Surgical hub with variable interconnection capabilities

Abstract

The surgical hub may obtain a hub connection mode based on the hub connection control parameters. For example, the hub connection mode may be selected from a plurality of connection modes, which may be pre-configured, dynamically updated, semi-dynamically updated, periodically updated, or preset. The hub connection mode may control device-to-device connections within a network associated with a hospital and / or communication with external networks associated with different hospitals. The surgical hub may determine whether to provide instruction information to at least one smart surgical instrument based on the hub connection mode. If the hub connection mode does not support provisioning of instruction information to the surgical instrument, provisioning of instruction information to the surgical instrument may be disabled. If the hub connection mode supports provisioning of instruction information to the surgical instrument, the surgical hub may determine to obtain and provide instruction information to the surgical instrument.

Description

[Technical Field]

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

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

[0003] According to various embodiments of the present invention, the following examples are provided. Example 1. A surgical hub including a receiver configured to receive surgical information from at least one smart surgical device; a transmitter configured to transmit surgical data to a remote server; and a processor configured to: determine a hub connection mode based on a hub connection control parameter; determine whether to send instruction information to the at least one smart device based on the hub connection mode; and communicate with the at least one smart device based on the determination.

[0004] Regardless of the particular configuration, the surgical hub can communicate with various devices, remote server(s), and / or devices, servers, and databases in external networks in different connection modes, allowing the hub to communicate with these devices, aggregate information, and then communicate with a remote processing server or database.

[0005] The hub connection mode may be selected from a plurality of connection modes, which may be pre-configured, dynamically updated, semi-dynamically updated, periodically updated, or preset. The hub connection mode may control device-to-device connections within a network associated with a healthcare facility, e.g., a hospital, and / or communications with external networks associated with different hospitals. The hub connection mode may be determined based on hub connection control parameters.

[0006] The hub connection control parameter(s) may include system capabilities such as, but not limited to, hardware capabilities, firmware capabilities, and / or software capabilities. The hub connection control parameter(s) may include consumer control parameters such as subscription level. The hub connection control parameter(s) may include instructions from the tiered system. The tiered system may scale communications between the surgical hub and device(s), between the surgical hub and external server(s), etc. based on available data bandwidth, power capacity and usage, processor and memory utilization, and / or internal or attached systems. The tiered system may determine the maximum communication capabilities under which the surgical hub may operate.

[0007] The surgical hub may operate in a flow-through connection mode, in which surgical information may flow through the surgical hub to a remote server. The surgical hub may operate in a bidirectional mode, in which the surgical hub may receive surgical data from the surgical device(s) and transmit data, such as instruction information, to the device(s). In an exemplary bidirectional mode, the surgical hub may aggregate surgical data received from the surgical device(s) before transmitting to the remote server(s) in the cloud. The bidirectional mode may enable situational awareness and control of the surgical device(s). The surgical hub may operate in a hub-connected mode that supports data aggregation with external datasets. In this hub-connected mode, the surgical hub may facilitate recording and archiving of surgical data and may exchange surgical data and / or related analytics with external network(s). Data from various hospitals or medical institutions may be aggregated. The surgical data, results, and patient information may be compiled to determine instruction information, surgical recommendations, aggregated analysis, etc. The surgical hub may retrieve aggregated analytics from remote server(s) or database(s) in the cloud. The aggregated analytics increase the likelihood of achieving desired outcomes for different surgical procedures. Surgeons may be provided with best practice recommendations, which may be generated based on an aggregated surgical dataset associated with multiple surgical procedures performed at multiple locations over time.

[0008] The surgical hub may determine whether to provide instruction information to at least one surgical instrument communicating with the surgical hub based on the hub connection mode. This allows the surgical hub to selectively operate with respect to providing instruction information to at least one surgical instrument according to the state of the hub connection mode. For example, if the hub connection mode does not support provisioning of instruction information to the surgical instrument, provisioning of instruction information to the surgical instrument may be disabled. This may be when the hub connection control parameter(s) indicate a lack of hardware capability in the surgical instrument to provide instruction information, and the surgical hub may switch to a connection mode that may disable providing instruction information to the surgical instrument. On the other hand, if the hub connection mode supports provisioning of instruction information to the surgical instrument, the surgical hub may decide to obtain and provide instruction information to the surgical instrument.

[0009] Example 2. The surgical hub of Example 1, wherein the transmitter is further configured to transmit data to at least one smart surgical device, and the processor is further configured to, based on a determination to transmit command information, obtain command information based on the received surgical information and transmit the obtained command information to the at least one smart surgical device via the transmitter.

[0010] As an example 2, the hub connection mode may support provisioning instructions to the surgical device. Thus, the surgical device is provided with instructions, which may include instructions that take into account situational awareness, historical information, etc. Depending on the instruction information provided, the outcome and quality of the surgical activity performed by the surgical device may be improved. The surgeon may be provided with warning messages and / or recommendations regarding the device, the patient, and the procedure. The operation of the device may be improved. Patient safety may be ensured.

[0011] Example 3. A surgical hub as described in Example 1 or 2, wherein the instruction information includes at least one of adjustments to surgical functions, prioritization information, cartridge use recommendations, warning messages, surgical device use recommendations, or surgical device use instructions.

[0012] As a third example, instructional information may be provided to the device and / or surgeon, which may contribute to improving the efficiency and / or effectiveness of the surgical function and / or the safety and security of the operation.

[0013] Example 4. The surgical hub of any preceding example, wherein the processor is further configured to determine whether to disable communication with external systems based on the hub connection mode.

[0014] As an example, communication with an external system based on a hub connection mode may be conditionally adapted. For example, in a condition where the hub connection mode does not support access to the external system as determined by hub connection control parameters, which may include consumer control parameters such as a subscription level, surgical hub communication with the external system may be disabled. This may be the case where a medical facility purchases a subscription to hub connection capabilities and the subscription level(s) limit hub connection to internal devices.

[0015] Example 5. The surgical hub of any preceding example, wherein the processor is further configured to determine whether to transmit recorded surgical information associated with the procedure to a remote server based on the hub connection mode.

[0016] A surgical instrument or surgical hub can record surgical information related to a procedure while the procedure is being performed. As example 5, a surgical hub may transmit recorded surgical information received from a surgical instrument to a remote server for archiving and / or analysis. The archived surgical information may be aggregated with information received from other surgical hub(s) and / or surgical information associated with other medical facilities. The aggregated information may be accessed to generate instruction information for one or more surgical instrument(s). For example, a surgical communication hub may aggregate information such as information received from smart surgical devices, information associated with multiple surgeries, surgical information, and corresponding results associated with multiple patients. The aggregated information may be stored in a remote database. For example, the surgical information may be aggregated at a remote server.

[0017] Example 6. The surgical hub of any preceding example, wherein the receiver is further configured to receive data from the remote server, and wherein the processor is further configured to: determine whether to retrieve an aggregate analysis from the remote server based on a hub connection mode; based on a determination to retrieve the aggregate analysis, generate an aggregate analysis request based on the received surgical data; send the aggregate analysis request to the remote server via the transmitter; receive an aggregate analysis response from the remote server via the receiver; generate instruction information based on the aggregate analysis response; and send the instruction information to the at least one smart device via the transmitter.

[0018] As an example, a surgical hub may be enabled to retrieve aggregated analytics from a remote server and provide instructional information, such as trends in surgical data and / or recommendations, to surgical devices based on the aggregated analytics. For example, the remote server may aggregate information received from the surgical hub(s) and / or surgical information associated with other medical facilities. The aggregated information may be accessed to generate instructional information for one or more surgical instrument(s). The aggregated analytics increases the likelihood of achieving desired outcomes for different surgical procedures. Surgeons may be provided with best practice recommendations, which may be generated based on aggregated surgical datasets associated with multiple surgical procedures performed at multiple locations over time.

[0019] Example 7. The surgical hub of any preceding example, wherein the hub connection control parameters include at least one of available data bandwidth, power capacity associated with the surgical hub, power capacity associated with the operating room, power capacity associated with the medical facility, power usage, processor utilization information, or memory utilization information.

[0020] As an example, the hub connection control parameters enable the hub connection mode to control communication between the surgical hub and surgical instruments and / or external servers based on the state of data bandwidth, power, and / or processor and memory utilization information.

[0021] Example 8. A surgical hub described in any one of Examples 1 to 6, wherein the hub connection control parameters include at least one of a subscription level associated with the hub connection, a user preference associated with the hub connection, or an instruction from a layered software control system.

[0022] As an example, the hub connection control parameters allow the hub connection mode to control or reduce the surgical hub's communications with surgical instruments and / or external servers based on subscription level, user preferences, or instructions from a tiered software control system. For example, if the hub connection control parameter(s) include instructions from the tiered system, the tiered system may scale communications between the surgical hub and surgical instruments, between the surgical hub and external servers, based on, for example, available data bandwidth, power capacity and usage, processor and memory utilization, and / or internal or attached systems. The tiered system may determine the maximum communication capacity under which the surgical hub can operate. For example, upon detecting that power capacity associated with the operating room, surgical hub, and / or medical facility is below a threshold, the tiered system may reduce the surgical hub's connection capacity. In another example, upon detecting available data bandwidth below a threshold, memory utilization above a particular threshold, power usage above a particular threshold, and / or other system conditions that may warrant reducing the surgical hub's connectivity capabilities, the tiered system may limit or disable communications between the surgical hub and at least one surgical instrument and / or communications between the surgical hub and an external server. For example, a bidirectional connection mode may be reduced to a flow-through connection mode. External communications may be disabled.

[0023] Example 9. A method for controlling a hub connection, the method including: receiving surgical information from at least one smart surgical device; determining a hub connection mode based on a hub connection control parameter; determining whether to send command information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination.

[0024] Example 10. The method of Example 9, further comprising, based on a decision to transmit command information, obtaining command information based on the received surgical information, and transmitting the obtained command information to at least one smart surgical device.

[0025] Example 11. The method of Example 9 or 10, wherein the instruction information includes at least one of surgical function adjustment, prioritization information, cartridge use recommendation, warning message, surgical device use recommendation, or surgical device use instruction.

[0026] Example 12. The method of any one of Examples 9 to 11, further comprising determining whether to disable communication with the external system based on the hub connection mode.

[0027] Example 13. The method of any one of Examples 9 to 12, further comprising determining whether to transmit recorded surgical information associated with the procedure to a remote server based on a hub connection mode.

[0028] Example 14. The method of any one of Examples 9 to 13, further comprising receiving data from a remote server or the remote server, wherein the processor is further configured to: determine whether to retrieve an aggregate analysis from the remote server based on a hub connection mode; based on the determination to retrieve the aggregate analysis, generate an aggregate analysis request based on the received surgical data; send the aggregate analysis request to the remote server via a transmitter of the hub; receive an aggregate analysis response from the remote server via a receiver of the hub; generate instruction information based on the aggregate analysis response; and send the instruction information to at least one smart device via the transmitter.

[0029] Example 15. The method of any one of Examples 9 to 14, wherein the hub connection control parameters include at least one of available data bandwidth, power capacity associated with the surgical hub, power capacity associated with the operating room, power capacity associated with the medical facility, power usage, processor utilization information, or memory utilization information.

[0030] Example 16. The method of any one of Examples 9-14, wherein the hub connection control parameters include at least one of a subscription level associated with the hub connection, a user preference associated with the hub connection, or an instruction from a layered software control system. The method of Examples 9-16 may be performed by a surgical hub.

[0031] Example 17. A computer-readable medium having stored thereon instructions that, when executed, perform the following: receiving surgical information from at least one smart surgical device; determining a hub connection mode based on a hub connection control parameter; determining whether to send instruction information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination.

[0032] Example 18. The computer-readable medium of claim 17, further comprising instructions that, when executed by a processor of a surgical hub, perform the following operations: obtain command information based on the received surgical information; and transmit the obtained command information to at least one smart surgical device based on a determination to transmit the command information.

[0033] Example 19. A computer-readable medium as described in Example 17 or 18, further comprising instructions that, when executed by a processor of a surgical hub, determine whether to disable communication with an external system based on the hub connection mode.

[0034] Example 20. The computer-readable medium of any one of Examples 17-19, further comprising instructions that, when executed by a processor of a surgical hub, execute determining whether to transmit recorded surgical information associated with the procedure to a remote server based on a hub connection mode. The instructions on the computer-readable medium of Examples 17-20 may be executed by a processor of a surgical hub.

[0035] The methods according to Examples 9-16 and the computer-readable media described in Examples 17-19 correspond to the apparatuses of Examples 1-8. Therefore, the above discussion regarding Examples 1-8 also applies to Examples 9-20.

[0036] Example 21. The surgical hub, method, or computer-readable medium of any preceding example, wherein the hub connection mode is selectable from a plurality of connection modes in which the surgical hub may operate, each of the hub connection modes configured to control device-to-device connections within the network and / or communication with an external network.

[0037] Example 22. The surgical hub, method, or computer readable medium of any preceding example, wherein the surgical information from the at least one smart surgical device includes surgical data related to a surgical procedure performed by the at least one smart surgical device, and optionally, the surgical data and surgical parameters are recorded by the at least one surgical device during the surgical procedure, and further optionally, the surgical parameters include at least one of firing force, closure force, firing progression, tissue gap, power level, impedance, and tissue compression stability.

[0038] According to further embodiments of the present invention, a surgical hub may be connected, wired or wirelessly, to various devices and servers within an operating room, within a medical facility, and / or outside of a medical facility. The surgical hub may determine a hub connection mode based on a hub connection control parameter. The hub connection mode may be selected from a plurality of connection modes that may be pre-configured, dynamically updated, semi-dynamically updated, periodically updated, or preset. The hub connection mode may control, for example, device-to-device connections within a network associated with a hospital and / or communication with external networks associated with different hospitals.

[0039] For example, the surgical hub may determine whether to disable obtaining instruction information based on the connection mode. Based on a determination that the current connection mode is flow-through mode, the surgical hub may disable obtaining instruction information.

[0040] For example, the surgical hub may determine whether to provide instruction information to at least one smart surgical instrument based on the hub connection mode. If the hub connection mode does not support provisioning of instruction information to the surgical device, provisioning of instruction information to the surgical device may be disabled. If the hub connection mode supports provisioning of instruction information to the surgical device, the surgical hub may determine to obtain and provide instruction information to the surgical device.

[0041] For example, the surgical hub may determine whether to retrieve aggregated analysis from a remote server based on the hub connection mode. Based on a determination that the current hub connection mode supports remote data aggregation and analysis, the surgical hub may generate an aggregated analysis request. The request may be generated based on the received surgical data and sent to the remote server. For example, the aggregated analysis request may indicate a request for recommendations regarding generator data associated with a particular step in a surgical procedure. In response, the surgical hub may receive an aggregated analysis response from the remote server. For example, the aggregated analysis response may include recommendations and / or reports. The aggregated analysis response may include one or more of the generator energy mode for the particular surgical procedure, the generator power output for the particular surgical procedure, and / or the duration of the generator power output for the particular surgical procedure. The aggregated analysis response may include instruction information as described herein. The surgical hub may generate and send instruction information to one or more surgical device(s) based on the received aggregated analysis response. Based on a determination that the current hub connection mode supports remote data aggregation and analysis, the surgical hub may disable the data aggregation analysis request.

[0042] The hub connection control parameter(s) may include system capabilities such as, but not limited to, hardware capabilities, firmware capabilities, and / or software capabilities. The hub connection control parameter(s) may include consumer control parameters such as subscription level. For example, a medical facility may purchase a subscription to hub connection capabilities. Some subscription level(s) may provide the hub access to surgical data collected from external systems, while other subscription levels may limit hub connectivity to internal devices.

[0043] In an exemplary hub connection mode, the surgical hub may receive information from the surgical instrument(s) and may transmit the received information to a remote server (such as a remote processing server and / or a remote database in the cloud).

[0044] In an exemplary connection mode, the surgical hub may receive information from the surgical instrument(s) and may transmit the received information to a remote server (such as a remote processing server and / or a remote database in the cloud). The surgical hub may receive information from the surgical instrument(s), obtain instruction information based on the information received from the surgical instrument(s), and transmit the instruction information to one or more surgical instrument(s).

[0045] In an exemplary connected mode, the surgical hub may receive information from the surgical instrument(s) and may transmit the received information to a remote server (e.g., a remote processing server and / or a remote database in the cloud). The surgical hub may receive information from the surgical instrument(s), obtain command information based on the information received from the surgical instrument(s), and transmit the command information to one or more surgical instrument(s). The surgical hub may record various surgical information and transmit the surgical information to a remote server for archiving and / or analysis. The archived surgical information may be aggregated with information received from other surgical hub(s) and / or with surgical information associated with other medical facilities. The aggregated information may be accessed to generate command information for one or more surgical instrument(s). In one example, the surgical communication hub may aggregate information such as information received from smart surgical devices, information associated with multiple surgeries, surgical information, and corresponding results associated with multiple patients. The aggregated information may be stored in a remote database. In one example, the surgical information may be aggregated at a remote server. [Brief explanation of the drawings]

[0046] [Figure 1] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 2] 1 is a surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. [Figure 3] 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument, according to at least one aspect of the present disclosure. [Figure 4] 1 illustrates a surgical data network comprising a modular communications hub configured to connect modular devices located at one or more surgical sites in a medical facility, or any room within a medical facility equipped for specialized surgical procedures, to a cloud, in accordance with at least one aspect of the present disclosure. [Figure 5]1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 6] 1 illustrates a surgical hub comprising multiple modules coupled to a modular control tower, according to at least one embodiment of the present disclosure. [Figure 7] 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 8] 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. [Figure 9] 1 shows a diagram of a context-aware surgical system according to at least one aspect of the present disclosure. [Figure 10] 1 illustrates an exemplary surgical procedure and inference timeline that a surgical hub can generate from data detected at each step in a surgical procedure, in accordance with at least one aspect of the present disclosure. [Figure 11] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 12] FIG. 1 is a block diagram illustrating a functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 13] 1 illustrates a block diagram of a computer-implemented interactive surgical system configured to adaptively generate updates to control programs of modular devices, in accordance with at least one aspect of the present disclosure. [Figure 14] 1 illustrates a surgical system including a handle having a controller and a motor, an adapter releasably coupled to the handle, and a loading unit releasably coupled to the adapter, according to at least one aspect of the present disclosure. [Figure 15A] 1 illustrates an example flow for determining an operating mode and operating in the determined mode, in accordance with at least one aspect of the present disclosure. [Figure 15B] 1 illustrates an example flow for changing an operational mode in accordance with at least one aspect of the present disclosure. [Figure 16A] 1 illustrates an exemplary hub connection mode. [Figure 16B] 1 illustrates an exemplary hub connection mode. [Figure 16C] 1 illustrates an exemplary hub connection mode. [Figure 17] 10 illustrates an exemplary flow for operating under a hierarchical hub communication mode. [Figure 18A] 10 illustrates an exemplary flow for operating under a hierarchical hub communication mode. [Figure 18B] 10 illustrates an exemplary flow for operating under a hierarchical hub communication mode. [Figure 18C] 10 illustrates an exemplary flow for operating under a hierarchical hub communication mode. [Figure 19] 1 illustrates an exemplary interactive surgical system according to at least one aspect of the present disclosure. [Figure 20] 1 illustrates exemplary surgical supplies packaged with RFID NFC chips. DETAILED DESCRIPTION OF THE INVENTION

[0047] The applicant of this application owns the following US patent applications, each of which is incorporated herein by reference in its entirety: ●U.S. Patent Application No. 15 / 940,654 (Attorney Docket No. END8501USNP), filed on March 29, 2018, titled "SURGICAL HUB SITUATION AWARENESS." ●U.S. Patent Application No. 15 / 940,668, filed March 29, 2018, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA," attorney docket number END8501USNP2. ●U.S. Patent Application No. 16 / 209,478 (Attorney Docket No. END9015USNP1), filed on December 4, 2018, titled "METHOD FOR SITUATIONAL AWARENESS FOR SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE CAPABLE OF ADJUSTING FUNCTION BASED ON A SENSED SITUATION OR USAGE." ●U.S. Patent Application No. 16 / 182,246 (Attorney Docket No. END9016USNP1), entitled "ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES," filed November 6, 2018. ●U.S. Patent Application No. 16 / 209,385 (Attorney Docket No. END8495USNP), entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," filed December 4, 2018.

[0048] 1 , a computer-implemented interactive surgical system 100 may include one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 may include at least one surgical hub 106 in communication with the cloud 104, which may include the remote server 113. In one example, as shown in FIG. 1 , a surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112, which are configured to communicate with each other and / or with the hub 106. In some embodiments, a surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P are integers greater than or equal to 1.

[0049] In various aspects, the visualization system 108 may include one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in FIG. 2. In one aspect, the visualization system 108 may include interfaces for HL7, PACS, and EMR. The various components of the visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1), entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety.

[0050] As shown in FIG. 2 , primary display 119 is positioned in the sterile field so as to be visible to the operator at operating table 114. In addition, visualization tower 111 is positioned outside the sterile field. Visualization tower 111 may include a first non-sterile display 107 and a second non-sterile display 109 facing opposite each other. Visualization system 108, guided by hub 106, is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, hub 106 can cause visualization system 108 to display snapshots of the surgical site captured by imager 124 on non-sterile displays 107 or 109 while maintaining a live video of the surgical site on primary display 119. The snapshots on non-sterile displays 107 or 109 can, for example, enable a non-sterile operator to perform diagnostic procedures related to the surgical procedure.

[0051] In one aspect, the hub 106 may also be configured to send diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to a primary display 119 in the sterile field for viewing by a sterile operator at the operating table. In one example, the input may be in the form of a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be sent by the hub 106 to the primary display 119.

[0052] 2, a surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 can also be configured to coordinate information flow to the display of the surgical instrument 112. See, for example, U.S. Patent Application Publication No. 2019-0200844(A1), entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 can be sent by the hub 106 to the surgical instrument display 115 in the sterile field, where it can be viewed by the operator of the surgical instrument 112. Exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in the section entitled "Surgical Instrument Hardware" and in U.S. Patent Application No. 2019-0200844(A1), filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), the entire disclosure of which is incorporated herein by reference.

[0053] FIG. 2 shows an example of a surgical system 102 being used to perform a surgical procedure on a patient lying on an operating table 114 in an operating room 116. A robotic system 110 may be used as part of the surgical system 102 in the surgical procedure. The robotic system 110 may include a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 through a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. Images of the surgical site are acquired by a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 can be used to process and then display the images of the surgical site to the surgeon through the surgeon's console 118.

[0054] Other types of robotic systems can be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Patent Application Publication No. 2019-0201137(A1), entitled "METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,407), the disclosure of which is incorporated herein by reference in its entirety.

[0055] Various examples of cloud-based analytics methods implemented by the cloud 104 and suitable for use with the present disclosure are described in U.S. Patent Application No. 2019-0206569(A1), entitled "METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,403), the entire disclosure of which is incorporated herein by reference.

[0056] In various embodiments, the imager 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.

[0057] The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. The one or more illumination sources may be directed to illuminate a portion of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.

[0058] The one or more illumination sources may be configured to emit electromagnetic energy within the visible spectrum as well as the invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or luminous spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and is sometimes referred to as visible light or simply light. The typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.

[0059] The invisible spectrum (e.g., non-radiative spectrum) is the portion of the electromagnetic spectrum located below and above the visible spectrum (i.e., wavelengths less than about 380 nm and greater than about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, which constitutes invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, which constitutes invisible ultraviolet, X-ray, and gamma-ray electromagnetic radiation.

[0060] In various aspects, the imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngological-nephroscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

[0061] The imaging device may employ multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths, including frequencies beyond the visible light range, e.g., IR and UV light. Spectral imaging can extract additional information that cannot be captured by the red, green, and blue receptors of the human eye. The use of multispectral imaging is described in more detail in U.S. Patent Application Publication No. 2019-0200844(A1) entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), under the heading "Advanced Imaging Acquisition Module," the entire disclosure of which is incorporated herein by reference. Multispectral monitoring can be a useful tool for repositioning the surgical field after the completion of a surgical task to perform one or more of the above-mentioned tests on the treated tissue. It is self-evident that any surgical procedure requires rigorous sterilization of the operating room and surgical equipment. The strict hygienic and sterile conditions required in the "surgical field," i.e., the operating room or procedure room, require the highest possible sterility of all medical devices and equipment. Part of the sterilization process described above includes the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It is understood that the sterile field may be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field may be considered the area immediately surrounding the patient who has been prepared for surgery. The sterile field may include cleaned team members in appropriate clothing, as well as all supplies and fixtures within the area.

[0062] Referring now to FIG. 3 , a hub 106 is shown in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communications module 130, a processor module 132, a storage array 134, and an operating room mapping module 133. In certain embodiments, as shown in FIG. 3 , the hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128. During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly associated with smoke evacuation, the aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular enclosure 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines. Aspects of the present disclosure present a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub enclosure and a combination generator module slidably receivable within a docking station of the hub enclosure. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combination generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.In one embodiment, the fluid line is a first fluid line, and a second fluid line extends from a remote surgical site to an aspiration and irrigation module slidably received within the hub enclosure. In one embodiment, the hub enclosure includes a fluid interface. Certain surgical procedures may require the application of two or more energy types to tissue. One energy type may be more beneficial for cutting tissue, while another, different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the hub's modular enclosure 136 is configured to house and facilitate interactive communication between various generators. One advantage of the hub's modular enclosure 136 is that it allows for rapid removal and / or replacement of various modules. Aspects of the present disclosure present a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. The modular surgical enclosure includes a first energy generator module configured to generate a first energy for application to tissue and a first docking station including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contacts and the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts. In addition to the above, the modular surgical enclosure also includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data and second power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts and the second energy generator module is slidably movable out of electrical engagement with the second power and second data contacts.In addition, the modular surgical enclosure also includes a communication bus between the first and second docking ports configured to facilitate communication between the first and second energy generator modules. Referring to FIG. 3 , an aspect of the present disclosure is presented regarding a hub modular enclosure 136 that enables modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The hub modular enclosure 136 further facilitates interactive communication between the modules 140, 126, and 128. The generator module 140 may be a generator module with integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit slidably insertable into the hub modular enclosure 136. The generator module 140 may be configured to connect to a monopolar device 142, a bipolar device 144, and an ultrasonic device 146. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the hub modular enclosure 136. The hub modular enclosure 136 may be configured to facilitate insertion of multiple generators and interactive communication between the generators docked to the hub modular enclosure 136 such that the multiple generators function as a single generator.

[0063] FIG. 4 illustrates a surgical data network 201 comprising a modular communications hub 203 configured to connect modular devices located in one or more surgical sites within a medical facility, or any room within a medical facility equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communications hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communications hub 203 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, allowing data to travel from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features that allow traffic to pass through the monitored surgical data network, configuring each port within the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

[0064] Modular devices 1a-1n located at the surgical site may be coupled to modular communication hub 203. Network hub 207 and / or network switch 209 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located at the same surgical site may also be coupled to network switch 209. Network switch 209 may be coupled to network hub 207 and / or network router 211 to connect devices 2a-2m to cloud 204. Data associated with devices 2a-2n may be transferred to cloud 204 via network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to local computer system 210 for local data processing and manipulation.

[0065] It will be appreciated that surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. Modular communications hub 203 may be housed within a modular control tower configured to receive multiple devices 1a-1n / 2a-2m. A local computer system 210 may also be housed in the modular control tower. Modular communications hub 203 may be connected to a display 212 to display images acquired by some of devices 1a-1n / 2a-2m, for example, during a surgical procedure. In various embodiments, devices 1a-1n / 2a-2m may include various modules such as, for example, an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communications module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and / or a non-contact sensor module, among other modular devices that may be connected to a modular communications hub 203 of a surgical data network 201.

[0066] In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(es), and network router(s) that connect the devices 1a-1n / 2a-2m to the cloud. Any one or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on sharing computing resources rather than having local servers or personal devices to handle software applications. While the term "cloud" may be used as a metaphor for the "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which various services, such as servers, storage, and applications, are delivered via the Internet to a modular communications hub 203 and / or computer system 210 located at the surgical site (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and / or computer system 210. The cloud infrastructure may be maintained by a cloud service provider. In this context, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located within one or more surgical sites. The cloud computing service may perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located within the surgical site. Hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

[0067] By applying cloud computer data processing technology to data collected by the devices 1a-1n / 2a-2m, the surgical data network can provide improved surgical outcomes, reduced costs, and improved patient satisfaction. After tissue sealing and cutting procedures, at least some of the devices 1a-1n / 2a-2m can be used to observe tissue status and evaluate leakage or perfusion of the sealed tissue. Using cloud-based computing, at least some of the devices 1a-1n / 2a-2m can be used to diagnostically examine data, including images of body tissue samples, to identify pathologies, such as the effects of disease. Such data can include tissue localization and margin confirmation, as well as phenotyping. At least some of the devices 1a-1n / 2a-2m can be used to identify anatomical structures of the body using various sensors integrated with the imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by the devices 1a-1n / 2a-2m, including image data, can be transferred to the cloud 204 or a local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data may be analyzed to improve surgical outcomes by determining whether further treatments can be pursued, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics to tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and the use of standardized techniques can provide useful feedback to either confirm or suggest modifications to surgical treatment and surgeon performance.

[0068] The surgical field devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. The network hub 207, in one aspect, may be implemented as a local network broadcast device operating on the physical layer of the Open System Interconnection (OSI) model. The network hub can provide connectivity to devices 1a-1n located within the same surgical field network. The network hub 207 can collect data in the form of packets and send them to a router in half-duplex mode. The network hub 207 may not store media access control / Internet Protocol (MAC / IP) information for forwarding any device data. Only one of the devices 1a-1n can send data through the network hub 207 at a time. The network hub 207 may not have a routing table or intelligence regarding where to send the information; it broadcasts all network data across each connection and to a remote server 213 (FIG. 4) on the cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose a security risk and cause bottlenecks.

[0069] The surgical field devices 2a-2m may be connected to the network switch 209 via wired or wireless channels. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 may be a multicast device for connecting devices 2a-2m located within the same surgical field to a network. The network switch 209 can transmit data in the form of frames to the network router 211 and functions in full duplex mode. Multiple devices 2a-2m can transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to forward data.

[0070] The network hub 207 and / or the network switch 209 may be coupled to a network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different surgical sites in the same medical facility or different surgical sites in different medical facilities. The network router 211 may transmit data in the form of packets to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.

[0071] In one example, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub can expand a single USB port into several tiers so that more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and 2a-2m located within the surgical field.

[0072] In other embodiments, the surgical field devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via the Bluetooth wireless technology standard to exchange data over short distances from fixed and mobile devices (using short-wavelength UHF radio waves in the 2.4-2.485 GHz ISM band) and to create a personal area network (PAN). The surgical field devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via numerous wireless or wired communications standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, New Radio (NR), Long Term Evolution (LTE), and any other wireless and wired protocols designated as Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as 3G, 4G, 5G, and beyond. The computing module may include multiple communication modules, for example, a first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.

[0073] The modular communications hub 203 can act as a central connection for one or all of the surgical field devices 1a-1n / 2a-2m and can handle data types known as frames. Frames can carry data generated by the devices 1a-1n / 2a-2m. Once a frame is received by the modular communications hub 203, it is amplified and transmitted to the network router 211, which forwards this data to cloud computing resources using a number of wireless or wired communications standards or protocols, as described herein.

[0074] The modular communications hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. Because the modular communications hub 203 is generally easy to install, configure, and maintain, the modular communications hub 203 may be a good choice for networking the surgical field devices 1a-1n / 2a-2m.

[0075] FIG. 5 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to multiple surgical field devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located within the surgical field. As shown in FIG. 6, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210.

[0076] As shown in the embodiment of FIG. 5 , modular control tower 236 may be coupled to an imaging module 238 that may be coupled to an endoscope 239, a generator module 240 that may be coupled to an energy device 241, a smoke evacuation module 226, a suction / irrigation module 228, a communications module 230, a processor module 232, a storage array 234, a smart device / instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. Surgical field devices may be coupled to cloud computing resources and data storage via modular control tower 236. Robotic hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices / instruments 235, visualization system 208, among others, may be coupled to modular control tower 236 via wired or wireless communication standards or protocols, as described herein. Modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from the imaging module, device / instrument display, and / or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with the images and overlaid images.

[0077] FIG. 6 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 may comprise a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for local processing, visualization, and imaging. As shown in FIG. 6, the modular communications hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communications hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 6, each of the network hubs / switches in the modular communications hub 203 may include three downstream ports and one upstream port. The upstream network hub / switch may be connected to a processor to provide communications connectivity to cloud computing resources and a local display 217. Communications to the cloud 204 may occur via either a wired or wireless communications channel.

[0078] The surgical hub 206 can use a non-contact sensor module 242 to measure the dimensions of the surgical field and generate a map of the surgical field using either an ultrasonic non-contact measurement device or a laser-based non-contact measurement device. The ultrasonic-based non-contact sensor module can scan the surgical field by transmitting bursts of ultrasound and receiving echoes as they bounce off the perimeter walls of the surgical field, as described under the heading "Spatial Awareness of a Surgical Hub Within an Operating Room" in U.S. Patent Application Publication No. 2019-0200844(A1) entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, and incorporated herein by reference in its entirety, and the sensor module is configured to determine the size of the surgical field and adjust Bluetooth pairing distance limits. The laser-based non-contact sensor module can, for example, scan the surgical field by transmitting laser light pulses, receive laser light pulses that reflect off the exterior walls of the surgical field, and compare the phase of the transmitted pulses with the received pulses to determine the size of the surgical field and, for example, adjust Bluetooth pairing distance limits.

[0079] Computer system 210 may include a processor 244 and a network interface 245. Processor 244 may be coupled to a communications module 247, storage 248, memory 249, non-volatile memory 250, and input / output interface 251 via a system bus. The system bus may be any of several types of bus structures, including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus using any of a variety of available bus architectures, including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), MicroChannel Architecture (MSA), Enhanced ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus.

[0080] Processor 244 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. This processor core includes 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product datasheet.

[0081] In one embodiment, the processor 244 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

[0082] System memory may include both volatile and nonvolatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. RAM is available in many forms, including static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync link DRAM (SLDRAM), and direct RAM (DRRAM).

[0083] The 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 magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage may include any of the above storage entities, either independently or in combination with other storage media. Other storage media include, but are not limited to, optical disk drives, such as compact disc read-only memory drives (CD-ROMs), compact disc recordable drives (CD-R drives), compact disc rewritable drives (CD-RW drives), or digital versatile disc read-only memory drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of the disk storage to the system bus.

[0084] It should be understood that computer system 210 may include software that acts as an intermediary between users and the basic computer resources described in a suitable operating environment. Such software may include an operating system. The operating system, which may be stored on disk storage, may function to control and allocate resources of the computer system. System applications may take advantage of resource management by the operating system through program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein may be implemented with various operating systems or combinations of operating systems.

[0085] A user can input commands or information into computer system 210 through input device(s) coupled to I / O interface 251. Input devices may include, but are not limited to, pointing devices such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, gamepad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, webcam, etc. These and other input devices connect to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial ports, parallel ports, game ports, and USB. Output device(s) use some of the same types of ports as the input device(s). Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. An output adapter may be provided to illustrate that some output devices may exist, such as monitors, displays, speakers, and printers, among other output devices that may require special adapters. Output adapters may include, by way of example and not limitation, video and sound cards that provide a means of connection between an output device and a system bus. It should be noted that other devices and / or systems of devices, such as remote computer(s), may provide both input and output capabilities.

[0086] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) can be personal computers, servers, routers, network PCs, workstations, microprocessor-based devices, peer devices, or other common network nodes, but typically include many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown along with the remote computer(s). The remote computer(s) can be logically connected to the computer system through a network interface, which can then be physically connected through a communications connection. The network interface can encompass communications 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, and the like. WAN technologies may include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and its variations, packet-switched networks, and Digital Subscriber Lines (DSL).

[0087] In various embodiments, the computer system 210 of FIG. 6 , the imaging module 238 of FIG. 5 and FIG. 6 , and / or the visualization system 208, and / or the processor module 232 may include an image processor, an image processing engine, a media processor, or any specialized digital signal processor (DSP) used to process digital images. The image processor may employ parallel computing using single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

[0088] The communications connection(s) may refer to the hardware / software used to connect the network interface to the bus. While the communications connections are shown internal to the computer system for clarity of illustration, the communications connections may also be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as regular telephone-grade modems, modems including cable modems and DSL modems, ISDN adapters, and Ethernet cards.

[0089] FIG. 7 shows a logic diagram of a surgical instrument or tool control system 470 according to one or more embodiments of the present disclosure. The system 470 may include control circuitry. The control circuitry may include a microcontroller 461 with a processor 462 and memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482, driven by a motor driver 492, operably couples a longitudinally movable displacement member to drive the I-beam knife element. A tracking system 480 may be configured to determine the position of the longitudinally movable displacement member. The position information may be provided to the processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member, as well as the positions of the firing member, firing bar, and I-beam knife element. Additional motors may be provided to the tool driver interface to control I-beam firing, closure tube movement, shaft rotation, and articulation. A display 473 displays various operating conditions of the instrument and may include touchscreen functionality for data entry. Information displayed on the display 473 can be overlaid with images acquired via the endoscopic imaging module.

[0090] In one embodiment, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, main microcontroller 461 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and / or one or more 12-bit ADCs with 12 analog input channels, details of which are available in the product datasheet.

[0091] In one embodiment, the microcontroller 461 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

[0092] The microcontroller 461 may be programmed to perform various functions, such as precise control over the speed and position of the knife and articulation system. In one embodiment, the microcontroller 461 may include a processor 462 and memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical linkage to the articulation or knife system. In one embodiment, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be easily substituted for use in the tracking system 480 with an absolute positioning system. A detailed description of absolute positioning systems is provided in U.S. Patent Application Publication No. 2017 / 0296213, published October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety.

[0093] The microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement members and articulation system. The microcontroller 461 may be configured to calculate a response within the microcontroller's 461 software. The calculated response may be compared to the measured response of the actual system to obtain an "observed" response, which is used to determine the actual feedback. The observed response may be a suitably adjusted value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.

[0094] In some examples, the motor 482 may be controlled by a motor driver 492 and may be used by a surgical instrument or tool firing system. In various configurations, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In some examples, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including field effect transistors (FETs). The motor 482 may be powered by a power supply assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery, which may include multiple battery cells connected in series, that may be used as a power source to power the surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and / or rechargeable. In at least one example, the battery cells may be a lithium-ion battery, which may be connectable to and separable from the power supply assembly.

[0095] The motor driver 492 may be the A3941 available from Allegro Microsystems, Inc. The A3941 492 may be a full-bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs), specifically designed for inductive loads such as brushed DC motors. The driver 492 may include an intrinsic charge pump regulator, which provides full (>10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive down to 5.5V. A bootstrap capacitor may be used to provide the required battery supply voltage above the N-channel MOSFET. An internal charge pump for the high-side drive allows DC (100% duty cycle) operation. The full-bridge may be driven in fast or slow decay mode using diode or synchronous rectification. In slow decay mode, current recirculation is possible through either the high-side or low-side FET. The power FETs may be protected from shoot-through by a resistor-adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system.

[0096] The tracking system 480 may include a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for an absolute positioning system can provide a unique position signal corresponding to the position of the displacement member. In some examples, the displacement member may represent a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In some examples, the displacement member may represent a firing member that may be adapted and configured to include a rack of drive teeth. In some examples, the displacement member may represent a firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Thus, as used herein, the term displacement member may be used generally to refer to any movable member of a surgical instrument or tool, such as a drive member, firing member, firing bar, I-beam, or any element that can be displaced. In one aspect, a longitudinally movable drive member may be coupled to a firing member, firing bar, and I-beam. Thus, the absolute positioning system can actually track the linear displacement of an I-beam by tracking the linear displacement of the longitudinally movable drive member. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member, firing member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact displacement sensor or a non-contact displacement sensor. The linear displacement sensor may include a linear variable differential transformer (LVDT), a differential variable reluctance transducer (DVRT), a slide potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical 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.

[0097] The electric motor 482 may include a rotatable shaft operably interfaced with a gear assembly mounted in meshing engagement with a set of drive teeth or rack on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to several linear longitudinal translations of the displacement member. The gearing and sensor arrangement may be connected to a linear actuator by a rack and pinion arrangement or to a rotary actuator by a spur gear or other connection. A power source provides 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 with a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reducer assembly. The displacement member may represent a longitudinally movable firing member, a firing bar, an I-beam, or a combination thereof.

[0098] One revolution of the sensor element associated with position sensor 472 may correspond to a longitudinal linear displacement d1 of the displacement member, where d1 is the longitudinal linear distance traveled by the displacement member from point "a" to point "b" after one revolution of the sensor element coupled to the displacement member. The sensor array may be coupled via a gear reduction that results in the position sensor 472 completing one or more revolutions for a full stroke of the displacement member. The position sensor 472 may complete multiple revolutions for a full stroke of the displacement member.

[0099] A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for two or more revolutions of position sensor 472. The states of the switches are fed back to microcontroller 461, which can apply logic to determine a unique position signal corresponding to longitudinal linear displacement d1+d2+...dn of the displacement member. The output of position sensor 472 is provided to microcontroller 461. Sensor array position sensor 472 may comprise a magnetic sensor, an analog rotation sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.

[0100] Position sensor 472 may comprise any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or a vector component of the magnetic field. The technologies used to produce both types of magnetic sensors may involve many aspects of physics and electronics. Technologies used to sense magnetic fields may include, among others, search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetodiodes, magnetotransistors, optical fiber, magneto-optical, and microelectromechanical systems-based magnetic sensors.

[0101] In one aspect, the position sensor 472 of the tracking system 480 with an absolute positioning system may comprise a magnetic rotary absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide the absolute positioning system. The position sensor 472 may be a low-voltage, low-power component and includes four Hall-effect elements in an area of ​​the position sensor 472 that may be located above the magnet. A high-resolution ADC and a smart power management controller may also be provided on-chip. A Coordinate Rotation Digital Computer (CORDIC) processor, also known as the Digit-by-Digit Method and the Boulder algorithm, may be provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. The angular position, alarm bits, and magnetic field information may be transmitted to the microcontroller 461 via a standard serial communications interface, such as a serial peripheral interface (SPI) interface. The position sensor 472 can provide 12-bit or 14-bit resolution and can be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

[0102] A tracking system 480 with an absolute positioning system may include and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply converts a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some embodiments, the other sensor(s) may include sensor arrangements such as those described in U.S. Pat. No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system may take into account properties such as mass, inertia, viscous friction, and induced drag in order to predict what the state and output of the physical system will be given knowledge of the input.

[0103] The absolute positioning system can provide the absolute position of the displacement member upon power-up of the instrument without retracting or advancing the displacement member to a reset (zero or home) position, as may be required with conventional rotary encoders that simply count the number of forward or backward steps taken by the motor 482 to estimate the position of the device actuator, drive bar, knife, etc.

[0104] A sensor 474, such as a strain gauge or micro-strain gauge, can be configured to measure one or more parameters of the end effector, such as the amplitude of strain exerted on the anvil during clamping, which can be indicative of the closure force applied to the anvil. The measured strain can be converted to a digital signal and provided to the processor 462. Instead of or in addition to the sensor 474, a sensor 476, such as a load sensor, can measure the closure force applied to the anvil by the closure drive system. For example, the sensor 476, such as a load sensor, can measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sled that cams the staple driver upward, forcing the staples into deforming contact with the anvil. The I-beam can also include a sharp cutting edge that can be used to cut tissue as the I-beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure the current drawn by the motor 482. The force required to advance the firing member may correspond, for example, to the current drawn by motor 482. The measured force may be converted to a digital signal and provided to processor 462.

[0105] In one form, a strain gauge sensor 474 can be used to measure the force applied to tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force applied by the end effector to the tissue being treated. A system for measuring the force applied to tissue grasped by the end effector can include a strain gauge sensor 474, such as a micro-strain gauge, configured to measure one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the jaw members of the end effector during clamping, which can be indicative of tissue compression. The measured strain can be converted to a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to operate the knife element, for example, to cut tissue captured between the anvil and the staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. The magnetic field sensor measurements can also be converted to a digital signal and provided to the processor 462.

[0106] Measurements of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, measured by sensors 474, 476, respectively, can be used by microcontroller 461 to characterize a selected position of the firing member and / or a corresponding value of firing member velocity. In one example, memory 468 can store techniques, equations, and / or look-up tables that can be used by microcontroller 461 during evaluation.

[0107] The surgical instrument or tool control system 470 may also include wired or wireless communication circuitry for communicating with the modular communications hub 203 as shown in FIGS.

[0108] 8 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions. In certain examples, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain examples, the motors of the robotic surgical instrument 600 can be individually activated to produce firing, closing, and / or articulation motions in the end effector. The firing, closing, and / or articulation motions can be transmitted to the end effector via, for example, a shaft assembly.

[0109] In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transfer the firing motion generated by the motor 602 to the end effector, particularly to displace an I-beam element. In certain examples, the firing motion generated by the motor 602 may, for example, deploy staples from a staple cartridge into tissue captured by the end effector and / or advance a cutting blade of the I-beam element to cut the captured tissue. The I-beam element may be retracted by reversing the direction of the motor 602.

[0110] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605, which may be configured to transmit the closure motion generated by the motor 603 to the end effector, specifically to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closure motion may transition the end effector from an open configuration to an approximation configuration, for example, to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.

[0111] In certain examples, a surgical instrument or tool may include, for example, one or more articulation motors 606 a, 606 b. The motors 606 a, 606 b may be operatively coupled to corresponding articulation motor drive assemblies 608 a, 608 b, which may be configured to transfer articulation motion generated by the motors 606 a, 606 b to an end effector. In certain examples, the articulation motion may, for example, cause the end effector to articulate relative to the shaft.

[0112] As described herein, a surgical instrument or tool may include multiple motors that can be configured to perform various independent functions. In certain examples, multiple motors of a surgical instrument or tool can be activated individually or separately to perform one or more functions while other motors remain stopped. For example, articulation motors 606 a, 606 b can be activated to articulate the end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 can be activated to fire multiple staples and / or advance a cutting blade while articulation motor 606 remains stopped. Additionally, closure motor 603 can be activated simultaneously with firing motor 602 to distally advance a closure tube and an I-beam element, as described in more detail herein below.

[0113] In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, the common control module 610 can accommodate one of the multiple motors at a time. For example, the common control module 610 may be individually connectable and detachable to multiple motors of a robotic surgical instrument. In certain examples, multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, the multiple motors of a surgical instrument or tool can be individually and selectively engaged with the common control module 610. In certain examples, the common control module 610 can selectively switch from interfacing with one of the multiple motors of the surgical instrument or tool to interfacing with another of the multiple motors of the surgical instrument or tool.

[0114] In at least one example, common control module 610 can be selectively switched between operative engagement with articulation motors 606 a, 606 b and operative engagement with either firing motor 602 or closure motor 603. In at least one embodiment, as shown in FIGURE 8, switch 614 can be moved or transitioned between multiple positions and / or states. For example, in a first position 616, switch 614 can electrically couple common control module 610 to firing motor 602, in a second position 617, switch 614 can electrically couple common control module 610 to closure motor 603, in a third position 618 a, switch 614 can electrically couple common control module 610 to first articulation motor 606 a, and in a fourth position 618 b, switch 614 can electrically couple common control module 610 to second articulation motor 606 b. In certain examples, a separate common control module 610 may be electrically coupled to the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b at the same time. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.

[0115] Each of the motors 602, 603, 606a, 606b may be equipped with a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor outside the jaws or by a torque sensor on the motor that actuates the jaws.

[0116] 8, common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. Motor driver 626 may modulate power transferred from a power supply 628 to a motor coupled to common control module 610 based on input from, for example, a microcontroller 620 ("controller"). In certain examples, the microcontroller 620 may be used to determine, for example, the current drawn by a motor while the motor is coupled to common control module 610, as described herein.

[0117] In particular examples, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In particular examples, memory 624 may store various program instructions that, when executed, cause processor 622 to perform multiple functions and / or calculations described herein. In particular examples, one or more of memory units 624 may be coupled to processor 622, for example.

[0118] In certain examples, the power supply 628 may be used to, for example, power the microcontroller 620. In certain examples, the power supply 628 may include a battery (or "battery pack" or "power pack"), such as, for example, a lithium-ion battery. In certain examples, the battery pack may be configured to releasably attach to the handle to power the surgical instrument 600. Multiple battery cells connected in series may be used as the power supply 628. In certain examples, the power supply 628 may be, for example, replaceable and / or rechargeable.

[0119] In various examples, the processor 622 can control the motor drivers 626 to control the position, direction of rotation, and / or speed of the motors coupled to the common control module 610. In certain examples, the processor 622 can signal the motor drivers 626 to stop and / or disable the motors coupled to the common control module 610. The term "processor," as used herein, should be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a computer's central processing unit (CPU) on one integrated circuit or up to a few integrated circuits. A processor may be a general-purpose programmable device that accepts digital data as input, processes that data according to instructions stored in memory, and provides a result as output. Because it may have internal memory, it may be an example of sequential digital logic. A processor can operate on numbers and symbols represented in the binary system.

[0120] Processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In a particular example, microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes, among other features readily available in the product datasheet, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with module 4410. Accordingly, the present disclosure should not be limited in this context.

[0121] The memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are connectable to the common control module 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b. Such program instructions may cause the processor 622 to control the firing, closing, and articulation functions according to inputs from an algorithm or control program of the surgical instrument or tool.

[0122] For example, one or more mechanisms and / or sensors, such as sensor 630, can be used to alert processor 622 to program instructions to use in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In certain examples, sensor 630 can include a position sensor that can be used to sense the position of switch 614, for example. Thus, processor 622 can use program instructions associated with firing an I-beam of the end effector when it detects, for example, via sensor 630, that switch 614 is in first position 616; processor 622 can use program instructions associated with closing an anvil when it detects, for example, that switch 614 is in second position 617 via sensor 630; and processor 622 can use program instructions associated with articulating the end effector when it detects, for example, via sensor 630, that switch 614 is in third position 618a or fourth position 618b.

[0123] 9 shows a diagram of a context-aware surgical system 5100 in accordance with at least one aspect of the present disclosure. In some examples, the data sources 5126 may include, for example, the modular device 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular device itself), a database 5122 (e.g., an EMR database containing patient records), and patient monitoring devices 5124 (e.g., a blood pressure (BP) monitor and an electrocardiogram (EKG) monitor). The surgical hub 5104 may be configured to derive contextual information about the surgical procedure from the data based, for example, on the particular combination(s) of data received or the particular order in which data is received from the data sources 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the particular step of the surgical procedure the surgeon is performing, the type of tissue being operated on, or the body cavity being treated. This ability of some aspects of the surgical hub 5104 to derive or infer information about the surgical procedure from the received data may be referred to as “situational awareness.” In one example, the surgical hub 5104 may incorporate a situational awareness system, which is hardware and / or programming associated with the surgical hub 5104 that derives contextual information related to a surgical procedure from received data.

[0124] The situational awareness system of the surgical hub 5104 can be configured to derive contextual information from data received from the data sources 5126 in a variety of different ways. In one example, the situational awareness system may include a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data to correlate various inputs (e.g., data from the database 5122, the patient monitor 5124, and / or the modular device 5102) with corresponding contextual information about the surgical procedure. In other words, the machine learning system can be trained to accurately derive contextual information about the surgical procedure from provided inputs. In an example, the situational awareness system may include a lookup table that stores pre-characterized contextual information about the surgical procedure in association with one or more inputs (or ranges of inputs) corresponding to the contextual information. In response to a query with one or more inputs, the lookup table can return corresponding contextual information for the situational awareness system to control the modular device 5102. In examples, the contextual information received by the surgical hub 5104 situational awareness system may be associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In examples, 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 provided with the contextual information as input.

[0125] A surgical hub 5104 incorporating a situational awareness system can provide many benefits to the surgical system 5100. One benefit can include improved interpretation of sensed and collected data, which in turn improves processing accuracy and / or use of the data during the course of a surgical procedure. Returning to the previous example, the situational aware surgical hub 5104 can determine what type of tissue is being operated on, and thus, if an unexpectedly high force to close the end effector of a surgical instrument is detected, the situational aware surgical hub 5104 can properly accelerate or decelerate the motor of the surgical instrument to match the tissue type.

[0126] The type of tissue being operated on can affect the adjustments made to the compression speed and load threshold of the surgical stapling and severing instrument for a particular tissue gap measurement. The context-aware surgical hub 5104 can infer whether the surgical procedure being performed is thoracic or abdominal surgery, which allows the surgical hub 5104 to determine whether the tissue being clamped by the end effector of the surgical stapling and severing instrument is pulmonary (in the case of thoracic surgery) or stomach (in the case of abdominal surgery). The surgical hub 5104 can then adjust the compression speed and load threshold of the surgical stapling and severing instrument appropriately for the tissue type.

[0127] The type of body cavity being operated on during an insufflation procedure can affect the function of the smoke evacuator. The context-aware surgical hub 5104 can determine if the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the procedure type. Since certain procedure types are generally performed within specific body cavities, the surgical hub 5104 can control the smoke evacuator motor speed appropriately to match the body cavity being operated on. Thus, the context-aware surgical hub 5104 can provide a consistent amount of smoke evacuation for both thoracic and abdominal procedures.

[0128] The type of procedure being performed can affect the optimal energy level at which an ultrasonic surgical instrument or a radio frequency (RF) electrosurgical instrument operates. For example, an arthroscopic procedure may require a higher energy level because the end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is immersed in fluid. The context-aware surgical hub 5104 can determine whether the surgical procedure is an arthroscopic procedure. The surgical hub 5104 can then adjust the RF power level or ultrasonic amplitude (i.e., "energy level") of the generator to compensate for the fluid-filled environment. Relatedly, the type of tissue being operated on can affect the optimal energy level at which an ultrasonic surgical instrument or an RF electrosurgical instrument operates. The context-aware surgical hub 5104 can determine which type of surgical procedure is being performed and then customize the energy level of the ultrasonic surgical instrument or the RF electrosurgical instrument, respectively, according to the tissue geometry expected for the surgery. Furthermore, the context-aware surgical hub 5104 can be configured to adjust the energy level of the ultrasonic surgical instrument or the RF electrosurgical instrument over the course of the surgical procedure, rather than simply on a procedure-by-procedure basis. The situation-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will continue to be performed and then update the generator and / or control algorithms of the ultrasonic surgical instrument or RF electrosurgical instrument to set the energy level to a value appropriate for the expected tissue type according to the step of the surgical procedure.

[0129] In examples, the surgical hub 5104 may derive data from additional data sources 5126 to improve conclusions drawn from one data source 5126. The context-aware surgical hub 5104 may augment data received from the modular devices 5102 with contextual information constructed about the surgical procedure from other data sources 5126. For example, the context-aware surgical hub 5104 may be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) according to video or image data received from a medical imaging device. However, in some cases, the video or image data may be inconclusive. Thus, in one example, the surgical hub 5104 may be further configured to compare a physiological measurement (e.g., blood pressure sensed on a BP monitor communicatively connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 (FIG. 2) communicatively coupled to the surgical hub 5104) to make a determination regarding the integrity of a staple line or tissue weld. In other words, the surgical hub's 5104 situational awareness system can take physiological measurement data into account to provide additional context when analyzing the visualization data, which can be useful when the visualization data may not be conclusive or incomplete on its own.

[0130] For example, the situation-aware surgical hub 5104 can proactively activate a generator to which an RF electrosurgical instrument is connected if it is determined that a subsequent step in a procedure requires the use of the instrument. By proactively activating the energy source, the instrument can be ready for use as soon as the preceding step in the procedure is completed.

[0131] The context-aware surgical hub 5104 can determine whether the current or subsequent steps in the surgical procedure require different views or magnifications on the display according to the feature(s) of the surgical site that the surgeon is expected to need to see. The surgical hub 5104 can then proactively change the displayed views (e.g., provided by medical imaging devices for the visualization system 108) so that the display automatically adjusts throughout the surgical procedure.

[0132] The context-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will be performed next, and whether specific data or data comparisons are required for that step of the surgical procedure. The surgical hub 5104 can be configured to automatically call up data screens based on the step of the surgical procedure being performed, without waiting for the surgeon to ask for specific information.

[0133] Errors may be checked during surgical setup or during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 may determine whether the surgical field is properly or optimally set up for the surgical procedure to be performed. The surgical hub 5104 may be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, product location, or setup requirements, and then compare the current surgical field layout to a standard layout for the type of surgical procedure that the surgical hub 5104 has determined is being performed. In some examples, the surgical hub 5104 may be configured to compare the list of items for the procedure and / or the list of devices paired with the surgical hub 5104 with a recommended or expected manifest of items and / or devices for a given surgical procedure. If a discontinuity exists between the lists, the surgical hub 5104 may be configured to provide an alert indicating that a particular modular device 5102, patient monitoring device 5124, and / or other surgical item is missing. In some examples, the surgical hub 5104 can be configured to determine the relative distance or relative position of the modular devices 5102 and the patient monitoring devices 5124, for example, by proximity sensors. The surgical hub 5104 can compare the relative positions of the devices to a recommended or predicted layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide an alert indicating that the current layout of the surgical procedure deviates from the recommended layout.

[0134] The context-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or deviating from the expected sequence of actions during the course of a surgical procedure. For example, the surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) a corresponding list of steps or sequences of equipment use, and then compare the steps being performed or the equipment being used during the surgical procedure with the expected steps or equipment for the type of surgical procedure that the surgical hub 5104 has determined is being performed. In some examples, the surgical hub 5104 can be configured to provide an alert indicating that an unexpected action is being performed or an unexpected device is being utilized at a particular step in the surgical procedure.

[0135] The surgical instruments (and other modular devices 5102) may be tailored to the specific circumstances of each surgical procedure (such as for different tissue types) and verified for operation during the surgical procedure. Subsequent steps, data, and display adjustments may be provided to the surgical instruments (and other modular devices 5102) within the surgical site according to the specific circumstances of the procedure.

[0136] FIG. 10 illustrates an exemplary timeline 5200 of surgical procedures and context information that the surgical hub 5104 can derive from data received from data sources 5126 at each step of the surgical procedure. The following description of the timeline 5200 shown in FIG. 9 also refers to FIG. 9. The timeline 5200 may illustrate the general steps that nurses, surgeons, and other medical personnel would take during the course of a lung segmentectomy surgery, beginning with the setup of the surgical site and concluding with the transport of the patient to the post-operative recovery room. The context-aware surgical hub 5104 can receive data from data sources 5126 throughout the surgical procedure, including data generated each time medical personnel use a modular device 5102 paired with the surgical hub 5104. The surgical hub 5104 can receive this data from the paired modular device 5102 and other data sources 5126 to continuously derive inferences (i.e., context information) about the ongoing procedure as new data is received, such as which step of the procedure is occurring at any given time. The situational awareness system of the surgical hub 5104 may, for example, record data regarding the procedure to generate a report, verify steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be relevant to a particular procedure step, adjust the modular device 5102 based on the context (e.g., activate a monitor, adjust the FOV of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and perform any other such actions described herein.

[0137] As a first step 5202 in this exemplary procedure, hospital personnel may retrieve the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, the surgery hub 5104 determines that the procedure to be performed is thoracic surgery. In a second step 5204, the personnel can scan incoming medical supplies for the procedure. The surgery hub 5104 cross-references the scanned supplies with a list of supplies that may be utilized in various types of procedures and verifies that the combination of supplies matches the thoracic procedure. Furthermore, the surgery hub 5104 may also determine that the procedure is not a wedge resection (either because the incoming supplies do not include specific supplies required for a thoracic wedge resection or are not otherwise compatible with a thoracic wedge resection). In a third step 5206, medical personnel scan the patient band via a scanner 5128 communicatively connected to the surgery hub 5104. The surgery hub 5104 can then verify the patient's identity based on the scanned data. In a fourth step 5208, medical personnel turn on the auxiliary devices. The auxiliary equipment utilized may vary according to the type of surgical procedure and the technology used by the surgeon, but in this exemplary case includes a smoke evacuator, an insufflator, and a medical imaging device. Once activated, the auxiliary device, which is a modular device 5102, may automatically pair with the surgical hub 5104, which may be located within a certain proximity of the modular device 5102, as part of its initialization process. The surgical hub 5104 can then derive contextual information about the surgical procedure by detecting the type of modular device 5102 that is paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 5104 can determine that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices 5102. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the types of modular devices 5102 connecting to the hub, the surgical hub 5104 can roughly deduce the particular procedure the surgical team will be performing.Once the surgical hub 5104 knows what particular procedure is being performed, it can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources 5126 (e.g., modular devices 5102 and patient monitors 5124) to deduce which steps of the surgical procedure the surgical team is performing. In a fifth step 5210, personnel attach EKG electrodes and other patient monitors 5124 to the patient. The EKG electrodes and other patient monitors 5124 can be paired with the surgical hub 5104. Once the surgical hub 5104 begins receiving data from the patient monitors 5124, the surgical hub 5104 can confirm that the patient is at the surgical site, for example, as described in process 5207. In a sixth step 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 devices 5102 and / or the patient monitor 5124, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Upon completion of the sixth step 5212, the pre-operative portion of the lung segmentectomy surgery is complete and the surgical portion begins.

[0138] In a seventh step 5214, the lung of the patient being operated on may be collapsed (while ventilation is switched to the contralateral lung). The surgery hub 5104 may, for example, infer from ventilator data that the patient's lung has been collapsed. The surgery hub 5104 may compare the detection of the patient's collapsed lung with the expected steps of the procedure (which may be accessed or retrieved in advance) and therefore infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung is the first surgical step in this particular procedure. In an eighth step 5216, a medical imaging device 5108 (e.g., a scope) may be inserted and video footage from the medical imaging device may be initiated. The surgery hub 5104 may receive medical imaging device data (i.e., video or image data) through a connection to the medical imaging device. Upon receiving the medical imaging device data, the surgery hub 5104 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 5104 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that a wedge resection has not already been taken into account by the surgical hub 5104 based on the data received in the second step 5204 of the procedure). Data from the medical imaging device 124 (FIG. 2) may be utilized to determine contextual information regarding the type of procedure being performed in various ways: by determining the angle of the medical imaging device pointed relative to the visualization of the patient's anatomy; by monitoring the number or medical imaging devices being utilized (i.e., activated and paired with the surgical hub 5104); and by monitoring the type of visualization device being utilized. For example, one technique for performing a VATS lobectomy may position the camera above the diaphragm in the anterior-inferior corner of the patient's thoracic cavity, while one technique for performing a VATS segmentectomy may position the camera in an intercostal position anterior to the segmental fissure. The situational awareness system may be trained to recognize the position of the medical imaging device according to the visualization of the patient's anatomy, for example, using pattern recognition or machine learning techniques. An exemplary technique for performing a VATS lobectomy can utilize a single medical imaging device.An exemplary technique for performing a VATS segmentectomy utilizes multiple cameras. One exemplary technique for performing a VATS segmentectomy utilizes an infrared light source (which may be communicatively coupled to the surgical hub as part of a visualization system) to visualize the segmental fissure, which is not utilized in a VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can determine the particular type of surgical procedure being performed and / or the technique being used for the particular type of surgical procedure.

[0139] In a ninth step 5218, the surgical team may begin the incision step of the procedure. Because the surgical hub 5104 receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired, it may infer that the surgeon is in the process of incising and ligating the patient's lungs. The surgical hub 5104 may cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the steps of the procedure described above have been completed) corresponds to the incision step. In a tenth step 5220, the surgical team may proceed to the ligation step of the procedure. Because the surgical hub 5104 receives data from the surgical stapling and severing instrument indicating that the instrument is being fired, it may infer that the surgeon is ligating arteries and veins. As with the previous step, the surgical hub 5104 may derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the steps in the retrieved process. In an eleventh step 5222, the segmentectomy portion of the procedure may be performed. Based on data from the surgical stapling and cutting instrument (including data from its cartridge), the surgical hub 5104 can infer that the surgeon is transecting parenchyma. The cartridge data can correspond, for example, to the size or type of staples being fired by the instrument. Because different types of staples are applied to different types of tissue, the cartridge data can indicate the type of tissue being stapled and / or transected. In this case, the type of staples being fired is applied to parenchyma (or other similar tissue type), allowing the surgical hub 5104 to infer that the segmentectomy portion of the procedure is being performed. Subsequently, in a twelfth step 5224, a nodule dissection step is performed. Based on data received from the generator indicating that an RF or ultrasonic instrument is being fired, the surgical hub 5104 can infer that the surgical team is dissecting nodules and performing a leak test. In this particular procedure, the RF or ultrasonic instrument utilized after the parenchyma has been transected corresponds to the nodule dissection step, allowing the surgical hub 5104 to make this inference.It should be noted that surgeons will routinely alternate between surgical stapling / severing instruments and surgical energy (i.e., RF or ultrasonic) instruments depending on the particular step in the procedure, as different instruments are better suited for particular tasks. Thus, the particular sequence in which the stapling / severing instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. Once the twelfth step 5224 is completed, the incision is closed and the post-operative portion of the procedure can begin.

[0140] In a thirteenth step 5226, the patient may be deanesthetized. The surgical hub 5104 may estimate that the patient is emerging from anesthesia, for example, based on ventilator data (i.e., the patient's breathing rate begins to increase). Finally, a fourteenth step 5228 may be for medical personnel to remove the various patient monitors 5124 from the patient. Thus, the surgical hub 5104 may estimate that the patient is being transferred to a recovery room when the hub loses EKG, BP, and other data from the patient monitors 5124. As can be seen from this exemplary procedure description, the surgical hub 5104 can determine or estimate when each step of a given surgical procedure is occurring according to data received from various data sources 5126 communicatively coupled to the surgical hub 5104.

[0141] As shown in the first step 5202 of the timeline 5200 shown in FIG. 10 , in addition to utilizing patient data from the EMR database(s) to estimate the type of surgical procedure to be performed, the patient data can also be utilized by the situation-aware surgical hub 5104 to generate control adjustments for the paired modular devices 5102.

[0142] FIG. 11 is a block diagram of a computer-implemented interactive surgical system according to at least one embodiment of the present disclosure. In one aspect, the computer-implemented interactive surgical system may be configured to monitor and analyze data related to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and surgical sites or medical facilities. The computer-implemented interactive surgical system may include a cloud-based analysis system. While the cloud-based analysis system may be described as a surgical system, it is not necessarily limited to such and may generally be a cloud-based medical system. As shown in FIG. 11 , the cloud-based analysis system may include a plurality of surgical instruments 7012 (which may be the same as or similar to instruments 112), a plurality of surgical hubs 7006 (which may be the same as or similar to hub 106), and a surgical data network 7001 (which may be the same as or similar to network 201) for coupling the surgical hubs 7006 to cloud 7004 (which may be the same as or similar to cloud 204). Each of the plurality of surgical hubs 7006 may be communicatively coupled to one or more surgical instruments 7012. The hub 7006 may also be communicatively coupled to a cloud 7004 of computer-implemented interactive surgical systems via a network 7001. The cloud 7004 may be a remote, centralized source of hardware and software for storing, manipulating, and communicating data generated based on the operation of various surgical systems. As shown in FIG. 11 , access to the cloud 7004 may be achieved via the network 7001, which may be the Internet or other suitable computer network. The surgical hub 7006, which may be coupled to the cloud 7004, may be considered the client side of a cloud computing system (i.e., a cloud-based analysis system). A surgical instrument 7012 may be paired with the surgical hub 7006 for control and performance of the various surgical procedures or operations described herein.

[0143] Additionally, the surgical instrument 7012 may include a transceiver for data transmission to and from a corresponding surgical hub 7006 (which may also include a transceiver). The combination of the surgical instrument 7012 and the corresponding hub 7006 can indicate a specific location, such as a surgical site within a medical facility (e.g., a hospital) for providing a medical procedure. For example, the memory of the surgical hub 7006 can store the location data. As shown in FIG. 11 , the cloud 7004 includes a central server 7013 (which may be the same as or similar to the remote server 7013), a hub application server 7002, a data analysis module 7034, and an input / output ("I / O") interface 7006. The central server 7013 of the cloud 7004 collectively manages the cloud computing system, which includes monitoring requests by the client modules 7006 and managing the processing power of the cloud 7004 to execute those requests. Each of the central servers 7013 may include one or more processors 7008 coupled to a suitable memory device 7010, which may include volatile memory such as random access memory (RAM) and non-volatile memory such as a magnetic storage device. The memory device 7010 may include machine-executable instructions that, when executed, cause the processor 7008 to execute a data analysis module 7034 for cloud-based data analysis, actions, recommendations, and other operations described below. Further, the processor 7008 may execute the data analysis module 7034 independently or in conjunction with a hub application executed independently by the hub 7006. The central server 7013 may also include a database 2212 of aggregated medical data, which may reside in the memory 2210.

[0144] Based on its connection to the various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from the various surgical instruments 7012 and the particular data generated by their corresponding hubs 7006. Such aggregated data may be stored in an aggregated medical database 7012 of the cloud 7004. Specifically, the cloud 7004 can advantageously perform data analysis and operations on the aggregated data to provide insights and / or perform functions that individual hubs 7006 cannot accomplish on their own. To this end, as shown in FIG. 11 , the cloud 7004 and the surgical hubs 7006 are communicatively coupled to send and receive information. An I / O interface 7006 is connected to the multiple surgical hubs 7006 via the network 7001. In this manner, the I / O interface 7006 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data database 7011. Thus, the I / O interface 7006 can facilitate read / write operations of the cloud-based analysis system. Such read / write operations may be performed upon request from the hubs 7006. These requests may be sent to the hub 7006 via the hub application. The I / O interface 7006 may include one or more high-speed data ports, which may include a universal serial bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting the cloud 7004 to the hub 7006. The hub application server 7002 of the cloud 7004 may be configured to host and provide shared functionality to software applications (e.g., hub applications) executed by the surgical hub 7006. For example, the hub application server 7002 may manage requests by the hub application through the hub 7006, control access to the database 7011 of aggregated medical data, and perform load balancing. The data analysis module 7034 is described in more detail with reference to FIG. 12 .

[0145] The particular cloud computing system configurations described in this disclosure may be specifically designed to address various problems that arise in the context of medical surgeries and procedures performed using medical devices, such as surgical instruments 7012, 112. In particular, the surgical instruments 7012 may be digital surgical devices configured to interact with the cloud 7004 to implement techniques for improving surgical outcomes. The various surgical instruments 7012 and / or the surgical hub 7006 may include touch-controlled user interfaces to allow a clinician to control aspects of the interaction between the surgical instruments 7012 and the cloud 7004. Other suitable user interfaces for control, such as an auditory-controlled user interface, may also be used.

[0146] FIG. 12 is a block diagram illustrating the functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. The cloud-based analysis system may include multiple data analysis modules 7034 that can be executed by a processor 7008 of a cloud 7004 to provide data analysis solutions to problems that arise specifically in the medical field. As shown in FIG. 12 , the functionality of the cloud-based data analysis modules 7034 may be supported via a hub application 7014 hosted by a hub application server 7002 that can be accessed on a surgical hub 7006. The cloud processor 7008 and the hub application 7014 may work in conjunction to execute the data analysis modules 7034. An application program interface (API) 7016 may define a set of protocols and routines corresponding to the hub application 7014. Additionally, the API 7016 may manage the storage and retrieval of data from a centralized medical database 7012 for operation of the applications 7014. A cache 7018 may also be coupled to the API 7016 to store data (e.g., temporarily) and for more efficient retrieval of data used by the applications 7014. 12 may include modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, control program updates 7026, patient outcome analysis 7028, recommendations 7030, and data classification and prioritization 7032. Other suitable data analysis modules may also be implemented by the cloud 7004, according to some aspects. In one aspect, the data analysis module may be used to make specific recommendations based on an analysis of trends, outcomes, and other data.

[0147] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata), including identifying notable features or configurations (e.g., trends), managing redundant data sets, and storing data into paired data sets that may be grouped by procedure but not necessarily matched to actual surgical procedure dates and surgeons. In particular, paired data sets generated from the operation of a surgical instrument 7012 may include applying a binary classification, such as a bleeding or non-bleeding event. More generally, the binary classification may be characterized as either a desirable event (e.g., a successful surgery) or an undesirable event (e.g., a misfired or misused surgical instrument 7012). The aggregated self-describing data may correspond to individual data received from various groups or subgroups of the surgical hub 7006. Thus, the data collection and aggregation module 7022 may generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. To this end, the processor 7008 may be operatively coupled to the hub application 7014 and the database of aggregated medical data 7011 for executing the data analysis module 7034. The data collection and aggregation module 7022 may store the aggregated, organized data in the database of aggregated medical data 2212.

[0148] The resource optimization module 7020 can be configured to analyze this aggregated data to determine optimal use of resources for a particular medical facility or group of medical facilities. For example, the resource optimization module 7020 can determine an optimal order point for surgical stapling instruments 7012 for a group of medical facilities based on corresponding predicted demand for surgical stapling instruments 7012. The resource optimization module 7020 can also evaluate resource usage or other operating configurations of various medical facilities to determine whether resource usage can be improved. Similarly, the recommendation module 7030 can be configured to analyze the aggregated organizational data from the data collection and aggregation module 7022 to provide recommendations. For example, the recommendation module 7030 can recommend to a medical facility (e.g., a healthcare provider such as a hospital) that a particular surgical instrument 7012 should be upgraded to an improved version based, for example, on a higher than expected error rate. Additionally, the recommendation module 7030 and / or resource optimization module 7020 can recommend better supply chain parameters, such as product reorder points, and provide suggestions for different surgical instruments 7012, their use, or procedure steps to improve surgical outcomes. The medical facility can receive such recommendations via the corresponding surgical hub 7006. More specific recommendations regarding various surgical instrument 7012 parameters or configurations can also be provided. The hub 7006 and / or surgical instruments 7012 can also each have a display screen that displays the data or recommendations provided by the cloud 7004.

[0149] The patient outcome analysis module 7028 may analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 may also analyze and evaluate other potential operating parameters. In this regard, the recommendation module 7030 may use these other potential operating parameters to make recommendations based on resulting in better surgical outcomes, such as a better seal or less bleeding. For example, the recommendation module 7030 may send recommendations to the surgery 7006 regarding when to use a particular cartridge with a corresponding stapling surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large-scale collected raw data and provide centralized recommendations (advantageously determined based on aggregated data) across multiple medical facilities while controlling for common variables. For example, the cloud-based analysis system may analyze, evaluate, and / or aggregate data based on type of medical procedure, type of patient, number of patients, geographic similarities between medical providers using similar types of instruments, in a manner that no single medical facility could analyze independently on its own. The control program update module 7026 can be configured to implement recommendations for various surgical instruments 7012 when the corresponding control programs are updated. For example, the patient outcome analysis module 7028 can identify correlations linking particular control parameters to successful (or unsuccessful) outcomes. Such correlations can be addressed when updated control programs are sent to the surgical instruments 7012 via the control program update module 7026. Updates to the instruments 7012, which can be sent via the corresponding hub 7006, may incorporate aggregated performance data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and recommendation module 7030 can identify improved ways to use the instruments 7012 based on the aggregated performance data.

[0150] The cloud-based analysis system may include security features implemented by the cloud 7004. These security features may be managed by the authorization and security module 7024. Each surgical hub 7006 may have associated unique credentials, such as a username, password, and other suitable security credentials. These credentials may be stored in memory 7010 and associated with an authorized cloud access level. For example, based on providing accurate credentials, a surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., send or receive certain defined types of information). To this end, the cloud's 7004 aggregated medical data database 7011 may include a database of certified credentials to verify the accuracy of the provided credentials. Different credentials may be associated with various levels of permission for interaction with the cloud 7004, such as a predetermined access level for receiving data analyses generated by the cloud 7004. Additionally, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices, which may include a "blacklist" of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist may not be permitted to interact with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the corresponding hub 7006. Additionally or alternatively, the cloud 7004 may flag instruments 7012 based on incompatibility or other specified criteria. In this manner, counterfeit medical devices and the inappropriate reuse of such devices across the cloud-based analysis system may be identified and addressed.

[0151] The surgical instrument 7012 may use a wireless transceiver to transmit a wireless signal that may represent, for example, authorization credentials for access to the corresponding hub 7006 and cloud 7004. A wired transceiver may also be used to transmit the signal. Such authorization credentials may be stored in a memory device of the surgical instrument 7012. The authorization and security module 7024 may determine whether the authorization credentials are accurate or forged. The authorization and security module 7024 may also dynamically generate authorization credentials for enhanced security. The credentials may also be encrypted, such as by using hash-based encryption. Upon transmitting the appropriate authorization, the surgical instrument 7012 may transmit a signal to the corresponding hub 7006 and ultimately the cloud 7004 indicating that the instrument 7012 is ready to acquire and transmit medical data. In response, the cloud 7004 may transition to a state capable of receiving medical data for storage in the aggregated medical data database 7011. This readiness to transmit data may be indicated, for example, by a light indicator on the instrument 7012. The cloud 7004 can also send signals to the surgical instruments 7012 to update their associated control programs. The cloud 7004 can send signals directed to specific classes of surgical instruments 7012 (e.g., electrosurgical instruments) so that software updates to control programs are sent only to the appropriate surgical instruments 7012. Additionally, the cloud 7004 can be used to implement system-wide solutions to address local or global issues based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 are identified as having a common manufacturing defect, the cloud 7004 can change the authorization credentials corresponding to this group to implement an operational lockout for this group.

[0152] The cloud-based analytics system may enable monitoring of multiple healthcare facilities (e.g., healthcare facilities such as hospitals) to determine improved practices and recommend changes accordingly (e.g., via recommendation module 2030). Thus, the processor 7008 of the cloud 7004 may analyze data associated with an individual healthcare facility to identify the facility and aggregate that data with other data associated with other healthcare facilities in the group. Groups may be defined, for example, based on similar operational behavior or geographic location. In this manner, the cloud 7004 may provide broader analysis and recommendations for groups of healthcare facilities. The cloud-based analytics system may also be used for enhanced situational awareness. For example, the processor 7008 may predictively model the effect of recommendations on cost and effectiveness for a particular facility (compared to overall operations and / or various healthcare procedures). The costs and effectiveness associated with that particular facility may also be compared to the corresponding local area of ​​other facilities or any other comparable facilities.

[0153] The data classification and prioritization module 7032 may prioritize and classify data based on criticality (e.g., the severity, surprise, or suspiciousness of the medical event associated with the data). This classification and prioritization may be used in conjunction with other data analysis module 7034 functionality described herein to improve the cloud-based analyses and operations described herein. For example, the data classification and prioritization module 7032 may assign priorities to data analyses performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels may result in specific responses from the cloud 7004 (corresponding to the level of urgency), such as elevation for rapid response, special processing, exclusion from the aggregated medical data database 7011, or other suitable responses. Additionally, if necessary, the cloud 7004 may send a request (e.g., a push message) via the hub application server for additional data from the corresponding surgical instrument 7012. The push message may result in a notification being displayed on the corresponding hub 7006 to request support or additional data. This push message may be needed in situations where the cloud detects a significant irregularity or outlier and is unable to determine the cause of the irregularity. The central server 7013 can be programmed to trigger this push message in certain critical situations, such as when data is determined to differ from expected values ​​by more than a predetermined threshold, or when security is deemed to be involved.

[0154] Further exemplary details regarding the various described functions are provided in the following description, each of which may utilize a cloud architecture, as illustrated in Figures 11 and 12 as one example of a hardware and software implementation.

[0155] 13 shows a block diagram of a computer-implemented adaptive surgical system 9060 configured to adaptively generate control program updates for modular devices 9050, in accordance with at least one embodiment of the present disclosure. In some examples, the surgical system may include a surgical hub 9000, a plurality of modular devices 9050 communicatively coupled to the surgical hub 9000, and an analysis system 9100 communicatively coupled to the surgical hub 9000. While a single surgical hub 9000 is shown, it should be noted that the surgical system 9060 may include any number of surgical hubs 9000, which may be connected to form a network of surgical hubs 9000 communicatively coupled to the analysis system 9010. In some examples, the surgical hub 9000 may include a processor 9010 coupled to a memory 9020 for executing stored instructions and a data relay interface 9030 through which data is transmitted to the analysis system 9100. In some examples, the surgical hub 9000 may further include a user interface 9090 having an input device 9092 (e.g., a capacitive touchscreen or keyboard) for receiving input from a user and an output device 9094 (e.g., a display screen) for providing output to the user. The output may include data from a query entered by the user, suggestions for products or product mixes to use in a given procedure, and / or instructions for actions to be taken before, during, or after a surgical procedure. The surgical hub 9000 may further include an interface 9040 for communicatively coupling a modular device 9050 to the surgical hub 9000. In one aspect, the interface 9040 may include a transceiver communicatively connectable to the modular device 9050 via a wireless communication protocol. The modular device 9050 may include, for example, a surgical stapling and cutting instrument, an electrosurgical instrument, an ultrasonic instrument, an aspirator, a ventilator, and a display screen. In some instances, the surgical hub 9000 can further be communicatively coupled to one or more patient monitoring devices 9052, such as an EKG monitor or a BP monitor.In some instances, the surgical hub 9000 can further be communicatively coupled to one or more databases 9054 or external computer systems, such as an EMR database of the medical facility in which the surgical hub 9000 is located.

[0156] When a 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 associate the received perioperative data with surgical outcome data. The perioperative data can indicate how the modular device 9050 was controlled during the course of a surgical procedure. The procedure outcome data includes data associated with results from a surgical procedure (or step thereof), which can include whether the surgical procedure (or step thereof) had a positive or negative outcome. For example, outcome data can include whether a patient suffered a post-operative complication from a particular procedure or whether there was a leak (such as bleeding or air leak) at a particular staple or incision line. The surgical hub 9000 can obtain surgical outcome data by receiving data from an external source (e.g., from an 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 regarding post-operative complications can be retrieved from the EMR database 9054, and data regarding leaks at staples or incision lines can be directly detected or inferred by the situational awareness system. Surgical outcome data can be inferred by the situational awareness system from data received from a variety of data sources, including the modular device 9050 itself, the patient monitoring device 9052, and the database 9054 to which the surgical hub 9000 is connected.

[0157] The surgical hub 9000 can transmit associated modular device 9050 data and outcome data to the analysis system 9100 for processing on the analysis system 9100. By transmitting both perioperative data indicating how the modular device 9050 is controlled and procedure outcome data, the analysis system 9100 can correlate different manners of controlling the modular device 9050 with surgical outcomes for particular procedure types. In some examples, the analysis system 9100 may include a network of analysis servers 9070 configured to receive data from the surgical hub 9000. Each of the analysis servers 9070 may include a memory and a processor coupled to the memory that executes instructions stored therein to analyze the received data. In some examples, the analysis servers 9070 may be connected in a distributed computing architecture and / or utilize a cloud computing architecture. Based on this paired data, the analysis system 9100 can then learn optimal or preferred operating parameters for various types of modular devices 9050, generate adjustments to the control programs of the modular devices 9050 in the field, and then transmit (or "push") updates to the control programs of the modular devices 9050.

[0158] Further details regarding the computer-implemented interactive surgical system 9060, including the surgical hub 9000 and various modular devices 9050 connectable thereto, are described in connection with Figures 5-6.

[0159] 14 provides a surgical system 6500 according to the present disclosure and may include a surgical instrument 6502 that can communicate with a console 6522 or a portable device 6526 through a local area network 6518 or a cloud network 6520 via a wired or wireless connection. In various aspects, the console 6522 and the portable device 6526 may be any suitable computing devices. The surgical instrument 6502 may include a handle 6504, an adapter 6508, and a loading unit 6514. The adapter 6508 releasably couples to the handle 6504, and the loading unit 6514 releasably couples to the adapter 6508 such that the adapter 6508 transfers force from the drive shaft to the loading unit 6514. The adapter 6508 or the loading unit 6514 may include a force gauge (not explicitly shown) disposed therein to measure force exerted on the loading unit 6514. The loading unit 6514 can include an end effector 6530 including a first jaw 6532 and a second jaw 6534. The loading unit 6514 can be an in-situ loading or multi-fire loading unit (MFLU) that allows a clinician to fire multiple fasteners multiple times without the loading unit 6514 having to be removed from the surgical site to reload the loading unit 6514.

[0160] The first jaw 6532 and the second jaw 6534 can be configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and cut the clamped tissue. The first jaw 6532 can be configured to fire at least one fastener multiple times or can be configured to include a replaceable multi-fire fastener cartridge containing multiple fasteners (e.g., staples, clips, etc.) that can be fired two or more times before being replaced. The second jaw 6534 can include an anvil that deforms or otherwise secures fasteners around tissue as they are ejected from the multi-fire fastener cartridge.

[0161] The handle 6504 can include a motor coupled to the drive shaft to affect rotation of the drive shaft. The handle 6504 can include a control interface for selectively activating the motor. The control interface can include buttons, switches, levers, sliders, a touch screen, and any other suitable input mechanism or user interface that can be engaged by a clinician to activate the motor.

[0162] The control interface of the handle 6504 can communicate with a controller 6528 of the handle 6504 to selectively activate the motors to affect rotation of the drive shaft. The controller 6528 may be disposed within the handle 6504 and configured to receive input from the control interface and adapter data from the adapter 6508 or loading unit data from the loading unit 6514. The controller 6528 may analyze the input from the control interface and the data received from the adapter 6508 and / or the loading unit 6514 to selectively activate the motors. The handle 6504 may also include a display viewable by a clinician while using the handle 6504. The display may be configured to display portions of the adapter or loading unit data before, during, or after firing of the instrument 6502.

[0163] The adapter 6508 may include an adapter identification device 6510 disposed therein, and the loading unit 6514 may include a loading unit identification device 6516 disposed therein. The adapter identification device 6510 may be in communication with a controller 6528, and the loading unit identification device 6516 may be in communication with the controller 6528. It will be appreciated that the loading unit identification device 6516 may be in communication with the adapter identification device 6510, which relays or passes communications from the loading unit identification device 6516 to the controller 6528.

[0164] The adapter 6508 may also include multiple sensors 6512 (one shown) disposed about its periphery to detect various conditions of the adapter 6508 or the environment (e.g., when the adapter 6508 is connected to the loading unit, when the adapter 6508 is connected to the handle, when the drive shaft is rotating, the torque of the drive shaft, the strain on the drive shaft, the temperature within the adapter 6508, the number of times the adapter 6508 has been fired, the peak force of the adapter 6508 during firing, the total amount of force applied to the adapter 6508, the peak retract force of the adapter 6508, the number of times the adapter 6508 has been paused during firing, etc.). The multiple sensors 6512 can provide input to the adapter identification device 6510 in the form of data signals. The data signals of the multiple sensors 6512 may be stored in the adapter identification device 6510 or may be used to update the adapter data stored in the adapter identification device. The data signals of the multiple sensors 6512 may be analog or digital. The plurality of sensors 6512 may include a force gauge for measuring the force exerted on the loading unit 6514 during firing.

[0165] 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 may be a direct electrical interface (i.e., including electrical contacts that engage with each other to transmit energy and signals therebetween). Additionally, or alternatively, the electrical interface may be a contactless electrical interface for wirelessly transmitting (e.g., inductively transmitting) energy and signals therebetween. It is also contemplated that the adapter identification device 6510 and the controller 6528 may wirelessly communicate with each other via a wireless connection that is separate from the electrical interface.

[0166] The handle 6504 may include a transmitter 6506 configured to transmit instrument data from the controller 6528 to other components of the system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522, or the portable device 6526). The transmitter 6506 may also receive data (e.g., cartridge data, loading unit data, or adapter data) from other components of the system 6500. For example, the controller 6528 may transmit instrument data to the console 6528 including the serial number of an attached adapter (e.g., adapter 6508) attached to the handle 6504, the serial number of a loading unit (e.g., loading unit 6514) attached to the adapter, and the serial number of a multi-fire fastener cartridge (e.g., multi-fire fastener cartridge) loaded in the loading unit. The console 6522 may then transmit data (e.g., cartridge data, loading unit data, or adapter data) associated with the attached cartridge, loading unit, and adapter, respectively, back to the controller 6528. The controller 6528 can display a message on the local device display or send a message via transmitter 6506 to the console 6522 or portable device 6526 to display the message on the display 6524 or portable device screen, respectively.

[0167] 15A shows an exemplary flow for determining an operating mode and operating in the determined mode. The computer-implemented interactive surgical system and / or its components and / or subsystems may be configured to be updated. Such updates may include the inclusion of features and benefits that were not available to the user prior to the update. These updates may be established by any method of hardware, firmware, and software update suitable for introducing functionality to the user. For example, replaceable / swappable (e.g., hot-swappable) hardware components, flashable firmware devices, and updatable software systems may be used to update the computer-implemented interactive surgical system and / or its components and / or subsystems.

[0168] An update may be contingent on any suitable criterion or set of criteria. For example, an update may be contingent on one or more hardware capabilities of the system, such as processing power, bandwidth, resolution, etc. For example, an update may be contingent on one or more software aspects, such as the purchase of certain software code. For example, an update may be contingent on a purchased service tier. A service tier may represent a feature and / or set of features that a user is entitled to use in connection with the computer-implemented interactive surgical system. A service tier may be determined by a license code, an e-commerce server authentication interaction, a hardware key, a username / password combination, a biometric authentication interaction, a public / private key exchange interaction, etc.

[0169] At 10704, a system / device parameter may be identified. A system / device parameter may be any element or set of elements upon which an update is conditioned. For example, the computer-implemented interactive surgical system may detect a certain bandwidth of communication between a modular device and a surgical hub. For example, the computer-implemented interactive surgical system may detect an indication to purchase a particular service tier.

[0170] At 10708, an operational mode may be determined based on the identified system / device parameters. This determination may be made by a process that maps system / device parameters to operational modes. The process may be a manual and / or automatic process. The process may be the result of local and / or remote computation. For example, a client / server interaction may be used to determine the operational mode based on the identified system / device parameters. For example, local software and / or locally embedded firmware may be used to determine the operational mode based on the identified system / device parameters. For example, a hardware key, such as a secure microprocessor, may be used to determine the operational mode based on the identified system / device parameters.

[0171] At 10710, operation may proceed according to the determined operating mode. For example, the system or device may proceed to operate in a default operating mode. For example, the system or device may proceed to operate in an alternate operating mode. The operating mode may be dictated by control hardware, firmware, and / or software already present in the system or device. The operating mode may also be dictated by newly installed / updated control hardware, firmware, and / or software.

[0172] 15B shows an example functional block diagram for changing the operational mode. The upgradeable element 10714 may include an initialization component 10716. The initialization component 10716 may include any hardware, firmware, and / or software suitable for determining the operational mode. For example, the initialization component 10716 may be part of a system or device startup procedure. The initialization component 10716 may be involved in interactions to determine the operational mode of the upgradeable element 10714. For example, the initialization component 10716 may interact with, for example, a user 10730, an external resource 10732, and / or a local resource 10718. For example, the initialization component 10716 may receive a license key from the user 10730 to determine the operational mode. The initialization component 10716 may query an external resource 10732, such as a server, using the serial number of the upgradeable device 10714 to determine the operational mode. For example, the initialization component 10716 may query local resources 10718, such as a local query to determine the amount of available bandwidth and / or a local query of a hardware key to determine the operating mode, for example.

[0173] The upgradeable element 10714 may include one or more operational components 10720, 10722, 10726, 10728 and an operational pointer 10724. The initialization component 10716 may direct the operational pointer 10724 to direct the operation of the upgradeable element 10741 to the operational components 10720, 10722, 10726, 10728 corresponding to the determined operational mode. The initialization component 10716 may direct the operational pointer 10724 to direct the operation of the upgradeable element to the default operational component 10720. For example, the default operational component 10720 may be selected on the condition that no other alternative operational mode has been determined. For example, the default operational component 10720 may be selected on the condition of a failure and / or interaction failure of the initialization component. The initialization component 10716 may direct the operational pointer 10724 to direct the operation of the upgradeable element 10714 to the resident operational component 10722. For example, a particular feature may be present in the upgradeable component 10714 but require activation to operate. The initialization component 10716 may direct the operational pointer 10724 to direct operation of the upgradeable component 10714 to install new operational components 10728 and / or newly installed operational components 10726. For example, new software and / or firmware may be downloaded. The new software and / or firmware may include code that enables the functionality represented by the selected operational mode. For example, new hardware components may be installed to enable the selected operational mode.

[0174] The surgical hub may be connected, wired or wirelessly, to various devices and servers within the operating room, within the medical facility, and / or outside the medical facility. For example, as shown in Figure 11, the surgical hub 7006 may be capable of communicating with surgical instruments 7012, as well as a data analysis module 7034, remote server(s) 7013, and / or a hub application server 7002. The surgical hub 7006 can communicate with various devices and servers in different connection modes, which are described in more detail herein with reference to Figures 16A-16C.

[0175] FIG. 17 shows an example flow for a hub operating under a tiered communication mode. At 16104, one or more hub connection control parameters may be identified. At 16108, a hub connection mode may be determined based on the identified hub connection control parameter(s). For example, the surgical hub 7006 shown in FIG. 11 may determine a hub connection mode based on the hub connection control parameters. The hub connection mode may be selected from multiple connection modes that may be pre-configured, dynamically updated, semi-dynamically updated, periodically updated, or preset. The hub connection mode may control, for example, device-to-device connections within a network associated with a hospital and / or communications with external networks associated with different hospitals.

[0176] The hub connection control parameter(s) may include system capabilities such as, but not limited to, hardware capabilities, firmware capabilities, and / or software capabilities. For example, if a surgical instrument lacks the hardware capability to provide display of instruction information, the surgical hub may switch to a connection mode that may disable the provision of instruction information to the surgical instrument.

[0177] The hub connection control parameter(s) can include consumer control parameters such as subscription level. For example, a medical facility may purchase a subscription to hub connection capabilities. Some subscription level(s) may provide the hub access to surgical data collected from external systems, while other subscription levels may limit hub connection to internal devices.

[0178] Hub connection control parameter(s) may include available data bandwidth, power capacity and usage, processor and memory utilization, and / or internal or attached systems.

[0179] The hub connection control parameter(s) may include instructions from the tiered system. The tiered system may scale communications between the surgical hub 7006 and device(s) 7012, between the surgical hub 7006 and external server(s) 7013 / 7002, etc., based on available data bandwidth, power capacity and usage, processor and memory utilization, and / or internal or attached systems. The tiered system may determine the maximum communication capabilities under which the surgical hub may operate. For example, upon detecting that the power capabilities associated with the operating room, surgical hub, and / or medical facility are below a threshold, the tiered system may reduce the surgical hub's connection capabilities. For example, upon detecting that available data bandwidth is below a threshold, memory utilization is above a certain threshold, power usage is above a certain threshold, and / or other system conditions that may warrant reducing the surgical hub's connection capabilities, the tiered system may limit or disable communications between the surgical hub and devices and / or communications between the surgical hub and external server(s). For example, a two-way connection mode (as shown in FIG. 16B) may be reduced to a flow-through connection mode (as shown in FIG. 16A). External communications (as in FIG. 16) may be disabled. In examples, the tiered system may be a module within a surgical hub or may be a system external to the surgical hub.

[0180] At 16110, the surgical hub may communicate with devices in the operating room and servers in the internal and / or external network(s) according to the determined hub connection mode.

[0181] In an exemplary hub connection mode, the surgical hub may receive information from the surgical instrument(s) and may transmit the received information to a remote server (such as a remote processing server and / or a remote database in the cloud).

[0182] In an exemplary connection mode, the surgical hub may receive information from the surgical instrument(s) and may transmit the received information to a remote server (such as a remote processing server and / or a remote database in the cloud). The surgical hub may receive information from the surgical instrument(s), obtain instruction information based on the information received from the surgical instrument(s), and transmit the instruction information to one or more surgical instrument(s).

[0183] In an exemplary connected mode, the surgical hub may receive information from the surgical instrument(s) and may transmit the received information to a remote server (e.g., a remote processing server and / or a remote database in the cloud). The surgical hub may receive information from the surgical instrument(s), obtain command information based on the information received from the surgical instrument(s), and transmit the command information to one or more surgical instrument(s). The surgical hub may record various surgical information and transmit the surgical information to a remote server for archiving and / or analysis. The archived surgical information may be aggregated with information received from other surgical hub(s) and / or with surgical information associated with other medical facilities. The aggregated information may be accessed to generate command information for one or more surgical instrument(s). In one example, the surgical communication hub may aggregate information such as information received from smart surgical devices, information associated with multiple surgeries, surgical information, and corresponding results associated with multiple patients. The aggregated information may be stored in a remote database. In one example, the surgical information may be aggregated at a remote server.

[0184] 16A-16C illustrate exemplary hub connection modes in which a surgical hub, such as surgical hub 7006, may operate. As shown in Figures 16A-16C, the surgical hub 15504 can communicate with various devices 15506, remote server(s) in the cloud 15502, and / or devices, servers, and databases in the external network 15508 in different connection modes.

[0185] For example, the surgical hub may decide to operate in a connected mode in which surgical information can flow through the surgical hub to a remote server. As shown in FIG. 16A, the surgical hub 15504 may act as a communications portal between local devices / systems (e.g., surgical instruments and other equipment in the operating room) 15506 and other connected systems 15502, including systems local or remote to the surgical hub. In this flow-through connection mode, the surgical hub 15504 may act as a communications bus between different devices and systems, allowing them to communicate through the surgical hub.

[0186] The surgical hub 15504 may receive surgical information data from one or more smart surgical devices 15506 in the operating room, for example, as described herein with reference to Figure 13. As shown in Figure 13, the surgical hub 9000 may receive surgical data associated with a surgical procedure being performed in the surgical operating room from modular surgical device(s) 9050.

[0187] During a surgical procedure, the surgical device 9050 can track and record surgical data and variables (e.g., surgical parameters) that may include firing force (FTF), closure force (FTC), firing progression, tissue gap, power level, impedance, tissue compressive stability (creep), etc.

[0188] The surgical device 9050 may include an end effector including a staple cartridge. The captured surgical data may include snapshots taken through an endoscope of the surgical hub during the stapling portion of the surgical procedure. The surgical device 9050 may include a temperature sensor. The captured surgical data may include at least one temperature detected by the temperature sensor during the tissue sealing portion of the surgical procedure.

[0189] For example, when operating under a flow-through connection mode, the surgical hub 15504 may disable interpretation, control, or action on received information. The surgical hub 15504 may determine whether to disable obtaining instruction information based on the connection mode. Based on a determination that the current connection mode is flow-through mode, the surgical hub 15504 may disable obtaining instruction information.

[0190] In an exemplary hub-connected mode, the surgical hub can generate instruction information based on received surgical data.

[0191] FIG. 18A shows an example flow for operating under a variable hub communication mode. As shown in FIG. 18A, at 16182, a hub connection mode may be determined based on the identified hub connection control parameter(s), as described herein. At 16184, it may be determined whether the hub connection mode indicates that the hub may provide instruction information to the surgical device. For example, a surgical hub 5104, as described with respect to FIG. 9, may determine whether to provide instruction information to at least one smart surgical device 5102 based on the hub connection mode. If the hub connection mode does not support provisioning of instruction information to the surgical device, at 16188, provisioning of instruction information to the surgical device may be disabled. If the hub connection mode supports provisioning of instruction information to the surgical device, the surgical hub may determine to obtain and provide instruction information to the surgical device at 16186.

[0192] The surgical hub may obtain instruction information for the surgical devices based at least in part on the surgical data received from one or more surgical devices. For example, based on determining that the current hub connection mode is a bidirectional mode, the surgical hub may receive surgical data from the surgical devices and obtain a response to the surgical devices based on the received surgical data. Based on determining that the current hub connection mode is a bidirectional mode, the surgical hub may receive surgical data from a first device and obtain instructions for a second device based on the surgical data received from the first device. The instructions for the second device may include the surgical data received from the first device and / or other information.

[0193] 16B illustrates an exemplary bidirectional mode. As shown, the surgical hub 15506 may receive surgical data from the surgical device(s) 15506 and may transmit data, such as instruction information, to the device(s) 15506. The surgical hub 15506 may aggregate the surgical data received from the surgical device(s) 15506 before transmitting it to a remote server(s) in the cloud 15502.

[0194] In one example, the surgical data received by the surgical hub and transmitted to the remote server(s) may include characteristics of suspended particles in the fluid within the patient's abdominal cavity, such as particle type, particle size, particle concentration, particle velocity, and / or particle direction. The command information obtained by the surgical hub based on the received surgical data may include, but is not limited to, adjustments to a surgical function, such as proportionally increasing the surgical function based on the characteristics of suspended particles in the fluid, adding auxiliary surgical functions to the surgical function, adjusting the power level provided to an energy device, adjusting the speed of a smoke evacuator pump, adjusting the flow path through a smoke evacuator filtration system, adjusting a surgical room vent to increase ventilation through the surgical room vent, adjusting the degree of actuator activation, and / or replacing a surgical function with an alternative surgical function.

[0195] In examples, the instruction information that the surgical hub obtains based on the received surgical data may include, but is not limited to, prioritization information (e.g., display prioritization information), cartridge use or selection recommendations, warning messages, and / or surgical device use instructions.

[0196] For example, if the current hub connection mode is a bidirectional mode, the surgical hub may determine to obtain and provide command information. An exemplary bidirectional connection mode may enable situational awareness and control of the surgical device(s). The surgical hub may infer the progress of the surgical procedure from the surgical data and may obtain command information based on the inferred progress of the surgical procedure. The surgical hub may evaluate surgical activities performed by the end effector of the modular surgical device at the surgical site from data extracted from at least one image frame.

[0197] For example, as shown in FIG. 9 , the surgical hub 5104 can receive perioperative data from devices 5102 and other data sources (e.g., database 5122 and patient monitoring devices 5124) communicatively coupled to the surgical hub 5706. The surgical hub 5104 can determine whether an event has occurred based on the received data. An event can include, for example, a surgical procedure, a step or portion of a surgical procedure, or a downtime between surgeries or steps of a surgical procedure. The surgical hub 5104 can track data associated with a particular event, such as the duration of the event, surgical instruments and / or other medical products utilized during the course of the event, and medical personnel associated with the event. The surgical hub 5104 can determine the event data, for example, via a situational awareness process as described herein.

[0198] The surgical hub 5104 can provide instruction information to the devices 5102, such as, but not limited to, control adjustment information, prioritization information, alerts, display instructions, etc. For example, the surgical hub 5104 may receive surgical data, which may include perioperative data detected by one or more smart surgical devices 5102 during a surgical procedure. The surgical hub 5104 can determine contextual information regarding the surgical procedure according to the perioperative data. The surgical hub can obtain control adjustments for the one or more surgical devices 5102 based on the contextual information. The perioperative data includes one or more parameters associated with the modular devices and / or one or more parameters associated with the patient.

[0199] The instruction data information is provided to the surgical device with an associated priority. The instruction information obtained by the surgical hub based on the received surgical data may include recommendations to clinicians in the operating room. The recommendations may be provided to the surgical device in a priority order that may be determined by the surgical hub. For example, a high priority level may be communicated with at least one of marking, emphasis, highlighting, or blinking. For example, the surgical hub may determine a surgical state based on the received surgical data and may determine a priority level of the recommendation based on the surgical state. For example, the surgical hub 5104 may determine the surgical state based on the received surgical data. The surgical state may include a step in the surgical procedure, an identification of a set of surgical devices currently being used at the surgical site, a position of a portion of the surgical device, a position of the jaws of the end effector of the surgical device, a total surgical step used, and / or a precision surgical step used.

[0200] The surgical hub may select one or more recommendations from a plurality of possible recommendations based on the surgical state. The priority level of the recommendation may be adjusted based on the expected surgical action. The expected surgical action may be determined based on the surgical state and / or based on the position of the surgical device at the surgical site.

[0201] The situational awareness process is described in U.S. patent application Ser. No. 15 / 940,654 (Attorney Docket No. END8501USNP), filed on March 29, 2018, entitled "SURGICAL HUB SITUATION AWARENESS," U.S. patent application Ser. No. 16 / 209,478 (Attorney Docket No. END9015USNP1), filed on December 4, 2018, entitled "METHOD FOR SITUATIONAL AWARENESS FOR SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE CAPABLE OF ADJUSTING FUNCTION BASED ON A SENSED SITUATION OR USAGE," and U.S. patent application Ser. No. 16 / 182,246 (Attorney Docket No. END9016USNP1), filed on November 6, 2018, entitled "ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES,” the disclosures of each of which are incorporated herein by reference in their entireties.

[0202] Surgical procedures are performed by different surgeons at different locations, some with much less experience than others. For a given surgical procedure, there may be many parameters that can be varied to attempt to achieve a desired outcome. For example, for a given surgical procedure utilizing energy supplied by a generator, surgeons often rely solely on experience to determine which mode of energy to utilize, what level of output power to utilize, the duration of energy application, etc., to attempt to achieve a desired outcome. To increase the likelihood of achieving a desired outcome for multiple different surgical procedures, each surgeon may be provided with best-case recommendations that may be generated based on an aggregated surgical dataset associated with multiple surgical procedures performed at multiple locations over time.

[0203] As shown in FIG. 18B , at 16202, a hub connection mode may be determined based on the identified hub connection control parameter(s), as described herein. At 16204, it may be determined whether the determined hub connection mode supports data aggregation with external sources. For example, the hub may determine, based on the hub connection mode, whether to transmit recorded surgical information associated with the procedure to a remote server for archiving and potential aggregation with data associated with external network(s). If the determined hub connection mode supports data aggregation with external sources, at 16206, the surgical hub may transmit the recorded surgical information to the remote server. For example, the surgical hub may enable communication to external system(s) when operating in a particular connection mode. Based on the determination to transmit the recorded surgical information to the remote server, the surgical data may be transmitted to an external hub associated with an external network (e.g., a different medical facility, a different hospital, etc.).

[0204] FIG. 16C illustrates an exemplary hub connection mode that supports data aggregation with external data sets. As shown, the surgical hub 15504 may receive surgical data from the surgical device(s) 15506 and may transmit data, such as instruction information, to the device(s) 15506. The surgical hub 15504 may facilitate recording and storage of surgical data and may exchange surgical data and / or related analytics with external network(s) 15508. Data from various hospital or medical institutions 15508 may be aggregated. The surgical data, results, and patient information may be compiled to determine instruction information, surgical recommendations, aggregate analysis, and the like. As shown, the surgical hub 15504 may retrieve aggregated analysis from remote server(s) or database(s) in the cloud 15502. The aggregated analysis may be used to generate instruction information for transmission to the surgical device(s) 15506.

[0205] 18B, the surgical hub may determine whether to disable communications to external systems based on the hub connection mode. If the determined hub connection mode does not support data aggregation with external sources, then transmitting the recorded surgical information for aggregation with external sources may be disabled at 16208. For example, the surgical hub may disable communications to external system(s) when operating under certain connection modes, such as the flow-through and bidirectional connection modes described herein.

[0206] Recording of surgical data is described in more detail in U.S. Patent Application No. 16 / 209,385, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," filed December 4, 2018 (Attorney Docket No. END8495USNP), the disclosure of which is incorporated herein by reference in its entirety. The recorded surgical data may include surgical event data as described herein. The surgical event data, for example, recorded and / or aggregated surgical event data, may be transmitted to a remote server for aggregation with surgical data from external networks and for further analysis.

[0207] Examples of aggregation (e.g., remote aggregation), requests, and analysis are described in detail in U.S. patent application Ser. No. 15 / 940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA," filed March 29, 2018, attorney docket number END8501USNP2, and incorporated herein by reference in its entirety.

[0208] When operating in a connection mode that allows external communication, the surgical hub may request information from a remote server and / or external system. As shown in FIG. 18C , at 16302, the hub connection mode may be determined based on the identified hub connection control parameter(s) as described herein. At 16304, the hub may determine whether to retrieve aggregated analytics from a remote server based on the hub connection mode. Based on a determination that the current hub connection mode supports remote data aggregation and analytics, the surgical hub may generate an aggregated analytics request at 16308. The request may be generated based on the received surgical data and may be sent to the remote server at 16310. For example, the aggregated analytics request may indicate a request for recommendations regarding generator data associated with a particular step in a surgical procedure. In response, the surgical hub may receive an aggregated analytics response from the remote server at 16312.

[0209] For example, the aggregate analysis response may include recommendations and / or reports. The aggregate analysis response may include one or more of the generator energy mode for the particular surgical procedure, the generator power output for the particular surgical procedure, and / or the duration of the generator power output for the particular surgical procedure. The aggregate analysis response may include instruction information as described herein. At 16314, the surgical hub may generate and send instruction information to one or more surgical device(s) based on the received aggregate analysis response. As shown in FIG. 18C, based on a determination that the current hub connection mode supports remote data aggregation analysis, the surgical hub may disable the data aggregation analysis request at 16306.

[0210] 19 shows a block diagram of a computer-implemented interactive surgical system 5700 according to at least one aspect of the present disclosure. The system 5700 may include several surgical hubs 5706 that can detect and track data related to surgical procedures in which the surgical hubs 5706 (and modular devices paired to the surgical hubs 5706) are associated and utilized, as described herein. The surgical hubs 5706 may be connected to form a local network such that data tracked by the surgical hubs 5706 is aggregated together across the network. A network of surgical hubs 5706 may be associated with, for example, a medical facility. Data aggregated from the network of surgical hubs 5706 may be analyzed to provide reports regarding data trends or recommendations. For example, a surgical hub 5706 at a first medical facility 5704a may be communicatively connected to a first local database 5708a, and a surgical hub 5706 at a second medical facility 5704b may be communicatively connected to a second local database 5708b. The network of surgical hubs 5706 associated with a first medical facility 5704a can be separate from the network of surgical hubs 5706 associated with a second medical facility 5704b, such that aggregated data from each network of surgical hubs 5706 can address each medical facility 5704a, 5704b individually. The surgical hubs 5706 or another computer terminal communicatively connected to the databases 5708a, 5708b can be configured to provide reports or recommendations based on the aggregated data associated with each medical facility 5704a, 5704b. Data tracked by the surgical hubs 5706 can be used to report, for example, whether a particular incidence of surgical procedures has deviated from the average in-network time to complete a particular procedure type.

[0211] The surgical hubs 5706 may upload the tracked data to the cloud 5702, which then processes and aggregates the tracked data across multiple surgical hubs 5706, networks of surgical hubs 5706, and / or medical facilities 5704a, 5704 connected to the cloud 5702. The surgical hubs 5706 may be used to provide reports or recommendations based on the aggregated data. Data tracked by the surgical hubs 5706 may be used to report, for example, whether a particular incidence of a surgical procedure has deviated from the average global time to complete a particular procedure type.

[0212] The surgical hub 5706 can be configured to access the cloud 5702 and compare locally tracked data with global data aggregated from surgical hubs 5706 communicatively connected to the cloud 5702. The surgical hub 5706 can provide reports or recommendations based on a comparison of the tracked local data with local (i.e., in-network) or global norms. Data tracked by the surgical hub 5706 can be used to report, for example, whether a particular incidence of a surgical procedure has deviated from either the average in-network time or the average global time to complete a particular procedure type.

[0213] The surgical hub 5706 or a computer system local to the surgical hub 5706 may locally aggregate data tracked by the surgical hub 5706, store the tracked data, and generate reports and / or recommendations according to the tracked data in response to queries. If the surgical hub 5706 is connected to a medical facility network (which may include additional surgical hubs 5706), the surgical hub 5706 may compare the tracked data with bulk medical facility data. The bulk medical facility data may include EMR data and aggregated data from the surgical hub's 5706's local network. The cloud 5702 (e.g., a remote server in the cloud) may aggregate data tracked by the surgical hub 5706, store the tracked data, and generate reports and / or recommendations according to the tracked data in response to queries.

[0214] The surgical hub 5706 may provide reports on data trends and / or recommendations for improving the efficiency or effectiveness of surgical procedures being performed. Data trends and recommendations may be based on data tracked by the surgical hub 5706 itself, data tracked across a local medical facility network including multiple surgical hubs 5706, and / or data tracked across multiple surgical hubs 5706 communicatively connected to the cloud 5702. Recommendations provided by the surgical hub 5706 may describe, for example, a particular surgical instrument or product combination to utilize for a particular surgical procedure based on a correlation between the surgical instrument / product combination and patient outcomes and surgical efficiency. Reports provided by the surgical hub 5706 may describe, for example, whether a particular surgical procedure was performed efficiently relative to local or global norms, whether a particular type of surgical procedure being performed at the medical facility is performed efficiently relative to global norms, and the average time taken to complete a particular surgical procedure or surgical step for a particular surgical team.

[0215] The Surgical Hub 5706 may determine when surgical site events occur (e.g., via a situational awareness module / system) and then track the amount of time spent on each event. A surgical site event is an event whose occurrence the Surgical Hub 5706 is able to detect or infer. A surgical site event may include, for example, a specific surgical procedure, a step or portion of a surgical procedure, or downtime between surgical procedures. Surgical site events may be categorized according to event type, such as the type of surgical procedure being performed, allowing data from individual procedures to be aggregated to form a searchable dataset. Data tracked by the Surgical Hub 5706 is analyzed to provide metrics related to the surgical procedure or the use of the Surgical Hub 5706.

[0216] The surgical hub 5706 may determine if a surgical procedure is occurring and then track both the amount of time spent between procedures (e.g., downtime) and the time spent in the procedure itself. The surgical hub 5706 may further determine and track the time spent in each individual step performed by medical personnel (e.g., surgeons, nurses, or janitors) either between or during surgical procedures. The surgical hub may determine when a surgical procedure or different steps of a surgical procedure are occurring via a situational awareness module / system, as described herein.

[0217] Near field communication (NFC) cards can be used to automate the supply chain. FIG. 20 shows exemplary surgical supplies packaged with a radio frequency identification (RFID) NFC chip. As shown, the surgical supplies 16510 can include surgical devices, sutures, biosurgical supplies, etc. Medical personnel can scan the chip 16530 on the surgical supplies 16510 before introducing them into a procedure. This can enable the supply chain for customer orders and provide a full case device profile, for example, via the cloud 16520. NFC readers can be used to track inventory, for example, by adding an RFID card 16530 to the device or packaging.

[0218] Disclosed Examples Example 1. A surgical hub including a receiver configured to receive surgical information from at least one smart surgical device; a transmitter configured to transmit surgical data to a remote server; and a processor configured to: determine a hub connection mode based on a hub connection control parameter; determine whether to send instruction information to the at least one smart device based on the hub connection mode; and communicate with the at least one smart device based on the determination.

[0219] Regardless of the particular configuration, the surgical hub can communicate with various devices, remote server(s), and / or devices, servers, and databases in external networks in different connection modes, allowing the hub to communicate with these devices, aggregate information, and then communicate with a remote processing server or database.

[0220] The hub connection mode may be selected from a plurality of connection modes, which may be pre-configured, dynamically updated, semi-dynamically updated, periodically updated, or preset. The hub connection mode may control device-to-device connections within a network associated with a healthcare facility, e.g., a hospital, and / or communications with external networks associated with different hospitals. The hub connection mode may be determined based on hub connection control parameters.

[0221] The hub connection control parameter(s) may include system capabilities such as, but not limited to, hardware capabilities, firmware capabilities, and / or software capabilities. The hub connection control parameter(s) may include consumer control parameters such as subscription level. The hub connection control parameter(s) may include instructions from the tiered system. The tiered system may scale communications between the surgical hub and device(s), between the surgical hub and external server(s), etc. based on available data bandwidth, power capacity and usage, processor and memory utilization, and / or internal or attached systems. The tiered system may determine the maximum communication capabilities under which the surgical hub may operate.

[0222] The surgical hub may operate in a flow-through connection mode, in which surgical information may flow through the surgical hub to a remote server. The surgical hub may operate in a bidirectional mode, in which the surgical hub may receive surgical data from the surgical device(s) and transmit data, such as instruction information, to the device(s). In an exemplary bidirectional mode, the surgical hub may aggregate surgical data received from the surgical device(s) before transmitting to the remote server(s) in the cloud. The bidirectional mode may enable situational awareness and control of the surgical device(s). The surgical hub may operate in a hub-connected mode that supports data aggregation with external datasets. In this hub-connected mode, the surgical hub may facilitate recording and archiving of surgical data and may exchange surgical data and / or related analytics with external network(s). Data from various hospitals or medical institutions may be aggregated. The surgical data, results, and patient information may be compiled to determine instruction information, surgical recommendations, aggregated analysis, etc. The surgical hub may retrieve aggregated analytics from remote server(s) or database(s) in the cloud. The aggregated analytics increase the likelihood of achieving desired outcomes for different surgical procedures. Surgeons may be provided with best practice recommendations, which may be generated based on an aggregated surgical dataset associated with multiple surgical procedures performed at multiple locations over time.

[0223] The surgical hub may determine whether to provide instruction information to at least one surgical instrument communicating with the surgical hub based on the hub connection mode. This allows the surgical hub to selectively operate with respect to providing instruction information to at least one surgical instrument according to the state of the hub connection mode. For example, if the hub connection mode does not support provisioning of instruction information to the surgical instrument, provisioning of instruction information to the surgical instrument may be disabled. This may be when the hub connection control parameter(s) indicate a lack of hardware capability in the surgical instrument to provide instruction information, and the surgical hub may switch to a connection mode that may disable providing instruction information to the surgical instrument. On the other hand, if the hub connection mode supports provisioning of instruction information to the surgical instrument, the surgical hub may decide to obtain and provide instruction information to the surgical instrument.

[0224] Example 2. The surgical hub of Example 1, wherein the transmitter is further configured to transmit data to at least one smart surgical device, and the processor is further configured to, based on a determination to transmit command information, obtain command information based on the received surgical information and transmit the obtained command information to the at least one smart surgical device via the transmitter.

[0225] As an example 2, the hub connection mode may support provisioning instructions to the surgical device. Thus, the surgical device is provided with instructions, which may include instructions that take into account situational awareness, historical information, etc. Depending on the instruction information provided, the outcome and quality of the surgical activity performed by the surgical device may be improved. The surgeon may be provided with warning messages and / or recommendations regarding the device, the patient, and the procedure. The operation of the device may be improved. Patient safety may be ensured.

[0226] Example 3. A surgical hub as described in Example 1 or 2, wherein the instruction information includes at least one of adjustments to surgical functions, prioritization information, cartridge use recommendations, warning messages, surgical device use recommendations, or surgical device use instructions.

[0227] As a third example, instructional information may be provided to the device and / or surgeon, which may contribute to improving the efficiency and / or effectiveness of the surgical function and / or the safety and security of the operation.

[0228] Example 4. The surgical hub of any preceding example, wherein the processor is further configured to determine whether to disable communication with external systems based on the hub connection mode.

[0229] As an example, communication with an external system based on a hub connection mode may be conditionally adapted. For example, in a condition where the hub connection mode does not support access to the external system as determined by hub connection control parameters, which may include consumer control parameters such as a subscription level, surgical hub communication with the external system may be disabled. This may be the case where a medical facility purchases a subscription to hub connection capabilities and the subscription level(s) limit hub connection to internal devices.

[0230] Example 5. The surgical hub of any preceding example, wherein the processor is further configured to determine whether to transmit recorded surgical information associated with the procedure to a remote server based on the hub connection mode.

[0231] A surgical instrument or surgical hub can record surgical information related to a procedure while the procedure is being performed. As example 5, a surgical hub may transmit recorded surgical information received from a surgical instrument to a remote server for archiving and / or analysis. The archived surgical information may be aggregated with information received from other surgical hub(s) and / or surgical information associated with other medical facilities. The aggregated information may be accessed to generate instruction information for one or more surgical instrument(s). For example, a surgical communication hub may aggregate information such as information received from smart surgical devices, information associated with multiple surgeries, surgical information, and corresponding results associated with multiple patients. The aggregated information may be stored in a remote database. For example, the surgical information may be aggregated at a remote server.

[0232] Example 6. The surgical hub of any preceding example, wherein the receiver is further configured to receive data from the remote server, and wherein the processor is further configured to: determine whether to retrieve an aggregate analysis from the remote server based on a hub connection mode; based on a determination to retrieve the aggregate analysis, generate an aggregate analysis request based on the received surgical data; send the aggregate analysis request to the remote server via the transmitter; receive an aggregate analysis response from the remote server via the receiver; generate instruction information based on the aggregate analysis response; and send the instruction information to the at least one smart device via the transmitter.

[0233] As an example, a surgical hub may be enabled to retrieve aggregated analytics from a remote server and provide instructional information to surgical devices, such as trends in surgical data and / or recommendations based on the aggregated analytics. For example, the remote server may aggregate information received from the surgical hub and / or surgical information associated with other medical facilities. The aggregated information may be accessed to generate instructional information for one or more surgical instrument(s). The aggregated analytics increases the likelihood of achieving desired outcomes for different surgical procedures. Surgeons may be provided with best practice recommendations, which may be generated based on aggregated surgical datasets associated with multiple surgical procedures performed at multiple locations over time.

[0234] Example 7. The surgical hub of any preceding example, wherein the hub connection control parameters include at least one of available data bandwidth, power capacity associated with the surgical hub, power capacity associated with the operating room, power capacity associated with the medical facility, power usage, processor utilization information, or memory utilization information.

[0235] As an example, the hub connection control parameters enable the hub connection mode to control communication between the surgical hub and surgical instruments and / or external servers based on the state of data bandwidth, power, and / or processor and memory utilization information.

[0236] Example 8. A surgical hub described in any one of Examples 1 to 6, wherein the hub connection control parameters include at least one of a subscription level associated with the hub connection, a user preference associated with the hub connection, or an instruction from a layered software control system.

[0237] As an example, the hub connection control parameters allow the hub connection mode to control or reduce the surgical hub's communications with surgical instruments and / or external servers based on subscription level, user preferences, or instructions from a tiered software control system. For example, if the hub connection control parameter(s) include instructions from the tiered system, the tiered system may scale communications between the surgical hub and surgical instruments, between the surgical hub and external servers, based on, for example, available data bandwidth, power capacity and usage, processor and memory utilization, and / or internal or attached systems. The tiered system may determine the maximum communication capacity under which the surgical hub can operate. For example, upon detecting that power capacity associated with the operating room, surgical hub, and / or medical facility is below a threshold, the tiered system may reduce the surgical hub's connection capacity. In another example, upon detecting available data bandwidth below a threshold, memory utilization above a particular threshold, power usage above a particular threshold, and / or other system conditions that may warrant reducing the surgical hub's connectivity capabilities, the tiered system may limit or disable communications between the surgical hub and at least one surgical instrument and / or communications between the surgical hub and an external server. For example, a bidirectional connection mode may be reduced to a flow-through connection mode. External communications may be disabled.

[0238] Example 9. A method for controlling a hub connection, the method including: receiving surgical information from at least one smart surgical device; determining a hub connection mode based on a hub connection control parameter; determining whether to send command information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination.

[0239] Example 10. The method of Example 9, further comprising, based on a decision to transmit command information, obtaining command information based on the received surgical information, and transmitting the obtained command information to at least one smart surgical device.

[0240] Example 11. The method of Example 9 or 10, wherein the instruction information includes at least one of surgical function adjustment, prioritization information, cartridge use recommendation, warning message, surgical device use recommendation, or surgical device use instruction.

[0241] Example 12. The method of any one of Examples 9 to 11, further comprising determining whether to disable communication with the external system based on the hub connection mode.

[0242] Example 13. The method of any one of Examples 9 to 12, further comprising determining whether to transmit recorded surgical information associated with the procedure to a remote server based on a hub connection mode.

[0243] Example 14. The method of any one of Examples 9 to 13, further comprising receiving data from a remote server or the remote server, wherein the processor is further configured to: determine whether to retrieve an aggregate analysis from the remote server based on a hub connection mode; based on the determination to retrieve the aggregate analysis, generate an aggregate analysis request based on the received surgical data; send the aggregate analysis request to the remote server via a transmitter of the hub; receive an aggregate analysis response from the remote server via a receiver of the hub; generate instruction information based on the aggregate analysis response; and send the instruction information to at least one smart device via the transmitter.

[0244] Example 15. The method of any one of Examples 9 to 14, wherein the hub connection control parameters include at least one of available data bandwidth, power capacity associated with the surgical hub, power capacity associated with the operating room, power capacity associated with the medical facility, power usage, processor utilization information, or memory utilization information.

[0245] Example 16. The method of any one of Examples 9-14, wherein the hub connection control parameters include at least one of a subscription level associated with the hub connection, a user preference associated with the hub connection, or an instruction from a layered software control system. The method of Examples 9-16 may be performed by a surgical hub.

[0246] Example 17. A computer-readable medium having instructions stored thereon that, when executed, perform the following: receiving surgical information from at least one smart surgical device; determining a hub connection mode based on a hub connection control parameter; determining whether to send instruction information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination.

[0247] Example 18. The computer-readable medium of claim 17, further comprising instructions that, when executed by a processor of a surgical hub, perform the following operations: obtain command information based on the received surgical information; and transmit the obtained command information to at least one smart surgical device based on a determination to transmit the command information.

[0248] Example 19. A computer-readable medium as described in Example 17 or 18, further comprising instructions that, when executed by a processor of a surgical hub, determine whether to disable communication with an external system based on the hub connection mode.

[0249] Example 20. The computer-readable medium of any one of Examples 17-19, further comprising instructions that, when executed by a processor of a surgical hub, execute determining whether to transmit recorded surgical information associated with the procedure to a remote server based on a hub connection mode. The instructions on the computer-readable medium of Examples 17-20 may be executed by a processor of a surgical hub.

[0250] The methods according to Examples 9-16 and the computer-readable media described in Examples 17-19 correspond to the apparatuses of Examples 1-8. Therefore, the above discussion regarding Examples 1-8 also applies to Examples 9-20.

[0251] Example 21. The surgical hub, method, or computer-readable medium of any preceding example, wherein the hub connection mode is selectable from a plurality of connection modes in which the surgical hub may operate, each of the hub connection modes configured to control device-to-device connections within the network and / or communication with an external network.

[0252] Example 22. The surgical hub, method, or computer readable medium of any preceding example, wherein the surgical information from the at least one smart surgical device includes surgical data related to a surgical procedure performed by the at least one smart surgical device, and optionally, the surgical data and surgical parameters are recorded by the at least one surgical device during the surgical procedure, and further optionally, the surgical parameters include at least one of firing force, closure force, firing progression, tissue gap, power level, impedance, and tissue compression stability.

[0253] Further embodiments according to the invention are provided below. 1. A surgical hub including: a receiver configured to receive surgical information from at least one smart surgical device; a transmitter configured to transmit surgical data to a remote server; and a processor configured to: determine a hub connection mode based on a hub connection control parameter; determine whether to send instruction information to the at least one smart device based on the hub connection mode; and communicate with the at least one smart device based on the determination. 2. A surgical hub as described in embodiment 1, wherein the transmitter is further configured to transmit data to at least one smart surgical device, and the processor is further configured to, based on a decision to transmit command information, obtain command information based on the received surgical information and transmit the obtained command information to the at least one smart surgical device via the transmitter. 3. The method of embodiment 1, wherein the instruction information includes at least one of adjustments to surgical functions, prioritization information, cartridge use recommendations, warning messages, surgical device use recommendations, or surgical device use instructions. 4. A surgical hub as described in embodiment 1, wherein the processor is further configured to determine whether to disable communication with an external system based on the hub connection mode. 5. A surgical hub as described in embodiment 1, wherein the processor is further configured to determine whether to transmit recorded surgical information associated with the procedure to a remote server based on the hub connection mode. 6. The surgical hub of embodiment 1, wherein the receiver is further configured to receive data from the remote server, and the processor is further configured to: determine whether to retrieve aggregated analysis from the remote server based on a hub connection mode; based on the determination to retrieve aggregated analysis, generate an aggregated analysis request based on the received surgical data; send the aggregated analysis request to the remote server via the transmitter; receive an aggregated analysis response from the remote server via the receiver; generate instruction information based on the aggregated analysis response; and send the instruction information to at least one smart device via the transmitter. 7. A surgical hub as described in embodiment 1, wherein the hub connection control parameters include at least one of available data bandwidth, power capacity associated with the surgical hub, power capacity associated with the operating room, power capacity associated with the medical facility, power usage, processor utilization information, or memory utilization information. 8. A surgical hub as described in embodiment 1, wherein the hub connection control parameters include at least one of a subscription level associated with the hub connection, a user preference associated with the hub connection, or an instruction from a layered software control system. 9. A method for controlling a hub connection, the method including: receiving surgical information from at least one smart surgical device; determining a hub connection mode based on a hub connection control parameter; determining whether to send command information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination. 10. The method of embodiment 9, further comprising, based on a decision to send command information, obtaining command information based on the received surgical information, and sending the obtained command information to at least one smart surgical device. 11. The method of embodiment 9, wherein the instruction information includes at least one of adjustments to surgical functions, prioritization information, cartridge use recommendations, warning messages, surgical device use recommendations, or surgical device use instructions. 12. The method of embodiment 9, further comprising determining whether to disable communication with the external system based on the hub connection mode. 13. The method of embodiment 9, further comprising determining whether to transmit recorded surgical information examples associated with the procedure to a remote server based on the hub connection mode. 14. The method of embodiment 9, further comprising receiving data from a remote server, wherein the processor is further configured to: determine whether to retrieve an aggregate analysis from the remote server based on a hub connection mode; based on the determination to retrieve the aggregate analysis, generate an aggregate analysis request based on the received surgical data; send the aggregate analysis request to the remote server via the transmitter; receive an aggregate analysis response from the remote server via the receiver; generate instruction information based on the aggregate analysis response; and send the instruction information to at least one smart device via the transmitter. 15. The method of embodiment 9, wherein the hub connection control parameters include at least one of available data bandwidth, power capacity associated with the surgical hub, power capacity associated with the operating room, power capacity associated with the medical facility, power usage, processor utilization information, or memory utilization information. 16. The method of embodiment 9, wherein the hub connection control parameters include at least one of a subscription level associated with the hub connection, a user preference associated with the hub connection, or an instruction from a layered software control system. 17. A computer-readable medium having instructions stored thereon that, when executed, perform the following operations: receiving surgical information from at least one smart surgical device; determining a hub connection mode based on a hub connection control parameter; determining whether to send instruction information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination. 18. The computer-readable medium of embodiment 17, further comprising instructions that, when executed, based on a determination to transmit command information, obtain command information based on the received surgical information, and transmit the obtained command information to at least one smart surgical device. 19. The computer-readable medium of embodiment 17, further comprising instructions that, when executed, perform determining whether to disable communication with an external system based on a hub connection mode. 20. The computer-readable medium of embodiment 17, further comprising instructions that, when executed, determine whether to transmit recorded surgical information associated with the procedure to a remote server based on a hub connection mode.

[0254] [Embodiment] (1) A surgical hub comprising: a receiver configured to receive surgical information from at least one smart surgical device; a transmitter configured to transmit the surgical data to a remote server; a processor, the processor determining a hub connection mode based on a hub connection control parameter; determining whether to send command information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination. (2) the transmitter is further configured to transmit data to the at least one smart surgical device, and the processor: Upon determining to transmit command information, obtaining command information based on the received surgical information; 2. The surgical hub of claim 1, further configured to transmit the acquired command information to the at least one smart surgical device via the transmitter. (3) the instruction information is Adjustments to surgical functions; prioritization information, Cartridge use recommended. warning messages, Surgical equipment recommended, or A surgical hub as described in embodiment 1 or 2, comprising at least one instruction for using a surgical device. (4) A surgical hub described in any one of embodiments 1 to 3, wherein the processor is further configured to determine whether to disable communication with an external system based on the hub connection mode. (5) A surgical hub described in any of embodiments 1 to 4, wherein the processor is further configured to determine whether to transmit recorded surgical information associated with the procedure to the remote server based on the hub connection mode.

[0255] (6) The receiver is further configured to receive data from the remote server, and the processor: determining whether to retrieve aggregate analytics from the remote server based on the hub connection mode; generating an aggregate analysis request based on the received surgical data based on the determination to retrieve the aggregate analysis; transmitting the aggregate analysis request to the remote server via the transmitter; receiving an aggregate analysis response from the remote server via the receiver; generating the instruction information based on the aggregate analysis response; A surgical hub as described in any one of embodiments 1 to 5, further configured to send the command information to the at least one smart device via the transmitter. (7) A surgical hub described in any of embodiments 1 to 6, wherein the hub connection control parameters include at least one of available data bandwidth, power capacity associated with the surgical hub, power capacity associated with an operating room, power capacity associated with a medical facility, power usage, processor utilization information, or memory utilization information. (8) A surgical hub described in any of embodiments 1 to 6, wherein the hub connection control parameters include at least one of a subscription level associated with the hub connection, a user preference associated with the hub connection, or an instruction from a layered software control system. (9) A method for controlling a hub connection, the method comprising: receiving surgical information from at least one smart surgical device; determining a hub connection mode based on a hub connection control parameter; determining whether to send command information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination. (10) based on the decision to transmit command information, obtaining command information based on the received surgery information; 10. The method of claim 9, further comprising transmitting the acquired command information to the at least one smart surgical device.

[0256] (11) The instruction information is Adjustments to surgical functions; prioritization information, Cartridge use recommended. warning messages, Surgical equipment recommended, or 11. The method of embodiment 9 or 10, further comprising at least one instruction for using the surgical device. (12) A method according to any one of embodiments 9 to 11, further comprising determining whether to disable communication with an external system based on the hub connection mode. (13) A method according to any one of embodiments 9 to 12, further comprising determining whether to transmit recorded surgical information associated with the procedure to a remote server based on the hub connection mode. (14) The method further includes receiving data from a remote server or the remote server, wherein the processor: determining whether to retrieve aggregate analytics from the remote server based on the hub connection mode; generating an aggregate analysis request based on the received surgical data based on the determination to retrieve the aggregate analysis; transmitting the aggregate analysis request to the remote server via a transmitter of the hub; receiving an aggregate analysis response from the remote server via a receiver at the hub; generating the instruction information based on the aggregate analysis response; A method according to any one of embodiments 9 to 13, further comprising transmitting the instruction information to the at least one smart device via the transmitter. (15) A method according to any of embodiments 9 to 14, wherein the hub connection control parameters include at least one of available data bandwidth, power capacity associated with the surgical hub, power capacity associated with the operating room, power capacity associated with the medical facility, power usage, processor utilization information, or memory utilization information.

[0257] (16) A method according to any one of embodiments 9 to 14, wherein the hub connection control parameters include at least one of a subscription level associated with the hub connection, a user preference associated with the hub connection, or an instruction from a layered software control system. (17) A computer-readable medium having stored thereon instructions that, when executed, receiving surgical information from at least one smart surgical device; determining a hub connection mode based on a hub connection control parameter; determining whether to send command information to the at least one smart device based on the hub connection mode; and communicating with the at least one smart device based on the determination. (18) When executed by the processor of the surgical hub, Upon determining to transmit command information, obtaining command information based on the received surgical information; 20. The computer-readable medium of claim 17, further comprising instructions for performing the steps of: transmitting the acquired instruction information to the at least one smart surgical device. (19) The computer-readable medium of any one of claims 17 to 18, further comprising instructions that, when executed by the processor of the surgical hub, determine whether to disable communication with an external system based on the hub connection mode. (20) A computer-readable medium described in any of embodiments 17 to 19, further comprising instructions that, when executed by the processor of the surgical hub, determine whether to send recorded surgical information associated with the procedure to the remote server based on the hub connection mode.

[0258] (21) A surgical hub, method, or computer-readable medium described in any of embodiments 1 to 20, wherein the hub connection mode is selectable from multiple connection modes in which the surgical hub can operate, and each of the hub connection modes is configured to control device-to-device connections within the network and / or communication with an external network. (22) A surgical hub, method, or computer-readable medium described in any of embodiments 1 to 21, wherein the surgical information from the at least one smart surgical device includes surgical data related to a surgical procedure performed by the at least one smart surgical device, and optionally, the surgical data and surgical parameters are recorded by the at least one surgical device during the surgical procedure, and further optionally, the surgical parameters include at least one of firing force, closure force, firing progression, tissue gap, power level, impedance, and tissue compression stability.

Claims

1. a surgical hub comprising: a receiver configured to receive surgical information from at least one smart surgical device; a transmitter configured to transmit the surgical information to a remote server; a processor, the processor determining a hub connection mode based on a hub connection control parameter; determining whether to send command information to the at least one smart surgical device based on the hub connection mode; and communicating with the at least one smart surgical device based on the determination; The receiver is further configured to receive data from the remote server, and the processor: determining whether to retrieve aggregate analytics from the remote server based on the hub connection mode; generating an aggregate analysis request based on the received surgical information based on the determination to retrieve the aggregate analysis; transmitting the aggregate analysis request to the remote server via the transmitter; receiving an aggregate analysis response from the remote server via the receiver; generating the instruction information based on the aggregate analysis response; and transmitting the command information to the at least one smart surgical device via the transmitter.

2. 1. A method for controlling a hub connection, the method comprising: a receiver at the surgical hub receiving surgical information from at least one smart surgical device; a processor of the surgical hub determining a hub connection mode based on a hub connection control parameter; determining whether to transmit command information to the at least one smart surgical device based on the hub connection mode; the processor communicating with the at least one smart surgical device based on the determination; and receiving data from a remote server or the remote server, wherein the processor: determining whether to retrieve aggregate analytics from the remote server based on the hub connection mode; generating an aggregate analysis request based on the received surgical information based on the determination to retrieve the aggregate analysis; transmitting the aggregate analysis request to the remote server via a transmitter at the surgical hub; receiving an aggregate analysis response from the remote server via the receiver at the surgical hub; generating the instruction information based on the aggregate analysis response; transmitting the instruction information to the at least one smart surgical device via the transmitter.

3. 3. The method of claim 2, wherein the surgical information from the at least one smart surgical device includes surgical information related to a surgical procedure performed by the at least one smart surgical device, and optionally, the surgical information and surgical parameters are recorded by the at least one smart surgical device during the surgical procedure, and further optionally, the surgical parameters include at least one of firing force, closure force, firing progression, tissue gap, power level, impedance, and tissue compression stability.

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