Communication function of smart stapler

Abstract

To provide a surgical instrument capable of performing communication through a surgical hub.SOLUTION: A surgical instrument includes a transmitter, a receiver, and a processor. When the surgical instrument is operated in a first operation mode, the processor can transmit information on the surgical instrument to a surgical hub, but cannot receive information from the surgical hub with the receiver. A second operation mode can be added to the surgical instrument, and when the second operation mode is added, the processor can transmit the information on the surgical instrument to the surgical hub, and can receive the information from the surgical hub. Furthermore, the processor can transmit the information on the surgical instrument to a remote server that can communicate with the surgical hub through the transmitter and the surgical hub. Still furthermore, the information from the remote server can be received with the receiver through the surgical hub.SELECTED DRAWING: Figure 23

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is related to a concurrently filed application entitled "METHOD FOR OPERATING TIERED OPERATION MODES IN A SURGICAL SYSTEM" bearing attorney docket number END9287USNP1, the contents of which are incorporated herein by reference. [Background technology]

[0002] Surgical systems often incorporate imaging systems that can enable a clinician to view the surgical site and / or one or more portions thereof on one or more displays, such as, for example, a monitor. The displays may be local to the surgical site and / or remote. The imaging system may include a scope with a camera that views the surgical site and transmits the view to a display viewable by the clinician. Scopes include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, esophagogastroduodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngological-nephroscopes, sigmoidoscopes, thoracoscopes, ureteroscopes, and exoscopes. Imaging systems may be limited by the information they can recognize and / or convey to the clinician. For example, certain hidden structures, physical contours, and / or dimensions in three-dimensional space may not be recognizable during surgery with a particular imaging system. Additionally, certain imaging systems may not be able to communicate and / or convey certain information to the clinician during surgery. Summary of the Invention [Means for solving the problem]

[0003] In accordance with various embodiments of the present invention, the following examples are provided. Example 1. A surgical instrument comprising: a sensor configured to provide a sensor signal according to a physiological parameter of tissue; a transmitter; and a processor, wherein the processor is configured to: determine, based on an instrument operating mode, whether to acquire a sensed parameter associated with the sensor signal from the sensor; determine, based on the instrument operating mode, whether to receive instrument usage instructions; and, based on at least one of the determinations, communicate with a surgical hub via the transmitter.

[0004] A surgical instrument according to Example 1 may selectively operate under one of several different instrument operating modes or hierarchies. The instrument operating modes may permit or restrict various instrument capabilities. The instrument capabilities that vary with the operating mode may include, for example, sensor, communication, display, data storage, data access, data aggregation, data analysis, feedback, recommendations, etc. Modes may vary with respect to communication capabilities, such as record keeping, data access and recall, data analysis, surgical recommendations, etc. Exemplary operating modes or hierarchies are described in connection with FIGS. 22-24 . The instrument operating mode may be determined by the surgical instrument according to instrument operating mode control parameters, which may refer to system parameters indicative of compatibility, such as connectivity, bandwidth, interference, conductivity, or the surgical facility's subscription level and authenticity. For example, a medical facility may require selected instrument capabilities to perform a particular procedure, which may be grouped into one or more instrument operating modes. According to Example 1, the surgical instrument determines whether to acquire sensed data from one or more sensors associated with the surgical instrument and whether to receive instrument use instructions from a surgical hub or a remote server based on an operational mode. For example, a surgical instrument (e.g., a surgical stapler) according to Example 1 may selectively receive recommended instrument use information (e.g., stapler cartridge selection) from the surgical hub that is generated based on aggregated instrument use history data (e.g., cartridge use data associated with a surgical procedure step).

[0005] As an example, a smart surgical instrument equipped with a control system has the ability to restrict or allow different communication modes, such as one-way communication, two-way communication, and interactive communication with a local hub or remote server. The smart control system enables the implementation of tiered communication control according to instrument capabilities, system capacities such as intra-device and inter-device connectivity and bandwidth, or other control parameters such as parameters provided by an external server. This provides control over selective data collection at the surgical instrument, selective data and information exchange between the surgical instrument and the surgical hub or remote server, and selective provision of data and instruction information to the user, for example, through a display associated with the surgical instrument. Thus, the user can be selectively provided with data and information, such as recommended instrument usage information, that is most appropriate for the instrument's operating mode. This can contribute to improved instrument operational safety and performance, the outcome and quality of surgical activities, and patient safety.

[0006] Example 2. The surgical instrument of example 1, wherein the processor is further configured to acquire and transmit the sensed parameter to the surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameter.

[0007] Example 2 relates to an instrument operating mode in which one-way or two-way communication with a surgical hub is supported. A surgical instrument according to Example 2 is capable of acquiring and transmitting sensed parameters to the surgical hub, where the information may be stored, processed, and / or aggregated for use in connection with an ongoing or future procedure.

[0008] Example 3. The surgical instrument of any one of Examples 1 or 2, further comprising a receiver. The processor is further configured to receive instrument use instructions from the surgical hub via the receiver based on a determination that the instrument operating mode supports receiving instrument use instructions, and to transmit the instrument use instructions to the display.

[0009] Example 3 relates to an instrument operating mode in which bidirectional communication with the surgical hub for receiving instrument usage instructions is supported. Under this operating mode, the surgical instrument receives instrument usage instructions from the hub and displays the instructions, which can be used by the user to further improve the operation of the instrument and the outcome of the surgical activity.

[0010] Example 4. The surgical instrument of Examples 1 or 2, further comprising a receiver and an end effector for removably storing the surgical staple cartridge. The processor is further configured to receive cartridge information from the end effector, determine whether to combine the cartridge information with instrument usage parameters based on an instrument operating mode, the instrument usage parameters including at least one of clamp-to-fire time or a user-controlled firing characterization, and, based on the combining decision, transmit the instrument usage parameters along with the cartridge information to a surgical hub via the transmitter. The surgical stapling instrument according to Example 4 can control communication with the end effector to receive the cartridge information and interactively combine the cartridge information with instrument actuator or configuration data to provide a broader understanding of complete instrument status. The surgical instrument can further control communication with the surgical hub to selectively transmit combined instrument static and usage data to the surgical hub, where the combined data can be stored, processed, and / or aggregated to determine tissue or functional data from system interaction with the surgical site.

[0011] Example 5. The surgical instrument of any one of Examples 1-4, wherein the processor is further configured to determine an instrument operation mode based on an instrument operation control parameter. The instrument operation control parameter includes at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode indication received from the hub, or a tiered communication mode indication received from a remote server. Example 5 relates to determining an instrument operation mode. Thus, the surgical instrument is capable of determining an instrument operation mode according to the control parameter related to the system status or capacity and / or the tiered communication mode indication, and controlling communication with the end effector and the surgical hub in a manner as described in one of the above examples.

[0012] Example 6. The surgical instrument of any one of Examples 1-5, further comprising a receiver and an end effector for removably storing a surgical staple cartridge. The processor is further configured to obtain staple cartridge information and instrument status information from the end effector and transmit the cartridge information and instrument status information to a surgical hub. The surgical instrument of Example 6 is directed to a surgical stapler having an end effector for removably receiving a staple cartridge and capable of controlling communication with the end effector and communication with the surgical hub to selectively obtain and forward cartridge information and instrument status information to the surgical hub, where the combined data may be stored, processed, and / or aggregated.

[0013] Example 7. The surgical instrument of any one of Examples 1-6, wherein the processor is further configured to determine whether to receive recommended instrument usage information generated based on aggregated instrument usage history data based on an instrument operating mode. The instrument usage information includes stapler cartridge selection. The surgical instrument according to Example 7 is capable of controlling communication with an external device / system to selectively receive recommended instrument usage information that can be displayed or otherwise provided to a user. This allows for modification of the procedure over time.

[0014] Example 8. The surgical instrument of any one of Examples 1-7, wherein the processor is further configured to determine, based on an instrument operating mode, whether to receive a stapler cartridge selection recommendation generated based on aggregated cartridge usage data associated with a procedure. The surgical instrument according to Example 8 is capable of controlling communication with an external device / system to selectively receive a stapler cartridge selection recommendation generated based on the aggregated cartridge usage data. The recommendation may be displayed or otherwise provided to a user for selecting an appropriate cartridge for performing the surgical procedure, thereby further improving the outcome of the surgical procedure and / or patient safety.

[0015] Example 9. A remote server comprising: an input / output interface configured to access data from a plurality of medical hub communication devices, one or each of which is communicatively coupled to at least one surgical instrument; and a processor, the processor configured to: receive instrument usage information associated with a medical procedure performed by a surgeon; aggregate the received instrument usage information with instrument usage history information associated with the surgeon; and transmit the aggregated instrument usage information.

[0016] Example 10. The remote server of Example 9, wherein the processor is further configured to correlate the received instrument usage information with the outcome of the medical procedure and / or the instrument operation status during the medical procedure, and transmit the correlated information.

[0017] Example 11. A remote server as described in Example 9 or 10, wherein the processor is further configured to determine recommended instrument usage information associated with an upcoming medical procedure based on the correlated information, and to transmit the recommended instrument usage information.

[0018] As in Examples 9-11, a remote server can receive information from one or more surgical instruments, aggregate and / or correlate the information, or generate instrument usage recommendations, and transmit the aggregated or correlated information or recommendations to the surgical instruments, which can be displayed or otherwise provided to the surgeon. This remote server can communicate with the surgical instruments and surgical hub as described in the above examples to provide useful information generated by cloud-based analysis.

[0019] Example 12. The method may include providing a sensor signal from a sensor according to a physiological parameter of the tissue; determining whether to acquire a sensed parameter associated with the sensor signal from the sensor based on an instrument operation mode; determining whether to receive an instrument use instruction based on the instrument operation mode; and communicating with a surgical hub via a transmitter based on at least one of the determinations.

[0020] Example 13. The method of example 12, wherein the method further includes acquiring and transmitting the sensed parameters to the surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameters.

[0021] Example 14. The method described in Example 12 or 13, wherein the method further includes receiving instrument use instructions from the surgical hub via the receiver based on a determination that the instrument operating mode supports receiving instrument use instructions, and transmitting the instrument use instructions to the display.

[0022] Example 15. The method of any one of Examples 12 to 14, wherein the method further comprises: receiving cartridge information from an end effector for removably storing a surgical staple cartridge; determining whether to combine the cartridge information with instrument usage parameters based on an instrument operating mode, the instrument usage parameters including at least one of clamp-to-fire time or a characterization of user-controlled firing; and, based on the decision to combine, transmitting the instrument usage parameters together with the cartridge information to a surgical hub via a transmitter.

[0023] Example 16. The method of any one of Examples 12-15, wherein the method further includes determining the appliance operating mode based on an appliance operating control parameter. The appliance operating control parameter includes at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode indication received from the hub, or a tiered communication mode indication received from a remote server.

[0024] Example 17. The method described in any one of Examples 12 to 16, wherein the method further includes acquiring staple cartridge information and instrument status information from an end effector for removably storing a surgical staple cartridge, and transmitting the cartridge information and instrument status information to a surgical hub.

[0025] Example 18. The method of any one of Examples 12-17, wherein the method further includes determining whether to receive recommended instrument usage information generated based on the aggregated instrument usage history data based on an instrument operating mode. The instrument usage information includes stapler cartridge selection.

[0026] Example 19. The method of any one of Examples 12-18, wherein the method further includes determining, based on an instrument operating mode, whether to receive stapler cartridge selection recommendations generated based on aggregated cartridge usage data associated with the procedure.

[0027] Example 20. A method comprising receiving instrument usage information associated with a medical procedure performed by a surgeon, aggregating the received instrument usage information with instrument usage history information associated with the surgeon, and transmitting the aggregated instrument usage information.

[0028] Example 21. The method of Example 20, further comprising correlating the received instrument usage information with the outcome of the medical procedure and / or the instrument operation status during the medical procedure, and transmitting the correlated information.

[0029] Example 22. The method described in Example 20 or 21, further comprising determining recommended instrument use information associated with an upcoming medical procedure based on the correlated information, and transmitting the recommended instrument use information.

[0030] Example 23. A computer-readable medium may store program instructions that, when executed by a processor, may include: providing a sensor signal from a sensor according to a physiological parameter of the tissue; determining, based on an instrument operating mode, whether to acquire a sensed parameter associated with the sensor signal from the sensor; determining, based on the instrument operating mode, whether to receive an instrument use instruction; and, based on at least one of the determinations, communicating with the surgical hub via the transmitter.

[0031] Example 24. The computer-readable medium of Example 23, further storing program instructions that, when executed by a processor, perform a method further including acquiring and transmitting sensed parameters to a surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameters.

[0032] Example 25. A computer-readable medium as described in Example 23 or 24, further storing program instructions that, when executed by a processor, perform a method further including, for example, receiving instrument use instructions from a surgical hub via a receiver and transmitting the instrument use instructions to a display based on a determination that the instrument operating mode supports receiving instrument use instructions.

[0033] Example 26. A computer-readable medium described in any one of Examples 23 to 25, further storing program instructions that, when executed by a processor, perform a method including receiving cartridge information from an end effector for removably storing a surgical staple cartridge, determining whether to combine the cartridge information with instrument usage parameters based on an instrument operating mode, the instrument usage parameters including at least one of clamp-to-fire time or a characterization of user-controlled firing, and, based on the decision to combine, transmitting the instrument usage parameters along with the cartridge information to a surgical hub via a transmitter.

[0034] Example 27. The computer-readable medium of any one of Examples 23-26, further storing program instructions that, when executed by a processor, perform a method further including determining an appliance operating mode based on, for example, appliance operating control parameters, wherein the appliance operating control parameters include at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode indication received from a hub, or a tiered communication mode indication received from a remote server.

[0035] Example 28. A computer-readable medium described in any one of Examples 23 to 27, further storing program instructions that, when executed by a processor, perform a method further including obtaining staple cartridge information and instrument status information from an end effector for removably storing a surgical staple cartridge, and transmitting the cartridge information and instrument status information to a surgical hub.

[0036] Example 29. The computer-readable medium of any one of Examples 23-28, further storing program instructions that, when executed by a processor, perform a method further comprising determining, based on an instrument operating mode, whether to receive recommended instrument usage information generated based on aggregated instrument usage history data. The instrument usage information includes stapler cartridge selection.

[0037] Example 30. The computer-readable medium of any one of Examples 23-29 may further store program instructions that, when executed by a processor, perform a method further including determining, based on an instrument operating mode, whether to receive stapler cartridge selection recommendations generated based on aggregated cartridge usage data associated with a procedure step.

[0038] Example 31. A computer-readable medium storing program instructions that, when executed by a processor, perform a method including receiving instrument usage information associated with a medical procedure performed by a surgeon, aggregating the received instrument usage information with instrument usage history information associated with the surgeon, and transmitting the aggregated instrument usage information.

[0039] Example 32. A computer-readable medium as described in Example 31, further storing program instructions that, when executed by a processor, perform a method further including correlating the received instrument usage information with the outcome of the medical procedure and / or the instrument operation status during the medical procedure, and transmitting the correlated information.

[0040] Example 33. A computer-readable medium as described in Example 31 or 32, further storing program instructions that, when executed by a processor, perform a method further including: determining recommended instrument usage information associated with an upcoming medical procedure based on the correlated information; and transmitting the recommended instrument usage information.

[0041] The methods according to Examples 12 to 19 and the computer-readable medium described in Examples 23 to 30 correspond to the devices of Examples 1 to 8. Therefore, the above description regarding Examples 1 to 8 also applies to Examples 12 to 19 and 23 to 30. Similarly, the methods according to Examples 20 to 22 and the computer-readable medium described in Examples 31 to 33 correspond to the devices of Examples 9 to 11. Therefore, the above description regarding Examples 9 to 11 also applies to Examples 20 to 22 and 31 to 33.

[0042] According to further embodiments of the present invention, a surgical instrument, such as a surgical stapler, may have multiple operational modes that may provide different combinations of communication, interaction, support, and / or other capabilities. The instrument operational mode may be selected from multiple operational modes that may be preconfigured, dynamically updated, semi-dynamically updated, periodically updated, or preset. Multi-modal instrument operation may control the availability, access, level of use, level of interaction, and / or support of one or more capabilities available through the instrument. The instrument operational mode may variously permit or restrict instrument capabilities. Instrument capabilities authorized by the operational mode may be variously unlocked, configured, or downloaded and installed. Surgical instrument-resident features not authorized by the operational mode may be unavailable, locked, or otherwise blocked. Instrument capabilities that change with the operational mode may include, for example, sensors, communications, displays, data storage, data access, data aggregation, data analysis, feedback, recommendations, etc. In some implementations, a multi-modal surgical instrument may be fully operable in multiple operational modes. Modes may vary with respect to communication capabilities such as record keeping, data access and recall, data analysis, surgical recommendations, and the like.

[0043] The instrument may be configured to determine the instrument operation mode based on one or more instrument operation control parameters, such as one or more of the following: system capabilities (e.g., hardware capabilities, firmware capabilities, and / or software capabilities), system capacity parameters (e.g., wired and / or wireless connection capabilities), system status parameters (e.g., bandwidth, interference, conductivity, current load level), system authorization parameters (e.g., compatibility, authorization (purchase or subscription) mode of instrument operation, parameters indicative of instrument authenticity) and / or external control parameters (e.g., provided by a surgical hub or remote / cloud server), such as system capabilities (e.g., hardware capabilities, firmware capabilities, and / or software capabilities), system capacity parameters (e.g., wired and / or wireless connection capabilities), system status parameters (e.g., bandwidth, interference, conductivity, current load level), software version, revision or update level, subscription level, interconnectivity with external / external systems, area of use, user input, or (e.g., secure) communication with an external database system.

[0044] The instrument operation mode control parameters may include consumer control parameters such as subscription level, for example, a medical facility may purchase subscriptions for selected instrument capabilities, which may be grouped into one or more modes of instrument operation.

[0045] For example, the surgical instrument may determine whether to acquire a sensed parameter associated with a sensor signal from a sensor based on the surgical instrument operating mode. The surgical instrument may determine whether to receive an instrument use instruction based on the surgical instrument operating mode. The surgical instrument may communicate with the surgical hub based on the determination.

[0046] For example, the surgical instrument may determine, based on the instrument operating mode, whether to receive recommended instrument usage information (e.g., stapler cartridge selection) generated based on aggregated instrument usage history data. The surgical instrument may determine, based on the instrument operating mode, whether to receive stapler cartridge selection recommendations generated based on aggregated cartridge usage data associated with the surgical procedure. The surgical instrument may communicate with the surgical hub based on the determination.

[0047] For example, the remote server may receive instrument usage information associated with a medical procedure performed by a surgeon based on a surgical instrument operation mode, aggregate the received instrument usage information with historical instrument usage information associated with the surgeon, and transmit the aggregated instruction usage information to the surgical instrument (e.g., directly or via a surgical hub). The remote server may correlate the received instrument usage information with the outcome of the medical procedure and the instrument operation status during the medical procedure based on a surgical instrument operation mode, and transmit the correlated information to the surgical instrument (e.g., directly or via a surgical hub). The remote server may determine recommended instrument usage information associated with an upcoming medical procedure based on the correlated information based on a surgical instrument operation mode, and transmit the recommended instrument usage information to the surgical instrument (e.g., directly or via a surgical hub).

[0048] In an exemplary surgical instrument mode of operation, the surgical instrument may engage in unidirectional communication during operation (e.g., following initialization, which may support limited bidirectional communication) by transmitting information (e.g., surgical procedure information such as staple cartridge type and / or ID, errors, instrument status, etc.) to the surgical hub, which may transmit the received information to a remote server (e.g., a remote processing server and / or a remote database in the cloud).

[0049] In an exemplary surgical instrument mode of operation, the surgical instrument may engage in two-way communication by sending information to and receiving information from the surgical hub, which may transmit the received information to a remote server (e.g., a remote processing server and / or a remote database in the cloud). The surgical instrument may receive information (e.g., surgical procedure recommendations) based on the information (e.g., surgical procedure, sensed parameters, instrument usage information) transmitted to the surgical hub and / or remote server. The surgical hub and / or remote server may analyze historical information and render recommendations (e.g., force fire, wait time, display information on one or more displays).

[0050] In an exemplary surgical instrument operating mode, the surgical instrument may engage in bidirectional communication by transmitting information to and receiving information from the surgical hub. The surgical hub may transmit the received information to a remote server (e.g., a remote processing server and / or a remote database in the cloud). The surgical instrument may receive information (e.g., surgical procedure recommendations) based on the information transmitted to the surgical hub and / or remote server (e.g., surgical procedure, sensed parameters, instrument usage information), and the surgical hub and / or remote server may analyze the historical information and render recommendations (e.g., force fire, wait time, display information on one or more displays). The surgical instrument may determine, based on the surgical instrument operating mode, whether to transmit various surgical information to the surgical hub and / or remote server for archiving, subsequent retrieval, data aggregation, analysis, and / or recommendations. Archived surgical information may be aggregated with historical information by a particular user (e.g., surgeon), information received from other surgical hubs, and / or surgical information associated with other medical facilities. The aggregated information may be accessed to generate instruction information for one or more surgical instruments. In one example, the aggregated information may include information received from the smart surgical device, information associated with multiple procedures, surgical information, and corresponding results associated with multiple patients. The aggregated information may be stored in a remote database. In one example, the surgical information may be aggregated at a remote server. The surgical instrument may determine whether to receive historical data, aggregated data, recommendations based on the aggregated historical data, etc. based on, for example, a surgical instrument operating mode. [Brief explanation of the drawings]

[0051] [Figure 1] FIG. 1 is a block diagram of a computer-implemented interactive surgical system. [Figure 2] 1 illustrates an exemplary surgical system being used to perform a surgical procedure in an operating room. [Figure 3]1 is an exemplary surgical hub paired with a visualization system, a robotic system, and an intelligent instrument, according to at least one aspect of the present disclosure. [Figure 4] 1 illustrates a surgical data network comprising a communication hub configured to connect modular devices located at one or more surgical sites in a medical facility, or any room within a medical facility equipped with specialized equipment for surgical procedures, to a cloud, in accordance with at least one embodiment of the present disclosure. [Figure 5] 1 illustrates a computer-implemented interactive surgical system. [Figure 6] 1 illustrates an exemplary surgical hub comprising multiple modules coupled to a modular control tower. [Figure 7] 1 illustrates an exemplary surgical instrument or tool. [Figure 8] 1 illustrates an exemplary surgical instrument or tool with multiple motors that can be activated to perform various functions. [Figure 9] 1 is a diagram of an exemplary situation-aware surgical system. [Figure 10] 1 illustrates an exemplary surgical procedure and an exemplary timeline of estimates that a surgical hub can generate from data detected at each step in the surgical procedure. [Figure 11] FIG. 1 is a block diagram of a computer-implemented interactive surgical system. [Figure 12] 1 illustrates the functional architecture of an exemplary computer-implemented interactive surgical system. [Figure 13] 1 illustrates an exemplary computer-implemented interactive surgical system configured to adaptively generate control program updates for modular devices. [Figure 14] 1 illustrates an exemplary surgical system including a handle having a controller and a motor, an adapter releasably coupled to the handle, and a loading unit releasably coupled to the adapter. [Figure 15A]10 illustrates an exemplary flow for determining an operating mode and operating in the determined mode. [Figure 15B] 10 illustrates an exemplary flow for changing the operating mode. [Figure 16] FIG. 1 is a perspective view of a powered surgical stapling system. [Figure 17] FIG. 17 is a perspective view of an interchangeable surgical shaft assembly of the powered surgical stapling system of FIG. 16; [Figure 18] FIG. 17 is an exploded view of a portion of the handle assembly of the powered surgical stapling system of FIG. 16; [Figure 19] FIG. 18 is an exploded view of the interchangeable surgical shaft assembly of FIG. 17. [Figure 20] FIG. 20 is another partial exploded view of a portion of the interchangeable surgical shaft assembly of FIG. 19. [Figure 21] FIG. 12 is a perspective view of another powered surgical stapling system; [Figure 22] 1 illustrates an exemplary surgical instrument mode of operation. [Figure 23] 1 illustrates an exemplary surgical instrument mode of operation. [Figure 24] 1 illustrates an exemplary surgical instrument mode of operation. [Figure 25] FIG. 1 illustrates an exemplary analysis system for updating a surgical tool control program, in accordance with at least one aspect of the present disclosure. [Figure 26] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 27] 10 illustrates an exemplary flow for operating according to a surgical tool operating mode. DETAILED DESCRIPTION OF THE INVENTION

[0052] The applicant of the present application owns the following US patent applications, each of which is incorporated herein by reference in its entirety: U.S. Patent Application No. 15 / 940,656, filed March 29, 2018, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES" (now U.S. Patent Application Publication No. 2019 / 0201141); U.S. Patent Application No. 16 / 361,793, filed March 22, 2019, entitled "SURGICAL INSTRUMENT COMPRISING AN ADAPTIVE CONTROL SYSTEM" (now U.S. Patent Application Publication No. 2019 / 0314015); U.S. Patent Application No. 13 / 803,086 (now U.S. Patent Application Publication No. 2014 / 0263541), entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK"; U.S. Patent Application No. 13 / 800,067, filed March 13, 2013, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" (now U.S. Patent Application Publication No. 2014 / 0263552); U.S. Patent Application No. 16 / 024,075, filed June 29, 2018, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING" (now U.S. Patent Application Publication No. 2019 / 0201146); U.S. Patent Application No. 16 / 182,246, filed November 6, 2018, entitled "ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES" (now U.S. Patent Application Publication No. 2019 / 0204201); U.S. Patent Application No. 15 / 940,679, filed March 29, 2018, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET" (now U.S. Publication No. 2019 / 0201144); U.S. Patent Application No. 15 / 940668, filed March 29, 2018, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA" (now U.S. Patent Application Publication No. 2019 / 0201115); · U.S. Patent Application No. 16 / 209,416 (now U.S. Patent Application Publication No. 2019 / 0206562).

[0053] 1 , a computer-implemented interactive surgical system 100 may include 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 may include at least one surgical hub 106 in communication with the cloud 104, which may include the remote server 113. In one example, as shown in FIG. 1 , a 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 embodiments, a surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P are integers greater than or equal to 1.

[0054] In various aspects, visualization system 108 may include one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in FIG. 2. In one aspect, visualization system 108 may include interfaces for HL7, PACS, and EMR. Various components of visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019 / 0200844(A1), filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety.

[0055] As shown in FIG. 2 , primary display 119 is positioned in the sterile field so as to be visible to the operator at operating table 114. In addition, visualization tower 111 is positioned outside the sterile field. Visualization tower 111 may include a first non-sterile display 107 and a second non-sterile display 109 facing opposite each other. Visualization system 108, guided by hub 106, is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, hub 106 can cause visualization system 108 to display snapshots of the surgical site captured by imaging device 124 on non-sterile display 107 or 109 while maintaining a live video of the surgical site on primary display 119. The snapshots on non-sterile display 107 or 109 can, for example, enable a non-sterile operator to perform diagnostic steps related to the surgical procedure.

[0056] In one aspect, the hub 106 may also be configured to send diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to a primary display 119 in the sterile field for viewing by a sterile operator at the operating table. In one example, the input may be in the form of a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be sent by the hub 106 to the primary display 119.

[0057] 2, a surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 can also be configured to coordinate information flow to the display of the surgical instrument 112. See, for example, U.S. Patent Application Publication No. 2019 / 0200844(A1), filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), 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 sent by the hub 106 to the surgical instrument display 115 in the sterile field, where it can be viewed by the operator of the surgical instrument 112. Exemplary surgical instruments suitable for use with surgical system 102 are described, for example, under the heading "Surgical Instrument Hardware" and in U.S. Patent Application No. 2019 / 0200844(A1) filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), the entire disclosure of which is incorporated herein by reference.

[0058] FIG. 2 shows an example of a surgical system 102 being used to perform a surgical procedure on a patient lying on an operating table 114 in an operating room 116. A robotic system 110 may be used as part of the surgical system 102 in the surgical procedure. The robotic system 110 may include a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 through a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. Images of the surgical site are acquired by 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 and then display the images of the surgical site to the surgeon through the surgeon's console 118.

[0059] Other types of robotic systems can be readily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Patent Application Publication No. 2019 / 0201137(A1), filed December 4, 2018, entitled "METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL" (U.S. Patent Application No. 16 / 209,407), the entire disclosure of which is incorporated herein by reference in its entirety.

[0060] Various examples of cloud-based analytics methods performed by the cloud 104 and suitable for use with the present disclosure are described in U.S. Patent Application No. 2019 / 0206569(A1), filed December 4, 2018, entitled "METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB" (U.S. Patent Application No. 16 / 209,403), the entire disclosure of which is incorporated herein by reference.

[0061] In various aspects, the imaging device 124 may include at least one image sensor and one or more optical components. Suitable image sensors may include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.

[0062] The optical components of the 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 a portion 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.

[0063] The one or more illumination sources may be configured to emit electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or luminous spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and is sometimes referred to as visible light or simply light. The typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.

[0064] The invisible spectrum (e.g., non-radiative spectrum) is the portion of the electromagnetic spectrum located below and above the visible spectrum (i.e., wavelengths less than about 380 nm and greater than 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, which constitutes invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, which constitutes invisible ultraviolet, X-ray, and gamma-ray electromagnetic radiation.

[0065] In various aspects, imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngological-nephroscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

[0066] Imaging devices may employ multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths, including frequencies beyond the visible light range, e.g., IR and UV light. Spectral imaging can extract additional information that cannot be captured by the red, green, and blue receptors of the human eye. The use of multispectral imaging is described in more detail under the heading "Advanced Imaging Acquisition Module." U.S. Patent Application Publication No. 2019 / 0200844(A1), filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring can be a useful tool for repositioning the surgical field after the surgical task is complete to perform one or more of the above-mentioned tests on the treated tissue. It is self-evident that strict sterilization of the operating room and surgical equipment is necessary in any surgical procedure. The strict hygiene and sterilization conditions required in the "surgical field," i.e., the operating room or procedure room, require the highest possible sterility of all medical device equipment and instruments. Part of the above sterilization process includes the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It is understood that the sterile field can be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field can be considered the area immediately surrounding the patient prepared for the surgical procedure. The sterile field can include cleaned team members wearing appropriate clothing, as well as all equipment and fixtures within the area.

[0067] Referring now to FIG. 3 , a hub 106 is shown in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communications module 130, a processor module 132, a storage array 134, and an operating room mapping module 133. In certain embodiments, as shown in FIG. 3 , the hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128. During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly associated with smoke evacuation, the aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular enclosure 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines. An embodiment of the present disclosure presents a surgical hub for use in a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub enclosure and a combination generator module slidably receivable within the hub enclosure's docking station. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one embodiment, the combination generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.In one embodiment, the fluid line is a first fluid line, and a second fluid line extends from a remote surgical site to an aspiration and irrigation module slidably received within the hub enclosure. In one embodiment, the hub enclosure includes a fluid interface. Certain surgical procedures may require the application of two or more energy types to tissue. One energy type may be more beneficial for cutting tissue, while another, different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. An embodiment of the present disclosure presents a solution in which the hub's modular enclosure 136 is configured to house and facilitate interactive communication between various generators. One advantage of the hub's modular enclosure 136 is that it allows for rapid removal and / or replacement of various modules. An embodiment of the present disclosure presents a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. The modular surgical enclosure includes a first energy generator module configured to generate a first energy for application to tissue and a first docking station including a first docking port 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 the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts. In addition to the above, the modular surgical enclosure also includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data and second power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts and the second energy generator module is slidably movable out of electrical engagement with the second power and second data contacts.In addition, the modular surgical enclosure also includes a communication bus between the first and second docking ports configured to facilitate communication between the first and second energy generator modules. Referring to FIG. 3 , an aspect of the present disclosure is presented regarding a hub modular enclosure 136 that enables modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The hub modular enclosure 136 further facilitates interactive communication between the modules 140, 126, and 128. The generator module 140 may be a generator module with integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit slidably insertable into the hub modular enclosure 136. The generator module 140 may be configured to connect to a monopolar device 142, a bipolar device 144, and an ultrasonic device 146. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the hub modular enclosure 136. The hub modular enclosure 136 may be configured to facilitate insertion of multiple generators and interactive communication between the generators docked to the hub modular enclosure 136 such that the multiple generators function as a single generator.

[0068] FIG. 4 illustrates a surgical data network 201 comprising a modular communications hub 203 configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped with specialized equipment for surgical procedures, to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communications hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communications hub 203 can also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to travel from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features that allow traffic to pass through the monitored surgical data network and configure each port within the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. A switched hub reads the destination address of each packet and then forwards the packet to the correct port.

[0069] Modular devices 1a-1n located in an operating room may be coupled to modular communication hub 203. Network hub 207 and / or network switch 209 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 may be coupled to network hub 207 and / or network router 211 to connect devices 2a-2m to cloud 204. Data associated with devices 2a-2n may be transferred to cloud 204 via network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to local computer system 210 for local data processing and manipulation.

[0070] It will be appreciated that surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. Modular communications hub 203 may be housed within a modular control tower configured to receive multiple devices 1a-1n / 2a-2m. A local computer system 210 may also be housed in the modular control tower. Modular communications hub 203 may be connected to a display 212 to display images acquired by some of devices 1a-1n / 2a-2m, for example, during a surgical procedure. In various embodiments, devices 1a-1n / 2a-2m may include various modules such as, for example, an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communications module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and / or a non-contact sensor module, among other modular devices that may be connected to a modular communications hub 203 of a surgical data network 201.

[0071] In one aspect, the surgical data network 201 may include a combination of a network hub, a network switch, and a network router that connects the devices 1a-1n / 2a-2m to the cloud. Any one or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on sharing computing resources rather than having local servers or personal devices to handle software applications. While the term "cloud" may be used as a metaphor for the "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which various services, such as servers, storage, and applications, are delivered via the Internet to a modular communications hub 203 and / or computer system 210 located in an operating room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and / or computer system 210. The cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services can perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

[0072] By applying cloud computing data processing technology to data collected by the devices 1a-1n / 2a-2m, a surgical data network can provide improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n / 2a-2m can be used to observe tissue status and evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. Using cloud-based computing, at least some of the devices 1a-1n / 2a-2m can be used to diagnostically examine data including images of body tissue samples to identify pathologies, such as the effects of disease. Such data can include tissue localization and margin confirmation, as well as phenotyping. At least some of the devices 1a-1n / 2a-2m can be used to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by devices 1a-1n / 2a-2m, including image data, may be transferred to cloud 204 or local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data may be analyzed to improve the outcome of the surgical procedure by determining whether further treatments, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics, can be performed on tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and the use of standardized techniques can provide useful feedback to either confirm or suggest modifications to surgical treatments and surgeon performance.

[0073] The operating room devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. The network hub 207, in one aspect, may be implemented as a local network broadcasting device operating on the physical layer of the Open System Interconnection (OSI) model. The network hub may provide connectivity to devices 1a-1n located within the same operating room network. The network hub 207 may collect data in the form of packets and send them to a router in half-duplex mode. The network hub 207 may not store any media access control / Internet Protocol (MAC / IP) information for forwarding any device data. Only one of the devices 1a-1n may transmit data through the network hub 207 at a time. The network hub 207 may not have a routing table or intelligence regarding where to send the information; it broadcasts all network data across each connection and to a remote server 213 (FIG. 4) on the cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose a security risk and cause bottlenecks.

[0074] The operating room devices 2a-2m may be connected to the network switch 209 via wired or wireless channels. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 may be a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 transmits data in the form of frames to the network router 211 and may function in full-duplex mode. Multiple devices 2a-2m can transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to forward data.

[0075] The network hub 207 and / or the network switch 209 may be coupled to a network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 may transmit data in the form of packets to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.

[0076] 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 can expand a single USB port into several tiers so that more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and 2a-2m located in the operating room.

[0077] In an embodiment, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard to exchange data over short distances from fixed and mobile devices (using short wavelength UHF radio waves in the ISM band of 2.4-2.485 GHz) and to create a personal area network (PAN). The operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via numerous wireless or wired communications standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, new radio (NR), long-term evolution (LTE), and any other wireless and wired protocols designated as 3G, 4G, 5G, and beyond, as well as Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives. The computing module may include multiple communications modules. For example, a first communications module may be dedicated to shorter-range wireless communications, such as Wi-Fi and Bluetooth, and a second communications module may be dedicated to longer-range wireless communications, such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.

[0078] The modular communications hub 203 may act as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and may handle data types known as frames. The frames may carry data generated by the devices 1a-1n / 2a-2m. Once the frames are received by the modular communications hub 203, they are amplified and transmitted to the network router 211, which forwards this data to cloud computing resources using a number of wireless or wired communications standards or protocols, as described herein.

[0079] The modular communications hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communications hub 203 may generally be easy to install, configure, and maintain, making the modular communications hub 203 a good choice for networking the operating room devices 1a-1n / 2a-2m.

[0080] FIG. 5 illustrates a computer-implemented interactive surgical system 200. 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 that communicates 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 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 6, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210.

[0081] As shown in the embodiment of FIG. 5 , modular control tower 236 may be coupled to an imaging module 238 that may be coupled to an endoscope 239, a generator module 240 that may be coupled to an energy device 241, a smoke evacuation module 226, a suction / irrigation module 228, a communications module 230, a processor module 232, a storage array 234, a smart device / instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. Operating room equipment may be coupled to cloud computing resources and data storage via modular control tower 236. Robotic hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices / instruments 235, visualization system 208, among others, may be coupled to modular control tower 236 via wired or wireless communication standards or protocols as described herein. Modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from the imaging module, device / instrument display, and / or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with the images and overlaid images.

[0082] FIG. 6 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 may comprise a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for local processing, visualization, and imaging. As shown in FIG. 6, the modular communications hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communications hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 6, each of the network hubs / switches in the modular communications hub 203 may include three downstream ports and one upstream port. The upstream network hub / switch may be connected to a processor to provide communication connectivity to cloud computing resources and a local display 217. Communication to the cloud 204 may occur via either a wired or wireless communication channel.

[0083] The surgical hub 206 may use the non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the surgical field using either an ultrasonic non-contact measurement device or a laser-based non-contact measurement device. As described under the heading "Surgical Hub Spatial Awareness Within an Operating Room," the ultrasonic-based non-contact sensor module may scan the surgical field by transmitting bursts of ultrasound and receiving echoes as they bounce off the surrounding walls of the surgical field. U.S. Patent Application Publication No. 2019 / 0200844(A1), filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), is incorporated herein by reference in its entirety, and the sensor module is configured to determine the size of the surgical field and adjust Bluetooth pairing distance limits. A laser-based non-contact sensor module can, for example, scan an operating room by transmitting laser light pulses, receive laser light pulses that reflect off the exterior walls of the operating room, and compare the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust Bluetooth pairing distance limits.

[0084] The computer system 210 may include a processor 244 and a network interface 245. The processor 244 may be coupled to a communication module 247, storage 248, memory 249, 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, an Industrial Standard Architecture (ISA), a Micro-Channel Architecture (MSA), an Extended ISA (EISA), an Intelligent Drive Electronics (IDE), a VESA Local Bus (VLB), a Peripheral Component Interconnect (PCI), a USB, an Advanced Graphics Port (AGP), a Personal Computer Memory Card International Association bus (PCMCIA), a Small Computer Systems Interface (SCSI), or any other proprietary bus.

[0085] Processor 244 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. The processor core includes 256KB of on-chip memory of single-cycle flash memory or other non-volatile memory at up to 40MHz, a prefetch buffer to improve performance above 40MHz, 32KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, more details of which are available in the product datasheet.

[0086] In one aspect, the processor 244 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

[0087] System memory may include both volatile and nonvolatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random-access memory (RAM), which acts as external cache memory. RAM is available in many forms, including static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct Rambus RAM (DRRAM).

[0088] The computer system 210 may also include removable / non-removable, volatile / non-volatile computer storage media, such as, for example, disk storage. Disk storage may include, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage may include storage media separately or in combination with other storage media, including, but not limited to, optical disk drives such as compact disc ROM (CD-ROM) devices, compact disc recordable drives (CD-R drives), compact disc rewritable drives (CD-RW drives), or digital versatile disc ROM (DVD-ROM) drives. Removable or non-removable interfaces may be used to facilitate connection of the disk storage to the system bus.

[0089] It should be understood that computer system 210 may include software that acts as an intermediary between users and the basic computer resources described in a suitable operating environment. Such software may include an operating system. The operating system, which may be stored on disk storage, may function to control and allocate resources of the computer system. System applications may take advantage of resource management by the operating system through program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein may be implemented with various operating systems or combinations of operating systems.

[0090] A user may input commands or information into the computer system 210 through input devices coupled to the I / O interface 251. Input devices may include, but are not limited to, pointing devices such as a mouse, trackball, stylus, or touchpad; keyboards; microphones; joysticks; gamepads; satellite dishes; scanners; TV tuner cards; digital cameras; digital video cameras; webcams; and the like. These and other input devices connect to the processor through the system bus via interface ports. Interface ports include, for example, serial ports, parallel ports, game ports, and USB. Output devices use some of the same types of ports as input devices. Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. Output adapters may be provided to illustrate that there may be several output devices, such as monitors, displays, speakers, and printers, among other output devices that may require special adapters. Output adapters may include, by way of example and not limitation, video and sound cards that provide a means of connection between the output device and the system bus. It should be noted that other devices and / or systems of devices, such as remote computers, may provide both input and output capabilities.

[0091] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as a cloud computer. The remote cloud computer can be a personal computer, a server, a router, a network PC, a workstation, a microprocessor-based device, a peer device, or other common network node, but typically includes many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown along with the remote computer. The remote computer may be logically connected to the computer system through a network interface and then physically connected through a communications connection. The network interface may encompass communications networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies may include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, etc. WAN technologies may include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and its variants, packet-switched networks, and Digital Subscriber Lines (DSL).

[0092] In various embodiments, the computer system 210 of FIG. 6 , the imaging module 238 of FIG. 5 and FIG. 6 , and / or the visualization system 208, and / or the processor module 232 may include an image processor, an image processing engine, a media processor, or any specialized digital signal processor (DSP) used to process digital images. The image processor may employ parallel computing using single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

[0093] The communications connection may refer to the hardware / software used to connect the network interface to the bus. While the communications connection is shown internal to the computer system for clarity of illustration, the communications connection may also be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as regular telephone-grade modems, modems including cable modems and DSL modems, ISDN adapters, and Ethernet cards.

[0094] FIG. 7 shows a logic diagram of a surgical instrument or tool control system 470 according to one or more embodiments of the present disclosure. The system 470 may include control circuitry. The control circuitry may include a microcontroller 461 with a processor 462 and a memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482, driven by a motor driver 492, operably couples a longitudinally movable displacement member to drive the I-beam knife element. A tracking system 480 may be configured to determine the position of the longitudinally movable displacement member. The position information may be provided to the processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member, as well as the positions of the firing member, firing bar, and I-beam knife element. Additional motors may be provided to the tool driver interface to control I-beam firing, closure tube movement, shaft rotation, and articulation. The display 473 may display various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on the display 473 may be overlaid with images acquired via the endoscopic imaging module.

[0095] In one embodiment, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, main microcontroller 461 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and / or one or more 12-bit ADCs with 12 analog input channels, details of which are available in the product datasheet.

[0096] In one embodiment, the microcontroller 461 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

[0097] The microcontroller 461 may be programmed to perform various functions, such as precise control over the speed and position of the knife and articulation system. In one embodiment, the microcontroller 461 may include a processor 462 and memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical linkage to the articulation or knife system. In one embodiment, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be easily substituted for use in the tracking system 480 with an absolute positioning system. A detailed description of absolute positioning systems is provided in U.S. Patent Application Publication No. 2017 / 0296213, published October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety.

[0098] The microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement members and articulation system. The microcontroller 461 may be configured to calculate a response within the microcontroller 461 software. The calculated response may be compared to the measured response of the actual system to obtain an "observed" response, which may be used to determine actual feedback. The observed response may be a suitably adjusted value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.

[0099] In some examples, the motor 482 may be controlled by a motor driver 492 and may be used by the surgical instrument or tool firing system. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In some examples, 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 field-effect transistors (FETs). The motor 482 may be powered by a power supply assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery, which may include multiple battery cells connected in series, that may be used as a power source to power the surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and / or rechargeable. In at least one example, the battery cells may be a lithium-ion battery, which may be connectable to and separable from the power supply assembly.

[0100] The motor driver 492 may be the A3941 available from Allegro Microsystems, Inc. The A3941 492 may be 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 may include an intrinsic charge pump regulator, which can provide full (>10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive down to 5.5V. A bootstrap capacitor may be used to provide the required battery supply voltage for the N-channel MOSFETs. An internal charge pump for the high-side drive allows DC (100% duty cycle) operation. The full-bridge may be driven in fast or slow decay mode using diode or synchronous rectification. In slow decay mode, current recirculation is possible through either the high-side or low-side FET. The power FETs may be protected from shoot-through by a resistor-adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system.

[0101] The tracking system 480 may include a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for an absolute positioning system may provide a unique position signal corresponding to the position of the displacement member. In some examples, the displacement member may represent a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In some examples, the displacement member may represent a firing member that may be adapted and configured to include a rack of drive teeth. In some examples, the displacement member may represent a firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Thus, as used herein, the term displacement member may be used generally to refer to any movable member of a surgical instrument or tool, such as a drive member, firing member, firing bar, I-beam, or any element that can be displaced. In one aspect, a longitudinally movable drive member may be coupled to a firing member, firing bar, and I-beam. Thus, the absolute positioning system may, in effect, track the linear displacement of an I-beam by tracking the linear displacement of a longitudinally movable drive member. In various aspects, the displacement member may be coupled to any suitable position sensor 472 for measuring linear displacement. Thus, the longitudinally movable drive member, firing member, firing bar, or I-beam, or combinations 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 comprising a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical detection system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical detection system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.

[0102] The electric motor 482 may include a rotatable shaft operably interfaced with a gear assembly mounted in meshing engagement with a set of drive teeth or rack on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to several linear longitudinal translations of the displacement member. The gearing and sensor arrangement may be connected to a linear actuator by a rack and pinion arrangement or to a rotary actuator by a spur gear or other connection. A power source may provide power to the absolute positioning system, and an output indicator may display the output of the absolute positioning system. The displacement member may represent a longitudinally movable drive member including a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reducer assembly. The displacement member may represent a longitudinally movable firing member, a firing bar, an I-beam, or a combination thereof.

[0103] One revolution of the sensor element associated with position sensor 472 may correspond to a longitudinal linear displacement d1 of the displacement member, where d1 is the longitudinal linear distance traveled by the displacement member from point "a" to point "b" after one revolution of the sensor element coupled to the displacement member. The sensor mechanism may be coupled via a gear reduction that results in the position sensor 472 completing one or more revolutions relative to the full stroke of the displacement member. The position sensor 472 may complete multiple revolutions relative to the full stroke of the displacement member.

[0104] A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for two or more revolutions of the position sensor 472. The state of the switches may be fed back to the microcontroller 461, which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+...dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor mechanism may comprise a magnetic sensor, an analog rotation sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.

[0105] Position sensor 472 may comprise any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or a vector component of the magnetic field. The technologies used to produce both types of magnetic sensors may involve many aspects of physics and electronics. Technologies used to sense magnetic fields may include, among others, search coils, fluxgates, optical pumping, nuclear perturbations, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetodiodes, magnetotransistors, fiber optics, magneto-optics, and microelectromechanical systems-based magnetic sensors.

[0106] In one embodiment, the position sensor 472 of the tracking system 480 with an absolute positioning system may comprise a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide the absolute positioning system. The position sensor 472 may be a low-voltage, low-power component and includes four Hall-effect elements in an area of the position sensor 472 that may be located above the magnet. A high-resolution ADC and a smart power management controller may also be provided on-chip. A coordinate rotation digital computer (CORDIC) processor, also known as the digit-by-digit method and the Boulder algorithm, may be provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. Angular position, alarm bits, and magnetic field information may be transmitted to the microcontroller 461 via a standard serial communications interface, such as a serial peripheral interface (SPI) interface. The position sensor 472 may provide 12-bit or 14-bit resolution and may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

[0107] A tracking system 480 with an absolute positioning system may include and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply converts a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensors may be provided to measure physical parameters of the physical system. In some embodiments, other sensors may include sensor arrangements such as those described in U.S. Pat. No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is 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 has a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system may take into account properties such as mass, inertia, viscous friction, and induced drag in order to predict what the state and output of the physical system will be given knowledge of the input.

[0108] The absolute positioning system can provide the absolute position of the displacement member upon power-up of the instrument without retracting or advancing the displacement member to a reset (zero or home) position, as may be required with conventional rotary encoders that simply count the number of forward or backward steps taken by the motor 482 to estimate the position of the device actuator, drive bar, knife, etc.

[0109] A sensor 474, such as a strain gauge or micro-strain gauge, can be configured to measure one or more parameters of the end effector, such as the amplitude of strain exerted on the anvil during clamping, which can be indicative of the closure force applied to the anvil. The measured strain can be converted to a digital signal and provided to the processor 462. Instead of or in addition to the sensor 474, a sensor 476, such as a load sensor, can measure the closure force applied to the anvil by the closure drive system. For example, the sensor 476, such as a load sensor, can measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sled, which is configured to cam the staple driver upward and drive the staples into deforming contact with the anvil. The I-beam can also include a sharp cutting edge that can be used to cut tissue as the I-beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure the current drawn by the motor 482. The force required to advance the firing member may correspond, for example, to the current drawn by motor 482. The measured force may be converted to a digital signal and provided to processor 462.

[0110] In one form, a strain gauge sensor 474 can be used to measure the force applied to tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force applied by the end effector to the tissue being treated. A system for measuring the force applied to tissue grasped by the end effector can include a strain gauge sensor 474, such as a micro-strain gauge configured to measure one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the jaw members of the end effector during a clamping operation, which can be indicative of tissue compression. The measured strain can be converted to 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 tissue captured between the anvil and the staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. The magnetic field sensor measurements can also be converted to a digital signal and provided to the processor 462.

[0111] Measurements of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, measured by sensors 474, 476, respectively, can be used by microcontroller 461 to characterize a selected position of the firing member and / or a corresponding value of firing member velocity. In one example, memory 468 can store techniques, equations, and / or look-up tables that can be used by microcontroller 461 during evaluation.

[0112] The surgical instrument or tool control system 470 may also include wired or wireless communication circuitry for communicating with the modular communications hub 203 as shown in FIGS.

[0113] 8 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions. In certain examples, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain examples, the motors of the robotic surgical instrument 600 can be individually activated to produce firing, closing, and / or articulation motions in the end effector. The firing, closing, and / or articulation motions can be transmitted to the end effector via, for example, a shaft assembly.

[0114] In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transfer the firing motion generated by the motor 602 to the end effector, particularly to displace an I-beam element. In certain examples, the firing motion generated by the motor 602 may, for example, deploy staples from a staple cartridge into tissue captured by the end effector and / or advance a cutting blade of the I-beam element to cut the captured tissue. The I-beam element may be retracted by reversing the direction of the motor 602.

[0115] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605, which may be configured to transmit the closure motion generated by the motor 603 to the end effector, specifically to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closure motion may transition the end effector from an open configuration to an approximation configuration, for example, to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.

[0116] In certain examples, a surgical instrument or tool may include, for example, one or more articulation motors 606 a, 606 b. The motors 606 a, 606 b may be operatively coupled to corresponding articulation motor drive assemblies 608 a, 608 b, which may be configured to transfer articulation motion generated by the motors 606 a, 606 b to an end effector. In certain examples, the articulation motion may, for example, cause the end effector to articulate relative to the shaft.

[0117] As described herein, a surgical instrument or tool may include multiple motors that can be configured to perform various independent functions. In certain examples, multiple motors of a surgical instrument or tool can be activated individually or separately to perform one or more functions while other motors remain stopped. For example, articulation motors 606 a, 606 b can be activated to articulate the end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 can be activated to fire multiple staples and / or advance a cutting blade while articulation motor 606 remains stopped. Additionally, closure motor 603 can be activated simultaneously with firing motor 602 to distally advance a closure tube and an I-beam element, as described in more detail herein below.

[0118] In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, the common control module 610 can accommodate one of the multiple motors at a time. For example, the common control module 610 may be individually connectable and detachable to multiple motors of a robotic surgical instrument. In certain examples, the multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, the multiple motors of a surgical instrument or tool can be individually and selectively engaged with the common control module 610. In certain examples, the common control module 610 can selectively 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.

[0119] In at least one example, common control module 610 can be selectively switched between operative engagement with articulation motors 606 a, 606 b and operative engagement with either firing motor 602 or closure motor 603. In at least one embodiment, as shown in FIGURE 8, switch 614 can be moved or transitioned between multiple positions and / or states. For example, in a first position 616, switch 614 can electrically couple common control module 610 to firing motor 602, in a second position 617, switch 614 can electrically couple common control module 610 to closure motor 603, in a third position 618 a, for example, switch 614 can electrically couple common control module 610 to first articulation motor 606 a, and in a fourth position 618 b, switch 614 can electrically couple common control module 610 to second articulation motor 606 b. In certain examples, a separate common control module 610 may be electrically coupled to the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b at the same time. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.

[0120] Each of the motors 602, 603, 606a, 606b may be equipped with 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 outside the jaws or by a torque sensor on the motor that actuates the jaws.

[0121] 8, common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. Motor driver 626 may modulate power transferred from a power supply 628 to a motor coupled to common control module 610, for example, based on input from a microcontroller 620 ("controller"). In certain examples, as described above, for example, microcontroller 620 may be used to determine the current drawn by a motor while the motor is coupled to common control module 610.

[0122] In particular examples, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In particular examples, memory 624 may store various program instructions that, when executed, cause processor 622 to perform multiple functions and / or calculations described herein. In particular examples, one or more of memory units 624 may be coupled to processor 622, for example.

[0123] In certain examples, power supply 628 may be used to, for example, power microcontroller 620. In certain examples, power supply 628 may include a battery (or "battery pack" or "power pack"), such as, for example, a lithium-ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power surgical instrument 600. Multiple battery cells connected in series may be used as power supply 628. In certain examples, power supply 628 may be, for example, replaceable and / or rechargeable.

[0124] In various examples, the processor 622 can control the motor drivers 626 to control the position, direction of rotation, and / or speed of the motors coupled to the common control module 610. In certain examples, the processor 622 can signal the motor drivers 626 to stop and / or disable the motors coupled to the common control module 610. The term "processor," as used herein, should be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a computer's central processing unit (CPU) on one integrated circuit or up to a few integrated circuits. A processor may be a general-purpose programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides a result as output. This may have internal memory and thus may be an example of sequential digital logic. A processor may operate on numbers and symbols represented in the binary system.

[0125] Processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In a particular example, microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes, among other features readily available in the product datasheet, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with module 4410. Accordingly, the present disclosure should not be limited in this context.

[0126] The memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are connectable to the common control module 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b. Such program instructions may cause the processor 622 to control the firing, closing, and articulation functions according to inputs from an algorithm or control program of the surgical instrument or tool.

[0127] For example, one or more mechanisms and / or sensors, such as sensor 630, can be used to alert processor 622 to program instructions to use in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In certain examples, sensor 630 can include a position sensor that can be used to sense the position of switch 614, for example. Thus, processor 622 can use program instructions associated with firing an I-beam of the end effector when it detects, for example, via sensor 630, that switch 614 is in first position 616; processor 622 can use program instructions associated with closing an anvil when it detects, for example, that switch 614 is in second position 617 via sensor 630; and processor 622 can use program instructions associated with articulating the end effector when it detects, for example, via sensor 630, that switch 614 is in third position 618a or fourth position 618b.

[0128] 9 shows a diagram of a context-aware surgical system 5100 according to at least one embodiment of the present disclosure. In some examples, the data sources 5126 may include, for example, the modular device 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular device itself), a database 5122 (e.g., an EMR database including patient records), and patient monitoring devices 5124 (e.g., blood pressure (BP) monitors and electrocardiography (EKG) monitors). The surgical hub 5104 may be configured to derive contextual information regarding the surgical procedure from the data based, for example, on a particular combination of the received data or a particular order in which the data is received from the data sources 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the particular step of the surgical procedure the surgeon is performing, the type of tissue being operated on, or the body cavity that is the target of the procedure. This ability of some aspects of the surgical hub 5104 to derive or infer information regarding the surgical procedure from received data may be referred to as “situational awareness.” In one example, the surgical hub 5104 may incorporate a situational awareness system, which is hardware and / or programming associated with the surgical hub 5104 that derives contextual information related to the surgical procedure from received data.

[0129] The situation awareness system of the surgical hub 5104 can be configured to derive context information from data received from the data sources 5126 in a variety of different ways. In one example, the situation awareness system may include a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data to correlate various inputs (e.g., data from the database 5122, the patient monitoring devices 5124, and / or the modular devices 5102) with corresponding context information about the surgical procedure. In other words, the machine learning system can be trained to accurately derive context information about the surgical procedure from provided inputs. In an example, the situation awareness system may include a lookup table that stores pre-characterized context information about the surgical procedure in association with one or more inputs (or ranges of inputs) corresponding to the context information. In response to querying with one or more inputs, the lookup table can return corresponding context information for the situation awareness system to control the modular devices 5102. In examples, the contextual information received by the situational awareness system of the surgical hub 5104 may be associated with a particular control adjustment or set of control adjustments of one or more modular devices 5102. In examples, the situational awareness system may include a further machine learning system, lookup table, or other such system that generates or retrieves one or more control adjustments of one or more modular devices 5102 when provided with the contextual information as input.

[0130] A surgical hub 5104 incorporating a situational awareness system can provide many benefits to the surgical system 5100. One benefit can include improved interpretation of sensed and collected data, which can improve processing accuracy and / or use of the data during the course of a surgical procedure. Returning to the previous example, the situational aware surgical hub 5104 can determine what type of tissue is being operated on, and thus, if an unexpectedly high force to close the end effector of the surgical instrument is detected, the situational aware surgical hub 5104 can properly accelerate or decelerate the motor of the surgical instrument to match the tissue type.

[0131] The type of tissue being operated on can affect the adjustments made to the compression speed and load threshold of the surgical stapling and cutting instrument for a particular tissue gap measurement. The situation-aware surgical hub 5104 can infer whether the surgical procedure being performed is thoracic or abdominal surgery, which allows the surgical hub 5104 to determine whether the tissue being clamped by the end effector of the surgical stapling and cutting instrument is pulmonary (in the case of thoracic surgery) or stomach (in the case of abdominal surgery). The surgical hub 5104 can then adjust the compression speed and load threshold of the surgical stapling and cutting instrument appropriately for the tissue type.

[0132] The type of body cavity being operated on during an insufflation procedure can affect the function of the smoke evacuator. The situation-aware surgical hub 5104 can determine if the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the procedure type. Generally, since certain procedure types may be performed within specific body cavities, the surgical hub 5104 can control the smoke evacuator motor speed appropriately to match the body cavity being operated on. Thus, the situation-aware surgical hub 5104 can provide a consistent amount of smoke evacuation for both thoracic and abdominal procedures.

[0133] The type of procedure being performed can affect the optimal energy level at which an ultrasonic surgical instrument or radio frequency (RF) electrosurgical instrument operates. For example, an arthroscopic procedure may require a higher energy level because the end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is immersed in fluid. The context-aware surgical hub 5104 can determine whether the surgical procedure is an arthroscopic procedure. The surgical hub 5104 can then adjust the RF power level or ultrasonic amplitude (i.e., "energy level") of the generator to compensate for the fluid-filled environment. Relatedly, the type of tissue being operated on can affect the optimal energy level at which an ultrasonic surgical instrument or RF electrosurgical instrument operates. The context-aware surgical hub 5104 can determine what type of surgical procedure is being performed and then customize the energy level of the ultrasonic surgical instrument or RF electrosurgical instrument, respectively, according to the tissue geometry expected for the surgical procedure. Additionally, the situation-aware surgical hub 5104 can be configured to adjust the energy level of the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than simply on a procedure-by-procedure basis. The situation-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will continue to be performed, and then update the generator and / or the control algorithms of the ultrasonic surgical instrument or RF electrosurgical instrument to set the energy level to a value appropriate for the tissue type expected according to the step of the surgical procedure.

[0134] In examples, the surgical hub 5104 may also derive data from additional data sources 5126 to improve conclusions drawn from one data source 5126. The context-aware surgical hub 5104 may augment the data received from the modular device 5102 with contextual information constructed about the surgical procedure from other data sources 5126. For example, the context-aware surgical hub 5104 may be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) according to video or image data received from a medical imaging device. However, in some cases, the video or image data may be inconclusive. Thus, in one example, the surgical hub 5104 may be further configured to compare a physiological measurement (e.g., blood pressure sensed by a BP monitor communicatively connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 (FIG. 2) communicatively coupled to the surgical hub 5104) to make a determination regarding the integrity of a staple line or tissue weld. In other words, the situational awareness system of the surgical hub 5104 can take physiological measurement data into account to provide additional context when analyzing the visualization data, which can be useful when the visualization data may not be conclusive or incomplete on its own.

[0135] For example, the situation-aware surgical hub 5104 may proactively activate a generator to which an RF electrosurgical instrument is connected if it is determined that a subsequent step in a procedure requires the use of the instrument. Actively activating the energy source may allow the instrument to be ready for use as soon as a previous step in the procedure is completed.

[0136] The situation-aware surgical hub 5104 can determine whether the current or subsequent steps in the surgical procedure require different views or magnifications on the display according to the geometry of the surgical site that the surgeon is expected to need to see. The surgical hub 5104 can then proactively change the displayed views (e.g., provided by a medical imaging device for the visualization system 108) appropriately, so that the display automatically adjusts throughout the surgical procedure.

[0137] The context-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will be performed next, and whether specific data or data comparisons are required for that step of the surgical procedure. The surgical hub 5104 can be configured to automatically call up data screens based on the step of the surgical procedure being performed, without waiting for the surgeon to ask for specific information.

[0138] Errors may be checked during the setup of a surgical procedure or during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 may determine whether the surgical field is properly or optimally set up for the surgical procedure to be performed. The surgical hub 5104 may be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, product locations, or setup requirements, and then compare the current surgical field layout to a standard layout for the type of surgical procedure the surgical hub 5104 has determined is being performed. In some examples, the surgical hub 5104 may be configured to compare the list of items for the procedure and / or the list of devices paired with the surgical hub 5104 to a recommended or expected manifest of items and / or devices for a given surgical procedure. If a discontinuity exists between the lists, the surgical hub 5104 may be configured to provide an alert indicating that a particular modular device 5102, patient monitoring device 5124, and / or other surgical item is missing. In some examples, the surgical hub 5104 can be configured to determine the relative distance or relative position of the modular device 5102 and the patient monitoring device 5124, for example, by a proximity sensor. The surgical hub 5104 can compare the relative positions of the devices to a recommended or predicted layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide an alert indicating that the current layout of the surgical procedure deviates from the recommended layout.

[0139] The context-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or deviating from an expected sequence of actions during the course of a surgical procedure. For example, the surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) a corresponding list of instrumentation steps or sequences, and then compare the steps being performed or instruments being used during the course of the surgical procedure with the expected steps or instruments for the type of surgical procedure that the surgical hub 5104 has determined is being performed. In some examples, the surgical hub 5104 can be configured to provide an alert indicating that an unexpected action is being performed or an unexpected device is being utilized at a particular step in the surgical procedure.

[0140] The surgical instruments (and other modular devices 5102) may be tailored to the specific context of each surgical procedure (such as for different tissue types) and may be verified for operation during the surgical procedure. Subsequent steps, data, and display adjustments may be provided to the surgical instruments (and other modular devices 5102) within the surgical field according to the specific context of the procedure.

[0141] 10 illustrates a timeline 5200 of an exemplary surgical procedure and contextual information that the surgical hub 5104 can derive from data received from data sources 5126 at each step of the surgical procedure. The following description of the timeline 5200 shown in FIG. 9 also refers to FIG. 9. The timeline 5200 may illustrate the general steps that nurses, surgeons, and other medical personnel may take during the course of a lung segmentectomy surgery, beginning with the setup of the surgical site and concluding with the transfer of the patient to a post-operative recovery room. The context-aware surgical hub 5104 may receive data from data sources 5126 throughout the course of the surgical procedure, including data generated each time a medical personnel uses a modular device 5102 paired with the surgical hub 5104. The surgical hub 5104 receives this data from the paired modular devices 5102 and other data sources 5126 and can continually derive inferences (i.e., contextual information) regarding the ongoing procedure as new data is received, such as which step of the procedure is occurring at any given time. The situational awareness system of the surgical hub 5104 may be able to, for example, record data regarding the procedure to generate reports, verify steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be relevant to particular procedure steps, adjust the modular device 5102 based on the context (e.g., activate a monitor, adjust the FOV of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and any other such actions described herein.

[0142] As a first step 5202 in this exemplary procedure, hospital personnel may retrieve the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, the surgical hub 5104 determines that the procedure to be performed is thoracic surgery. In a second step 5204, the personnel may scan incoming medical supplies for the procedure. The surgical hub 5104 cross-references the scanned supplies with a list of supplies available for various types of procedures and verifies that the combination of supplies matches the thoracic procedure. Furthermore, the surgical hub 5104 may also be able to determine that the procedure is not a wedge resection (either because the incoming supplies do not include specific supplies needed for a thoracic wedge resection or are otherwise not compatible with a thoracic wedge resection). In a third step 5206, medical personnel may scan the patient band via a scanner 5128 communicatively connected to the surgical hub 5104. The surgical hub 5104 can then verify the patient's identity based on the scanned data. In a fourth step 5208, medical personnel turn on the auxiliary devices. The auxiliary equipment utilized may vary according to the type of surgical procedure and the techniques used by the surgeon, but in this exemplary case includes a smoke evacuator, an insufflator, and a medical imaging device. Once activated, the auxiliary device, which is a modular device 5102, may automatically pair with the surgical hub 5104, which may be located within a certain proximity of the modular device 5102, as part of its initialization process. The surgical hub 5104 may then derive contextual information regarding the surgical procedure by detecting the type of modular device 5102 paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 5104 may determine that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices 5102. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the types of modular devices 5102 connecting to the hub, the surgical hub 5104 may roughly deduce the particular procedure the surgical team will be performing.Once the surgical hub 5104 knows what particular procedure is being performed, it can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources 5126 (e.g., modular apparatus 5102 and patient monitoring devices 5124) to deduce which steps of the surgical procedure the surgical team is performing. In a fifth step 5210, personnel attach EKG electrodes and other patient monitoring devices 5124 to the patient. The EKG electrodes and other patient monitoring devices 5124 may pair with the surgical hub 5104. Once the surgical hub 5104 begins receiving data from the patient monitoring devices 5124, the surgical hub 5104 may confirm that the patient is in the operating room, for example, as described in process 5207. In a sixth step 5212, medical personnel may administer anesthesia to the patient. The surgical hub 5104 can infer that the patient is under anesthesia based on data from the modular device 5102 and / or the patient monitoring device 5124, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Upon completion of the sixth step 5212, the pre-operative portion of the lung segmentectomy surgery is complete and the surgical portion begins.

[0143] In a seventh step 5214, the lung of the patient being operated on may be collapsed (while ventilation is switched to the contralateral lung). The surgical hub 5104 may, for example, infer from ventilator data that the patient's lung has been collapsed. The surgical hub 5104 may compare the detection of the patient's collapsed lung with the expected steps of the procedure (which may be accessed or retrieved in advance) and therefore infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung may be the first surgical step in this particular procedure. In an eighth step 5216, a medical imaging device 5108 (e.g., a scope) may be inserted and video footage from the medical imaging device may be initiated. The surgical hub 5104 may receive medical imaging device data (i.e., video or image data) through a connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 5104 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 5104 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that based on the data received in the second step 5204 of the procedure, a wedge resection has not already been taken into account by the surgical hub 5104). Data from the medical imaging device 124 (FIG. 2) may be utilized to determine contextual information regarding the type of procedure being performed in a variety of ways, such as by determining the angle of the medical imaging device pointed relative to visualization of the patient's anatomy, by monitoring the number or medical imaging devices being utilized (i.e., activated and paired with the surgical hub 5104), and by monitoring the type of visualization device being utilized. For example, one technique for performing a VATS lobectomy may position the camera above the diaphragm in the anterior-inferior corner of the patient's chest cavity, while one technique for performing a VATS segmentectomy may position the camera in an intercostal position anterior to the segmental fissure. The situational awareness system can be trained to recognize the position of the medical imaging device according to a visualization of the patient's anatomy, for example, using pattern recognition or machine learning techniques.An exemplary technique for performing a VATS lobectomy may utilize a single medical imaging device. An exemplary technique for performing a VATS segmentectomy utilizes multiple cameras. An exemplary technique for performing a VATS segmentectomy utilizes an infrared light source (which may be communicatively coupled to the surgical hub as part of a visualization system) to visualize the segmental fissure, which is not utilized in a VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can determine the particular type of surgical procedure being performed and / or the technique being used for the particular type of surgical procedure.

[0144] In a ninth step 5218, the surgical team may begin the incision step of the procedure. Because the surgical hub 5104 receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired, it can infer that the surgeon is in the process of incising and separating the patient's lungs. The surgical hub 5104 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the steps of the procedure described above have been completed) corresponds to the incision step. In a tenth step 5220, the surgical team may proceed to the ligation step of the procedure. Because the surgical hub 5104 may receive data from the surgical stapling and severing instrument indicating that the instrument is being fired, it can infer that the surgeon is ligating arteries and veins. As with the previous step, the surgical hub 5104 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the steps in the retrieved process. In an eleventh step 5222, the segmentectomy portion of the procedure may be performed. The surgical hub 5104 may infer, based on data from the surgical stapling and severing instrument (including data from its cartridge), that the surgeon is transecting parenchymal tissue. The cartridge data may correspond, for example, to the size or type of staples being fired by the instrument. Because different types of staples are used on different types of tissue, the cartridge data may indicate the type of tissue being stapled and / or transected. In this case, the type of staples being fired will be used on parenchymal tissue (or other similar tissue type), thereby allowing the surgical hub 5104 to infer that the segmentectomy portion of the procedure is being performed. This is followed by a twelfth step 5224, in which a knot dissection step is performed. The surgical hub 5104 may infer, based on data received from the generator indicating that an RF or ultrasonic instrument is being fired, that the surgical team is dissecting knots and performing a leak test. In this particular procedure, the RF or ultrasonic instrument utilized after the parenchyma has been transected corresponds to the nodal dissection step, allowing the surgical hub 5104 to make this estimation.It should be noted that surgeons will routinely alternate between surgical stapling / cutting instruments and surgical energy (e.g., RF or ultrasonic) instruments depending on the particular step in the procedure, as different instruments are better suited for particular tasks. Thus, the particular sequence in which the stapling / cutting instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. Once the twelfth step 5224 is completed, the incision is closed and the post-operative portion of the procedure can begin.

[0145] In a thirteenth step 5226, the patient may be deanesthetized. The surgical hub 5104 may estimate that the patient is emerging from anesthesia, for example, based on ventilator data (i.e., the patient's breathing rate begins to increase). Finally, a fourteenth step 5228 may be a step in which medical personnel remove the various patient monitoring devices 5124 from the patient. Thus, the surgical hub 5104 may estimate that the patient is being transferred to a recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices 5124. As can be seen from the description of this exemplary procedure, the surgical hub 5104 can determine or estimate when each step of a given surgical procedure is occurring according to data received from various data sources 5126 communicatively coupled to the surgical hub 5104.

[0146] As shown in the first step 5202 of the timeline 5200 shown in FIG. 10 , in addition to utilizing patient data from the EMR database to estimate the type of surgical procedure to be performed, the patient data can also be utilized by the situation-aware surgical hub 5104 to generate control adjustments for the paired modular devices 5102.

[0147] FIG. 11 is a block diagram of a computer-implemented interactive surgical system according to at least one embodiment of the present disclosure. In one embodiment, the computer-implemented interactive surgical system may be configured to monitor and analyze data related to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and surgical sites or medical facilities. The computer-implemented interactive surgical system may include a cloud-based analysis system. While the cloud-based analysis system may be described as a surgical system, it need not necessarily be limited to such and may be a cloud-based medical system. As shown in FIG. 11 , the cloud-based analysis system may include a plurality of surgical instruments 7012 (which may be the same as or similar to instrument 112), a plurality of surgical hubs 7006 (which may be the same as or similar to hub 106), and a surgical data network 7001 (which may be the same as or similar to network 201) for coupling the surgical hubs 7006 to cloud 7004 (which may be the same as or similar to cloud 204). Each of the plurality of surgical hubs 7006 may be communicatively coupled to one or more surgical instruments 7012. The hub 7006 may also be communicatively coupled to a cloud 7004 of computer-implemented interactive surgical systems via a network 7001. The cloud 7004 may be a remote, centralized source of hardware and software for storing, manipulating, and communicating data generated based on the operation of various surgical systems. As shown in FIG. 11 , access to the cloud 7004 may be achieved via the network 7001, which may be the Internet or other suitable computer network. The surgical hub 7006, which may be coupled to the cloud 7004, may be considered the client side of a cloud computing system (i.e., a cloud-based analysis system). A surgical instrument 7012 may be paired with the surgical hub 7006 for control and performance of various surgical procedures or operations described herein.

[0148] Additionally, the surgical instrument 7012 may include a transceiver for data transmission to and from a corresponding surgical hub 7006 (which may also include a transceiver). The combination of the surgical instrument 7012 and the corresponding hub 7006 can indicate a specific location, such as a surgical site within a medical facility (e.g., a hospital) for providing a medical procedure. For example, the memory of the surgical hub 7006 can store the location data. As shown in FIG. 11 , the cloud 7004 includes a central server 7013 (which may be the same as or similar to the remote server 7013), a hub application server 7002, a data analysis module 7034, and an input / output ("I / O") interface 7006. The central server 7013 of the cloud 7004 collectively manages the cloud computing system, which includes monitoring requests by the client modules 7006 and managing the processing power of the cloud 7004 to execute those requests. Each of the central servers 7013 may include one or more processors 7008 coupled to a suitable memory device 7010, which may include volatile memory such as random access memory (RAM) and non-volatile memory such as a magnetic storage device. The memory device 7010 may include machine-executable instructions that, when executed, cause the processor 7008 to execute a data analysis module 7034 for cloud-based data analysis, actions, recommendations, and other operations described below. Further, the processor 7008 may execute the data analysis module 7034 independently or in conjunction with a hub application executed independently by the hub 7006. The central server 7013 may also include a database 2212 of aggregated medical data, which may reside in the memory 2210.

[0149] Based on its connection to the various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from the various surgical instruments 7012 and the particular data generated by their corresponding hubs 7006. Such aggregated data may be stored in an aggregated medical database 7012 of the cloud 7004. Specifically, the cloud 7004 can advantageously perform data analysis and operations on the aggregated data to provide insights and / or perform functions that individual hubs 7006 cannot accomplish on their own. To this end, as shown in FIG. 11 , the cloud 7004 and the surgical hubs 7006 are communicatively coupled to send and receive information. An I / O interface 7006 is connected to the multiple surgical hubs 7006 via the network 7001. In this manner, the I / O interface 7006 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data database 7011. Accordingly, the I / O interface 7006 can facilitate read / write operations of the cloud-based analysis system. Such read / write operations may be performed in response to requests from the hub 7006. These requests may be sent to the hub 7006 via a hub application. The I / O interface 7006 may include one or more high-speed data ports, which may include a universal serial bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting the cloud 7004 to the hub 7006. The hub application server 7002 of the cloud 7004 may be configured to host and provide shared functionality to software applications (e.g., hub applications) executed by the surgical hub 7006. For example, the hub application server 7002 may manage requests by the hub application through the hub 7006, control access to the database 7011 of aggregated medical data, and perform load balancing. The data analysis module 7034 is described in further detail with reference to FIG. 12 .

[0150] The particular cloud computing system configurations described in this disclosure may be specifically designed to address various problems that arise in the context of medical surgeries and procedures performed using medical devices, such as surgical instruments 7012, 112. In particular, the surgical instruments 7012 may be digital surgical devices configured to interact with the cloud 7004 to implement techniques for improving surgical outcomes. The various surgical instruments 7012 and / or the surgical hub 7006 may include touch-controlled user interfaces to allow a clinician to control aspects of the interaction between the surgical instruments 7012 and the cloud 7004. Other suitable user interfaces for control, such as an auditory-controlled user interface, may also be used.

[0151] FIG. 12 is a block diagram illustrating the functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. The cloud-based analysis system may include multiple data analysis modules 7034 that may be executed by a processor 7008 of a cloud 7004 to provide data analysis solutions to problems that arise specifically in the medical field. As shown in FIG. 12 , the functionality of the cloud-based data analysis modules 7034 may be supported via a hub application 7014 hosted by a hub application server 7002 that is accessible on a surgical hub 7006. The cloud processor 7008 and the hub application 7014 may work in conjunction to execute the data analysis modules 7034. An application program interface (API) 7016 may define a set of protocols and routines corresponding to the hub application 7014. Additionally, the API 7016 may manage the storage and retrieval of data in a centralized medical database 7012 for operation of the applications 7014. The cache 7018 may also store data (e.g., temporarily) and may be coupled to the API 7016 for more efficient retrieval of data used by the applications 7014. The data analysis module 7034 of FIG. 12 may include modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, control program updates 7026, patient outcome analysis 7028, recommendations 7030, and data classification and prioritization 7032. Other suitable data analysis modules may also be implemented by the cloud 7004, according to some aspects. In one aspect, the data analysis module may be used to make specific recommendations based on an analysis of trends, outcomes, and other data.

[0152] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata), including identifying notable features or configurations (e.g., trends), managing redundant data sets, and storing data in paired data sets that may be grouped by procedure but not necessarily matched to actual surgical procedure dates and surgeons. In particular, paired data sets generated from the operation of the surgical instrument 7012 may include applying a binary classification, such as a bleeding or non-bleeding event. More generally, the binary classification may be characterized as either a desired event (e.g., a successful surgical procedure) or an undesired event (e.g., a misfired or misused surgical instrument 7012). The aggregated self-describing data may correspond to individual data received from various groups or subgroups of the surgical hub 7006. Thus, the data collection and aggregation module 7022 may generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. To this end, the processor 7008 may be operatively coupled to the hub application 7014 and the database of aggregated medical data 7011 for executing the data analysis module 7034. The data collection and aggregation module 7022 may store the aggregated, organized data in the database of aggregated medical data 2212.

[0153] The resource optimization module 7020 can be configured to analyze this aggregated data to determine optimal use of resources for a particular medical facility or group of medical facilities. For example, the resource optimization module 7020 can determine an optimal order point for surgical stapling instruments 7012 for a group of medical facilities based on corresponding predicted demand for surgical stapling instruments 7012. The resource optimization module 7020 can also evaluate resource usage or other operating configurations of various medical facilities to determine whether resource usage can be improved. Similarly, the recommendation module 7030 can be configured to analyze the aggregated organizational data from the data collection and aggregation module 7022 to provide recommendations. For example, the recommendation module 7030 can recommend to a medical facility (e.g., a health care provider such as a hospital) that a particular surgical instrument 7012 should be upgraded to an improved version based, for example, on a higher than expected error rate. Additionally, the recommendation module 7030 and / or resource optimization module 7020 can recommend better supply chain parameters, such as product reorder points, and provide suggestions for different surgical instruments 7012, their use, or procedure steps that will improve surgical outcomes. The medical facility can receive such recommendations via the corresponding surgical hub 7006. More specific recommendations regarding the parameters or configurations of various surgical instruments 7012 can also be provided. The hub 7006 and / or surgical instruments 7012 can also each have a display screen that displays the data or recommendations provided by the cloud 7004.

[0154] The patient outcome analysis module 7028 may analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 may also analyze and evaluate other potential operating parameters. In this regard, the recommendation module 7030 may use these other potential operating parameters to make recommendations based on resulting in better surgical outcomes, such as a better seal or less bleeding. For example, the suggestion module 7030 may be able to send suggestions to the surgical 7006 regarding when to use a particular cartridge with a corresponding stapling surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large-scale collected raw data and provide centralized recommendations (advantageously determined based on aggregated data) across multiple medical facilities while controlling for common variables. For example, the cloud-based analysis system may analyze, evaluate, and / or aggregate type of medical procedure, type of patient, number of patients, geographic similarities between medical providers using similar types of instruments, etc., in ways that no single medical facility could analyze independently. The control program update module 7026 can be configured to implement recommendations for various surgical instruments 7012 when the corresponding control programs are updated. For example, the patient outcome analysis module 7028 can identify correlations linking particular control parameters to successful (or unsuccessful) outcomes. Such correlations can be addressed when an updated control program is sent to the surgical instrument 7012 via the control program update module 7026. Updates to the instrument 7012, which can be sent via the corresponding hub 7006, may incorporate aggregated performance data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and recommendation module 7030 can identify improved ways to use the instrument 7012 based on the aggregated performance data.

[0155] The cloud-based analysis system may include security features implemented by the cloud 7004. These security features may be managed by the authorization and security module 7024. Each surgical hub 7006 may have associated unique credentials, such as a username, password, and other suitable security credentials. These credentials may be stored in memory 7010 and associated with an authorized cloud access level. For example, based on providing accurate credentials, the surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., send or receive certain defined types of information). To this end, the cloud 7004's aggregated medical data database 7011 may include a database of certified credentials to verify the accuracy of the provided credentials. Different credentials may be associated with various levels of permission for interaction with the cloud 7004, such as a predetermined access level for receiving data analyses generated by the cloud 7004. Furthermore, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices, which may include a "blacklist" of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist may not be permitted to interact with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the corresponding hub 7006. Additionally or alternatively, the cloud 7004 may flag instruments 7012 based on incompatibility or other specified criteria. In this manner, counterfeit medical devices and the inappropriate reuse of such devices across the cloud-based analysis system may be identified and addressed.

[0156] The surgical instrument 7012 may use a wireless transceiver to transmit a wireless signal that may represent, for example, authorization credentials for access to the corresponding hub 7006 and cloud 7004. A wired transceiver may also be used to transmit the signal. Such authorization credentials may be stored in a respective memory device of the surgical instrument 7012. The authorization and security module 7024 may determine whether the authorization credentials are accurate or forged. The authorization and security module 7024 may also dynamically generate authorization credentials for enhanced security. The credentials may also be encrypted, such as by using hash-based encryption. Upon transmitting the appropriate authorization, the surgical instrument 7012 may transmit a signal to the corresponding hub 7006 and ultimately the cloud 7004 indicating that the instrument 7012 is ready to acquire and transmit medical data. In response, the cloud 7004 may transition to a state capable of receiving medical data for storage in the aggregated medical data database 7011. This readiness to transmit data may be indicated, for example, by a light indicator on the instrument 7012. The cloud 7004 may also send signals to the surgical instruments 7012 to update their associated control programs. The cloud 7004 may send signals directed to a particular class of surgical instruments 7012 (e.g., electrosurgical instruments) so that software updates to control programs are sent only to the appropriate surgical instruments 7012. Additionally, the cloud 7004 may be used to implement system-wide solutions to address local or global issues based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 are identified as having a common manufacturing defect, the cloud 7004 may change the authorization credentials corresponding to this group to implement an operational lockout for this group.

[0157] The cloud-based analytics system may enable monitoring of multiple healthcare facilities (e.g., healthcare facilities such as hospitals) to determine improved practices and recommend changes accordingly (e.g., via the proposal module 2030). Thus, the processor 7008 of the cloud 7004 may analyze data associated with an individual healthcare facility to identify the facility and aggregate that data with other data associated with other healthcare facilities. Groups may be defined, for example, based on similar operational behavior or geographic location. In this manner, the cloud 7004 may provide broader analysis and recommendations for groups of healthcare facilities. The cloud-based analytics system may also be used for enhanced situational awareness. For example, the processor 7008 may predictively model the effect of recommendations on cost and effectiveness for a particular facility (compared to overall operations and / or various healthcare procedures). The costs and effectiveness associated with that particular facility may also be compared to the corresponding local area of other facilities or any other comparable facilities.

[0158] The data classification and prioritization module 7032 may prioritize and classify data based on criticality (e.g., the severity, surprise, or suspiciousness of the medical event associated with the data). This classification and prioritization may be used in conjunction with other data analysis module 7034 functionality described herein to improve the cloud-based analyses and operations described herein. For example, the data classification and prioritization module 7032 may assign priorities to data analyses performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels may result in specific responses from the cloud 7004 (corresponding to the level of urgency), such as elevation for rapid response, special handling, exclusion from the aggregated medical data database 7011, or other suitable responses. Additionally, if necessary, the cloud 7004 may send a request (e.g., a push message) via the hub application server for additional data from the corresponding surgical instrument 7012. The push message may result in a notification being displayed on the corresponding hub 7006 to request support or additional data. This push message may be needed in situations where the cloud detects a significant irregularity or outlier and is unable to determine the cause of the irregularity. The central server 7013 can be programmed to trigger this push message in certain critical situations, such as when data is determined to differ from expected values by more than a predetermined threshold, or when security is deemed to be involved.

[0159] Further exemplary details regarding the various described functions are provided in the following description, each of which may utilize a cloud architecture, as illustrated in Figures 11 and 12 as one example of a hardware and software implementation.

[0160] 13 shows a block diagram of a computer-implemented adaptive surgical system 9060 configured to adaptively generate control program updates for modular devices 9050, in accordance with at least one embodiment of the present disclosure. In some examples, the surgical system may include a surgical hub 9000, a plurality of modular devices 9050 communicatively coupled to the surgical hub 9000, and an analysis system 9100 communicatively coupled to the surgical hub 9000. While a single surgical hub 9000 is shown, it should be noted that the surgical system 9060 may include any number of surgical hubs 9000, which may be connected to form a network of surgical hubs 9000 communicatively coupled to the analysis system 9010. In some examples, the surgical hub 9000 may include a processor 9010 coupled to a memory 9020 for executing stored instructions and a data relay interface 9030 through which data is transmitted to the analysis system 9100. In some examples, the surgical hub 9000 may further include a user interface 9090 having an input device 9092 (e.g., a capacitive touchscreen or keyboard) for receiving input from a user and an output device 9094 (e.g., a display screen) for providing output to the user. The output may include data from a query entered by the user, suggestions for products or product mixes to use in a given procedure, and / or instructions for actions to be taken before, during, or after a surgical procedure. The surgical hub 9000 may further include an interface 9040 for communicatively coupling a modular device 9050 to the surgical hub 9000. In one aspect, the interface 9040 may include a transceiver communicatively connectable to the modular device 9050 via a wireless communication protocol. The modular device 9050 may include, for example, a surgical stapling and cutting instrument, an electrosurgical instrument, an ultrasonic instrument, an aspirator, a ventilator, and a display screen. In some examples, the surgical hub 9000 may further be communicatively coupled to one or more patient monitoring devices 9052, such as an EKG monitor or a BP monitor.In some examples, the surgical hub 9000 may further be communicatively coupled to one or more databases 9054 or external computer systems, such as an EMR database of the medical facility in which the surgical hub 9000 is located.

[0161] When the modular devices 9050 are connected to the surgical hub 9000, the surgical hub 9000 can sense or receive perioperative data from the modular devices 9050 and then associate the received perioperative data with surgical procedure outcome data. The perioperative data may indicate how the modular devices 9050 were controlled during the course of a surgical procedure. The procedure outcome data includes data associated with the results from the surgical procedure (or steps thereof), which may include whether the surgical procedure (or steps thereof) had a positive or negative outcome. For example, the outcome data may include whether a patient suffered a post-operative complication from a particular procedure or whether there was a leak (e.g., bleeding or air leak) at a particular staple or schnitt. The surgical hub 9000 can obtain the surgical procedure outcome data by receiving the surgical procedure outcome data from an external source (e.g., from an EMR database 9054) (e.g., via one of the connected modular devices 9050), by directly detecting the outcome, or by inferring the occurrence of the outcome through a situational awareness system. For example, data regarding post-operative complications can be retrieved from the EMR database 9054, and data regarding staple or schnit leaks can be detected directly or inferred by the situational awareness system. Surgical procedure outcome data can be inferred by the situational awareness system from data received from a variety of data sources, including the modular device 9050 itself, the patient monitoring device 9052, and the database 9054 to which the surgical hub 9000 is connected.

[0162] The surgical hub 9000 can transmit data and outcome data of associated modular devices 9050 to the analysis system 9100 for processing on the analysis system 9100. By transmitting both perioperative data indicating how the modular devices 9050 are controlled and procedure outcome data, the analysis system 9100 can correlate different manners of controlling the modular devices 9050 with surgical outcomes for specific procedure types. In some examples, the analysis system 9100 may include a network of analysis servers 9070 configured to receive data from the surgical hub 9000. Each of the analysis servers 9070 may include a memory and a processor coupled to the memory that executes instructions stored therein to analyze the received data. In some examples, the analysis servers 9070 may be connected in a distributed computing architecture and / or utilize a cloud computing architecture. Based on this paired data, the analysis system 9100 can then learn optimal or preferred operating parameters for various types of modular devices 9050, generate adjustments to the control programs of modular devices 9050 in the field, and then transmit (or "push") updates to the control programs of the modular devices 9050.

[0163] Further details regarding the computer-implemented interactive surgical system 9060, including the surgical hub 9000 and various modular devices 9050 connectable thereto, are described in connection with Figures 5-6.

[0164] 14 provides a surgical system 6500 according to the present disclosure and may include a surgical instrument 6502 that can communicate with a console 6522 or a portable device 6526 through a local area network 6518 or a cloud network 6520 via a wired or wireless connection. In various aspects, the console 6522 and the portable device 6526 may be any suitable computing device. The surgical instrument 6502 may include a handle 6504, an adapter 6508, and a loading unit 6514. The adapter 6508 releasably couples to the handle 6504, and the loading unit 6514 releasably couples to the adapter 6508 such that the adapter 6508 transfers force from the drive shaft to the loading unit 6514. The adapter 6508 or the loading unit 6514 may include a force gauge (not explicitly shown) disposed therein to measure force exerted on the loading unit 6514. The loading unit 6514 can include an end effector 6530 including a first jaw 6532 and a second jaw 6534. The loading unit 6514 can be an in-situ loading or multi-firing loading unit (MFLU) that allows a clinician to fire multiple fasteners multiple times without the loading unit 6514 having to be removed from the surgical site to reload the loading unit 6514.

[0165] The first jaw 6532 and the second jaw 6534 can be configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and cut the clamped tissue. The first jaw 6532 can be configured to fire at least one fastener multiple times or can be configured to include a replaceable multi-fire fastener cartridge containing multiple fasteners (e.g., staples, clips, etc.) that can be fired two or more times before being replaced. The second jaw 6534 can include an anvil that deforms or otherwise secures fasteners around tissue as they are ejected from the multi-fire fastener cartridge.

[0166] The handle 6504 may include a motor coupled to the drive shaft to affect rotation of the drive shaft. The handle 6504 may include a control interface for selectively activating the motor. The control interface may include buttons, switches, levers, sliders, a touch screen, and any other suitable input mechanism or user interface that can be engaged by a clinician to activate the motor.

[0167] The control interface of the handle 6504 can communicate with a controller 6528 of the handle 6504 to selectively activate the motor to affect rotation of the drive shaft. The controller 6528 can be disposed within the handle 6504 and configured to receive input from the control interface and adapter data from the adapter 6508 or loading unit data from the loading unit 6514. The controller 6528 can analyze the input from the control interface and the data received from the adapter 6508 and / or the loading unit 6514 in order to selectively activate the motor. The handle 6504 can also include a display viewable by a clinician while using the handle 6504. The display can be configured to display portions of the adapter data or loading unit data before, during, or after firing of the instrument 6502.

[0168] The adapter 6508 may include an adapter identification device 6510 disposed therein, and the loading unit 6514 includes a loading unit identification device 6516 disposed therein. The adapter identification device 6510 may be in communication with a controller 6528, and the loading unit identification device 6516 may be in communication with the controller 6528. It will be appreciated that the loading unit identification device 6516 may be in communication with the adapter identification device 6510, which relays or passes communications from the loading unit identification device 6516 to the controller 6528.

[0169] The adapter 6508 may also include multiple sensors 6512 (one shown) disposed about its periphery to detect various conditions of the adapter 6508 or the environment (e.g., when the adapter 6508 is connected to the loading unit, when the adapter 6508 is connected to the handle, when the drive shaft is rotating, the torque of the drive shaft, the strain on the drive shaft, the temperature within the adapter 6508, the number of times the adapter 6508 has been fired, the peak force of the adapter 6508 during firing, the total amount of force applied to the adapter 6508, the peak retract force of the adapter 6508, the number of times the adapter 6508 has been dwelled during firing, etc.). The multiple sensors 6512 may provide input to the adapter identification device 6510 in the form of data signals. The data signals of the multiple sensors 6512 may be stored in the adapter identification device 6510 or may be used to update the adapter data stored in the adapter identification device 6510. The data signals of the multiple sensors 6512 may be analog or digital. The plurality of sensors 6512 may include a force gauge for measuring the force exerted on the loading unit 6514 during firing.

[0170] The handle 6504 and adapter 6508 may be configured to interconnect the adapter identification device 6510 and the loading unit identification device 6516 with the controller 6528 via an electrical interface. The electrical interface may be a direct electrical interface (i.e., including electrical contacts that engage with each other to transmit energy and signals therebetween). Additionally or alternatively, the electrical interface may be a contactless electrical interface for wirelessly transmitting (e.g., inductively transmitting) energy and signals therebetween. It is also contemplated that the adapter identification device 6510 and the controller 6528 may wirelessly communicate with each other via a wireless connection that is separate from the electrical interface.

[0171] The handle 6504 may include a transmitter 6506 configured to transmit instrument data from the controller 6528 to other components of the system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522, or the portable device 6526). The transmitter 6506 may also receive data (e.g., cartridge data, loading unit data, or adapter data) from other components of the system 6500. For example, the controller 6528 may transmit instrument data to the console 6528 including the serial number of the mounting adapter (e.g., adapter 6508) attached to the handle 6504, the serial number of the loading unit (e.g., loading unit 6514) attached to the adapter, and the serial number of the multi-fire fastener cartridge (e.g., multi-fire fastener cartridge) loaded in the loading unit. The console 6522 may then transmit data (e.g., cartridge data, loading unit data, or adapter data) associated with the attached cartridge, loading unit, and adapter, respectively, back to the controller 6528. The controller 6528 can display a message on the local instrument display or can send a message via transmitter 6506 to the console 6522 or portable device 6526 to display the message on the display 6524 or portable device screen, respectively.

[0172] 15A shows an exemplary flow for determining an operating mode and operating in the determined mode. The computer-implemented interactive surgical system and / or components and / or subsystems of the computer-implemented interactive surgical system may be configured to be updated. Such updates may include the inclusion of features and benefits that were not available to users prior to the update. These updates may be established by any method of hardware, firmware, and software update suitable for introducing functionality to users. For example, replaceable / interchangeable (e.g., hot-swappable) hardware components, flashable firmware devices, and updatable software systems may be used to update the computer-implemented interactive surgical system and / or components and / or subsystems of the computer-implemented interactive surgical system.

[0173] An update may be contingent on any suitable criterion or set of criteria. For example, an update may be contingent on one or more hardware capabilities of the system, such as processing power, bandwidth, resolution, etc. For example, an update may be contingent on one or more software aspects, such as the purchase of certain software code. For example, an update may be contingent on a purchased service tier. A service tier may represent a feature and / or set of features that a user is entitled to use in connection with the computer-implemented interactive surgical system. A service tier may be determined by a license code, an e-commerce server authentication interaction, a hardware key, a username / password combination, a biometric authentication interaction, a public / private key exchange interaction, etc.

[0174] At 10704, a system / device parameter may be identified. A system / device parameter may be any element or set of elements upon which an update is conditioned. For example, the computer-implemented interactive surgical system may detect a particular bandwidth of communication between a modular device and a surgical hub. For example, the computer-implemented interactive surgical system may detect an indication to purchase a particular service tier.

[0175] At 10708, an operational mode may be determined based on the identified system / device parameters. This determination may be made by a process that maps system / device parameters to operational modes. The process may be a manual and / or automatic process. The process may be the result of local and / or remote computation. For example, a client / server interaction may be used to determine the operational mode based on the identified system / device parameters. For example, local software and / or locally embedded firmware may be used to determine the operational mode based on the identified system / device parameters. For example, a hardware key, such as a secure microprocessor, may be used to determine the operational mode based on the identified system / device parameters.

[0176] At 10710, operation may proceed according to the determined operating mode. For example, the system or device may proceed to operate in a default operating mode. For example, the system or device may proceed to operate in an alternate operating mode. The operating mode may be dictated by control hardware, firmware, and / or software already present in the system or device. The operating mode may also be dictated by newly installed / updated control hardware, firmware, and / or software.

[0177] FIG. 15B shows an example functional block diagram for changing the operational mode. The upgradeable element 10714 may include an initialization component 10716. The initialization component 10716 may include any hardware, firmware, and / or software suitable for determining the operational mode. For example, the initialization component 10716 may be part of a system or device startup procedure. The initialization component 10716 may engage in interactions to determine the operational mode of the upgradeable element 10714. For example, the initialization component 10716 may interact with, for example, a user 10730, an external resource 10732, and / or a local resource 10718. For example, the initialization component 10716 may receive a license key from the user 10730 to determine the operational mode. The initialization component 10716 may query an external resource 10732, such as a server, using the serial number of the upgradeable device 10714 to determine the operational mode. For example, the initialization component 10716 may query local resources 10718, such as a local query to determine the amount of available bandwidth and / or a local query of a hardware key to determine the operating mode, for example.

[0178] The upgradeable element 10714 may include one or more operational components 10720, 10722, 10726, 10728 and an operational pointer 10724. The initialization component 10716 may direct the operational pointer 10724 to direct operation of the upgradeable element 10741 to the operational components 10720, 10722, 10726, 10728 corresponding to the determined operational mode. The initialization component 10716 may direct the operational pointer 10724 to direct operation of the upgradeable element to the default operational component 10720. For example, the default operational component 10720 may be selected in the condition that no other alternative operational mode has been determined. For example, the default operational component 10720 may be selected in the condition of a failure and / or interaction failure of the initialization component. The initialization component 10716 may direct the operation pointer 10724 to direct the operation of the upgradeable component 10714 to the resident operation component 10722. For example, a particular function may be resident in the upgradeable component 10714 but require activation to operate. The initialization component 10716 may direct the operation pointer 10724 to direct the operation of the upgradeable component 10714 to install a new operation component 10728 and / or a newly installed operation component 10726. For example, new software and / or firmware may be downloaded. The new software and / or firmware may include code that enables the functionality represented by the selected operation mode. For example, a new hardware component may be installed to enable the selected operation mode.

[0179] FIG. 16 is a perspective view of a powered surgical stapling system. FIG. 16 shows a surgical instrument 1010 (e.g., an endocutter) including an interchangeable shaft assembly 1200 operably coupled to a housing 1012. FIG. 17 is a perspective view of the interchangeable surgical shaft assembly of the powered surgical stapling system of FIG. 16. FIG. 17 illustrates the interchangeable shaft assembly 1200 removed from the housing 1012 or handle 1014. FIG. 18 is an exploded view of a portion of the handle assembly of the powered surgical stapling system of FIG. 16. As shown in FIG. 18, the handle 1014 can include a pair of interconnectable handle housing segments 1016 and 1018 that can be interconnected by screws, snap mechanisms, adhesive, or the like. In the illustrated arrangement, the handle housing segments 1016, 1018 cooperate to form a pistol grip portion 1019. FIGS. 16 and 18 show a motor-driven surgical cutting and fastening instrument 1010 that may or may not be reusable. In the illustrated embodiment, the instrument 1010 comprises the aforementioned housing 1012 with a handle 1014 configured to be grasped, manipulated, and actuated by a clinician. The housing 1012 may be configured to operably attach to an interchangeable shaft assembly 1200 operably coupled to a surgical end effector 1300, which may be configured to perform one or more surgical tasks or procedures. As the detailed description of the present invention progresses, it will be understood that the various forms of interchangeable shaft assemblies disclosed herein may also be effectively used in connection with robotically controlled surgical systems. Accordingly, the term “housing” may also encompass a housing or similar portion of a robotic system that houses or otherwise operably supports at least one drive system configured to generate and apply at least one control motion that can be used to actuate the interchangeable shaft assemblies disclosed herein and their respective equivalents. Additionally, various components may be “housed” or included within the housing, or various components may be “associated” with the housing.In such instances, the components may not be contained within or directly supported by the housing. The term "frame" may refer to a portion of a handheld surgical instrument. The term "frame" may also refer to a portion of a robotically controlled surgical instrument and / or a portion of a robotic system that may be used to operatively control a surgical instrument. For example, the interchangeable shaft assemblies disclosed herein can be used with the various disclosed robotic systems, instruments, components, and methods, which are incorporated herein by reference in their entirety.

[0180] The aforementioned housing 1012 shown in FIG. 16 is illustrated in connection with an interchangeable shaft assembly 1200 ( FIGS. 17 , 19 , and 20 ) including an end effector 1300 with a surgical cutting and fastening device configured to operably support a surgical staple cartridge 4000 therein. The housing 1012 may be configured for use in connection with interchangeable shaft assemblies having various shaft lengths, sizes, and types, including end effectors adapted to support various sizes and types of staple cartridges. In addition, the housing 1012 may also be effectively used in connection with a variety of other interchangeable shaft assemblies, including assemblies configured to apply, for example, motion and other forms of energy, such as radio frequency (RF) energy, ultrasonic energy, and / or motion, to end effector arrangements adapted for use in connection with various surgical applications and procedures. Furthermore, the end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system may utilize any suitable fastener that can be grasped and manipulated by a clinician. As described in more detail below, the handle 1014 operably supports a number of drive systems therein that are configured to generate and apply various control actions to corresponding portions of interchangeable shaft assemblies operably attached to the handle.

[0181] 18 , the handle 1014 may further include a frame 1020 that operably supports a plurality of drive systems. For example, the frame 1020 may operably support a “first” or closure drive system, generally designated 1030, that may be used to apply a closing or opening motion to an interchangeable shaft assembly 1200 operably attached or coupled thereto. In at least one form, the closure drive system 1030 may include an actuator in the form of a closure trigger 1032 that is pivotally supported by the frame 1020. More specifically, as shown in FIG. 18 , the closure trigger 1032 may be pivotally coupled to the housing 1014 by a pin 1033. Such an arrangement allows the closure trigger 1032 to be manipulated by a clinician. Specifically, when a clinician grasps the pistol grip portion 1019 of the handle 1014, the closure trigger 1032 can be easily pivoted from a starting or “unactuated” position to an “actuated” position, more specifically, a fully squeezed or fully actuated position. The closure trigger 1032 may be biased to the unactuated position by a spring or other biasing arrangement (not shown). In various forms, the closure drive system 1030 further includes a closure linkage assembly 1034 that may be pivotally coupled to the closure trigger 1032. As shown in FIG. 18 , the closure linkage assembly 1034 may include a first closure link 1036 and a second closure link 1038 pivotally coupled to the closure trigger 1032 by a pin 1035. The second closure link 1038, also sometimes referred to herein as a “mounting member,” includes a lateral mounting pin 1037.

[0182] 18 , it can be seen that the first closure link 1036 can have a locking wall or end 1039 thereon that is configured to cooperate with a closure release assembly 1060 that is pivotally coupled to the frame 1020. In at least one form, the closure release assembly 1060 can include a release button assembly 1062 having a distally projecting locking pawl 1064 formed thereon. The release button assembly 1062 can be pivoted counterclockwise by a release spring (not shown). When the clinician depresses the closure trigger 1032 from its unactuated position toward the pistol grip portion 1019 of the handle 1014, the first closure link 1036 pivots upward to a point where the locking pawl 1064 drops into retaining engagement with the locking wall 1039 on the first closure link 1036, thereby preventing the closure trigger 1032 from returning to the unactuated position. Thus, the closure release assembly 1060 may act to lock the closure trigger 1032 in the fully actuated position. When a clinician wishes to unlock the closure trigger 1032 so that it can be biased to the unactuated position, the clinician may simply pivot the closure release button assembly 1062, thereby moving the locking pawl 1064 out of engagement with the locking wall 1039 on the first closure link 1036. Once the locking pawl 1064 is moved out of engagement with the first closure link 1036, the closure trigger 1032 may pivot back to the unactuated position. Other closure trigger lock and release configurations may be used.

[0183] An arm 1061 may extend from the closure release button 1062. A magnetic element 1063, such as, for example, a permanent magnet, may be attached to the arm 1061. Rotating the closure release button 1062 from its first position to its second position may cause the magnetic element 1063 to move toward the circuit board 1100. The circuit board 1100 may include at least one sensor configured to detect movement of the magnetic element 1063. In at least one embodiment, for example, a "Hall Effect" sensor (not shown) may be attached to a bottom surface of the circuit board 1100. The Hall Effect sensor may be configured to detect a change in a magnetic field surrounding the Hall Effect sensor caused by movement of the magnetic element 1063. The Hall effect sensor can, for example, communicate signals with a microcontroller to determine whether the closure release button 1062 is in a first position associated with an inactive position of the closure trigger 1032 and an open configuration of the end effector, a second position associated with an active position of the closure trigger 1032 and a closed configuration of the end effector, and / or any position between the first and second positions.

[0184] In at least one form, the handle 1014 and frame 1020 can operably support another drive system, referred to herein as a firing drive system 1080, configured to apply a firing motion to a corresponding portion of an interchangeable shaft assembly attached thereto. The firing drive system 1080 can also be referred to herein as a “second drive system.” The firing drive system 1080 can employ an electric motor 1082, which can be positioned within the pistol grip portion 1019 of the handle 1014. In various forms, the motor 1082 can be a brushed DC drive motor having a maximum rotational speed of, for example, approximately 25,000 RPM. In other device configurations, the motor can include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor 1082 can be powered by a power source 1090, which in one form can include a removable power pack 1092. For example, as can be seen in FIG. 3 , the power pack 1092 may include a proximal housing portion 1094 configured to attach to a distal housing portion 1096. The proximal housing portion 1094 and the distal housing portion 1096 may be configured to operably support a plurality of batteries 1098 therein. The batteries 1098 may each include, for example, Lithium Ion ("LI") or other suitable batteries. The distal housing portion 1096 may be configured to be removably and operably attached to a circuit board 1100, which may also be operably coupled to the motor 1082. Several batteries 1098 may be connected in series and used as a power source for the surgical instrument 1010. Additionally, the power source 1090 may be replaceable and / or rechargeable.

[0185] As outlined above in connection with various other configurations, the electric motor 1082 may include a rotatable shaft (not shown) operably interfaced with a gear reducer assembly 1084 mounted in meshing engagement with a set or rack of drive teeth 1122 on the longitudinally movable drive member 1120. In use, the voltage polarity provided by the power source 1090 causes the electric motor 1082 to operate in a clockwise direction, while the voltage polarity applied to the electric motor by the battery can be reversed to cause the electric motor 1082 to operate in a counterclockwise direction. When the electric motor 1082 is rotated in one direction, the drive member 1120 will be driven axially in a distal direction "DD." When the motor 1082 is driven in the opposite rotational direction, the drive member 1120 will be driven axially in a proximal direction "PD." The handle 1014 may include a switch that may be configured to reverse the polarity applied to the electric motor 1082 by the power source 1090. Similar to other configurations described herein, the handle 1014 may also include a sensor configured to detect the position of the drive member 1120 and / or the direction in which the drive member 1120 is being moved.

[0186] Actuation of the motor 1082 may be controlled by a firing trigger 1130 pivotally supported on the handle 1014. The firing trigger 1130 may pivot between an inactivated position and an activated position. The firing trigger 1130 may be biased to the inactivated position by a spring 1132 or other biasing arrangement, such that when the clinician releases the firing trigger 1130, it may be pivoted or otherwise returned to the inactivated position by the spring 1132 or other biasing arrangement. In at least one form, the firing trigger 1130 may be located “outside” of the closure trigger 1032, as described above. In at least one form, a firing trigger safety button 1134 may be pivotally attached to the closure trigger 1032 by a pin 1035. The safety button 1134 may have a pivot arm 1136 positioned between and projecting from the firing trigger 1130 and the closure trigger 1032. When the closure trigger 1032 is in the unactuated position, the safety button 1134 can be housed in the handle 1014. In this case, the safety button 1134 cannot be easily accessed by a clinician, nor can it be moved between a safety position that prevents actuation of the firing trigger 1130 and a firing position in which the firing trigger 1130 may be fired. When the clinician depresses the closure trigger 1032, the safety button 1134 and firing trigger 1130 pivot down, allowing them to then be operated by the clinician.

[0187] As shown above, in at least one form, the longitudinally movable drive member 1120 has a rack of teeth 1122 formed thereon for meshing engagement with a corresponding drive gear 1086 of the gear reducer assembly 1084. At least one form also includes a manually actuated “emergency breakaway” assembly 1140 that can be configured to allow a clinician to manually retract the longitudinally movable drive member 1120 when the motor 1082 is disabled. The emergency breakaway assembly 1140 can include a lever or emergency breakaway handle assembly 1142 configured to be manually pivoted to ratchet engagement with teeth 1124 also provided on the drive member 1120. Thus, a clinician can manually retract the drive member 1120 by using the emergency breakaway handle assembly 1142 to ratchet the drive member 1120 in the proximal direction “PD.” U.S. Patent No. 8,608,045, entitled "POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM," discloses an emergency detachment arrangement, as well as other components, arrangements, and systems that may also be used with the various instruments disclosed herein. U.S. Patent No. 8,608,045 is incorporated herein by reference in its entirety.

[0188] 17 and 20 , the interchangeable shaft assembly 1200 may include a surgical end effector 1300 that includes an elongated channel 1310 that may be configured to operably support a staple cartridge 4000 therein. The end effector 1300 may further include an anvil 2000 pivotally supported relative to the elongated channel 1310. The interchangeable shaft assembly 1200 may further include an articulation joint 3020 and an articulation lock 2140 that may be configured to releasably retain the end effector 1300 in a desired position relative to the shaft axis SA. Various features of an embodiment of the end effector 1300, the articulation joint 3020, and at least one form of articulation lock are described in U.S. patent application Ser. No. 13 / 803,086, filed March 14, 2013, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK" (now U.S. Patent Application Publication No. 2014 / 0263541), which is incorporated herein by reference in its entirety. Figure 19 is an exploded view of the interchangeable surgical shaft assembly of Figure 17. As shown in Figure 19, the interchangeable shaft assembly 1200 can further include a proximal housing or nozzle 1201 comprised of nozzle portions 1202 and 1203.

[0189] The interchangeable shaft assembly 1200 can further include a closure system or closure member assembly 3000 that can be utilized to open and close the anvil 2000 of the end effector 1300. The shaft assembly 1200 can include a spine 1210 that can be configured to (1) slidably support a firing member therein and (2) slidably support a closure member assembly 3000 extending therearound. FIG. 20 is a partially exploded view of a portion of the interchangeable surgical shaft assembly of FIG. 19. As shown in FIG. 20 , the distal end 1212 of the spine 1210 terminates in an upper lug attachment mechanism 1270 and a lower lug attachment mechanism 1280. The upper lug attachment mechanism 1270 can have a lug slot 1272 formed therein that can securely support an upper attachment link 1274. Similarly, the lower lug attachment mechanism 1280 includes a lug slot 1282 formed therein that may be adapted to fixedly support a lower mounting link 1284 therein. The upper mounting link 1274 may include a pivot socket 1276 therein that may be adapted to rotatably receive a pivot pin 1292 formed on a channel cap or anvil retainer 1290 attached to the proximal end portion 1312 of the elongated channel 1310. The lower mounting link 1284 may include a lower pivot pin 1286 that may be received in a pivot hole 1314 formed in the proximal end portion 1312 of the elongated channel 1310. See FIG. 20 . The lower pivot pin 1286 may be vertically aligned with the pivot socket 1276 to define an articulation axis AA about which the surgical end effector 1300 may articulate relative to the shaft axis SA. Please refer to Figure 17.

[0190] In the illustrated embodiment, the surgical end effector 1300 is selectively articulatable about an articulation axis AA by an articulation system 2100. In one form, the articulation system 2100 may include a proximal articulation drive 2102 that may be pivotally coupled to an articulation link 2120. As can be seen most particularly in FIG. 20 , an offset mounting lug 2114 may be formed on the distal end 2110 of the proximal articulation drive 2102. A pivot hole 2116 may be formed in the offset mounting lug 2114 and configured to pivotally receive a proximal link pin 2124 formed on the proximal end 2122 of the articulation link 2120. The distal end 2126 of the articulation link 2120 may include a pivot hole 2128 that is configured to pivotally receive a channel pin 1317 formed in the proximal end portion 1312 of the elongate channel 1310. Axial movement of the proximal articulation drive 2102 thus imparts articulation to the elongated channel 1310, which in turn articulates the surgical end effector 1300 about the articulation axis AA relative to the spine assembly 1210. Further details regarding the construction and operation of the articulation system 2100 can be found in various references incorporated herein by reference, such as U.S. Patent Application No. 15 / 635,631, filed June 28, 2017, entitled "SURGICAL INSTRUMENT WITH AXIALLY MOVABLE CLOSURE MEMBER" (now U.S. Patent Application Publication No. 2019 / 0000464), which is incorporated herein by reference in its entirety. In various circumstances, when the proximal articulation drive 2102 is not moving proximally or distally, the proximal articulation drive 2102 can be held in place by a joint lock 2140. Further details regarding examples of joint locks 2140 can be found in U.S. Patent Application Publication No. 2019 / 0000464, as well as other references incorporated by reference herein.

[0191] In various circumstances, the spine 1210 can include a proximal end 1211 that can be rotatably supported within the chassis 1240. In one arrangement, for example, the proximal end 1211 of the spine 1210 is threaded 1214 for threaded attachment to a spine bearing 1216 configured to be supported within the chassis 1240. See FIG. 19 . Such an arrangement facilitates rotatable attachment of the spine 1210 to the chassis 1240, such that the spine 1210 can be selectively rotated relative to the chassis 1240 about the shaft axis SA.

[0192] 19 , the interchangeable shaft assembly 1200 may include a closure shuttle 1250 slidably supported therein for axial movement relative to the chassis 1240. The closure shuttle 1250 may include a pair of proximally projecting hooks 1252 that may be configured for attachment to a mounting pin 1037 ( FIG. 3 ), which may be attachable to a second closure link 1038, as described in further detail below. In at least one example, the closure member assembly 3000 may include a proximal closure member segment 3010 that may have a proximal end 3012 that may be coupled to the closure shuttle 1250 for rotation relative to the closure shuttle 1250. For example, a U-shaped connector 1263 may be insertable into an annular slot 3014 in the proximal end 3012 of the proximal closure member segment 3010 and may be retained within a vertical slot 1253 in the closure shuttle 1250. Such an arrangement may serve to mount the proximal closure member segment 3010 and the closure shuttle 1250 for axial movement together, while allowing the proximal closure member segment 3010 to rotate relative to the closure shuttle 1250 about the shaft axis SA. A closure spring 1268 may be journaled on the proximal closure member 3010 and serve to bias the proximal closure member 3010 in the proximal direction "PD", thereby pivoting the closure trigger 1032 to an unactuated position when the shaft assembly is operably coupled to the handle 1014.

[0193] In at least one form, the interchangeable shaft assembly 1200 may further include an articulation joint 3020. However, other interchangeable shaft assemblies may not be articulatable. As shown in FIG. 20 , for example, a distal closure member or distal closure tube segment 3030 may be coupled to the distal end of the proximal closure member segment 3010. The articulation joint 3020 includes a dual-pivoting closure sleeve assembly 3022. According to various forms, the dual-pivoting closure sleeve assembly 3022 includes an end effector closure tube 3050 having an upper distally-extending tang 3052 and a lower distally-extending tang 3054. The upper double pivot link 3056 includes upwardly projecting distal and proximal pivot pins that engage with upper distal and upper proximal pin holes of the upper proximally extending tangs 3052 on the distal closure tube segment 3030. The lower double pivot link 3058 includes upwardly projecting distal and proximal pivot pins that engage with lower distal and lower proximal pin holes of the lower proximally extending tangs 3054 and 3034, respectively. See FIGS. 19 and 20 . As described in more detail below, the closure member assembly 3000 is translated distally (direction DD) to close the anvil 2000, for example, in response to actuation of the closure trigger 1032. The anvil 2000 is opened by translating the closure member assembly 3000 proximally, which causes the end effector closure sleeve to interact with the anvil 2000 and pivot to an open position.

[0194] As also described above, the interchangeable shaft assembly 1200 further includes a firing member 1900 supported for axial movement within the shaft spine 1210. The firing member 1900 includes an intermediate firing shaft portion 1222 configured to attach to a distal cutting portion or knife bar 1910. The intermediate firing shaft portion 1222 may include a longitudinal slot 1223 at its distal end, which may be configured to receive a tab 1912 on the proximal end of the distal knife bar 1910. The longitudinal slot 1223 and the proximal end tab 1912 may be sized and configured to allow relative movement therebetween and may include a slip joint 1914. The slip joint 1914 may allow the intermediate firing shaft portion 1222 of the firing member 1900 to move and articulate the end effector 1300 without moving, or at least substantially without moving, the knife bar 1910. Once the end effector 1300 is properly oriented, the intermediate firing shaft portion 1222 can be advanced distally until the proximal sidewall of the longitudinal slot 1223 contacts the tab 1912, thereby advancing the knife bar 1910 and firing the staple cartridge 4000 located within the channel 1310. The knife bar 1910 includes a knife portion 1920, which may include a blade or tissue-cutting edge 1922, and may include an upper anvil engagement tab 1924 and a lower channel engagement tab 1926. The configurations and operation of various firing members may be disclosed in various other references, which are incorporated herein by reference.

[0195] 19 , the shaft assembly 1200 may further include a switch drum 1500 that may be rotatably received on the proximal closure member segment 3010. The switch drum 1500 may include a hollow shaft segment 1502 that may have a shaft boss formed therein for receiving an outwardly protruding actuation pin. Under various circumstances, the actuation pin may extend through a slot into a longitudinal slot provided in the locking sleeve to facilitate axial movement of the locking sleeve when engaged with the articulation driver. The rotational torsion spring 1420 may be configured to engage a boss on the switch drum 1500 and a portion of the nozzle housing 1203 to apply a biasing force to the switch drum 1500. The switch drum 1500 may further include an at least partially circumferential opening 1506 defined therein, which may be configured to receive a circumferential mount extending from the nozzle portions 1202, 1203 and to permit relative rotation but not translation between the switch drum 1500 and the nozzle 1201. The mount may also extend through an opening 3011 in the proximal closure member segment 3010 and fit within a recess 1219 in the spine 1210. Rotation of the switch drum 1500 about the shaft axis SA ultimately rotates the actuation pin and locking sleeve between their engaged and disengaged positions. In one arrangement, rotation of the switch drum 1500 may be coupled to axial advancement of a closure tube or closure member. Thus, essentially, actuation of the closure system can operatively engage and disengage the articulation drive system from the firing drive system in a variety of manners as described in more detail in U.S. Patent Application No. 13 / 803,086 (now U.S. Patent Application Publication No. 2014 / 0263541), entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," and U.S. Patent No. 9,913,642, entitled "SURGICAL INSTRUMENT COMPRISING A SENSOR SYSTEM," both of which are incorporated herein by reference in their entireties.For example, when the closure tube is in its proximal-most position corresponding to the "jaws open" position, the closure member segment 3010 positions the switch drum 1500 to link the articulation system with the firing drive system. When the closure tube is moved to its distal position corresponding to the "jaws closed" position, the closure tube rotates the switch drum 1500 to a position where the articulation system is decoupled from the firing drive system.

[0196] 19 , the shaft assembly 1200 can include a slip ring assembly 1600 that can be configured, for example, to conduct power to and / or communicate signals with the end effector 1300. The slip ring assembly 1600 can include a proximal connector flange 1604 that can be attached to a chassis flange 1242 extending from the chassis 1240 and a distal connector flange positioned in a slot defined in the shaft housing. The proximal connector flange 1604 can include a first surface, and the distal connector flange can include a second surface positioned adjacent to and movable relative to the first surface. The distal connector flange can rotate relative to the proximal connector flange 1604 about the shaft axis SA. The proximal connector flange 1604 can include a plurality of concentric, or at least substantially concentric, conductors defined in its first surface. The connector may be attached proximally to the connector flange and may have multiple contacts, each corresponding to and in electrical contact with one of the conductors. Such a configuration may allow the proximal connector flange 1604 and the distal connector flange to rotate relative to each other while maintaining electrical contact therebetween. The proximal connector flange 1604 may include an electrical connector 1606 that can place conductors in signal communication with, for example, a shaft circuit board 1610 attached to the shaft chassis 1240. In at least one example, a wiring harness comprising multiple conductors may extend between the electrical connector 1606 and the shaft circuit board 1610. The electrical connector 1606 may extend proximally through a connector opening 1243 defined in the chassis flange 1242. See FIG. 19 .Further details regarding the slip ring assembly 1600 can be found, for example, in U.S. Patent Application No. 13 / 803,086 (now U.S. Patent Application Publication No. 2014 / 0263541), entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," U.S. Patent Application No. 13 / 800,067 (now U.S. Patent Application Publication No. 2014 / 0263552), entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," filed March 13, 2013, which is incorporated herein by reference in its entirety, and U.S. Patent No. 9,345,481, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety.

[0197] As described above, the shaft assembly 1200 may include a proximal portion fixably attached to the handle 1014 and a distal portion rotatable about a longitudinal axis. The rotatable distal shaft portion may be rotatable relative to the proximal portion about the slip ring assembly 1600, as described above. The distal connector flange of the slip ring assembly 1600 may be positioned within the rotatable distal shaft portion. Additionally to the above, the switch drum 1500 may also be positioned within the rotatable distal shaft portion. Rotation of the rotatable distal shaft portion may cause the distal connector flange and the switch drum 1500 to rotate synchronously with one another. Additionally, the switch drum 1500 may be rotated between a first position and a second position relative to the distal connector flange. When the switch drum 1500 is in its first position, the articulation drive system may be operably disengaged from the firing drive system, such that operation of the firing drive system may not articulate the end effector 1300 of the shaft assembly 1200. When the switch drum 1500 is in its second position, an articulation drive system may be operatively engaged with the firing drive system, such that operation of the firing drive system can articulate the end effector 1300 of the shaft assembly 1200. Moving the switch drum 1500 between its first position and its second position causes the switch drum 1500 to move relative to the distal connector flange. In various examples, the shaft assembly 1200 can include at least one sensor configured to detect the position of the switch drum 1500.

[0198] Referring again to FIG. 19 , the chassis 1240 may include at least one, and preferably two, tapered mounting portions 1244 formed thereon that are adapted to be received within corresponding dovetail slots 1702 formed in the distal mounting flange portion 1700 of the frame 1020. See FIG. 18 . Each dovetail slot 1702 may be tapered, or in other words, somewhat V-shaped, to seat and receive the mounting portion 1244 therein. As further shown in FIG. 19 , a shaft mounting lug 1226 is formed on the proximal end of the intermediate firing shaft portion 1222. As will be described in more detail below, when the interchangeable shaft assembly 1200 can be coupled to the handle 1014, the shaft mounting lug 1226 can be received in a firing shaft mounting cradle 1126 formed on the distal end 1125 of the longitudinal drive member 1120. See FIG. 18 .

[0199] Various shaft assembly embodiments may employ a latch system 1710 to removably couple the shaft assembly 1200 to the housing 1012, and more particularly, to the frame 1020. As can be seen in FIG. 4 , for example, in at least one form, the latch system 1710 includes a locking member or lock yoke 1712 that is movably coupled relative to the chassis 1240. In the illustrated embodiment, for example, the lock yoke 1712 has a U-shape with two spaced apart, downwardly extending legs 1714. Each leg 1714 may be formed with a pivot lug 1715 that is adapted to be received in a corresponding hole 1245 formed in the chassis 1240. Such an arrangement may facilitate pivotally attaching the lock yoke 1712 to the chassis 1240. The locking yoke 1712 may include two proximally protruding locking lugs 1716 configured to releasably engage corresponding locking detents or grooves 1704 in the distal mounting flange portion 1700 of the frame 1020. See FIG. 18 . In various forms, the locking yoke 1712 may be proximally biased by a spring or biasing member (not shown). Actuation of the locking yoke 1712 may be accomplished by a latch button 1722 slidably mounted on a latch actuator assembly 1720 attached to the chassis 1240. The latch button 1722 may be biased proximally relative to the locking yoke 1712. As described in more detail below, distal biasing of the latch button may move the locking yoke 1712 to an unlocked position, which may also pivot the locking yoke 1712 out of retaining engagement with the distal mounting flange 1700 of the frame 1020. When the locking yoke 1712 is in “retaining engagement” with the distal mounting flange 1700 of the frame 1020 , the locking lugs 1716 may be retained within corresponding locking detents or grooves 1704 in the distal mounting flange 1700 .

[0200] When using interchangeable shaft assemblies, including end effectors of the type described herein adapted to cut and fasten tissue, as well as other types of end effectors, it may be desirable to prevent the interchangeable shaft assembly from being inadvertently separated from the housing during actuation of the end effector. For example, during use, a clinician may actuate the closure trigger 1032 to grasp and manipulate target tissue into a desired position. Once the target tissue can be positioned in the end effector 1300 in a desired orientation, the clinician may then fully actuate the closure trigger 1032 to close the anvil 2000 and clamp the target tissue in place for cutting and stapling. In that case, the first drive system 1030 may be fully actuated. After the target tissue is clamped in the end effector 1300, it may be desirable to prevent the shaft assembly 1200 from being inadvertently separated from the housing 1012. One form of the latch system 1710 may be configured to prevent such inadvertent separation.

[0201] As can be seen most particularly in FIG. 19 , the locking yoke 1712 may include at least one, and preferably two, locking hooks 1718 adapted to contact corresponding locking lug portions 1256 that may be formed on the closure shuttle 1250. When the closure shuttle 1250 is in the inactivated position (i.e., the first drive system 1030 is inactivated and the anvil 2000 is open), the locking yoke 1712 may pivot distally to unlock the interchangeable shaft assembly 1200 from the housing 1012. In that position, the locking hooks 1718 are not in contact with the locking protrusion portions 1256 of the closure shuttle 1250. However, when the closure shuttle 1250 is moved to the activated position (i.e., the first drive system 1030 is activated and the anvil 2000 is in the closed position), the locking yoke 1712 may be prevented from pivoting to the unlocked position. In other words, if a clinician attempts to pivot the lock yoke 1712 to the unlocked position, or if, for example, the lock yoke 1712 is inadvertently pushed out or contacted in a manner that causes it to pivot distally, the lock hook 1718 of the lock yoke 1712 will contact the lock protrusion portion 1256 of the closure shuttle 1250, preventing the lock yoke 1712 from moving to the unlocked position.

[0202] The attachment of the interchangeable shaft assembly 1200 to the handle 1014 is described below. To begin the coupling process, the clinician may position the chassis 1240 of the interchangeable shaft assembly 1200 above or adjacent to the distal mounting flange 1700 of the frame 1020 so that the tapered mounting portion 1244 formed on the chassis 1240 is aligned with the dovetail slot 1702 of the frame 1020. The clinician may then move the shaft assembly 1200 along a mounting axis, which may be perpendicular to the shaft axis SA, to seat the mounting portion 1244 in operative engagement with the corresponding dovetail receiving slot 1702. In doing so, the shaft mounting lug 1226 on the intermediate firing shaft portion 1222 is also seated within the cradle 1126 of the longitudinally movable drive member 1120, and portions of the pin 1037 on the second closure link 1038 are received within corresponding hooks 1252 of the closure shuttle 1250. As used herein, the term "operably engaged" in the context of two components may mean that the two components are sufficiently engaged with one another such that, upon application of an actuation motion thereto, the components can perform an intended action, function, and / or procedure.

[0203] At least five systems of the interchangeable shaft assembly 1200 can be operably coupled to at least five corresponding systems of the handle 1014. A first system can include a frame system that couples and / or aligns the frame or spine of the shaft assembly 1200 with the frame 1020 of the handle 1014. Another system can include a closure drive system 1030 that can operably connect the closure trigger 1032 of the handle 1014, and the closure tube 1260 and anvil 2000 of the shaft assembly 1200. As generally described above, the closure shuttle 1250 of the shaft assembly 1200 can engage the pin 1037 of the second closure link 1038. Another system can include a firing drive system 1080 that can operably connect the firing trigger 1130 of the handle 1014 with the intermediate firing shaft portion 1222 of the shaft assembly 1200. As outlined above, the shaft mounting lug 1226 can be operably connected to the cradle 1126 of the longitudinal drive member 1120. Another system can include an electrical system that can signal a controller in the handle 1014, such as, for example, a microcontroller, that a shaft assembly, such as, for example, shaft assembly 1200, is operably engaged with the handle 1014, and / or secondarily conduct power and / or communication signals between the shaft assembly 1200 and the handle 1014. By way of example, the shaft assembly 1200 can include an electrical connector 1810 operably attached to the shaft circuit board 1610. The electrical connector 1810 can be configured to conformally mate with a corresponding electrical connector 1800 on the handle control board 1100. Further details regarding the circuitry and control system can be found in U.S. Patent Application Serial No. 13 / 803,086, now U.S. Patent Application Publication No. 2014 / 0263541, and U.S. Patent No. 9,913,642. A fifth system may include a latching system that releasably locks the shaft assembly 1200 to the handle 1014 .

[0204] The anvil 2000 in the illustrated example may include an anvil body 2002 terminating in an anvil mounting portion 2010. The anvil mounting portion 2010 may be movably or pivotally supported on the elongated channel 1310 and selectively pivotally movable relative to the elongated channel 1310 about a fixed anvil pivot axis PA, which may transverse the shaft axis SA. In the illustrated configuration, a pivot member or anvil trunnion 2012 may extend laterally from each lateral side of the anvil mounting portion 2010 and be received in a corresponding trunnion cradle 1316 formed in an upstanding wall 1315 of the proximal end portion 1312 of the elongated channel 1310. The anvil trunnion 2012 may be pivotally retained in the corresponding trunnion cradle 1316 by a channel cap or anvil retainer 1290. The channel cap or anvil retainer 1290 can have a pair of mounting lugs configured to be received and retained within corresponding lug grooves or notches formed in the upstanding wall 1315 of the proximal end portion 1312 of the elongated channel 1310. See FIG.

[0205] 20 , in at least one arrangement, the distal closure member or end effector closure tube 3050 may employ two axially offset proximal and distal positive jaw opening features 3060 and 3062. The positive jaw opening features 3060, 3062 may be configured to interact with corresponding relieved regions and stepped portions formed on the anvil mounting portion 2010, as described in further detail in U.S. Patent Application No. 15 / 635,631 (now U.S. Patent No. 10,639,037). Other jaw opening arrangements may also be used.

[0206] Figure 21 is a perspective view of another powered surgical stapling system. Figure 21 shows a conventional surgical cutting and fastening instrument 5010 configured to generate a rotational drive motion for operating a surgical end effector 5012. The endoscopic surgical instrument 5010 may have a handle 5006, a shaft 5008, and an articulating surgical end effector 5012 pivotally connected to the shaft 5008 at an articulation pivot point 5014. An articulation control 5016 may be provided adjacent the handle 5006 for rotating the end effector 5012 about the articulation pivot point 5014. It will be understood that various embodiments may include a non-pivoting end effector and thus may not have an articulation pivot point 5014 or an articulation control 5016.

[0207] The handle 5006 of the instrument 5010 may include a closure trigger 5018 and a firing trigger 5020 for actuating the end effector 5012. It will be understood that instruments having end effectors intended for different surgical tasks may have a different number or type of triggers or other suitable controls for manipulating the end effector 5012. In one embodiment, a clinician or operator of the instrument 5010 can articulate the end effector 5012 relative to the shaft 5008 by utilizing the articulation control 5016, as described in more detail in pending U.S. Patent No. 7,670,334, entitled "SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR," which is incorporated herein by reference in its entirety. In this example, the end effector 5012 can include, among other things, a staple channel 5022 and a pivotally translatable clamping member, such as an anvil 5024, which can be held at a distance to ensure effective stapling and severing of tissue clamped by the end effector 5012. The handle 5006 can have a pistol grip 5026 that allows a clinician to pivot and pull the closure trigger 5018 toward the pistol grip 5026 to clamp or close the anvil 5024 toward the staple channel 5022 of the end effector 5012, thereby clamping tissue located between the anvil 5024 and the channel 5022.

[0208] Examples of parameters that may be collected and communicated (e.g., as instructions for use, recommendations, and / or other information) during one or more modes of operation of a multimodal surgical instrument are presented in Figure 25. Various parameters that may be collected and communicated (e.g., as instructions for use, recommendations, and / or other information) during one or more modes of operation of a multimodal surgical instrument are disclosed in U.S. Patent Application No. 16 / 209,416, filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUD ANALYTICS" (now U.S. Patent Application Publication No. 2019 / 0206562), which is incorporated herein by reference in its entirety.

[0209] 25 shows an exemplary illustrative analysis. As shown, parameters collected by the surgical hub from a paired modular device 9050 can include, for example, firing force (e.g., the force required to advance the cutting member of a surgical stapling instrument through tissue), closing force (e.g., the force required to clamp the jaws of the surgical stapling instrument on tissue), power algorithm (i.e., the change in power of an electrosurgical or ultrasonic instrument over time in response to the internal state of the instrument and / or tissue conditions), tissue characteristics (e.g., impedance, thickness, stiffness, etc.), tissue gap (i.e., tissue thickness), and closure rate (i.e., the rate at which the jaws of the instrument clamp shut). It should be noted that the modular device 9050 data transmitted to the analysis system 9100 (shown in FIG. 13 ) is not limited to a single type of data, but can include multiple different data types paired with procedure outcome data. Procedure outcome data for a surgical procedure (or step thereof) may include, for example, whether there was bleeding at the surgical site, whether there was an air or fluid leak at the surgical site, and whether the staples at a particular staple line were properly formed. The procedure outcome data may further include or be associated with a positive or negative outcome, for example, as determined by the surgical hub 9000 or the analysis system 9100 (shown in FIG. 13 ). The procedure outcome data corresponding to the modular device 9050 data and the modular device 9050 perioperative data can be paired or otherwise associated with each other when uploaded to the analysis system 9100, such that the analysis system 9100 can recognize procedure outcome trends based on the underlying data of the modular device 9050 that produced each particular outcome. In other words, the analysis system 9100 can aggregate the modular device 9050 data and the procedure outcome data to search for trends or patterns in the underlying device module data 9050 that may indicate adjustments that can be made to the modular device 9050's control program.

[0210] In the depicted example, analysis system 9100 may receive modular device 9050 data and treatment outcome data (9202). Once transmitted to analysis system 9100, the treatment outcome data may be associated or paired with modular device 9050 data corresponding to the modular device 9050 operation that caused the particular treatment outcome. The modular device 9050 perioperative data and the corresponding treatment outcome data may be referred to as a data pair. The data is illustrated as including a first group 9212 of data associated with successful treatment outcomes and a second group 9214 of data associated with negative treatment outcomes. For the purposes of this particular example, a subset of the data 9212, 9214 received by analysis system 9100 (9202) is highlighted to further illustrate the concepts described herein.

[0211] For the first data pair 9212a, the modular device 9050 data may include force to close (FTC) over time, force to fire (FTF) over time, tissue type (parenchyma), tissue condition (the tissue is from a patient with emphysema and has been irradiated), how many times this has been fired against the instrument (3rd time), an anonymous timestamp (to protect patient confidentiality while still allowing the analysis system to calculate the elapsed time between firings and other such metrics), and an anonymous patient identifier (002). Procedure outcome data may include data indicating there was no bleeding, which corresponds to a successful outcome (e.g., successful firing of the surgical stapling instrument). For the second data pair 9212b, the modular device 9050 data may include the wait time before the instrument was fired (corresponding to the first firing of the instrument), the FTC over time, the FTF over time (indicating there was a force spike near the end of the firing stroke), the tissue type (1.1 mm vessel), the tissue condition (tissue irradiated), how many times this instrument was fired (1 time), an anonymous timestamp, and an anonymous patient identifier (002). The procedure outcome data includes data indicating there was a leak, which corresponds to a negative result (i.e., a failure to fire the surgical stapling instrument). For the third data pair 9212c, the modular device 9050 data may include the wait time before the instrument was fired (corresponding to the first firing of the instrument), the FTC over time, the FTF over time (indicating there was a force spike near the end of the firing stroke), the tissue type (1.8 mm vessel), the tissue condition (no significant condition), how many times this instrument was fired (1 time), an anonymous timestamp, and an anonymous patient identifier (012). The procedure outcome data may include data indicating that there was a leak, which corresponds to a negative result (i.e., a failure to fire the surgical stapling instrument). Again, it should be noted that this data is intended for illustrative purposes only to aid in understanding the concepts described herein and should not be construed as limiting the data received and / or analyzed by analysis system 9100 to generate control program updates.

[0212] Once analysis system 9100 receives 9202 perioperative data from a communicatively connected surgical hub 9000, it proceeds to aggregate and / or store the data according to the type of procedure (or steps thereof) associated with the data, the type of modular device 9050 that generated the data, and other such categories. By collating the data accordingly, analysis system 9100 can analyze the dataset to identify correlations between particular methods of controlling each particular type of modular device 9050 and positive or negative treatment outcomes. Based on whether a particular method of controlling a modular device 9050 can be correlated to a positive or negative treatment outcome, analysis system 9100 can determine 9204 whether the control program for the type of modular device 9050 should be updated.

[0213] In this particular example, analysis system 9100 may perform a first analysis 9216a of the data set by analyzing peak FTF 9213 (e.g., maximum FTF per particular firing of the surgical stapling instrument) against the number of firings 9211 per peak FTF value. In this exemplary case, analysis system 9100 may determine that there is no particular correlation between peak FTF 9213 and the occurrence of a positive or negative outcome for the particular data set. In other words, there is no clear distribution of peak FTF 9213 for positive and negative outcomes. Because there is no particular correlation between peak FTF 9213 and positive or negative outcomes, analysis system 9100 may therefore determine that a control program update to address this variable is not necessary. Further, analysis system 9100 may perform a second analysis 9216b of the data set by analyzing wait time 9215 before the instrument is fired against the number of firings 9211. For this particular analysis 9216b, analysis system 9100 may determine that there is a clear negative outcome distribution 9217 and a positive outcome distribution 9219. In this exemplary case, negative outcome distribution 9217 has a mean of 4 seconds, and the positive outcome distribution has a mean of 11 seconds. Accordingly, analysis system 9100 may determine that there is a correlation between wait time 9215 and the type of outcome for this surgical procedure step. That is, negative outcome distribution 9217 may indicate that there is a relatively large proportion of negative outcomes for wait times of 4 seconds or less. Based on this analysis 9216b demonstrating that there may be a large deviation between negative outcome distribution 9217 and positive outcome distribution 9219, analysis system 9100 may then determine (9204) that a control program update should be generated (9208).

[0214] If the analysis system 9100 analyzes the dataset and determines 9204 that adjustments to the control program of the particular modular device 9050 that is the subject of the dataset will improve the performance of the modular device 9050, the analysis system 9100 can generate a control program update 9208 accordingly. In this exemplary case, based on analysis 9216b of the dataset, the analysis system 9100 may determine that a control program update 9218 recommending a wait time of greater than 5 seconds will prevent 90% of the distribution of negative results at a 95% confidence interval. Alternatively, based on analysis 9216b of the dataset, the analysis system 9100 may determine that a control program update 9218 recommending a wait time of greater than 5 seconds will result in a greater proportion of positive results than negative results. Thus, the analysis system 9100 may determine that a particular type of surgical instrument should wait more than 5 seconds before firing under particular tissue conditions, such that negative results are less common than positive results. Based on analysis 9216b satisfying either or both of these constraints for generating 9208 a control program update determined by analysis system 9100, analysis system 9100 can generate 9208 a control program update for the surgical instrument that, under given circumstances, imposes a wait time of 5 seconds or more on the surgical instrument before the particular surgical instrument may be fired, or causes the surgical instrument to display a warning or recommendation to the user indicating that the user should wait at least 5 seconds before firing the instrument. Various other constraints may be utilized by analysis system 9100 in determining whether to generate 9208 a control program update, such as whether the control program update reduces the rate of negative outcomes by a particular percentage, or whether the control program update maximizes the rate of positive outcomes.

[0215] After the control program update 9218 is generated 9208, the analysis system 9100 can transmit 9210 the control program update 9218 for the appropriate type of modular device 9050 to the surgical hub 9000. In one example, when the modular device 9050 corresponding to the control program update 9218 is next connected to the surgical hub 9000 that downloaded the control program update 9218, the modular device 9050 then automatically downloads the update 9218. In another example, the surgical hub 9000 controls the modular device 9050 according to the control program update 9218, rather than the control program update 9218 being transmitted directly to the modular device 9050 itself.

[0216] In one aspect, the surgical system 9060 may be configured to push down software parameter and update verification if the modular device 9050 is detected to be out of date in the surgical hub 9000 data stream. In one example, the analysis system 9000 may be configured to send control program updates generated for a particular type of modular device 9050 to the surgical hub 9000. In one aspect, each time the modular device 9050 connects to the surgical hub 9000, the modular device 9050 determines whether an updated version of its control program is on or otherwise accessible via the surgical hub 9000. If the surgical hub 9000 has an updated control program for the particular type of modular device 9050 (or an updated control program is otherwise available from the analysis system 9100), the modular device 9050 downloads the control program update from there.

[0217] In one example, any data set sent to the analysis system 9100 includes the unique ID of the surgical hub 9000 and the current version of its control program or operating system. In one example, any data set sent to the analysis system 9100 may include the unique ID of the modular device 9050 and the current version of its control program or operating system. The unique ID of the surgical hub 9000 and / or modular device 9050 associated with the uploaded data may allow the analysis system 9100 to determine whether the data corresponds to the most recent version of the control program. The analysis system 9100 may, for example, choose not to take into account (or ignore) data generated by a modular device 9050 or surgical hub 9000 that is controlled by an older control program, and / or have an updated version of the control program pushed to the modular device 9050 or surgical hub 9000.

[0218] In one example, the operational versions of modular devices 9050 for which the surgical hub 9000 has updated control software may also be included in a surgical hub 9000 status data block that is periodically transmitted to the analysis system 9100. If the analysis system 9100 identifies that the operational version of the control program of any of the surgical hub 9100 and / or connectable modular devices 9050 is out of date, the analysis system 9100 can push the latest revision of the associated control program to the surgical hub 9000.

[0219] In one example, the surgical hub 9000 and / or modular device 9050 may be configured to automatically download any software updates. In another example, the surgical hub 9000 and / or modular device 9050 may be configured to provide a prompt to the user at the next setup step (e.g., between surgical procedures) asking whether the user wants to update an out-of-date control program. In another example, the surgical hub 9000 may be programmable by the user to never allow updates or to only allow updates of the modular device 9050 and not the surgical hub 9000 itself.

[0220] An example of cloud aggregation of data from hubs is provided in FIG. 26 . FIG. 26 illustrates a block diagram of a computer-implemented interactive surgical system 5700 in accordance with at least one aspect of the present disclosure. The system 5700 may include several surgical hubs 5706 that can detect and track data related to surgical procedures in which the surgical hubs 5706 (and modular devices paired to the surgical hubs 5706) are utilized in conjunction with, as described above. In one example, the surgical hubs 5706 may be connected to form a local network such that data tracked by the surgical hubs 5706 is aggregated together across the network. A network of surgical hubs 5706 may be associated with a medical facility, for example. Data aggregated from the network of surgical hubs 5706 may be analyzed to provide reports regarding data trends or recommendations. For example, the surgical hub 5706 at a first medical facility 5704a may be communicatively connected to a first local database 5708a, and the surgical hub 5706 at a second medical facility 5704b may be communicatively connected to a second local database 5708b. The network of surgical hubs 5706 associated with the first medical facility 5704a may be separate from the network of surgical hubs 5706 associated with the second medical facility 5704b, with aggregated data from each network of surgical hubs 5706 corresponding to each medical facility 5704a, 5704b individually. The surgical hub 5706 or another computer terminal communicatively connected to the databases 5708a, 5708b may be configured to provide reports or recommendations based on the aggregated data associated with each medical facility 5704a, 5704b. In this example, data tracked by the surgical hub 5706 can be utilized to report, for example, whether a particular incidence of a surgical procedure deviates from the average in-network time to complete a particular procedure type.

[0221] In another example, each surgical hub 5706 may upload tracked data to the cloud 5702, which may then be configured to process and aggregate the tracked data across multiple surgical hubs 5706, networks of surgical hubs 5706, and / or medical facilities 5704a, 5704b connected to the cloud 5702. Each surgical hub 5706 may then be utilized to provide reports or recommendations based on the aggregated data. In this example, the data tracked by the surgical hubs 5706 may be utilized to report, for example, whether a particular incidence of a surgical procedure has deviated from the average global time to complete a particular procedure type.

[0222] In another example, each surgical hub 5706 can be further configured to access the cloud 5702 and compare locally tracked data to global data aggregated from all surgical hubs 5706 communicatively connected to the cloud 5702. Each surgical hub 5706 can be configured to provide reports or recommendations based on a comparison of the tracked local data to local (i.e., in-network) or global norms. In this example, data tracked by a surgical hub 5706 can be utilized to report, for example, whether a particular incidence of a surgical procedure has deviated from either the average in-network time or the average global time to complete a particular procedure type.

[0223] In one example, each surgical hub 5706 or another computer system local to the surgical hub 5706 may be configured to locally aggregate data tracked by the surgical hub 5706, store the tracked data, and generate reports and / or recommendations according to the tracked data in response to queries. If the surgical hub 5706 is connected to a medical facility network (which may include additional surgical hubs 5706), the surgical hub 5706 may be configured to compare the tracked data with bulk medical facility data. The bulk medical facility data may include EMR data and aggregated data from the surgical hub's 5706's local network. In another example, the cloud 5702 may be configured to aggregate data tracked by the surgical hubs 5706, store the tracked data, and generate reports and / or recommendations according to the tracked data in response to queries.

[0224] Each surgical hub 5706 can provide reports on data trends and / or recommendations for improving the efficiency or effectiveness of the surgical procedure being performed. In various examples, the data trends and recommendations can be based on data tracked by the surgical hub 5706 itself, data tracked across a local medical facility network including multiple surgical hubs 5706, or data tracked across multiple surgical hubs 5706 communicatively connected to the cloud 5702. Recommendations provided by the surgical hub 5706 can describe, for example, a particular surgical instrument or product combination to utilize for a particular surgical procedure based on a correlation between the surgical instrument / product combination and patient outcomes and surgical efficiency. Reports provided by the surgical hub 5706 can describe, for example, whether a particular surgical procedure was performed efficiently relative to local or global norms, whether a particular type of surgical procedure being performed at the medical facility is being performed efficiently relative to global norms, and the average time taken to complete a particular surgical procedure or step of a surgical procedure for a particular surgical team.

[0225] For example, the surgical hub 5706 may be utilized to conduct performance tests by instrument type or cartridge type for various procedures. For example, the surgical hub 5706 may be utilized to conduct studies on the performance of individual surgeons. For example, the surgical hub 5706 may be utilized to conduct studies on the effectiveness of different surgical procedures according to patient characteristics or disease states. Examples of data aggregation and analysis are described in detail in U.S. Patent Application No. 15 / 940,668, filed March 29, 2018, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA" (now U.S. Patent Application Publication No. 2019 / 0201115), which is incorporated herein by reference in its entirety.

[0226] In one example, each surgical hub 5706 may be configured to determine when operating room events occur (e.g., via a situational awareness system) and then track the amount of time spent on each event. An operating room event may be an event whose occurrence the surgical hub 5706 is able to detect or infer. An operating room event may include, for example, a specific surgical procedure, a step or portion of a surgical procedure, or downtime between surgical procedures. Operating room events may be categorized according to event type, such as the type of surgical procedure being performed, allowing data from individual procedures to be aggregated to form a searchable dataset.

[0227] Data tracked by the surgical hub 5706 can be analyzed to provide more detailed metrics related to the surgical procedure or use of the surgical hub 5706 for example data sets. In one example, the surgical hub 5706 can be configured to determine whether a surgical procedure is occurring and then track both the amount of time spent between procedures (i.e., downtime) and the time spent in the procedure itself. The surgical hub 5706 can further be configured to determine and track the time spent on each individual step performed by medical personnel (e.g., surgeons, nurses, or janitors) either between or during the surgical procedure. The surgical hub can determine when a surgical procedure or different steps of a surgical procedure are occurring via a situational awareness system, which is described in further detail herein. Aggregation (e.g., cloud aggregation) of data (e.g., from the hub) is further described in U.S. Patent Application Serial No. 16 / 209,416 (now U.S. Patent Application Publication No. 2019 / 0206562).

[0228] A surgical instrument (e.g., a powered intelligent surgical stapler) may have a means for displaying instrument functional data to a surgical user. The displayed data may be based, for example, on the intercommunication capabilities of the instrument (e.g., surgical stapler), its accessories or consumables (e.g., cartridges), and the display system. Data communicated from the accessories or consumables (e.g., cartridges) to the user through the instrument may be or include one or more static cartridge functional aspects, or the accessory or consumable (e.g., cartridge) data may be interactively combined with other data (e.g., instrument actuator or configuration data) to provide a broader understanding (e.g., a more complete or overall context) of the instrument status.

[0229] The combined data may be (e.g., additionally) aggregated to determine, for example, tissue or functional data from system interactions with the surgical site. Some or all (e.g., aggregated) data may be transferred to a remote server or storage. A user may be enabled to review, aggregate, or use the stored data to provide insights for future use of the instrument (e.g., a stapler). Capabilities, such as instrument capabilities, features, and / or user interactions, permitted (e.g., and / or limited) by the system (e.g., an instrument control system) may be based on, for example, system capacity parameters (e.g., connection capabilities), system status parameters (e.g., bandwidth, interference, conductivity, current load level), system authorization parameters (e.g., compatibility, authorized (e.g., purchased) operating mode / tier level, parameters indicating authenticity), and / or control parameters (e.g., external control parameters) provided to the instrument by a hub or external remote server, such as software version, revision or update level, subscription level, interconnectivity with external / external systems, area of use, user input, or (e.g., secure) communication with an external database system.

[0230] The instruments may have operational mode (e.g., staged) control that can be controlled by the hub. In some examples, the surgical hub can control instrument authentication, operational mode, and communications. Information regarding surgical hub coordination and control is provided in U.S. Patent Application Serial No. 15 / 940,656, filed March 29, 2018, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES" (now U.S. Patent Application Publication No. 2019 / 0201141), which is incorporated herein by reference in its entirety.

[0231] Instruments can be initialized and may or may not be operationally upgraded, for example, based on mode / tier control. A surgical instrument may be initialized, for example, upon initial or subsequent power-on or wake-up. For example, a surgical instrument may wake up (e.g., turned on and powered up) and initialize, for example, by pairing with a surgical hub. A surgical instrument may initialize, for example, in an initial operating mode (e.g., default or entry-level mode). For example, a surgical instrument (e.g., upon initialization) may transmit initialization mode (e.g., Mode 1 or Tier 1) information to the hub. The surgical instrument may receive an operating mode instruction from the hub, which may be the same or different from the initialization mode. The instrument may receive (e.g., from the hub) operating parameters, instructions to download additional software, instructions to activate one or more functions, etc. (e.g., depending on the operating mode). Tiered operation (e.g., tiered access) of an instrument (e.g., an endocutter) may be controlled, for example, by the surgical hub. For example, the surgical instrument may receive instructions to download a software upgrade, e.g., to change operation from an initialization tier to another (e.g., higher or lower) tier. In one example, the surgical instrument may receive instructions to downgrade a mode / tier, e.g., by disabling functionality associated with the tier (e.g., an unauthorized or unsupported tier).

[0232] The surgical device may include communication capabilities, which may be wireless. For example, the instrument may have a Bluetooth communication array (e.g., to communicate with a hub). A wireless connection may be established between the instrument and the hub, for example, during instrument initialization. The instrument may provide information describing the instrument to the hub, such as one or more of a serial number, a model number, etc. The instrument may be configured with the ability to receive information (e.g., during initialization and / or operation). Communication bandwidth may vary between operational modes. For example, the instrument may have limited bandwidth during initialization (e.g., to download basic information). The instrument may be capable of and / or configurable for higher bandwidth communications following initialization and / or when promoted to another operational mode / tier. The hub may provide the instrument with improved firmware and / or software (e.g., communications software) to enable / support high-bandwidth, high-data-rate transfers (e.g., for real-time data transfers), for example, if the improved communications software is not pre-loaded on the device at initialization. An upgrade may include, for example, downloading and installing firmware (e.g., BIOS) and / or software. Data aggregation capabilities, internal memory usage, and / or other characteristics may also change with operational mode.

[0233] A processor within the surgical instrument may determine whether to enable or limit bidirectional communication. The initialized communication mode may be treated differently from the operational communication mode. For example, a first operational mode may include one-way communication (e.g., from the instrument to the hub), a second operational mode may include two-way communication, and a third operational mode may include interactive communication (e.g., with a local hub or other remote network portal).

[0234] 22-24 show examples of three operational modes (e.g., tiers) of a surgical instrument. Other examples may implement more or fewer tiers / modes with the same or different operational characteristics. The various levels / modes / tiers of instrument operation may vary in availability, access, level of use, level of interaction, and / or support of one or more features available through the instrument, such as sensors, communications, displays, storage, analytics, feedback, recommendations, or advice. In examples, the instrument processor may be configured to determine the operational mode based, for example, on instrument operational control parameters (e.g., one or more of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode indication received from a hub, and / or a tiered communication mode indication received from a remote server).

[0235] FIG. 22 illustrates exemplary surgical instrument operating modes. FIG. 22 illustrates an example of a first operating mode (e.g., Tier I). In an example of the first operating mode, the surgical instrument 11012 may engage in one-way communication with the surgical hub 11006 and provide information for display on the display 11025. A processor within the surgical instrument 11012, such as a surgical stapler, may obtain cartridge information (e.g., identification and / or authentication information), cartridge authentication information, status information (e.g., firing status information), error information, etc. Cartridge information may include, for example, cartridge identification information (e.g., color, type, length, serial number, etc.) and / or cartridge authentication information (e.g., verified origin, lot information, etc.). Status information may include instrument status (e.g., ready, fired, connected, etc.). Error information may include instrument or accessory (e.g., cartridge) errors (e.g., inability to read cartridge parameters, etc.). A surgical instrument 11012, such as a surgical stapler, may transmit cartridge identification information, cartridge authentication information, status information, error information, and / or other information, for example, to the surgical hub 11006 and / or the display 11025 (e.g., for display to a user). The information may be transmitted, for example, via a (e.g., wireless) transmitter (e.g., Bluetooth).

[0236] In one example, the first mode (e.g., Tier I) information may indicate that the powered endocutter was fired with a particular color cartridge, and the cartridge may be associated with a serial number. Such information may be used to annotate the procedure, for example, to describe how the powered endocutter was used. For example, the instrument processor may be configured to obtain staple cartridge information and instrument status information from the end effector (e.g., for removably storing surgical staple cartridges). The instrument processor may transmit the cartridge information and instrument status information to the surgical hub.

[0237] Figure 23 illustrates exemplary surgical instrument modes of operation. Figure 23 illustrates an example of a second mode of operation (e.g., Tier II). In an example of the second mode of operation, the surgical instrument 11012 may engage in bidirectional communication with the surgical hub 11006 and provide information to the display 11025 (e.g., for display to a user). The surgical hub 11006 may communicate with a remote server 11013. The second mode of operation may build on the first mode of operation (e.g., add capabilities or functionality to the first mode of operation).

[0238] Examples of interactive communication may include, for example, sensed information from the end effector (e.g., sensed parameters such as tissue thickness), sensed information from the handle (e.g., motor function, firing / closing force, etc.), usage information (e.g., clamp-to-fire time, user-controlled firing characterization, etc.), prioritization of information to display, location to display information, compiled recommendations from database analysis, etc. Information may be communicated, for example, to / from the operating room (OR) locally (e.g., within the OR) and / or to / from one or more systems outside the OR (e.g., cloud-based storage, etc.).

[0239] 27 shows an example flow for operating according to a surgical instrument operation mode. In one example, a surgical instrument may include a processor, a transmitter, and at least one sensor configured to provide a sensor signal (e.g., according to a physiological parameter of tissue). The processor may be configured to make one or more decisions and / or take one or more actions based on the instrument operation mode.

[0240] At 11510, a determination may be made based on the mode of operation whether to acquire a sensed parameter from a sensor. For example, a processor (e.g., within a surgical instrument) may determine (e.g., based on the instrument mode of operation) whether to acquire (e.g., and / or transmit) a sensed parameter associated with a sensor signal from a sensor.

[0241] One or more sensors may sense and provide (e.g., in a sensor signal) information from one or more portions (e.g., components or subcomponents) of a surgical instrument (e.g., a handle, end effector, knife, and / or clamp), for example. For example, numerous sensors are shown and described (e.g., in FIG. 19 ) in a surgical instrument with an adaptive control system in U.S. Patent Application No. 16 / 361,793, filed March 22, 2019, entitled “SURGICAL INSTRUMENT COMPRISING AN ADAPTIVE CONTROL SYSTEM” (now U.S. Patent Application Publication No. 2019 / 0314015), which is incorporated herein by reference in its entirety. Sensed information from the handle may include, for example, motor function, force to fire / close, etc.

[0242] The sensor can be configured to sense and provide a sensor signal according to a physiological parameter of the tissue. For example, a surgical instrument can have a tissue thickness sensing module including a sensor that generates a sensor signal (e.g., a tissue thickness signal) according to a physiological parameter of the tissue (e.g., tissue thickness), as shown and described with respect to Figures 7-15 of U.S. Pat. No. 9,345,481 and U.S. Patent Application No. 13 / 800,067 (now U.S. Patent Application Publication No. 2014 / 0263552). In one example, a surgical instrument (e.g., an endocutter or surgical stapler) can include a tissue thickness sensing module that can be located adjacent the distal end of the staple cartridge, for example. The tissue thickness sensing module can include a sensor and a controller. The sensor can be configured to generate a sensor signal, for example, a tissue thickness signal indicative of the thickness of the tissue (e.g., tissue located between an anvil and a staple cartridge of an end effector portion of the surgical instrument). The controller can be in signal communication with the sensor. The controller can include means for identifying a staple cartridge type of the staple cartridge. The staple cartridge type and tissue thickness can be used to determine, for example, whether the thickness of the tissue located between the anvil and the staple cartridge is within the optimal tissue thickness range for the staple cartridge.

[0243] In examples, display or analysis (e.g., at a hub or remote server) can combine sensed information with other information (e.g., interactively). For example, cartridge data may be interactively combined with instrument actuator or configuration data, e.g., to provide a broader understanding of (e.g., complete) instrument status. Cartridge data may correspond, for example, to the size or type of staple being fired by the instrument. Different types of staples may be utilized for different types of tissue. Usage information (e.g., clamp-to-fire time, characterization of user-controlled firing, etc.) may be displayed and / or processed, for example, in combination with sensed information and / or other information.

[0244] At 11520, a determination may be made based on the operating mode whether to receive information (e.g., instrument use instructions, operational information, and / or recommendations). For example, a processor (e.g., within the surgical instrument) may determine (e.g., based on the instrument operating mode) whether to receive information (e.g., from the hub 11006 or from the remote server 11013 via the surgical hub 11006).

[0245] The received information may include, for example, an identification of the tissue to be operated on or being operated on (e.g., based on instrument or component position tracking information). See, for example, FIG. 19 and accompanying description in U.S. Patent Application No. 16 / 361,793 (now U.S. Patent Application Publication No. 2019 / 0314015), which shows multiple sensors that may be used in a tracking system. The tracking procedure performed by the tracking system may be performed in a hub (e.g., surgical hub 11006). A processor in the instrument may receive position information from the tracking procedure in the hub.

[0246] The received information may include, for example, recommended use information (e.g., clamp-to-fire time, user-controlled firing characterization, etc.). The received information may include, for example, firing force, wait time / duration, velocity, clamp-to-fire time, etc. The received information may include, for example, information for display and / or information indicating whether to display on one or more displays (e.g., a display on the instrument handle, a display associated with a hub or other display system), prioritization of the information to display, where to display the information (e.g., on one or more display screens), etc. The received information may include, for example, instructions determined based on sensed information, the disease state in question, previous firing of a surgical instrument or device (e.g., an endocutter) and associated sensed information, etc. The received information may include, for example, a cartridge selection sequence / order.

[0247] The received information may include a recommendation to the surgeon whether another available stapler, another available energy device, and / or another stapler component (e.g., a staple cartridge, shaft, etc. available for use with the selected stapler / device) would be more optimal or optional. The received information may include a warning that a safety issue exists with the selected cartridge or stapler / device. Examples of recommendations based on safety systems are described in detail in U.S. Patent Application No. 16 / 024,075, filed June 29, 2018, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING" (now U.S. Patent Application Publication No. 2019 / 0201146), which is incorporated herein by reference in its entirety.

[0248] The received information may include, for example, situational awareness information. Recommendations may be indicated with a high priority level based on the anticipated surgical procedure and input from a situation-aware surgical hub. For example, an organ problem (e.g., stomach, lung, etc.) may be identified based on sensed information. Decisions may be made based on sensed information such as texture and / or compressibility (e.g., stomach tissue is very thick and highly incompressible, while lung tissue is very thick and highly compressible). Clamping operation recommendations (e.g., speed and timing) and firing operation recommendations (e.g., speed and timing of wait periods, etc.) may be determined based on tissue identification, for example.

[0249] Examples of situational awareness-based recommendations are presented with respect to Figures 9 and 10. Figure 9 is a diagram of an exemplary situational awareness surgical system. Figure 10 shows an exemplary surgical procedure and an exemplary timeline of estimates that the surgical hub can make from data detected at each step in the surgical procedure. Other examples of situational awareness-based recommendations are disclosed in U.S. Patent Application No. 16 / 182,246, filed November 6, 2018, entitled "ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES" (now U.S. Patent Application Publication No. 2019 / 0204201), which is incorporated herein by reference in its entirety.

[0250] At 11530, communication with the surgical hub may occur (e.g., via the instrument transmitter) based on the determination at 11510 or 11520. Communication with the surgical instrument (e.g., in the second mode / tier of operation) may include transmitting and / or receiving information using the transmitter and / or receiver, respectively (e.g., as shown by the example of FIG. 23 ). In an example, the instrument processor may be configured to acquire and transmit sensed parameters to the surgical hub, for example, based on a determination that the instrument operating mode supports acquiring sensed parameters. In an example, the instrument processor may be configured to receive instrument use instructions from the surgical hub via the receiver, for example, based on a determination that the instrument operating mode supports receiving instrument use instructions. The instrument processor may transmit the received instrument use instructions to a display. In an example, the instrument processor may be configured to receive cartridge information from the end effector. The instrument processor may determine whether to combine cartridge information with instrument use parameters (e.g., clamp-to-fire time and / or user-controlled firing characterization) based on the instrument operating mode. The instrument processor may transmit instrument usage parameters along with cartridge information to the surgical hub (e.g., via a transmitter) based on a determination that the instrument operating mode supports this capability.

[0251] Figure 24 illustrates an exemplary surgical instrument operating mode. Figure 24 illustrates an example of a third operating mode (e.g., Tier III). In an example of the third operating mode, the surgical instrument 11012 may engage in bidirectional communication with the surgical hub 11006 and provide information to the display 11025 (e.g., for display to a user). The surgical hub 11006 may communicate with a remote server 11013. The remote server 11013 may communicate with a storage 11022 that stores aggregated data. The remote server 11013 may communicate with a user portal 11026.

[0252] A third operational mode may build on the first and second operational modes described herein (e.g., add capabilities or functions to the first and second operational modes). In some examples, the third operational mode may add cloud storage of instrument usage, user accessibility, data aggregation, analysis, and recommendations. For example, the instrument processor may be configured (e.g., based on the operational mode) to determine whether to transmit information (e.g., instrument accessory information such as cartridge data) that may be interactively combined (e.g., by a remote / cloud server) with instrument actuator or configuration data (e.g., for aggregation). Information that may be stored and aggregated (e.g., with instrument usage information) may include, for example, one or more of physician identification information, procedure type, patient information, or disease state. The instrument processor may be configured to transmit the information to the hub and / or (e.g., directly) to a remote server.

[0253] The instrument processor may be configured to determine (e.g., based on an operational mode) whether to receive recommendations (e.g., instrument usage recommendations and / or accessory selection recommendations) based on stored information (e.g., aggregated historical / typical instrument usage information). For example, the recommendations may be recommended instrument usage information (e.g., stapler cartridge selection) generated based on aggregated instrument usage history data. For example, the recommendations may be stapler cartridge selection recommendations generated based on aggregated cartridge usage data associated with a procedure step (e.g., using an instrument).

[0254] The historical information stored, aggregated, analyzed, and used for recommendations may include information about previous procedures, such as type of procedure, tissue, tissue condition, type of accessory (e.g., cartridge) selected, and sequence of use in surgical instruments (e.g., surgical staplers). In various examples, the historical information may include one or more of the following: compiled recommendations from database analysis (e.g., based on aggregated data), surgeon identification information (e.g., Dr. X), procedure information (e.g., type of bariatric procedure), surgeon usage information (e.g., trends, predictions, typical usage), cartridge selection sequence / order, and / or display usage (e.g., on the instrument handle or hub display / display system).

[0255] The remote server may aggregate data from multiple surgeries and users (e.g., surgeons). The remote server may transmit the aggregated data and / or usage recommendations to the surgical instrument (e.g., directly or via a hub). The remote server may allow the user to review, aggregate, or use the stored data to provide insights for future use of the instrument (e.g., stapler).

[0256] A third instrument operating mode / tier may provide the user (e.g., a surgeon) with access to historical data (e.g., the user's own data). The surgeon may modify procedures over time (e.g., change the type, combination, and sequence of cartridge selections). Cartridges may be color-coded to indicate staple height, for example (e.g., gray, white, blue, green, gold, or gold, green, and black). Different staple heights may be used to staple tissue based on one or more variables, such as, for example, tissue type, tissue condition, and / or gap between tissues.

[0257] Cartridge selection and usage information associated with a surgeon may be stored for future review. Cartridge selection and usage information associated with a surgeon may be stored (e.g., over time). Surgical procedure information may be correlated with post-operative data such as post-operative leakage, secondary complications, and / or reoperation information.

[0258] Data analyses may be retrieved and viewed, for example, in user portal 11026. Information regarding data collection, data aggregation, surgical data analysis, and remote (e.g., cloud) server access to data and recommendations is disclosed in U.S. Patent Application Serial No. 15 / 940,679, filed March 29, 2018, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET" (now U.S. Patent Application Publication No. 2019 / 0201144), which is incorporated herein by reference in its entirety.

[0259] The remote (e.g., cloud) server 11013 may include an input / output interface configured to access data from multiple medical hub communication devices (e.g., including the surgical hub 11006). The medical hub may be communicatively coupled to at least one surgical instrument (e.g., the surgical instrument 11012). The remote server 11013 may include a processor configured to receive instrument usage information associated with a medical procedure performed by a user (e.g., a surgeon). The remote server processor may be configured to aggregate the received instrument usage information with historical usage information associated with the user. The processor may be configured to transmit the aggregated instruction usage information to, for example, a data analysis server, a hub (e.g., the surgical hub 11006), etc.

[0260] A remote server processor (e.g., within the remote server 11013) may be configured to correlate the received instrument usage information with the outcome of the medical procedure and / or instrument operation status during the medical procedure. The remote server processor may be configured to transmit the correlated information, for example, to a hub (e.g., the surgical hub 11006 for display to a user before, during, and / or after a medical procedure using the surgical instrument 11012). The remote server may transmit the correlated information, for example, as a reference before, during, and / or after the medical procedure.

[0261] A remote server processor (e.g., within the remote server 11013) may be configured to determine recommended instrument use information associated with an upcoming (e.g., or ongoing) medical procedure based on the correlation information. The remote server processor may be configured to transmit the recommended instrument use information, for example, to a hub (e.g., the surgical hub 11006 for display to a user before or during a medical procedure using the surgical instrument 11012).

[0262] Examples of the present disclosure Example 1. A surgical instrument including a sensor configured to provide a sensor signal according to a physiological parameter of tissue, a transmitter, and a processor configured to: determine whether to acquire a sensed parameter associated with the sensor signal from the sensor based on an instrument operating mode; determine whether to receive instrument usage instructions based on the instrument operating mode; and communicate with a surgical hub via the transmitter based on at least one of the determinations.

[0263] A surgical instrument according to Example 1 may selectively operate under one of several different instrument operating modes or hierarchies. The instrument operating modes may permit or restrict various instrument capabilities. The instrument capabilities that vary with the operating mode may include, for example, sensors, communications, displays, data storage, data access, data aggregation, data analysis, feedback, recommendations, and the like. Modes may vary with respect to communication capabilities, such as record keeping, data access and recall, data analysis, and surgical recommendations. Exemplary operating modes or hierarchies are described in connection with FIGS. 22-24 . The instrument operating mode may be determined by the surgical instrument according to instrument operating mode control parameters, which may refer to system parameters indicative of compatibility, such as connectivity, bandwidth, interference, conductivity, or the surgical facility's subscription level and authenticity. For example, a medical facility may require selected instrument capabilities to perform a particular procedure, which may be grouped into one or more instrument operating modes. According to Example 1, the surgical instrument determines whether to acquire sensed data from one or more sensors associated with the surgical instrument and whether to receive instrument use instructions from a surgical hub or a remote server based on an operational mode. For example, a surgical instrument (e.g., a surgical stapler) according to Example 1 may selectively receive recommended instrument use information (e.g., stapler cartridge selection) from the surgical hub that is generated based on aggregated instrument use history data (e.g., cartridge use data associated with a surgical procedure step).

[0264] Thus, Example 1 provides a smart surgical instrument with a control system capable of restricting or allowing different communication modes, e.g., one-way communication, two-way communication, and interactive communication with a local hub or remote server. The smart control system enables the implementation of tiered communication control according to instrument capabilities, system capacities such as intra-device and inter-device connectivity and bandwidth, or other control parameters, such as parameters provided by an external server. This provides control over selective data collection at the surgical instrument, selective data and information exchange between the surgical instrument and the surgical hub or remote server, and selective provision of data and instruction information to the user, for example, through a display associated with the surgical instrument. Thus, the user can be selectively provided with data and information, such as recommended instrument usage information, that is best suited to the instrument's operating mode. This can contribute to improved instrument operational safety and performance, surgical outcomes and quality, and patient safety.

[0265] Example 2. The surgical instrument of example 1, wherein the processor is further configured to acquire and transmit the sensed parameter to the surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameter.

[0266] Example 2 relates to an instrument operating mode in which one-way or two-way communication with a surgical hub is supported. A surgical instrument according to Example 2 is capable of acquiring and transmitting sensed parameters to the surgical hub, where the information may be stored, processed, and / or aggregated for use in connection with an ongoing or future procedure.

[0267] Example 3. The surgical instrument of any one of Examples 1 or 2, further comprising a receiver. The processor is further configured to receive instrument use instructions from the surgical hub via the receiver based on a determination that the instrument operating mode supports receiving instrument use instructions, and to transmit the instrument use instructions to the display.

[0268] Example 3 relates to an instrument operating mode in which bidirectional communication with the surgical hub for receiving instrument usage instructions is supported. Under this operating mode, the surgical instrument receives instrument usage instructions from the hub and displays the instructions, which can be used by the user to further improve the operation of the instrument and the outcome of the surgical activity.

[0269] Example 4. The surgical instrument of Examples 1 or 2, further comprising a receiver and an end effector for removably storing the surgical staple cartridge. The processor is further configured to receive cartridge information from the end effector, determine whether to combine the cartridge information with instrument usage parameters based on an instrument operating mode, the instrument usage parameters including at least one of clamp-to-fire time or a user-controlled firing characterization, and, based on the combining decision, transmit the instrument usage parameters along with the cartridge information to a surgical hub via the transmitter. The surgical stapling instrument according to Example 4 can control communication with the end effector to receive the cartridge information and interactively combine the cartridge information with instrument actuator or configuration data to provide a broader understanding of complete instrument status. The surgical instrument can further control communication with the surgical hub to selectively transmit combined instrument static and usage data to the surgical hub, where the combined data can be stored, processed, and / or aggregated to determine tissue or functional data from system interaction with the surgical site.

[0270] Example 5. The surgical instrument of any one of Examples 1-4, wherein the processor is further configured to determine an instrument operation mode based on an instrument operation control parameter. The instrument operation control parameter includes at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode indication received from the hub, or a tiered communication mode indication received from a remote server. Example 5 relates to determining an instrument operation mode. Thus, the surgical instrument is capable of determining an instrument operation mode according to the control parameter related to the system status or capacity and / or the tiered communication mode indication, and controlling communication with the end effector and the surgical hub in a manner as described in one of the above examples.

[0271] Example 6. The surgical instrument of any one of Examples 1-5, further comprising a receiver and an end effector for removably storing a surgical staple cartridge. The processor is further configured to obtain staple cartridge information and instrument status information from the end effector and transmit the cartridge information and instrument status information to a surgical hub. The surgical instrument of Example 6 is directed to a surgical stapler having an end effector for removably receiving a staple cartridge and capable of controlling communication with the end effector and communication with the surgical hub to selectively obtain and forward cartridge information and instrument status information to the surgical hub, where the combined data may be stored, processed, and / or aggregated.

[0272] Example 7. The surgical instrument of any one of Examples 1-6, wherein the processor is further configured to determine whether to receive recommended instrument usage information generated based on aggregated instrument usage history data based on an instrument operating mode. The instrument usage information includes stapler cartridge selection. The surgical instrument according to Example 7 is capable of controlling communication with an external device / system to selectively receive recommended instrument usage information that can be displayed or otherwise provided to a user. This allows for modification of the procedure over time.

[0273] Example 8. The surgical instrument of any one of Examples 1-7, wherein the processor is further configured to determine, based on an instrument operating mode, whether to receive a stapler cartridge selection recommendation generated based on aggregated cartridge usage data associated with a procedure. The surgical instrument according to Example 8 is capable of controlling communication with an external device / system to selectively receive a stapler cartridge selection recommendation generated based on the aggregated cartridge usage data. The recommendation may be displayed or otherwise provided to a user for selecting an appropriate cartridge for performing the surgical procedure, thereby further improving the outcome of the surgical procedure and / or patient safety.

[0274] Example 9. A remote server comprising: an input / output interface configured to access data from a plurality of medical hub communication devices, one or each of which is communicatively coupled to at least one surgical instrument; and a processor, wherein the processor is configured to: receive instrument usage information associated with a medical procedure performed by a surgeon; aggregate the received instrument usage information with instrument usage history information associated with the surgeon; and transmit the aggregated instrument usage information.

[0275] Example 10. The remote server of Example 9, wherein the processor is further configured to correlate the received instrument usage information with the outcome of the medical procedure and / or the instrument operation status during the medical procedure, and transmit the correlated information.

[0276] Example 11. A remote server as described in Example 9 or 10, wherein the processor is further configured to determine recommended instrument usage information associated with an upcoming medical procedure based on the correlated information, and to transmit the recommended instrument usage information.

[0277] Examples 9-11 relate to a remote server that can receive information from one or more surgical instruments, aggregate and / or correlate the information, or generate instrument usage recommendations, and transmit the aggregated or correlated information or recommendations to the surgical instruments, where the information or recommendations can be displayed or otherwise provided to the surgeon. This remote server can communicate with the surgical instruments and surgical hub as described in the above examples to provide useful information generated by cloud-based analysis.

[0278] Example 12. The method may include providing a sensor signal from a sensor according to a physiological parameter of the tissue; determining whether to acquire a sensed parameter associated with the sensor signal from the sensor based on an instrument operation mode; determining whether to receive an instrument use instruction based on the instrument operation mode; and communicating with a surgical hub via a transmitter based on at least one of the determinations.

[0279] Example 13. The method of example 12, wherein the method further includes acquiring and transmitting the sensed parameters to the surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameters.

[0280] Example 14. The method described in Example 12 or 13, wherein the method further includes receiving instrument use instructions from the surgical hub via the receiver based on a determination that the instrument operating mode supports receiving instrument use instructions, and transmitting the instrument use instructions to the display.

[0281] Example 15. The method of any one of Examples 12 to 14, further comprising: receiving cartridge information from an end effector for removably storing a surgical staple cartridge; determining whether to combine the cartridge information with instrument usage parameters based on an instrument operating mode, the instrument usage parameters including at least one of clamp-to-fire time or a characterization of user-controlled firing; and, based on the decision to combine, transmitting the instrument usage parameters together with the cartridge information to a surgical hub via a transmitter.

[0282] Example 16. The method of any one of Examples 12-15, wherein the method further includes determining the appliance operating mode based on an appliance operating control parameter. The appliance operating control parameter includes at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode indication received from the hub, or a tiered communication mode indication received from a remote server.

[0283] Example 17. The method described in any one of Examples 12 to 16, wherein the method further includes acquiring staple cartridge information and instrument status information from an end effector for removably storing a surgical staple cartridge, and transmitting the cartridge information and instrument status information to a surgical hub.

[0284] Example 18. The method of any one of Examples 12-17, wherein the method further includes determining whether to receive recommended instrument usage information generated based on the aggregated instrument usage history data based on an instrument operating mode. The instrument usage information includes stapler cartridge selection.

[0285] Example 19. The method of any one of Examples 12-18, wherein the method further includes determining, based on an instrument operating mode, whether to receive stapler cartridge selection recommendations generated based on aggregated cartridge usage data associated with the procedure.

[0286] Example 20. A method comprising receiving instrument usage information associated with a medical procedure performed by a surgeon, aggregating the received instrument usage information with instrument usage history information associated with the surgeon, and transmitting the aggregated instrument usage information.

[0287] Example 21. The method of Example 20, further comprising correlating the received instrument usage information with the outcome of the medical procedure and / or the instrument operation status during the medical procedure, and transmitting the correlated information.

[0288] Example 22. The method described in Example 20 or 21, further comprising determining recommended instrument use information associated with an upcoming medical procedure based on the correlated information, and transmitting the recommended instrument use information.

[0289] Example 23. A computer-readable medium may store program instructions that, when executed by a processor, perform a method including: providing a sensor signal from a sensor according to a physiological parameter of tissue; determining, based on an instrument operating mode, whether to acquire a sensed parameter associated with the sensor signal from the sensor; determining, based on the instrument operating mode, whether to receive an instrument use instruction; and, based on at least one of the determinations, communicating with a surgical hub via a transmitter.

[0290] Example 24. The computer-readable medium of Example 23, further storing program instructions that, when executed by a processor, perform a method further including acquiring and transmitting sensed parameters to a surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameters.

[0291] Example 25. A computer-readable medium as described in Example 23 or 24, further storing program instructions that, when executed by a processor, perform a method further including, for example, receiving instrument use instructions from a surgical hub via a receiver and transmitting the instrument use instructions to a display based on a determination that the instrument operating mode supports receiving instrument use instructions.

[0292] Example 26. A computer-readable medium described in any one of Examples 23 to 25, further storing program instructions that, when executed by a processor, perform a method including receiving cartridge information from an end effector for removably storing a surgical staple cartridge, determining whether to combine the cartridge information with instrument usage parameters based on an instrument operating mode, the instrument usage parameters including at least one of clamp-to-fire time or a characterization of user-controlled firing, and, based on the decision to combine, transmitting the instrument usage parameters along with the cartridge information to a surgical hub via a transmitter.

[0293] Example 27. The computer-readable medium of any one of Examples 23-26, further storing program instructions that, when executed by a processor, perform a method further including determining an appliance operating mode based on, for example, appliance operating control parameters, wherein the appliance operating control parameters include at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode indication received from a hub, or a tiered communication mode indication received from a remote server.

[0294] Example 28. A computer-readable medium described in any one of Examples 23 to 27, further storing program instructions that, when executed by a processor, perform a method further including obtaining staple cartridge information and instrument status information from an end effector for removably storing a surgical staple cartridge, and transmitting the cartridge information and instrument status information to a surgical hub.

[0295] Example 29. The computer-readable medium of any one of Examples 23-28, further storing program instructions that, when executed by a processor, perform a method further comprising determining, based on an instrument operating mode, whether to receive recommended instrument usage information generated based on aggregated instrument usage history data. The instrument usage information includes stapler cartridge selection.

[0296] Example 30. The computer-readable medium of any one of Examples 23-29 may further store program instructions that, when executed by a processor, perform a method further including determining, based on an instrument operating mode, whether to receive stapler cartridge selection recommendations generated based on aggregated cartridge usage data associated with a procedure step.

[0297] Example 31. A computer-readable medium storing program instructions that, when executed by a processor, perform a method including receiving instrument usage information associated with a medical procedure performed by a surgeon, aggregating the received instrument usage information with instrument usage history information associated with the surgeon, and transmitting the aggregated instrument usage information.

[0298] Example 32. A computer-readable medium as described in Example 31, further storing program instructions that, when executed by a processor, perform a method further including correlating the received instrument usage information with the outcome of the medical procedure and / or the instrument operation status during the medical procedure, and transmitting the correlated information.

[0299] Example 33. A computer-readable medium as described in Example 31 or 32, further storing program instructions that, when executed by a processor, perform a method further including: determining recommended instrument usage information associated with an upcoming medical procedure based on the correlated information; and transmitting the recommended instrument usage information.

[0300] The methods according to Examples 12 to 19 and the computer-readable medium described in Examples 23 to 30 correspond to the devices of Examples 1 to 8. Therefore, the above description regarding Examples 1 to 8 also applies to Examples 12 to 19 and 23 to 30. Similarly, the methods according to Examples 20 to 22 and the computer-readable medium described in Examples 31 to 33 correspond to the devices of Examples 9 to 11. Therefore, the above description regarding Examples 9 to 11 also applies to Examples 20 to 22 and 31 to 33.

[0301] The following list of embodiments forms part of this disclosure. Embodiment 1. A surgical instrument including a sensor configured to provide a sensor signal according to a physiological parameter of tissue, a transmitter, and a processor configured to: determine whether to acquire a sensed parameter associated with the sensor signal from the sensor based on an instrument operating mode; determine whether to receive instrument use instructions based on the instrument operating mode; and communicate with a surgical hub via the transmitter based on at least one of the determinations.

[0302] Embodiment 2. A surgical instrument as described in embodiment 1, wherein the processor is further configured to acquire and transmit sensed parameters to the surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameters.

[0303] Embodiment 3. A surgical instrument as described in embodiment 1, further comprising a receiver, wherein the processor is further configured to receive instrument use instructions from the surgical hub via the receiver and transmit the instrument use instructions to the display based on a determination that the instrument operating mode supports receiving instrument use instructions.

[0304] Embodiment 4. A surgical instrument as described in embodiment 1, further comprising a receiver and an end effector for removably storing a surgical staple cartridge, wherein the processor is further configured to receive cartridge information from the end effector, determine based on the instrument operating mode whether to combine the cartridge information with instrument usage parameters, the instrument usage parameters including at least one of clamp-to-fire time or a characterization of user-controlled firing, and, based on the decision to combine, transmit the instrument usage parameters together with the cartridge information to the surgical hub via the transmitter.

[0305] Embodiment 5. A surgical instrument as described in embodiment 1, wherein the processor is further configured to determine an instrument operation mode based on instrument operation control parameters, the instrument operation control parameters including at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode instruction received from a hub, or a tiered communication mode instruction received from a remote server.

[0306] Embodiment 6. A surgical instrument as described in embodiment 1, further comprising a receiver and an end effector for removably storing a surgical staple cartridge, wherein the processor is further configured to obtain staple cartridge information and instrument status information from the end effector and transmit the cartridge information and instrument status information to the surgical hub.

[0307] Embodiment 7. A surgical instrument as described in embodiment 1, wherein the processor is further configured to determine, based on the instrument operating mode, whether to receive recommended instrument usage information generated based on aggregated instrument usage history data, and the instrument usage information includes stapler cartridge selection.

[0308] Embodiment 8. A surgical instrument as described in embodiment 1, wherein the processor is further configured to determine, based on the instrument operating mode, whether to receive stapler cartridge selection recommendations generated based on aggregated cartridge usage data associated with the treatment step.

[0309] Embodiment 9. A remote server comprising: an input / output interface configured to access data from a plurality of medical hub communication devices, each of the medical hub communication devices being communicatively coupled to at least one surgical instrument; and a processor, the processor configured to receive instrument usage information associated with a medical procedure performed by a surgeon, aggregate the received instrument usage information with instrument usage history information associated with the surgeon, and transmit the aggregated instruction usage information.

[0310] Embodiment 10. A remote server as described in embodiment 9, wherein the processor is further configured to correlate the received instrument usage information with the outcome of the medical procedure and transmit the correlated information.

[0311] Embodiment 11. The remote server described in embodiment 10, wherein the processor is further configured to determine recommended instrument usage information associated with an upcoming medical procedure based on the correlated information, and to transmit the recommended instrument usage information.

[0312] Embodiment 12. A method comprising: providing a sensor signal from a sensor according to a physiological parameter of tissue; determining whether to acquire a sensed parameter associated with the sensor signal based on an instrument operation mode; determining whether to receive an instrument use instruction based on the instrument operation mode; and communicating with a surgical hub via a transmitter based on the determination.

[0313] Embodiment 13. The method of embodiment 12, further comprising acquiring and transmitting sensed parameters to the surgical hub based on a determination that the instrument operating mode supports acquiring sensed parameters.

[0314] Embodiment 14. The method of embodiment 12, further comprising receiving instrument use instructions from the surgical hub via the receiver based on a determination that the instrument operating mode supports receiving instrument use instructions, and transmitting the instrument use instructions to the display.

[0315] Embodiment 15. The method of embodiment 12, further comprising receiving cartridge information from an end effector for removably storing a surgical staple cartridge, determining whether to combine the cartridge information with instrument usage parameters based on an instrument operation mode, wherein the instrument usage parameters include at least one of clamp-to-fire time or a characterization of user-controlled firing, and based on the decision to combine, transmitting the instrument usage parameters together with the cartridge information to a surgical hub via a transmitter.

[0316] Embodiment 16. The method of embodiment 12, further comprising determining an appliance operating mode based on appliance operating control parameters, the appliance operating control parameters including at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a tiered communication mode indication received from a hub, or a tiered communication mode indication received from a remote server.

[0317] Embodiment 17. The method described in embodiment 12, further comprising obtaining staple cartridge information and instrument status information from an end effector for removably storing a surgical staple cartridge, and transmitting the cartridge information and instrument status information to a surgical hub.

[0318] Embodiment 18. The method of embodiment 12, further comprising determining whether to receive recommended instrument usage information generated based on aggregated instrument usage history data based on an instrument operating mode, wherein the instrument usage information includes stapler cartridge selection.

[0319] Embodiment 19. The method of embodiment 12, further comprising determining, based on the instrument operating mode, whether to receive stapler cartridge selection recommendations generated based on aggregated cartridge usage data associated with the treatment step.

[0320] [Embodiment] (1) A surgical instrument, a sensor configured to provide a sensor signal according to a physiological parameter of the tissue; A transmitter; a processor, the processor determining whether to acquire a sensed parameter associated with the sensor signal from the sensor based on an appliance operating mode; determining whether to receive appliance use instructions based on the appliance operating mode; and communicating with a surgical hub via the transmitter based on at least one of the determinations. (2) A surgical instrument as described in embodiment 1, wherein the processor is further configured to acquire and transmit the sensed parameters to the surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameters. (3) The apparatus further includes a receiver, wherein the processor: receiving the instrument use instructions from the surgical hub via the receiver based on a determination that the instrument operating mode supports receiving the instrument use instructions; 3. The surgical instrument of claim 1 or 2, further configured to transmit the instrument usage instructions to a display. (4) a receiver; an end effector for removably storing a surgical staple cartridge; the processor: receiving cartridge information from the end effector; determining whether to combine the cartridge information with an instrument usage parameter based on the instrument operating mode, the instrument usage parameter including at least one of a clamp-to-fire time or a user-controlled firing characterization; 3. The surgical instrument of claim 1 or 2, further configured to transmit the instrument usage parameters together with the cartridge information to the surgical hub via the transmitter based on the combination decision. (5) A surgical instrument according to any one of embodiments 1 to 4, wherein the processor is further configured to determine the instrument operating mode based on instrument operating control parameters, the instrument operating control parameters including at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a hierarchical communication mode instruction received from the hub, or a hierarchical communication mode instruction received from a remote server.

[0321] (6) a receiver; an end effector for removably storing a surgical staple cartridge; A surgical instrument as described in any of claims 1 to 5, wherein the processor is further configured to acquire staple cartridge information and instrument status information from the end effector and transmit the cartridge information and the instrument status information to the surgical hub. (7) A surgical instrument according to any one of claims 1 to 6, wherein the processor is further configured to determine, based on the instrument operation mode, whether to receive recommended instrument usage information generated based on aggregated instrument usage history data, and the instrument usage information includes stapler cartridge selection. (8) A surgical instrument according to any one of claims 1 to 7, wherein the processor is further configured to determine, based on the instrument operating mode, whether to receive a stapler cartridge selection recommendation generated based on aggregated cartridge usage data associated with a treatment step. (9) A remote server comprising: an input / output interface configured to access data from a plurality of medical hub communication devices, one or each of which is communicatively coupled to at least one surgical instrument; and a processor, the processor configured to receive instrument usage information associated with a medical procedure performed by a surgeon, aggregate the received instrument usage information with historical instrument usage information associated with the surgeon, and transmit the aggregated instrument usage information. (10) The remote server of embodiment 9, wherein the processor is further configured to correlate the received instrument usage information with the outcome of the medical procedure and / or instrument operation status during the medical procedure, and transmit the correlated information.

[0322] (11) The remote server of embodiment 9 or 10, wherein the processor is further configured to determine recommended instrument use information associated with an upcoming medical procedure based on the correlated information, and to transmit the recommended instrument use information. (12) A method comprising: providing a sensor signal from a sensor according to a physiological parameter of tissue; determining whether to acquire a sensed parameter associated with the sensor signal from the sensor based on an instrument operating mode; determining whether to receive an instrument use command based on the instrument operating mode; and communicating with a surgical hub via a transmitter based on at least one of the determinations. (13) The method of claim 12, further comprising acquiring and transmitting the sensed parameters to the surgical hub based on a determination that the instrument operating mode supports acquisition of the sensed parameters. (14) The method of embodiment 12 or 13, further comprising receiving the instrument use instruction from the surgical hub via the receiver based on a determination that the instrument operating mode supports receiving the instrument use instruction, and transmitting the instrument use instruction to a display. (15) receiving cartridge information from an end effector for removably storing a surgical staple cartridge; determining whether to combine the cartridge information with an instrument usage parameter based on the instrument operating mode, the instrument usage parameter including at least one of a clamp-to-fire time or a user-controlled firing characterization; A method according to any one of claims 12 to 14, further comprising transmitting the instrument usage parameters together with the cartridge information to the surgical hub via the transmitter based on the combination decision.

[0323] (16) A method according to any of embodiments 12 to 15, wherein the method further includes determining the appliance operating mode based on appliance operating control parameters, the appliance operating control parameters including at least one of a system capacity parameter, a system status parameter, a system authorization parameter, a hierarchical communication mode instruction received from the hub, or a hierarchical communication mode instruction received from a remote server. (17) A method according to any one of embodiments 12 to 16, further comprising acquiring staple cartridge information and instrument status information from the end effector for removably storing a surgical staple cartridge, and transmitting the cartridge information and th...

Claims

1. A surgical instrument comprising: A transmitter; a receiver; a processor, the surgical instrument is operable in a first mode of operation; When the surgical instrument operates in the first mode of operation, the processor can transmit information about the surgical instrument to a surgical hub via the transmitter, but cannot receive information from the surgical hub at the receiver; A surgical instrument, wherein a second operating mode can be added to the surgical instrument, and when the second operating mode is added to the surgical instrument, the processor can transmit information about the surgical instrument to the surgical hub via the transmitter and receive information from the surgical hub at the receiver, and the processor can transmit information about the surgical instrument to a remote server that is in communication with the surgical hub via the transmitter and the surgical hub, and receive information from the remote server via the surgical hub at the receiver.

2. 2. The surgical instrument of claim 1, wherein a third operating mode can be added to the surgical instrument, and when the third operating mode is added to the surgical instrument, the remote server can communicate with a storage that stores aggregated data, and the processor can receive the aggregated data stored in the storage at the receiver via the remote server and the surgical hub.

3. a sensor configured to provide a sensor signal according to a physiological parameter of the tissue; The surgical instrument of claim 1 , wherein the processor is capable of transmitting the sensor signal provided by the sensor to the surgical hub via the transmitter.

4. 1. A method of operating a processor included in a surgical instrument including a transmitter and a receiver, comprising: When the surgical instrument operates in a first mode of operation, the processor transmits information about the surgical instrument to a surgical hub via the transmitter, but does not receive information from the surgical hub at the receiver; A method of operating a processor, wherein when a second operating mode is added to the surgical instrument, the processor transmits information about the surgical instrument to the surgical hub via the transmitter and receives information from the surgical hub at the receiver, and the processor further transmits information about the surgical instrument to a remote server capable of communicating with the surgical hub via the transmitter and the surgical hub, and further receives information from the remote server via the surgical hub at the receiver.

5. 5. The method of claim 4, wherein when a third operating mode is added to the surgical instrument, the remote server communicates with a storage that stores aggregated data, and the processor receives the aggregated data stored in the storage at the receiver via the remote server and the surgical hub.

6. the surgical instrument further comprising a sensor configured to provide a sensor signal according to a physiological parameter of tissue; The method of claim 4 , wherein the processor transmits the sensor signal provided by the sensor to the surgical hub via the transmitter.

7. A computer program comprising: a processor is included in a surgical instrument that includes a transmitter and a receiver; When the computer program is executed by the processor, when the surgical instrument operates in a first operating mode, the processor transmits information about the surgical instrument to the surgical hub via the transmitter but does not receive information from the surgical hub at the receiver, and when a second operating mode is added to the surgical instrument, the processor transmits information about the surgical instrument to the surgical hub via the transmitter and receives information from the surgical hub at the receiver, and the processor transmits information about the surgical instrument to a remote server that is in communication with the surgical hub via the transmitter and the surgical hub, and the processor receives information from the remote server via the surgical hub at the receiver.

8. the computer program, when executed by the processor, adds a third operational mode to the surgical instrument; and the remote server communicates with storage that stores aggregate data; 8. The computer program of claim 7, wherein when the computer program is executed by the processor, the processor receives the aggregated data stored in the storage at the receiver via the remote server and the surgical hub.

9. the surgical instrument further comprising a sensor configured to provide a sensor signal according to a physiological parameter of tissue; The computer program of claim 7 , wherein when the computer program is executed by the processor, the processor transmits the sensor signal provided by the sensor to the surgical hub via the transmitter.

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