. 9 A computer-implemented interactive surgical system according to at least one aspect of the present disclosure.

[0018] Fig.10 A surgical hub comprising multiple modules coupled to a modular control tower is shown in accordance with at least one aspect of the present disclosure.

[0019] Fig.11 An aspect of a universal serial bus (USB) hub device in accordance with at least one aspect of the present disclosure is shown.

[0020] Fig.12 A logic diagram of a control system for a surgical instrument or tool according to at least one aspect of the present disclosure is shown.

[0021] Fig.13 Control circuitry configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure is shown.

[0022] Fig.14 Combinatorial logic circuits configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure are shown.

[0023] Fig.15 A sequential logic circuit configured to control various aspects of a surgical instrument or tool according to at least one aspect of the present disclosure is shown.

[0024] Fig.16 A surgical instrument or tool including multiple motors that can be activated to perform various functions in accordance with at least one aspect of the present disclosure is shown.

[0025] Fig.17 is a schematic diagram of a robotic surgical instrument configured to operate the surgical tools described herein according to at least one aspect of the present disclosure.

[0026] Fig.18 A block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure is shown.

[0027] Fig.19 is a schematic diagram of a surgical instrument configured to control various functions according to at least one aspect of the present disclosure.

[0028] Fig. 20 A simplified block diagram of a generator configured to provide, among other benefits, inductorless tuning in accordance with at least one aspect of the present disclosure.

[0029] Fig.21 An example of a generator according to at least one aspect of the present disclosure is shown. Fig. 20 A form of generator.

[0030] Fig. 22 A diagram illustrating a technique for interacting with a patient electronic medical record (EMR) database in accordance with at least one aspect of the present disclosure.

[0031] Fig.23 A method for anonymizing surgical procedures by replacing a real-time clock with an artificial time measurement for all information stored within instruments, robots, surgical hubs, and / or hospital computer equipment in accordance with at least one aspect of the present disclosure is shown.

[0032] Fig.24 Ultrasonic inspection of an operating room wall to determine the distance between a surgical hub and the operating room wall is shown in accordance with at least one aspect of the present disclosure.

[0033] Fig.25 A diagram depicting a method of importing patient data stored in an electronic medical record (EMR) database, stripping the patient data, and identifying smart device meanings in accordance with at least one aspect of the present disclosure is shown.

[0034] Fig.26 The application of cloud-based analytics in compiling and stripping patient data and independent data pairs according to at least one aspect of the present disclosure is shown.

[0035] Fig. 27 A logic flow diagram is provided for illustrating a method of a control program or logic configuration for associating a patient data set from a first data source and a second data source in accordance with at least one aspect of the present disclosure.

[0036] Fig.28A logic flow diagram depicting a method for stripping data to extract relevant portions of the data for use in a control program or logic configuration for configuring and operating a surgical hub and modules (e.g., instruments) connected to the surgical hub in accordance with at least one aspect of the present disclosure.

[0037] Fig.29 A self-describing data packet including self-describing data in accordance with at least one aspect of the present disclosure is shown.

[0038] Fig.30 A logic flow diagram is depicted for a method for using a control program or logic configuration that includes data packets that include self-describing data in accordance with at least one aspect of the present disclosure.

[0039] Fig.31 A logic flow diagram is depicted for a method for using a control program or logic configuration that includes data packets that include self-describing data in accordance with at least one aspect of the present disclosure.

[0040] Fig.32 is an image of a tumor embedded in the right upper posterior lobe of the right lung in accordance with at least one aspect of the present disclosure.

[0041] Fig.33 FIG. 1 is a diagram of a lung tumor resection surgical procedure according to at least one aspect of the present disclosure, the lung tumor resection surgical procedure including four separate firings of a surgical stapler to seal and cut exposed fissures leading to and from the Fig.32 The bronchial vessels of the upper and lower lobes of the right lung are shown.

[0042] Fig.34 For characterization according to at least one aspect of the present disclosure as Fig.32 Graphic illustrations of the closing force (FTC) versus time curve and the firing force (FTF) versus time curve for the first firing of the device 002 are shown.

[0043] Fig.35 A suture visualization laser Doppler image for assessing suture seal integrity by monitoring vessel bleeding after firing of a surgical stapler in accordance with at least one aspect of the present disclosure.

[0044] Fig.36 Paired datasets grouped by surgery in accordance with at least one aspect of the present disclosure are shown.

[0045] Fig.37 This is a picture of the right lung.

[0046] Fig.38 Diagram of the bronchial tree including the trachea and bronchi of the lungs.

[0047] Fig.39A logic flow diagram depicts a method of a control program or logic configuration for storing paired anonymized data sets grouped by surgery in accordance with at least one aspect of the present disclosure.

[0048] Fig.40 A logic flow diagram depicts a method of a control program or logic configuration for determining the rate, frequency, and type of data transmitted to a cloud-based remote analysis network in accordance with at least one aspect of the present disclosure.

[0049] Fig.41 A timeline of situational awareness for a surgical hub is depicted in accordance with at least one aspect of the present disclosure. DETAILED DESCRIPTION

[0050] The applicant of the present patent application owns the following U.S. Provisional Patent Applications filed on March 28, 2018, each of which is incorporated herein by reference in its entirety:

[0051] U.S. Provisional Patent Application Serial No. 62 / 649,302, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;

[0052] U.S. Provisional Patent Application Serial No. 62 / 649,294, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD;

[0053] U.S. Provisional Patent Application Serial No. 62 / 649,300, entitled SURGICAL HUB SITUATIONAL AWARENESS;

[0054] U.S. Provisional Patent Application Serial No. 62 / 649,309, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER;

[0055] U.S. Provisional Patent Application Serial No. 62 / 649,310, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;

[0056] U.S. Provisional Patent Application Serial No. 62 / 649,291, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT;

[0057] U.S. Provisional Patent Application Serial No. 62 / 649,296, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;

[0058] U.S. Provisional Patent Application Serial No. 62 / 649,333, entitled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER;

[0059] U.S. Provisional Patent Application Serial No. 62 / 649,327, entitled CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES;

[0060] U.S. Provisional Patent Application Serial No. 62 / 649,315, entitled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;

[0061] U.S. Provisional Patent Application Serial No. 62 / 649,313, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;

[0062] U.S. Provisional Patent Application Serial No. 62 / 649,320, entitled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;

[0063] U.S. Provisional Patent Application Serial No. 62 / 649,307, entitled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and

[0064] • U.S. Provisional Patent Application Serial No. 62 / 649,323, entitled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

[0065] The applicant of the present patent application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:

[0066] U.S. Patent Application Serial No. ____________ entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES; Attorney Docket No. END8499USNP / 170766;

[0067] U.S. Patent Application Serial No. ____________ entitled INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES; Attorney Docket No. END8499USNP1 / 170766-1;

[0068] U.S. Patent Application Serial No. ____________ entitled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES; Attorney Docket No. END8499USNP2 / 170766-2;

[0069] U.S. Patent Application Serial No. ____________ entitled SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS; Attorney Docket No. END8499USNP3 / 170766-3;

[0070] U.S. Patent Application Serial No. ____________ entitled COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS; Attorney Docket No. END8499USNP4 / 170766-4;

[0071] U.S. Patent Application Serial No. ____________, entitled SURGICAL HUB CONTROL ARRANGEMENTS; Attorney Docket No. END8499USNP5 / 170766-5;

[0072] U.S. Patent Application Serial No. ____________ entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD; Attorney Docket No. END8500USNP / 170767;

[0073] U.S. Patent Application Serial No. ____________, entitled SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT; Attorney Docket No. END8500USNP2 / 170767-2;

[0074] U.S. Patent Application Serial No. ____________ entitled DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME; Attorney Docket No. END8500USNP3 / 170767-3;

[0075] U.S. Patent Application Serial No. ____________, entitled SURGICAL HUB SITUATIONAL AWARENESS; Attorney Docket No. END8501USNP / 170768;

[0076] U.S. Patent Application Serial No. ____________, entitled SURGICAL SYSTEM DISTRIBUTED PROCESSING; Attorney Docket No. END8501USNP1 / 170768-1;

[0077] U.S. Patent Application Serial No. ____________, entitled AGGREGATION AND REPORTING OF SURGICAL HUB DATA; Attorney Docket No. END8501USNP2 / 170768-2;

[0078] U.S. Patent Application Serial No. ____________ entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER; Attorney Docket No. END8502USNP / 170769;

[0079] U.S. Patent Application Serial No. ____________ entitled DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE; Attorney Docket No. END8502USNP1 / 170769-1;

[0080] U.S. Patent Application Serial No. ____________ entitled STERILE FIELD INTERACTIVE CONTROL DISPLAYS; Attorney Docket No. END8502USNP2 / 170769-2;

[0081] U.S. Patent Application Serial No. ____________, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS; Attorney Docket No. END8503USNP / 170770;

[0082] U.S. Patent Application Serial No. ____________ entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT; Attorney Docket No. END8504USNP / 170771;

[0083] U.S. Patent Application Serial No. ____________ entitled CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY; Attorney Docket No. END8504USNP1 / 170771-1; and

[0084] · U.S. Patent Application Serial No. ____________, entitled DUAL CMOS ARRAY IMAGING; Attorney Docket No. END8504USNP2 / 170771-2.

[0085] The applicant of the present patent application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:

[0086] U.S. Patent Application Serial No. ____________, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES; Attorney Docket No. END8506USNP / 170773;

[0087] U.S. Patent Application Serial No. ____________, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS; Attorney Docket No. END8506USNP1 / 170773-1;

[0088] U.S. Patent Application Serial No. ____________ entitled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER; Attorney Docket No. END8507USNP / 170774;

[0089] U.S. Patent Application Serial No. ____________ entitled CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGETRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET; Attorney Docket No. END8507USNP1 / 170774-1;

[0090] U.S. Patent Application Serial No. ____________ entitled CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION; Attorney Docket No. END8507USNP2 / 170774-2;

[0091] U.S. Patent Application Serial No. ____________ entitled CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES; Attorney Docket No. END8508USNP / 170775;

[0092] U.S. Patent Application Serial No. ____________ entitled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; Attorney Docket No. END8509USNP / 170776; and

[0093] U.S. Patent Application Serial No. ____________ entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES; Attorney Docket No. END8510USNP / 170777.

[0094] The applicant of the present patent application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:

[0095] U.S. Patent Application Serial No. ____________, entitled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney Docket No. END8511USNP / 170778;

[0096] U.S. Patent Application Serial No. ____________, entitled COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS; Attorney Docket No. END8511USNP1 / 170778-1;

[0097] U.S. Patent Application Serial No. ____________, entitled CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney Docket No. END8511USNP2 / 170778-2;

[0098] U.S. Patent Application Serial No. ____________ entitled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS; Attorney Docket No. END8512USNP / 170779;

[0099] U.S. Patent Application Serial No. ____________, entitled CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney Docket No. END8512USNP1 / 170779-1;

[0100] U.S. Patent Application Serial No. ____________ entitled COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICALPLATFORMS; Attorney Docket No. END8512USNP2 / 170779-2;

[0101] U.S. Patent Application Serial No. ____________ entitled DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney Docket No. END8512USNP3 / 170779-3; and

[0102] · U.S. Patent Application Serial No. ____________ entitled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; Attorney Docket No. END8513USNP / 170780.

[0103] Before describing in detail various aspects of the surgical device and generator, it should be noted that the application or use of the illustrative examples is not limited to the details of the configuration and arrangement of the components shown in the drawings and detailed description. The illustrative examples may be implemented alone or in combination with other aspects, variations and modifications, and may be practiced or performed in a variety of ways. In addition, unless otherwise indicated, the terms and expressions used herein are selected for the convenience of the reader to describe the exemplary embodiments and are not for limiting purposes. Moreover, it should be understood that one or more of the aspects, expressions of aspects and / or examples described below may be combined with any one or more of the other aspects, expressions of aspects and / or examples described below.

[0104] See also Figure 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104 that may include the remote server 113. In one example, as Figure 1 As shown in , the surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112, which are configured to communicate with each other and / or with the hub 106. In some aspects, the surgical system 102 may include M number of hubs 106, N number of visualization systems 108, O number of robotic systems 110, and P number of handheld intelligent surgical instruments 112, where M, N, O, and P are integers greater than or equal to one.

[0105] Figure 3 An example of a surgical system 102 is shown for performing a surgical procedure on a patient lying flat on an operating table 114 in a surgical operating room 116. A robotic system 110 is used as part of the surgical system 102 during a surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robotic hub 122. While the surgeon views the surgical site through the surgeon's console 120, the patient side cart 117 can manipulate at least one removably coupled surgical tool 118 through a minimally invasive incision in the patient's body. Images of the surgical site can be obtained through a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 can be used to process images of the surgical site for subsequent display to the surgeon through the surgeon's console 118.

[0106] Other types of robotic systems may be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application Serial No. 62 / 611,339, filed on December 28, 2017, entitled ROBOT ASSISTED SURGICAL PLATFORM, the disclosure of which is incorporated herein by reference in its entirety.

[0107] Various examples of cloud-based analytics performed by cloud 104 and suitable for use in the present disclosure are described in U.S. Provisional Patent Application Serial No. 62 / 611,340, filed on December 28, 2017, entitled “CLOUD-BASED MEDICAL ANALYTICS,” the disclosure of which is incorporated herein by reference in its entirety.

[0108] In various aspects, imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.

[0109] The optics of imaging device 124 may include one or more illumination sources and / or one or more lenses. The one or more illumination sources may be directed to illuminate portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.

[0110] One or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as in the invisible spectrum. The visible spectrum (sometimes referred to as the optical spectrum or the luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and may be referred to as visible light or simply light. A typical human eye will respond to wavelengths in the range of about 380 nm to about 750 nm in air.

[0111] The invisible spectrum (i.e., non-luminescent spectrum) is the portion of the electromagnetic spectrum below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwaves, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray, and gamma-ray electromagnetic radiation.

[0112] In various aspects, the imaging device 124 is configured to be used in minimally invasive surgery. Examples of imaging devices suitable for the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophago-duodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngeal-renal endoscopes, sigmoidoscopes, thoracoscopes, and hysteroscopes.

[0113] In one aspect, the imaging device uses multispectral monitoring to distinguish topography and underlying structure. Multispectral images are images that capture image data within a specific wavelength range across the electromagnetic spectrum. The wavelengths can be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible light range, such as IR and ultraviolet. Spectral imaging allows the extraction of additional information that the human eye fails to capture with its red, green, and blue receptors. The use of multispectral imaging is described in more detail under the title "Advanced Imaging Acquisition Module" of U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled "INTERACTIVE SURGICALPLATFORM", filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. After completing the surgical task to perform one or more of the previously described tests on the treated tissue, multispectral monitoring can be a useful tool for repositioning the surgical site.

[0114] It is self-evident that during any surgical procedure, the operating room and surgical equipment need to be strictly sterilized. The strict sanitary and sterile conditions required in a "surgical room" (i.e., an operating room or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is the need to sterilize any material that contacts the patient or penetrates the sterile field, including the imaging device 124 and its attachments and devices. It should be understood that the sterile field can be considered to be a designated area that is considered to be free of microorganisms, such as within a tray or sterile towels, or the sterile field can be considered to be the area around the patient that has been prepared for surgical procedures. The sterile field can include a scrubbed team member that is appropriately dressed, as well as all furniture and fixtures in the area.

[0115] In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays that are strategically arranged relative to the sterile field, such as Figure 2 . In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the title “Advanced Imaging Acquisition Module” in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0116] like Figure 2, the main display 119 is positioned in the sterile field to be visible to the operator at the operating table 114. In addition, 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 are separated from each other. The visualization system 108 guided by the hub 106 is configured to be able to coordinate the flow of information to the operators inside and outside the sterile field using the displays 107, 109 and 119. For example, the 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 real-time feed of the surgical site on the main display 119. The snapshot on the non-sterile display 107 or 109 can allow the non-sterile operator to perform diagnostic steps related to the surgical procedure, for example.

[0117] In one aspect, the hub 106 is also configured to be able to route diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to the primary display 119 within the sterile field, where it can be viewed by a sterile operator at the operating table. In one example, the input can be a modified form of a snapshot displayed on the non-sterile display 107 or 109, which can be routed to the primary display 119 via the hub 106.

[0118] See also Figure 2 , surgical instruments 112 are used in surgical procedures as part of the surgical system 102. The hub 106 is also configured to coordinate the flow of information to the display of the surgical instruments 112. For example, U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 can be routed by the hub 106 to the surgical instrument display 115 within the sterile field, where the operator of the surgical instrument 112 can observe the input or feedback. Exemplary surgical instruments suitable for use with surgical system 102 are described under the title “Surgical Instrument Hardware” in U.S. provisional patent application serial number 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0119] See now Figure 3, the hub 106 is depicted as communicating with the visualization system 108, the robotic system 110, and the handheld intelligent surgical instrument 112. The hub 106 includes a 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 Figure 3 As shown in , the hub 106 also includes a smoke evacuation module 126 and / or a suction / rinsing module 128.

[0120] During surgery, energy application to tissue for sealing and / or cutting is usually associated with smoke evacuation, suction of excess fluid and / or flushing of tissue. Fluid lines, power lines and / or data lines from different sources are usually tangled during surgery. Valuable time can be lost in solving this problem during surgery. Disconnecting a line may require disconnecting the line from its corresponding module, which may require resetting the module. The hub modular housing 136 provides a unified environment for managing power lines, data lines and fluid lines, which reduces the frequency of tangling between such lines.

[0121] Aspects of the present disclosure provide a surgical hub for a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably accommodated in a docking base of the hub housing. The docking base includes data contacts and power contacts. The combination generator module includes two or more of an ultrasonic energy generator device, a bipolar RF energy generator device, and a monopolar RF energy generator device seated in a single unit. In one aspect, the combination generator module also includes a smoke exhaust device for connecting the combination generator module to at least one energy delivery cable of a surgical instrument, at least one smoke exhaust device configured to be able to exhaust smoke, fluids and / or particles generated by applying therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke exhaust device.

[0122] In one aspect, the fluid line is a first fluid line and the second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.

[0123] Certain surgical procedures may require more than one energy type to be applied to tissue. One energy type may be more conducive to cutting tissue, while another different energy type may be more conducive to sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the hub modular housing 136 is the ability to quickly remove and / or replace various modules.

[0124] Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving 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 base including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts.

[0125] Further describing the above, the modular surgical shell also includes a second energy generator module, which is configured to generate a second energy different from the first energy for application to tissue, and a second docking base, which includes a second docking port, the second docking port including second data and power contacts, wherein the second energy generator module is capable of sliding movement into electrical engagement with the power and data contacts, and wherein the second energy generator is capable of sliding movement out of electrical engagement with the second power and data contacts.

[0126] Additionally, the modular surgical housing further includes a communication bus between the first docking port and the second docking port that is configured to facilitate communication between the first energy generator module and the second energy generator module.

[0127] See also Figure 3-7 , aspects of the present disclosure are presented as a hub modular housing 136 that allows modular integration of the generator module 140, the smoke evacuation module 126, and the suction / irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. Figure 5 As shown in , the generator module 140 may be a generator module having integrated monopolar devices, bipolar devices, and ultrasonic devices supported in a single housing unit 139 that is slidably inserted into the hub modular housing 136. Figure 5 As shown in , the generator module 140 can be configured to be connected to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 can include a series of monopolar generator modules, bipolar generator modules, and / or ultrasonic generator modules that interact through the hub modular housing 136. The hub modular housing 136 can be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked into the hub modular housing 136 so that the generators will act as a single generator.

[0128] In one aspect, the hub modular housing 136 includes a modular power and communications backplane 149 with external and wireless communications connectors to enable removable attachment of the modules 140, 126, 128 and interactive communications therebetween.

[0129] In one aspect, the hub modular housing 136 includes a docking base or drawer 151 (also referred to herein as a drawer) that is configured to slidably accommodate the modules 140, 126, 128. Figure 4 A partial perspective view of a surgical hub housing 136 and a combination generator module 145 slidably received in a docking station 151 of the surgical hub housing 136 is shown. A docking port 152 having power and data contacts on the back of the combination generator module 145 is configured to engage the corresponding docking port 150 with the power and data contacts of the corresponding docking station 151 of the hub modular housing 136 when the combination generator module 145 is slid into place within the corresponding docking station 151 of the hub modular housing 136. In one aspect, the combination generator module 145 includes bipolar, ultrasonic and monopolar modules and a smoke evacuation module integrated together into a single housing unit 139, such as Figure 5 as shown in .

[0130] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that delivers captured / collected smoke and / or fluid from the surgical site to, for example, the smoke evacuation module 126. Vacuum suction from the smoke evacuation module 126 can draw smoke into an opening of a common conduit at the surgical site. The common conduit coupled to the fluid line can be in the form of a flexible tube that terminates at the smoke evacuation module 126. The common conduit and the fluid line define a fluid path that extends toward the smoke evacuation module 126 housed in the hub housing 136.

[0131] In various aspects, the suction / irrigation module 128 is coupled to a surgical tool including an aspiration fluid line and a suction fluid line. In one example, the aspiration fluid line and the suction fluid line are in the form of flexible tubes extending from the surgical site toward the suction / irrigation module 128. One or more drive systems can be configured to be able to flush fluid to the surgical site and to aspirate fluid from the surgical site.

[0132] In one aspect, the surgical tool comprises a shaft having an end effector at its distal end and at least one energy treatment associated with the end effector, a suction tube, and a flushing tube. The suction tube may have an inlet at its distal end, and the suction tube extends through the shaft. Similarly, the suction tube may extend through the shaft and may have an inlet adjacent to an energy delivery tool. The energy delivery tool is configured to be able to deliver ultrasonic energy and / or RF energy to a surgical site, and is coupled to a generator module 140 by a cable initially extending through the shaft.

[0133] The irrigation tube may be in fluid communication with a fluid source, and the aspiration tube may be in fluid communication with a vacuum source. The fluid source and / or vacuum source may be seated in the suction / irrigation module 128. In one example, the fluid source and / or vacuum source may be seated in the hub housing 136 independently of the suction / irrigation module 128. In such examples, a fluid interface is capable of connecting the suction / irrigation module 128 to the fluid source and / or vacuum source.

[0134] In one aspect, the modules 140, 126, 128 and / or their corresponding docking stations on the hub modular housing 136 may include alignment features configured to align the docking ports of the modules to engage with their corresponding ports in the docking stations of the hub modular housing 136. For example, Figure 4 As shown in , the combination generator module 145 includes a side bracket 155, which is configured to be slidably engaged with a corresponding bracket 156 of a corresponding docking base 151 of the hub modular housing 136. The bracket cooperates to guide the docking port contacts of the combination generator module 145 to electrically engage with the docking port contacts of the hub modular housing 136.

[0135] In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the size of the module is adjusted to be accommodated in the drawer 151. For example, the side brackets 155 and / or 156 can be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are different sizes and each is designed to accommodate a specific module.

[0136] Additionally, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting a module into a drawer with mismatched contacts.

[0137] like Figure 4 As shown in , the docking port 150 of one drawer 151 can be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate interactive communication between modules seated in the hub modular housing 136. Alternatively or additionally, the docking port 150 of the hub modular housing 136 can facilitate wireless interactive communication between modules seated in the hub modular housing 136. Any suitable wireless communication can be employed, such as, for example, Air Titan-Bluetooth.

[0138] Figure 6A single power bus attachment is shown for multiple lateral docking ports of a lateral modular housing 160 that is configured to accommodate multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to accommodate and interconnect modules 161 laterally. The modules 161 are slidably inserted into docking bases 162 of the lateral modular housing 160 that include a bottom plate for interconnecting the modules 161. Figure 6 As shown in FIG, the modules 161 are arranged transversely in the transverse modular housing 160. Alternatively, the modules 161 may be arranged vertically in the transverse modular housing.

[0139] Figure 7 A vertical modular housing 164 is shown that is configured to accommodate multiple modules 165 of the surgical hub 106. The modules 165 can be slidably inserted into a docking base or drawer 167 of the vertical modular housing 164, which includes a bottom plate for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are arranged vertically, in some cases, the vertical modular housing 164 may include drawers arranged horizontally. In addition, the modules 165 can interact with each other through the docking port of the vertical modular housing 164. Figure 7 In the example of FIG. 1 , a display 177 is provided for displaying data related to the operation of the module 165. In addition, the vertical modular housing 164 includes a main module 178 that seats a plurality of sub-modules that are slidably received in the main module 178.

[0140] In various aspects, the imaging module 138 includes an integrated video processor and a modular light source, and is suitable for use with various imaging devices. In one aspect, the imaging device is composed of a modular housing that can be equipped with a light source module and a camera module. The housing can be a disposable housing. In at least one example, the disposable housing is removably connected 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. On the other hand, the camera module includes a CMOS sensor. On the other hand, the camera module is configured for scanning beam imaging. Similarly, the light source module can be configured to deliver white light or different light, depending on the surgical procedure.

[0141] During a surgical procedure, it may 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 sight of the surgical field may lead to undesirable consequences. The modular imaging device of the present disclosure is configured to allow for mid-stream replacement of a light source module or a camera module during a surgical procedure without having to remove the imaging device from the surgical field.

[0142] In one aspect, an imaging device includes a tubular housing including a plurality of channels. A first channel is configured to slidably receive a camera module, which can be configured to snap-fit ​​into engagement with the first channel. A second channel is configured to slidably receive a light source module, which can be configured to snap-fit ​​into engagement with the second channel. In another example, the camera module and / or the light source module can be rotated into a final position within their respective channels. A threaded engagement can be used in place of a snap-fit ​​engagement.

[0143] In various examples, multiple imaging devices are placed at different locations in the surgical field to provide multiple views. The imaging module 138 can be configured to switch between imaging devices to provide the best view. In various aspects, the imaging module 138 can be configured to integrate images from different imaging devices.

[0144] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Pat. No. 7,995,045, entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, issued on August 9, 2011, which is incorporated herein by reference in its entirety. In addition, U.S. Pat. No. 7,982,776, entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, issued on July 19, 2011, describes various systems for removing motion artifacts from image data, which is incorporated herein by reference in its entirety. Such systems may be integrated with imaging module 138. In addition, U.S. patent application publication 2011 / 0306840, entitled CONTROLLABLE MAGNETIC SOURCE TO FIXTUREINTRACORPOREAL APPARATUS, published on December 15, 2011, and U.S. patent application publication 2014 / 0243597, entitled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, published on August 28, 2014, each of the above patents is incorporated herein by reference in its entirety.

[0145] Figure 8A surgical data network 201 is shown that includes a modular communication hub 203 that is configured to connect modular devices located in one or more operating rooms of a medical facility or any room in a medical facility that is specifically equipped for surgical operations to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 connected to a storage device 205). In one aspect, the modular communication hub 203 includes a network hub 207 and / or a network switch 209 that communicates with a network router. The modular communication hub 203 may also be connected to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, enabling it to be transferred from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuration of each port in the network hub 207 or network switch 209. The intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

[0146] Modular devices 1a-1n located in an operating room may be connected to a modular communication hub 203. A network hub 207 and / or a network switch 209 may be connected to a network router 211 to connect devices 1a-1n to a cloud 204 or a local computer system 210. Data associated with devices 1a-1n may be transmitted to a cloud-based computer via a router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transmitted to a local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be connected to a network switch 209. A network switch 209 may be connected to a network hub 207 and / or a network router 211 to connect devices 2a-2m to a cloud 204. Data associated with devices 2a-2n may be transmitted to a cloud 204 via a network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transmitted to a local computer system 210 for local data processing and manipulation.

[0147] It should be understood that the surgical data network 201 can be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. The modular communication hub 203 can be included in a modular control tower that is configured to accommodate multiple devices 1a-1n / 2a-2m. A local computer system 210 can also be included in the modular control tower. The modular communication hub 203 is connected to a display 212 to display images obtained by some of the devices 1a-1n / 2a-2m during a surgical procedure, for example. In various aspects, devices 1a-1n / 2a-2m may include, for example, various modules, such as an imaging module 138 connected to an endoscope, a generator module 140 connected 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 connected to a display, and / or a non-contact sensor module in other modular devices that can be connected to a modular communication hub 203 of a surgical data network 201.

[0148] In one aspect, the surgical data network 201 may include a combination of (one or more) network hubs, (one or more) network switches, and (one or more) network routers that connect the devices 1a-1n / 2a-2m to the cloud. Any or all of the devices 1a-1n / 2a-2m connected to the network hub or network switch can collect data in real time and transmit the data to the cloud computer for data processing and manipulation. It should be understood that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term "cloud" can be used as a metaphor for "Internet", although the term is not limited to this. Therefore, the term "cloud computing" can be used herein to refer to "a type of Internet-based computing", in which different services (such as servers, storage devices, and applications) are delivered to a modular communication hub 203 and / or a computer system 210 located in a surgical room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and a device 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 case, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services may perform a large number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

[0149] Applying cloud computer data processing technology to the data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical results, reduced costs and improved patient satisfaction. At least some of the devices 1a-1n / 2a-2m can be used to observe tissue status to evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. At least some of the devices 1a-1n / 2a-2m can be used to identify pathology, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes positioning and edge confirmation of tissue and phenotype. At least some of the devices 1a-1n / 2a-2m can be used to identify the anatomical structure of the body using various sensors integrated with imaging devices and technologies (such as overlapping images captured by multiple imaging devices). The data (including image data) collected by the devices 1a-1n / 2a-2m can be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve surgical outcomes by determining whether further treatment can be pursued, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and precision robotic applications to tissue-specific sites and conditions. Such data analysis can be further processed using outcome analysis, and using standardized methods can provide helpful feedback to confirm surgical treatments and surgeon behavior, or suggest modifications to surgical treatments and surgeon behavior.

[0150] In one specific implementation, operating room devices 1a-1n may be connected to the modular communication hub 203 via a wired channel or a wireless channel, depending on the configuration of the devices 1a-1n to the network hub. In one aspect, the network hub 207 may be implemented as a local network broadcast device that operates on the physical layer of the open system interconnection (OSI) model. The network hub provides connections to devices 1a-1n located in the same operating room network. The network hub 207 collects data in the form of packets and sends it to a router in half-duplex mode. The network hub 207 does not store any media access control / Internet protocol (MAC / IP) for transmitting device data. Only one of the devices 1a-1n can send data through the network hub 207 at a time. The network hub 207 has no knowledge of where to send information and broadcasts all network data on each connection and to the remote server 213 ( Fig. 9 ) Routing tables or intelligence that broadcasts all network data. The network hub 207 can detect basic network errors such as collisions, but broadcasting all information to multiple ports can pose security risks and cause bottlenecks.

[0151] In another specific implementation, the operating room devices 2a-2m can be connected to the network switch 209 through a wired channel or a wireless channel. The network switch 209 operates in the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 sends data to the network router 211 in the form of a frame and operates in full-duplex mode. Multiple devices 2a-2m can send data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to transmit data.

[0152] The network hub 207 and / or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 operates in the network layer of the OSI model. The network router 211 creates a route for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources to further process and manipulate data collected by any or all of the devices 1a-1n / 2a-2m. The network router 211 can be used to connect two or more different networks located in different locations, such as, for example, different operating rooms in the same medical facility or different networks located in different operating rooms in different medical facilities. The network router 211 sends data to the cloud 204 in the form of packets and operates in full-duplex mode. Multiple devices can send data simultaneously. The network router 211 uses IP addresses to transmit data.

[0153] In one example, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub may expand a single USB port to multiple levels so that more ports are available to connect devices to a host system computer. The network hub 207 may include wired or wireless capabilities for receiving information through a wired channel or a wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in an operating room.

[0154] In other examples, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard for exchanging data from fixed and mobile devices over short distances (using short wavelength UHF radio waves in the ISM band of 2.4 to 2.485 GHz) and building 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 variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE) and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, and any other wireless and wired protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[0155] The modular communication hub 203 can serve as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles data types called frames. The frames carry data generated by the devices 1a-1n / 2a-2m. When the modular communication hub 203 receives a frame, it is amplified and transmitted to the network router 211, which transmits the data to the cloud computing resources using multiple wireless or wired communication standards or protocols as described herein.

[0156] Modular communication hub 203 can be used as a standalone device or connected to compatible network hubs and network switches to form a larger network. Modular communication hub 203 is generally easy to install, configure and maintain, making it a good option for networking operating room devices 1a-1n / 2a-2m.

[0157] Fig. 9A computer-implemented interactive surgical system 200 is shown. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 that is connected to a plurality of operating room devices, such as, for example, smart surgical instruments, robots, and other computerized devices located in the operating room. Fig.10 As shown in FIG, modular control tower 236 includes modular communication hub 203 coupled to computer system 210. Fig. 9 As shown in the example of , the modular control tower 236 is connected to an imaging module 238 connected to an endoscope 239, a generator module 240 connected to an energy device 241, a smoke evacuator 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 connected to a display 237, and a non-contact sensor module 242. The operating room devices are connected to cloud computing resources and data storage via the modular control tower 236. The robotic hub 222 can also be connected to the modular control tower 236 and cloud computing resources. The devices / instruments 235, the visualization system 208, etc. can be connected to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 can be connected to the hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device / instrument display and / or other visualization system 208. The hub display may also combine graphics and overlay images to display data received from devices connected to the modular control tower.

[0158] Fig.10 A surgical hub 206 is shown comprising a plurality of modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communication hub 203 (e.g., network connectivity means) and a computer system 210 to provide, for example, local processing, visualization, and imaging. Fig.10 As shown in , the modular communication hub 203 can be hierarchically configured to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203 and transmit data associated with the modules to the computer system 210, cloud computing resources, or both. Fig.10As shown in , each of the network hubs / switches in the modular communication hub 203 includes three downstream ports and one upstream port. The upstream network hub / switch is connected to the processor to provide communication connections with cloud computing resources and local display 217. Communication with the cloud 204 can be carried out through wired or wireless communication channels.

[0159] The surgical hub 206 employs a non-contact sensor module 242 to measure the size of the operating room and generates a map of the surgical room using an ultrasound or laser-based non-contact measurement device. The ultrasound-based non-contact sensor module scans the operating room by transmitting a burst of ultrasound waves and receiving an echo as it bounces off the walls of the operating room, as described in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, under the title “Surgical Hub Spatial Awareness Within an Operating Room,” which is incorporated herein by reference in its entirety, wherein the sensor module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limit. The laser-based non-contact sensor module scans the operating room by transmitting laser pulses, receiving laser pulses that bounce off the 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.

[0160] The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled to a communication module 247, a storage device 248, a memory 249, a non-volatile memory 250, and an input / output interface 251 via a system bus. The system bus may be any of several types of bus structures including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus using any of a variety of available bus architectures including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), Micro Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other peripheral bus.

[0161] Controller 244 may be any single-core or multi-core processor, such as those offered by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be a commercially available ARM Cortex-M4F processor core, such as the Texas Instruments LM4F230H5QR, which includes 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle sequential random access memory (SRAM), a 32KB MCU loaded with Internal read-only memory (ROM) for software, 2KB electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) simulations, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which can be found in the product data sheet.

[0162] In one aspect, the processor 244 may include a safety controller including two families based on controllers such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by Texas Instruments. The safety controller may be configured to be specialized for IEC 61508 and ISO26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

[0163] System memory includes volatile memory and non-volatile memory. The basic input / output system (BIOS), which contains basic routines such as transferring information between elements within the computer system during startup, is stored in non-volatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM) that acts as external cache memory. In addition, RAM is available in a variety of forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM) enhanced SDRAM (ESDRAM), synchronous link DRAM (SLDRAM) and direct Rambus RAM (DRRAM).

[0164] Computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as, for example, disk storage. Disk storage includes, but is not limited to, devices such as disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage may include storage media individually or in combination with other storage media, including but not limited to optical disk drives such as optical disk ROM devices (CD-ROM), optical disk recordable drives (CD-R drives), optical disk rewritable drives (CD-RW drives), or digital universal disk ROM drives (DVD-ROM). In order to facilitate the connection of the disk storage device to the system bus, a removable or non-removable interface may be used.

[0165] It should be understood that the computer system 210 includes software that acts as an intermediary between a user and the basic computer resources described in a suitable operating environment. Such software includes an operating system. An operating system that can be stored on a disk storage device is used to control and allocate the resources of the computer system. System applications use the operating system to manage resources through program modules and program data stored in system memory or disk storage devices. It should be understood that the various devices described herein can be implemented with various operating systems or combinations of operating systems.

[0166] The user inputs commands or information into the computer system 210 through (one or more) input devices connected to the I / O interface 251. Input devices include, but are not limited to, pointing devices such as a mouse, a touch ball, a stylus, a touch pad, a keyboard, a microphone, a joystick, a game pad, a satellite dish, a scanner, a TV tuner card, a digital camera, a digital video camera, a web camera, etc. These and other input devices are connected to the processor through the system bus via (one or more) interface ports. (One or more) interface ports include, for example, serial ports, parallel ports, game ports, and USB. (One or more) output devices use the same type of port as (one or more) input devices. Thus, for example, a USB port can be used to provide input to the computer system and output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (such as monitors, displays, speakers, and printers) that require special adapters among other output devices. Output adapters include, by way of example, but are not limited to, video and sound cards that provide connection means between output devices and the system bus. It should be noted that other devices or systems of devices such as (one or more) remote computers provide both input capabilities and output capabilities.

[0167] The computer system 210 can operate in a networked environment using a logical connection with one or more remote computers (such as (one or more) cloud computers) or local computers. (One or more) remote cloud computers can be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or other public network nodes, etc., and generally include many or all of the elements described relative to the computer system. For simplicity, only a memory storage device with (one or more) remote computers is shown. (One or more) remote computers are logically connected to the computer system through a network interface, and then physically connected via a communication connection. The network interface covers communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet / IEEE 802.3, token ring / IEEE 802.5, etc. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks such as integrated services digital networks (ISDN) and their variants, packet switching networks, and digital subscriber lines (DSL).

[0168] In various aspects, Fig.10 computer system 210, imaging module 238 and / or visualization system 208, and / or Figure 9-10 The processor module 232 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) for processing digital images. The image processor may employ parallel computing with single instruction, multiple data (SIMD) or multiple instructions, multiple data (MIMD) techniques to improve speed and efficiency. The digital image processing engine may perform a range of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

[0169] The communication connection(s) refers to the hardware / software used to connect the network interface to the bus. Although the communication connections are shown for exemplary clarification within the computer system, they may also be located external to the computer system 210. The hardware / software necessary to connect to the network interface includes internal and external technologies such as modems, including conventional telephone grade modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards for exemplary purposes only.

[0170] Fig.11A functional block diagram of one aspect of a USB network hub 300 device according to one aspect of the present disclosure is shown. In the illustrated aspect, the USB network hub device 300 employs a TUSB2036 integrated circuit hub from 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 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP0) input paired with a differential data positive (DM0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, each of which includes a differential data positive (DP1-DP3) output paired with a differential data negative (DM1-DM3) output.

[0171] The USB network hub 300 device is implemented with a digital state machine rather than a microcontroller, and does not require firmware programming. A fully compatible USB transceiver is integrated into the circuit for 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 full-speed devices and low-speed devices by automatically setting the conversion rate according to the speed of the device attached to the port. The USB network hub 300 device can be configured to be in bus-powered mode or self-powered mode, and includes a hub power logic 312 for managing power.

[0172] 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 generally includes up to transaction-level signaling. The functions it handles may include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection / generation, clock / data separation, non-return to zero inversion (NRZI) data encoding / decoding and digit filling, CRC generation and verification (token and data), packet ID (PID) generation and verification / decoding, and / or serial-to-parallel / parallel-to-serial conversion. The 310 receives a clock input 314 and is connected to the pause / resume logic and frame timer 316 circuits and the hub repeater circuit 318 to control the communication between the upstream USB transceiver port 302 and the downstream USB transceiver port 304, 306, 308 through the port logic circuits 320, 322, 324. SIE 310 is coupled to command decoder 326 via interface logic to control commands from the serial EEPROM via serial EEPROM interface 330 .

[0173] In various aspects, the USB network hub 300 can connect 127 functions configured in up to six logical layers (hierarchies) to a single computer. In addition, the USB network hub 300 can be connected to all external devices using a standardized four-wire cable that provides both communication and power distribution. The power is configured as a bus-powered mode and a self-powered mode. The USB network hub 300 can be configured to support four power management modes: a bus-powered hub with individual port power management or a complete set of port power management, and a self-powered hub with individual port power management or a complete set of port power management. In one aspect, using a USB cable, the USB network hub 300 inserts the upstream USB transceiver port 302 into the USB host controller, and exposes the downstream USB transceiver ports 304, 306, 308 for connecting USB compatible devices, etc.

[0174] Surgical Instrument Hardware

[0175] Fig.12 A logic diagram of a control system 470 of a surgical instrument or tool according to one or more aspects of the present disclosure is shown. The system 470 includes a control circuit. The control circuit includes a microcontroller 461, which includes a processor 462 and a memory 468. For example, one or more of the sensors 472, 474, 476 provide real-time feedback to the processor 462. The motor 482 driven by the motor driver 492 is operably connected to the displacement member capable of longitudinal movement to drive the I-beam blade element. The tracking system 480 is configured to determine the position of the displacement member capable of longitudinal movement. The position information is provided to the processor 462, which can be programmed or configured to determine the position of the drive member capable of longitudinal movement and the position of the firing member, the firing rod and the I-beam blade element. Additional motors can be provided at the tool driver interface to control the I-beam firing, the closure tube travel, the shaft rotation and the joint movement. The display 473 displays a variety of operating conditions of the instrument and may include a touch screen function for data input. The information displayed on the display 473 may be superimposed with an image acquired via an endoscopic imaging module.

[0176] In one aspect, the microprocessor 461 can be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In one aspect, the microcontroller 461 can be a LM4F230H5QR ARM Cortex-M4F processor core available from, for example, Texas Instruments, which includes 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle SRAM, a 32-bit MCU, and a 32-bit MCU. Internal ROM for software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADC with 12 analog input channels, details of which can be found in the product data sheet.

[0177] In one aspect, the microcontroller 461 may include a safety controller including two families based on controllers such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by Texas Instruments. The safety controller may be configured to be specialized for IEC 61508 and ISO26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

[0178] Microcontroller 461 can be programmed to perform various functions, such as precise control of the speed and position of the knife and articulation system. In one aspect, microcontroller 461 includes processor 462 and memory 468. Electric motor 482 can be a brushed DC (DC) motor with a gear box and a mechanical link to the articulation or knife system. In one aspect, motor driver 492 can be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily replaced for use in tracking system 480 including an absolute positioning system. A detailed description of the absolute positioning system is described in U.S. Patent Application Publication 2017 / 0296213 entitled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT published on October 19, 2017, which is incorporated herein by reference in its entirety.

[0179] The microcontroller 461 can be programmed to provide precise control of the speed and position of the displacement member and articulation system. The microcontroller 461 can be configured to be able to calculate the response in the software of the microcontroller 461. The calculated response is compared with the measured response of the actual system to obtain the "observed" response, which is used for actual feedback decisions. The observed response is a favorable tuning value that balances the smooth continuous nature of the simulated response with the measured response, which can detect external influences on the system.

[0180] In one aspect, the motor 482 can be controlled by a motor driver 492 and can be adopted by the firing system of a surgical instrument or tool. In various forms, the motor 482 can be a brushed DC drive motor with a maximum rotation speed of about 25,000 RPM. In other arrangements, 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 include, for example, an H-bridge driver including a field effect transistor (FET). The motor 482 can be powered by a power assembly that can be releasably mounted to a handle assembly or a tool housing for supplying control power to a surgical instrument or tool. The power assembly may include a battery that may include a plurality of battery cells connected in series that can be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and / or rechargeable. In at least one example, the battery cell may be a lithium-ion battery that can be coupled to the power assembly and can be separated from the power assembly.

[0181] The motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full-bridge controller for use with external N-channel power metal oxide semiconductor field effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. The driver 492 includes a unique charge pump regulator that provides full (>10V) gate drive for battery voltages as low as 7V and allows the A3941 to operate at reduced gate drive as low as 5.5V. A bootstrap capacitor may be used to provide the above-mentioned battery supply voltage required for the N-channel MOSFET. The internal charge pump of the high-side driver allows DC (100% duty cycle) operation. The full bridge may be driven in fast decay mode or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation may pass through the high-side or low-side FETs. The power FETs are protected from breakdown by resistor-adjustable dead time. The overall diagnostics provide indications of undervoltage, overtemperature, and power bridge faults, 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 including the absolute positioning system.

[0182] The tracking system 480 includes a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a drive member capable of longitudinal movement, which includes a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member, which can be adapted and configured to include a rack of drive teeth. In another aspect, the displacement member represents a firing rod or an I-beam, each of which can be adapted and configured to include a rack of drive teeth. Therefore, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool such as a driving member, a firing member, a firing rod, an I-beam, or any element that can be displaced. In one aspect, the drive member capable of longitudinal movement is connected to the firing member, the firing rod, and the I-beam. Therefore, the absolute positioning system can actually track the linear displacement of the I-beam by tracking the linear displacement of the drive member capable of longitudinal movement. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, a drive member, firing member, firing rod or I-beam capable of longitudinal movement or a combination thereof may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact displacement sensor or a 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 linearly arranged Hall effect sensors, a magnetic sensing system including a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical sensing system including a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing system including a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.

[0183] The electric motor 482 may include a rotatable shaft operably interfacing with a gear assembly that is mounted on the displacement member in meshing engagement with a group or rack of drive teeth. The sensor element may be operably coupled to the gear assembly so that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The arrangement of the gear transmission and the sensor may be connected to a linear actuator via a rack and pinion arrangement, or to a rotary actuator via a spur gear or other connection. The power source supplies power to the absolute positioning system, and the output indicator may display the output of the absolute positioning system. The displacement member represents a drive member capable of longitudinal movement, the drive member capable of longitudinal movement including a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents a firing member, a firing rod, an I-beam, or a combination thereof capable of longitudinal movement.

[0184] A single rotation of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement of the displacement member d1, where d1 is the longitudinal linear distance the displacement member moves from point "a" to point "b" after a single rotation of the sensor element coupled to the displacement member. The sensor arrangement may be connected via a gear reduction that enables the position sensor 472 to complete only one or more rotations for a full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a full stroke of the displacement member.

[0185] A series of switches (where n is an integer greater than one) may be employed alone or in combination with gear reduction to provide unique position signals for more than one rotation of the position sensor 472. 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 this sensor arrangement may include a magnetic sensor, an analog rotation sensor (such as a potentiometer), an array of analog Hall effect elements that output a unique combination of position signals or values.

[0186] Position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector component of the magnetic field. The technologies used to produce the above two types of magnetic sensors cover many aspects of physics and electronics. Technologies for magnetic field sensing include probe coils, fluxgates, optical pumps, nuclear spins, superconducting quantum interference devices (SQUIDs), Hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetosensitive diodes, magnetosensitive transistors, optical fibers, magneto-optics, and magnetic sensors based on micro-electromechanical systems, among others.

[0187] In one aspect, the position sensor 472 for the tracking system 480 including the absolute positioning system includes a magnetic rotation absolute positioning system. The position sensor 472 can be implemented as an AS5055EQFT monolithic magnetic rotation position sensor purchased from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage and low power device and includes four Hall effect elements in the area of ​​the position sensor 472 located on the magnet. A high resolution ADC and an intelligent power management controller are also provided on the chip. A coordinate rotation digital computer (CORDIC) processor (also known as the bitwise method and Volder algorithm) is provided to perform a simple and efficient algorithm to calculate hyperbolic and trigonometric functions, which only requires addition, subtraction, digit shift and table lookup operations. The angular position, alarm bit 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 12 or 14 bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4×4×0.85 mm package.

[0188] The tracking system 480 including the absolute positioning system may include and / or may be programmed to implement a feedback controller such as a PID, state feedback, and an adaptive controller. The power source converts the 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, the other sensor(s) may include sensor arrangements such as those described in U.S. Patent 9,345,481, entitled STAPLE CARTRIDGE TISSUE THICKNESS, issued on May 24, 2016, which is incorporated herein by reference in its entirety; U.S. Patent Application Publication 2014 / 0263552, entitled STAPLE CARTRIDGE TISSUE THICKNESS, issued on September 18, 2014, which is incorporated herein by reference in its entirety; and U.S. Patent Application Serial No. 15 / 628,175, entitled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTORVELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed on June 20, 2017, which is incorporated herein 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 will have a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuits to combine the calculated response with the measured response using algorithms (such as weighted averages and theoretical control loops) that drive the calculated response toward the measured response. The calculated response of the physical system takes into account properties such as mass, inertia, viscous friction, inductance and resistance to predict the state and output of the physical system by knowing the input.

[0189] Thus, the absolute positioning system provides the absolute position of the displacement member when the instrument is powered on, and does not retract or advance the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders, which simply count the number of forward or backward steps taken by the motor 482 to infer the position of the device actuator, drive rod, knife, etc.

[0190] The sensor 474 (such as, for example, a strain gauge or a micro strain gauge) is configured to measure one or more parameters of the end effector, such as, for example, the amplitude of the strain applied to the anvil during the clamping operation, which can indicate the closing force applied to the anvil. The measured strain is converted into a digital signal and provided to the processor 462. Alternatively or in addition to the sensor 474, the sensor 476, such as, for example, a load sensor, can measure the closing force applied to the anvil by the closed drive system. The sensor 476, such as, for example, a load sensor, can measure the firing force applied to the I-beam in the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sliding member, which is configured to enable the nail driver to cam upward to push the nail out to contact with the deformation of the anvil. The I-beam also includes a sharp cutting edge, which can be used to cut off tissue when the I-beam is pushed distally by the firing rod. Alternatively, a current sensor 478 can be used to measure the current consumed by the motor 482. The force required to advance the firing member may correspond to, for example, the current consumed by the motor 482. The measured force is converted into a digital signal and provided to the processor 462.

[0191] In one form, a strain gauge sensor 474 can be used to measure the force applied to the tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force on the tissue processed by the end effector. A system for measuring the force applied to the tissue grasped by the end effector includes a strain gauge sensor 474, such as, for example, a micro strain gauge, which is configured to measure, for example, 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 applied to the jaw member of the end effector during the clamping operation, which can indicate tissue compression. The measured strain is converted into a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to operate the knife element, for example, to cut the tissue captured between the anvil and the nail magazine. A magnetic field sensor can be used to measure the thickness of the captured tissue. The measurement value of the magnetic field sensor can also be converted into a digital signal and provided to the processor 462.

[0192] The microcontroller 461 can characterize the corresponding values ​​of the selected position of the firing member and / or the velocity of the firing member using the measurements of tissue compression, tissue thickness, and / or the force required to close the end effector measured by the sensors 474, 476, respectively. In one example, the memory 468 can store techniques, formulas, and / or lookup tables that can be used by the microcontroller 461 in the evaluation.

[0193] The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with the modular communication hub, such as Figure 8-11 as shown in .

[0194] Fig.13A control circuit 500 is shown, which is configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. The control circuit 500 may be configured to implement the various methods described herein. The circuit 500 may include a microcontroller, which includes one or more processors 502 (e.g., microprocessors, microcontrollers) connected to at least one memory circuit 504. The memory circuit 504 stores machine executable instructions that cause the processor 502 to execute machine instructions to implement the various processes described herein when executed by the processor 502. The processor 502 may be any of a variety of single-core or multi-core processors known in the art. The memory circuit 504 may include a volatile storage medium and a non-volatile storage medium. The processor 502 may include an instruction processing unit 506 and an operation unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

[0195] Fig.14 Combinatorial logic circuit 510 is shown, which is configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. Combinatorial logic circuit 510 can be configured to implement various methods described herein. Combinatorial logic circuit 510 may include a finite state machine that includes combinatorial logic 512 that is configured to receive data associated with a surgical instrument or tool at input 514, process the data through combinatorial logic 512, and provide output 516.

[0196] Fig.15 A sequential logic circuit 520 is shown that is configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. The sequential logic circuit 520 or the combinatorial logic 522 may be configured to implement the various methods described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, the combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store the current state of the finite state machine. In some cases, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with a surgical instrument or tool from an input 526, process the data through the combinatorial logic 522, and provide an output 528. In other aspects, the circuit may include a processor (e.g., the processor 502, Fig.13 ) and a finite state machine to implement the various processes herein. In other embodiments, the finite state machine may include a combinational logic circuit (e.g., combinational logic circuit 510, Fig.14 ) and a sequential logic circuit 520.

[0197] Fig.16A surgical instrument or tool is shown that includes multiple motors that can be activated to perform various functions. In some cases, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, and a third motor can be activated to perform a third function. In some cases, multiple motors of the robotic surgical instrument 600 can be individually activated to cause a firing motion, a closing motion, and / or an articulation motion in an end effector. The firing motion, the closing motion, and / or the articulation motion can be transmitted to the end effector, for example, via a shaft assembly.

[0198] In some cases, 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, which may be configured to transmit the firing motion generated by the motor 602 to the end effector, specifically for displacing an I-shaped beam element. In some cases, the firing motion generated by the motor 602 may, for example, cause a staple to be deployed from a staple cartridge into tissue captured by the end effector and / or cause the cutting edge of the I-shaped beam element to be advanced to cut the captured tissue. The I-shaped beam element may be retracted by reversing the direction of the motor 602.

[0199] In some cases, the surgical instrument or tool may include a closing motor 603. The closing motor 603 may be operably coupled to a closing motor drive assembly 605, which is configured to transmit the closing motion generated by the motor 603 to the end effector, specifically for displacing the closing tube to close the anvil and compressing the tissue between the anvil and the staple cartridge. The closing motion may cause, for example, the end effector to transition from an open configuration to a close configuration to capture tissue. The end effector may be transitioned to an open position by reversing the direction of the motor 603.

[0200] In some cases, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operably coupled to respective articulation motor drive assemblies 608a, 608b, which may be configured to transmit the articulation generated by the motors 606a, 606b to the end effector. In some cases, the articulation may cause the end effector to articulate relative to an axis, for example.

[0201] As described above, surgical instruments or tools may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of surgical instruments or tools may be individually or independently activated to perform one or more functions, while other motors remain inactive. For example, articulation motors 606a, 606b may be activated to articulate the end effector, while firing motor 602 remains inactive. Alternatively, firing motor 602 may be activated to fire multiple nails and / or advance cutting edges, while articulation motor 606 remains inactive. In addition, closing motor 603 may be activated simultaneously with firing motor 602, so that closing tube and I-beam element are advanced toward the distal side, as described in more detail below.

[0202] In some cases, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 can adjust one of the multiple motors at a time. For example, the common control module 610 can be individually connected to multiple motors of the surgical instrument and can be separated from the multiple motors of the surgical instrument. In some cases, multiple motors of the surgical instrument or tool can share one or more common control modules such as the common control module 610. In some cases, multiple motors of the surgical instrument or tool can independently and selectively engage the common control module 610. In some cases, the common control module 610 can switch from interfacing with one of the multiple motors of the surgical instrument or tool to interfacing with another of the multiple motors of the surgical instrument or tool.

[0203] In at least one example, the common control module 610 can selectively switch between operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or the closing motor 603. Fig.16 As shown in , the switch 614 can move or change between multiple positions and / or states. In the first position 616, the switch 614 can electrically connect the common control module 610 to the firing motor 602; in the second position 617, the switch 614 can electrically connect the common control module 610 to the closing motor 603; in the third position 618a, the switch 614 can electrically connect the common control module 610 to the first joint motion motor 606a; and in the fourth position 618b, the switch 614 can electrically connect the common control module 610 to, for example, the second joint motion motor 606b. In some cases, a separate common control module 610 can be electrically connected to the firing motor 602, the closing motor 603, and the joint motion motors 606a, 606b at the same time. In some cases, the switch 614 can be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switch mechanism.

[0204] Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of the motor used to actuate the jaws.

[0205] In various cases, such as Fig.16 As shown in , the common control module 610 may include a motor driver 626, which may include one or more H-bridge field effect FETs. The motor driver 626 may regulate the power transmitted from a power source 628 to a motor coupled to the common control module 610, for example, based on input from a microcontroller 620 ("controller"). In some cases, when a motor is coupled to the common control module 610, the microcontroller 620 may be used, for example, to determine the current consumed by the motor, as described above.

[0206] In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform a number of functions and / or calculations described herein. In some cases, one or more of memory units 624 may be coupled to processor 622, for example.

[0207] In some cases, the power source 628 can be used, for example, to power the microcontroller 620. In some cases, the power source 628 can include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In some cases, the battery pack can be configured to be releasably mounted to the handle for powering the surgical instrument 600. Multiple battery cells connected in series can be used as the power source 628. In some cases, the power source 628 can be, for example, replaceable and / or rechargeable.

[0208] In various cases, the processor 622 may control the motor driver 626 to control the position, rotation direction, and / or speed of the motor connected to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and / or deactivate the motor connected to the common controller 610. It should be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that combines the functions of the central processing unit (CPU) of a computer on an integrated circuit or at most several integrated circuits. A processor is a multi-purpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides a result as output. Because the processor has internal memory, it is an example of sequential digital logic. The operating objects of the processor are numbers and symbols represented in the binary number system.

[0209] In one example, processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In some cases, microcontroller 620 may be, for example, LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle SRAM, a 32-bit MCU loaded with The 4410 includes an internal ROM for software, 2KB of EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, and other features readily available from product data sheets. Other microcontrollers can be easily substituted for use with module 4410. Therefore, the present disclosure should not be limited to this context.

[0210] In some cases, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that may be coupled to the common controller 610. 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 may cause the processor 622 to control the firing, closing, and articulation functions based on input from an algorithm or control program of the surgical instrument or tool.

[0211] In some cases, one or more mechanisms and / or sensors, such as, for example, sensor 630, may be used to alert processor 622 of program instructions that should be used in a particular setting. For example, sensor 630 may alert processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In some cases, sensor 630 may include, for example, a position sensor that may be used to sense the position of switch 614. Thus, processor 622 may use program instructions associated with firing an I-beam of an end effector when, for example, sensor 630 detects that switch 614 is in first position 616; processor 622 may use program instructions associated with closing anvil when, for example, sensor 630 detects that switch 614 is in second position 617; and processor 622 may use program instructions associated with articulating the end effector when, for example, sensor 630 detects that switch 614 is in third position 618a or fourth position 618b.

[0212] Fig.17 7 is a schematic diagram of a robotic surgical instrument 700 configured to operate the surgical tools described herein according to one aspect of the present disclosure. The robotic surgical instrument 700 can be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of a closure tube, shaft rotation, and articulation with a single or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to individually control a firing member, a closure member, an axis member, and / or one or more articulation members. The surgical instrument 700 includes a control circuit 710 that is configured to control a motor-driven firing member, a closure member, an axis member, and / or one or more articulation members.

[0213] In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control the anvil 716 and I-beam 714 (including sharp cutting edges) portions of the end effector 702 via a plurality of motors 704a-704e, a removable staple cartridge 718, an axis 740, and one or more articulation 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 counting 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 may be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.

[0214] In one aspect, the control circuit 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the 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 as determined by the position sensor 734 with the output of the timer / counter 731 so that the control circuit 710 can determine the position of the I-beam 714 at a particular time (t) relative to the starting position or at a time (t) when the I-beam 714 is at a particular position relative to the starting position. The timer / counter 731 can be configured to measure elapsed time, count external events, or time external events.

[0215] In one aspect, the control circuit 710 can be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuit 710 can be programmed to sense tissue conditions such as thickness directly or indirectly, as described herein. The control circuit 710 can be programmed to select a firing control program or a closing control program based on the tissue conditions. The firing control program can describe the distal movement of the displacement member. Different firing control programs can be selected to better handle different tissue conditions. For example, the control circuit 710 can be programmed to translate the displacement member at a lower speed and / or at a lower power when thicker tissue is present. The control circuit 710 can be programmed to translate the displacement member at a higher speed and / or at a higher power when thinner tissue is present. The closing control program can control the closing force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and the articulation members 742a, 742b.

[0216] In one aspect, the control circuit 710 may generate a motor set point signal. The motor set point 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 the motors 704a-704e to drive the motors 704a-704e as described herein. In some examples, the motors 704a-704e may be brushed DC electric motors. For example, the speed of the motors 704a-704e may be proportional to the corresponding motor drive signals. In some examples, the motors 704a-704e may be brushless DC motors, and the corresponding motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Moreover, in some examples, the motor controllers 708a-708e may be omitted, and the control circuit 710 may directly generate the motor drive signals.

[0217] In one aspect, the control circuit 710 can initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the travel, the control circuit 710 can select a firing control program in a closed-loop configuration. The response of the instrument can include the translation distance of the displacement member during the open-loop portion, the time consumed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, the sum of the pulse widths of the motor drive signal, etc. After the open-loop portion, the control circuit 710 can implement the selected firing control program for a second portion of the travel of the displacement member. For example, during the closed-loop portion of the travel, the control circuit 710 can modulate one of the motors 704a-704e based on the translation data describing the position of the displacement member in a closed-loop manner to cause the displacement member to translate at a constant speed.

[0218] In one aspect, the motors 704a-704e may receive power from the energy source 712. The energy source 712 may be a DC power source driven by a main AC power source, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to separate movable mechanical elements, such as the I-beam 714, the anvil 716, the shaft 740, the articulation 742a, and the articulation 742b, via corresponding transmission devices 706a-706e. The transmission devices 706a-706e may include one or more gears or other linkage devices to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 may 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 the control circuit 710 when the I-beam 714 is translated toward the distal side and toward the proximal side. The control circuit 710 can track the pulses to determine the position of the I-beam 714. Other suitable position sensors can be used, including, for example, proximity sensors. Other types of position sensors can provide other signals indicating the movement of the I-beam 714. Moreover, in some examples, the position sensor 734 can be omitted. In the case where 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 up the number and direction of steps that the motor 704 has been commanded to perform. The position sensor 734 can be located in the end effector 702 or at any other part of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force, and has an encoder for sensing the rotation of the drive shaft.

[0219] In one aspect, the control circuit 710 is configured to drive a firing member such as an I-beam 714 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor control 708a, which provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission device 706a, which is coupled to the I-beam 714. The transmission device 706a includes a movable mechanical element such as a rotating element and a firing member to control the movement of the I-beam 714 along the longitudinal axis of the end effector 702 toward the distal side and toward the proximal side. In one aspect, the motor 704a can be coupled to a knife gear assembly, which includes a knife gear reduction group, and the knife gear reduction group includes 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 can be configured to provide the position of the I-beam 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710. The end actuator 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 708a. In response to the firing signal, the motor 704a can drive the firing member from the proximal stroke start position to the distal end of the stroke start position along the longitudinal axis of the end actuator 702. When the firing member is translated toward the distal side, the I-beam 714 with the cutting element positioned at the distal end is advanced toward the distal side to cut the tissue between the nail magazine 718 and the anvil 716.

[0220] 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 set point to the motor control 708b, which provides a drive signal to the motor 704b. The output shaft of the motor 704b is coupled to the torque sensor 744b. The torque sensor 744b is coupled to the transmission device 706b, which is coupled to the anvil 716. The transmission device 706b includes a movable mechanical element such as a rotating element and a closing member to control 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, which includes a closing reduction gear set supported to mesh 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. The position sensor 734 can be configured to provide the position of the closing member as a feedback signal to the control circuit 710. The additional sensor 738 in the end effector 702 can provide a closing force feedback signal to the control circuit 710. The pivotable anvil 716 is positioned opposite the staple cartridge 718. When ready for use, the control circuit 710 can provide a closing signal to the motor control 708b. In response to the closing signal, the motor 704b advances the closing member to grasp the tissue between the anvil 716 and the staple cartridge 718.

[0221] In one aspect, the control circuit 710 is configured to enable a shaft member such as shaft 740 to rotate so that the end effector 702 rotates. The control circuit 710 provides a motor set point to a motor control 708c, which 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 shaft 740 to rotate more than 360° clockwise or counterclockwise. In one aspect, the motor 704c is coupled to a rotating transmission device assembly, which includes a tube gear segment formed on (or attached to) the proximal end of the proximal closure tube to be operably engaged by a rotating gear assembly operably supported on a 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. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.

[0222] In one aspect, the control circuit 710 is configured to enable the end effector 702 to articulate. The control circuit 710 provides a motor set point to a motor control 708d, which provides a drive signal 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 device 706d coupled to the articulation member 742a. ​​The transmission device 706d includes a movable mechanical element such as an articulation element to control the articulation of the end effector 702 ± 65°. In one aspect, the motor 704d is coupled to an articulation nut that is rotatably journaled on a proximal end portion of a distal spine and rotatably driven thereon by an articulation gear assembly. 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 articulation position of the end effector 702 to the control circuit 710 .

[0223] On the other hand, the joint motion function of the robotic surgical system 700 may include two joint motion components or connecting rods 742a, 742b. These joint motion components 742a, 742b are driven by a separate disk driven by two motors 708d, 708e on the robot interface (rack). When a separate firing motor 704a is provided, each of the joint motion connecting rods 742a, 742b can be driven in an antagonistic manner relative to another connecting rod so as to provide resistance to the head to maintain motion and load when the head is not moving, and to provide joint motion when the head is articulated. When the head rotates, the joint motion components 742a, 742b are attached to the head with a fixed radius. Therefore, when the head rotates, the mechanical advantage of the push-pull connecting rod changes. This change in mechanical advantage can be more obvious for other joint motion connecting rod drive systems.

[0224] In one aspect, one or more motors 704a-704e may include a brushed DC motor with a gearbox and a mechanical link with a firing member, a closing member, or an articulation member. Another example includes an electric motor 704a-704e that operates a movable mechanical element such as a displacement member, an articulation link, a closing tube, and an axis. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body, and friction on a physical system. Such external influences may be referred to as drag, which acts relative to one of the electric motors 704a-704e. External influences such as drag may cause the operation of a physical system to deviate from the desired operation of the physical system.

[0225] In one aspect, the position sensor 734 can be implemented as an absolute positioning system. In one aspect, the position sensor 734 can include a magnetic rotation absolute positioning system implemented as an AS5055EQFT monolithic magnetic rotation position sensor purchased from AustriaMicrosystems, AG. The position sensor 734 can interact with the control circuit 710 to provide an absolute positioning system. The position can include a Hall effect element located above the magnet and coupled to a CORDIC processor, which is also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions, which only require addition operations, subtraction operations, digit shift operations, and table lookup operations.

[0226] In one aspect, the control circuit 710 may communicate with one or more sensors 738. The sensor 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 sensor 738 may include a magnetic sensor, a magnetic field sensor, a strain gauge, a load sensor, a pressure sensor, a force sensor, a torque sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 may include one or more sensors. The sensor 738 may be located on the nail magazine 718 platform to determine tissue position using segmented electrodes. The torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and / or joint motion forces. Thus, the control circuit 710 can sense: (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) the portion of the staple cartridge 718 having tissue thereon, and (4) the loads and positions on the two articulation rods.

[0227] In one aspect, one or more sensors 738 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of the strain in the anvil 716 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 738 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. The sensor 738 may be configured to detect the impedance of the tissue section between the anvil 716 and the staple cartridge 718, which indicates the thickness and / or completeness of the tissue located therebetween.

[0228] In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, and the like. In other implementations, the sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and the like. Likewise, the switch may be a solid-state device, such as a transistor (e.g., a FET, a junction FET, a MOSFET, a bipolar transistor, and the like). In other implementations, the sensor 738 may include a non-electrical conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and the like.

[0229] In one aspect, the sensor 738 may be configured to measure the force applied by the closure drive system to the anvil 716. For example, one or more sensors 738 may be located at the interaction point between the closure tube and the anvil 716 to detect the closing force applied by the closure tube to the anvil 716. The force applied to the anvil 716 may represent the tissue compression experienced by the tissue segment captured between the anvil 716 and the staple cartridge 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closing force applied by the closure drive system to the anvil 716. 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 the real-time sample measurement results to provide and analyze time-based information and estimate the closing force applied to the anvil 716 in real time.

[0230] In one aspect, the current sensor 736 can be used to measure the current consumed by each of the motors 704a-704e. The force required to propel any of the movable mechanical elements, such as the I-beam 714, corresponds to the current consumed by one of the motors 704a-704e. The force is converted into a digital signal and provided to the control circuit 710. The control circuit 710 can be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member can be actuated to move the I-beam 714 in the end effector 702 at a target speed or close to the target speed. The robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers, including but not limited to, for example, PID, state feedback, linear square (LQR) and / or adaptive controllers. The robotic surgical instrument 700 may include a power source to, for example, convert a signal from the feedback controller into a physical input, such as a housing voltage, a PWM voltage, a frequency modulated voltage, a current, a torque and / or a force. Additional details are disclosed in U.S. patent application serial number 15 / 636,829, filed on June 29, 2017, entitled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, which is incorporated herein by reference in its entirety.

[0231] Fig.18 A block diagram of a surgical instrument 750 programmed to control distal translation of a displacement member according to one aspect of the present disclosure is shown. In one aspect, the surgical instrument 750 is programmed to control distal translation of a displacement member such as an I-beam 764. The surgical instrument 750 includes an end effector 752, which may include an anvil 766, an I-beam 764 (including a sharp cutting edge), and a removable staple cartridge 768.

[0232] 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 arrangement and a position sensor 784. Since the I-beam 764 is coupled to a drive member capable of longitudinal movement, the position of the I-beam 764 can be determined by measuring the position of the drive member capable of longitudinal movement 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 as described herein. The control circuit 760 can be programmed to control the translation of a displacement member such as the I-beam 764. In some examples, the control circuit 760 may include one or more microcontrollers, microprocessors or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the I-beam 764) in the manner described. 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 as determined by the position sensor 784 with the output of the timer / counter 781 so 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 can be configured to be able to measure elapsed time, count external events, or time external events.

[0233] The control circuit 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754 as described herein. In some examples, 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. Moreover, in some examples, the motor controller 758 may be omitted, and the control circuit 760 may directly generate the motor drive signal 774.

[0234] The motor 754 may receive power from the energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via the transmission device 756. The transmission device 756 may include one or more gears or other connecting rod components to couple the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or 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 when the I-beam 764 is translated toward the distal side and toward the proximal side. The control circuit 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicating the movement of the I-beam 764. Moreover, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuit 760 can track the position of I-beam 764 by summing the number and direction of steps that motor 754 has been commanded to perform. Position sensor 784 may be located in end effector 752 or at any other portion of the instrument.

[0235] The control circuit 760 may communicate with one or more sensors 788. The sensor 788 may be positioned on the end effector 752 and 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 sensor 788 may include, for example, a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 752. The sensor 788 may include one or more sensors.

[0236] One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of the strain in the anvil 766 during the clamping condition. 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 compressed tissue between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of the tissue section between the anvil 766 and the staple cartridge 768, which indicates the thickness and / or completeness of the tissue located therebetween.

[0237] The sensor 788 may be configured to measure the force applied to the anvil 766 by the closure drive system. For example, one or more sensors 788 may be located at the interaction point between the closure tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closure tube. The force applied to the anvil 766 may represent the tissue compression experienced by the tissue segment captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied to the anvil 766 by the closure 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 measurement results to provide and analyze time-based information and estimate the closing force applied to the anvil 766 in real time.

[0238] A current sensor 786 may be employed to measure the current consumed by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.

[0239] The control circuit 760 can be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member can be actuated to move the I-beam 764 in the end effector 752 at a target speed or close to the target speed. The surgical instrument 750 may include a feedback controller, which can be one of any feedback controllers, including but not limited to, for example, PID, state feedback, LQR and / or adaptive controllers. The surgical instrument 750 may include a power source to, for example, convert a signal from the feedback controller into a physical input, such as a housing voltage, a PWM voltage, a frequency modulated voltage, a current, a torque and / or a force.

[0240] The actual drive system of the surgical instrument 750 is configured to be able to drive the displacement member, cutting member or I-beam 764 through a brushed DC motor with a gear box and mechanical connections to the articulation and / or knife system. Another example is an electric motor 754 that operates the displacement member and articulation drive of, for example, an interchangeable shaft assembly. External influences are the unmeasured, unpredictable effects of things such as tissue, surrounding body, and friction on the physical system. Such external influences may be referred to as drag forces that act in opposition to the electric motor 754. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.

[0241] Various exemplary aspects relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical stapling and cutting tool. For example, a motor 754 can drive a displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 can include a pivotable anvil 766, and when configured for use, a staple cartridge 768 is positioned relative to the anvil 766. The clinician can grasp tissue between the anvil 766 and the staple cartridge 768, as described herein. When the instrument 750 is ready to be used, 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 can drive the displacement member distally from a proximal stroke start position to a stroke end position distal to the stroke start position along the longitudinal axis of the end effector 752. When the displacement member translates distally, an I-beam 764 having a cutting element positioned at the distal end can cut tissue between the staple cartridge 768 and the anvil 766.

[0242] In various examples, the surgical instrument 750 may include a control circuit 760 that is programmed to control the distal translation of a displacement member, such as an I-beam 764, based on one or more tissue conditions, for example. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, directly or indirectly, as described herein. The control circuit 760 may be programmed to select a firing control program based on the tissue conditions. The firing control program may describe the distal movement of the displacement member. Different firing control programs may be selected to better handle different tissue conditions. For example, the control circuit 760 may be programmed to translate the displacement member at a lower speed and / or at a lower power when thicker tissue is present. The control circuit 760 may be programmed to translate the displacement member at a higher speed and / or at a higher power when thinner tissue is present.

[0243] In some examples, the control circuit 760 may initially operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's travel. Based on the response of the instrument 750 during the open-loop portion of the travel, the control circuit 760 may select a firing control program. The response of the instrument may include the distance the displacement member was translated 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 sum of the pulse widths of the motor drive signal, etc. After the open-loop portion, the control circuit 760 may implement the selected firing control program for a second portion of the displacement member's travel. For example, during the closed-loop portion of the travel, the control circuit 760 may adjust the motor 754 based on the translation data describing the position of the displacement member in a closed-loop manner so that the displacement member translates at a constant speed. Additional details are disclosed in U.S. patent application serial number 15 / 720,852, filed on September 29, 2017, entitled SYSTEM AND METHODS FOR CONTROLLING ADISPLAY OF A SURGICAL INSTRUMENT, which is incorporated herein by reference in its entirety.

[0244] Fig.19 Schematic diagram of a surgical instrument 790 configured to control various functions according to 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, which may include an anvil 766, an I-beam 764, and a removable staple cartridge 768 that is interchangeable with an RF cartridge 796 (shown in phantom).

[0245] In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid-state switch, a Hall effect device, an MR device, a GMR device, a magnetometer, and the like. In other implementations, the sensor 638 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and the like. Likewise, the switch may be a solid-state device, such as a transistor (e.g., a FET, a junction FET, a MOSFET, a bipolar transistor, and the like). In other implementations, the sensor 788 may include a non-electrical conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and the like.

[0246] In one aspect, the position sensor 784 can be implemented as an absolute positioning system including a magnetic rotary absolute positioning system implemented as an AS5055EQFT monolithic magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 784 can interact with the control circuit 760 to provide an absolute positioning system. The position can include a Hall effect element located above a magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that only require addition operations, subtraction operations, bit shift operations, and table lookup operations.

[0247] In one aspect, the I-beam 764 can be implemented as a knife member, which includes a knife body on which a tissue cutting blade is operably supported, and the I-beam can also include an anvil engagement tab or feature and a channel engagement feature or foot. In one aspect, the staple cartridge 768 can be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, the RF cartridge 796 can be implemented as an RF cartridge. These and other sensor arrangements are described in co-owned U.S. patent application serial number 15 / 628,175, entitled TECHNIQUES FORADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed on June 20, 2017, which is incorporated herein by reference in its entirety.

[0248] 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 arrangement, and a position sensor, represented as position sensor 784. Because the I-beam 764 is coupled to a drive member capable of longitudinal movement, the position of the I-beam 764 can be determined by measuring the position of the drive member capable of longitudinal movement 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 as described herein. The control circuit 760 can be programmed to control the translation of a displacement member such as the I-beam 764, as described herein. In some examples, the control circuit 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the I-beam 764) in the manner described. 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 as determined by the position sensor 784 with the output of the timer / counter 781 so 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 can be configured to be able to measure elapsed time, count external events, or time external events.

[0249] The control circuit 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754 as described herein. In some examples, 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. Moreover, in some examples, the motor controller 758 may be omitted, and the control circuit 760 may directly generate the motor drive signal 774.

[0250] The motor 754 may receive power from the energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via the transmission device 756. The transmission device 756 may include one or more gears or other connecting rod components to couple the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or 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 when the I-beam 764 is translated toward the distal side and toward the proximal side. The control circuit 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicating the movement of the I-beam 764. Moreover, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuit 760 can track the position of I-beam 764 by summing the number and direction of steps the motor has been commanded to perform. Position sensor 784 may be located in end effector 792 or at any other portion of the instrument.

[0251] The control circuit 760 may communicate with one or more sensors 788. The sensor 788 may be positioned on the end effector 792 and 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 sensor 788 may include, for example, a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 792. The sensor 788 may include one or more sensors.

[0252] One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of the strain in the anvil 766 during the clamping condition. 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 compressed tissue between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of the tissue section between the anvil 766 and the staple cartridge 768, which indicates the thickness and / or completeness of the tissue located therebetween.

[0253] The sensor 788 may be configured to measure the force applied to the anvil 766 by the closure drive system. For example, one or more sensors 788 may be located at the interaction point between the closure tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closure tube. The force applied to the anvil 766 may represent the tissue compression experienced by the tissue segment captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied to the anvil 766 by the closure drive system. One or more sensors 788 may be sampled in real time by the processor portion of the control circuit 760 during the clamping operation. The control circuit 760 receives the real-time sample measurement results to provide and analyze time-based information and estimate the closing force applied to the anvil 766 in real time.

[0254] A current sensor 786 may be employed to measure the current consumed by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.

[0255] When the RF cartridge 796 is loaded in the end effector 792 in place of the staple cartridge 768, the RF energy source 794 is coupled to the end effector 792 and the RF energy source is applied to the RF cartridge 796. The control circuit 760 controls the delivery of RF energy to the RF cartridge 796.

[0256] Additional details are disclosed in U.S. patent application serial number 15 / 636,096 filed on 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.

[0257] Generator Hardware

[0258] Fig. 208 is a simplified block diagram of a generator 800 configured to provide, among other benefits, inductorless tuning. Additional details of the generator 800 are described in U.S. Patent No. 9,060,775, filed on 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. A secondary winding 808 of the power transformer 806 is included in the isolation stage 802 and may include a tap configuration (e.g., a center tap or a non-center tap configuration) to define drive signal outputs 810a, 810b, 810c for delivering drive signals to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-function surgical instruments including ultrasonic energy modes and RF energy modes that may be delivered separately or simultaneously. Specifically, the drive signal output terminals 810a, 810c can output ultrasonic drive signals (e.g., 420V root mean square (RMS) drive signals) to the ultrasonic surgical instrument, and the drive signal output terminals 810b, 810c can output RF electrosurgical drive signals (e.g., 100V RMS drive signals) to the RF electrosurgical instrument, wherein the drive signal output terminal 810b corresponds to the center tap of the power transformer 806.

[0259] In some forms, the ultrasonic drive signal and the electrosurgical drive signal can be provided simultaneously to different surgical instruments and / or a single surgical instrument such as a multifunctional surgical instrument having the ability to deliver both ultrasonic energy and electrosurgical energy to tissue. It should be understood that the electrosurgical signal provided to a dedicated electrosurgical instrument and / or a combined multifunctional ultrasonic / electrosurgical instrument can be a therapeutic level signal or a sub-therapeutic level signal, wherein the sub-therapeutic signal can be used, for example, to monitor tissue or instrument conditions and provide feedback to the generator. For example, an ultrasonic signal and an RF signal can be delivered separately or simultaneously from a generator having a single output port to provide a desired output signal to the surgical instrument, as will be discussed in more detail below. Therefore, the generator can combine ultrasonic energy and electrosurgical RF energy and deliver the combined energy to the multifunctional ultrasonic / electrosurgical instrument. A bipolar electrode can be placed on one or both jaws of the end effector. In addition to electrosurgical RF energy, one jaw can be driven simultaneously by ultrasonic energy. Ultrasonic energy can be used to dissect tissue, while electrosurgical RF energy can be used for vessel sealing.

[0260] The non-isolated stage 804 may include a power amplifier 812 having an output connected to a primary winding 814 of a power transformer 806. In certain forms, the power amplifier 812 may include a push-pull amplifier. For example, the non-isolated stage 804 may also include a logic device 816 for supplying a digital output to a digital-to-analog converter (DAC) circuit 818, which in turn supplies a corresponding analog signal to an input of the power amplifier 812. In certain forms, the logic device 816 may include a programmable gate array (PGA), an FPGA, a programmable logic device (PLD), for example, in addition to other logic circuits. Thus, by controlling the input of the power amplifier 812 via the DAC circuit 818, the logic device 816 may control any one of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal appearing at the drive signal outputs 810a, 810b, 810c. In certain forms and as discussed below, the logic device 816 in conjunction with a processor (e.g., a DSP discussed below) may implement a plurality of DSP-based algorithms and / or other control algorithms to control parameters of the drive signal output by the generator 800.

[0261] Power may be supplied to the power rail of the power amplifier 812 by a switch-mode regulator 820 (e.g., a power converter). In certain forms, the switch-mode regulator 820 may include, for example, an adjustable buck regulator. For example, the non-isolated stage 804 may also include a first processor 822, which may include a DSP processor in one form, such as, for example, an Analog Devices ADSP-21469SHARC DSP available from Analog Devices (Norwood, MA), but any suitable processor may be employed in various forms. In certain forms, 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 an ADC circuit 824. In one form, for example, the DSP processor 822 may receive as input a waveform envelope of a signal (e.g., an RF signal) amplified by the power amplifier 812 via the ADC circuit 824. The DSP processor 822 can then control the switch mode regulator 820 (e.g., via a PWM output) so that the rail voltage supplied to the power amplifier 812 tracks the waveform envelope of the amplified signal. By dynamically adjusting the rail voltage of the power amplifier 812 based on the waveform envelope, the efficiency of the power amplifier 812 can be significantly improved relative to a fixed rail voltage amplifier solution.

[0262] In certain forms, the logic device 816 in conjunction 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 lookup table (LUT), such as a RAM LUT, which may be embedded in an FPGA. The control algorithm is particularly useful for ultrasound applications where an ultrasonic transducer, such as an ultrasonic transducer, may be driven by a pure sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the overall distortion of the motional branch current may correspondingly minimize or reduce adverse resonance effects. Because the waveform shape of the drive signal output by the generator 800 is affected by various sources of distortion present in the output drive circuit (e.g., power transformer 806, power amplifier 812), voltage and current feedback data based on the drive signal can be input into an algorithm, such as an error control algorithm implemented by the DSP processor 822, which compensates for distortion by appropriately pre-distorting or modifying the waveform samples stored in the LUT on a dynamic, ongoing basis (e.g., in real time). In one form, the amount or degree of pre-distortion applied to the LUT samples can be based on the error between the calculated motional branch current and the desired current waveform shape, where the error can be determined on a sample-by-sample basis. In this way, the pre-distorted LUT samples, when processed by the drive circuit, can cause the motional branch drive signal to have a desired waveform shape (e.g., a sinusoidal shape) to optimally drive the ultrasonic transducer. Therefore, in such forms, when the distortion effects are taken into account, the LUT waveform samples will not exhibit the desired waveform shape of the drive signal, but rather will exhibit the waveform shape required to ultimately produce the desired waveform shape of the motional branch drive signal.

[0263] The non-isolated stage 804 may also include a first ADC circuit 826 and a second ADC circuit 828, which are coupled to the output of the power transformer 806 via respective isolation transformers 830, 832, for respectively sampling the voltage and current of the drive signal output by the generator 800. In certain forms, the ADC circuits 826, 828 may be configured to be capable of sampling at a 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 approximately 200x (depending on the frequency) oversampling of the drive signal. In certain forms, the sampling operation of the ADC circuits 826, 828 may be performed by having a single ADC circuit receive input voltage and current signals via a bidirectional multiplexer. The use of high speed sampling in forms of the generator 800 may enable, among other things, calculation of complex currents flowing through the motional branch (which in certain forms may be used to implement the above-described DDS-based waveform shape control), accurate digital filtering of the sampled signal, and calculation of actual power consumption with high accuracy. 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) and stored in a data memory for subsequent retrieval by, for example, the DSP processor 822. As described above, the voltage and current feedback data may be used as input to an algorithm for pre-distorting or modifying LUT waveform samples in a dynamic, ongoing manner. In some forms, when voltage and current feedback data pairs are acquired, it may be desirable to index or otherwise associate each stored voltage and current feedback data pair with the corresponding LUT sample output by the logic device 816. Synchronizing the LUT samples and the voltage and current feedback data in this manner facilitates accurate timing and stability of the pre-distortion algorithm.

[0264] In certain forms, the voltage and current feedback data may be used to control the frequency and / or amplitude (e.g., current amplitude) of the drive signal. In one form, for example, the voltage and current feedback data may be used to determine the impedance phase. The frequency of the drive signal may then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the impedance phase measurement accuracy. The determination of the phase impedance and frequency control signal may be implemented in the DSP processor 822, for example, where the frequency control signal is supplied as an input to a DDS control algorithm implemented by the logic device 816.

[0265] In another form, for example, current feedback data may be monitored to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude set point may be specified directly or determined indirectly based on a specific voltage amplitude and power set point. In certain forms, control of the current amplitude may be achieved by a control algorithm in the DSP processor 822, such as, for example, a proportional integral derivative (PID) control algorithm. Variables controlled by the control algorithm to appropriately control the current amplitude of the drive signal may include, for example, the scale of the LUT waveform samples stored in the logic device 816 and / or the full-scale output voltage of the DAC circuit 818 (which supplies input to the power amplifier 812) via the DAC circuit 834.

[0266] The non-isolated stage 804 may also include a second processor 836, which is used to provide user interface (UI) functions in addition to other matters. In one form, the UI processor 836 may include, for example, an Atmel AT91SAM9263 processor with an ARM 926EJ-S core purchased 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 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., via an SPI bus). Although the UI processor 836 may primarily support UI functions, in some forms, it may also collaborate 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 input (e.g., touch screen input, foot switch input, temperature sensor input) and may disable the drive output of the generator 800 when an error condition is detected.

[0267] In certain forms, for example, both the DSP processor 822 and the UI processor 836 may determine and monitor the operating state of the generator 800. For the DSP processor 822, the operating state of the generator 800 may indicate, for example, which control and / or diagnostic processes are implemented by the DSP processor 822. For the UI processor 836, the operating state of the generator 800 may indicate, for example, which elements of the UI (e.g., display screen, sound) are presented to the user. The respective DSP processor 822 and UI processor 836 may independently maintain the current operating state of the generator 800 and identify and evaluate possible transitions of the current operating state. The DSP processor 822 may act as the principal in this relationship and determine when a transition between operating states occurs. The UI processor 836 may know the valid transitions between operating states and may confirm whether a particular transition is appropriate. For example, when the DSP processor 822 commands the UI processor 836 to transition to a particular state, the UI processor 836 may verify that the requested transition is valid. If the UI processor 836 determines that the requested transition between states is invalid, the UI processor 836 may cause the generator 800 to enter a failure mode.

[0268] The non-isolated stage 804 may also include a controller 838 for monitoring input devices (e.g., capacitive touch sensors, capacitive touch screens for turning the generator 800 on and off). In certain forms, the controller 838 may include at least one processor and / or other controller device in communication with the UI processor 836. In one form, 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 form, the controller 838 may include a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) to control and manage the collection of touch data from the capacitive touch screen.

[0269] In certain forms, 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 a power source of the generator 800, such as the power source 854 discussed below). In this manner, the controller 838 may continue to monitor an input device (e.g., a capacitive touch sensor located on a front panel of the generator 800) for turning the generator 800 on and off. When the generator 800 is in the power off state, if activation of a user "on / off" input device is detected, the controller 838 may wake up the power source (e.g., enable operation of one or more DC / DC voltage converters 856 of the power source 854). Thus, the controller 838 may initiate a sequence for transitioning the generator 800 to the "power on" state. Conversely, when the generator 800 is in the power on state, if activation of the "on / off" input device is detected, the controller 838 may initiate a sequence for transitioning the generator 800 to the power off state. In certain forms, for example, the controller 838 may report activation of an "on / off" input device to the UI processor 836, which in turn implements the necessary process sequence to transition the generator 800 to a power-off state. In such forms, the controller 838 may not have an independent ability to remove power from the generator 800 after its power-on state has been established.

[0270] In some forms, the controller 838 may cause the generator 800 to provide audible or other sensory feedback to alert the user that a power-on or power-off sequence has been initiated. Such an alert may be provided at the start of a power-on or power-off sequence and before other processes associated with the sequence begin.

[0271] In certain forms, the isolation stage 802 may include an instrument interface circuit 840, e.g., to provide a communication interface between the control circuitry of the surgical instrument (e.g., control circuitry including a handpiece switch) and components of the non-isolated stage 804, such as, for example, the logic device 816, the DSP processor 822, and / or the UI processor 836. The instrument interface circuit 840 may exchange information with components of the non-isolated stage 804 via a communication link, such as, for example, an IR-based communication link, that maintains a suitable degree of electrical isolation between the isolation stage 802 and the non-isolated stage 804. For example, power may be supplied to the instrument interface circuit 840 using a low-dropout voltage regulator powered by an isolation transformer, which is driven from the non-isolated stage 804.

[0272] 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) in communication with a signal conditioning circuit 844. The signal conditioning circuit 844 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the logic circuit 842 to generate a bipolar interrogation signal having the same frequency. For example, the interrogation signal may be generated using a bipolar current source fed by a differential amplifier. The interrogation signal may be transmitted to a surgical instrument control circuit (e.g., by 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 plurality of switches, resistors, and / or diodes to modify one or more characteristics of the interrogation signal (e.g., amplitude, rectification) so that the state or configuration of the control circuit can be uniquely discerned based on the one or more characteristics. In one form, for example, the signal conditioning circuit 844 may include an ADC circuit for generating a sample of a voltage signal appearing at the input of the control circuit due to the interrogation signal passing through the control circuit. Logic circuit 842 (or a component of non-isolated stage 804 ) may then determine a state or configuration of the control circuit based on the ADC circuit samples.

[0273] In one form, the instrument interface circuit 840 may include a first data circuit interface 846 to enable information exchange between the logic circuit 842 (or other elements of the instrument interface circuit 840) and the first data circuit disposed in the surgical instrument or otherwise associated with the surgical instrument. In some forms, for example, the first data circuit may be disposed in a cable integrally attached to the surgical instrument handpiece, or in an adapter for interfacing a specific 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 according to any suitable protocol including, for example, those described herein with respect to the first data circuit. In some forms, the first data circuit may include a non-volatile storage device, such as an EEPROM device. In some forms, the first data circuit interface 846 may be implemented separately from the logic circuit 842 and include suitable circuits (e.g., discrete logic devices, processors) to enable communication between the logic circuit 842 and the first data circuit. In other forms, the first data circuit interface 846 may be integrated with the logic circuit 842.

[0274] In some forms, the first data circuit may store information related to the specific surgical instrument with which it is associated. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and / or any other type of information. The information may be read by the instrument interface circuit 840 (e.g., via the logic circuit 842), transmitted to the components of the non-isolated stage 804 (e.g., to the logic device 816, the DSP processor 822 and / or the UI processor 836) for presentation to the user via an output device and / or for controlling the function or operation of the generator 800. In addition, any type of information may be transmitted to the first data circuit via the first data circuit interface 846 (e.g., using the logic circuit 842) for storage therein. Such information may include, for example, an updated number of operations in which the surgical instrument has been used and / or a date and / or time of use of the surgical instrument.

[0275] As previously discussed, surgical instruments may be detachable from handpieces (e.g., multifunctional surgical instruments may be detachable from handpieces) to facilitate instrument interchangeability and / or disposability. In such cases, the ability of conventional generators to identify the specific instrument configuration being used and to optimize control and diagnostic processes accordingly may be limited. However, addressing this issue by adding readable data circuits to surgical instruments is problematic from a compatibility perspective. For example, designing surgical instruments to maintain backward compatibility with generators that lack the requisite data reading functionality may be impractical due to, for example, different signaling schemes, design complexity, and cost. The form of the instrument discussed herein addresses these issues by using data circuits that can be economically implemented in existing surgical instruments and with minimal design changes to maintain compatibility of the surgical instrument with current generator platforms.

[0276] In addition, the form of the generator 800 can enable communication with an instrument-based data circuit. For example, the generator 800 can be configured to communicate with a second data circuit contained in an instrument (e.g., a multifunctional surgical instrument). In some forms, the second data circuit can be implemented in a manner similar to the first data circuit described herein. The instrument interface circuit 840 may include a second data circuit interface 848 for implementing the communication. In one form, the second data circuit interface 848 may include a tri-state digital interface, but other interfaces may also be used. In some 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 related to an associated specific surgical instrument. Such information may include, for example, a model number, a serial number, a plurality of operations in which the surgical instrument has been used, and / or any other type of information.

[0277] In some forms, the second data circuit may store information about the electrical and / or ultrasonic performance of the associated ultrasonic transducer, end effector, or ultrasonic drive system. For example, the first data circuit may indicate an aging frequency slope, as described herein. Additionally or alternatively, any type of information may be transmitted to the second data circuit via the second data circuit interface 848 (e.g., using the logic circuit 842) for storage therein. Such information may, for example, include an updated number of operations in which a surgical instrument is used and / or the date and / or time of its use. In certain forms, the second data circuit may transmit data collected by one or more sensors (e.g., an instrument-based temperature sensor). In certain forms, the second data circuit may receive data from the generator 800 and provide an indication to the user (e.g., an LED indication or other visual indication) based on the received data.

[0278] 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 may be achieved without providing additional conductors for this purpose (e.g., dedicated conductors of a cable connecting the handpiece to the generator 800). In one form, for example, a single bus communication scheme implemented on an existing cable, such as one of the conductors used to transmit an interrogation signal from the signal conditioning circuit 844 to the control circuit in the handpiece, may be used to transmit information to and from the second data circuit. In this way, design changes or modifications to the surgical instrument that might otherwise be necessary may be minimized or reduced. In addition, because the different types of communications implemented on a common physical channel may be frequency-band separated, the presence of the second data circuit may be "invisible" to generators that do not have the requisite data reading functionality, thereby achieving backward compatibility of surgical instruments.

[0279] In some forms, the isolation stage 802 may include at least one blocking capacitor 850-1 connected to the drive signal output terminal 810b to prevent DC current from flowing to the patient. For example, the signal blocking capacitor may be required to comply with medical regulations or standards. Although relatively few errors occur in single capacitor designs, such errors may have adverse consequences. In one form, a second blocking capacitor 850-2 may be provided in series with the blocking capacitor 850-1, wherein current leakage from a point between the blocking capacitors 850-1 and 850-2 is monitored, for example, by an ADC circuit 852 to sample the voltage induced by the leakage current. These samples may be received, for example, by a logic circuit 842. Based on changes in the leakage current (as indicated by the voltage samples), the generator 800 may determine when at least one of the blocking capacitors 850-1, 850-2 has failed, thereby providing benefits over single capacitor designs with a single failure point.

[0280] In certain forms, the non-isolated stage 804 may include a power source 854 for delivering DC power at an appropriate 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 also include one or more DC / DC voltage converters 856 for receiving the output of the power source to generate a DC output at the voltage and current required by the various components of the generator 800. As discussed above in conjunction with the controller 838, when the controller 838 detects that a user activates an "on / off" input device to enable operation of the DC / DC voltage converter 856 or wake up the DC / DC voltage converter 856, one or more of the DC / DC voltage converters 856 may receive input from the controller 838.

[0281] Fig.21 An example of a generator 900 is shown, which is a generator 800 ( Fig. 20 ) is a form of a surgical instrument. Generator 900 is configured to be capable of delivering multiple energy modalities to a surgical instrument. Generator 900 provides RF signals and ultrasonic signals for independently or simultaneously delivering energy to a surgical instrument. The RF signal and the ultrasonic signal may be provided separately or in combination, and may be provided simultaneously. As described above, at least one generator output may deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation and / or microwave energy, etc.) through a single port, and these signals may be delivered separately or simultaneously to an end effector to treat tissue.

[0282] The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to be able to generate various signal waveforms based on information stored in a memory coupled to the processor 902, which is not shown for clarity of the present disclosure. Digital information associated with the waveform is provided to the waveform generator 904, which includes one or more DAC circuits to convert digital inputs into analog outputs. The analog output is fed to the amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to the power transformer 908. The signal is coupled to the secondary side in the patient isolation side through the power transformer 908. The first signal of the first energy mode is provided to the surgical instrument between the terminals marked as ENERGY1 and RETURN. The second signal of the second energy mode is coupled to the two ends of the capacitor 910 and is provided to the surgical instrument between the terminals marked as ENERGY2 and RETURN. It should be understood that more than two energy modes may be output, and thus the subscript "n" may be used to specify that up to n ENERGYn terminals may be provided, where n is a positive integer greater than 1. It should also be understood that up to "n" return paths RETURNn may be provided without departing from the scope of the present disclosure.

[0283] The first voltage sensing circuit 912 is connected to both ends of the terminals marked as ENERGY1 and RETURN paths to measure the output voltage therebetween. The second voltage sensing circuit 924 is connected to both ends of the terminals marked as ENERGY2 and RETURN paths to measure the output voltage therebetween. As shown, the current sensing circuit 914 is arranged in series with the RETURN branch on the secondary side of the power transformer 908 to measure the output current of any energy mode. If a different return path is provided for each energy mode, a separate current sensing circuit should be provided in each return branch. 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 of the power transformer 908 (non-patient isolation side) 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 output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument and calculate parameters such as output impedance. Input / output communication between the processor 902 and the patient isolation circuit is provided through the interface circuit 920. The sensor can also be in electrical communication with the processor 902 through the interface 920.

[0284] In one aspect, the impedance may be determined by the processor 902 by dividing the output of 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 branch on the secondary side of the power transformer 908. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 for calculating the impedance. For example, the first energy modality ENERGY1 may be ultrasonic energy, and the second energy modality ENERGY2 may be RF energy. However, in addition to ultrasonic and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, etc. Moreover, although Fig.21 The illustrated example shows that a single return path RETURN may be provided for two or more energy modalities, but in other aspects, multiple return paths RETURNn may be provided for each energy modality ENERGYn. Thus, as described herein, the ultrasonic transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914, and the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.

[0285] like Fig.21 As shown in , a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities (such as ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy with a higher voltage and lower current to drive an ultrasonic transducer, deliver energy with a lower voltage and higher current to drive an RF electrode for sealing tissue, or deliver energy with a coagulation waveform for use with monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 may be manipulated, 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 the generator 900 will preferably be located between the outputs labeled ENERGY1 and RETURN, as shown in FIG. Fig.21In one example, the connection of the RF bipolar electrode to the generator 900 output will preferably be between the outputs labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection would be an active electrode (e.g., a pencil or other probe) at the ENERGY2 output and a suitable return pad connected to the RETURN output.

[0286] Additional details are disclosed in U.S. patent application publication 2017 / 0086914, entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS, published on March 30, 2017, which is incorporated herein by reference in its entirety.

[0287] As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that can transmit data through non-solid media using modulated electromagnetic radiation. The term does not mean that the associated organization does not contain any wires, although in some aspects they may not. The communication module may implement any of a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, and its Ethernet derivatives, and any other wireless and wired protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[0288] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually a memory or some other data stream). The term is used herein to refer to a central processing unit (central processing unit) in one or more systems (especially a system on a chip (SoC)) that combines multiple specialized "processors".

[0289] As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all the components of a computer or other electronic system. It can contain digital, analog, mixed signal, and often radio frequency functions - all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), a Wi-Fi module, or a coprocessor. A SoC may or may not include built-in memory.

[0290] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for a microcontroller unit) can be implemented as a small computer on a single integrated circuit. It can be similar to a SoC; an SoC may include a microcontroller as one of its devices. A microcontroller may include one or more core processing units (CPUs) as well as memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory, or OTP ROM, as well as a small amount of RAM, is also often included on the chip. Compared to microprocessors used in personal computers or other general-purpose applications consisting of various discrete chips, microcontrollers can be used for embedded applications.

[0291] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a link between the two components of a computer or a controller on an external device that manages the operation of the device (and the connection to the device).

[0292] Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those offered by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be, for example, the LM4F230H5QR ARMCortex-M4F processor core available from Texas Instruments, which includes: 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improving performance beyond 40 MHz, 32KB of single-cycle serial random access memory (SRAM), a 32-bit MCU loaded with 128-bit MCUs, and a 32-bit MCU. Internal read-only memory (ROM) for software, 2KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) simulations, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features readily available from product data sheets.

[0293] In one example, the processor may include a safety controller including two families based on controllers such as the TMS570 and RM4x also offered by Texas Instruments under the trade name Hercules ARMCortex R4. The safety controller may be configured to be specialized for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

[0294] The modular device includes a module that can be accommodated in a surgical hub (such as a combination of Figure 3 and Fig. 9 The invention relates to a surgical device or instrument that can be connected to various modules so as to be connected or paired with a corresponding surgical hub. The modular device includes, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays. The modular device described herein can be controlled by a control algorithm. The control algorithm can be executed on the modular device itself, on a surgical hub paired with a specific modular device, 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 in, on, or connected to the modular device). The data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which the knife is advanced, the motor current, or the energy level). For example, the control algorithm of a surgical suturing and cutting instrument can control the rate at which the motor of the instrument drives its knife through the tissue according to the resistance encountered by the knife as it advances.

[0295] Data management and collection

[0296] In one aspect, the surgical hub provides data storage capabilities. Data storage includes the creation and use of self-describing data including identifying features, management of redundant data sets, and storage of data in paired data sets that can be grouped by surgery but not necessarily keyed to the actual surgical date and surgeon to maintain data anonymity. The following description incorporates by reference all "hub" and "cloud" analysis system hardware and software processing technologies to implement the specific data management and collection techniques described below, as incorporated herein by reference. The interactive surgical system 100 will be described in the context of the environment. Figure 22-Figure 41 The interactive surgical system 100 environment includes a combination of Figure 1-Figure 11 The surgical hubs 106, 206 and the combination described Figure 12-Figure 21 Describe the smart devices and generators.

[0297] Electronic Medical Record (EMR) Interaction

[0298] Fig. 22 A diagram 4000 is shown of a technique for interacting with a patient electronic medical record (EMR) database 4002 according to one aspect of the present disclosure. In one aspect, the present disclosure provides a method of embedding a key 4004 within an EMR database 4002 located within a hospital or medical facility. A data barrier 4006 is provided to protect patient data privacy and allow for reintegration of stripped and isolated data pairs as described below from a surgical hub 106, 206 or cloud 104, 204 for reassembly. Figure 1-Figure 11 And especially Figure 9-10 A schematic diagram of the surgical hub 206 is generally described in FIG. Fig. 22 In the description of the surgical hub 206, the reader is directed to any implementation details of the surgical hub 206. Figure 1-Figure 11 , and especially Figure 9-10 ; For the sake of brevity and clarity of disclosure, these details may be omitted here. Return to Fig. 22 , which allows the user full access to all data collected during the surgical procedure and patient information stored in the form of the electronic medical record 4012. The reassembled data may be displayed on a monitor 4010 or secondary monitor connected to the surgical hub 206, but is not permanently stored on any surgical hub storage device 248. The reassembled data is temporarily stored in a storage device 248 located in the surgical hub 206 or the cloud 204, and is deleted and overwritten at the end of use to ensure that it cannot be recovered. The key 4004 in the EMR database 4002 is used to reintegrate the anonymized hub data back into the fully integrated patient electronic medical record 4012 data.

[0299] like Fig. 22 As shown, the EMR database 4002 is located within the hospital data barrier 4006. The EMR database 4002 can be configured to store, retrieve, and manage associative arrays or other data structures known today as dictionaries or hashes. A dictionary contains a collection of objects or records, which in turn have many different fields, each containing data. A key 4004 can be used to store and retrieve patient electronic medical records 4012, which uniquely identifies the patient electronic medical record 4012 and is used to quickly find data within the EMR database 4002. The key value EMR database 4002 system treats the data as a single opaque collection, where each record can have different fields.

[0300] Information from the EMR database 4002 may be transferred to the surgical hub 206 and the patient electronic medical record 4012 data may be edited and stripped before being sent to the analysis system based on the hub 206 or the cloud 204. An anonymous data file 4016 is created by editing the personal patient data and stripping the relevant patient data 4018 from the patient electronic medical record 4012. As used herein, the editing process includes deleting or removing personal patient information from the patient electronic medical record 4012 to create an edited record that includes only anonymous patient data. An edited record is a record from which sensitive patient information has been cleared. Unedited data may be deleted 4019. The relevant patient data 4018 may be referred to herein as stripped / extracted data 4018. The relevant patient data 4018 is used for analysis purposes by the processing engine of the surgical hub 206 or the cloud 204 and may be stored on the storage device 248 of the surgical hub 206 or may be stored on the analysis system storage device 205 based on the cloud 204. The surgical hub anonymous data file 4016 may be reconstructed using the key 4004 stored in the EMR database 4002 to reintegrate the surgical hub anonymous data file 4016 back into the fully integrated patient electronic medical record 4012. The relevant patient data 4018 used in the analysis process may include information such as the patient's emphysema diagnosis, preoperative treatment (e.g., chemotherapy, radiation, blood thinners, blood pressure medications, etc.), typical blood pressure, or any data that cannot be used alone to determine the patient's identity. The data to be edited 4020 includes personal information removed from the patient's electronic medical record 4012, which may include age, work unit, body mass index (BMI), or any data that can be used to determine the patient's identity. The surgical hub 206 creates a unique anonymous surgical ID number (e.g., 380i4z), for example, Fig.23 Within the EMR database 4002 located in the hospital data barrier 4006, the surgical hub 206 may recombine the data in the anonymous data file 4016 stored on the surgical hub 206 storage device 248 with the data in the patient electronic medical record 4012 stored on the EMR database 4002 for the surgeon to review. The surgical hub 206 displays the combined patient electronic medical record 4012 on a display or monitor 4010 connected to the surgical hub 206. Finally, the unredacted data is deleted 4019 from the storage device 248 of the surgical hub 206.

[0301] Create a hospital data barrier where non-anonymized data can be used to compare data from the hub Data must be stripped outside the hospital data barrier

[0302] In one aspect, the present disclosure provides a Fig. 9 and Fig.10The surgical hub 206, for example, wherein the surgical hub 206 includes a processor 244; and a memory 249 coupled to the processor 244. The memory 249 stores instructions executable by the processor 244 to perform the following operations: querying the surgical instrument 235, retrieving a first data set from the surgical instrument 235, querying the medical imaging device 238, retrieving a second data set from the medical imaging device 238, associating the first data set with the second data set by a key, and transmitting the associated first data set and second data set to a remote network (e.g., cloud 204) outside the surgical hub 206. The surgical instrument 235 is a first source of patient data, and the first data set is associated with a surgical procedure. The medical imaging device 238 is a second source of patient data, and the second data set is associated with an effect of the surgical procedure. The first data record and the second data record are uniquely identified by the key.

[0303] On the other hand, the surgical hub 206 provides a memory 249 storing instructions executable by the processor 244 to perform the following operations: retrieving a first data set using a key, anonymizing the first data set, retrieving a second data set using a key, anonymizing the second data set, pairing the anonymized first data set and the second data set, and determining a success rate of surgical procedures grouped by surgical procedures based on the anonymized paired first data set and the second data set.

[0304] In another aspect, the surgical hub 206 provides a memory 249 storing instructions executable by the processor 244 to retrieve an anonymized first data set, retrieve an anonymized second data set, and reassemble the anonymized first data set and the second data set using a key.

[0305] In another aspect, the first and second data sets define first and second data payloads in respective first and second data packets.

[0306] In various aspects, the present disclosure provides a control circuit for associating a first data set with a second data set via a key as described above. In various aspects, the present disclosure provides a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to associate a first data set with a second data set via a key as described above.

[0307] During a surgical procedure, it would be desirable to monitor data associated with the surgical procedure to enable configuration and operation of instruments used during the procedure to improve surgical outcomes. The technical challenge is to retrieve the data in a manner that maintains the anonymity of the patient and thus the privacy of the data associated with the patient. The data can be used to aggregate with other data without individualizing the data.

[0308] One solution provides a surgical hub 206 for querying the electronic medical record database 4002 for data from the patient electronic medical record 4012, stripping the required or relevant patient data 4018 from the patient electronic medical record 4012, and redacting any personal information that can be used to identify the patient. The redaction technique removes any information that can be used to associate the stripped relevant patient data 4018 with a specific patient, procedure, or time. The surgical hub 206 and the instruments 235 connected to the surgical hub 206 can then be configured and operated based on the stripped relevant patient data 4018.

[0309] As combined Fig. 22 As disclosed, relevant patient data 4018 is extracted (or stripped) from the patient electronic medical record 4012, while redacting any information that can be used to associate the patient with the surgery or the scheduled time of the surgery, so that the relevant patient data 4018 can be anonymized. The anonymous data file 4016 can then be sent to the cloud 204 for aggregation, processing, and manipulation. The anonymous data file 4016 can be used to perform a surgical instrument 235 or a surgical procedure during surgery based on the extracted anonymous data file 4016. Fig. 9 and Fig.10 Any of the modules shown or the surgical hub 206 is configured.

[0310] In one aspect, a hospital data barrier 4006 is created such that within the data barrier 4006, non-anonymized, unredacted data may be used to compare data from various surgical hubs 206, and outside the data barrier 4006, data from various surgical hubs 206 is stripped to maintain anonymity and protect patient and surgeon privacy. Fig.26 This aspect is further described.

[0311] In one aspect, data from the surgical hubs 206 may be exchanged between surgical hubs 206 (e.g., hub to hub, switch to switch, or router to router) to provide intra-hospital analysis and data display. Figure 1 An example of multiple hubs 106 in communication with each other and with the cloud 104 is shown. Fig.26 This aspect is further described.

[0312] In another aspect, the real-time clock is replaced with an artificial time measurement for all information stored internally within the instrument 235, the robot located in the robotic hub 222, the surgical hub 206, and / or hospital computer equipment. The anonymized data (which may include anonymized patient and surgeon data) is transmitted to the server 213 in the cloud 204 and stored in the cloud storage device 205 connected to the server 213. The replacement of the artificial real-time clock enables the anonymization of the patient data and the surgeon data while maintaining data continuity. In one aspect, the instrument 235, the robotic hub 222, the surgical hub 206, and / or the cloud 204 are configured to be able to hide the patient identity (ID) while maintaining data continuity. In combination Fig.23 This aspect is further described.

[0313] Within the surgical hub 206, the local decryption key 4004 allows information retrieved from the surgical hub 206 itself to be restored to real-time information from the anonymized data set located in the anonymous data file 4016. However, data stored on the hub 206 or the cloud 204 cannot be restored to real-time information from the anonymized data set in the anonymous data file 4016. The key 4004 is stored locally in an encrypted format on the computer / storage device 248 of the surgical hub 206. The network processor ID of the surgical hub 206 is part of the decryption mechanism so that if the key 4004 and the data are removed, the anonymized data set in the anonymous data file 4016 cannot be restored without being on the computer / storage device 248 of the original surgical hub 206.

[0314] Replace the real-time clock with an artificial time measurement for all internally stored information and for sending information to the cloud for Means for anonymizing patient and surgeon data

[0315] Fig.23 A method 4030 of anonymizing a surgical procedure by replacing a real-time clock with an artificial time measurement for all information stored internally within an instrument, robot, surgical hub, and / or hospital computer equipment is shown in accordance with one aspect of the present disclosure. Fig.23 As shown, the surgical procedure setup start time 4032 is scheduled to start at an actual time of 11:31:14 (EST) based on the real time clock. At the surgical procedure setup start time 4032, the surgical hub 206 starts 4034 the artificial randomized real time clock timing scheme at artificial real time 07:36:00. Then, at artificial real time 07:36:01, the surgical hub 206 ultrasonically checks 4036 the operating room (e.g., sends out an ultrasonic pulse train and listens for echoes as they bounce off the walls of the operating room (e.g., a fixed, mobile, temporary or on-site operating room)) (as combined Fig.244040 ) to verify the size of the operating room and adjust the short-range wireless (e.g., Bluetooth) pairing distance limit. At artificial real time 07:36:03, the surgical hub 206 strips 4038 the relevant data and applies a timestamp to the stripped data. At artificial real time 07:36:05, the surgical hub 206 wakes up and begins pairing 4040 the devices located only in the operating room as verified using the ultrasound verification 4036 process.

[0316] Fig.24 Ultrasonic inspection of an operating room wall to determine the distance between a surgical hub and the operating room wall is shown in accordance with at least one aspect of the present disclosure. Figure 2 , the spatial awareness of the surgical hub 206 and its ability to map the operating room for potential components of the surgical system allows the surgical hub 206 to make autonomous decisions about whether to include such potential components as part of the surgical system or to exclude such potential components, which relieves the surgical staff from handling such tasks. In addition, the surgical hub 206 is configured to be able to make inferences about, for example, the type of surgical procedure to be performed in the operating room based on information collected before, during, and / or after the performance of the surgical procedure. Examples of the information collected include the type of devices brought into the operating room, the time of introduction of such devices into the operating room, and / or the device activation sequence.

[0317] In one aspect, the surgical hub 206 employs an operating room mapping module such as, for example, a non-contact sensor module 242 to determine the boundaries of a surgical room (e.g., a fixed, mobile, or temporary operating room or space) using an ultrasonic non-contact measurement device or a laser non-contact measurement device.

[0318] See now Fig.24 , the ultrasound-based non-contact sensor 3002 can be used to scan the operating room by transmitting an ultrasound pulse train and receiving an echo as it bounces off the operating room's walls 3006 to determine the size of the operating room and adjust the short-range wireless (e.g., Bluetooth) pairing distance limit. In one example, the non-contact sensor 3002 can be a Ping ultrasound distance sensor, such as Fig.24 shown.

[0319] Fig.24It shows how the ultrasonic sensor 3002 uses its ultrasonic speaker 3003 to send a short chirp and allows the microcontroller 3004 of the operating room mapping module to measure the time it takes for the echo to return to the ultrasonic microphone 3005 of the ultrasonic sensor. The microcontroller 3004 must send a pulse to the ultrasonic sensor 3002 to start the measurement. The ultrasonic sensor 3002 then waits long enough for the microcontroller program to start the pulse input command. Then, at about the same time as the ultrasonic sensor 3002 chirps the 40kHz tone, the ultrasonic sensor sends a high signal to the microcontroller 3004. When the ultrasonic sensor 3002 detects the echo using its ultrasonic microphone 3005, it changes the high signal back to a low signal. The pulse input command of the microcontroller measures the time between the high change and the low change and stores the measurement in a variable. This value can be used together with the speed of sound in air to calculate the distance between the surgical hub 106 and the operating room wall 3006.

[0320] In one example, the surgical hub 206 may be equipped with four ultrasound sensors 3002, wherein each of the four ultrasound sensors is configured to be able to estimate the distance between the surgical hub 206 and a wall of the operating room 3000. The surgical hub 206 may be equipped with more or less than four ultrasound sensors 3002 for determining the boundaries of the operating room.

[0321] The operating room mapping module may use other distance sensors to determine the boundaries of the operating room. In one example, the operating room mapping module may be equipped with one or more photoelectric sensors that can be used to estimate the boundaries of the operating room. In one example, a suitable laser distance sensor may also be used to estimate the boundaries of the operating room. A laser-based non-contact sensor can scan the operating room by transmitting a laser pulse, receiving a laser pulse that bounces off the walls of the operating room, and comparing the phase of the transmitted pulse with the received pulse to determine the size of the operating room and adjust the short-range wireless (e.g., Bluetooth) pairing distance limit.

[0322] Stripping data from images and connected smart device data to allow aggregation without individualization

[0323] In one aspect, the present disclosure provides a data stripping method that interrogates provided electronic patient records and extracts relevant portions to configure and operate a surgical hub and instruments connected to the surgical hub, while anonymizing the procedure, patient, and all identification parameters to maintain patient privacy.

[0324] Now see again Fig.23 Also see Figure 1-Figure 11To illustrate interaction with the environment of the interactive surgical system 100 including the surgical hub 106, 206, once the size of the operating room has been verified and the Bluetooth pairing is complete, based on manual real-time, the computer processor 244 of the surgical hub 206 begins stripping 4038 data received from the modules connected to the surgical hub 206. In one example, the processor 244 begins stripping 4083 images received, for example, from the imaging module 238 and the connected smart device 235. Stripping 4038 data allows aggregation of data, but does not allow individualization of data. This enables stripping 4038 data identifiers, linking data, and monitoring events, while maintaining patient privacy by anonymizing the data.

[0325] See also Figure 1-Figure 24 In one aspect, a data stripping 4038 method is provided. According to the data stripping 4038 method, the processor 244 of the surgical hub 206 interrogates the patient record stored in the surgical hub database 238 and extracts the relevant portion of the patient record to configure and operate the surgical hub 206 and its instruments 235, robots, and other modular devices (e.g., modules). The data stripping 4038 method anonymizes the surgical procedure, the patient, and all identifying parameters associated with the surgical procedure. Stripping 4038 the data in flight ensures that the data is not associated with a specific patient, surgical procedure, surgeon, time, or other possible identifiers that can be used to associate the data at any time.

[0326] The data may be stripped 4038 for compiling basic information at a database storage device 205 of a remote cloud 204 coupled to a remote server 213. The data stored in the database storage device 248 may be used for cloud-based advanced analytics as described in U.S. Provisional Patent Application Serial No. 62 / 611,340, filed on December 28, 2017, entitled CLOUD-BASED MEDICAL ANALYTICS, which is incorporated herein by reference in its entirety. A copy of the datalink-complete information may also be stored in the patient EMR database 4002 ( Fig. 22 For example, the surgical hub 206 may import patient tissue irregularities or comorbidities to add to an existing data set stored in the database 248. The data may be stripped 4038 prior to surgery and / or may be stripped 4038 as the data is transmitted to the database storage device 205 of the cloud 204 coupled to the remote server 213.

[0327] Continue to see Figure 1-Figure 11 and Figure 22-Figure 24 , Fig.25is a diagram 4050 depicting a process of importing a patient electronic medical record 4012 containing surgical procedures and related patient data 4018 stored in an EMR database 4002, stripping 4038 the related patient data 4018 from the imported medical record 4012, and identifying 4060 smart device meanings 4062 or inferences according to one aspect of the present disclosure. Fig.25 As shown, a patient electronic medical record 4012 containing information stored in the patient EMR database 4002 is retrieved from the EMR database 4002, imported into the surgical hub 206 and stored in the storage device 248 of the surgical hub 206. Fig. 22 ) is removed or deleted 4019 from the patient electronic medical record 4012 before it is stored in the surgical hub 206 storage device 248. The relevant patient data 4018 is then stripped 4038 from the medical record 4012 to remove the required relevant patient data 4018, and the unredacted data is deleted 4019 to maintain patient anonymity. In the example shown, the stripped data 4058 includes emphysema, hypertension, small lung cancer, warfarin / blood thinners, and / or radiation pre-treatment. As described below, the stripped data 4058 is used to identify 4060 smart device meaning while maintaining patient anonymity.

[0328] Although the surgical data and associated patient data 4018 are described as being imported from the patient's electronic medical record 4012 stored in the EMR database 4002, in various aspects, the surgical data and associated patient data 4018 may be retrieved from modular devices coupled to the surgical hub 206 prior to being stored in the EMR database 4002. For example, the surgical hub 206 may interrogate the modules to retrieve the surgical data and associated patient data 4018 from the modules. As described herein, the modules include an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke evacuator 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, as well as a display 237. Figure 3 and Figure 8-Figure 10 Other modules shown.

[0329] For example, the anonymized stripped data 4058 may be used to identify 4060 significant failures of instruments and other smart devices, and may initiate an automated archiving process and submission of the data for further meaning analysis. For example, the meaning of detecting a counterfeit component or adapter on an original equipment manufacturer (OEM) device would be to initiate documentation of the component and the results and effects of its use. For example, the surgical hub 206 may perform such as in conjunction with Fig.41The situational awareness algorithm described. In one aspect, the surgical hub 206 may initially receive or identify a plurality of meanings 4062 derived from the anonymized stripped data 4058. The surgical hub 206 is configured to be able to control the instruments 235 or other modules so that they operate corresponding to the derived meanings 4062. In one example, the control logic of the surgical hub 206 identifies the following: (i) lung tissue may be more fragile than normal (e.g., due to emphysema), (ii) bleeding problems are more likely to occur (e.g., due to hypertension and / or the patient is receiving blood thinners such as warfarin), (iii) the cancer may be more aggressive (e.g., because the target of surgery is small cell lung cancer), and (iv) the lung tissue may be harder and more prone to rupture (e.g., because the patient has received radiation pre-treatment). The control logic or processor 244 of the surgical hub 206 then interprets how the data affects the instruments 235 or other modules so that the instruments 235 operate in accordance with the data, and then transmits corresponding adjustments to each of the instruments 235.

[0330] In one example involving a stapler type of surgical instrument 235, based on the meaning 4062 identified 4060 from the anonymized stripping data 4058, the control logic or processor 244 of the surgical hub 206 may perform the following operations: (i) notify the stapler to adjust the compression rate threshold parameter, (ii) adjust the surgical hub 206 visualization threshold to quantify bleeding and internal parameters, (iii) notify the combined generator module 240 of the lung tissue and vascular tissue type so that the power and control algorithms of the generator module 240 are adjusted accordingly, (iv) notify the imaging module 238 of the invasive cancer label to adjust the margin range accordingly, (v) notify the stapler of the required margin parameter adjustment (the margin parameter corresponds to the distance or amount of surrounding cancer tissue to be removed), and (vi) notify the stapler that the tissue is potentially friable. In addition, the anonymized stripping data 4058 on which the meaning 40602 is based is identified by the surgical hub 206 and fed into the situational awareness algorithm (see Fig.41 ). Examples include, but are not limited to, thoracopulmonary resections, such as segmental resections, etc.

[0331] Fig.26 FIG4070 is a diagram illustrating the application of cloud-based analytics to unredacted data, stripped-out patient data 4018, and independent data pairs according to one aspect of the present disclosure. As shown, multiple surgical hubs (hub #1 4072, hub #3 4074, and hub #4 4076) are located within the hospital data barrier 4006 (see also FIG4070 ). Fig. 22). The unredacted patient electronic medical record 4012 including the patient data and the procedure-related data may be used and exchanged between the surgical hubs (hub #1 4072, hub #3 4074, and hub #4 4076) located within the hospital data barrier 4006. However, before the unredacted patient electronic medical record 4012 including the patient data and the procedure-related data is transmitted outside the hospital data barrier 4006, the patient data of the patient electronic medical record 4012 is redacted and stripped to create an anonymous data file 4016 containing anonymized information for further analysis and processing of the redacted / stripped data in the cloud 204 through a cloud-based analysis process.

[0332] Fig. 27 4080 is a logic flow diagram illustrating a method of a control program or logic configuration for associating a patient data set from a first data source and a second data source according to one aspect of the present disclosure. Fig. 27 Also see Figure 1-Figure 11 To illustrate interaction with an environment of an interactive surgical system 100 including a surgical hub 106, 206, in one aspect, the present disclosure provides a surgical hub 206 including: a processor 244; and a memory 249 coupled to the processor 244. The memory 249 stores instructions executable by the processor 244 to: interrogate 4082 a surgical instrument 235, retrieve 4084 a first data set from the surgical instrument 235, interrogate 4086 a medical imaging device 238, retrieve 4088 a second data set from the medical imaging device 238, associate 4090 the first data set with the second data set by a key, and transmit the associated first and second data sets to a remote network external to the surgical hub 206. The surgical instrument 235 is a first source of patient data, and the first data set is associated with a surgical procedure. The medical imaging device 238 is a second source of patient data, and the second data set is associated with an effect of the surgical procedure. The first data record and the second data record are uniquely identified by a key.

[0333] On the other hand, the surgical hub 206 provides a memory 249 storing instructions executable by the processor 244 to perform the following operations: retrieving a first data set using a key, anonymizing the first data set, retrieving a second data set using a key, anonymizing the second data set, pairing the anonymized first data set and the second data set, and determining a success rate of surgical procedures grouped by surgical procedures based on the anonymized paired first data set and the second data set.

[0334] In another aspect, the surgical hub 206 provides a memory 249 storing instructions executable by the processor 244 to retrieve an anonymized first data set, retrieve an anonymized second data set, and reassemble the anonymized first data set and the second data set using a key.

[0335] Fig.28 4400 is a logic flow diagram depicting a method 4400 of a control program or logic configuration for stripping data to extract relevant portions of the data for configuring and operating a surgical hub 206 and modules (e.g., instruments 235) coupled to the surgical hub 206 in accordance with one aspect of the present disclosure. Fig.28 Also see Figure 1-Figure 11 To illustrate interaction with an environment of an interactive surgical system 100 including a surgical hub 106, 206, in one aspect, the surgical hub 206 can be configured to be able to interrogate modules coupled to the surgical hub 206 to obtain data, and to strip the data to extract relevant portions of the data in order to configure and operate the surgical hub 206 and the modules (e.g., instruments 235) coupled to the surgical hub 206, and to anonymize the surgery, the patient, and other parameters that can be used to identify the patient to maintain patient privacy. According to method 4400, in one aspect, the present disclosure provides a surgical hub 206 comprising a processor 244, a modular communication hub 203 coupled to the processor 244, wherein the modular communication hub 203 is configured to be able to connect modular devices located in one or more operating rooms to the surgical hub 206. The processor 244 is coupled to a memory 249, wherein the memory 249 stores instructions executable by the processor 244 to cause the processor to interrogate 4402 a modular device coupled to the processor 244 via the modular communication hub 203. The modular device is a source of a data set including patient identification data and surgical data. The processor 244 receives 4404 the data set from the modular device. The processor 244 discards 4406 the patient identification data and any portion of the surgical data that identifies the patient from the data set. The processor 244 extracts 4408 anonymous data from the data set and creates 4410 an anonymized data set. The processor 244 configures 4412 the operation of the surgical hub 206 or the modular device based on the anonymized data set.

[0336] On the other hand, in the case where the anonymized data set includes a major failure of the modular device, the memory 249 stores instructions that can be executed by the processor 244 to initiate automatic archiving and submission of data for meaning analysis based on the major failure of the modular device. On the other hand, the memory 249 stores instructions that can be executed by the processor 244 to detect forged component information from the anonymized data set. On the other hand, the memory 249 stores instructions that can be executed by the processor 244 to derive the meaning of the modular device from the anonymized data set, and the memory 249 stores instructions that can be executed by the processor 244 to configure the modular device to operate based on the derived meaning or to configure the surgical hub based on the derived meaning. On the other hand, the memory 249 stores instructions that can be executed by the processor 244 to aggregate the anonymized data. On the other hand, the memory 249 stores instructions that can be executed by the processor 244 to extract the anonymized data before storing the received data in a storage device connected to the surgical hub. On the other hand, the memory 249 stores instructions executable by the processor to transmit the anonymized data to a remote network external to the surgical hub, compile the anonymized data at the remote network, and store a copy of the data set from the modular device in a patient electronic medical record database.

[0337] Data creation, storage and use of self-describing data including identifying characteristics

[0338] In one aspect, the present disclosure provides self-describing data packets that are generated at the issuing device and include identifiers of all devices that process the packets. Self-description allows a processor to interpret the data in the self-describing packets without knowing the data type in advance before receiving the self-describing packets. The data applies to each data point or data string and includes the data type, the source of the self-describing packet, the device identification that generated the packet, the unit, the time the packet was generated, and the authentication that the data contained in the packet has not been changed. When a processor (in a device or surgical hub) receives an unexpected packet and verifies the source of the packet, the processor changes the collection technique to prepare for any subsequent packets from that source.

[0339] See also Figure 1-Figure 11 To illustrate the interaction with the environment of the interactive surgical system 100 including the surgical hub 106, 206, during a surgical procedure performed in the environment of the surgical hub 206, the size and amount of data generated by the surgical devices 235 coupled to the surgical hub 206 can become quite large. Moreover, the data exchanged between the surgical devices 235 and / or the surgical hub 206 can also become quite large.

[0340] One solution provides a technique for minimizing the size of data and the processing of data within the surgical hub 206 by generating self-describing packets. Initially, the self-describing packets are assembled by the instrument 235 that generates it. The packets are then sorted and encrypted b, thereby generating an encryption certificate that is unique to each data packet. The data is then transmitted from the instrument 235 via an encrypted wired or wireless protocol and stored on the surgical hub 206 for processing and transmission to the analysis engine of the cloud 204. Each self-describing data packet includes an identifier for identifying the specific instrument that generated the data packet and the time when the data packet was generated. When the packet is received by the surgical hub 206, the identifier of the surgical hub 206 is added to the packet.

[0341] In one aspect, the present disclosure provides a surgical hub 206 that includes a processor 244 and a memory 249 coupled to the processor 244. The memory 249 stores instructions that can be executed by the processor 244 to perform the following operations: receiving a first data packet from a first source, receiving a second data packet from a second source, associating the first data packet with the second data packet, and generating a third data packet including a first data payload and a second data payload. The first data packet includes a first preamble, a first data payload, a source of the first data payload, and a first encryption certificate. The first preamble defines the first data payload, and the first encryption certificate verifies the authenticity of the first data packet. The second data packet includes a second preamble, a second data payload, a source of the second data payload, and a second encryption certificate. The second preamble defines the second data payload, and the second encryption certificate verifies the authenticity of the second data packet.

[0342] On the other hand, the memory 249 stores instructions executable by the processor 244 to perform the following operations: determine that the data payload is from a new source, verify the new source of the data payload, and change the data collection process at the surgical hub to receive subsequent data packets from the new source.

[0343] In another aspect, the memory 249 stores instructions executable by the processor 244 to associate the first data packet with the second data packet based on the key. In another aspect, the memory 249 stores instructions executable by the processor 244 to anonymize the data payload of the third data packet. In another aspect, the memory 249 stores instructions executable by the processor 244 to receive the anonymized third data packet and reintegrate the anonymized third data packet into the first data packet and the second data packet using the key.

[0344] In various aspects, the present disclosure provides a control circuit for receiving and processing data packets as described above. In various aspects, the present disclosure provides a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to receive and process data packets as described above.

[0345] In other aspects, the present disclosure provides a method for generating a data packet including self-describing data. In one aspect, a surgical instrument includes a processor and a memory, a control circuit, and / or a computer-readable medium connected to the processor, the computer-readable medium being configured to generate a data packet including a preamble, a data payload, a source of the data payload, and an encryption certificate. The preamble defines the data payload, and the encryption certificate verifies the authenticity of the data packet. In various aspects, the data packet can be generated by any module connected to a surgical hub. The self-describing data packet minimizes the data size and data processing in the surgical hub.

[0346] In one aspect, the present disclosure provides a self-describing data packet generated at a publishing device (e.g., an instrument, tool, robot). The self-describing data packet includes: identifiers of all devices along a communication path that process the data packet; a self-description that enables a processor to interpret the data contained in the data packet without being informed in advance of the receipt of the data packet along the path; data for each data point or data string; and the data type, data source, device ID that generated the data, data unit, generation time, and authentication that the data packet has not been altered. In another aspect, when a processor receives a data packet from an unexpected source and verifies the data source, the processor changes the data collection technique to prepare for any subsequent data packets from that source.

[0347] The surgical hub includes an identification feature structure when creating and using data packets that include self-describing data. The hub and smart devices use self-describing data packets to minimize data size and data processing. In surgical hubs that generate large amounts of data, self-describing data packets minimize data size and data processing, saving time and enabling operating rooms to run more efficiently.

[0348] Fig.29 A self-describing data packet 4100 including self-describing data is shown according to one aspect of the present disclosure. Figure 1-Figure 11 To illustrate interaction with the environment of the interactive surgical system 100 including the surgical hub 106, 206, in one aspect, as Fig.29The self-describing data packet 4100 shown is generated at the issuing instrument 235 or a device or module located in or in communication with the operating room, and includes identifiers of all devices 235 that process the packet along the communication path. Self-description allows the processor 244 to interpret the data payload of the packet 4100 without knowing the definition of the data payload in advance before receiving the self-describing data packet 4100. The processor 244 can interpret the data payload by parsing the incoming self-describing packet 4100 as it is received and identifying the data payload without being notified in advance that the self-describing packet 4100 has been received. Data is used for each data point or data string. The data payload includes the data type, data source, device ID that generated the data, data unit, time when the data was generated, and authentication that the self-describing data packet 4100 has not been altered. Once the processor 244, which may be located in the device or surgical hub 206, receives an unexpected self-describing data packet 4100 and verifies the source of the self-describing data packet 4100, the processor 244 changes the data collection device to prepare for any subsequent self-describing data packets 4100 from the source. In one example, the information contained in the self-describing packet 4100 may be combined with Figure 31-Figure 35 The lung tumor resection surgery was recorded during the first shot 4172.

[0349] The self-describing data packet 4100 includes not only the data, but also a preamble that defines what the data is and where the data comes from, as well as an encryption certificate that verifies the authenticity of each data packet 4100. Fig.29 As shown, when the self-describing data header 4102 includes FTF (firing force), the data packet 4100 may include the self-describing data header 4102 (e.g., firing force [FTF], closing force [FTC], energy amplitude, energy frequency, energy pulse width, firing speed, etc.), the device ID 4104 (e.g., 002), the axis ID 4106 (e.g., W30), the cartridge ID 4108 (e.g., ESN736), the unique timestamp 4110 (e.g., 09:35:15), the firing force value 4112 (e.g., 85), otherwise, this position in the data packet 4100 includes the closing force value, energy amplitude, energy frequency, energy pulse width, firing speed, etc. The data packet 4100 also includes a tissue thickness value 4114 (e.g., 1.1 mm) and an identification certificate of a data value 4116 (e.g., 01101010001001) that is unique to each data packet 4100. Once the self-describing data packet 4100 is received by another instrument 235, surgical hub 206, cloud 204, etc., the receiver parses the self-describing data header 4102 and based on its value knows what data type is contained in the self-describing data packet 4100. Table 1 below lists the values ​​of the self-describing data header 4102 and the corresponding data values.

[0350] Self-describing data header (4102) Data Types FTF Trigger force (N) FTC Closing force(N) EA Energy amplitude (J) EF Energy frequency (Hz) EPW Energy pulse width(S) SOF Firing speed (mm / s)

[0351] Table 1

[0352] Initially, each self-describing data packet 4100 including self-describing data is assembled by the instrument 235, device or module that generates the self-describing data packet 4100. Subsequently, the self-describing data packets 4100 including the self-describing data are sorted and encrypted to generate an encryption certificate. The encryption certificate is unique to each self-describing data packet 4100. The data is then transmitted via an encrypted wired or wireless protocol and stored on the surgical hub 206 for processing and transmission to the analysis engine of the cloud 204.

[0353] Each self-describing data packet 4100 that includes self-describing data includes a device ID 4104 that identifies the specific instrument 235 that generated the self-describing data packet 4100, a timestamp 4110 that indicates the time the data packet 4100 was generated, and when the self-describing data packet 4100 was received by the surgical hub 206. The ID of the surgical hub 206 may also be added to the self-describing data packet 4100.

[0354] Each of the self-describing data packets 4100 that include self-describing data may include a packet encapsulator that defines the start of the data packet 4100 and the end of the data packet 4100, including any identifiers necessary to predict the number and order of bits in the self-describing data packet.

[0355] The surgical hub 206 also manages redundant data sets. When the devices 235 are active and interconnected with other surgical hubs 206, multiple sets of identical data may be created and stored on the various devices 235. Thus, the surgical hub 206 manages multiple images of redundant data as well as anonymization and security of the data. The surgical hub 206 also provides temporary visualization and communication, event management, peer or distributed processing, and storage backup and protection of data.

[0356] Fig.30 4120 is a logic flow diagram depicting a method for using a control program or logic configuration that includes data packets that include self-describing data according to one aspect of the present disclosure. Figure 1-Figure 29In one aspect, the present disclosure provides a surgical hub 206 comprising a processor 244 and a memory 249 coupled to the processor 244. The memory 249 stores instructions executable by the processor 244 to perform the following operations: receiving a first data packet from a first source, receiving a second data packet from a second source, associating the first data packet with the second data packet, and generating a third data packet including a first data payload and a second data payload. The first data packet comprises a first preamble, a first data payload, a source of the first data payload, and a first encryption certificate. The first preamble defines the first data payload, and the first encryption certificate verifies the authenticity of the first data packet. The second data packet comprises a second preamble, a second data payload, a source of the second data payload, and a second encryption certificate. The second preamble defines the second data payload, and the second encryption certificate verifies the authenticity of the second data packet.

[0357] On the other hand, the memory 249 stores instructions executable by the processor 244 to perform the following operations: determine that the data payload is from a new source, verify the new source of the data payload, and change the data collection process at the surgical hub to receive subsequent data packets from the new source.

[0358] In another aspect, the memory 249 stores instructions executable by the processor 244 to associate the first data packet with the second data packet based on the key. In another aspect, the memory 249 stores instructions executable by the processor 244 to anonymize the data payload of the third data packet. In another aspect, the memory 244 stores instructions executable by the processor 244 to receive the anonymized third data packet and reintegrate the anonymized third data packet into the first data packet and the second data packet using the key.

[0359] Fig.31 4130 is a logic flow diagram depicting a method for using a control program or logic configuration that includes data packets that include self-describing data according to one aspect of the present disclosure. Fig.31 Also see Figure 1-Figure 11To illustrate interaction with an environment of an interactive surgical system 100 including a surgical hub 106, 206, in one aspect, the present disclosure provides a surgical hub 206 including a processor 244 and a memory 249 coupled to the processor 244. The memory 249 stores instructions executable by the processor 244 to receive 4132 a first self-describing data packet from a first data source, the first self-describing data packet including a first preamble, a first data payload, a source of the first data payload, and a first encryption certificate. The first preamble defines the first data payload, and the first encryption certificate verifies the authenticity of the first data packet. The memory 249 stores instructions executable by the processor 244 to parse 4134 the received first preamble and interpret 4136 the first data payload based on the first preamble.

[0360] In various aspects, the memory 249 stores instructions that can be executed by the processor 244 to receive a second self-describing data packet from a second data source, the second self-describing data packet including a second preamble, a second data payload, a source of the second data payload, and a second encryption certificate. The second preamble defines the second data payload, and the second encryption certificate verifies the authenticity of the second data packet. The memory 249 stores instructions that can be executed by the processor 244 to perform the following operations: parsing the received second preamble, interpreting the second data payload based on the second preamble, associating the first self-describing data packet with the second self-describing data packet, and generating a third self-describing data packet including the first data payload and the second data payload. In one aspect, the memory stores instructions that can be executed by the processor to anonymize the data payload of the third self-describing data packet.

[0361] In various aspects, the memory stores instructions executable by the processor to determine that the data payload was generated by a new data source, verify the new data source of the data payload, and change the data collection process at the surgical hub to receive subsequent data packets from the new data source. In one aspect, the memory stores instructions executable by the processor to associate a first self-describing data packet with a second self-describing data packet based on a key. In another aspect, the memory stores instructions executable by the processor to receive an anonymized third self-describing data packet, and reintegrate the anonymized third self-describing data packet back into the first self-describing data packet and the second self-describing data packet using the key.

[0362] Data is stored as paired datasets that can be grouped by surgery but not necessarily keyed to the actual surgery. Surgery date and surgeon

[0363] In one aspect, the present disclosure provides a data pairing method that allows a surgical hub to interconnect device measurement parameters with surgical effects. The data pair includes all relevant surgical data or patient qualifiers without any patient identifier data. The data pair is generated at two separate and different times. The present disclosure also provides for configuring and storing data in a manner that enables reconstruction of a series of time-series events or only a series of connected but unconstrained data sets. The present disclosure also provides for storing data in encrypted form and having predefined backups and mirroring to the cloud.

[0364] In order to determine the success or failure of a surgical procedure, the data stored in the surgical instrument should be associated with the effectiveness of the surgical procedure while anonymizing the data to protect the privacy of the patient. One solution is to pair the data associated with the surgical procedure recorded by the surgical instrument during the surgical procedure with the data estimating the efficacy of the surgery. The data is paired without identifiers associated with the procedure, patient, or time to maintain anonymity. The paired data is generated at two separate and different times.

[0365] In one aspect, the present disclosure provides a surgical hub configured to communicate with a surgical instrument. The surgical hub includes a processor and a memory connected to the processor. The memory stores instructions that can be executed by the processor to perform the following operations: receiving a first data set associated with a surgical procedure, receiving a second data set associated with the efficacy of the surgical procedure, anonymizing the first data set and the second data set by removing information identifying a patient, a procedure, or a scheduled time of the procedure, and storing the first anonymized data set and the second anonymized data set to generate data pairs grouped by procedure. The first data set is generated at a first time, the second data set is generated at a second time, and the second time is separate and different from the first time.

[0366] In another aspect, the memory stores instructions executable by the processor to reconstruct a series of time-series events based on the data pairs. In another aspect, the memory stores instructions executable by the processor to reconstruct a series of connected but unconstrained data sets based on the data pairs. In another aspect, the memory stores instructions executable by the processor to: encrypt the data pairs, define a backup format for the data pairs, and mirror the data pairs to a cloud storage device.

[0367] In various aspects, the present disclosure provides a control circuit for receiving and processing a data set as described above. In various aspects, the present disclosure provides a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to receive and process a data set as described above.

[0368] The storage of paired anonymized data enables a hospital or surgeon to use the data pairs locally to link them to a specific surgery or to store the data pairs to analyze overall trends without extracting specific events in a chronological manner.

[0369] In one aspect, the surgical hub provides user-defined data storage and configuration. The storage of data can be done in paired data sets that can be grouped by surgery but not necessarily keyed to the actual surgery date and surgeon. This technology provides anonymity of data about patients and surgeons.

[0370] In one aspect, the present disclosure provides a data pairing method. The data pairing method includes enabling a surgical hub to interconnect device measurement parameters with effects, wherein the data pair includes all relevant tissue or patient qualifiers without any identifiers, wherein the data pair is generated at two different and separate times. On the other hand, the present disclosure provides a data configuration, which includes whether the data is stored in a manner that enables reconstruction of a series of time-series events or only a series of connected but unconstrained data sets. On the other hand, the data can be stored in encrypted form. The stored data may include predefined backups and mirrors to the cloud.

[0371] Data can be encrypted locally to the device. Data backup can be automatic for the integrated load auxiliary storage device. The device and / or surgical hub can be configured to maintain the storage time of the data, and compile the data and transmit it to another location (e.g., another surgical hub or cloud storage device) for storage. The data can be grouped together and keyed for transmission to a cloud analysis location. Cloud-based analysis systems are described in co-owned U.S. provisional patent application serial number 62 / 611,340 entitled CLOUD-BASEDMEDICAL ANALYTICS, filed on December 28, 2017, which is incorporated herein by reference in its entirety.

[0372] In another aspect, the hub provides user selectable options for storing data. In one technique, the hub enables the hospital or surgeon to select whether the data should be stored in a manner such that the data can be used locally in the surgical hub to link to a specific surgery. In another technique, the surgical hub enables the data to be stored as data pairs so that overall trends can be analyzed without extracting specific events in a chronological manner.

[0373] Fig.32Figure 4150 is a diagram of a tumor 4152 embedded in the right upper posterior lobe 4154 of a right lung 4156 according to one aspect of the present disclosure. To remove the tumor 4152, the surgeon cuts around the tumor 4152 along a perimeter generally referred to as a margin 4158. A fissure 4160 separates the upper lobe 4162 and the middle lobe 4164 of the right lung 4156. To cut out the tumor 4152 around the margin 4158, the surgeon must cut the bronchial vessels 4166 leading to and from the middle lobe 4164 and the upper lobe 4162 of the right lung 4156. The bronchial vessels 4166 must be sealed and cut using a device such as a surgical stapler, an electrosurgical instrument, an ultrasonic instrument, a combination electrosurgical / ultrasonic instrument, and / or a combination stapler / electrosurgical device, generally represented herein as an instrument / device 235 coupled to the surgical hub 206. The device 235 is configured to be able to record data as described above, which is formed into data packets, encrypted, stored and / or transmitted to the remote data storage device 105 and processed by the server 113 in the cloud 104 . Fig.37 and Fig.38 A diagram showing the right lung 4156 and the bronchial tree 4250 embedded within the soft tissue of the lung.

[0374] In one aspect, the data packets may be combined Figure 29-Figure 31The self-describing data 4100 described above will be in the form of a packet. The self-describing data packet 4100 will contain information recorded by the device 235 during the procedure. Such information may include, for example, a self-describing data header 4102 based on specific variables (e.g., firing force [FTF], closing force [FTC], energy amplitude, energy frequency, energy pulse width, firing speed, etc.). The device ID 4104 (e.g., 002) of the instrument / device 235 used in the procedure includes components of the instrument / device 235, such as the shaft ID 4106 (e.g., W30) and the cartridge ID 4108 (e.g., ESN736). When the self-describing data header 4102 includes FTF (firing force), the self-describing packet 4100 also records a unique timestamp 4110 (e.g., 09:35:15) and process variables such as the firing force value 4112 (e.g., 85), otherwise, this position in the data packet 4100 includes the closing force (FTC) value, energy amplitude, energy frequency, energy pulse width, firing speed, etc., for example, as shown in Table 1. The data packet 4100 may also include a tissue thickness value 4114 (e.g., 1.1 mm), which in this example refers to the thickness of the bronchial vessel 4166 exposed in the cleft 4160 that is sealed and cut. Finally, each self-describing packet 4100 includes an identification certificate of data value 4116 (e.g., 01101010001001) that uniquely identifies each data packet 4100 that is transmitted by the device / instrument 235 to the surgical hub 206, further transmitted from the surgical hub 206 to the cloud 204 and stored on a storage device 205 connected to the server 213 and / or further transmitted to the robot hub 222 and stored.

[0375] The data transmitted via the self-describing data packets 4100 is sampled by the instrument device 235 at a predetermined sampling rate. Each sample is formed into a self-describing data packet 4100, which is transmitted to the surgical hub 206 and ultimately transmitted from the surgical hub 206 to the cloud 204. The samples may be stored locally in the instrument device 235 before being grouped, or may be transmitted on the fly. The predetermined sampling rate and transmission rate are determined by the communication traffic in the surgical hub 206 and may be dynamically adjusted to accommodate current bandwidth limitations. Thus, in one aspect, the instrument device 235 may record all samples taken during surgery, and at the end of the surgery, group each sample into a self-describing packet 4100 and transmit the self-describing packet 4100 to the surgical hub 206. In another aspect, the sampled data may be grouped when recorded and transmitted to the surgical hub 206 on the fly.

[0376] Fig.33FIG. 4170 is a diagram of a lung tumor resection surgical procedure according to one aspect of the present disclosure, the lung tumor resection surgical procedure including four separate firings of the surgical stapler device 235 to seal and cut the exposed openings to and from the cleft 4160. Fig.32 The bronchial vessels 4166 of the upper lobe 4162 and lower lobe 4164 of the right lung 4156 are shown. The surgical stapler device 235 is identified by the device ID "002". The data from each firing of the surgical stapler device 235 is recorded and formed as follows Fig.30 Data packet 4100 is shown including self-describing data. Fig.30 The self-describing data packet 4100 shown represents the first firing of device "002" having a cartridge serial number ESN736, for example. In the following description, see also Figure 12-Figure 19 In order to describe various architectures of instruments / devices 235, these instruments / devices include a processor or control circuit coupled to a memory for recording (e.g., saving or storing) data collected during a surgical procedure.

[0377] The first shot 4172 was recorded at an anonymous time of 09:35:15. The first shot 4172 sealed and severed the first bronchial vessel 4166 leading to and from the middle lobe 4164 and the upper lobe 4162 of the right lung 4156 into a first portion 4166a and a second portion 4166b, wherein each portion 4166a, 4166b is sealed by a respective first suture 4180a and a second suture 4180b. Information associated with the first shot 4172 (e.g., in conjunction with Fig.30 The information) is recorded in the memory of the surgical stapler device 235 and is used to construct the combined Figure 29-Figure 31 The first self-describing data packet 4100 is described. The first self-describing data packet 4100 may be transmitted when the first firing 4172 is completed, or may remain stored in the memory of the surgical stapler device 235 until the surgical procedure is completed. Once transmitted by the surgical stapler device 235, the first self-describing data packet 4100 is received by the surgical hub 206. The first self-describing data packet 4100 is anonymized by stripping and time stamping 4038 the data, such as in combination with Fig.23 After the lung resection surgery is completed, for example Fig.34 The sealing integrity of the first suture 4182a and the second suture 4182b are evaluated as shown, and the evaluation results are paired with the information associated with the first firing 4172.

[0378] The second shot 4174 seals and severs the second bronchial vessel 4166 leading to and from the middle lobe 4164 and the upper lobe 4162 of the right lung 4156 into a first portion 4166c and a second portion 4166d, wherein each portion 4166c, 4166d is sealed by a first suture 4180c and a second suture 4180d. Information associated with the second shot 4174 (e.g., in conjunction with Figure 29-Figure 31 The information) is recorded in the memory of the surgical stapler device 235 and is used to construct the combined Figure 29-Figure 31 The second self-describing data packet 4100 described above can be transmitted when the second firing 4174 is completed, or can remain stored in the memory of the surgical stapler device 235 until the surgical procedure is completed. Once transmitted by the surgical stapler device 235, the second self-describing data packet 4100 is received by the surgical hub 206. The second self-describing data packet 4100 is anonymized by stripping and time stamping 4038 the data, such as in combination with Fig.23 After the lung resection surgery is completed, for example Fig.34 The sealing integrity of the first suture 4182c and the second suture 4182d are evaluated as shown, and the evaluation results are paired with information associated with the second firing 4174.

[0379] The third shot 4176 was recorded at an anonymous time of 09:42:12. The third shot 4176 seals and severs the outer portions of the upper lobe 4162 and the middle lobe 4164 of the right lung 4156. The first suture 4182a and the second suture 4182b are used to seal the outer portions of the upper lobe 4162 and the middle lobe 4164. Information associated with the third shot 4176 (e.g., in conjunction with Figure 29-Figure 31 The information) is recorded in the memory of the surgical stapler device 235 and is used to construct the combined Figure 29-Figure 31 The third self-describing data packet 4100 is described. The third self-describing data packet 4100 may be transmitted when the third firing 4176 is completed, or may remain stored in the memory of the surgical stapler device 235 until the surgical procedure is completed. Once transmitted by the surgical stapler device 235, the third self-describing data packet 4100 is received by the surgical hub 206. The third self-describing data packet 4100 is anonymized by stripping and time stamping 4038 the data, such as in conjunction with Fig.23 After the lung resection surgery is completed, for example Fig.34 The sealing integrity of the first suture 4180a and the second suture 4180b are evaluated as shown, and the evaluation results are paired with the information associated with the third firing 4172.

[0380] The fourth shot 4178 seals and cuts the inner portion of the upper lobe 4162 and the middle lobe 4164 of the right lung 4156. The first suture 4182c and the second suture 4182d are used to seal the inner portion of the upper lobe 4162 and the middle lobe 4164. Information associated with the fourth shot 4178 (e.g., in combination with Fig.30 The information) is recorded in the memory of the surgical stapler device 235 and is used to construct the combined Figure 29-Figure 31 The fourth self-describing data packet 4100 is described. The fourth self-describing data packet 4100 may be transmitted when the fourth firing 4178 is completed, or may remain stored in the memory of the surgical stapler device 235 until the surgical procedure is completed. Once transmitted by the surgical stapler device 235, the fourth self-describing data packet 4100 is received by the surgical hub 206. The fourth self-describing data packet 4100 is anonymized by stripping and time stamping the data 4038, such as in conjunction with Fig.23 After the lung resection surgery is completed, for example Fig.34 The sealing integrity of the first suture 4182a and the second suture 4182b are evaluated as shown, and the evaluation results are paired with the information associated with the fourth firing 4172.

[0381] Fig.34 According to one aspect of the present disclosure, Fig.33 A graphical illustration 4190 of the closing force (FTC) versus time curve 4192 and the firing force (FTF) versus time curve 4194 for the first firing 4172 of the device 002 is shown. The surgical stapler device 235 is identified as 002, which has a 30 mm staple cartridge S / N ESN736 and a PVS shaft S / N M3615N (shaft ID W30). For the first firing 4172, the surgical stapler device 235 is used to complete Fig.33 Lung resection surgery as shown. Fig.34 As shown, at the anonymous time 09:35:15, a peak firing force of 85 N was recorded. The algorithm in the surgical stapler device 235 determined that the tissue thickness was approximately 1.1 mm. As described below, the FTC versus time curve 4192 and the FTF versus time curve 4194 characterizing the first firing 4172 of the surgical device 235 identified as ID 002 will be paired with the effect of the lung resection surgery, transmitted to the surgical hub 206, anonymized and stored in the surgical hub 206 or transmitted to the cloud 204 for aggregation, further processing, analysis, etc.

[0382] Fig.35Figure 4200 of suture visualization laser Doppler for evaluating suture seal integrity by monitoring bleeding of a vessel after firing of a surgical stapler is shown according to one aspect of the present disclosure. The above-described laser Doppler technology is described in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled "Advanced Imaging Acquisition Modulation," filed on December 28, 2017, and entitled INTERACTIVE SURGICAL PLATFORM, which is hereby incorporated herein by reference in its entirety. Laser Doppler provides an image 4202 suitable for inspecting the seal along sutures 4180a, 4180b, 4182a and for visualizing bleeding 4206 of any defective seal. Laser Doppler inspection of the first firing 4172 of the device 002 shows that the seal at the first suture 4180a of the first portion 4166a of the bronchial vessel sealed during the first firing 4172 is defective. Suture 4180a seals bleeding 4206 at a volume of 0.5cc. Image 4202 was recorded at an anonymous time 09:55:15 4204 and compared to Fig.34 The closure force curve 4192 and the firing force curve 4194 are shown paired. The data pair sets are grouped by surgery and stored locally in the storage device 248 of the surgical hub 206 and / or remotely stored to the storage device 205 of the cloud 204 for, for example, aggregation, processing, and analysis. For example, the analysis engine of the cloud 204 associates the information associated with the first firing 4172 contained in the first self-describing group 4100 and indicates that a defective seal was created at the suture line 4166a. Over time, this information can be aggregated, analyzed, and used to improve the effectiveness of surgical procedures such as, for example, lung tumor resection.

[0383] Fig.36 Two paired datasets 4210 grouped by surgery according to one aspect of the present disclosure are shown. The upper paired dataset 4212 is grouped by one surgery, and the lower paired dataset 4214 is grouped by another surgery. For example, the upper paired dataset 4212 is grouped by combining Figure 33-Figure 36 The lung tumor resection procedures discussed were grouped into groups. Fig.36 The remainder of the description will be found in Figure 32-Figure 35 as well as Figure 1-Figure 21The information is presented to illustrate interaction with the environment of the interactive surgical system 100 including the surgical hubs 106, 206. The lower paired data set 4214 is grouped by liver tumor resection surgery, in which the surgeon treats soft tissue. The upper paired data set is associated with failed suture seals, and the lower paired data set is associated with successful suture seals. The upper paired data set 4212 and the lower paired data set 4214 are sampled by the instrument device 235, and each sample is formed into a self-describing data packet 4100, which is transmitted to the surgical hub 206 and ultimately transmitted from the surgical hub 206 to the cloud 204. The samples may be stored locally in the instrument device 235 before grouping, or may be transmitted on the fly. The sampling rate and the transmission rate are determined by the communication traffic in the surgical hub 206 and may be dynamically adjusted to accommodate current bandwidth limitations.

[0384] The upper paired dataset 4212 includes a left dataset 4216 recorded by the instrument / device 235 during the first firing 4172, which is linked 4224 to a right dataset 4218 recorded when evaluating the suture seal 4180a of the first bronchial vessel 4166a. The left dataset 4216 indicates a "vascular" tissue type 4236 having a thickness 4238 of 1.1 mm. Also included in the left dataset 4216 are the closing force curve 4192 and the firing force curve 4194 (anonymous real-time) recorded over time during the first firing 4172 of the lung tumor resection surgery. The left dataset 4216 shows a peak at 85 Lbs. and a peak at 4240 t in the anonymous real-time. 1a (09:35:15) recorded firing force. Right data set 4218 depicts suture visualization curve 4228, which depicts leakage versus time. Right data set 4218 indicates that "vascular" tissue type 4244 with a thickness 4246 of 1.1 mm experienced suture 4180a seal failure 4242. Suture visualization curve 4228 depicts leakage volume (CC) versus time for suture 4180a seal. Suture visualization curve 4228 shows leakage volume recorded at anonymous time 4248 (09:55:15) reaching 0.5cc, indicating a failed suture 4180a seal of bronchial vessel 4166a.

[0385] The lower paired data set 4214 includes a left data set 4220 recorded by the instrument / device 235 during firing, which is linked 4226 to a right data set 4222 recorded when evaluating the suture seal of soft tissue. The left data set 4220 indicates a "parenchymal" tissue type 4236 with a thickness 4238 of 2.1 mm. Also included in the left data set 4220 are a closing force curve 4230 and a firing force curve 4232 (anonymous real-time) recorded over time during the first firing of a liver tumor resection surgery. The left data set 4220 shows a peak at 100 Lbs. and a peak at 4240t in anonymous real-time. 1b (09:42:12) recorded firing force. Right data set 4222 depicts suture visualization curve 4228, which depicts leakage versus time. Right data set 4234 indicates that "parenchymal" tissue type 4244 with a thickness 4246 of 2.2 mm experienced a successful suture seal. Suture visualization curve 4234 depicts leakage volume (CC) versus time for suture seal. Suture visualization curve 4234 shows a leakage volume of 0.0 cc, indicating a successful suture seal of soft tissue, recorded at anonymous time 4248 (10:02:12).

[0386] Paired date sets 4212, 4214 grouped by surgery are collected for many surgeries, and the data contained in the paired date sets 4212, 4214 are recorded and stored anonymously in the storage device 205 of the cloud 204 to protect patient privacy, such as in combination with Figure 22-Figure 29 In one aspect, the paired date sets 4212, 4214 data are combined as shown. Fig.31 and Fig.32 The self-describing data packet 4100 and the combination Figure 32-Figure 36 The form of the surgical example described is transmitted from the instrument / device 235 or other module connected to the surgical hub 206 to the surgical hub 206 and the cloud 204. The data of the paired date sets 4212, 4214 stored in the storage device 205 of the cloud 204 is analyzed in the cloud 204 to provide feedback to the instrument / device 235 or other module connected to the surgical hub 206, thereby notifying the surgical robot or surgeon connected to the robotic hub 222 of the conditions identified by the left data set that ultimately led to a successful or failed seal. As combined Fig.36 As shown, the upper left dataset 4216 resulted in a failed seal, while the lower left dataset 4220 resulted in a successful seal. This is advantageous because the information provided in paired datasets grouped by surgery can be used to improve the creation of resections, transections, and anastomoses in a variety of tissue types. This information can be used to avoid defects that may lead to failed seals.

[0387] Fig.37 is a diagram of the right lung 4156, and Fig.38 FIG. 4 is a diagram of a bronchial tree 4250 including a trachea 4252 and bronchi 4254, 4256 of the lungs. Fig.37 As shown, the right lung 4156 is composed of three lobes divided into an upper lobe 4162, a middle lobe 4160 and a lower lobe 4165, which are separated by an oblique fissure 4167 and a horizontal fissure 4160. Due to the position of the heart, the left lung is composed of only two smaller lobes. Fig.38 As shown, inside each lung, the right bronchus 4254 and the left bronchus 4256 divide into many smaller airways called bronchi 4258, thereby greatly increasing the surface area. Each bronchus 4258 terminates in an air sac called an alveolus 4260, in which gas exchange with the bloodstream occurs.

[0388] Fig.39 4300 is a logic flow diagram depicting a method of a control program or logic configuration for storing paired anonymized data sets grouped by surgery according to one aspect of the present disclosure. Figure 1-Figure 39 In one aspect, the present disclosure provides a surgical hub 206 configured to communicate with a surgical instrument 235. The surgical hub 206 includes a processor 244 and a memory 249 coupled to the processor 244. The memory 249 stores instructions executable by the processor 244 to perform the following operations: receiving 4302 a first data set from a first source, the first data set associated with a surgical procedure; receiving 4304 a second data set from a second source, the second data set associated with the efficacy of the surgical procedure; anonymizing 4306 the first data set and the second data set by removing information identifying a patient, a procedure, or a predetermined time of the procedure; and storing 4308 the first anonymized data set and the second anonymized data set to generate a data pair grouped by procedure. The first data set is generated at a first time, the second data set is generated at a second time, and the second time is separate and different from the first time.

[0389] In another aspect, the memory 249 stores instructions executable by the processor 244 to reconstruct a series of time-series events based on the data pairs. In another aspect, the memory 249 stores instructions executable by the processor 244 to reconstruct a series of connected but unconstrained data sets based on the data pairs. In another aspect, the memory 249 stores instructions executable by the processor 244 to encrypt the data pairs, define a backup format for the data pairs, and mirror the data pairs to the storage device 205 of the cloud 204.

[0390] Determination of data transmitted to cloud-based medical analytics

[0391] In one aspect, the present disclosure provides a communication hub and storage device for storing parameters and states of a surgical device with the ability to determine when, how often, the transmission rate and type of data to be shared with a cloud-based analysis system. The present disclosure also provides techniques for determining where the analysis system transmits new operating parameters for the hub and surgical device.

[0392] In a surgical hub environment, large amounts of data can be generated quite quickly and can cause storage and communication bottlenecks in the surgical hub network. One solution may include local determination of when and what data to transfer to a cloud-based medical analysis system for further processing and manipulation of the surgical hub data. The timing and rate of exporting surgical hub data may be determined based on available local data storage capacity. User-defined inclusion or exclusion of specific users, patients, or surgeries enables data sets to be included for analysis or automatically deleted. The time to upload or transfer to a cloud-based medical analysis system may be determined based on detected surgical hub network downtime or available capacity.

[0393] See also Figure 1-Figure 39 In one aspect, the present disclosure provides a surgical hub 206 that includes a storage device 248, a processor 244 coupled to the storage device 248, and a memory 249 coupled to the processor 244. The memory 249 stores instructions executable by the processor 244 to receive data from surgical instruments 235, determine a rate at which data is transmitted to a cloud-based telemedicine analysis network 204 based on available storage capacity of the storage device 248, determine a frequency at which data is transmitted to the cloud-based telemedicine analysis network 204 based on available storage capacity of the storage device 248 or detected downtime of the surgical hub network 206, and determine the type of data to transmit to the cloud-based telemedicine analysis network 204 based on whether data associated with a user, a patient, or a surgical procedure is included or not included.

[0394] On the other hand, the memory 249 stores instructions executable by the processor 244 to receive new operating parameters for the surgical hub 206 or the surgical instrument 235.

[0395] In various aspects, the present disclosure provides a control circuit for determining the rate, frequency, and type of data transmitted to a cloud-based telemedicine analysis network as described above. In various aspects, the present disclosure provides a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to determine the rate, frequency, and type of data transmitted to a cloud-based telemedicine analysis network.

[0396] In one aspect, the surgical hub 206 is configured to be able to determine what data to transmit to the cloud-based analysis system 204. For example, the surgical hub 206 modular device 235 including local processing capabilities can determine the rate, frequency, and type of data transmitted to the cloud-based analysis system 204 for analysis and processing.

[0397] In one aspect, the surgical hub 206 includes a modular communication hub 203 and a storage device 248 for storing parameters and states of a device 235 having the ability to determine when and how often data may be shared with the cloud-based analysis system 204, the transfer rate and type of data that may be shared with the cloud-based analysis system 204. In another aspect, the cloud analysis system 204 transmits new operating parameters for the surgical hub 206 and the surgical devices 235 coupled to the surgical hub 206. The cloud-based analysis system 204 is described in commonly owned U.S. Provisional Patent Application Serial No. 62 / 611,340, filed on December 28, 2017 and entitled CLOUD-BASED MEDICALANALYTICS, which is incorporated herein by reference in its entirety.

[0398] In one aspect, the device 235 coupled to the local surgical hub 206 determines when and what data to transmit to the cloud analytics system 204 for corporate analytics improvements. In one example, the available local data storage capacity remaining in the storage device 248 controls the timing and rate of exporting data. As another example, user-defined inclusion or exclusion of specific users, patients, or surgeries allows for data sets to be included for analysis or automatically deleted. As another example, detected network downtime or available capacity determines the time for upload or transfer.

[0399] In another aspect, the transmission of data used to diagnose failure modes is keyed by specific events. For example, a user-defined device, instrument, or tool failure during surgery initiates the archiving and transmission of data recorded about that instrument for failure mode analysis. In addition, when a failure event is identified, all data surrounding that event is archived and packaged for sending back for predictive information (PI) analysis. Data that is part of a PI failure is marked for storage and maintenance until the hospital or cloud-based analysis system releases the hold on the data.

[0400] A critical failure of an instrument may initiate the automatic archiving and submission of data for analysis. The detection of a counterfeit component or adapter on an Original Equipment Manufacturer (OEM) device may initiate the documentation of that component and the results and effects of its use.

[0401] Fig.404320 is a logic flow diagram depicting a method of a control program or logic configuration for determining the rate, frequency, and type of data transmitted to a cloud-based remote analysis network in accordance with one aspect of the present disclosure. Figure 1-Figure 40 In one aspect, the present disclosure provides a surgical hub 206 comprising a storage device 248, a processor 244 coupled to the storage device 248, and a memory 249 coupled to the processor 244. The memory 249 stores instructions executable by the processor 244 to receive 4322 data from a surgical instrument 235, determine 4324 a rate at which to transmit the data to a cloud-based telemedical analysis network 204 based on available storage capacity of the storage device 248. Optionally, the memory 249 stores instructions executable by the processor 244 to determine 4326 a frequency at which to transmit the data to the cloud-based telemedical analysis network 204 based on available storage capacity of the storage device 248. Optionally, the memory 249 stores instructions executable by the processor 244 to detect surgical hub network downtime, and determine 4326 a frequency at which to transmit the data to the cloud-based telemedical analysis network 204 based on the detected surgical hub network 206 downtime. Optionally, memory 249 stores instructions executable by processor 244 to determine 4328 the type of data to transmit to cloud-based telemedicine analysis network 204 based on the inclusion or exclusion of data associated with a user, patient, or surgical procedure.

[0402] On the other hand, the memory 249 stores instructions executable by the processor 244 to receive new operating parameters for the surgical hub 206 or the surgical instrument 235.

[0403] Situational awareness is the ability of a surgical system to determine or infer some aspects of information related to a surgical procedure based on data received from a database and / or instrument. This information may include the type of surgery being performed, the type of tissue being operated on, or the body cavity that is the subject of the surgery. Using contextual information related to the surgical procedure, the surgical system can, for example, improve the way it controls modular devices (e.g., robotic arms and / or robotic surgical tools) connected to the surgical system and provide contextualized information or suggestions to the surgeon during the course of the surgical procedure.

[0404] See now Fig.41, which shows a timeline 5200 depicting the situational awareness of a hub, such as, for example, the surgical hub 106 or 206. The timeline 5200 is an illustrative surgical procedure and background information that the surgical hub 106, 206 can derive from data received from data sources at each step in the surgical procedure. The timeline 5200 depicts typical steps that nurses, surgeons, and other medical personnel will take during a segmentectomy surgery, starting with setting up the operating room and ending with transferring the patient to a postoperative recovery room.

[0405] The situational awareness surgical hub 106, 206 receives data from data sources throughout the surgical procedure, including data generated each time medical personnel utilize a modular device paired with the surgical hub 106, 206. The surgical hub 106, 206 may receive this data from paired modular devices and other data sources, and continually derive inferences about the ongoing surgery (i.e., contextual information) as new data is received, such as which step of the surgery is being performed at any given time. The situational awareness system of the surgical hub 106, 206 is capable of, for example, recording data related to the surgery for generating a report, verifying the steps being taken by medical personnel, providing data or prompts that may be related to a particular surgical step (e.g., via a display screen), adjusting modular devices based on the context (e.g., activating a monitor, adjusting the field of view (FOV) of a medical imaging device, or changing the energy level of an ultrasonic surgical instrument or an RF electrosurgical instrument), and taking any other such actions described above.

[0406] As a first step 5202 in this exemplary operation, hospital staff retrieves the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the surgical hub 106, 206 determines that the operation to be performed is a thoracic operation.

[0407] In a second step 5204, the staff scans the incoming medical supplies for the procedure. The surgical hub 106, 206 cross-references the scanned supplies with a list of supplies used in various types of surgeries and confirms that the mix of supplies corresponds to a thoracic procedure. Additionally, the surgical hub 106, 206 can also determine that the procedure is not a wedge procedure (because the incoming supplies lack certain supplies required for a thoracic wedge procedure or otherwise do not correspond to a thoracic wedge procedure).

[0408] In a third step 5206, the medical personnel scans the patient belt via a scanner communicatively connected to the surgical hub 106, 206. The surgical hub 106, 206 may then confirm the identity of the patient based on the scanned data.

[0409] In a fourth step 5208, the medical staff turns on the auxiliary equipment. The auxiliary equipment utilized may vary depending on the type of surgical procedure and the technique to be used by the surgeon, but in this exemplary case, they include a smoke evacuator, an insufflator, and a medical imaging device. When activated, as part of its initialization process, the auxiliary equipment, which is a modular device, can be automatically paired with a surgical hub 106, 206 located in a specific vicinity of the modular device. The surgical hub 106, 206 can then derive background information about the surgical procedure by detecting the type of modular device paired with it during this preoperative phase or initialization phase. In this specific example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this specific combination of paired modular devices. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the type of modular device connected to the hub, the surgical hub 106, 206 can generally infer the specific procedure that the surgical team will perform. Once the surgical hub 106, 206 knows what specific procedure is being performed, the surgical hub 106, 206 can retrieve the steps of that procedure from memory or the cloud and then cross-reference the data it subsequently receives from connected data sources (e.g., modular devices and patient monitoring devices) to infer what steps of the surgical procedure the surgical team is performing.

[0410] In a fifth step 5210, a staff member attaches EKG electrodes and other patient monitoring devices to the patient. The EKG electrodes and other patient monitoring devices can be paired with the surgical hub 106, 206. When the surgical hub 106, 206 begins receiving data from the patient monitoring devices, the surgical hub 106, 206 thus confirms that the patient is in the operating room.

[0411] In step 5212, the medical staff induces anesthesia in the patient. The surgical hub 106, 206 may infer that the patient is under anesthesia based on data from the modular device and / or the patient monitoring device (including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof). Upon completion of step 5212, the preoperative portion of the lung segmentectomy surgery is completed and the surgical portion begins.

[0412] In a seventh step 5214, collapse the patient's lung being operated on (while ventilation is switched to the contralateral lung). For example, the surgical hub 106, 206 may infer from the ventilator data that the patient's lung has collapsed. The surgical hub 106, 206 may infer that the surgical portion of the surgery has begun because it may compare the detection of the patient's lung collapsing to the expected steps of the surgery (which may have been previously accessed or retrieved) to determine that collapsing the lung is a surgical step in this particular surgery.

[0413] In an eighth step 5216, a medical imaging device (e.g., an endoscope) is inserted and video from the medical imaging device is initiated. The surgical hub 106, 206 receives medical imaging device data (i.e., video or image data) through its connection to the medical imaging device. After receiving the medical imaging device data, the surgical hub 106, 206 can determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 can determine that the particular procedure being performed is a segmentectomy, rather than a lobectomy (note that a wedge procedure has been ruled out based on the data received by the surgical hub 106, 206 at the second step 5204 of the procedure). From the medical imaging device 124 ( Figure 2 ) can be used to determine contextual information related to the type of surgery being performed in a variety of different ways, including by determining the angle of the medical imaging device relative to the visualization orientation of the patient's anatomy, monitoring the number of medical imaging devices utilized (i.e., activated and paired with the surgical hub 106, 206), and monitoring the type of visualization device utilized. For example, one technique for performing a VATS lobectomy places a camera in the lower anterior corner of the patient's thorax above the diaphragm, while a technique for performing a VATS segmentectomy places a camera in an anterior intercostal position relative to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situational awareness system can be trained to identify the positioning of the medical imaging device based on the visualization of the patient's anatomy. As another example, a technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmentectomy utilizes multiple cameras. As another example, a technique for performing a VATS segmentectomy utilizes an infrared light source (which can be communicatively coupled to the surgical hub as part of the visualization system) to visualize a segmental fissure that is not used in a VATS pulmonary resection. By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can therefore determine the specific type of surgery being performed and / or the techniques used for a particular type of surgery.

[0414] In step 5218, the surgical team begins the dissection step of the procedure. The surgical hub 106, 206 may infer that the surgeon is dissecting to mobilize the patient's lung because it receives data from the RF generator or ultrasonic generator indicating that an energy instrument is being fired. The surgical hub 106, 206 may intersect the received data with the retrieval step of the surgical procedure to determine that the energy instrument fired at this point in the process (i.e., after the previously discussed surgical steps are completed) corresponds to the dissection step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of a robotic surgical system.

[0415] In step 10 5220, the surgical team proceeds with the ligation step of the procedure. The surgical hub 106, 206 may infer that the surgeon is ligating the artery and vein because it receives data from the surgical stapling and cutting instrument indicating that the instrument is being fired. Similar to the previous step, the surgical hub 106, 206 may derive this inference by cross-referencing the receipt of data from the surgical stapling and cutting instrument with the retrieval step in the process. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.

[0416] Eleventh step 5222, perform the segmentectomy portion of the surgery. The surgical hub 106, 206 may infer that the surgeon is transecting soft tissue based on data from the surgical stapling and cutting instrument (including data from its bin). The bin data may correspond to, for example, the size or type of staples fired by the instrument. Since different types of staples are used for different types of tissue, the bin data may indicate the type of tissue being sutured and / or transected. In this case, the type of staple fired is for soft tissue (or other similar tissue types), which allows the surgical hub 106, 206 to infer that the segmentectomy portion of the surgery is in progress.

[0417] In the twelfth step 5224, a node dissection step is performed. The surgical hub 106, 206 can infer that the surgical team is dissecting the node and performing a leak test based on data received from the generator indicating that the RF or ultrasonic instrument is being fired. For this particular operation, the RF or ultrasonic instrument used after transecting the soft tissue corresponds to a node dissection step, which allows the surgical hub 106, 206 to make such inferences. It should be noted that the surgeon regularly switches back and forth between surgical suturing / cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments according to the specific steps in the operation because different instruments are better suited for specific tasks. Therefore, a specific sequence in which the suturing / cutting instruments and surgical energy instruments are used can indicate the steps of the operation being performed by the surgeon. In addition, in some cases, a robotic tool can be used for one or more steps in the surgical operation, and / or a handheld surgical instrument can be used for one or more steps in the surgical operation. (One or more) surgeons can, for example, alternate between robotic tools and handheld surgical instruments and / or can use the device simultaneously. When the twelfth step 5224 is completed, the incision is closed and the postoperative portion of the operation begins.

[0418] Thirteenth step 5226, reverse the patient's anesthesia. For example, the surgical hub 106, 206 can infer that the patient is waking up from anesthesia based on, for example, ventilator data (ie, the patient's breathing rate begins to increase).

[0419] Finally, the fourteenth step 5228 is for the medical staff to remove the various patient monitoring devices from the patient. Thus, the surgical hub 106, 206 can infer that the patient is being transferred to a recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices. As can be seen from the description of this exemplary surgery, the surgical hub 106, 206 can determine or infer when each step of a given surgical procedure occurs based on data received from various data sources that are communicatively coupled to the surgical hub 106, 206.

[0420] Situational awareness is further described in U.S. Provisional Patent Application Serial No. 62 / 611,341, filed on December 28, 2017, entitled INTERACTIVE SURGICAL PLATFORM, which is incorporated herein by reference in its entirety. In some cases, the operation of a robotic surgical system (including various robotic surgical systems disclosed herein) may be controlled by the hub 106, 206 based on its situational awareness and / or feedback from its devices and / or based on information from the cloud 102.

[0421] In one aspect, the present disclosure provides a surgical hub, comprising: a processor; and a memory connected to the processor, the memory storing instructions that can be executed by the processor to perform the following operations: querying a surgical instrument, wherein the surgical instrument is a first source of patient data; retrieving a first data set from the surgical instrument, wherein the first data set is associated with a patient and a surgical procedure; querying a medical imaging device, wherein the medical imaging device is a second source of patient data; retrieving a second data set from the medical imaging device, wherein the second data set is associated with the patient and the effect of the surgical procedure; associating the first data set and the second data set by a key; and transmitting the associated first and second data sets to a remote network outside the surgical hub. The present disclosure also provides a surgical hub, wherein the memory stores instructions that can be executed by the processor to perform the following operations: using a key to retrieve a first data set; anonymizing the first data set by removing the association of the first data set with the patient; using a key to retrieve a second data set; anonymizing the second data set by removing the association of the second data set with the patient; pairing the anonymized first and second data sets; and determining the success rate of the surgical procedures grouped by the surgical procedure based on the anonymized paired first and second data sets. The present disclosure also provides a surgical hub, wherein a memory stores instructions executable by a processor to perform the following operations: retrieving an anonymized first data set; retrieving an anonymized second data set; and re-integrating the anonymized first data set and the second data set using a key. The present disclosure also provides a surgical hub, wherein the first data set and the second data set define a first data payload and a second data payload in corresponding first data packets and second data packets. The present disclosure also provides a control circuit and / or a non-transitory computer-readable medium for performing any of the above functions, the non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to perform any of the above functions.

[0422] In another aspect, the present disclosure provides a surgical hub, comprising: a processor; and a memory connected to the processor, the memory storing instructions executable by the processor to perform the following operations: receiving a first data packet from a first source, the first data packet including a first preamble, a first data payload, a source of the first data payload, and a first encryption certificate, wherein the first preamble defines the first data payload, and the first encryption certificate verifies the authenticity of the first data packet; receiving a second data packet from a second source, the second data packet including a second preamble, a second data payload, a source of the second data payload, and a second encryption certificate, wherein the second preamble defines the second data payload, and the second encryption certificate verifies the authenticity of the second data packet; associating the first data packet with the second data packet; and generating a third data packet including the first data payload and the second data payload. The present disclosure also provides a surgical hub, wherein the memory stores instructions executable by the processor to perform the following operations: determining that the data payload is from a new source; verifying the new source of the data payload; and changing the data collection process performed at the surgical hub to receive subsequent data packets from the new source. The present disclosure also provides a surgical hub, wherein the memory stores instructions that can be executed by a processor to associate a first data group and a second data group based on a key. The present disclosure also provides a surgical hub, wherein the memory stores instructions that can be executed by a processor to anonymize the data payload of the third data group. The present disclosure also provides a surgical hub, wherein the memory stores instructions that can be executed by a processor to perform the following operations: receiving an anonymized third data group, and reintegrating the anonymized third data group into the first data group and the second data group using the key. The present disclosure also provides a control circuit and / or a non-transitory computer-readable medium for performing any of the above functions, the non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to perform any of the above functions.

[0423] On the o...

Claims

1. A surgical hub, comprising: a memory device configured to store parameters and states of surgical instruments coupled to the surgical hub; a processor coupled to the storage device; as well as A memory coupled to the processor, the memory storing instructions executable by the processor to: receiving data from the surgical instrument coupled to the surgical hub; as well as the memory storing instructions executable by the processor to determine a rate for transmitting the data from the surgical hub to a cloud-based telemedicine analysis network based on available storage capacity of the storage device; transmitting data from the surgical hub to the remote cloud-based medical analytics network for analysis to improve surgical outcomes; identifying a malfunction event of the surgical instrument; Based on the identification of the fault event, the following operations are automatically initiated: identifying data associated with the fault event in data received from the surgical instrument; Archiving data related to the failure event; and Data related to the failure event is transmitted from the surgical hub to the cloud-based telemedicine analysis network.

2. The surgical hub according to claim 1, wherein: The memory stores instructions executable by the processor to determine a frequency of transmitting the data from the surgical hub to the cloud-based telemedical analysis network based on the available storage capacity of the storage device.

3. The surgical hub according to claim 1, wherein: The memory stores instructions executable by the processor to: Detecting surgical hub network downtime; as well as A frequency for transmitting the data from the surgical hub to the cloud-based telemedicine analysis network is determined based on detected surgical hub network downtime.

4. The surgical hub according to claim 1, wherein: The memory stores instructions executable by the processor to determine the type of data transmitted from the surgical hub to the cloud-based telemedicine analysis network based on the inclusion or exclusion of data associated with a user, patient, or surgical procedure.

5. The surgical hub of claim 1, wherein: The memory stores instructions executable by the processor to receive new operating parameters for the surgical hub from the cloud-based telemedicine analysis network.

6. The surgical hub of claim 1, wherein: The memory stores instructions executable by the processor to receive new operating parameters for the surgical instrument from the cloud-based telemedicine analysis network.

7. A method of transmitting data from a surgical hub to a cloud-based telemedical analysis network, the surgical hub comprising a storage device, a processor coupled to the storage device, and a memory coupled to the processor, the storage device being configured to store parameters and states of surgical instruments coupled to the surgical hub, the memory storing instructions executable by the processor, the method comprising: receiving, by a processor, data from the surgical instrument coupled to the surgical hub; as well as determining, by the processor, a rate at which the data is transmitted from the surgical hub to the cloud-based telemedical analysis network based on available storage capacity of a storage device coupled to the surgical hub; transmitting data from the surgical hub to the remote cloud-based medical analytics network for analysis to improve surgical outcomes; identifying a malfunction event of the surgical instrument; Based on the identification of the fault event, the following operations are automatically initiated: identifying data associated with the fault event in data received from the surgical instrument; Archiving data related to the failure event; and Data related to the failure event is transmitted from the surgical hub to the cloud-based telemedicine analysis network.

8. The method of claim 7, comprising determining, by the processor, a frequency of transmitting the data from the surgical hub to the cloud-based telemedicine analysis network based on the available storage capacity of the storage device.

9. The method according to claim 7, comprising: detecting, by the processor, surgical hub network downtime; as well as The processor determines, based on detected surgical hub network downtime, a frequency for transmitting the data from the surgical hub to the cloud-based telemedicine analysis network.

10. The method of claim 7, comprising determining, by the processor, the type of data transmitted from the surgical hub to the cloud-based telemedicine analysis network based on whether data associated with a user, patient, or surgical procedure is included or not included.

11. The method of claim 7, comprising receiving, by the processor, new operating parameters for the surgical hub from the cloud-based telemedicine analysis network.

12. The method of claim 7, comprising receiving, by the processor, new operating parameters for the surgical instrument from the cloud-based telemedicine analysis network.

13. A non-transitory computer readable medium storing computer readable instructions that, when executed by a processor of a surgical hub, cause the surgical hub to: receiving data from a surgical instrument coupled to the surgical hub; as well as causing the surgical hub to determine a rate at which the data is transmitted from the surgical hub to a cloud-based telemedicine analysis network based on available storage capacity of a storage device included in the surgical hub, wherein the storage device is configured to store parameters and states of surgical instruments coupled to the surgical hub; transmitting data from the surgical hub to the remote cloud-based medical analytics network for analysis to improve surgical outcomes; identifying a malfunction event of the surgical instrument; Based on the identification of the fault event, the following operations are automatically initiated: identifying data associated with the fault event in data received from the surgical instrument; Archiving data related to the failure event; and Data related to the failure event is transmitted from the surgical hub to the cloud-based telemedicine analysis network.

14. The non-transitory computer-readable medium of claim 13, storing computer-readable instructions that, when executed, cause a machine to: determine a frequency for transmitting the data from the surgical hub to the cloud-based telemedicine analysis network based on the available storage capacity of the storage device.

15. The non-transitory computer readable medium of claim 13, storing computer readable instructions that when executed cause the surgical hub to: Detecting surgical hub network downtime; and A frequency for transmitting the data from the surgical hub to the cloud-based telemedicine analysis network is determined based on detected surgical hub network downtime.

16. A non-transitory computer-readable medium according to claim 13, storing computer-readable instructions, which when executed cause the surgical hub to: determine the type of data transmitted from the surgical hub to the cloud-based telemedicine analysis network based on whether data associated with a user, patient, or surgical procedure is included or not.

17. The non-transitory computer-readable medium of claim 13, storing computer-readable instructions that, when executed, cause the surgical hub to: receive new operating parameters for the surgical hub from the cloud-based telemedicine analysis network.

18. The non-transitory computer-readable medium of claim 13, storing computer-readable instructions that, when executed, cause the surgical hub to: receive new operating parameters for the surgical instrument from the cloud-based telemedicine analysis network.

Images