Communication capabilities of a smart stapler
Patent Information
- Application Number
- CN202180081209.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-10-02
- Filing Date
- 2021-09-29
- Publication Date
- 2026-10-16
- Estimated Expiration
- 2041-09-29
AI Technical Summary
成像系统可受到它们能够识别和/或传达给临床医生的信息的限制
Smart Images

Figure CN116583226B_ABST
Abstract
Description
[0001] Cross-reference to related applications
[0002] This application relates to the concurrently filed application entitled “METHOD FOR OPERATING TIERED OPERATIONMODES IN A SURGICAL SYSTEM” (Agent’s File No. END9287USNP1), the contents of which are incorporated herein by reference. Background Technology
[0003] Surgical systems are often integrated with imaging systems that allow clinicians to view the surgical site and / or one or more parts thereof on one or more monitors, such as a monitor. The monitors can be local to the operating room and / or remote. Imaging systems may include viewing mirrors with cameras that view the surgical site and transmit the view to a monitor accessible to the clinician. Viewing mirrors include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, duodenoscopes, colonoscopes, esophagogastric-duodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngoscopes-nephroscopes, sigmoidoscopes, thoracoscopes, ureteroscopes, and external endoscopes. Imaging systems may be limited by the information they can identify and / or convey to the clinician. For example, some imaging systems may not be able to identify certain hidden structures, physical contours, and / or dimensions in three-dimensional space during surgery. Additionally, some imaging systems may not be able to transmit and / or convey certain information to the clinician during surgery. Summary of the Invention
[0004] According to various embodiments of the present invention, the following examples are provided:
[0005] Example 1. A surgical instrument, comprising: a sensor configured to provide a sensor signal based on physiological parameters of a tissue; a transmitter; and a processor configured to: determine, based on an instrument operating mode, whether to acquire sensing parameters associated with the sensor signal from the sensor; determine, based on the instrument operating mode, whether to receive an instrument use instruction; and communicate with a surgical hub via the transmitter based on at least one of these determinations.
[0006] The surgical instruments according to Example 1 can selectively operate in one of a variety of different instrument operation modes or levels. Instrument operation modes can allow or limit instrument capabilities in different ways. Instrument capabilities that vary with the operation mode may include, for example, sensors, communication, displays, data storage, data access, data aggregation, data analysis, feedback, recommendations, etc. Modes can vary in communication capabilities, such as record keeping, data access and retrieval, data analysis, surgical recommendations, etc. Figures 22 to 24Exemplary operating modes or hierarchies are described. Instrument operating modes can be determined by a surgical instrument based on instrument operating mode control parameters or system parameters indicating compatibility, such as the surgical facility's subscription level and availability. These instrument operating mode control parameters may indicate connectivity, bandwidth, interference, and conduction. For example, a medical facility may require selected instrument capabilities to perform certain surgeries, which may be grouped into one or more instrument operating modes. According to Example 1, the surgical instrument determines, based on the operating mode, whether to obtain sensing data from one or more sensors associated with the surgical instrument and whether to receive instrument usage instructions from a surgical hub or a remote server. For example, a surgical instrument according to Example 1 (e.g., a surgical suture device) may selectively receive recommended instrument usage information (e.g., suture device selection) generated from a surgical hub based on aggregated historical instrument usage data (e.g., suturing device usage data associated with surgical procedures).
[0007] Taking Example 1 as an example, intelligent surgical instruments with control systems can restrict or allow different modes of communication, such as one-way communication, two-way communication, and interactive communication with a local hub or remote server. The intelligent control system enables hierarchical communication control based on instrument capabilities, system capabilities (such as intra- 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. Therefore, data and information, such as recommended instrument usage information, can be selectively provided to the user in accordance with the most suitable operating mode for the instrument. These can help improve the operational safety and performance of the instrument, the outcome and quality of surgical procedures, and patient safety.
[0008] Example 2. The surgical instrument according to Example 1, wherein the processor is further configured to obtain the sensing parameters based on the determination of the sensing parameters supported by the instrument operating mode, and to send the sensing parameters to the surgical hub.
[0009] Example 2 relates to an instrument operating mode in which one-way or two-way communication with a surgical hub is supported. The surgical instrument according to Example 2 is capable of acquiring sensed parameters and sending them to a surgical hub, where the information can be stored, processed, and / or aggregated for use in relation to ongoing or future surgeries.
[0010] Example 3. The surgical instrument according to Example 1 or 2 further includes: a receiver. The processor is further configured to: support the determination of receiving an instrument use instruction based on the instrument operating mode, receive the instrument use instruction from the surgical hub via the receiver; and send the instrument use instruction to a display.
[0011] Example 3 relates to an instrument operation mode that supports bidirectional communication with a surgical hub for receiving instrument usage instructions. In this operation mode, the surgical instrument receives and displays instrument usage instructions from the hub, which can be used by the user to further manipulate the instrument and the results of surgical activities.
[0012] Example 4. The surgical instrument according to Example 1 or 2 further includes: a receiver; and an end effector for removably storing a surgical staple cartridge. The processor is further configured to: receive cartridge information from the end effector; determine, based on an instrument operating mode, whether to combine the cartridge information with instrument usage parameters, wherein the instrument usage parameters include at least one of a time from clamping to firing or a characterization of user-controlled firing; and, based on the determination of combination, transmit the instrument usage parameters and the cartridge information to the surgical hub via a transmitter. The surgical suture instrument according to Example 4 can control communication with the end effector to receive cartridge information and interactively combine the cartridge information with instrument actuators or configuration data to provide a broader understanding of the overall instrument status. The surgical instrument can also control communication with the surgical hub to selectively transmit combined static and usage data of the instrument to the surgical hub, where the combined data can be stored, processed, and / or aggregated to determine tissue or functional data from system-surgical site interactions.
[0013] Example 5. A surgical instrument according to any one of Examples 1 to 4, wherein the processor is further configured to determine an instrument operating mode based on instrument operating control parameters. These instrument operating control parameters include at least one of: system capacity parameters, system condition parameters, system authorization parameters, hierarchical communication mode indication received from a hub, or hierarchical communication mode indication received from a remote server. Example 5 relates to the determination of an instrument operating mode. The surgical instrument is thus able to determine the instrument operating mode based on control parameters and / or hierarchical communication mode indications related to the system's condition or capability, and to control communication with the end effector and surgical hub in a manner as described in one of the examples above.
[0014] Example 6. The surgical instrument according to any of the foregoing examples further includes: a receiver; and an end effector for removably storing a surgical cartridge. The processor is further configured to obtain cartridge information and instrument status information from the end effector; and to transmit the cartridge information and the instrument status information to a surgical hub. The surgical instrument according to Example 6 relates to a surgical stapler having an end effector for removably receiving a cartridge, and being capable of controlling communication with the end effector and with a surgical hub to selectively obtain cartridge information and instrument status information and transmit such cartridge information and instrument status information to the surgical hub, where combined data can be stored, processed, and / or aggregated.
[0015] Example 7. A surgical instrument according to any of the foregoing examples, wherein the processor is further configured to determine, based on the instrument's operating mode, whether to receive recommended instrument usage information generated based on aggregated historical instrument usage data. This instrument usage information includes a suture chamber selection. The surgical instrument according to Example 7 can control communication with external devices / systems to selectively receive recommended instrument usage information, which may be displayed or otherwise provided to the user. This allows the surgery to vary over time.
[0016] Example 8. A surgical instrument according to any of the foregoing examples, wherein the processor is further configured to determine, based on the instrument's operating mode, whether to receive a stapler cartridge selection recommendation generated based on aggregated stapler cartridge usage data associated with the surgical procedure. The surgical instrument according to Example 8 is capable of controlling communication with external devices / systems to selectively receive stapler cartridge selection recommendations generated based on aggregated stapler cartridge usage data. This recommendation may be displayed or otherwise provided to the user for selecting an appropriate cartridge to perform the surgical procedure, thereby further improving surgical outcomes and / or patient safety.
[0017] Example 9. A remote server comprising: an input / output interface configured to access data from a plurality of medical hub communication devices, wherein one or each of the medical hub communication devices is communicatively coupled to at least one surgical instrument; and a 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.
[0018] Example 10. The remote server according to Example 9, wherein the processor is further configured to associate the received instrument usage information with the outcome of a medical procedure and / or the instrument operation status during the medical procedure; and to send the associated information.
[0019] Example 11. The remote server according to Example 9 or 10, wherein the processor is further configured to determine, based on the associated information, recommended device usage information associated with the upcoming medical procedure; and to send the recommended device usage information.
[0020] Using Examples 9 to 11 as examples, a remote server can receive information from one or more surgical instruments, aggregate and / or correlate that information, or generate instrument usage recommendations, and send 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. The remote server can communicate with surgical instruments and surgical hubs as described in the examples above to provide useful information generated by cloud-based analytics.
[0021] Example 12. A method may include: providing a sensor signal from a sensor based on physiological parameters of a tissue; determining, based on an instrument operating mode, whether a sensing parameter associated with the sensor signal from the sensor is acquired; determining, based on the instrument operating mode, whether an instrument use instruction is received; and communicating with a surgical hub via a transmitter based on at least one of these determinations.
[0022] Example 13. The method according to Example 12, wherein the method further includes: determining the sensing parameters based on the instrument operation mode support, obtaining the sensing parameters, and sending the sensing parameters to the surgical hub.
[0023] Example 14. The method according to Example 12 or 13, wherein the method further comprises: determining, based on the instrument operation mode, a support for receiving an instrument use instruction; receiving the instrument use instruction from a surgical hub via the receiver; and sending the instrument use instruction to a display.
[0024] Example 15. The method according to any one of Examples 12 to 14, wherein the method further comprises: receiving cartridge information from an end effector for removably storing a surgical cartridge; determining, based on a device operating mode, whether to combine the cartridge information with device usage parameters, wherein the device usage parameters include at least one of a time from clamping to firing or a characterization of user-controlled firing; and, based on the determination of the combination, transmitting the device usage parameters and the cartridge information to the surgical hub via a transmitter.
[0025] Example 16. The method according to any one of Examples 12 to 15, wherein the method further comprises determining an instrument operating mode based on instrument operating control parameters. The instrument operating control parameters include at least one of: system capacity parameters, system condition parameters, system authorization parameters, hierarchical communication mode indication received from a hub, or hierarchical communication mode indication received from a remote server.
[0026] Example 17. The method according to any one of Examples 12 to 16, wherein the method further comprises: obtaining cartridge information and instrument status information from an end effector for removably storing a surgical cartridge; and sending the cartridge information and the instrument status information to a surgical hub.
[0027] Example 18. The method according to any one of Examples 12 to 17, wherein the method further comprises: determining, based on the instrument operating mode, whether to receive recommended instrument usage information generated based on aggregated historical instrument usage data. The instrument usage information includes a suture compartment selection.
[0028] Example 19. The method according to any one of Examples 12 to 18, wherein the method further comprises determining, based on the instrument operation mode, whether to receive a stapler cartridge selection recommendation generated based on aggregated stapler cartridge usage data associated with the surgical step.
[0029] Example 20. A method comprising: receiving instrument use information associated with a medical procedure performed by a surgeon; aggregating the received instrument use information with historical instrument use information associated with the surgeon; and sending the aggregated instruction use information.
[0030] Example 21. The method according to Example 20 further includes: associating the received device usage information with the outcome of the medical procedure and / or the device operation status during the medical procedure; and sending the associated information.
[0031] Example 22. The method according to Example 20 or 21 further includes: determining recommended device use information associated with the upcoming medical procedure based on the associated information; and sending the recommended device use information.
[0032] Example 23. A computer-readable medium capable of storing program instructions that, when executed by a processor, perform a method comprising the steps of: providing sensor signals from a sensor based on physiological parameters of a tissue; determining, based on an instrument operating mode, whether to acquire sensing parameters associated with the sensor signals from the sensor; determining, based on the instrument operating mode, whether to receive an instrument use instruction; and, based on at least one of these determinations, communicating with a surgical hub via a transmitter.
[0033] Example 24. According to the computer-readable medium of Example 23, additionally storing program instructions that, when executed by a processor, perform a method further comprising the following steps: determining a sensing parameter based on instrument operation mode support, obtaining the sensing parameter, and sending the sensing parameter to a surgical hub.
[0034] Example 25. The computer-readable medium according to Example 23 or 24 further stores program instructions that, when executed by a processor, perform a method including the following steps: for example, determining, based on a device operation mode, to receive a device use instruction from a surgical hub via a receiver; and sending the device use instruction to a display.
[0035] Example 26. A computer-readable medium according to any one of Examples 23 to 25, further storing program instructions that, when executed by a processor, perform a method comprising the steps of: receiving cartridge information from an end effector for removably storing a surgical cartridge; determining, based on a device operating mode, whether to combine the cartridge information with device usage parameters, wherein the device usage parameters include at least one of a time from clamping to firing or a characterization of user-controlled firing; and, based on the determination of the combination, transmitting the device usage parameters and the cartridge information to the surgical hub via a transmitter.
[0036] Example 27. A computer-readable medium according to any one of Examples 23 to 26, further storing program instructions that, when executed by a processor, perform a method including the following steps: for example, determining an instrument operating mode based on instrument operating control parameters. The instrument operating control parameters include at least one of: system capacity parameters, system condition parameters, system authorization parameters, a hierarchical communication mode indication received from a hub, or a hierarchical communication mode indication received from a remote server.
[0037] Example 28. A computer-readable medium according to any one of Examples 23 to 27, further storing program instructions that, when executed by a processor, perform a method comprising the steps of: obtaining cartridge information and instrument status information from an end effector for removably storing a surgical cartridge; and sending the cartridge information and the instrument status information to a surgical hub.
[0038] Example 29. The computer-readable medium according to any one of Examples 23 to 28 further stores program instructions, and additionally stores program instructions that, when executed by a processor, perform a method comprising the steps of: determining, based on a device operating mode, whether to receive recommended device usage information generated based on aggregated historical device usage data. The device usage information includes a suture compartment selection.
[0039] Example 30. A computer-readable medium according to any one of Examples 23 to 29, further storing program instructions that, when executed by a processor, perform a method comprising the following steps: determining, based on an instrument operating mode, whether to receive a stapler cartridge selection recommendation generated based on aggregate stapler cartridge usage data associated with a surgical step.
[0040] Example 31. A computer-readable medium storing program instructions that, when executed by a processor, perform a method comprising the steps of: receiving instrument usage information associated with a medical procedure performed by a surgeon; aggregating the received instrument usage information with historical instrument usage information associated with the surgeon; and transmitting the aggregated instruction usage information.
[0041] Example 32. According to the computer-readable medium of Example 31, additionally storing program instructions that, when executed by a processor, perform a method further comprising the steps of: associating received instrument usage information with the outcome of a medical procedure and / or the instrument operating status during the medical procedure; and sending the associated information.
[0042] Example 33. According to the computer-readable medium of Example 31 or 32, additionally storing program instructions that, when executed by a processor, perform a method further comprising the steps of: determining recommended device use information associated with an upcoming medical procedure based on the associated information; and sending the recommended device use information.
[0043] The methods described according to Examples 12 to 19 and the computer-readable media described in Examples 23 to 30 correspond to the devices described in Examples 1 to 8. The above discussion regarding Examples 1 to 8 therefore also applies to Examples 12 to 19 and 23 to 30. Similarly, the methods described according to Examples 20 to 22 and the computer-readable media described in Examples 31 to 33 correspond to the devices described in Examples 9 to 11. The above discussion regarding Examples 9 to 11 therefore also applies to Examples 20 to 22 and 31 to 33.
[0044] According to another embodiment of the invention, surgical instruments (such as surgical suture devices) may have multiple operating modes that provide different combinations of communication, interaction, support, and / or other capabilities. Instrument operating modes can be selected from multiple operating modes, which may be pre-configured, dynamically updated, semi-dynamically updated, periodically updated, or preset. Multimodal instrument operation can control the availability, access, usage level, interaction level, and / or support of one or more capabilities available through the instrument. Instrument operating modes may allow or restrict instrument capabilities in different ways. Instrument capabilities authorized by an operating mode may be unlocked, configured, or downloaded and installed in different ways. The residency capabilities of a surgical instrument not authorized by an operating mode may be unused, locked, or otherwise prevented. Instrument capabilities that vary with operating modes may include, for example, sensors, communication, displays, data storage, data access, data aggregation, data analysis, feedback, recommendations, etc. In some specific embodiments, multimodal surgical instruments can operate fully in multiple operating modes. Modes may vary depending on communication capabilities, such as record keeping, data access and retrieval, data analysis, surgical recommendations, etc.
[0045] The device can be configured to determine the device operating mode based on one or more device operating 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 connectivity); system condition parameters (e.g., bandwidth, interference, conductivity, current load level); device authorization parameters (e.g., parameters indicating compatibility, authorized (purchased or subscribed) device operating modes, device authenticity); and / or external control parameters (e.g., provided by a surgical hub or remote / cloud server), such as software version, revision or update level, subscription level, interconnectivity with external / external systems, usage area, user input, or (e.g.,) communication with external database systems.
[0046] Device operating mode control parameters may include consumer-controlled parameters, such as subscription levels. For example, a healthcare facility may purchase a subscription to selected device capabilities, which may be grouped into one or more device operating modes.
[0047] For example, a surgical instrument can determine whether to acquire sensing parameters associated with a sensor signal from a sensor based on its operating mode. The surgical instrument can also determine whether to receive an instrument usage instruction based on its operating mode. Based on this determination, the surgical instrument can communicate with a surgical hub.
[0048] For example, a surgical instrument may determine whether to receive recommended instrument usage information (e.g., stapler cartridge selection) based on aggregated historical instrument usage data, based on its instrument operating mode. The surgical instrument may also determine whether to receive stapler cartridge selection recommendations based on aggregated stapler cartridge usage data associated with surgical procedures, based on its instrument operating mode. The surgical instrument may then communicate with the surgical hub based on this determination.
[0049] For example, a remote server may receive instrument usage information associated with a medical procedure performed by a surgeon based on the surgical instrument operating mode, aggregate the received instrument usage information with the surgeon's associated historical instrument usage information, and send the aggregated instruction usage information to the surgical instrument (e.g., directly or via a surgical hub). The remote server may also correlate the received instrument usage information with the outcome of the medical procedure and with the instrument operating status during the medical procedure based on the surgical instrument operating mode; and send the relevant information to the surgical instrument (e.g., directly or via a surgical hub). Furthermore, the remote server may determine recommended instrument usage information associated with an upcoming medical procedure based on the relevant information, and send the recommended instrument usage information to the surgical instrument (e.g., directly or via a surgical hub).
[0050] In an exemplary surgical instrument operating mode, the surgical instrument may perform unidirectional communication during operation (e.g., after initialization, it may support limited bidirectional communication) by sending information (e.g., surgical information, such as stapler type and / or ID, errors, instrument status) to a surgical hub. The surgical hub may then send the received information to a remote server (e.g., a remote processing server and / or a cloud-based remote database).
[0051] In an exemplary surgical instrument operating mode, the surgical instrument can communicate bidirectionally by sending and receiving information from a surgical hub, which can then transmit the received information to a remote server (e.g., a teleprocessing server and / or a cloud-based remote database). The surgical instrument can receive information (e.g., surgical recommendations) based on the information sent to the surgical hub and / or the remote server (e.g., surgical procedures, sensed parameters, instrument usage information). The surgical hub and / or the remote server can analyze historical information to present recommendations (e.g., force used for firing, latency, information displayed on one or more displays).
[0052] In an exemplary surgical instrument operating mode, the surgical instrument can communicate bidirectionally by sending and receiving information from a surgical hub. The surgical hub can send the received information to a remote server (e.g., a teleprocessing server and / or a cloud-based remote database). The surgical instrument can receive information (e.g., surgical recommendations) based on the information sent to the surgical hub and / or the remote server (e.g., surgical procedures, sensed parameters, instrument usage information), which can be analyzed from historical information to present recommendations (e.g., force used for firing, latency, information displayed on one or more displays). The surgical instrument can determine, based on the surgical instrument operating mode, whether to send various surgical information to the surgical hub and / or the remote server for archiving, subsequent retrieval, data aggregation, analysis, and / or recommendation. Archived surgical information can be aggregated with historical information of a specific user (e.g., a surgeon) and / or information received from other surgical hubs and / or surgical information associated with other medical facilities. Access to the aggregated information can generate instruction information for one or more surgical instruments. In one example, aggregated information may include information received from a smart surgical device, information associated with multiple surgical procedures, surgical information, and corresponding results associated with multiple patients. Aggregated information may be stored in a remote database. In one example, surgical information may be aggregated at a remote server. Surgical instruments may determine, for example, whether to receive historical data, aggregated data, or make recommendations based on aggregated historical data, based on the surgical instrument's operating mode. Attached Figure Description
[0053] Figure 1 This is a block diagram of a computer-implemented interactive surgical system.
[0054] Figure 2 An exemplary surgical system for performing surgical procedures in an operating room is shown.
[0055] Figure 3 An exemplary surgical hub, according to at least one aspect of this disclosure, is shown for pairing with a visualization system, a robotic system, and a smart instrument.
[0056] Figure 4 A surgical data network according to at least one aspect of this disclosure is shown, the surgical data network having a communication hub configured to connect modular devices located in one or more operating rooms of a medical facility or any room in a medical facility specifically equipped for surgery to the cloud.
[0057] Figure 5 An exemplary computer-implemented interactive surgical system is shown.
[0058] Figure 6 An exemplary surgical hub is shown, comprising multiple modules coupled to a modular control tower.
[0059] Figure 7 An exemplary surgical instrument or tool is shown.
[0060] Figure 8 An exemplary surgical instrument or tool is shown, which has a motor that can be activated to perform various functions.
[0061] Figure 9 This is a diagram of an exemplary situational awareness surgical system.
[0062] Figure 10 The timeline of an exemplary surgical procedure is shown, along with inferences drawn from data detected by the surgical hub at each step of the procedure.
[0063] Figure 11 This is a block diagram of a computer-implemented interactive surgical system.
[0064] Figure 12 The functional architecture of an exemplary computer-implemented interactive surgical system is shown.
[0065] Figure 13 An exemplary computer-implemented interactive surgical system is shown, which is configured to adaptively generate control program updates for modular devices.
[0066] Figure 14 An exemplary surgical system is shown, which includes a handle having a controller and a motor, an adapter releasably coupled to the handle, and a loading unit releasably coupled to the adapter.
[0067] Figure 15A An exemplary process for determining an operating mode and operating within that mode is shown.
[0068] Figure 15B An exemplary process for changing the operating mode is shown.
[0069] Figure 16 A perspective view of an electric surgical suture system.
[0070] Figure 17 for Figure 16 Perspective view of interchangeable surgical shaft components of an electric surgical suture system.
[0071] Figure 18 for Figure 16 An exploded assembly view of multiple parts of the handle assembly of an electric surgical suture system.
[0072] Figure 19 for Figure 17 Exploded assembly view of interchangeable surgical shaft components.
[0073] Figure 20 for Figure 19 Another partially exploded assembly view of a part of the interchangeable surgical shaft assembly.
[0074] Figure 21 A perspective view of another electric surgical suture system.
[0075] Figure 22 An exemplary surgical instrument operation mode is shown.
[0076] Figure 23 An exemplary surgical instrument operation mode is shown.
[0077] Figure 24 An exemplary surgical instrument operation mode is shown.
[0078] Figure 25 A diagram illustrating an illustrative analysis system for updating surgical instrument control procedures according to at least one aspect of this disclosure.
[0079] Figure 26 This is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure.
[0080] Figure 27 An exemplary procedure for operating according to a surgical instrument operation mode is shown. Detailed Implementation
[0081] The applicant of this application holds the following U.S. patent applications, each of which is incorporated herein by reference in its entirety:
[0082] • U.S. Patent Application Serial No. 15 / 940,656, entitled “SURGICAL HUB COORDINATION OF CONTROLAND COMMUNICATION OF OPERATING ROOM DEVICES”, filed on March 29, 2018, is now published as U.S. Patent Application No. 2019 / 0201141.
[0083] • U.S. Patent Application Serial No. 16 / 361,793, entitled “SURGICAL INSTRUMENT COMPRISING ANADAPTIVE CONTROL SYSTEM”, filed on March 22, 2019, is now published as U.S. Patent Application Publication No. 20190314015;
[0084] • U.S. Patent Application Serial No. 13 / 803,086 entitled “ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATIONLOCK” is now published as U.S. Patent Application No. 2014 / 0263541;
[0085] • U.S. Patent Application Serial No. 13 / 800,067, entitled “STAPLE CARTRIDGE TISSUE THICKNESSSENSOR SYSTEM”, filed on March 13, 2013, is now published as U.S. Patent Application No. 2014 / 0263552.
[0086] • U.S. Patent Application Serial No. 16 / 024,075, entitled “SAFETY SYSTEMS FOR SMART POWEREDSURGICAL STAPLING”, filed on June 29, 2018, is now published as U.S. Patent Application No. 2019 / 0201146;
[0087] • U.S. Patent Application Serial No. 16 / 182,246, entitled “ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES”, filed on November 6, 2018, is now published as U.S. Patent Application No. 2019 / 0204201.
[0088] • U.S. Patent Application Serial No. 15 / 940,679, filed on March 29, 2018, entitled “CLOUD-BASED MEDICAL ANALYTICS FORLINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET”, is now published as U.S. Patent Application Publication No. 2019 / 0201144;
[0089] • U.S. Patent Application Serial No. 15 / 940,668, filed on March 29, 2018, entitled “AGGREGATION AND REPORTING OF SURGICALHUB DATA,” is now published as U.S. Patent Application Publication No. 2019 / 0201115; and
[0090] • U.S. Patent Application Serial No. 16 / 209,416, now published as U.S. Patent Application No. 20190206562.
[0091] See Figure 1 The 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 communicating with the cloud 104, which may include the remote server 113. In one example, such as Figure 1 As shown, the surgical system 102 includes a visualization system 108, a robotic system 110, and handheld intelligent surgical instruments 112, which are configured to communicate with each other and / or with a hub 106. In some aspects, the surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P may be integers greater than or equal to one.
[0092] In various aspects, the visualization system 108 may include one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays, which are strategically arranged relative to the sterile field, such as... Figure 2As shown in the figure. In one aspect, visualization system 108 may include interfaces for HL7, PACS, and EMR. Various components of visualization system 108 are described in U.S. Patent Application Publication No. 2019-0200844A1 (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY,” under the title “Advanced Imaging Acquisition Module,” the entire disclosure of which is incorporated herein by reference.
[0093] like Figure 2 As shown, the main display 119 is positioned within the sterile field for visibility to the operator at the operating table 114. Furthermore, a visualization tower 111 is positioned outside the sterile field. The visualization tower 111 may include a first non-sterile display 107 and a second non-sterile display 109 positioned opposite each other. A visualization system 108, guided by a hub 106, is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators both inside and outside the sterile field. For example, the hub 106 may enable the visualization system 108 to display snapshots of the surgical site recorded by the imaging device 124 on the non-sterile displays 107 or 109 while maintaining a real-time feed of the surgical site on the main display 119. The snapshots on the non-sterile displays 107 or 109 may allow a non-sterile operator to perform diagnostic steps related to the surgical procedure, for example.
[0094] In one aspect, hub 106 may also be configured to route diagnostic input or feedback entered by a non-sterile operator at visualization tower 111 to a main display 119 within a sterile area, where the diagnostic input or feedback can be observed by a sterile operator at the operating table. In one example, the input may be a modified form of a snapshot displayed on non-sterile displays 107 or 109, which can be routed to the main display 119 via hub 106.
[0095] See Figure 2Surgical instrument 112 is used in surgical procedures as part of surgical system 102. Hub 106 may be further configured to coordinate the flow of information to the display of surgical instrument 112. For example, it is described in U.S. Patent Application Publication No. US 2019-0200844 A1 (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY,” the entire disclosure of which is incorporated herein by reference. Diagnostic input or feedback entered by a non-aseptic operator at visualization tower 111 may be routed by hub 106 to surgical instrument display 115 within the aseptic area, where the operator of surgical instrument 112 can observe the input or feedback. For example, an exemplary surgical instrument suitable for surgical system 102 is described in U.S. Patent Application No. 2019-0200844 A1 (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY,” under the title “Surgical Instrument Hardware,” the entire disclosure of which is incorporated herein by reference.
[0096] Figure 2 An example of a surgical system 102 for performing surgery on a patient lying supine on an operating table 114 in an operating room 116 is shown. A robotic system 110 may be used as part of the surgical system 102 during the surgery. The robotic system 110 may include a surgeon's console 118, a patient-side trolley 120 (surgical robot), and a surgical robot hub 122. While the surgeon views the surgical site through the surgeon's console 118, the patient-side trolley 120 can manipulate at least one removably coupled surgical instrument 117 through a minimally invasive incision within the patient's body. Images of the surgical site may be obtained via a medical imaging device 124, which may be manipulated by the patient-side trolley 120 to orient the imaging device 124. The robotic hub 122 may be used to process the images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.
[0097] 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 this disclosure are described in U.S. Patent Application No. 2019-0201137A1 (U.S. Patent Application No. 16 / 209,407), filed December 4, 2018, entitled “METHOD OFROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL,” the disclosure of which is incorporated herein by reference in its entirety.
[0098] Various examples of cloud-based analytics performed by Cloud 104 and suitable for use with this disclosure are described in U.S. Patent Application Publication No. 2019-0206569A1 (U.S. Patent Application No. 16 / 209,403), filed December 4, 2018, entitled “METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB,” the disclosure of which is incorporated herein by reference in its entirety.
[0099] 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.
[0100] The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. One or more illumination sources may be directed to illuminate multiple portions of the surgical site. One or more image sensors may receive light reflected or refracted from the surgical site, including light reflected or refracted from tissue and / or surgical instruments.
[0101] One or more illumination sources can be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum (sometimes referred to as the optical spectrum or emission spectrum) is the portion of the electromagnetic spectrum that is visible to the human eye (i.e., detectable by it) and can be called visible light or simple light. The typical human eye responds to wavelengths in air from about 380 nm to about 750 nm.
[0102] The invisible spectrum (e.g., the non-luminescent spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is undetectable to the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum and become invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum and become invisible ultraviolet, X-ray, and gamma-ray electromagnetic radiation.
[0103] In various respects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use in this disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, colonoscopes, esophagoduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngeal-renal endoscopes, sigmoidoscopes, thoracoscopes, and hysteroscopes.
[0104] Imaging devices can employ multispectral monitoring to distinguish morphology and underlying structures. A multispectral image is an image that captures image data across a specific wavelength range of the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths, including light from frequencies outside the visible light range, such as IR and ultraviolet. Spectral imaging allows the extraction of additional information that the human eye fails to capture with its red, green, and blue receptors. The use of multispectral imaging is described under the title “Advanced Imaging Acquisition Module” in U.S. Patent Application Publication No. US 2019-0200844 A1 (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY,” the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring can be a useful tool for repositioning the surgical site after completing a surgical task to perform one or more of the previously described tests on the treated tissue. It goes without saying that rigorous sterilization of the operating room and surgical equipment is required during any surgical procedure. The stringent hygienic and sterilization conditions required in the “surgical room” (i.e., operating room or treatment room) necessitate the highest possible sterility of all medical devices and equipment. Part of this sterilization process requires the sterilization of any material that comes into contact with the patient or penetrates the sterile area, including the imaging device 124 and its attachments and components. It should be understood that a sterile area can be considered a designated area deemed free of microorganisms, such as within a tray or sterile towel, or can be considered the area around the patient prepared for surgical procedures. A sterile area may include properly dressed scrubbed team members, as well as all equipment and fixtures within that area.
[0105] Now for reference Figure 3 Hub 106 is depicted as communicating with visualization system 108, robotic system 110, and handheld smart surgical instruments 112. Hub 106 includes a hub display 135, imaging module 138, generator module 140, communication module 130, processor module 132, storage array 134, and operating room mapping module 133. In some aspects, such as Figure 3As shown, hub 106 also includes a fume extraction module 126 and / or a suction / flushing module 128. During surgical procedures, the application of energy to tissue for sealing and / or cutting is typically associated with fume extraction, suction of excess fluid, and / or flushing of tissue. Fluid lines, power lines, and / or data lines from different sources often become entangled during surgical procedures. Addressing this issue during a surgical procedure can result in lost valuable time. Disconnecting lines may require disconnecting the lines from their respective modules, which may require resetting the modules. Hub modular housing 136 provides a unified environment for managing power lines, data lines, and fluid lines, reducing the frequency of entanglement between such lines. Aspects of this disclosure provide a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combined generator module that can be slidably received in a docking base within the hub housing. The docking base includes data contacts and power contacts. The combined 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 in a single unit. In one aspect, the combined generator module also includes a smoke extraction component, at least one energy delivery cable for connecting the combined generator module to surgical instruments, at least one smoke extraction component configured to extract smoke, fluid, and / or particles generated by applying therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke extraction component. In one aspect, the fluid line is a first fluid line, and a second fluid line extends from a remote surgical site to a suction and flushing module slidably received in a hub housing. In one aspect, the hub housing includes a fluid interface. Certain surgical procedures may require the application of more than one type of energy to tissue. One type of energy may be more advantageous for cutting tissue, while another different type of energy may be more advantageous for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut sealed tissue. Various aspects of this disclosure provide a solution in which a hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication between them. One advantage of the hub modular housing 136 is that it enables the rapid removal and / or replacement of various modules. Aspects of this disclosure provide a modular surgical housing for use in surgical procedures involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking base including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable to electrically engage with the power and data contacts, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts.Further describing the above, the modular surgical housing also includes a second energy generator module configured to generate a second energy, different from the first energy, for application to tissue, and a second docking base including a second docking port with second data and power contacts. The second energy generator module is slidably movable to electrically engage with the power and data contacts, and the second energy generator is slidably movable out of electrical contact with the second power and data contacts. Furthermore, the modular surgical housing includes a communication bus between the first and second docking ports, configured to facilitate communication between the first and second energy generator modules. Reference. Figure 3 Various aspects of this disclosure are presented as a hub modular housing 136, which allows for modular integration of generator module 140, smoke extraction module 126, and suction / flushing module 128. The hub modular housing 136 also facilitates interactive communication between modules 140, 126, and 128. Generator module 140 may be a generator module with integrated monopolar, bipolar, and ultrasonic components, supported in a single housing unit slidably inserted into hub modular housing 136. Generator module 140 may be configured to connect to monopolar device 142, bipolar device 144, and ultrasonic device 146. Alternatively, generator module 140 may include a series of monopolar generator modules, bipolar generator modules, and / or ultrasonic generator modules interacting via hub modular housing 136. Hub modular housing 136 may be configured to facilitate the insertion of multiple generators and interactive communication between generators connected to hub modular housing 136, such that a generator functions as a single generator.
[0106] Figure 4A surgical data network 201 is illustrated, including a modular communication hub 203 configured to connect modular units located in one or more operating rooms within a medical facility, or any room in a medical facility specifically equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to storage device 205). In one aspect, the modular communication hub 203 includes a network hub 207 and / or a network switch 209 communicating with a network router. The modular communication hub 203 may 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, enabling its transfer from one device (or segment) to another and cloud computing resources. An intelligent surgical data network includes additional features to enable monitoring of traffic traversing the surgical data network and configuration of each port in the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.
[0107] Modular devices 1a-1n located in the operating room can be coupled to a modular communication hub 203. A network hub 207 and / or a network switch 209 can be coupled to a network router 211 to connect devices 1a-1n to a cloud 204 or a local computer system 210. Data associated with devices 1a-1n can be transmitted via the router to a cloud-based computer for remote data processing and manipulation. Data associated with devices 1a-1n can also be transmitted to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room can also be coupled to a network switch 209. The network switch 209 can be coupled to a network hub 207 and / or a network router 211 to connect devices 2a-2m to the cloud 204. Data associated with devices 2a-2n can be transmitted via the network router 211 to the cloud 204 for data processing and manipulation. Data associated with devices 2a-2m can also be transmitted to the local computer system 210 for local data processing and manipulation.
[0108] It should be understood that the surgical data network 201 can be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. A modular communication hub 203 may be included in a modular control tower configured to accommodate multiple devices 1a-1n / 2a-2m. A local computer system 210 may also be included in the modular control tower. The modular communication hub 203 is connected to a display 212 to display images, for example, acquired by some of the devices 1a-1n / 2a-2m during surgical procedures. In various aspects, the devices 1a-1n / 2a-2m may include, for example, various modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke extraction module 126, a suction / rinsing module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device connected to a display, and / or other modular devices such as a modular communication hub 203 that may be connected to a surgical data network 201, including non-contact sensor modules.
[0109] In one aspect, the surgical data network 201 may include a combination of network hubs, network switches, and network routers that connect devices 1a-1n / 2a-2m to the cloud. Any or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch may collect data in real time and transmit the data to a cloud computer for data processing and manipulation. It should be understood that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term “cloud” may be used as a metaphor for “the Internet,” although the term is not limited thereto. Therefore, the term “cloud computing” may be used herein to refer to “a type of Internet-based computing” in which different services (such as servers, storage, and applications) are delivered to a modular communication hub 203 and / or computer system 210 located in a surgical room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communication hub 203 and / or computer system 210 via the Internet. The cloud infrastructure may be maintained by a cloud service provider. In this context, the cloud service provider can be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services can perform extensive computations based on data collected by intelligent surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.
[0110] By applying cloud computing data processing technology to the data collected by devices 1a-1n / 2a-2m, surgical data networks can provide improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of devices 1a-1n / 2a-2m can be used to observe tissue condition to assess leakage or perfusion of tissue sealed after tissue sealing and cutting procedures. At least some of devices 1a-1n / 2a-2m can be used to identify pathologies, such as disease effects, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This may include tissue and phenotypic localization and edge confirmation. At least some of 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) can be transferred to cloud 204 or local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. Data can be analyzed to improve surgical outcomes by determining whether further treatment can be carried out (such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precise robotics to tissue-specific sites and conditions). Such data analysis can be further processed using outcome analysis, and the use of standardized methods can provide helpful feedback to validate surgical treatment and surgeon behavior, or to suggest modifications to surgical treatment and surgeon behavior.
[0111] Operating room devices 1a-1n can be connected to modular communication hub 203 via wired or wireless channels, depending on the configuration of devices 1a-1n to the network hub. In one aspect, network hub 207 can be implemented as a local network broadcasting device operating at the physical layer of the Open Systems Interconnection (OSI) model. This network hub provides connectivity to devices 1a-1n located within the same operating room network. Network hub 207 can collect data in packet form and transmit it to a router in half-duplex mode. Network hub 207 may not store any Media Access Control / Internet Protocol (MAC / IP) for transmitting device data. Only one of devices 1a-1n may transmit data through network hub 207 at a time. Network hub 207 may not have information about where to send it and may broadcast all network data on each connection and to a remote server 213 via cloud 204. Figure 4 The routing table or intelligence broadcasts all network data. The network hub 207 can detect basic network errors such as collisions, but broadcasting all information to multiple ports can pose security risks and cause bottlenecks.
[0112] Operating room devices 2a-2m can be connected to network switch 209 via wired or wireless channels. Network switch 209 operates at the data link layer of the OSI model. Network switch 209 is a multicast device used to connect devices 2a-2m located in the same operating room to the network. Network switch 209 can send data to network router 211 in frame form and operates in full-duplex mode. Multiple devices 2a-2m can simultaneously send data through network switch 209. Network switch 209 stores and uses the MAC addresses of devices 2a-2m to transmit data.
[0113] Network hub 207 and / or network switch 209 may be coupled to network router 211 to connect to cloud 204. Network router 211 operates at the network layer of the OSI model. Network router 211 generates routes for data packets received from network hub 207 and / or network switch 211 to be sent to cloud-based computing resources for further processing and manipulation of data collected by any or all of devices 1a-1n / 2a-2m. Network router 211 can be used to connect two or more different networks located in different locations, such as, for example, different operating rooms in the same medical facility or different networks in different operating rooms in different medical facilities. Network router 211 can send data to cloud 204 in packet form and operates in full-duplex mode. Multiple devices can send data simultaneously. Network router 211 uses IP addresses to transmit data.
[0114] In the example, network hub 207 can be implemented as a USB hub, which allows multiple USB devices to connect to the host. A USB hub can extend a single USB port to multiple tiers so that more ports are available for connecting devices to the host system computer. Network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol can be used for communication between devices 1a-1n and devices 2a-2m located in the operating room.
[0115] In the example, the operating room device 1a-1n / 2a-2m can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard for exchanging data from stationary and moving devices over short distances (using short-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz) and constructing a personal area network (PAN). The operating room device 1a-1n / 2a-2m can communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, New Radio (NR), Long Term Evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any other wireless and wired protocols specified as 3G, 4G, 5G, and above. The computing module may include multiple communication modules. For example, the first communication module can be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module can be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.
[0116] Modular communication hub 203 can be used as the central connection for one or all of the operating room devices 1a-1n / 2a-2m, and can handle a data type called a frame. A frame can carry data generated by device 1a-1n / 2a-2m. When modular communication hub 203 receives a frame, it is amplified and transmitted to network router 211, which transmits the data to cloud computing resources using multiple wireless or wired communication standards or protocols as described herein.
[0117] The modular communication hub 203 can be used as a standalone unit or connected to compatible network hubs and network switches to form a larger network. The modular communication hub 203 is generally easy to install, configure, and maintain, making it a good option for networking operating room units 1a-1n / 2a-2m.
[0118] Figure 5An interactive surgical system 200 implemented by a computer is illustrated. The interactive surgical system 200 implemented by a computer is similar in many respects to the interactive surgical system 100 implemented by a computer. For example, the interactive surgical system 200 implemented by a computer includes one or more surgical systems 202 that are similar in many respects to surgical system 102. Each surgical system 202 includes at least one surgical hub 206 communicating with a cloud 204 that may include a remote server 213. In one aspect, the interactive surgical system 200 implemented by a computer 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. Figure 6 As shown, the modular control tower 236 includes a modular communication hub 203 coupled to the computer system 210.
[0119] like Figure 5 As illustrated in the example, the modular control tower 236 may be coupled to an imaging module 238 (which may be coupled to an endoscope 239), a generator module 240 that may be coupled to an energy device 241, a fume extractor module 226, a suction / flushing module 228, a communication module 230, a processor module 232, a storage array 234, an intelligent 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 the modular control tower 236. A robot hub 222 may also be connected to the modular control tower 236 and cloud computing resources. Devices / instruments 235, visualization systems 208, etc., may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 may be coupled to a hub display 215 (e.g., a monitor, a screen) to display and overlay images received from the imaging module, device / instrument display, and / or other visualization systems 208. The hub display can also combine images and overlays to display data received from devices connected to the modular control tower.
[0120] Figure 6 A surgical hub 206 is shown, comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 may include a modular communication hub 203 (e.g., a network connectivity device) and a computer system 210 to provide, for example, local processing, visualization, and imaging. Figure 6 As shown, the modular communication hub 203 can be hierarchically configured with connections to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203 and to transmit data associated with the modules to computer system 210, cloud computing resources, or both. Figure 6As shown, each of the network hubs / switches in the modular communication hub 203 may include three downstream ports and one upstream port. The upstream network hub / switch may be connected to the processor to provide communication connectivity with cloud computing resources and the local display 217. Communication with the cloud 204 may be conducted via wired or wireless communication channels.
[0121] The surgical hub 206 may employ a non-contact sensor module 242 to measure the dimensions of the operating room and use an ultrasonic or laser-based non-contact measuring device to generate a mapping of the operating room. The ultrasonic-based non-contact sensor module scans the operating room by emitting ultrasonic pulses and receiving echoes as they bounce off the walls of the operating room, as described in U.S. Patent Application Publication No. US 2019-0200844 A1 (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY,” entitled “Surgical Hub Spatial Awareness Within an Operating Room,” the entire disclosure of which is incorporated herein by reference. The sensor module is configured to determine the dimensions of the operating room and adjust Bluetooth pairing distance limits. Laser-based non-contact sensor modules can scan the operating room by emitting laser pulses, receiving laser pulses bounced off the walls of the operating room, and comparing the phase of the emitted pulses with the received pulses to determine the size of the operating room and adjust Bluetooth pairing distance limits.
[0122] Computer system 210 may include processor 244 and network interface 245. Processor 244 may be coupled to communication module 247, storage device 248, memory 249, non-volatile memory 250, and input / output interface 251 via system bus. The system bus may be any of several types of bus architectures, including memory bus or memory controller, peripheral bus or external bus, and / or local bus using any of the various available bus architectures, including but not limited to 9-bit bus, Industry Standard Architecture (ISA), Micro Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), PCMCIA, Small Computer System Interface (SCSI), or any other peripheral bus.
[0123] The controller 244 can be any single-core or multi-core processor, such as those commercially available from Texas Instruments under the name ARM Cortex. In one aspect, the processor can be, for example, a Texas Instruments LM4F230H5QR ARM Cortex-M4F processor core, which includes 256KB of single-cycle flash memory or other non-volatile memory (up to 40MHz) on-chip memory, a prefetch buffer for improving execution above 40MHz, 32KB of single-cycle sequential random access memory (SRAM), and loaded with… The software includes an internal read-only memory (ROM), a 2KB electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog modules, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which can be found in the product datasheet.
[0124] In one aspect, the processor 244 may include a safety controller comprising two controller-based series (such as the TMS570 and RM4x), also known as the Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO26262 safety-critical applications, etc., to provide advanced integrated safety features while delivering scalable execution, connectivity, and memory options.
[0125] System memory can include both volatile and non-volatile memory. The Basic Input / Output System (BIOS), which contains basic routines such as transferring information between components within the computer system during startup, is stored in non-volatile memory. For example, non-volatile memory can include ROM, Programmable ROM (PROM), Electrically Programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes Random Access Memory (RAM), which acts as an external cache memory. Furthermore, RAM can be available in various forms, such as SRAM, Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDR SDRAM), Enhanced SDRAM (ESDRAM), Synchronous Link DRAM (SLDRAM), and Direct Rambus RAM (DRRAM).
[0126] Computer system 210 may also include removable / non-removable, volatile / non-volatile computer storage media, such as disk storage. Disk storage may include, but is not limited to, devices such as disk drives, floppy disk drives, magnetic tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory modules. Furthermore, disk storage may include storage media, alone or in combination with other storage media, including, but not limited to, optical disc drives such as optical disc ROM devices (CD-ROM), optical disc recordable drives (CD-R drives), optical disc rewritable drives (CD-RW drives), or digital universal disk ROM drives (DVD-ROM). Removable or non-removable interfaces may be used to facilitate the connection of the disk storage device to the system bus.
[0127] It should be understood that computer system 210 may include software that acts as an intermediary between the user and basic computer resources described in a suitable operating environment. Such software may include an operating system. An operating system, which may be stored on a disk storage device, may be used to control and allocate the resources of the computer system. System applications may utilize the operating system to manage resources through program modules and program data stored in system memory or a disk storage device. It should be understood that the various components described herein may be implemented using various operating systems or combinations of operating systems.
[0128] Users can input commands or information into computer system 210 through input devices coupled to I / O interface 251. Input devices may include, but are not limited to, pointing devices such as mice, touchballs, styluses, touchpads, keyboards, microphones, joysticks, game pads, satellite dishes, scanners, TV tuner cards, digital cameras, digital video cameras, webcams, etc. These and other input devices are connected to the processor via the system bus through one or more interface ports. The one or more interface ports include, for example, serial ports, parallel ports, game ports, and USB. The one or more output devices use the same type of port as the one or more input devices. Thus, for example, a USB port can be used to provide input to the computer system and output information from the computer system to an output device. Output adapters are provided to illustrate that some output devices, such as monitors, displays, speakers, and printers, may require special adapters. Output adapters may, by way of example, include, video and sound cards that provide a connection between the output device and the system bus. It should be noted that other devices or systems, such as one or more remote computers, may provide both input and output capabilities.
[0129] Computer system 210 can operate in a networked environment using logical connections to one or more remote computers (such as cloud computers) or a local computer. The remote cloud computers (one or more) can be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer-to-peer devices, or other public network nodes, and typically include many or all of the elements described relative to the computer system. For simplicity, only memory storage devices with one or more remote computers are shown. The remote computers (one or more) can be logically connected to the computer system via a network interface and then physically connected via a communication connection. The network interface can encompass communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies can include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, etc. WAN technologies can include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Network (ISDN) and its variants, packet-switched networks, and Digital Subscriber Line (DSL).
[0130] In various aspects, Figure 6 The computer system 210, the imaging module 238 and / or the visualization system 208, and / or Figures 5 to 6 The processor module 232 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) for processing digital images. The image processor may employ parallel computing with Single Instruction, Multiple Data (SIMD) or Multiple Instruction, Multiple Data (MIMD) techniques to improve speed and efficiency. The digital image processing engine may perform a range of tasks. The image processor may be a system-on-a-chip with a multi-core processor architecture.
[0131] A communication connection may refer to the hardware / software used to connect a network interface to a bus. While a communication connection is shown for illustrative clarification within a computer system, it may also be located outside of computer system 210. The hardware / software necessary to connect to the network interface, for illustrative purposes only, may include internal and external technologies such as modems, including conventional telephone-grade modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards.
[0132] Figure 7A logic diagram of a control system 470 for a surgical instrument or tool according to one or more aspects of this disclosure is shown. System 470 may include control circuitry. The control circuitry may include a microcontroller 461, which includes a processor 462 and a memory 468. For example, one or more of sensors 472, 474, and 476 provide real-time feedback to processor 462. A motor 482, driven by a motor driver 492, is operatively coupled to a longitudinally movable displacement member to drive an I-beam blade element. A tracking system 480 may be configured to determine the position of the longitudinally movable displacement member. Position information may be provided to processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member and the positions of the firing member, firing lever, and I-beam blade element. An additional motor may be located at the tool driver interface to control I-beam firing, tube closure travel, shaft rotation, and joint movement. A display 473 may display various operating conditions of the instrument and may include touchscreen functionality for data input. Information displayed on display 473 may be overlaid with images acquired via an endoscopic imaging module.
[0133] In one aspect, the microprocessor 461 can be any single-core or multi-core processor, such as those known to be manufactured by Texas Instruments under the trade name ARM Cortex. In another aspect, the microcontroller 461 can be an LM4F230H5QR ARM Cortex-M4F processor core from, for example, Texas Instruments, which includes 256KB of single-cycle flash memory or other non-volatile memory (up to 40MHz) on-chip memory, a prefetch buffer for improving performance above 40MHz, 32KB of single-cycle SRAM, and loaded with… The software includes an internal ROM, a 2KB electrical EEPROM, one or more PWM modules, one or more QEI analog modules, and one or more 12-bit ADCs with 12 analog input channels. Details can be found in the product datasheet.
[0134] In one aspect, the microcontroller 461 may include a safety controller comprising two controller-based series (such as the TMS570 and RM4x), also known as the Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO26262 safety-critical applications, etc., to provide advanced integrated safety features while delivering scalable execution, connectivity, and memory options.
[0135] The controller 461 can be programmed to perform various functions, such as precise control of the speed and position of the blade and joint motion system. In one aspect, the microcontroller 461 may include a processor 462 and a memory 468. The electric motor 482 may be a brushed direct current (DC) motor having a gearbox and a mechanical link to the joint motion or blade system. In one aspect, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be readily replaced for use in a tracking system 480 that includes an absolute positioning system. A detailed description of the absolute positioning system is described in U.S. Patent Application Publication 2017 / 0296213, entitled “SYSTEMS AND METHODS FOR CONTROLLING ASURGICAL STAPLING AND CUTTING INSTRUMENT,” published October 19, 2017, the entire contents of which are incorporated herein by reference.
[0136] The microcontroller 461 can be programmed to provide precise control over the velocity and position of displacement components and articulated motion systems. The microcontroller 461 can be configured to calculate the response in its software. The calculated response can be compared with the measured response of the actual system to obtain an "observed" response, which is used for actual feedback decisions. The observed response can be a favorable tuning value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.
[0137] In some aspects, motor 482 may be controlled by motor driver 492 and may be employed by a firing system of a surgical instrument or tool. In various forms, motor 482 may be a brushed DC drive motor having a maximum rotational speed of approximately 25,000 RPM. In some examples, motor 482 may include a brushless motor, cordless motor, synchronous motor, stepper motor, or any other suitable electric motor. Motor driver 492 may include, for example, an H-bridge driver including a field-effect transistor (FET). Motor 482 may be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool. The power assembly may include a battery comprising multiple battery cells connected in series and capable of serving as a power source to power the surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and / or rechargeable. In at least one example, the battery cells may be lithium-ion batteries that are coupled to and decoupled from the power assembly.
[0138] The motor driver 492 can be the A3941, available from Allegro Microsystems, Inc. The A3941 492 can be a full-bridge controller designed 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 a unique charge pump regulator that provides full (>10V) gate drive for battery voltages as low as 7V and allows the A3941 to operate with reduced gate drive voltages as low as 5.5V. A bootstrap capacitor can be used to provide the aforementioned battery supply voltage required by the N-channel MOSFETs. The internal charge pump of the high-side drive allows DC (100% duty cycle) operation. The full bridge can be driven in fast decay or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation can pass through either the high-side or low-side FET. Resistor-adjustable no-load time protection against breakdown of the power FETs is available. The comprehensive diagnostics provide indications of undervoltage, overheating, and power bridge faults, and can be configured to protect the power MOSFETs under most short-circuit conditions. Other motor drivers can be easily replaced for use in the tracking system 480, which includes an absolute positioning system.
[0139] The tracking system 480 may include a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of this disclosure. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of a displacement member. In some examples, the displacement member may represent a longitudinally movable drive member including a rack with drive teeth for meshing with a corresponding drive gear of a gear reducer assembly. In some examples, the displacement member may represent a firing member that can be adapted and configured to include a rack with drive teeth. In some examples, the displacement member may represent a firing lever or an I-beam, each of which can be adapted and configured to include a rack with drive teeth. Thus, as used herein, the term displacement member may be generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, firing member, firing lever, I-beam, or any element capable of displacement. In one aspect, the longitudinally movable drive member may be coupled to the firing member, firing lever, and I-beam. Thus, the absolute positioning system can effectively track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. In various respects, the displacement member can be coupled to any position sensor 472 suitable for measuring linear displacement. Therefore, a longitudinally movable drive member, firing member, firing rod, or I-beam, or combinations thereof, can be coupled to any suitable linear displacement sensor. The linear displacement sensor can include contact or non-contact displacement sensors. The linear displacement sensor can include a linearly variable differential transformer (LVDT), a differential variable magnetoresistive transducer (DVRT), a sliding 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 sensing system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
[0140] The electric motor 482 may include a rotatable shaft operably coupled to a gear assembly, which is mounted on a displacement member in meshing with a set of drive teeth or a rack. A sensor element may be operably coupled to the gear assembly such that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The arrangement of the transmission and sensor may be connected to a linear actuator via a rack and pinion arrangement, or to a rotary actuator via a spur gear or other connection. A power source may supply 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 with drive teeth formed thereon for meshing with a corresponding drive gear of a gear reducer assembly. The displacement member may represent a longitudinally movable firing member, a firing lever, an I-beam, or a combination thereof.
[0141] A single rotation of the sensor element associated with position sensor 472 is equivalent to a longitudinal linear displacement d1 of the displacement member, where d1 is the longitudinal linear distance the displacement member moves from point "a" to point "b" after a single rotation of the sensor element coupled to the displacement member. The sensor arrangement can be connected via a gear reduction mechanism, which allows position sensor 472 to complete only one or more rotations over the full stroke of the displacement member. Position sensor 472 can also complete multiple rotations over the full stroke of the displacement member.
[0142] A series of switches (where n is an integer greater than one) can be used individually or in combination with gear reduction to provide unique position signals for more than one rotation of position sensor 472. The states of the switches can be fed back to microcontroller 461, which applies logic to determine unique position signals corresponding to longitudinal linear displacements d1+d2+…dn of the displacement member. The output of position sensor 472 is provided to microcontroller 461. Position sensor 472 in this sensor arrangement may include magnetic sensors, analog rotation sensors (such as potentiometers), or an array of analog Hall effect elements that output unique combinations of position signals or values.
[0143] Position sensor 472 may include any number of magnetic sensing elements, such as magnetic sensors classified, for example, according to whether they measure the total magnetic field or vector components of a magnetic field. Techniques for generating the two types of magnetic sensors described above can encompass multiple aspects of physics and electronics. Techniques for magnetic field sensing may include probe coils, fluxgates, optical pumps, nuclear swirls, superconducting quantum interference devices (SQUIDs), the Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoresistance, magnetostrictive / piezoelectric composites, magnetodiodes, magnetotransistors, optical fibers, magnetooptics, and microelectromechanical systems-based magnetic sensors, etc.
[0144] In one aspect, the position sensor 472 for the tracking system 480, which includes an absolute positioning system, may include a magnetic rotary absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. The position sensor 472 interfaces with a microcontroller 461 to provide the absolute positioning system. The position sensor 472 may be a low-voltage and low-power component and includes four Hall effect elements in a region of the position sensor 472 that may be located above a magnet. A high-resolution ADC and a smart power management controller may also be provided on-chip. A coordinate rotating digital computer (CORDIC) processor (also known as bitwise and Volder algorithms) may be provided to perform simple and efficient algorithms to calculate hyperbolic and trigonometric functions, requiring only addition, subtraction, digital displacement, and table lookup operations. Angular position, alarm bit, and magnetic field information may be transmitted to the microcontroller 461 via a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. The position sensor 472 may provide 12- or 14-bit resolution. The position sensor 472 is available as an AS5055 chip in a small QFN 16-pin 4×4×0.85mm package.
[0145] The tracking system 480, including the 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 source converts the signal from the feedback controller into a physical input to the system: in this case, a voltage. Other examples include PWM for voltage, current, and force. In addition to the position measured by the position sensor 472, one or more other sensors may be provided to measure the physical parameters of the physical system. In some aspects, one or more other sensors may include sensor arrangements such as those described in U.S. Patent No. 9,345,481 entitled “STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM”, published May 24, 2016, the entire contents of which are incorporated herein by reference; U.S. Patent Application Publication No. 2014 / 0263552 entitled “STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM”, published September 18, 2014, the entire contents of which are incorporated herein by reference; and U.S. Patent Application Serial No. 15 / 628,175 entitled “TECHNIQUES FORADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTINGINSTRUMENT”, filed June 20, 2017, the entire contents of which are incorporated herein by reference. In digital signal processing systems, absolute positioning systems are coupled to digital data acquisition systems, where the output of the absolute positioning system will have 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 averaging and theoretical control loops. This algorithm drives the calculated response toward the measured response. The calculated response of the physical system may take into account characteristics such as mass, inertia, viscous friction, inductance, and resistance to predict the state and output of the physical system by knowing the input.
[0146] Therefore, the absolute positioning system can provide the absolute position of the displacement member when the instrument is powered on, without causing the displacement member to retract or advance to a reset (zero or home position) position as required by conventional rotary encoders, which only count the number of forward or backward steps taken by motor 482 to infer the position of the device actuator, drive bar, knife, etc.
[0147] Sensor 474 (such as, for example, a strain gauge or microstrain gauge) may be configured to measure one or more parameters of the end effector, such as, for example, the amplitude of the strain applied to the anvil during clamping operation, which may indicate the closing force applied to the anvil. The measured strain may be converted into a digital signal and provided to processor 462. Alternatively, or in addition to sensor 474, sensor 476 (such as a load sensor) may measure the closing force applied to the anvil by the closing drive system. Sensor 476, such as a load sensor, may measure the firing force applied to the I-beam during the firing stroke of a surgical instrument or tool. The I-beam is configured to engage a wedge-shaped slider configured to cause the staple driver to cam upward to push the staple into deformable contact with the anvil. The I-beam may also include a sharp cutting edge that may be used to cut tissue when the I-beam is advanced distally by the firing lever. Alternatively, a current sensor 478 may be employed to measure the current consumed by motor 482. The force required to propel the firing mechanism can correspond to, for example, the current consumed by the motor 482. The measured force can be converted into a digital signal and provided to the processor 462.
[0148] In one embodiment, strain gauge sensor 474 can be used to measure the force applied to tissue by an end effector. The strain gauge may be coupled to the end effector to measure the force on the tissue being handled by the end effector. A system for measuring the force applied to tissue gripped by the end effector may include strain gauge sensor 474, such as a microstrain gauge, which may be configured to measure one or more parameters, for example, of the end effector. In one aspect, strain gauge sensor 474 may measure the amplitude or magnitude of the strain applied to the jaw members of the end effector during clamping operations, which may indicate tissue compression. The measured strain may be converted into a digital signal and provided to processor 462 of microcontroller 461. Load sensor 476 may measure the force used to operate the blade element, for example, to cut tissue captured between the anvil and the cartridge. A magnetic field sensor may be used to measure the thickness of the captured tissue. The measurements from the magnetic field sensor may also be converted into digital signals and provided to processor 462.
[0149] The microcontroller 461 can characterize the selected position of the firing member and / or the corresponding value of the firing member velocity using measurements of tissue compression, tissue thickness, and / or the force required for the closed end effector, respectively, measured by sensors 474 and 476. In one case, the memory 468 can store techniques, formulas, and / or lookup tables that can be used by the microcontroller 461 in the evaluation.
[0150] The control system 470 for surgical instruments or tools may also include wired or wireless communication circuitry for communicating with the modular communication hub 203, such as... Figure 5 and Figure 6 As shown in the image.
[0151] Figure 8 A surgical instrument or tool is illustrated, comprising multiple motors that can be activated to perform various functions. In some cases, a first motor may be activated to perform a first function, a second motor to perform a second function, a third motor to perform a third function, and a fourth motor to perform a fourth function. In other cases, multiple motors of the robotic surgical instrument 600 may be individually activated to cause firing motion, closing motion, and / or articulation motion in the end effector. Firing motion, closing motion, and / or articulation motion may be transmitted to the end effector, for example, via a shaft assembly.
[0152] In some cases, a surgical instrument system or tool may include a firing motor 602. The firing motor 602 is operatively coupled to a firing motor drive assembly 604, which may be configured to transmit the firing motion generated by the motor 602 to an end effector, specifically for displacing an I-beam element. In some cases, the firing motion generated by the motor 602 may, for example, deploy a staple from a staple cartridge into tissue captured by the end effector and / or advance the cutting edge of the I-beam element to cut the captured tissue. The I-beam element may be retracted by reversing the direction of the motor 602.
[0153] In some cases, surgical instruments or tools may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605 configured to transmit the closing motion generated by the motor 603 to an end effector, specifically for displacing the closure tube to close the anvil and compress tissue between the anvil and the cartridge. The closing motion may cause, for example, the end effector to change from an open configuration to an approach configuration to capture tissue. The end effector may be changed to an open position by reversing the direction of the motor 603.
[0154] In some cases, surgical instruments or tools may include, for example, one or more articulated motors 606a, 606b. Motors 606a, 606b may be operatively coupled to corresponding articulated motor drive assemblies 608a, 608b, which may be configured to transmit joint motion generated by motors 606a, 606b to an end effector. In some cases, the joint motion may cause the end effector to articulate relative to an axis, for example.
[0155] As described herein, surgical instruments or tools may include multiple motors that can be configured to perform various independent functions. In some cases, multiple motors of a surgical instrument or tool may be activated individually or independently to perform one or more functions, while other motors remain inactive. For example, articulation motors 606a and 606b may be activated to articulate the end effector, while firing motor 602 remains inactive. Alternatively, firing motor 602 may be activated to fire multiple pins and / or advance a cutting edge, while articulation motor 606 remains inactive. Furthermore, closure motor 603 may be activated simultaneously with firing motor 602 to advance the closure tube and I-beam element distally, as described in more detail below.
[0156] In some cases, surgical instruments or tools may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 can adjust one of the multiple motors at a time. For example, the common control module 610 may be individually coupled to multiple motors of the surgical instrument and may be detached from the multiple motors of the surgical instrument. In some cases, multiple motors of the surgical instrument or tool may share one or more common control modules such as the common control module 610. In some cases, multiple motors of the surgical instrument or tool may independently and selectively engage the common control module 610. In some cases, the common control module 610 may switch from engagement with one of the multiple motors of the surgical instrument or tool to engagement with another of the multiple motors of the surgical instrument or tool.
[0157] In at least one example, the common control module 610 can selectively switch between operably engaging joint motion motors 606a, 606b and operably engaging firing motor 602 or closing motor 603. In at least one example, as... Figure 8 As shown, switch 614 can move or change between multiple positions and / or states. In a first position 616, switch 614 can electrically couple the common control module 610 to the firing motor 602; in a second position 617, switch 614 can electrically couple the common control module 610 to the closing motor 603; in a third position 618a, switch 614 can electrically couple the common control module 610 to the first articulated motor 606a; and in a fourth position 618b, switch 614 can electrically couple the common control module 610 to, for example, a second articulated motor 606b. In some cases, the individual common control module 610 can be electrically coupled simultaneously to the firing motor 602, the closing motor 603, and the articulated motors 606a and 606b. In some cases, switch 614 can be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.
[0158] Each of motors 602, 603, 606a, and 606b may include a torque sensor to measure the output torque on the motor shaft. Force on the end effector can be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of the motor used to actuate the jaws.
[0159] In various situations, such as Figure 8 As shown, the common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. The motor driver 626 may, for example, modulate the power delivered from the power source 628 to the motor coupled to the common control module 610 based on inputs obtained from the microcontroller 620 (“controller”). In some cases, when the motor is coupled to the common control module 610, the microcontroller 620 may be used, for example, to determine the current consumed by the motor, as described herein.
[0160] In some cases, the microcontroller 620 may include a microprocessor 622 (“processor”) and one or more non-transitory computer-readable media or storage units 624 (“memory”). In some cases, the memory 624 may store various program instructions that, when executed, cause the processor 622 to perform the various functions and / or calculations described herein. In some cases, one or more memory units in the memory unit 624 may, for example, be coupled to the processor 622.
[0161] In some cases, power source 628 may be used, for example, to supply power to microcontroller 620. In some cases, power source 628 may include a battery (or “battery pack” or “power supply pack”), such as a lithium-ion battery. In some cases, the battery pack may be configured to be releasably mounted to the handle for supplying power to surgical instrument 600. Multiple battery cells connected in series may be used as power source 628. In some cases, power source 628 may be, for example, replaceable and / or rechargeable.
[0162] In various situations, processor 622 can control motor driver 626 to control the position, direction of rotation, and / or speed of a motor coupled to common controller 610. In some cases, processor 622 can signal motor driver 626 to stop and / or deactivate the motor coupled to common controller 610. It should be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that combines the functionality of a computer's central processing unit (CPU) on one or at most a few integrated circuits. A processor can be a versatile programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides results as output. Because a processor may have internal memory, it can be an example of sequential digital logic. The objects operated on by a processor can be numbers and symbols represented in a binary number system.
[0163] Processor 622 can be any single-core or multi-core processor, such as those traded as ARM Cortex processors supplied by Texas Instruments. In some cases, microcontroller 620 can be, for example, an LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor chip that includes: 256KB of single-cycle flash memory or other non-volatile memory (up to 40MHz) on-chip memory, a prefetch buffer for improving performance above 40MHz, 32KB of single-cycle SRAM, and a... The software includes an internal ROM, a 2KB EEPROM, one or more PWM modules, one or more QEI emulations, one or more 12-bit ADCs with 12 analog input channels, and other readily available features. Other microcontrollers can be easily substituted for use with module 4410. Therefore, this disclosure should not be limited to this context.
[0164] Memory 624 may include program instructions for controlling each of the motors in the surgical instrument 600, which can be coupled to a common controller 610. For example, memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606a, 606b. Such program instructions enable processor 622 to control the firing, closing, and articulation functions based on inputs from an algorithm or control program from the surgical instrument or tool.
[0165] One or more mechanisms and / or sensors, such as sensor 630, may be used to alert processor 622 to program instructions that should be used in a particular setting. For example, sensor 630 may alert processor 622 to use program instructions associated with firing, closing, and articulating end effectors. In some cases, sensor 630 may include, for example, a position sensor that can be used to sense the position of switch 614. Thus, processor 622 may use program instructions associated with the I-beam of the firing end effector, for example, when sensor 630 detects that switch 614 is in a first position 616; processor 622 may use program instructions associated with the closing anvil, for example, when sensor 630 detects that switch 614 is in a second position 617; and processor 622 may use program instructions associated with the articulated end effector, for example, when sensor 630 detects that switch 614 is in a third position 618a or a fourth position 618b.
[0166] Figure 9 A diagram of a situation-aware surgical system 5100 according to at least one aspect of this disclosure is shown. In some examples, a data source 5126 may include, for example, a 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 containing patient records), and a patient monitoring device 5124 (e.g., a blood pressure (BP) monitor and an electrocardiogram (EKG) monitor). A surgical hub 5104 may be configured to derive contextual information relating to surgical procedures from the data, for example, based on a specific combination of one or more received data or a specific order in which data is received from the data source 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the specific steps of the surgical procedure being performed by the surgeon, the type of tissue being operated on, or the body cavity to which the procedure is being performed. This ability of some aspects of the surgical hub 5104 to derive or infer information relating to surgical procedures from the received data may be referred to as “situational awareness.” In the example, the surgical hub 5104 may be incorporated into a situational awareness system, which is a hardware and / or programming associated with the surgical hub 5104 that derives contextual information related to the surgical procedure from the received data.
[0167] The situational awareness system of the surgical hub 5104 can be configured to derive contextual information from data received from the data source 5126 in a variety of different ways. In an example, the situational awareness system may include a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained on training data to associate various inputs (e.g., data from the database 5122, the patient monitoring device 5124, and / or the modular device 5102) with corresponding contextual information about the surgical procedure. In other words, the machine learning system may be trained to accurately derive contextual information about the surgical procedure from the provided inputs. In an example, the situational awareness system may include a lookup table that stores contextual information about the surgical procedure that is pre-represented and associated with one or more inputs (or ranges of inputs) corresponding to the contextual information. In response to a query using one or more inputs, the lookup table may return the corresponding contextual information used by the situational awareness system to control the modular device 5102. In the example, the contextual information received by the situational awareness system of the surgical hub 5104 may be associated with a specific control adjustment or a set of control adjustments for one or more modular devices 5102. In the example, the situational awareness system may include additional machine learning systems, lookup tables, or other such systems that generate or retrieve one or more control adjustments for one or more modular devices 5102 when contextual information is provided as input.
[0168] The surgical hub 5104, incorporating a situational awareness system, can provide numerous benefits to the surgical system 5100. One benefit may include improved interpretation of the sensed and collected data, which in turn improves processing accuracy and / or data utilization during the surgical procedure. Returning to the previous example, the situational awareness surgical hub 5104 can determine the type of tissue being operated on; therefore, when an unexpectedly high force is detected on the end effector of the surgical instrument used for closure, the situational awareness surgical hub 5104 can correctly adjust the motor speed of the surgical instrument according to the tissue type by gradually increasing or decreasing it.
[0169] The type of tissue being operated on can influence the adjustment of the compression rate and load threshold of surgical suture and cutting instruments for specific tissue gap measurements. The situation-aware surgical hub 5104 can infer whether the surgery being performed is thoracic or abdominal, allowing it to determine whether the tissue held by the end effector of the surgical suture and cutting instruments is lung tissue (for thoracic surgery) or stomach tissue (for abdominal surgery). The surgical hub 5104 can then appropriately adjust the compression rate and load threshold of the surgical suture and cutting instruments according to the tissue type.
[0170] The type of body cavity operated on during a blow-through procedure can affect the function of the fumigator. The situation-aware surgical hub 5104 determines whether the surgical site is under pressure (by determining that a blow-through procedure is being performed) and identifies the type of surgery. Since a type of surgery can typically be performed within a specific body cavity, the surgical hub 5104 can then appropriately control the motor speed of the fumigator for the body cavity in which the procedure is being performed. Therefore, the situation-aware surgical hub 5104 can provide consistent smoke extraction for both thoracic and abdominal surgeries.
[0171] The type of surgery being performed can affect the optimal energy level for operating ultrasound surgical instruments or radiofrequency (RF) electrosurgical instruments. For example, arthroscopic surgery may require a higher energy level because the end effectors of the ultrasound surgical instruments or RF electrosurgical instruments are immersed in fluid. A situational-aware surgical hub 5104 can determine whether a surgery is arthroscopic. The surgical hub 5104 can then adjust the RF power level or ultrasound amplitude (i.e., the “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 for operating ultrasound surgical instruments or RF electrosurgical instruments. The situational-aware surgical hub 5104 can determine the type of surgery being performed and then tailor the energy level of the ultrasound surgical instruments or RF electrosurgical instruments separately based on the expected tissue profile of that surgery. Furthermore, the situational-aware surgical hub 5104 can be configured to adjust the energy level of the ultrasound surgical instruments or RF electrosurgical instruments throughout the entire surgical procedure, rather than just on a per-operative basis. The situational awareness surgical hub 5104 can determine the steps of a surgical procedure being performed or to be performed subsequently, and then update the control algorithms for the generator and / or ultrasound surgical instruments or RF electrosurgical instruments to set the energy level to a value suitable for the expected tissue type based on the surgical step.
[0172] In the example, data can be extracted from an additional data source 5126 to improve the conclusions drawn by the surgical hub 5104 from one data source 5126. The situational-aware surgical hub 5104 can augment the data received from the modular device 5102 with contextual information about the surgical procedure already constructed from other data sources 5126. For example, the situational-aware surgical hub 5104 can be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) based on video or image data received from a medical imaging device. However, in some cases, the video or image data may be indeterminate. Therefore, in this example, the surgical hub 5104 can be further configured to compare physiological measurements (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 communicatively coupled to the surgical hub 5104). Figure 2 The comparison is used to determine the integrity of sutures or tissue welds. 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 visualization data. Additional background can be useful when the visualization data itself may be uncertain or incomplete.
[0173] For example, if the situational-aware surgical hub 5104 determines that a subsequent step in the procedure requires the use of an RF electrosurgical instrument, it can actively activate a generator connected to that instrument. Actively activating the power source allows the instrument to be ready for use as soon as the previous steps of the procedure are completed.
[0174] The situation-aware surgical hub 5104 can determine whether the current or subsequent steps of the surgical procedure require a different view or magnification on the display based on one or more features(s) that the surgeon expects to view at the surgical site. The surgical hub 5104 can then proactively change the displayed view accordingly (e.g., provided by a medical imaging device for the visualization system 108), thereby automatically adjusting the display throughout the surgical procedure.
[0175] The situation-aware surgical hub 5104 can determine which step of a surgical procedure is being performed or will be performed subsequently, and whether that step of the procedure requires specific data or comparisons between data. The surgical hub 5104 can be configured to automatically invoke data screens based on the step of the surgical procedure being performed, without waiting for the surgeon to request that specific information.
[0176] Errors can be checked during surgical setup or during the surgical procedure. For example, a situational-aware surgical hub 5104 can determine whether the operating room is correctly or optimally set up for the surgical procedure to be performed. The surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve the corresponding list, product location, or setup requirements (e.g., from memory), and then compare the current operating room layout with a standard layout determined by the surgical hub 5104 for that type of surgical procedure. In some examples, the surgical hub 5104 can be configured to compare a list of items for the procedure and / or a list of devices paired with the surgical hub 5104 with a suggested or anticipated list of items and / or devices for a given surgical procedure. The surgical hub 5104 can be configured to provide alerts indicating the absence of a specific modular device 5102, patient monitoring device 5124, and / or other surgical items if any discontinuities exist between the lists. In some examples, the surgical hub 5104 may be configured to determine the relative distance or position of the modular device 5102 and the patient monitoring device 5124, for example, via a proximity sensor. The surgical hub 5104 may compare the relative position of the devices with a suggested or anticipated layout for a particular surgical procedure. The surgical hub 5104 may be configured to provide an alert indicating that the current layout for the surgical procedure deviates from the suggested layout if any discontinuity exists between the layouts.
[0177] The situational awareness surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or otherwise deviating from the intended procedure during a surgical operation. For example, the surgical hub 5104 may be configured to determine the type of surgery being performed, retrieve (e.g., from memory) a corresponding list of steps or the order of equipment used, and then compare the steps being performed or the equipment being used during the surgical procedure with the expected steps or equipment determined by the surgical hub 5104 for that type of surgery. In some examples, the surgical hub 5104 may be configured to provide alerts indicating that an unexpected action is being performed or an unexpected device is being used at a specific step in the surgical procedure.
[0178] Surgical instruments (and other modular devices 5102) can be adapted for the specific context of each surgical procedure (such as adjustment to different tissue types) and for verification actions during the surgical procedure. Subsequent steps, data, and display adjustments can be provided to the surgical instruments (and other modular devices 5102) in the operating room according to the specific context of the surgery.
[0179] Figure 10An exemplary surgical procedure timeline 5200 is illustrated, along with contextual information that a surgical hub 5104 can derive from data received from a data source 5126 at each step of the surgical procedure. Figure 9 The following description of timeline 5200 shown should also refer to... Figure 9 The timeline 5200 depicts the typical steps nurses, surgeons, and other medical personnel will take during a segmental lung resection, from setting up the operating room to transferring the patient to the postoperative recovery room. The situation-aware surgical hub 5104 receives data from data source 5126 throughout the surgical procedure, including data generated each time medical personnel utilize the modular device 5102 paired with the surgical hub 5104. The surgical hub 5104 receives this data from the paired modular device 5102 and other data sources 5126, and continuously derives inferences about the ongoing procedure (i.e., contextual information) as new data is received, such as which step of the procedure is performed at any given time. The situational awareness system of the surgical hub 5104 may be able to, for example, record data related to the surgery used to generate a report, verify the steps being taken by the medical personnel, (e.g., via a display screen) provide data or prompts that may be related to a particular surgical step, adjust the modular device 5102 based on context (e.g., activate a monitor, adjust the FOV of a medical imaging device, or change the energy level of an ultrasound surgical instrument or an RF electrosurgical instrument), and take any other such actions described herein.
[0180] As a first step 5202 in this exemplary procedure, hospital staff can retrieve the patient's EMR from the hospital's EMR database. Based on the patient data selected in the EMR, the surgical hub 5104 determines that the procedure to be performed is a thoracic procedure. Second 5204, staff can scan the medical supplies brought in for the procedure. The surgical hub 5104 cross-references the scanned supplies with a list of supplies available for various types of surgery and confirms that the supplied mix corresponds to a thoracic procedure. Additionally, the surgical hub 5104 may also be able to determine that the procedure is not a wedge procedure (because the brought-in supplies lack certain supplies required for a thoracic wedge procedure, or are otherwise not corresponding to a thoracic wedge procedure). Third 5206, medical personnel can 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. Fourth 5208, medical staff activate the assistive devices. The assistive devices used can vary depending on the type of surgery and the techniques the surgeon will use, but in this exemplary case, they include fumigators, inhalers, and medical imaging devices. When activated, the assistive devices, as modular devices 5102, can automatically pair with a surgical hub 5104, which may be located in a specific vicinity of the modular device 5102 as part of its initialization process. The surgical hub 5104 can then derive background information about the surgical procedure by detecting the type of modular device 5102 paired with it during this preoperative or initialization phase. In this specific example, the surgical hub 5104 can determine that the surgery is a VATS procedure based on this specific combination of paired modular devices 5102. Based on data from the patient's EMR, a list of medical supplies to be used in the procedure, and a combination of the types of modular devices 5102 connected to the hub, the surgical hub 5104 can generally infer the specific procedure that the surgical team will perform. Once the surgical hub 5104 knows the specific procedure being performed, it can retrieve the steps of that procedure from memory or the cloud and then cross-reference it with data subsequently received from a connected data source 5126 (e.g., modular device 5102 and patient monitoring device 5124) to infer the steps of the surgical procedure being performed by the surgical team. Fifth, 5210, staff attach EKG electrodes and other patient monitoring devices 5124 to the patient. The EKG electrodes and other patient monitoring devices 5124 can be paired with the surgical hub 5104. When the surgical hub 5104 begins receiving data from the patient monitoring devices 5124, it can confirm that the patient is in the operating room, for example, as described in process 5207. Sixth, 5212, medical personnel can induce anesthesia in 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 step 5212, the preoperative portion of the lung segmental resection is completed, and the surgical portion begins.
[0181] Seventh, 5214, the lungs of a patient undergoing surgery can be collapsed (while ventilation is switched to the contralateral lung). For example, the surgical hub 5104 can infer from ventilator data that the patient's lungs have collapsed. The surgical hub 5104 can infer that the surgical portion of the procedure has begun because it can compare the detection of the patient's lung collapse with the expected steps of the surgery (which can be previously accessed or retrieved), thereby determining that collapsing the lungs is likely the first operational step in that particular surgery. Eighth, 5216, a medical imaging device 5108 (e.g., an endoscope) can be inserted, and video from the medical imaging device can be activated. The surgical hub 5104 can receive data (i.e., video or image data) from the medical imaging device through its connection to the medical imaging device. After receiving the medical imaging device data, the surgical hub 5104 can determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 5104 can determine that the specific procedure being performed is a segmental resection, rather than a lobectomy (note that the surgical hub 5104 has already ruled out wedge procedures based on data received at the second step 5204 of the procedure). (Source: Medical Imaging Device 124) Figure 2 The data can be used to determine contextual information relevant to the type of procedure being performed in a variety of different ways, including by determining the angle of the visualization orientation of the medical imaging device relative to the patient's anatomy, monitoring the number of medical imaging devices used (i.e., those activated and paired with the surgical hub 5104), and monitoring the type of visualization device used. For example, a technique for performing a VATS lobectomy may place the camera in the lower anterior corner of the patient's thoracic cavity above the diaphragm, while a technique for performing a VATS segmental resection may place the camera in an anterior intercostal position relative to the segmental fissure. For example, a situational awareness system may be trained, for example, using pattern recognition or machine learning techniques, to identify the positioning of the medical imaging device based on the visualization of the patient's anatomy. Exemplary techniques for performing a VATS lobectomy may utilize a single medical imaging device. Exemplary techniques for performing a VATS segmental resection may utilize multiple cameras. A technique for performing a VATS segmental resection may utilize an infrared light source (which may be communicatively coupled to the surgical hub as part of a visualization system) to visualize segmental fissures not used in VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can thus determine the specific type of surgical procedure being performed and / or the technique used for a particular type of surgical procedure.
[0182] Step 9, 5218: The surgical team can begin the anatomical step of the surgery. The surgical hub 5104 can infer that the surgeon is in the process of dissecting to access the patient's lungs because it receives data from the RF generator or ultrasound generator indicating that an energy device is being fired. The surgical hub 5104 can cross-reference the received data with the retrieval steps of the surgical procedure to determine that the energy device fired at that point in the method (i.e., after the previously discussed procedural steps are completed) corresponds to the anatomical step. Step 10, 5220: The surgical team can proceed to the ligation step of the surgery. The surgical hub 5104 can infer that the surgeon is ligating arteries and veins because it receives data from the surgical suture and cutting instruments indicating that an instrument is being fired. Similar to the previous steps, the surgical hub 5104 can derive this inference by cross-referencing the reception of data from the surgical suture and cutting instruments with the retrieval steps in the method. Step 11, 5222: The segmental resection portion of the surgery can be performed. The surgical hub 5104 can infer that the surgeon is transecting soft tissue based on data from surgical suture and cutting instruments (including data from their chambers). Chamber data may correspond, for example, to the size or type of staples fired by the instruments. Since different types of staples are used for different types of tissue, the chamber data can indicate the type of tissue being sutured and / or transected. In this case, the type of staple fired is for soft tissue (or other similar tissue type), which allows the surgical hub 5104 to infer the segmental resection portion of the procedure being performed. Twelfth, 5224, the node dissection step is performed. The surgical hub 5104 can infer that the surgical team is dissecting a node and performing a leak test based on data received from the generator indicating that an RF or ultrasound instrument is being fired. For this particular procedure, the use of an RF or ultrasound instrument after transecting the soft tissue corresponds to the node dissection step, which allows the surgical hub 5104 to make this inference. It should be noted that surgeons periodically switch between surgical suture / cutting instruments and surgical energy (e.g., RF or ultrasound) instruments depending on the specific steps in the operation, as different instruments are better suited to specific tasks. Therefore, the specific sequence of suture / cutting instruments and surgical energy instruments indicates the steps of the surgery being performed by the surgeon. Upon completion of step 12, 5224, the incision is closed and the postoperative portion of the surgery can begin.
[0183] The thirteenth step, 5226, involves reversing the patient's anesthesia. For example, the surgical hub 5104 can infer that the patient is waking up from anesthesia based on ventilator data (i.e., the patient's respiratory rate begins to increase). Finally, the fourteenth step, 5228, can be the removal of various patient monitoring devices 5124 from the patient by medical personnel. Thus, when the surgical hub 5104 loses EKG, BP, and other data from the patient monitoring devices 5124, the hub can infer that the patient is being transferred to the recovery room. As can be seen from the description of this exemplary procedure, the surgical hub 5104 can determine or infer when each step of a given surgical procedure occurs based on data received from various data sources 5126 communicatively coupled to the surgical hub 5104.
[0184] In addition to using patient data from one or more EMR databases to infer the type of surgical procedure to be performed, such as Figure 10 As shown in the first step 5202 of the timeline 5200, the situational awareness surgical hub 5104 can also use patient data to generate control adjustments for the paired modular device 5102.
[0185] Figure 11 This is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. In one aspect, the computer-implemented interactive surgical system can be configured to monitor and analyze data related to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and operating rooms or medical facilities. The computer-implemented interactive surgical system may include a cloud-based analytics system. While a cloud-based analytics system may be described as a surgical system, it is not necessarily limited to this description and can generally be a cloud-based medical system. Figure 11 As shown, the cloud-based analytics system may include multiple surgical instruments 7012 (which may be the same as or similar to instrument 112), multiple 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) to couple the surgical hubs 7006 to a cloud 7004 (which may be the same as or similar to cloud 204). Each of the multiple surgical hubs 7006 is communicatively coupled to one or more surgical instruments 7012. The hubs 7006 may also be communicatively coupled to the cloud 7004 of a computer-implemented interactive surgical system via network 7001. The cloud 7004 may be a remote, centralized source of hardware and software for storing, manipulating, and transmitting data generated from the operation of various surgical systems. Figure 11As shown, access to the cloud 7004 can be achieved via network 7001, which can be the Internet or some other suitable computer network. A surgical hub 7006, which can be coupled to the cloud 7004, can be considered as a client-side component of a cloud computing system (i.e., a cloud-based analytics system). Surgical instruments 7012 can be paired with the surgical hub 7006 for controlling and performing various surgical procedures or operations as described herein.
[0186] Furthermore, the surgical instrument 7012 may include a transceiver for transmitting data to and from its 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 for providing medical procedures, such as an operating room in a medical facility (e.g., a hospital). For example, the memory of the surgical hub 7006 may store location data. Figure 11 As shown, cloud 7004 includes a central server 7013 (which may be the same as or similar to 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 cloud 7004 collectively manages the cloud computing system, which includes monitoring requests from client hubs 7006 and managing the processing capacity of cloud 7004 to execute 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 magnetic storage. Memory device 7010 may include machine-executable instructions that, when executed, cause processor 7008 to execute data analysis module 7034 for cloud-based data analysis, manipulation, recommendation, and other operations described below. Furthermore, the processor 7008 can 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 clustered medical data database 2212 that can reside in memory 2210.
[0187] Based on the connection via network 7001 to various surgical hubs 7006, cloud 7004 can aggregate data from various surgical instruments 7012 and their corresponding hubs 7006, generating specific data. This aggregated data can be stored within the aggregated medical database 7012 of cloud 7004. Specifically, cloud 7004 can advantageously perform data analysis and manipulation on the aggregated data to generate insights and / or perform functions that individual hubs 7006 cannot achieve on their own. For this purpose, as... Figure 11As shown, cloud 7004 and surgical hub 7006 are communicatively coupled to transmit and receive information. I / O interface 7006 is connected to multiple surgical hubs 7006 via network 7001. Thus, I / O interface 7006 can be configured to transmit information between surgical hubs 7006 and aggregated medical data database 7011. Therefore, I / O interface 7006 facilitates read / write operations for cloud-based analytics systems. Such read / write operations can be performed in response to requests from hub 7006. These requests can be transmitted to hub 7006 via hub applications. I / O interface 7006 may include one or more high-speed data ports, including a Universal Serial Bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting cloud 7004 to hub 7006. The hub application server 7002 of the cloud 7004 can be configured to host software applications (e.g., hub applications) executed by the surgical hub 7006 and provide them with sharing capabilities. For example, the hub application server 7002 can manage requests made by the hub application through the hub 7006, control access to the aggregated medical data database 7011, and perform load balancing. (Reference) Figure 12 The data analysis module 7034 is described in more detail.
[0188] The specific cloud computing system configurations described in this disclosure can be specifically designed to address various problems arising in scenarios involving medical procedures and surgeries performed using medical devices such as surgical instruments 7012, 112. Specifically, the surgical instrument 7012 can be a digital surgical device configured to interact with the cloud 7004 to implement techniques that improve the execution of surgical procedures. Various surgical instruments 7012 and / or surgical hubs 7006 may include touch-controlled user interfaces, allowing clinicians to control various aspects of the interaction between the surgical instrument 7012 and the cloud 7004. Other suitable user interfaces for control, such as auditory-controlled user interfaces, may also be used.
[0189] Figure 12 A block diagram illustrating the functional architecture of a computer-implemented interactive surgical system is shown according to at least one aspect of this disclosure. A cloud-based analytics system may include multiple data analysis modules 7034, which can be executed by a processor 7008 of a cloud 7004 to provide data analysis solutions for problems particularly arising in the medical field. Figure 12As shown, the functionality of the cloud-based data analytics module 7034 can be aided by a hub application 7014 hosted by a hub application server 7002, which is accessible on the surgical hub 7006. The cloud processor 7008 and the hub application 7014 can operate in combination to execute the data analytics module 7034. An application programming interface (API) 7016 can define a set of protocols and routines corresponding to the hub application 7014. Additionally, the API 7016 can manage the storage and retrieval of data in or from the aggregated medical database 7012 for use by the application 7014. A cache 7018 can also store data (e.g., temporarily) and can be coupled to the API 7016 for more efficient retrieval of data used by the application 7014. Figure 12 The data analysis module 7034 may include a resource optimization module 7020, a data collection and aggregation module 7022, an authorization and security module 7024, a control program update module 7026, a patient outcome analysis module 7028, a recommendation module 7030, and a data classification and prioritization module 7032. Depending on some aspects, the cloud 7004 may also implement other suitable data analysis modules. In one aspect, the data analysis module can be used for specific recommendations based on analytical trends, results, and other data.
[0190] For example, the data collection and aggregation module 7022 can be used to generate self-descriptive data (e.g., metadata), including the identification of salient features or configurations (e.g., trends), the management of redundant datasets, and the storage of data in paired datasets that can be grouped by surgical procedures but are not necessarily locked to actual surgical dates and surgeons. Specifically, paired datasets generated by the operation of surgical instruments 7012 may include the application of binary classification, such as bleeding or non-bleeding events. More generally, binary classification may characterize expected events (e.g., successful surgical procedures) or unexpected events (e.g., accidental firing or misuse of surgical instrument 7012). The aggregated self-descriptive 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 tissue data based on the raw data received from the surgical hub 7006. For this purpose, the processor 7008 may be operatively coupled to the hub application 7014 and the aggregated medical data database 7011 for executing the data analysis module 7034. The data collection and aggregation module 7022 can store aggregated organizational data into the aggregated medical data database 2212.
[0191] Resource optimization module 7020 can be configured to analyze the aggregated data to determine the optimal use of resources for a specific or set of medical facilities. For example, resource optimization module 7020 can determine the optimal sequence point of surgical suture instruments 7012 for a set of medical facilities based on corresponding predicted demand for such instruments 7012. Resource optimization module 7020 can also evaluate the resource use or other operational configurations of various medical facilities to determine whether resource use can be improved. Similarly, recommendation module 7030 can be configured to analyze aggregated tissue data from data collection and aggregation module 7022 to provide recommendations. For example, recommendation module 7030 can recommend to medical facilities (e.g., healthcare providers, such as hospitals) that a specific surgical instrument 7012 should be upgraded to an improved version based on, for example, a higher-than-expected error rate. In addition, recommendation module 7030 and / or resource optimization module 7020 can recommend better supply chain parameters, such as product reordering points, and provide suggestions for different surgical instruments 7012, their use, or procedural steps to improve surgical outcomes. Medical facilities can receive such recommendations via a corresponding surgical hub 7006. More specific recommendations regarding parameters or configurations of various surgical instruments 7012 can also be provided. The hub 7006 and / or surgical instruments 7012 may also each have a display screen showing data or recommendations provided by the cloud 7004.
[0192] The patient outcome analysis module 7028 can analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 can also analyze and evaluate other potential operating parameters. In this regard, the recommendation module 7030 can recommend the use of these other potential operating parameters based on producing better surgical outcomes (such as better sealing or less bleeding). For example, the recommendation module 7030 can transmit recommendations to the surgical hub 7006 regarding when to use a specific compartment for the corresponding suture surgical instrument 7012. Therefore, the cloud-based analytics system, when controlling common variables, can be configured to analyze large collections of raw data and provide centralized recommendations (advantageously based on aggregated data) for multiple medical facilities. For example, the cloud-based analytics system can analyze, evaluate, and / or aggregate data based on the type of medical practice, patient type, number of patients, geographical similarity between medical providers, which medical providers / facilities use similar types of instruments, etc., so that no single medical facility can be analyzed independently. The control procedure update module 7026 can be configured to perform various surgical instrument 7012 recommendations when the corresponding control procedure is updated. For example, the patient outcome analysis module 7028 can identify correlations linking specific control parameters to successful (or unsuccessful) outcomes. Such correlations can be addressed when updated control procedures are transmitted to the surgical instrument 7012 via the control procedure update module 7026. Updates to the instrument 7012, which can be transmitted via the corresponding hub 7006, can incorporate aggregated performance data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Furthermore, the patient outcome analysis module 7028 and the recommendation module 7030 can identify methods for improving the use of the instrument 7012 based on the aggregated performance data.
[0193] The cloud-based analytics 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 permitted cloud access levels. For example, based on providing accurate credentials, a surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., it may only participate in transmitting or receiving certain limited types of information). To this end, the aggregated medical data database 7011 of the cloud 7004 may include a database of authorization credentials for verifying the accuracy of the provided credentials. Different credentials may be associated with different permission levels for interacting with the cloud 7004, such as a predetermined access level for receiving data analysis generated by the cloud 7004. Furthermore, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices that may include a "blacklist" of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist can be prohibited from interacting with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to their corresponding hubs 7006 and / or may be prevented from functioning completely when paired with their corresponding hubs 7006. Additionally or alternatively, the cloud 7004 may tag instruments 7012 based on incompatibility or other specified criteria. This allows for the identification and resolution of counterfeit medical devices and the improper reuse of such devices throughout the cloud-based analytics system.
[0194] Surgical instrument 7012 may use a wireless transceiver to transmit wireless signals representing, for example, authorization credentials for accessing the corresponding hub 7006 and cloud 7004. Wired transceivers may also be used for signal transmission. Such authorization credentials may be stored in a corresponding memory device of surgical instrument 7012. Authorization and security module 7024 may determine whether the authorization credential is accurate or counterfeit. Authorization and security module 7024 may also dynamically generate authorization credentials for enhanced security. Credentials may also be encrypted, such as by using hash-based encryption. Upon transmission of appropriate authorization, surgical instrument 7012 may transmit signals to the corresponding hub 7006 and ultimately to cloud 7004 to indicate that instrument 7012 is ready to acquire and transmit medical data. In response, cloud 7004 may transition to a state capable of receiving medical data for storage in aggregated medical data database 7011. This readiness for data transmission may be indicated, for example, by a light indicator on instrument 7012. Cloud 7004 may also transmit signals to surgical instrument 7012 for updating its associated control procedures. The cloud 7004 can transmit signals relating to a specific class of surgical instruments 7012 (e.g., electrosurgical instruments), ensuring that software updates to the control program are only transmitted to the appropriate surgical instrument 7012. Furthermore, the cloud 7004 can be used to implement system-wide solutions to address local or global problems based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 is identified as having a common manufacturing defect, the cloud 7004 can modify the authorization credentials corresponding to that group to implement an operational lockout for that group.
[0195] Cloud-based analytics systems can allow monitoring of multiple healthcare facilities (e.g., hospitals) to identify practices for improvement and recommend changes accordingly (e.g., via recommendation module 2030). Therefore, the processor 7008 of the cloud 7004 can analyze data associated with individual healthcare facilities to identify that facility and aggregate that data with other data associated with other healthcare facilities in the group. For example, groups can be defined based on similar operational practices or geographical locations. In this way, the cloud 7004 can provide analytics and recommendations across groups of healthcare facilities. Cloud-based analytics systems can also be used to enhance situational awareness. For example, the processor 7008 can perform predictive modeling of the impact of recommendations on the cost and effectiveness of a particular facility (relative to overall operations and / or various medical protocols). The cost and effectiveness associated with that particular facility can also be compared to corresponding local areas of other facilities or any other comparable facilities.
[0196] The data classification and prioritization module 7032 can prioritize and classify data based on criticality (e.g., the severity, unexpectedness, or suspicion of the medical event associated with the data). This classification and prioritization can be used in conjunction with the functionality of other data analysis modules 7034 described herein to improve the cloud-based analytics and operations described herein. For example, the data classification and prioritization module 7032 can assign priorities to data analyses performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels can elicit specific responses from the cloud 7004 (corresponding to urgency levels), such as escalating responses, special handling, exclusion from the aggregated medical data database 7011, or other appropriate responses. Furthermore, if needed, the cloud 7004 can transmit requests for additional data from the corresponding surgical instrument 7012 (e.g., push messages) via the hub application server. Push messages can elicit notifications displayed on the corresponding hub 7006 for requests for support or additional data. Such push messages may be required if the cloud detects significant irregularities or anomalies and cannot determine the cause of the irregularities. The central server 7013 can be programmed to trigger the push message under certain significant circumstances, such as when data is determined to be different from the expected value exceeding a predetermined threshold or when it indicates that security has been included.
[0197] Additional examples and details of the various functions are provided in the subsequent descriptions below. Each of the available features in the various descriptions is as follows: Figure 11 and Figure 12 The cloud architecture described is an example of hardware and software implementation.
[0198] Figure 13A block diagram of a computer-implemented adaptive surgical system 9060, configured to adaptively generate control program updates for a modular device 9050, is shown according to at least one aspect of this 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. Although a single surgical hub 9000 may be depicted, 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 and a data relay interface 9030, the processor being coupled to a memory 9020 for executing instructions stored thereon, through which data is transmitted to the analysis system 9100. In some examples, the surgical hub 9000 may also include a user interface 9090 having an input device 9092 (e.g., a capacitive touchscreen or keyboard) for receiving input from the user and an output device 9094 (e.g., a display screen) for providing output to the user. The output may include data from the user's query input, suggestions for products or product mixtures used in a given procedure, and / or instructions for actions to be performed before, during, or after a surgical procedure. The surgical hub 9000 may also 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 capable of communicatively connecting to the modular device 9050 via a wireless communication protocol. The modular device 9050 may include, for example, surgical suture and cutting instruments, electrosurgical instruments, ultrasound instruments, insufflators, respirators, and displays. In some examples, the surgical hub 9000 may also be communicatively coupled to one or more patient monitoring devices 9052, such as EKG monitors or BP monitors. In some examples, the surgical hub 9000 may also be communicatively coupled to one or more databases 9054 or external computer systems, such as the EMR database of the medical facility where the surgical hub 9000 is located.
[0199] When the modular device 9050 is connected to the surgical hub 9000, the surgical hub 9000 can sense or receive perioperative data from the modular device 9050 and then correlate the received perioperative data with surgical procedure outcome data. The perioperative data can indicate how to control the modular device 9050 during the surgical procedure. The procedure outcome data includes data associated with the results from a surgical procedure (or its steps), which can include whether the surgical procedure (or its steps) had a positive or negative outcome. For example, outcome data may include whether the patient suffered postoperative complications from a particular procedure or whether there was leakage (e.g., bleeding or air leakage) at a particular staple or incision line. The surgical hub 9000 can obtain surgical procedure outcome data by receiving data from an external source (e.g., from the EMR database 9054), by directly detecting the outcome (e.g., via one of the connected modular devices 9050), or by inferring the occurrence of the outcome through a situational awareness system. For example, data on postoperative complications can be retrieved from the EMR database 9054, and data on staple or suture leakage can be directly detected or inferred by the situational awareness system. Surgical procedure outcome data can be inferred by the situational awareness system from data received from various data sources, including the modular device 9050 itself, the patient monitoring device 9052, and the database 9054 connected to the surgical hub 9000.
[0200] The surgical hub 9000 can transmit associated modular device 9050 data and outcome data to the analysis system 9100 for processing thereon. By transmitting both perioperative data and procedural outcome data instructing how to control the modular device 9050, the analysis system 9100 can associate different ways of controlling the modular device 9050 with surgical outcomes specific to a particular procedural type. 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 memory and a processor coupled to the memory, which executes instructions stored thereon 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 for the field modular devices 9050, and then transmit (or “push”) updates to the control programs of the modular devices 9050.
[0201] Combination Figures 5 to 6 Additional details are described regarding a computer-implemented interactive surgical system 9060, including a surgical hub 9000 and various modular devices 9050 that can be connected to it.
[0202] Figure 14 A surgical system 6500 according to this disclosure is provided, and may include a surgical instrument 6502 communicating with a console 6522 or a portable device 6526 via a wired or wireless connection through a local area network 6518 or a cloud network 6520. 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 is releasably coupled to the handle 6504, and the loading unit 6514 is releasably coupled to the adapter 6508 such that the adapter 6508 transmits force from a 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 the force applied to the loading unit 6514. The loading unit 6514 may include an end effector 6530 having a first jaw 6532 and a second jaw 6534. The loading unit 6514 can be an in-situ loaded or multiple-fire loading unit (MFLU), which allows clinicians to fire multiple fasteners multiple times without removing the loading unit 6514 from the surgical site to reload it.
[0203] The first jaw 6532 and the second jaw 6534 may be configured to clamp tissue therebetween, fire a fastener through the clamped tissue, and cut the clamped tissue. The first jaw 6532 may be configured to fire at least one fastener multiple times, or may be configured to include a replaceable multiple-fire fastener cartridge comprising multiple fasteners (e.g., nails, clamps, etc.) that can be fired more than once before being replaced. The second jaw 6534 may include an anvil that deforms or otherwise secures the fastener around the tissue when it is ejected from the multiple-fire fastener cartridge.
[0204] The handle 6504 may include a motor coupled to a drive shaft to influence its rotation. The handle 6504 may also include a control interface for selectively activating the motor. The control interface may include buttons, switches, levers, sliders, touchscreens, and any other suitable input mechanisms or user interfaces that can be engaged by a clinician to activate the motor.
[0205] The control interface of the handle 6504 can communicate with the controller 6528 of the handle 6504 to selectively activate the motor to affect the rotation of the drive shaft. The controller 6528 may be disposed within the handle 6504 and is 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 loading unit 6514 to selectively activate the motor. The handle 6504 may also include a display that a clinician can view during use of the handle 6504. The display may be configured to display portions of the adapter or loading unit data before, during, or after the firing instrument 6502.
[0206] Adapter 6508 may include an adapter identification device 6510 disposed therein, and loading unit 6514 includes a loading unit identification device 6516 disposed therein. Adapter identification device 6510 may communicate with controller 6528, and loading unit identification device 6516 may communicate with controller 6528. It should be understood that loading unit identification device 6516 may communicate with adapter identification device 6510, and the adapter identification device may relay or transmit communications from loading unit identification device 6516 to controller 6528.
[0207] The adapter 6508 may also include a plurality of sensors 6512 (one shown) disposed around it to detect various conditions of the adapter 6508 or the environment (e.g., whether the adapter 6508 is connected to the loading unit, whether the adapter 6508 is connected to the handle, whether the drive shaft rotates, the torque of the drive shaft, the strain of the drive shaft, the temperature within the adapter 6508, the number of times the adapter 6508 is fired, the peak force of the adapter 6508 during firing, the total force applied to the adapter 6508, the peak retraction force of the adapter 6508, the number of pauses of the adapter 6508 during firing, etc.). The plurality of sensors 6512 may provide input to the adapter identification device 6510 in the form of data signals. The data signals of the plurality of sensors 6512 may be stored in the adapter identification device 6510 or may be used to update adapter data stored in the adapter identification device. The data signals of the plurality of sensors 6512 may be analog or digital. The plurality of sensors 6512 may include force gauges to measure the force applied to the loading unit 6514 during firing.
[0208] The handle 6504 and adapter 6508 can 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 can 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 can be a contactless electrical interface for wirelessly transmitting energy and signals therebetween (e.g., inductive transmission). It is also conceivable that the adapter identification device 6510 and the controller 6528 can communicate wirelessly with each other via a wireless connection separate from the electrical interface.
[0209] Handle 6504 may include transmitter 6506 configured to transmit instrument data from controller 6528 to other components of system 6500 (e.g., LAN 6518, cloud 6520, console 6522, or portable device 6526). Transmitter 6506 may also receive data (e.g., cartridge data, loading unit data, or adapter data) from other components of system 6500. For example, controller 6528 may transmit instrument data to console 6528, including the serial number of an attachment adapter (e.g., adapter 6508) attached to handle 6504, the serial number of a loading unit (e.g., loading unit 6514) attached to the adapter, and the serial number of a multiple-fire fastener cartridge (e.g., a multiple-fire fastener cartridge) loaded into the loading unit. 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 controller 6528. The controller 6528 can display the message on the local instrument display, or transmit the message via the transmitter 6506 to the console 6522 or the portable device 6526 to display the message on the display 6524 or the portable device screen, respectively.
[0210] Figure 15A An exemplary process for determining an operating mode and operating within that mode is illustrated. Computer-implemented interactive surgical systems and / or components and / or subsystems of such systems may be configured to be updatable. Such updates may include features and benefits not previously available to the user. These updates can be implemented using any method suitable for introducing features to the user, such as hardware, firmware, and software updates. For example, replaceable / interchangeable (e.g., hot-swappable) hardware components, flashable firmware devices, and updatable software systems may be used to update computer-implemented interactive surgical systems and / or components and / or subsystems of such systems.
[0211] These updates can be conditional on any suitable standard or set of standards. For example, an update can be conditional on one or more hardware capabilities of the system, such as processing power, bandwidth, resolution, etc. For example, an update can be conditional on one or more software aspects, such as the purchase of certain software code. For example, an update can be conditional on a purchased service level. A service level can represent the features and / or set of features that a user is entitled to use in conjunction with a computer-implemented interactive surgical system. Service levels can be determined by license codes, e-commerce server authentication interactions, hardware keys, username / password combinations, biometric authentication interactions, public / private key exchange interactions, etc.
[0212] At position 10704, system / device parameters can be identified. System / device parameters can be any element or set of elements conditioned on updates. For example, a computer-implemented interactive surgical system can detect specific bandwidth of communication between a modular device and a surgical hub. For example, a computer-implemented interactive surgical system can detect an indication to purchase a certain service level.
[0213] At 10708, the operating mode can be determined based on the identified system / device parameters. This determination can be made by a process that maps the system / device parameters to the operating mode. This process can be manual and / or automatic. The process can be the result of local and / or remote computation. For example, client / server interaction can be used to determine the operating mode based on the identified system / device parameters. For example, local software and / or locally embedded firmware can be used to determine the operating mode based on the identified system / device parameters. For example, hardware keys such as secure microprocessors can be used to determine the operating mode based on the identified system / device parameters.
[0214] At 10710, operation can be performed according to the determined operating mode. For example, the system or device can continue to operate in the default operating mode. Alternatively, the system or device can continue to operate in an alternative operating mode. The operating mode can be initiated by control hardware, firmware, and / or software already residing in the system or device. The operating mode can also be initiated by newly installed / updated control hardware, firmware, and / or software.
[0215] Figure 15BAn exemplary functional block diagram for changing an operating mode is shown. Upgradeable element 10714 may include initialization component 10716. Initialization component 10716 may include any hardware, firmware, and / or software suitable for determining the operating mode. For example, initialization component 10716 may be part of a system or device startup process. Initialization component 10716 may interact to determine the operating mode of upgradeable element 10714. For example, initialization component 10716 may interact with, for example, user 10730, external resource 10732, and / or local resource 10718. For example, initialization component 10716 may receive a license key from user 10730 to determine the operating mode. Initialization component 10716 may use the serial number of upgradeable device 10714 to query external resource 10732, such as a server, to determine the operating mode. For example, initialization component 10716 may query local resource 10718, such as a local query to determine the amount of available bandwidth and / or a local query, such as a hardware key, to determine the operating mode.
[0216] Upgradeable element 10714 may include one or more operating components 10720, 10722, 10726, 10728 and an operating pointer 10724. Initialization component 10716 may direct operating pointer 10724 to direct operation of upgradeable element 10741 to operating components 10720, 10722, 10726, 10728 corresponding to a determined operating mode. Initialization component 10716 may also direct operating pointer 10724 to direct operation of upgradeable element to default operating component 10720. For example, default operating component 10720 may be selected if no other alternative operating mode is determined. For example, default operating component 10720 may be selected in the event of initialization component failure and / or interaction failure. Initialization component 10716 may also direct operating pointer 10724 to direct operation of upgradeable element 10714 to resident operating component 10722. For example, certain features may reside in the upgradeable component 10714 but require activation to function. The initialization component 10716 may direct the operation pointer 10724 to guide the operation of the upgradeable component 10714 to install new operating components 10728 and / or newly installed operating components 10726. For example, new software and / or firmware may be downloaded. The new software and / or firmware may contain code for enabling features represented by the selected operating mode. For example, new hardware components may be installed to enable the selected operating mode.
[0217] Figure 16 A perspective view of an electric surgical suture system. Figure 16 A surgical instrument 1010 (e.g., an endoscopic cutter) is shown, comprising an interchangeable shaft assembly 1200 operatively coupled to a housing 1012.
[0218] Figure 17 for Figure 16 Perspective view of interchangeable surgical shaft components of an electric surgical suture system. Figure 17 An interchangeable shaft assembly 1200 is shown that is detached from the housing 1012 or the handle 1014. Figure 18 for Figure 16 An exploded assembly view of the handle assembly of an electric surgical suture system, showing multiple parts. Figure 18 As can be seen, the handle 1014 may include a pair of interconnectable handle housing segments 1016 and 1018, which can be interconnected by screws, snap-on features, adhesives, etc. In the illustrated structure, the handle housing segments 1016 and 1018 cooperate to form a pistol grip 1019. Figure 16 and Figure 18 A reusable or non-reusable motor-driven surgical cutting and fastening instrument 1010 is illustrated. In an illustrated embodiment, the instrument 1010 includes a prior housing 1012 comprising a handle 1014 configured to be grasped, manipulated, and actuated by a clinician. The housing 1012 may be configured for operatively attaching to an interchangeable shaft assembly 1200 having a surgical end effector 1300 operatively coupled thereto, the surgical end effector being configured to perform one or more surgical tasks or procedures. Continuing to refer to this specific embodiment, it will be understood that the various forms of interchangeable shaft assemblies disclosed herein can also be effectively used in conjunction with robot-controlled surgical systems. Therefore, the term "housing" may also encompass a housing or similar portion of a robotic system that houses or otherwise operatively supports at least one drive system configured to generate and apply at least one control action that can be used to actuate the interchangeable shaft assemblies disclosed herein and their corresponding equivalents. Furthermore, various components may be "received" or contained within the housing, or various components may be "associated" with the housing. In such cases, the component may not be housed within a housing or may be 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 robot-controlled surgical instrument and / or a portion of a robotic system that can be used to operatively control the surgical instrument. For example, the interchangeable axis assemblies disclosed herein may be used in conjunction with the various robotic systems, instruments, components, and methods disclosed herein, which are incorporated herein by reference throughout.
[0219] Figure 16 The previously depicted housing 1012 combined with the interchangeable shaft assembly 1200 is shown ( Figure 17 , Figure 19 and Figure 20The interchangeable shaft assembly includes an end effector 1300 comprising a surgical cutting and fastening device configured to operably support a surgical cartridge 4000 therein. A housing 1012 can be configured for use in conjunction with interchangeable shaft assemblies including end effectors adapted to support cartridges of different sizes and types, and the interchangeable shaft assemblies having different shaft lengths, sizes, and types, etc. Furthermore, housing 1012 can also be effectively used with a variety of other interchangeable shaft assemblies, including those configured to apply other actions and forms of energy (such as, for example, radio frequency (RF) energy, ultrasonic energy, and / or motion) to end effector arrangements suitable for use with various surgical applications and procedures. Additionally, the end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system can utilize any suitable fastener that can be gripped and manipulated by a clinician. As will be discussed in further detail below, the shank 1014 operably supports a plurality of drive systems configured to generate various control actions and apply these control actions to corresponding portions of interchangeable shaft assemblies operably attached thereto.
[0220] See now Figure 18 The handle 1014 may also include a frame 1020 operably supporting multiple drive systems. For example, the frame 1020 may operably support a “first” or closing drive system, typically designated 1030, which can be used to apply closing and opening actions to an interchangeable shaft assembly 1200 operably attached to or coupled thereto. In at least one form, the closing drive system 1030 may include an actuator in the form of a closing trigger 1032 pivotally supported by the frame 1020. More specifically, as Figure 18 As shown, the closure trigger 1032 is pivotally coupled to the handle 1014 via pin 1033. This arrangement allows the closure trigger 1032 to be manipulated by a clinician, such that when the clinician grips the pistol grip 1019 of the handle 1014, the closure trigger 1032 can be easily pivoted from an initial or "unacted" position to an "acted" position, and more specifically, to a fully compressed or fully actuated position. The closure trigger 1032 can be biased to the unacted position by a spring or other biasing arrangement (not shown). In various forms, the closure actuation system 1030 also includes a closure linkage assembly 1034 pivotally coupled to the closure trigger 1032. Figure 18 As can be seen, the closing linkage assembly 1034 may include a first closing connector 1036 and a second closing connector 1038 pivotally coupled to the closing trigger 1032 via a pin 1035. The second closing connector 1038 may also be referred to herein as an "attachment member" and includes a lateral attachment pin 1037.
[0221] See also Figure 18 It can be observed that the first closure connector 1036 may have a locking wall or locking end 1039 thereon, which is configured to engage with a closure release assembly 1060 pivotally coupled to the frame 1020. In at least one form, the closure release assembly 1060 may include a release button assembly 1062 having a locking pawl 1064 formed thereon projecting distally. The release button assembly 1062 may be pivoted counterclockwise by a release spring (not shown). When a clinician presses the closure trigger 1032 from its unacted position toward the pistol grip portion 1019 of the handle 1014, the first closure connector 1036 pivots upward to a point where the locking pawl 1064 falls into the point to engage with the locking wall 1039 on the first closure connector 1036, thereby preventing the closure trigger 1032 from returning to the unacted position. Therefore, the closure release assembly 1060 can be used to lock the closure trigger 1032 in the fully actuated position. When the clinician wishes to unlock the closure trigger 1032 to allow it to be biased to the unacted position, the clinician can simply pivot the closure release button assembly 1062, causing the locking pawl 1064 to move and disengage from the locking wall 1039 on the first closure connector 1036. When the locking pawl 1064 has moved and disengaged from the first closure connector 1036, the closure trigger 1032 can pivot back to the unacted position. Other closure trigger locking and release arrangements may also be used.
[0222] Arm 1061 may extend from closed release button 1062. A magnetic element 1063 (such as a permanent magnet) may be mounted to arm 1061, for example. When closed release button 1062 rotates from its first position to its second position, magnetic element 1063 may move toward circuit board 1100. Circuit board 1100 may include at least one sensor configured to detect movement of magnetic element 1063. In at least one embodiment, for example, a Hall effect sensor (not shown) may be mounted to the bottom surface of circuit board 1100. Hall effect sensor may be configured to detect changes in the magnetic field surrounding Hall effect sensor caused by movement of magnetic element 1063. Hall effect sensor may signal to, for example, a microcontroller that may determine whether closed release button 1062 is in a first position associated with the unactuated position of closed trigger 1032 and the open configuration of the end effector, a second position associated with the actuated position of closed trigger 1032 and the closed configuration of the end effector, and / or any position between the first and second positions.
[0223] In at least one embodiment, the handle 1014 and frame 1020 operatively support another drive system, referred to herein as a firing drive system 1080, configured to apply a firing action to a corresponding portion of an interchangeable shaft assembly attached thereto. The firing drive system 1080 may also be referred to herein as a “second drive system.” The firing drive system 1080 may employ an electric motor 1082 positioned in a pistol grip portion 1019 of the handle 1014. In various embodiments, the motor 1082 may be a DC brushed drive motor having a maximum speed, for example, about 25,000 RPM. In other arrangements, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor 1082 may be powered by a power source 1090, in one embodiment of which the power source may include a removable power supply unit 1092. Figure 3 As can be seen, for example, the power supply 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. Each battery 1098 may each include, for example, lithium-ion (“LI”) or other suitable batteries. The distal housing portion 1096 may be configured to be removably operably attached to a handle circuit board 1100 that is also operably coupled to the motor 1082. The plurality of batteries 1098 may be connected in series and may be used as a power source for the surgical instrument 1010. Furthermore, the power source 1090 may be replaceable and / or rechargeable.
[0224] As outlined above relative to other various forms, the electric motor 1082 may include a rotatable shaft (not shown) operatively coupled to a gear reducer assembly 1084, which is mounted on a longitudinally movable drive member 1120 in engagement with a set of drive teeth 1122 of a rack or pinion. In use, the voltage polarity provided by the power source 1090 can operate the electric motor 1082 in a clockwise direction, while the voltage polarity applied to the electric motor by the battery can be reversed to operate the electric motor 1082 in a counterclockwise direction. When the electric motor 1082 rotates in one direction, the drive member 1120 will be axially driven in the distal direction "DD". When the motor 1082 is driven in the opposite direction of rotation, the drive member 1120 will be axially driven in the proximal direction "PD". The handle 1014 may include a switch that can be configured to reverse the polarity applied to the electric motor 1082 by the power source 1090. As with other forms 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 moving.
[0225] Actuation of motor 1082 can be controlled by a trigger 1130 pivotally supported on handle 1014. Trigger 1130 is pivotable between an unactuated position and an actuated position. Trigger 1130 can be biased to the unactuated position by spring 1132 or other biasing arrangement such that when a clinician releases trigger 1130, trigger 1130 can be pivoted by spring 1132 or biasing arrangement or otherwise returned to the unactuated position. In at least one embodiment, trigger 1130 can be positioned “outside” the closed trigger 1032, as discussed above. In at least one embodiment, trigger safety button 1134 can be pivotally mounted to closed trigger 1032 by pin 1035. Safety button 1134 can be positioned between trigger 1130 and closed trigger 1032 and has a pivot arm 1136 projecting therefrom. When the closed trigger 1032 is in the unactivated position, the safety button 1134 can be accommodated in the handle 1014. In this position, the clinician may not be able to easily access the button or move it between a safe position preventing actuation of the trigger 1130 and a firing position where the trigger 1130 can be fired. When the clinician depresses the closed trigger 1032, the safety button 1134 and the trigger 1130 pivot downwards and can then be operated by the clinician.
[0226] As described above, in at least one form, the longitudinally movable drive member 1120 has teeth 1122 formed thereon on a rack for meshing with a corresponding drive gear 1086 of the gear reducer assembly 1084. At least one form also includes a manually actuated "emergency" assembly 1140, which can be configured to allow a clinician to manually retract the longitudinally movable drive member 1120 in the event that the motor 1082 fails. The emergency assembly 1140 may include a lever or emergency handle assembly 1142 configured to be manually pivotable to engage a ratchet with teeth 1124 also disposed in the drive member 1120. Thus, a clinician can manually retract the drive member 1120 by using the emergency handle assembly 1142 to cause the drive member 1120 to ratchet in the proximal direction "PD". U.S. Patent No. 8,608,045, entitled “POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLEFIRING SYSTEM,” discloses emergency arrangement structures and other components, arrangement structures, and systems that can also be used with the various devices disclosed herein. U.S. Patent No. 8,608,045 is incorporated herein by reference in its entirety.
[0227] Now go to Figure 17 and Figure 20 The interchangeable shaft assembly 1200 may include a surgical end effector 1300, which may include an elongated channel 1310 configured to operably support a staple cartridge 4000 therein. The end effector 1300 may also include an anvil 2000 pivotally supported relative to the elongated channel 1310. The interchangeable shaft assembly 1200 may also include an articulation joint 3020 and an articulation lock 2140, which may be configured to releasably hold the end effector 1300 in a desired position relative to the shaft axis SA. Examples of various features relating to at least one form of the end effector 1300, the articulation joint 3020, and the articulation lock can be seen in U.S. Patent Application Serial No. 13 / 803,086 (now U.S. Patent Application Publication No. 2014 / 0263541), filed March 14, 2013, entitled “ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK”, the entire contents of which are incorporated herein by reference. Figure 19 for Figure 17 An exploded assembly view of interchangeable surgical shaft assemblies. (See attached image.) Figure 19 As can be seen, the interchangeable shaft assembly 1200 may also include a proximal housing or nozzle 1201 consisting of nozzle portions 1202 and 1203.
[0228] The interchangeable shaft assembly 1200 may also include a closure system or closure member assembly 3000, which can be used to close and / or open the anvil 2000 of the end effector 1300. The shaft assembly 1200 may include a ridge 1210, which may be configured to: first, slidably support the firing member therein; and second, slidably support the closure member assembly 3000 extending around the ridge 1210. Figure 20 It shows Figure 19 A partially exploded assembly view of a portion of an interchangeable surgical shaft assembly. (See attached image.) Figure 20As can be seen, the distal end 1212 of the ridge 1210 terminates at an upper lug mounting feature 1270 and a lower lug mounting feature 1280. The upper lug mounting feature 1270 may have a lug slot 1272 therein, adapted to mount a support-mounted connector 1274 therein. Similarly, the lower lug mounting feature 1280 may have a lug slot 1282 therein, adapted to mount a support-mounted connector 1284 therein. The upper mounting connector 1274 may include a pivot housing 1276 adapted to rotatably receive a pivot pin 1292 formed on a channel cap or anvil holder 1290 attached to the proximal end portion 1312 of the elongated channel 1310. The lower mounting connector 1284 may include a lower pivot pin 1286 adapted to be received within a pivot hole 1314 formed in the proximal end portion 1312 of the elongated channel 1310. See also Figure 20 The lower pivot pin 1286 can be vertically aligned with the pivot bearing socket 1276 to define the joint motion axis AA, around which the surgical end effector 1300 can perform joint movement relative to the axis SA. See also Figure 17 .
[0229] In the illustrated example, the surgical end effector 1300 can be selectively articulated about a joint axis AA by the articulation system 2100. In one form, the articulation system 2100 may include a proximal joint motion actuator 2102, which is pivotally coupled to the joint motion connector 2120. Figure 20As can be seen most specifically, a bias attachment lug 2114 may be formed on the distal end 2110 of the proximal joint motion actuator 2102. A pivot hole 2116 may be formed in the bias attachment lug 2114 and configured to pivotally receive a proximal connector pin 2124 formed on the proximal end 2122 of the joint motion connector 2120. The distal end 2126 of the joint motion connector 2120 may include a pivot hole 2128 configured to pivotally receive a channel pin 1317 formed on the proximal end portion 1312 of the elongated channel 1310. Thus, axial movement of the proximal joint motion actuator 2102 will thereby apply joint movement to the elongated channel 1310, thereby causing the surgical end effector 1300 to articulate about the joint motion axis AA relative to the spine 1210. Further details regarding the construction and operation of the joint motion system 2100 can be found in various references incorporated herein by reference, including U.S. Patent Application Serial No. 15 / 635,631 (now U.S. Patent Application Publication No. 2019 / 0000464), filed June 28, 2017, entitled “SURGICAL INSTRUMENT WITHAXIALLY MOVABLE CLOSURE MEMBER,” the entire contents of which are incorporated herein by reference. In various cases, when the proximal joint motion actuator 2102 is not moving in the proximal or distal direction, the proximal joint motion actuator 2102 may be held in place by the joint motion lock 2140. Additional details regarding examples of the joint motion lock 2140 can be found in U.S. Patent Application Publication No. 2019 / 0000464 and other references incorporated herein by reference.
[0230] In various configurations, the ridge 1210 may include a proximal end 1211 rotatably supported within the base 1240. In one arrangement, for example, the proximal end 1211 of the ridge 1210 has threads 1214 formed thereon for threaded attachment to a ridge bearing 1216, which is configured to be supported within the base 1240. See also Figure 19 This arrangement facilitates the rotatable attachment of the ridge 1210 to the base 1240, allowing the ridge 1210 to rotate selectively about the axis SA relative to the base 1240.
[0231] See also Figure 19 The interchangeable shaft assembly 1200 may include a closing shuttle 1250 slidably supported within a base 1240, allowing the closing shuttle to move axially relative to the base. The closing shuttle 1250 may include a pair of proximal-facing hooks 1252 configured for attachment to an attachment pin 1037. Figure 3The attachment pin can be attached to a second closing connector 1038, as will be discussed in further detail below. In at least one example, the closing member assembly 3000 may include a proximal closing member segment 3010 having a proximal end 3012 that can be coupled to the closing shuttle 1250 for rotation relative to the closing shuttle. For example, a U-shaped connector 1263 may be inserted into an annular slot 3014 in the proximal end 3012 of the proximal closing member segment 3010 and retained within a vertical slot 1253 in the closing shuttle 1250. Such a configuration can be used to attach the proximal closing member segment 3010 to the closing shuttle 1250 for axial travel with the closing shuttle, while allowing the proximal closing member segment 3010 to rotate relative to the closing shuttle 1250 about an axis SA. The closing spring 1268 journal can be connected to the proximal closing member section 3010 and used to bias the proximal closing member section 3010 in the proximal direction “PD”. When the shaft assembly is operatively coupled to the shank 1014, the closing spring can be used to pivot the closing trigger 1032 to the unacted position.
[0232] In at least one form, the interchangeable shaft assembly 1200 may also include an articulated joint 3020. However, other interchangeable shaft assemblies may not be able to perform articulation. For example... Figure 20 As can be seen, for example, the distal closure member or distal closure segment 3030 may be coupled to the distal end of the proximal closure member segment 3010. The articulated joint 3020 includes a dual-pivot closure sleeve assembly 3022. According to various forms, the dual-pivot closure sleeve assembly 3022 includes an end actuator closure tube 3050 having an upper handle 3052 and a lower handle 3054 projecting distally. The upper dual-pivot connector 3056 includes an upwardly projecting distal pivot pin and a proximal pivot pin, which respectively engage an upper distal pin hole in the upper handle 3052 projecting proximally on the distal closure segment 3030 and an upper proximal pin hole in the upper handle 3032 projecting distally. The dual-pivot connector 3058 includes an upwardly projecting distal pivot pin and a proximal pivot pin, which respectively engage a lower distal pin hole in a proximal lower shank 3054 and a lower proximal pin hole in a distal lower shank 3034. See Figure 19 and Figure 20 As will be discussed in further detail below, the closing member assembly 3000 translates distally (direction “DD”) to close the anvil 2000, for example, in response to the actuation of the closing trigger 1032. The anvil 2000 is opened by translating the closing member assembly 3000 proximally, which causes the end effector closing sleeve to interact with the anvil 2000 and pivot it to the open position.
[0233] As described above, the interchangeable shaft assembly 1200 also includes a firing member 1900 supported for axial travel within the spine 1210. The firing member 1900 includes an intermediate firing shaft portion 1222 configured for attachment to the distal cutting portion or shank 1910. The intermediate firing shaft portion 1222 may include a longitudinal slot 1223 in its distal end, configured to receive a tab 1912 on the proximal end of the distal shank 1910. The longitudinal slot 1223 and the proximal end tab 1912 may be sized and configured to allow relative movement between the longitudinal slot and the proximal end tab and may include a sliding joint 1914. The sliding joint 1914 may allow movement of the intermediate firing shaft portion 1222 of the firing member 1900 to articulate the end effector 1300 without moving or at least substantially without moving the shank 1910. Once the end effector 1300 has been properly oriented, the intermediate firing shaft portion 1222 can be advanced distally until the proximal sidewall of the longitudinal slot 1223 contacts the insert 1912, thereby advancing the shank 1910 and firing the staple cartridge 4000 positioned within the channel 1310. The shank 1910 may include a blade portion 1920 and includes an upper anvil engagement insert 1924 and a lower channel engagement insert 1926, the blade portion including a blade or tissue cutting edge 1922. Various firing member configurations and operations are disclosed in various other references incorporated herein by reference.
[0234] like Figure 19As can be seen, the shaft assembly 1200 may also include a switching cylinder 1500 rotatably received on the proximal closure member segment 3010. The switching cylinder 1500 may include a hollow shaft segment 1502, which may have a shaft boss formed thereon for receiving an outwardly projecting actuating pin therein. In various cases, the actuating pin may extend through a slot into a longitudinal slot provided in a locking sleeve to facilitate axial movement of the locking sleeve when it engages with a joint motion actuator. A rotary torsion spring 1420 may be configured to engage a boss on the switching cylinder 1500 and a portion of the nozzle housing 1203 to apply a biasing force to the switching cylinder 1500. The switching cylinder 1500 may also include at least a portion of peripheral openings 1506 defined therein, these openings being configured to receive peripheral mounts extending from the nozzle portions 1202, 1203 and allowing relative rotation rather than relative translation between the switching cylinder 1500 and the nozzle 1201. The mounting base may also extend through an opening 3011 in the proximal closure member segment 3010 of the recess 1219 to be placed in the ridge 1210. Rotation of the switching cylinder 1500 about axis SA will ultimately cause the actuating pin and locking sleeve to rotate between their engaged and disengaged positions. In one arrangement, rotation of the switching cylinder 1500 may be associated with axial advancement of the closure tube or closure member. Therefore, in essence, the actuation of the closure system can operatively engage and disengage the joint motion drive system from the firing drive system in various ways, as described in more detail in U.S. Patent Application Serial No. 13 / 803,086 entitled “ARTICULATION LOCK” (now U.S. Patent Application Publication No. 2014 / 0263541) and U.S. Patent No. 9,913,642 entitled “SURGICAL INSTRUMENT COMPRISING A SENSOR SYSTEM”, the entire contents of which are incorporated herein by reference. For example, when the closure tube is in its proximal position corresponding to the “jaw open” position, the closure member segment 3010 will position the switching cylinder 1500 to connect the joint motion system to the firing drive system. When the closing tube has moved to its distal position corresponding to the "jaw closure" position, the closing tube has rotated the switching cylinder 1500 to a position where the joint motion system is disengaged from the firing drive system.
[0235] Similarly, Figure 19As shown, shaft assembly 1200 may include slip ring assembly 1600, which may be configured, for example, to conduct power to and / or from end effector 1300, and / or to transmit signals to and / or from end effector 1300. Slip ring assembly 1600 may include a proximal connector flange 1604 and a distal connector flange, the proximal connector flange being mountable to a base flange 1242 extending from base 1240, and the distal connector flange being positioned within a slot defined in a shaft housing. Proximal connector flange 1604 may include a first face, and the distal connector flange may include a second face positioned adjacent to and movable relative to the first face. The distal connector flange is rotatable about shaft axis SA relative to proximal connector flange 1604. Proximal connector flange 1604 may include a plurality of concentric or at least substantially concentric conductors defined in its first face. The connector can be mounted on the proximal side of the connector flange and can have multiple contacts, each corresponding to and electrically contacting one of the conductors. This arrangement allows relative rotation between the two flanges while maintaining electrical contact between the proximal connector flange 1604 and the distal connector flange. For example, the proximal connector flange 1604 may include an electrical connector 1606 that enables signal communication between the conductor and a shaft circuit board 1610 mounted to the shaft base 1240. In at least one case, a wire 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 base flange 1242. See also Figure 19 Further details regarding the slip ring assembly 1600 can be found, for example, U.S. Patent Application Serial No. 13 / 803,086 entitled “ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATIONLOCK” (now U.S. Patent Application Publication No. 2014 / 0263541), filed March 13, 2013 entitled “STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM” (now U.S. Patent Application Publication No. 2014 / 0263552), the entire contents of which are incorporated herein by reference, and U.S. Patent No. 9,345,481 entitled “STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM”, the entire contents of which are incorporated herein by reference.
[0236] As discussed above, shaft assembly 1200 may include a proximal portion and a distal portion, the proximal portion being fixedly mounted to shank 1014, and the distal portion being rotatable about a longitudinal axis. The rotatable distal shaft portion is rotatable relative to the proximal portion about slip ring assembly 1600, as discussed above. The distal connector flange of slip ring assembly 1600 is positioned within the rotatable distal shaft portion. Furthermore, in addition to the above, switching cylinder 1500 is also positioned within the rotatable distal shaft portion. When the rotatable distal shaft portion rotates, the distal connector flange and switching cylinder 1500 rotate synchronously with each other. Additionally, switching cylinder 1500 is rotatable relative to the distal connector flange between a first position and a second position. When switching cylinder 1500 is in its first position, the articulation drive system is operably disengaged from the firing drive system, and therefore, operation of the firing drive system does not cause articulation of the end actuator 1300 of shaft assembly 1200. When the switching cylinder 1500 is in its second position, the articulation drive system can be operatively engaged with the firing drive system, so that operation of the firing drive system can cause the end actuator 1300 of the shaft assembly 1200 to articulate. When the switching cylinder 1500 moves between its first and second positions, the switching cylinder 1500 moves relative to the distal connector flange. In various embodiments, the shaft assembly 1200 may include at least one sensor configured to detect the position of the switching cylinder 1500.
[0237] See you again Figure 19 The base 1240 may include at least one, and preferably two, tapered attachment portions 1244 formed thereon, which are adapted to be received within corresponding dovetail-shaped slots 1702 formed within the distal attachment flange portion 1700 of the frame 1020. See also Figure 18 Each dovetail-shaped slot 1702 may be tapered, or in other words, slightly V-shaped, to receive the attachment portion 1244 therein in a mounting manner. Figure 19 As further seen below, a shaft attachment lug 1226 is formed on the proximal end of the intermediate firing shaft portion 1222. As will be discussed in further detail below, when the interchangeable shaft assembly 1200 is coupled to the handle 1014, the shaft attachment lug 1226 can be received in a firing shaft attachment bracket 1126 formed in the distal end 1125 of the longitudinal drive member 1120. See also Figure 18 .
[0238] Various shaft assembly implementations may employ a latching system 1710 to removably couple the shaft assembly 1200 to the housing 1012 and more specifically, to the frame 1020. For example... Figure 4As can be seen, for example, in at least one form, the latching system 1710 includes a locking member or locking yoke 1712 movably coupled to the base 1240. In an illustrated embodiment, for example, the locking yoke 1712 is U-shaped, having two spaced-apart and downwardly extending legs 1714. Each leg 1714 may have a pivot lug 1715 formed thereon, these pivot lugs being adapted to be received in corresponding holes 1245 formed in the base 1240. This arrangement facilitates pivotally attaching the locking yoke 1712 to the base 1240. The locking yoke 1712 may include two proximal-projecting locking lugs 1716 configured to releasably engage with corresponding locking pawls or recesses 1704 in the distal attachment flange portion 1700 of the frame 1020. See also Figure 18 In various forms, the locking yoke 1712 may be biased proximally by a spring or biasing member (not shown). Actuation of the locking yoke 1712 may be achieved by a latch button 1722, which is slidably mounted on a latch actuator assembly 1720 mounted on a base 1240. The latch button 1722 may be biased proximally relative to the locking yoke 1712. As will be discussed in further detail below, the locking yoke 1712 may be moved to the unlocked position by biasing the latch button distally, which also causes the locking yoke 1712 to pivot so that it is no longer engaged with the distal attachment flange portion 1700 of the frame 1020. When the locking yoke 1712 is "engaged" with the distal attachment flange portion 1700 of the frame 1020, the locking lug 1716 may remain seated within the corresponding locking pawl or recess 1704 in the distal attachment flange portion 1700.
[0239] When using interchangeable shaft assemblies, including those suitable for cutting and securing tissue as described herein, as well as other types of end actuators, it may be advantageous to prevent the interchangeable shaft assembly from inadvertently disengaging from the housing during end actuator actuation. For example, in use, a clinician may actuate the closure trigger 1032 to grasp and manipulate target tissue into a desired position. Once the target tissue is positioned within the end actuator 1300 in the desired orientation, the clinician may fully actuate the closure trigger 1032 to close the anvil 2000 and clamp the target tissue in place for cutting and suturing. In this case, the first drive system 1030 may have been fully actuated. After the target tissue has been clamped in the end actuator 1300, it may be advantageous to prevent the shaft assembly 1200 from inadvertently disengaging from the housing 1012. One form of the latching system 1710 may be configured to prevent such inadvertent disengagement.
[0240] like Figure 19As can be seen most specifically, the locking yoke 1712 may include at least one, and preferably two, locking hooks 1718 adapted to engage corresponding locking lugs 1256 formed on the closed shuttle 1250. When the closed shuttle 1250 is in the unacted position (i.e., the first drive system 1030 is not actuated and the anvil 2000 is open), the locking yoke 1712 may pivot in a distal direction to unlock the interchangeable shaft assembly 1200 from the housing 1012. In this position, the locking hooks 1718 do not engage the locking lugs 1256 on the closed shuttle 1250. However, when the closed shuttle 1250 is moved to the actuated position (i.e., the first drive system 1030 is actuated and the anvil 2000 is closed), the locking yoke 1712 may be obstructed and cannot pivot to the unlocked position. In other words, if a clinician attempts to pivot the locking yoke 1712 to the unlocked position, or for example, if the locking yoke 1712 is inadvertently bumped or contacted in a manner that would otherwise cause it to pivot distally, the locking hook 1718 on the locking yoke 1712 will contact the locking lug portion 1256 on the closed shuttle 1250 and prevent the locking yoke 1712 from moving to the unlocked position.
[0241] The attachment of the interchangeable shaft assembly 1200 to the handle 1014 will now be described. To begin the coupling process, the clinician can position the base 1240 of the interchangeable shaft assembly 1200 above or near the distal attachment flange 1700 of the frame 1020, such that the tapered attachment portion 1244 formed on the base 1240 can be aligned with the dovetail slot 1702 in the frame 1020. The clinician can then move the shaft assembly 1200 along a mounting axis that may be perpendicular to the shaft axis SA, so that the attachment portion 1244 is positioned to be “operably engaged” with the corresponding dovetail receiving slot 1702. In doing so, the shaft attachment lug 1226 on the intermediate firing shaft portion 1222 will also be seated in the bracket 1126 in the longitudinally movable drive member 1120, and a portion of the pin 1037 on the second closing connector 1038 will be seated in the corresponding hook 1252 in the closing shuttle 1250. As used herein, the term operable engagement in the context of two components can refer to two components being fully engaged with each other such that, once an actuation is applied to them, these components can perform their intended actions, functions, and / or procedures.
[0242] At least five systems of the interchangeable shaft assembly 1200 can be operatively coupled to at least five corresponding systems of the shank 1014. A first system may include a frame system that couples and / or aligns the frame or ridge of the shaft assembly 1200 to the frame 1020 of the shank 1014. Another system may include a closure drive system 1030 that operatively connects the closure trigger 1032 of the shank 1014 to the closure tube 1260 and anvil 2000 of the shaft assembly 1200. As outlined above, the closure shuttle 1250 of the shaft assembly 1200 may engage with a pin 1037 on a second closure connector 1038. An additional system may include a firing drive system 1080 that operatively connects the firing trigger 1130 of the shank 1014 to the intermediate firing shaft portion 1222 of the shaft assembly 1200. As outlined above, the shaft attachment lug 1226 may be operatively connected to the bracket 1126 of the longitudinal drive member 1120. Another system may include an electrical system capable of: transmitting a signal that the shaft assembly (such as shaft assembly 1200) has been operatively engaged with the shank 1014 to a controller (such as a microcontroller) in the shank 1014, and / or conducting power and / or communication signals between the shaft assembly 1200 and the shank 1014. For example, the shaft assembly 1200 may include an electrical connector 1810 operatively mounted to a shaft circuit board 1610. The electrical connector 1810 may be configured to mate with a corresponding electrical connector 1800 on the shank control board 1100. Further details regarding the circuitry and control system can be found in U.S. Patent Application Serial 13 / 803,086 (now U.S. Patent Application Publication 2014 / 0263541) and U.S. Patent 9,913,642. The fifth system may include a latching system for releasably locking the shaft assembly 1200 to the shank 1014.
[0243] In the illustrated example, the anvil 2000 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 an elongated channel 1310 to allow selective pivoting about a fixed anvil pivot axis PA transverse to the axial axis SA relative to the elongated channel. In the illustrated arrangement, a pivot member or anvil trunnion 2012 may extend laterally out of each lateral side of the anvil mounting portion 2010 to be received in a corresponding trunnion holder 1316 in an upright wall 1315 formed in the proximal end portion 1312 of the elongated channel 1310. The anvil trunnion 2012 may be pivotally held in its corresponding trunnion holder 1316 by a channel cover or anvil retainer 1290. The channel cover or anvil holder 1290 may include a pair of attachment lugs configured to be retainably received within corresponding lug recesses or notches in the upright wall 1315 of the proximal end portion 1312 of the elongated channel 1310. See also Figure 20 .
[0244] See still Figure 20 In at least one configuration, the distal closing member or end effector closing tube 3050 may employ two axially offset proximal positive jaw opening features 3060 and distal positive jaw opening features 3062. The positive jaw opening features 3060, 3062 may be configured to interact with corresponding release areas and stepped portions formed on the anvil mounting portion 2010, as described in more detail in U.S. Patent Application Serial 15 / 635,631 (now U.S. Patent Application Publication 10,639,037). Other jaw opening arrangements may be employed.
[0245] Figure 21 A perspective view of another electric surgical suture system. Figure 21 A prior art surgical cutting and fastening instrument 5010 is depicted, configured to generate rotational drive action for manipulating a surgical end effector 5012. The endoscopic surgical instrument 5010 may include a handle 5006, a shaft 5008, and a surgical end effector 5012 that performs articulation, pivotally connected to the shaft 5008 at an articulation pivot 5014. An articulation control 5016 may be configured adjacent to the handle 5006 to allow rotation of the end effector 5012 about the articulation pivot 5014. It should be understood that various embodiments may include a non-pivoting end effector and therefore may not have an articulation pivot 5014 or an articulation control 5016.
[0246] The handle 5006 of the instrument 5010 may include a closing trigger 5018 and a firing trigger 5020 for actuating the end effector 5012. It should be understood that instruments with end effectors involved in different surgical tasks may have different numbers or types of triggers or other suitable controls for operating the end effector 5012. In one embodiment, a clinician or operator of the instrument 5010 may articulate the end effector 5012 relative to the axis 5008 using 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”. In this example, the end effector 5012 may include (among others) a staple channel 5022 and a pivotally translatable clamping member such as an anvil 5024, which may be held at a distance to ensure effective suturing and cutting of tissue clamped in the end effector 5012. The handle 5006 may include a pistol grip 5026, toward which a clinician pivotally pulls a closure trigger 5018 to cause the anvil 5024 to clamp or close toward the pin channel 5022 of the end effector 5012, thereby clamping tissue positioned between the anvil 5024 and the channel 5022.
[0247] Examples of parameters that can be collected and transmitted (e.g., as usage instructions, recommendations, and / or other information) in one or more operating modes of a multimodal surgical instrument are presented in Figure 25 Multiple parameters that can be collected and transmitted (e.g., as instructions for use, recommendations, and / or other information) in one or more operating modes of a multimodal surgical instrument are disclosed in U.S. Patent Application Serial No. 16 / 209,416 (now U.S. Patent Application Publication No. 2019 / 0206562), filed December 4, 2018, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUDANALYTICS”, which is incorporated herein by reference in its entirety.
[0248] Figure 25An exemplary analysis is illustrated. As shown, parameters collected by the surgical hub from its paired modular device 9050 may include, for example, firing force (e.g., the force required to advance the cutting member of a surgical suture instrument through tissue), closing force (e.g., the force required to clamp the jaws of the surgical suture instrument onto the 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 ratio (i.e., the ratio at which the jaws of the instrument close). It should be noted that the data from the modular device 9050 transmitted to the analysis system 9100 ( Figure 13 The data (as shown) is not limited to a single type and may include multiple different data types paired with procedure outcome data. Procedure outcome data for a surgical procedure (or its steps) may include, for example, whether there is bleeding at the surgical site, whether there is air or fluid leakage at the surgical site, and whether the staples for a particular suture were properly formed. Surgical outcome data may also include, for example, data generated by the surgical hub 9000 or analysis system 9100. Figure 13 (As shown) positive or negative results or their associations. Modular device 9050 data and corresponding perioperative data of modular device 9050 can be paired together or otherwise correlated when they are uploaded to analysis system 9100, enabling analysis system 9100 to identify trends in the procedure results based on the underlying data of modular device 9050 that produced each specific result. In other words, analysis system 9100 can aggregate modular device 9050 data and procedure result data to search for trends or patterns in the underlying modular device data 9050 that may indicate adjustments that can be made to the control program of modular device 9050.
[0249] In the illustrated example, the analysis system 9100 may receive data from the modular device 9050 (9202) and surgical outcome data. When transmitted to the analysis system 9100, the procedure outcome data may be associated with or paired with modular device 9050 data corresponding to the operation of the modular device 9050 that resulted in a specific procedure outcome. The perioperative data of the modular device 9050 and the corresponding procedure outcome data may be referred to as a data pair. This data is depicted as including a first set of data (9212) associated with successful procedure outcomes and a second set of data (9214) associated with negative procedure outcomes. For this particular example, a subset of the data (9212, 9214) received by the analysis system 9100 (9202) is highlighted to further clarify the concepts discussed herein.
[0250] For the first data pair 9212a, the modular device 9050 data may include time-varying closing force (FTC), time-varying firing force (FTF), tissue type (solid), tissue condition (tissue from a patient with emphysema and who has been irradiated), number of instrument firings (third), anonymized timestamps (to protect patient confidentiality while still allowing the analysis system to calculate the time elapsed between firings and other such measures), and anonymized patient identifier (002). Surgical outcome data may include data indicating the absence of bleeding, which corresponds to a successful outcome (e.g., successful firing of a surgical suture instrument). For the second data pair 9212b, the modular device 9050 data may include the waiting time before the instrument is fired (which corresponds to the first firing of the instrument), time-varying FTC, time-varying FTF (which indicates the presence of a force peak near the end of the firing stroke), tissue type (1.1 mm blood vessel), tissue condition (tissue already irradiated), number of instrument firings (first), anonymized timestamps, and anonymized patient identifier (002). The procedural outcome data includes data indicating leakage, which corresponds to a negative outcome (i.e., failure of the surgical suture instrument to fire). For the third data pair 9212c, the modular device 9050 data may include the waiting time before the instrument is fired (which corresponds to the first firing of the instrument), the FTC over time, the FTF over time, the tissue type (1.8 mm vessel), the tissue condition (no significant condition), the number of firings of the instrument (first firing), the anonymous timestamp, and the anonymous patient identifier (012). The surgical outcome data may include data indicating leakage, which corresponds to a negative outcome (i.e., failure of the surgical suture instrument to fire). Again, it should be noted that this data is merely illustrative to aid in understanding the concepts discussed herein and should not be construed as limiting the data received and / or analyzed by the analysis system 9100 to generate control procedure updates.
[0251] When the analysis system 9100 receives perioperative data 9202 from a communicatively connected surgical hub 9000, the analysis system 9100 continues to aggregate and / or store the data according to the procedure type (or its steps) associated with the data, the type of the modular device 9050 that generated the data, and other such categories. By appropriately organizing the data, the analysis system 9100 can analyze the dataset to identify the correlation between a specific mode of controlling the modular device 9050 for each specific type and a positive or negative procedural outcome. Based on whether a specific mode of controlling the modular device 9050 may be associated with a positive or negative surgical outcome, the analysis system 9100 can determine 9204 whether the control procedure for the type of modular device 9050 should be updated.
[0252] For this particular example, the analysis system 9100 can perform a first analysis 9216a of the dataset by analyzing the peak FTF 9213 (e.g., the maximum FTF of a surgical suture instrument for each specific shot) relative to the number of shots 9211 for each peak FTF value. In this exemplary case, the analysis system 9100 can determine that there is no specific correlation between the peak FTF 9213 and the occurrence of positive or negative outcomes for the particular dataset. In other words, the peak FTF 9213 does not have a different distribution for positive and negative outcomes. Since there is no specific correlation between the peak FTF 9213 and positive or negative outcomes, the analysis system 9100 will determine that no control procedure update is needed to address this variable. Furthermore, the analysis system 9100 can perform a second analysis 9216b of the dataset by analyzing the waiting time 9215 before the instrument is shot relative to the number of shots 9211. For this particular analysis 9216b, the analysis system 9100 can determine that there are different distributions of negative outcomes 9217 and positive outcomes 9219. In this exemplary case, the negative result distribution 9217 has an average duration of 4 seconds, and the positive result distribution has an average duration of 11 seconds. Therefore, the analysis system 9100 can determine a correlation between the waiting time 9215 and the result type of the surgical procedure step. That is, the negative result distribution 9217 may indicate a relatively large proportion of negative results within a waiting time of 4 seconds or less. Based on this analysis 9216b confirming a large divergence between the negative result distribution 9217 and the positive result distribution 9219, the analysis system 9100 can then determine 9204 that a control procedure update 9208 should be generated.
[0253] Once the analysis system 9100 analyzes the dataset and determines 9204 that adjustments to the control program of a specific modular device 9050, which is the subject of the dataset, will improve the performance of the modular device 9050, the analysis system 9100 can then generate a control program update 9208 accordingly. In this exemplary case, the analysis system 9100 may determine, based on the analysis of the dataset 9216b, that a control program update 9218 recommending a waiting time of more than 5 seconds will prevent a 90% distribution of negative results with a 95% confidence interval. Alternatively, the analysis system 9100 may determine, based on the analysis of the dataset 9216b, that a control program update 9218 recommending a waiting time of more than 5 seconds will result in a higher rate of positive results than negative results. Therefore, the analysis system 9100 can determine that a certain type of surgical instrument should be delayed for more than 5 seconds before firing under specific tissue conditions, making negative results less common than positive results. Based on any one or two of these constraints used by the analysis system 9100 to determine the control procedure update satisfied by the analyzed 9216B, the analysis system 9100 can generate a control procedure update 9218 for a surgical instrument, which causes the surgical instrument to impose a waiting time of 5 seconds or longer before a particular surgical instrument can be fired under given conditions, or causes the surgical instrument to display a warning or suggestion to the user instructing the user to wait at least 5 seconds before firing the instrument. The analysis system 9100 can utilize various other constraints to determine whether to generate a control procedure update 9218, such as whether the control procedure update reduces the rate of negative results by a certain percentage or maximizes the rate of positive results.
[0254] After generating control program update 9218, analysis system 9100 can then transmit control program update 9218 of the appropriate type of modular device 9050 to surgical hub 9000. In one example, when modular device 9050 corresponding to control program update 9218 is subsequently connected to surgical hub 9000 which has downloaded control program update 9218, modular device 9050 then automatically downloads update 9218. In another example, surgical hub 9000 controls modular device 9050 according to control program update 9218, rather than transmitting control program update 9218 directly to modular device 9050 itself.
[0255] In one aspect, the surgical system 9060 may be configured to push down the verification and updating of software parameters when an outdated modular device 9050 is detected in the data stream of the surgical hub 9000. In one example, the analysis system 9000 may be configured to transmit control program updates generated for a specific type of modular device 9050 to the surgical hub 9000. In one aspect, whenever the modular device 9050 is connected to the surgical hub 9000, the modular device 9050 determines whether an updated version of its control program is on the surgical hub 9000 or otherwise accessible via the surgical hub 9000. If the surgical hub 9000 does indeed have an updated control program for the specific type of modular device 9050 (or the updated control program is otherwise available from the analysis system 9100), the modular device 9050 downloads the control program update from it.
[0256] In one example, any dataset transmitted to the analysis system 9100 includes a unique ID for the surgical hub 9000 and the current version of its control program or operating system. In another example, any dataset sent to the analysis system 9100 may include a unique ID for 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 allows the analysis system 9100 to determine whether the data corresponds to a recent version of the control program. The analysis system 9100 may, for example, choose to discount (or ignore) data generated by the modular device 9050 or surgical hub 9000 that is controlled by an outdated control program and / or causes an updated version of the control program to be pushed to the modular device 9050 or surgical hub 9000.
[0257] In one example, the operating version of the modular device 9050 with updated control software for the surgical hub 9000 may also be included in the surgical hub 9000 status data blocks that are periodically transmitted to the analysis system 9100. If the analysis system 9100 identifies that the operating version of the control program for either the surgical hub 9100 or the connectable modular device 9050 is outdated, the analysis system 9100 may push the most recent revision of the relevant control program to the surgical hub 9000.
[0258] 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 prompt the user at the next setup step (e.g., between surgical procedures) whether they want to update outdated control programs. In yet another example, the surgical hub 9000 may be programmed by the user to either disallow updates or allow updates only to the modular device 9050 without disallowing updates to the surgical hub 9000 itself.
[0259] An example of cloud aggregation of data from a hub is in Figure 26 Presented in the middle. Figure 26 A block diagram of a computer-implemented interactive surgical system 5700 according to at least one aspect of this disclosure is shown. System 5700 may include multiple surgical hubs 5706, which, as described above, are capable of detecting and tracking surgical procedure-related data that can be used in conjunction with surgical hubs 5706 (and modular devices paired with surgical hubs 5706). In one example, surgical hubs 5706 may be connected to form a local network, such that data tracked by surgical hubs 5706 is aggregated across the network. For example, the network of surgical hubs 5706 may be associated with a medical facility. Data aggregated from the network of surgical hubs 5706 can be analyzed to provide reports on data trends or recommendations. For example, surgical hubs 5706 of a first medical facility 5704a may be communicatively connected to a first local database 5708a, and surgical hubs 5706 of 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 differ from the network of surgical hubs 5706 associated with the second medical facility 5704b, such that aggregated data from each network of surgical hubs 5706 corresponds individually to each medical facility 5704a, 5704b. Surgical hubs 5706, or another computer terminal communicatively connected to databases 5708a, 5708b, may be configured to provide reports or recommendations based on aggregated data associated with the respective medical facilities 5704a, 5704b. In this example, data tracked by surgical hubs 5706 can be used, for example, to report whether a specific incidence rate of a surgical procedure deviates from the average in-network time for completing that particular type of procedure.
[0260] In another example, each surgical hub 5706 may be configured to upload tracked data to a cloud 5702, which then processes and aggregates the tracked data across multiple surgical hubs 5706 connected to the cloud 5702, the network of surgical hubs 5706, and / or medical facilities 5704a, 5704b. Each surgical hub 5706 can then be used to provide reports or recommendations based on the aggregated data. In this example, the data tracked by the surgical hub 5706 can be used, for example, to report whether a particular incidence rate of a surgical procedure deviates from the average global time to complete that particular type of procedure.
[0261] In another example, each surgical hub 5706 is also configured to access cloud 5702 to compare locally tracked data with global data aggregated from all surgical hubs 5706 communicatively connected to cloud 5702. Each surgical hub 5706 may be configured to provide reports or recommendations based on comparisons between the tracked local data and local (i.e., intra-network) or global specifications. In this example, data tracked by surgical hub 5706 can be used, for example, to report whether a particular incidence rate of a surgical procedure deviates from the average intra-network time or average global time for completing that particular procedure type.
[0262] In one example, each surgical hub 5706, or another computer system located locally on 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 based on the tracked data in response to queries. Where the surgical hub 5706 is connected to a healthcare facility network (which may include additional surgical hubs 5706), the surgical hub 5706 may be configured to compare the tracked data with overall healthcare facility data. Overall healthcare facility data may include EMR data and aggregated data from the local network of the surgical hub 5706. In another example, a cloud 5702 may be configured to aggregate data tracked by the surgical hub 5706, store the tracked data, and generate reports and / or recommendations based on the tracked data in response to queries.
[0263] Each surgical hub 5706 can provide reports on data trends and / or recommendations on improving the efficiency or effectiveness of surgical procedures being performed. In various paradigms, data trends and recommendations may be based on data tracked by the surgical hub 5706 itself, data tracked across a local healthcare facility network containing 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 may, for example, describe a particular surgical instrument or product mix for a specific surgical procedure based on the correlation between that particular mix of surgical instruments / products and patient outcomes and procedure efficiency. Reports provided by the surgical hub 5706 may describe, for example, whether a particular surgical procedure is performed effectively relative to local or global standards, whether a particular type of surgical procedure performed at a healthcare facility is performed effectively relative to global standards, and the average time required for a particular surgical team to complete a particular surgical procedure or steps of a surgical procedure.
[0264] For example, the surgical hub 5706 can be used to perform performance studies according to instrument type or chamber type for various procedures. For example, the surgical hub 5706 can be used to study the performance of a single surgeon. For example, the surgical hub 5706 can be used to study the effectiveness of different surgical procedures based on patient characteristics or disease status. Examples of data aggregation and analysis are described in detail in U.S. Patent Application Serial No. 15 / 940,668 (now U.S. Patent Application Publication No. 2019 / 0201115), filed March 29, 2018, entitled “AGGREGATION AND REPORTING OF SURGICAL HUBDATA,” which is incorporated herein by reference in its entirety.
[0265] In one example, each surgical hub 5706 may be configured to determine when an operating room event occurs (e.g., via a situational awareness system) and then track the length of time spent on each event. Operating room events can be events that the surgical hub 5706 can detect or infer as to have occurred. Operating room events may include, for example, a specific surgical procedure, a step or part of a surgical procedure, or downtime between surgical procedures. Operating room events can be categorized according to event type (such as the type of surgical procedure being performed) so that data from individual procedures can be aggregated to form a searchable dataset.
[0266] Data tracked by the surgical hub 5706 can be parsed to provide increasingly detailed metrics related to surgical procedures or the use of the surgical hub 5706 for an exemplary dataset. In one example, the surgical hub 5706 can be configured to determine whether a surgical procedure is being performed, and then track both the length of time spent between procedures (e.g., downtime) and the time spent on the procedure itself. The surgical hub 5706 can also be configured to determine and track the time spent on each individual step taken by a medical professional (e.g., surgeon, nurse, caregiver) between or during surgical procedures. The surgical hub can determine when a surgical procedure or different steps of a surgical procedure are performed via a situational awareness system, which is described in further detail herein. Aggregation of data (e.g., cloud aggregation) from the hub is further described in U.S. Patent Application Serial No. 16 / 209,416 (now U.S. Patent Application Publication 20190206562).
[0267] Surgical instruments (e.g., electrically powered intelligent surgical suture devices) may have means for displaying instrument functional data to a surgical user. The displayed data may be based on, for example, the intercommunication capabilities of the instrument (e.g., surgical suture device), its accessories or consumables (e.g., cartridges), and the display system. Data transmitted from the instrument to the user from the accessories or consumables (e.g., cartridges) may be or may include one or more static cartridge functional aspects, or 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 of the instrument's status (e.g., a more comprehensive or complete context).
[0268] The combined data may (e.g., additionally) be aggregated, for example, to determine tissue or functional data from system interactions with the surgical site. Some or all (e.g., aggregated) of the data may be transferred to a remote server or storage device. Users may be allowed to view, aggregate, or use the stored data to provide insights into the future use of the instrument (e.g., suture device). Capabilities permitted (e.g., and / or limited) by the system (e.g., the instrument's control system), such as instrument capabilities, characteristics, and / or user interactions, may be based on, for example, system capacity parameters (e.g., connectivity); system condition parameters (e.g., bandwidth, interference, conductivity, current load level); system authorization parameters (e.g., parameters indicating compatibility, authorized (e.g., purchased) operating modes / levels, authenticity); and / or control parameters provided to the instrument by a hub or external remote server (e.g., external control parameters), such as software version, revision or update level, subscription level, interconnectivity with external / external systems, usage area, user input, or (e.g., secure) communication with external database systems.
[0269] The device may be subject to operating mode (e.g., layering) control, which can be controlled by the hub. In some examples, the surgical hub can control device authentication, operating modes, and communications. Information regarding hub coordination and control is provided in U.S. Patent Application Serial No. 15 / 940,656 (now U.S. Patent Application Publication No. 2019 / 0201141), filed March 29, 2018, entitled “SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES,” which is incorporated herein by reference in its entirety.
[0270] Instruments may be initialized, for example, based on mode / layer control, and may or may not be operationally upgraded. Surgical instruments may be initialized, for example, upon initial or subsequent power-on or wake-up. For example, a surgical instrument may be woken up (e.g., turned on, powered on) and initialized, for example, by pairing with a surgical hub. Surgical instruments may be initialized, for example, in an initial operating mode (e.g., default or entry-level mode). For example, a surgical instrument (e.g., when initialized) may send initialization mode (e.g., mode 1 or level 1) information to the hub. Surgical instruments may receive an operating mode indication from the hub, which may be the same as or different from the initialization mode. Instruments may (e.g., depending on the operating mode) receive (e.g., from the hub) operating parameters, instructions for downloading additional software, instructions for activating one or more functions, etc. Layered operation (e.g., layered access) for instruments (e.g., endoscopic cutters) may be controlled, for example, by a surgical hub. For example, a surgical instrument may receive an instruction to download software upgrades, for example, to change operation from the initialization layer to another (e.g., a higher or lower) layer. In one example, a surgical instrument may receive an instruction to downgrade a mode / layer, for example, by disabling the functionality associated with the layer (e.g., an unauthorized or unsupported layer).
[0271] Surgical devices may include communication capabilities, which may be wireless. For example, the device may have a Bluetooth communication array (e.g., for communication with a hub). For example, a wireless connection may be established between the device and the hub during device initialization. The device may provide the hub with information describing the device, such as one or more of a serial number, model number, etc. The device may be configured to have the ability to receive information (e.g., during initialization and / or during operation). Communication bandwidth may vary between operating modes. For example, the device may have limited bandwidth during initialization (e.g., downloading basic information). After initialization and / or if upgraded to another operating mode / layer, the device may be able to and / or be configurable for higher bandwidth communication. The hub may provide the device with improved firmware and / or software (e.g., communication software) to allow / support high-bandwidth, high-data-transmission (e.g., for real-time data transmission), for example, if the improved communication software was not pre-loaded into the device during initialization. Upgrades may involve, for example, downloading and installing firmware (e.g., BIOS) and / or software. Data aggregation capabilities, internal memory usage, and / or other characteristics may also vary depending on the operating mode.
[0272] The processor in the surgical instrument can determine whether to allow or restrict bidirectional communication. The initial communication mode can be treated differently from the operational communication mode. For example, a first operational mode may include unidirectional communication (e.g., from instrument to hub), a second operational mode may include bidirectional communication, and a third operational mode may include interactive communication (e.g., with a local hub or other remote network portal).
[0273] Figures 22 to 24 An example of three operating modes (e.g., layers) for a surgical instrument is shown. Other examples may implement more or fewer layers / modes with the same or different operating characteristics. The various levels / modes / layers of instrument operation can alter availability, access, usage levels, interaction levels, and / or support for one or more features available through the instrument, such as sensors, communications, displays, storage, analytics, feedback, recommendations, or suggestions. In the example, the instrument processor may be configured to determine the operating mode, for example, based on one or more of the instrument operation control parameters (e.g., system capacity parameters, system condition parameters, system authorization parameters, hierarchical communication mode indications received from a hub, and / or hierarchical communication mode indications received from a remote server).
[0274] Figure 22 An exemplary surgical instrument operation mode is shown. Figure 22An example of a first operating mode (e.g., layer I) is shown. In this example of the first operating mode, the surgical instrument 11012 can communicate unidirectionally with the surgical hub 11006 and provide information for display to the display 11025. The processor in the surgical instrument 11012, such as a surgical stapler, can obtain compartment information (e.g., identification and / or authentication information), compartment authentication information, status information (e.g., firing status information), error information, etc. Compartment information may include, for example, compartment identification information (e.g., color, type, length, serial number, etc.) and / or compartment authentication information (e.g., verified origin, batch information, etc.). Status information may include instrument status (e.g., ready, fired, connected, etc.). Error information may include instrument or accessory (e.g., compartment) errors (e.g., inability to read compartment parameters, etc.). The surgical instrument 11012, such as a surgical stapler, can send, for example, compartment identification information, compartment authentication information, status information, error information, and / or other information to the surgical hub 11006 and / or the display 11025 (e.g., for display to a user). Information can be transmitted, for example, via a wireless transmitter (e.g., Bluetooth).
[0275] In one example, first-mode (e.g., layer I) information may indicate that the motorized endoscopic cutter is fired using a cartridge of a specific color, and this cartridge may be associated with a serial number. This information can be used to annotate the surgery, for example, to describe how the motorized endoscopic cutter is used. For example, the instrument processor may be configured to obtain cartridge information and instrument status information (e.g., for removably storing surgical cartridges) from the end effector. The instrument processor may send the cartridge information and instrument status information to the surgical hub.
[0276] Figure 23 An exemplary surgical instrument operation mode is shown. Figure 23 An example of a second operating mode (e.g., Layer II) is shown. In this example of the second operating mode, surgical instrument 11012 can communicate bidirectionally with surgical hub 11006 and provide information to display 11025 (e.g., for display to a user). Surgical hub 11006 can communicate with remote server 11013. The second operating mode can be built upon the first operating mode (e.g., adding capabilities or functions to the first operating mode).
[0277] Examples of bidirectional communication may include, for example, sensing information from the end effector (e.g., sensing parameters such as tissue thickness), sensing information from the handle (e.g., motor function, force for firing / closing, etc.), usage information (e.g., time from clamping to firing, characterization of user-controlled firing, etc.), prioritization of information to be displayed, location of information to be displayed, compiled recommendations from database analysis, etc. Information may be transmitted, for example, locally to / from the operating room (OR) (e.g., within the OR), and / or to / from one or more systems outside the OR (e.g., cloud-based storage devices, etc.).
[0278] Figure 27 An exemplary process for operating according to a surgical instrument operating mode is illustrated. In one example, the surgical instrument may include a processor, a transmitter, and at least one sensor configured to provide sensor signals (e.g., based on physiological parameters of the tissue). The processor may be configured to make one or more determinations and / or take one or more actions based on the instrument operating mode.
[0279] At 11510, a determination can be made based on the operating mode to determine whether to obtain sensing parameters from the sensor. For example, a processor (e.g., a processor in a surgical instrument) can determine (e.g., based on the instrument's operating mode) whether to obtain (e.g., and / or transmit) sensing parameters associated with the sensor signal from the sensor.
[0280] One or more sensors can sense and provide (e.g., in a sensor signal) information, for example, from one or more parts (e.g., components or sub-components) of a surgical instrument (e.g., a handle, an end effector, a knife, and / or a clamp). For example, various sensors are shown in U.S. Patent Application Serial No. 16 / 361,793 (now U.S. Patent Application Publication No. 20190314015), filed March 22, 2019, entitled “SURGICAL INSTRUMENT COMPRISING ANADAPTIVE CONTROL SYSTEM” (e.g., in…). Figure 19 (As shown in the image) and described in surgical instruments including adaptive control systems, this application is incorporated herein by reference in its entirety. Sensing information from the handle may include, for example, motor function, force for firing / closing, etc.
[0281] Sensors can be configured to sense and provide sensor signals based on physiological parameters of a tissue. For example, a surgical instrument may have a tissue thickness sensing module with a sensor that generates a sensor signal (e.g., a tissue thickness signal) based on physiological parameters of the tissue (e.g., tissue thickness), as described in, for example, U.S. Patent No. 9,345,481 and U.S. Patent Application Serial No. 13 / 800,067 (now U.S. Patent Application Publication No. 2014 / 0263552). Figures 7 to 1 As shown and described in Figure 5. In one example, a surgical instrument (e.g., an endoscopic cutter or surgical suture device) may include a tissue thickness sensing module that can be positioned, for example, adjacent to the distal end of the staple cartridge. The tissue thickness sensing module may include a sensor and a controller. The sensor may be configured to generate a sensor signal, such as a tissue thickness signal indicating tissue thickness (e.g., for tissue located between the anvil and the staple cartridge at the end effector portion of the surgical instrument). The controller may communicate signalally with the sensor. The controller may include means for identifying the type of staple cartridge. The staple cartridge type and tissue thickness can be used, for example, to determine whether the thickness of the tissue located between the anvil and the staple cartridge is within the optimal tissue thickness range of the staple cartridge.
[0282] In the example, the display or analysis (e.g., at a hub or remote server) may (e.g., interactively) combine sensed information with other information. For example, bin data may be interactively combined with instrument actuator or configuration data, for example, to provide a broader understanding of (e.g., all) instrument status. Bin data may correspond to, for example, the size or type of staple fired by the instrument. Different types of staples may be used for different types of tissues. Usage information (e.g., time from clamping to firing, characterization of user-controlled firing, etc.) may be displayed and / or processed, for example, in combination with sensed information and / or other information.
[0283] At 11520, it can be determined whether to receive information (e.g., instrument usage instructions, operating information, and / or recommendations) based on the operating mode. For example, a processor (e.g., a processor in a surgical instrument) can determine (e.g., based on the instrument operating mode) whether to receive information (e.g., received from hub 11006 or received via surgical hub 11006 from remote server 11013).
[0284] The received information may include, for example, identification of the tissue to be operated on or being operated on (e.g., based on instrument or component location tracking information). See, for example, U.S. Patent Application Serial No. 16 / 361,793 (now U.S. Patent Application Publication No. 2019 / 0314015). Figure 19As illustrated in the accompanying discussion, it shows multiple sensors that can be used in the tracking system. The tracking process performed by the tracking system can be executed at a hub (e.g., surgical hub 11006). A processor in the instrument can receive position information from the tracking process at the hub.
[0285] The received information may include, for example, recommended usage information (e.g., time from clamping to firing, characterization of user-controlled firing, etc.). The received information may include, for example, the force used for firing, waiting time / cycle, speed, time from clamping to firing, etc. The received information may include, for example, information for display and / or indications of whether to display on one or more displays (e.g., a display on the handle of the instrument, a display associated with a hub, or other display systems), prioritization of information to be displayed, and the location of the displayed information (e.g., on one or more displays), etc. The received information may include, for example, sensing information, the disease state of the tissue, previous firings of surgical instruments or devices (e.g., endoscopic cutters), and associated sensing information, etc. The received information may include, for example, the order / sequence of chamber selection.
[0286] The information received may include recommendations to the surgeon regarding whether another available stapler, another available power device, and / or another stapler component (e.g., a cartridge, shaft, etc., that can be used with the selected stapler / device) is superior or optional. The information received may include warnings about safety issues with the selected cartridge or stapler / device. Examples of safety-based system recommendations are described in detail in U.S. Patent Application Serial No. 16 / 024,075 (now U.S. Patent Application Publication No. 2019 / 0201146), filed June 29, 2018, entitled “SAFETY SYSTEMS FOR SMART POWERED SURGICALSTAPLING,” which is incorporated herein by reference in its entirety.
[0287] The received information may include, for example, situational awareness information. The recommendation may be indicated with increased priority based on the anticipated surgical action and input from the situational awareness surgical hub. For example, organ problems (e.g., stomach, lungs, etc.) may be identified based on sensed information. Determinations may be made based on sensed information such as texture and / or compressibility (e.g., stomach tissue is very thick and extremely 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, such as waiting periods) may be determined, for example, based on tissue identification.
[0288] about Figure 9 and Figure 10 An example of situational awareness-based recommendation is given. Figure 9 This is a diagram of an exemplary situational awareness surgical system. Figure 10 A timeline of an exemplary surgical procedure and inferences drawn from data detected by the surgical hub at each step of the procedure are illustrated. Further examples of situation-aware-based recommendations are disclosed in U.S. Patent Application Serial No. 16 / 182,246 (now U.S. Patent Application Publication No. 2019 / 0204201), filed November 6, 2018, entitled “ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES,” which is incorporated herein by reference in its entirety.
[0289] At 11530, communication with the surgical hub (e.g., via an instrument transmitter) may occur based on the determination at 11510 or 11520. Communication involving surgical instruments (e.g., in a second mode / layer operation) may include sending and / or receiving information using transmitters and / or receivers respectively (e.g., as...). Figure 23 (As shown in the example). In the example, the instrument processor may be configured to acquire sensing parameters and send them to the surgical hub, for example, based on a determination that the instrument operating mode supports the acquisition of sensing parameters. In the example, the instrument processor may be configured to receive instrument use instructions from the surgical hub via a receiver, for example, based on a determination that the instrument operating mode supports the receipt of instrument use instructions. The instrument processor may send the received instrument use instructions to a display. In the example, the instrument processor may be configured to receive cartridge information from an end effector. The instrument processor may determine, based on the instrument operating mode, whether to combine the cartridge information with instrument use parameters (e.g., the time from clamping to firing and / or a characterization of user-controlled firing). The instrument processor may send the instrument use parameters along with the cartridge information to the surgical hub (e.g., via a transmitter) based on a determination that the instrument operating mode supports this capability.
[0290] Figure 24 An exemplary surgical instrument operation mode is shown. Figure 24 An example of a third operating mode (e.g., Layer III) is shown. In this example of the third operating mode, surgical instrument 11012 can communicate bidirectionally with surgical hub 11006 and provide information to display 11025 (e.g., for display to a user). Surgical hub 11006 can communicate with remote server 11013. Remote server 11013 can communicate with storage device 11022 storing aggregated data. Remote server 11013 can communicate with user portal 11026.
[0291] A third operating mode can be built upon the first and second operating modes described herein (e.g., by adding capabilities or functionalities). In some examples, the third operating mode may add cloud storage for device usage, user accessibility, data aggregation, analytics, and recommendations. For example, a device processor may be configured to determine (e.g., based on the operating mode) whether to send information (e.g., device accessory information, such as warehouse data) that can be interactively combined (e.g., via a remote / cloud server) with device actuators or configuration data (e.g., for aggregation). Information that can be stored and aggregated (e.g., along with device usage information) may include one or more of the following: physician identification information, surgical procedure type, patient information, or disease status. The device processor may be configured to send information to a hub and / or (e.g., directly) to a remote server.
[0292] The instrument processor can be configured to determine whether to receive a recommendation (e.g., instrument usage recommendation and / or accessory selection recommendation) based on stored information (e.g., aggregated historical / typical instrument usage information) (e.g., based on operating modes). For example, a recommendation could be recommended instrument usage information (e.g., suture chamber selection) generated based on aggregated historical instrument usage data. Alternatively, a recommendation could be a suture chamber selection recommendation generated based on aggregated chamber usage data associated with a surgical step (e.g., the surgical step using the instrument).
[0293] The stored, aggregated, analyzed, and recommended historical information may include, for example, information about previous surgeries, such as surgery type, tissue, tissue condition, type of attachments selected (e.g., sac), and order of use of surgical instruments (e.g., surgical staplers). In various examples, 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); surgical information (e.g., type of bariatric surgery); surgeon usage information (e.g., trends, predictions, typical usage); sac selection order / sequence; and / or display utilization (e.g., on the instrument handle or on a hub display / display system).
[0294] A remote server can aggregate data from multiple surgical procedures and users (e.g., surgeons). The remote server can send aggregated data and / or usage recommendations to surgical instruments (e.g., directly or via a hub). The remote server can allow users to view, aggregate, or use the stored data to provide insights into the future use of instruments (e.g., surgical sutures).
[0295] The third mode / layer of instrument operation can provide users (e.g., surgeons) with access to historical data (e.g., their own data). Surgeons can change procedures over time (e.g., changing the type, combination, and sequence of compartment selection). Compartments can be distinguished by color, for example, to indicate staple height (e.g., gray, white, blue, green, gold, or gold, green, and black). For example, different staple heights can be used to suture tissue based on one or more variables, such as tissue type, tissue condition, and / or the gap between tissues.
[0296] Surgeon-associated ward selection and usage information can be stored for future review. Surgeon-associated ward selection and usage information can be aggregated (e.g., aggregated over time). Surgical information can be correlated with postoperative data, such as postoperative leakage, secondary complications, and / or reoperation information.
[0297] Data analytics can be retrieved and viewed, for example, at user portal 11026. Information regarding data collection, data aggregation, surgical data analysis, and access to data and recommendations via remote (e.g., cloud) servers is disclosed in U.S. Patent Application Serial No. 15 / 940,679 (now U.S. Patent Application Publication No. 2019 / 0201144), filed March 29, 2018, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THERESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET,” which is incorporated herein by reference in its entirety.
[0298] 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 surgical hub 11006). The medical hubs are communicatively coupled to at least one surgical instrument (e.g., surgical instrument 11012). 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 send the aggregated instruction usage information, for example, to a data analysis server, to a hub (e.g., surgical hub 11006), etc.
[0299] A remote server processor (e.g., in remote server 11013) may be configured to correlate received instrument usage information with the outcome of a medical procedure and / or the instrument's operational status during the procedure. The remote server processor may be configured to send relevant information, for example, to a hub (e.g., a surgical hub 11006 used to display information to a user before, during, and / or after a medical procedure using surgical instruments 11012). The remote server may send relevant information, for example, as a reference before and during the medical procedure, and / or as a postoperative follow-up.
[0300] A remote server processor (e.g., in remote server 11013) may be configured to determine recommended instrument use information associated with an upcoming (e.g., ongoing) medical procedure based on relevant information. The remote server processor may be configured to send the recommended instrument use information, for example, to a hub (e.g., a surgical hub 11006 used to display to a user before or during a medical procedure using surgical instruments 11012).
[0301] This public example
[0302] Example 1. A surgical instrument, comprising: a sensor configured to provide a sensor signal based on physiological parameters of a tissue; a transmitter; and a processor configured to: determine, based on an instrument operating mode, whether to acquire sensing parameters associated with the sensor signal from the sensor; determine, based on the instrument operating mode, whether to receive an instrument use instruction; and communicate with a surgical hub via the transmitter based on at least one of these determinations.
[0303] The surgical instruments according to Example 1 can selectively operate in one of a variety of different instrument operation modes or levels. Instrument operation modes can allow or limit instrument capabilities in different ways. Instrument capabilities that vary with the operation mode may include, for example, sensors, communication, displays, data storage, data access, data aggregation, data analysis, feedback, recommendations, etc. Modes can vary in communication capabilities, such as record keeping, data access and retrieval, data analysis, surgical recommendations, etc. Figures 22 to 24Exemplary operating modes or hierarchies are described. Instrument operating modes can be determined by a surgical instrument based on instrument operating mode control parameters or system parameters indicating compatibility, such as the surgical facility's subscription level and availability. These instrument operating mode control parameters may indicate connectivity, bandwidth, interference, and conduction. For example, a medical facility may require selected instrument capabilities to perform certain surgeries, which may be grouped into one or more instrument operating modes. According to Example 1, the surgical instrument determines, based on the operating mode, whether to obtain sensing data from one or more sensors associated with the surgical instrument and whether to receive instrument usage instructions from a surgical hub or a remote server. For example, a surgical instrument according to Example 1 (e.g., a surgical suture device) may selectively receive recommended instrument usage information (e.g., suture device selection) generated from a surgical hub based on aggregated historical instrument usage data (e.g., suturing device usage data associated with surgical procedures).
[0304] Therefore, Example 1 provides an intelligent surgical instrument with a control system capable of restricting or allowing different modes of communication, such as one-way communication, two-way communication, and interactive communication with a local hub or remote server. The intelligent control system enables hierarchical communication control based on instrument capabilities, system capabilities (such as intra- 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, via a display associated with the surgical instrument. Thus, data and information, such as recommended instrument usage information, can be selectively provided to the user in accordance with the most suitable operating mode for the instrument. These can help improve the operational safety and performance of the instrument, the outcome and quality of surgical procedures, and patient safety.
[0305] Example 2. The surgical instrument according to Example 1, wherein the processor is further configured to obtain the sensing parameters based on the determination of the sensing parameters supported by the instrument operating mode, and to send the sensing parameters to the surgical hub.
[0306] Example 2 relates to an instrument operating mode in which one-way or two-way communication with a surgical hub is supported. The surgical instrument according to Example 2 is capable of acquiring sensed parameters and sending them to a surgical hub, where the information can be stored, processed, and / or aggregated for use in relation to ongoing or future surgeries.
[0307] Example 3. The surgical instrument according to Example 1 or 2 further includes: a receiver. The processor is further configured to: support the determination of receiving an instrument use instruction based on the instrument operating mode, receive the instrument use instruction from the surgical hub via the receiver; and send the instrument use instruction to a display.
[0308] Example 3 relates to an instrument operation mode that supports bidirectional communication with a surgical hub for receiving instrument usage instructions. In this operation mode, the surgical instrument receives and displays instrument usage instructions from the hub, which can be used by the user to further manipulate the instrument and the results of surgical activities.
[0309] Example 4. The surgical instrument according to Example 1 or 2 further includes: a receiver; and an end effector for removably storing a surgical staple cartridge. The processor is further configured to: receive cartridge information from the end effector; determine, based on an instrument operating mode, whether to combine the cartridge information with instrument usage parameters, wherein the instrument usage parameters include at least one of a time from clamping to firing or a characterization of user-controlled firing; and, based on the determination of combination, transmit the instrument usage parameters and the cartridge information to the surgical hub via a transmitter. The surgical suture instrument according to Example 4 can control communication with the end effector to receive cartridge information and interactively combine the cartridge information with instrument actuators or configuration data to provide a broader understanding of the overall instrument status. The surgical instrument can also control communication with the surgical hub to selectively transmit combined static and usage data of the instrument to the surgical hub, where the combined data can be stored, processed, and / or aggregated to determine tissue or functional data from system-surgical site interactions.
[0310] Example 5. A surgical instrument according to any one of Examples 1 to 4, wherein the processor is further configured to determine an instrument operating mode based on instrument operating control parameters. These instrument operating control parameters include at least one of: system capacity parameters, system condition parameters, system authorization parameters, hierarchical communication mode indication received from a hub, or hierarchical communication mode indication received from a remote server. Example 5 relates to the determination of an instrument operating mode. The surgical instrument is thus able to determine the instrument operating mode based on control parameters and / or hierarchical communication mode indications related to the system's condition or capability, and to control communication with the end effector and surgical hub in a manner as described in one of the examples above.
[0311] Example 6. The surgical instrument according to any of the foregoing examples further includes: a receiver; and an end effector for removably storing a surgical cartridge. The processor is further configured to obtain cartridge information and instrument status information from the end effector; and to transmit the cartridge information and the instrument status information to a surgical hub. The surgical instrument according to Example 6 relates to a surgical stapler having an end effector for removably receiving a cartridge, and being capable of controlling communication with the end effector and with a surgical hub to selectively obtain cartridge information and instrument status information and transmit such cartridge information and instrument status information to the surgical hub, where combined data can be stored, processed, and / or aggregated.
[0312] Example 7. A surgical instrument according to any of the foregoing examples, wherein the processor is further configured to determine, based on the instrument's operating mode, whether to receive recommended instrument usage information generated based on aggregated historical instrument usage data. This instrument usage information includes a suture chamber selection. The surgical instrument according to Example 7 can control communication with external devices / systems to selectively receive recommended instrument usage information, which may be displayed or otherwise provided to the user. This allows the procedure to vary over time.
[0313] Example 8. A surgical instrument according to any of the foregoing examples, wherein the processor is further configured to determine, based on the instrument's operating mode, whether to receive a stapler cartridge selection recommendation generated based on aggregated stapler cartridge usage data associated with the surgical procedure. The surgical instrument according to Example 8 is capable of controlling communication with external devices / systems to selectively receive stapler cartridge selection recommendations generated based on aggregated stapler cartridge usage data. This recommendation may be displayed or otherwise provided to the user for selecting an appropriate cartridge to perform the surgical procedure, thereby further improving surgical outcomes and / or patient safety.
[0314] Example 9. A remote server comprising: an input / output interface configured to access data from a plurality of medical hub communication devices, wherein one or each of the medical hub communication devices is communicatively coupled to at least one surgical instrument; and a 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.
[0315] Example 10. The remote server according to Example 9, wherein the processor is further configured to associate the received instrument usage information with the outcome of a medical procedure and / or the instrument operation status during the medical procedure; and to send the associated information.
[0316] Example 11. The remote server according to Example 9 or 10, wherein the processor is further configured to determine, based on the associated information, recommended device usage information associated with the upcoming medical procedure; and to send the recommended device usage information.
[0317] Examples 9 to 11 relate to a remote server that can receive information from one or more surgical instruments, aggregate and / or correlate that information, or generate instrument usage recommendations, and send 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. The remote server can communicate with surgical instruments and surgical hubs as described in the examples above to provide useful information generated by cloud-based analytics.
[0318] Example 12. A method may include: providing a sensor signal from a sensor based on physiological parameters of a tissue; determining, based on an instrument operating mode, whether a sensing parameter associated with the sensor signal from the sensor is acquired; determining, based on the instrument operating mode, whether an instrument use instruction is received; and communicating with a surgical hub via a transmitter based on at least one of these determinations.
[0319] Example 13. The method according to Example 12, wherein the method further includes: determining the sensing parameters based on the instrument operation mode support, obtaining the sensing parameters, and sending the sensing parameters to the surgical hub.
[0320] Example 14. The method according to Example 12 or 13, wherein the method further comprises: determining, based on the instrument operation mode, a support for receiving an instrument use instruction; receiving the instrument use instruction from a surgical hub via the receiver; and sending the instrument use instruction to a display.
[0321] Example 15. The method according to any one of Examples 12 to 14, wherein the method further comprises: receiving cartridge information from an end effector for removably storing a surgical cartridge; determining, based on a device operating mode, whether to combine the cartridge information with device usage parameters, wherein the device usage parameters include at least one of a time from clamping to firing or a characterization of user-controlled firing; and, based on the determination of the combination, transmitting the device usage parameters and the cartridge information to the surgical hub via a transmitter.
[0322] Example 16. The method according to any one of Examples 12 to 15, wherein the method further comprises determining an instrument operating mode based on instrument operating control parameters. The instrument operating control parameters include at least one of: system capacity parameters, system condition parameters, system authorization parameters, hierarchical communication mode indication received from a hub, or hierarchical communication mode indication received from a remote server.
[0323] Example 17. The method according to any one of Examples 12 to 16, wherein the method further comprises: obtaining cartridge information and instrument status information from an end effector for removably storing a surgical cartridge; and sending the cartridge information and the instrument status information to a surgical hub.
[0324] Example 18. The method according to any one of Examples 12 to 17, wherein the method further comprises: determining, based on the instrument operating mode, whether to receive recommended instrument usage information generated based on aggregated historical instrument usage data. The instrument usage information includes a suture compartment selection.
[0325] Example 19. The method according to any one of Examples 12 to 18, wherein the method further comprises determining, based on the instrument operation mode, whether to receive a stapler cartridge selection recommendation generated based on aggregated stapler cartridge usage data associated with the surgical step.
[0326] Example 20. A method comprising: receiving instrument use information associated with a medical procedure performed by a surgeon; aggregating the received instrument use information with historical instrument use information associated with the surgeon; and sending the aggregated instruction use information.
[0327] Example 21. The method according to Example 20 further includes: associating the received device usage information with the outcome of the medical procedure and / or the device operation status during the medical procedure; and sending the associated information.
[0328] Example 22. The method according to Example 20 or 21 further includes: determining recommended device use information associated with the upcoming medical procedure based on the associated information; and sending the recommended device use information.
[0329] Example 23. A computer-readable medium capable of storing program instructions that, when executed by a processor, perform a method comprising the steps of: providing sensor signals from a sensor based on physiological parameters of a tissue; determining, based on an instrument operating mode, whether to acquire sensing parameters associated with the sensor signals from the sensor; determining, based on the instrument operating mode, whether to receive an instrument use instruction; and, based on at least one of these determinations, communicating with a surgical hub via a transmitter.
[0330] Example 24. According to the computer-readable medium of Example 23, additionally storing program instructions that, when executed by a processor, perform a method further comprising the following steps: determining a sensing parameter based on instrument operation mode support, obtaining the sensing parameter, and sending the sensing parameter to a surgical hub.
[0331] Example 25. The computer-readable medium according to Example 23 or 24 further stores program instructions that, when executed by a processor, perform a method including the following steps: for example, determining, based on a device operation mode, to receive a device use instruction from a surgical hub via a receiver; and sending the device use instruction to a display.
[0332] Example 26. A computer-readable medium according to any one of Examples 23 to 25, further storing program instructions that, when executed by a processor, perform a method comprising the steps of: receiving cartridge information from an end effector for removably storing a surgical cartridge; determining, based on a device operating mode, whether to combine the cartridge information with device usage parameters, wherein the device usage parameters include at least one of a time from clamping to firing or a characterization of user-controlled firing; and, based on the determination of the combination, transmitting the device usage parameters and the cartridge information to the surgical hub via a transmitter.
[0333] Example 27. A computer-readable medium according to any one of Examples 23 to 26, further storing program instructions that, when executed by a processor, perform a method including the following steps: for example, determining an instrument operating mode based on instrument operating control parameters. The instrument operating control parameters include at least one of: system capacity parameters, system condition parameters, system authorization parameters, a hierarchical communication mode indication received from a hub, or a hierarchical communication mode indication received from a remote server.
[0334] Example 28. A computer-readable medium according to any one of Examples 23 to 27, further storing program instructions that, when executed by a processor, perform a method comprising the steps of: obtaining cartridge information and instrument status information from an end effector for removably storing a surgical cartridge; and sending the cartridge information and the instrument status information to a surgical hub.
[0335] Example 29. The computer-readable medium according to any one of Examples 23 to 28 further stores program instructions, and additionally stores program instructions that, when executed by a processor, perform a method comprising the steps of: determining, based on a device operating mode, whether to receive recommended device usage information generated based on aggregated historical device usage data. The device usage information includes a suture compartment selection.
[0336] Example 30. A computer-readable medium according to any one of Examples 23 to 29, further storing program instructions that, when executed by a processor, perform a method comprising the following steps: determining, based on an instrument operating mode, whether to receive a stapler cartridge selection recommendation generated based on aggregate stapler cartridge usage data associated with a surgical step.
[0337] Example 31. A computer-readable medium storing program instructions that, when executed by a processor, perform a method comprising the steps of: receiving instrument usage information associated with a medical procedure performed by a surgeon; aggregating the received instrument usage information with historical instrument usage information associated with the surgeon; and transmitting the aggregated instruction usage information.
[0338] Example 32. According to the computer-readable medium of Example 31, additionally storing program instructions that, when executed by a processor, perform a method further comprising the steps of: associating received instrument usage information with the outcome of a medical procedure and / or the instrument operating status during the medical procedure; and sending the associated information.
[0339] Example 33. According to the computer-readable medium of Example 31 or 32, additionally storing program instructions that, when executed by a processor, perform a method further comprising the steps of: determining recommended device use information associated with an upcoming medical procedure based on the associated information; and sending the recommended device use information.
[0340] The methods described according to Examples 12 to 19 and the computer-readable media described in Examples 23 to 30 correspond to the devices described in Examples 1 to 8. The above discussion regarding Examples 1 to 8 therefore also applies to Examples 12 to 19 and 23 to 30. Similarly, the methods described according to Examples 20 to 22 and the computer-readable media described in Examples 31 to 33 correspond to the devices described in Examples 9 to 11. The above discussion regarding Examples 9 to 11 therefore also applies to Examples 20 to 22 and 31 to 33.
[0341] The following list of implementation schemes forms part of this disclosure:
[0342] 1. A surgical instrument, comprising: a sensor configured to provide a sensor signal based on physiological parameters of a tissue; a transmitter; and a processor configured to: determine, based on an instrument operating mode, whether to acquire a sensing parameter associated with the sensor signal from the sensor; determine, based on the instrument operating mode, whether to receive an instrument use instruction; and communicate with a surgical hub via the transmitter based on at least one of the determinations.
[0343] 2. The surgical instrument according to embodiment 1, wherein the processor is further configured to: support the determination of the sensing parameters based on the instrument operating mode, obtain the sensing parameters, and send the sensing parameters to the surgical hub.
[0344] 3. The surgical instrument according to embodiment 1 further includes: a receiver, wherein the processor is further configured to: support the determination of receiving the instrument use instruction based on the instrument operation mode, receive the instrument use instruction from the surgical hub via the receiver; and send the instrument use instruction to a display.
[0345] 4. The surgical instrument according to embodiment 1 or 2 further includes: 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, wherein the instrument usage parameters include at least one of a time from clamping to firing or a characterization of user-controlled firing; and based on the determination of the combination, transmit the instrument usage parameters and the cartridge information to the surgical hub via the transmitter.
[0346] 5. The surgical instrument according to embodiment 1, wherein the processor is further configured to determine the instrument operating mode based on instrument operating control parameters, wherein the instrument operating control parameters include at least one of the following: system capacity parameters, system condition parameters, system authorization parameters, hierarchical communication mode indication received from the hub, or hierarchical communication mode indication received from a remote server.
[0347] 6. The surgical instrument according to embodiment 1 or 2 further includes: 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 to send the cartridge information and the instrument status information to the surgical hub.
[0348] 7. The surgical instrument according to 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 historical instrument usage data, wherein the instrument usage information includes suture compartment selection.
[0349] 8. The surgical instrument according to embodiment 1, 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 aggregate stapler cartridge usage data associated with the surgical procedure.
[0350] 9. A remote server, comprising: an input / output interface configured to access data from a plurality of medical hub communication devices, each of the plurality of medical hub communication devices being communicatively coupled to at least one surgical instrument; and a 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 instruction usage information.
[0351] 10. The remote server according to embodiment 9, wherein the processor is further configured to: associate the received instrument usage information with the outcome of the medical procedure; and send the associated information.
[0352] 11. The remote server according to embodiment 9 or 10, wherein the processor is further configured to determine, based on the associated information, recommended device usage information associated with the upcoming medical procedure; and to send the recommended device usage information.
[0353] 12. A method comprising: providing a sensor signal from a sensor based on physiological parameters of a tissue; determining, based on an instrument operating mode, whether a sensing parameter associated with the sensor signal is acquired; determining, based on the instrument operating mode, whether an instrument use instruction is received; and communicating with a surgical hub via a transmitter based on the determination.
[0354] 13. The method according to embodiment 12 further includes: determining the sensing parameters based on the instrument operation mode support, obtaining the sensing parameters, and sending the sensing parameters to the surgical hub.
[0355] 14. The method according to embodiment 12 further includes: determining that the instrument operation mode supports receiving the instrument use instruction; receiving the instrument use instruction from the surgical hub via a receiver; and sending the instrument use instruction to a display.
[0356] 15. The method according to embodiment 12 further includes: receiving cartridge information from an end effector for removably storing a surgical staple cartridge; determining, based on the instrument operating mode, whether to combine the cartridge information with instrument usage parameters, wherein the instrument usage parameters include at least one of a time from clamping to firing or a characterization of user-controlled firing; and, based on the determination of the combination, transmitting the instrument usage parameters and the cartridge information to the surgical hub via the transmitter.
[0357] 16. The method according to embodiment 12 further includes: determining the device operation mode based on device operation control parameters, wherein the device operation control parameters include at least one of the following: system capacity parameters, system condition parameters, system authorization parameters, hierarchical communication mode indication received from the hub, or hierarchical communication mode indication received from a remote server.
[0358] 17. The method according to embodiment 12 further includes: obtaining cartridge information and instrument status information from an end effector for removably storing a surgical cartridge; and sending the cartridge information and the instrument status information to the surgical hub.
[0359] 18. The method according to embodiment 12 further includes: determining whether to receive recommended instrument usage information generated based on aggregated historical instrument usage data based on the instrument operation mode, wherein the instrument usage information includes suture compartment selection.
[0360] 19. The method according to embodiment 12, wherein the method further comprises determining, based on the instrument operating mode, whether to receive a stapler cartridge selection recommendation generated based on aggregated stapler cartridge usage data associated with the surgical procedure.
Claims
1. A surgical instrument configured to selectively operate in a variety of different instrument operation modes, said surgical instrument comprising: A sensor configured to provide sensor signals based on physiological parameters of the tissue; Receiver; Transmitter; and Processor, the processor being configured to: Based on the instrument operating mode, determine whether to obtain sensing parameters associated with the sensor signal from the sensor; Determine whether bidirectional communication with the surgical hub via the receiver and transmitter is permitted based on the instrument operation mode. as well as Based on at least one of the determinations, communication is made with the surgical hub via the transmitter.
2. The surgical instrument according to claim 1, wherein, The processor is further configured to obtain the sensing parameters based on the instrument operation mode, and to send the sensing parameters to the surgical hub.
3. The surgical instrument according to claim 1 or 2, wherein the processor is further configured to: Based on the determination that the instrument operation mode supports bidirectional communication with the surgical hub, the instrument usage command is received from the surgical hub via the receiver; and Send the device usage instructions to the display.
4. The surgical instrument according to claim 1 or 2, further comprising: End effector for removably storing a surgical staple cartridge. The processor is further configured to be able to: Receive bin information from the end effector; Based on the instrument operation mode, determine whether to combine the chamber information with instrument usage parameters, wherein the instrument usage parameters include at least one of the time from clamping to firing or a user-controlled firing characteristic; and Based on the determined combination, the instrument usage parameters and the compartment information are sent to the surgical hub via the transmitter.
5. The surgical instrument according to any one of claims 1 to 4, wherein, The processor is further configured to determine the device operation mode based on device operation control parameters, wherein the device operation control parameters include at least one of the following: system capacity parameters, system condition parameters, system authorization parameters, hierarchical communication mode indication received from the hub, or hierarchical communication mode indication received from a remote server.
6. The surgical instrument according to any one of the preceding claims further comprises: 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 to send the cartridge information and the instrument status information to the surgical hub.
7. The surgical instrument according to any of the preceding claims, 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 historical instrument usage data, wherein the instrument usage information includes suture compartment selection.
8. The surgical instrument according to any of the preceding claims, 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 stapler cartridge usage data associated with the surgical procedure.
9. A system comprising at least one surgical instrument as claimed in any one of claims 1-8 and a remote server, said remote server comprising: An input / output interface configured to access data from a plurality of medical hub communication devices, wherein one or each of the medical hub communication devices is communicatively coupled to at least one of the surgical instruments; 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 historical instrument usage information associated with the surgeon; and transmit the aggregated instrument usage information.
10. The system according to claim 9, wherein, The processor is further configured to associate the received instrument usage information with the outcome of the medical procedure and / or the instrument operation status during the medical procedure; and to send the associated information.
11. The system according to claim 9 or 10, wherein, The processor is further configured to determine recommended instrument usage information associated with the upcoming medical procedure based on the associated information; and to send the recommended instrument usage information to at least one of the surgical instruments.
12. A method comprising: Receive instrument usage information associated with medical procedures performed by a surgeon; Aggregate the received instrument usage information with historical instrument usage information associated with the surgeon; and send the aggregated instruction usage information to at least one surgical instrument as claimed in any one of claims 1-8.
13. The method of claim 12, further comprising: The received device usage information is associated with the outcome of the medical procedure and / or the device operation status during the medical procedure. And send the associated information.
14. The method according to claim 12 or 13, further comprising: Based on the associated information, recommended device usage information is determined in connection with the upcoming medical procedure; And send the recommended device usage information.
15. A computer-readable medium capable of storing program instructions, which, when executed by a processor, perform the method as described in any one of claims 12-14.
Citation Information
Patent Citations
Surgical instrument with axially movable closure member
US10639037B2
Techniques for adaptive control of motor velocity of a surgical stapling and cutting instrument
US10881399B2
Surgical instrument comprising an adaptive control system
US11090047B2
Surgical hub coordination of control and communication of operating room devices
US11166772B2
Method of robotic hub communication, detection, and control
US11559307B2