Cloud Analysis Package

The surgical hub and instrument system addresses the limitations of surgical imaging by aggregating data from multiple devices and updating control algorithms via cloud computing, enhancing surgical site recognition and procedural efficiency.

JP7815226B2Active Publication Date: 2026-02-17CILAG GMBH INTERNATIONAL
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Patent Information

Application Number
JP2023520167
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2020-10-02
Filing Date
2021-09-29
Publication Date
2026-02-17
Estimated Expiration
2041-09-29

AI Technical Summary

Technical Problem

Surgical imaging systems often fail to recognize and convey critical three-dimensional structural information and hidden features during surgeries, limiting clinician understanding.

Method used

A surgical hub and instrument system that establishes communication with a cloud computing system to aggregate data from multiple surgical devices, update control algorithms, and receive updates for improved recognition and communication, utilizing a processor to determine communication availability and manage data aggregation.

Benefits of technology

Enhances surgical outcomes by providing real-time data analysis and updates, enabling better recognition of surgical site structures and improving procedural efficiency and safety.

✦ Generated by Eureka AI based on patent content.

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Abstract

Examples herein describe a surgical system that may include a cloud computing system, a surgical hub, and a surgical instrument. The cloud computing system may be configured to aggregate data from multiple surgical devices. The surgical hub may determine whether communication with the cloud computing system is available, receive aggregated data from the multiple surgical devices via a receiver, update one or more surgical hub control algorithms based on the received aggregated data, and continue to communicate with the cloud computing system to receive additional updates, where the additional updates are related to the updated aggregated data determined by the cloud computing system. The surgical instrument may determine whether communication with the cloud computing system and the surgical hub is available, and receive aggregated data related to the multiple surgical devices from the cloud computing system or the surgical hub via the receiver.
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Description

[Technical Field]

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

[0002] Surgical systems often incorporate imaging systems that can enable 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) can be local to the surgical theater and / or remote. The imaging system can 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] In accordance with various embodiments of the present invention, the following examples are provided. 1. A surgical hub comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and a cloud computing system configured to aggregate data from a plurality of surgical devices; a processor, wherein the processor: determining whether communication with a cloud computing system is available; receiving, from the cloud computing system via the receiver, aggregated data from the plurality of surgical devices; updating one or more control algorithms based on the received aggregated data; and A surgical hub configured to receive updates from the cloud computing system, the updates relating to updated aggregated data. 2. The surgical hub of Example 1, wherein the surgical hub is configured to use aggregate data to determine trends in outcomes, usage, and products. 3. The surgical hub of example 1, wherein the aggregated data relates to use of setup, EMR information, procedure information, and product configuration. 4. The surgical hub described in Example 1, wherein the aggregated data relates to a compiled use procedure and treatment plan. 5. The surgical hub of example 1, wherein the surgical hub is configured to use the aggregated data for an education and process improvement system. 6. A surgical hub described in any one of Examples 1 to 5, wherein the processor is configured to operate in a default operating mode if communication with the cloud computing system is not available. 7. A surgical hub described in any one of Examples 1 to 6, wherein the determination of whether communication with a cloud computing system is available is determined according to one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity. 8. A surgical instrument comprising: a transmitter and a receiver configured to establish a communication path between the surgical instrument and a cloud computing system configured to aggregate data from a plurality of surgical devices; a processor, wherein the processor: determining whether communication with a cloud computing system is available; receiving, from the cloud computing system via the receiver, aggregated data from the plurality of surgical devices; updating one or more control algorithms based on the received aggregated data; and A surgical instrument configured to receive updates from a cloud computing system, the updates relating to updated aggregated data. 9. The surgical instrument of Example 8, wherein aggregate data is used to determine trends in outcomes, usage, and product. 10. The surgical instrument of example 8, wherein the aggregate data relates to use of setup, EMR information, procedure information, and product configuration. 11. The surgical instrument of Example 8, wherein the aggregate data relates to a compiled use process and treatment plan. 12. The surgical instrument of example 8, wherein the aggregated data is for an education and process improvement system. 13. A surgical instrument described in any one of Examples 8 to 12, wherein the processor is configured to operate in a default operating mode if communication with a cloud computing system is not available. 14. A surgical instrument described in any one of Examples 8 to 13, wherein the determination of whether communication with a cloud computing system is available is determined by one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity. 15. A surgical system comprising: a cloud computing system configured to aggregate data from a plurality of surgical devices; 1. A surgical hub comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and the cloud computing system; a processor, wherein the processor: determining whether communication with a cloud computing system is available; receiving, from the cloud computing system via the receiver, aggregated data from the plurality of surgical devices; updating one or more surgical hub control algorithms based on the received aggregated data; and a surgical hub configured to receive updates from the cloud computing system, the updates relating to updated aggregated data; A surgical instrument comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and the cloud computing system; a processor, wherein the processor: determining whether communications with a cloud computing system and a surgical hub are available; receiving aggregate data related to the plurality of surgical devices from a cloud computing system or a surgical hub via a receiver on the surgical instrument; updating one or more surgical tool control algorithms based on the received aggregated data; and A surgical system comprising: a surgical instrument configured to receive updates from a cloud computing system or a surgical hub, the updates relating to updated aggregate data. 16. The surgical system of Example 15, wherein the aggregated data relates to one or more of setup, EMR information, procedure information, and product configuration usage. 17. The surgical system of Example 15, wherein the aggregated data relates to a compiled use procedure and treatment plan. 18. The surgical system of Example 15, wherein the surgical hub is configured to use aggregate data to determine trends in outcomes, usage, and products. 19. The surgical system of Example 15, wherein the surgical hub is configured to use the aggregated data in an education and process improvement system. 20. A surgical system described in any one of Examples 15 to 19, wherein the determination of whether communication with a cloud computing system is available is determined by one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity.

[0004] As at least examples 1, 8, and 18, a system with multiple levels or "tiers" of data analysis is provided. The cloud computing system has data aggregation capabilities for aggregating data from multiple surgical devices. The cloud computing system also provides updates to the local hub and / or connected devices for setup and other uses. As an example of the above, updates may be provided to the surgical devices directly or via the local hub. As an example of the above, the cloud computing system has analytical capabilities. The cloud computing system aggregates data and looks for trends in outcomes, usage, and products. The cloud computing system can aggregate setup, EMR information, procedure videos, and product configuration usage. The cloud computing system can also suggest alternate product usage, usage steps, procedure plans, trocar locations, and operating room settings.

[0005] The scope of updates can vary from simple updates to the control algorithms of the hub and its connected equipment, which may be provided by a "push" from the cloud computing system, to more elaborate interactive communication and data transfer with the devices and HCPs. As an example of the above, the cloud computing system may selectively provide multiple levels of updates, thereby providing the appropriate level of update based on dynamic requirements such as system capacity, data capacity, or power capacity. This allows for controlled usage aggregation and system updates, which in turn contributes to further device improvement and treatment success.

[0006] In accordance with a further embodiment of the present invention, a surgical hub is provided comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and a cloud computing system; and a processor configured to determine whether communication with a cloud computing system configured to aggregate data from a plurality of surgical devices is available, receive aggregated data from the plurality of surgical devices via the receiver, update one or more control algorithms based on the received aggregated data, and continue communication with the cloud computing system to receive additional updates related to the updated aggregated data as determined by the cloud computing system.

[0007] In accordance with a further embodiment of the present invention, a surgical instrument is provided, the surgical instrument comprising: a transmitter and a receiver configured to establish a communication path between a surgical hub and a cloud computing system; and a processor configured to determine whether communication with a cloud computing system configured to aggregate data from a plurality of surgical devices is available, receive aggregated data from the plurality of surgical devices via the receiver, update one or more control algorithms based on the received aggregated data, and continue communication with the cloud computing system to receive additional updates related to the updated aggregated data as determined by the cloud computing system.

[0008] According to a further embodiment of the present invention, a surgical system is provided, the surgical system comprising: a cloud computing system; a surgical hub; and a surgical instrument. The cloud computing system is configured to aggregate data from a plurality of surgical devices. The surgical hub comprises a transmitter and a receiver and a processor configured to establish a communication path between the surgical hub and the cloud computing system. The processor is configured to determine whether communication with the cloud computing system is available, receive aggregated data from the plurality of surgical devices via the receiver, update one or more surgical hub control algorithms based on the received aggregated data, and continue communication with the cloud computing system to receive additional updates, the additional updates related to the updated aggregated data determined by the cloud computing system. The surgical instrument comprises a transmitter and a receiver and a processor configured to establish a communication path between the surgical instrument and the cloud computing system. The process is configured to determine whether communication with a cloud computing system and a surgical hub is available, receive aggregate data related to a plurality of surgical devices from the cloud computing system or the surgical hub via a receiver, update one or more surgical instrument control algorithms based on the received aggregate data, and continue communication with the cloud computing system and the surgical hub to receive additional updates related to the updated aggregate data determined by the cloud computing system. [Brief explanation of the drawings]

[0009] [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 in one or more operating rooms of a medical facility, or any room within a medical facility equipped with specialized equipment for surgical procedures, to a cloud, in accordance with at least one embodiment 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 is a diagram of a context-aware surgical system according to at least one aspect of the present disclosure. [Figure 10] 1 illustrates an exemplary timeline of a surgical procedure and inferences that a surgical hub can make from data detected at each step in the 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 shows a block diagram of a computer-implemented interactive surgical system configured to adaptively generate control program updates for 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 16] 1 illustrates a logic flow diagram of a process for updating a control program of a modular device in accordance with at least one aspect of the present disclosure. [Figure 17] 10A-10C show diagrams of an analysis system pushing updates to modular devices through a surgical hub in accordance with at least one embodiment of the present disclosure. [Figure 18] 1 shows a diagram of a computer-implemented interactive surgical system configured to adaptively generate control program updates for a surgical hub, in accordance with at least one aspect of the present disclosure. [Figure 19] 1 illustrates a logic flow diagram of a process for updating a control program of a surgical hub, according to at least one aspect of the present disclosure. [Figure 20] 1 illustrates a logic flow diagram of a process for updating a data analysis algorithm of a control program of a surgical hub, in accordance with at least one aspect of the present disclosure. [Figure 21] 1 illustrates a system for communication between a surgical instrument, a surgical hub, and a cloud computing system according to at least one aspect of the present disclosure. [Figure 22] 1 illustrates a logic flow diagram of a process for updating a control algorithm of a surgical hub, in accordance with at least one aspect of the present disclosure. [Figure 23] FIG. 10 illustrates a logic flow diagram of a process for updating an algorithm of a surgical instrument, in accordance with at least one aspect of the present disclosure. [Figure 24]1 illustrates a logic flow diagram of a process for updating a surgical system, according to at least one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] The applicant of the present application owns the following concurrently filed US patent applications, the entire contents of each of which are incorporated herein by reference: U.S. Patent Application No. 15 / 940,636 (Attorney Docket No. END8506USNP), entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES," filed March 29, 2018, now U.S. Patent Application Publication No. 2019 / 0206003; and • U.S. Patent Application No. 16 / 209,490 (Attorney Docket No. END9017USNP1), entitled "METHOD FOR FACILITY DATA COLLECTION AND INTERPRETATION," filed December 4, 2018, now U.S. Patent Application Publication No. 2019 / 0206564.

[0011] 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 may be integers greater than or equal to 1.

[0012] In various aspects, visualization system 108 may include one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in FIG. 2. In one aspect, visualization system 108 may include interfaces for HL7, PACS, and EMR. Various components of visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1), 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.

[0013] 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 directions. Visualization system 108, guided by hub 106, is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, hub 106 can cause visualization system 108 to display snapshots of the surgical site captured by imaging device 124 on non-sterile 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 steps related to the surgical procedure.

[0014] In one aspect, the hub 106 can 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 can be in the form of a modification to a snapshot displayed on the non-sterile display 107 or 109, which can be sent by the hub 106 to the primary display 119.

[0015] 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 surgical system 102 are described, for example, under the heading "Surgical Instrument Hardware" 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.

[0016] 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.

[0017] Other types of robotic systems can be readily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Patent Application Publication No. 2019-0201137(A1), 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.

[0018] 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 Publication 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 disclosure of which is incorporated herein by reference in its entirety.

[0019] In various embodiments, the imaging device 124 may include at least one image sensor and one or more optical components. Suitable image sensors may include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] In various aspects, imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngological-nephroscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

[0024] 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 detail 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. Multispectral monitoring can be a useful tool for repositioning the surgical field after the surgical task is complete to perform one or more of the above-mentioned tests on the treated tissue. It is self-evident that strict sterilization of the operating room and surgical equipment is necessary in any surgical procedure. The strict hygiene and sterilization conditions required in the "surgical field," i.e., the operating room or procedure room, require the highest possible sterility of all medical device equipment and instruments. Part of the above sterilization process includes the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It is understood that the sterile field can be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field can be considered the area immediately surrounding the patient who has been prepared for surgery. The sterile field can include cleaned team members wearing appropriate clothing, as well as all equipment and fixtures within the area.

[0025] Referring now to FIG. 3 , a hub 106 is shown in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communications module 130, a processor module 132, a storage array 134, and an operating room mapping module 133. In certain embodiments, as shown in FIG. 3 , the hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128. During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly associated with smoke evacuation, the aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular enclosure 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines. An embodiment of the present disclosure presents a surgical hub for use in 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 the hub enclosure's docking station. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one embodiment, the combination generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.In one aspect, 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 aspect, 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.

[0026] FIG. 4 illustrates a surgical data network 201 comprising a modular communications hub 203 configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204, which may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communications hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communications hub 203 can also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to travel from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features that allow traffic to pass through the monitored surgical data network and configure each port in the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.

[0027] Modular devices 1a-1n located in an operating room may be coupled to modular communication hub 203. Network hub 207 and / or network switch 209 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 may be coupled to network hub 207 and / or network router 211 to connect devices 2a-2m to cloud 204. Data associated with devices 2a-2n may be transferred to cloud 204 via network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to local computer system 210 for local data processing and manipulation.

[0028] 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 is 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.

[0029] In one aspect, the surgical data network 201 may include a combination of a network hub, a network switch, and a network router that connects the devices 1a-1n / 2a-2m to the cloud. Any one or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on sharing computing resources rather than having local servers or personal devices to handle software applications. While the term "cloud" may be used as a metaphor for the "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which various services, such as servers, storage, and applications, are delivered via the Internet to a modular communications hub 203 and / or computer system 210 located at the surgical site (e.g., a fixed, mobile, temporary, or on-site operating room or space) and devices connected to the modular communications hub 203 and / or computer system 210. The cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services can perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

[0030] By applying cloud computing data processing technology to data collected by the devices 1a-1n / 2a-2m, a surgical data network can provide improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n / 2a-2m can be used to observe tissue status and evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. Using cloud-based computing, at least some of the devices 1a-1n / 2a-2m can be used to diagnostically examine data including images of bodily 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 bodily anatomical structures using various sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by devices 1a-1n / 2a-2m, including image data, may be transferred to cloud 204 or local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data may be analyzed to improve the outcome of the surgical procedure by determining whether further treatments, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics, can be performed on tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and the use of standardized techniques can provide useful feedback to either confirm or suggest modifications to surgical treatments and surgeon performance.

[0031] The operating room devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. The network hub 207, in one aspect, may be implemented as a local network broadcasting device operating on the physical layer of the Open System Interconnection (OSI) model. The network hub can provide connectivity to devices 1a-1n located within the same operating room 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 cannot store the media access control / Internet Protocol (MAC / IP) for forwarding any device data. Only one of the devices 1a-1n can transmit data through the network hub 207 at a time. The network hub 207 cannot 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.

[0032] The operating room devices 2a-2m may be connected to the network switch 209 via wired or wireless channels. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 may be a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 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.

[0033] The network hub 207 and / or the network switch 209 may be coupled to a network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 can 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.

[0034] In one example, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub can expand a single USB port into several tiers so that more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and 2a-2m located in the operating room.

[0035] In an example, the operating room 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 establish a personal area network (PAN). The operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via numerous wireless or wired communications standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, New Radio (NR), Long Term Evolution (LTE), and any other wireless and wired protocols designated as 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.

[0036] The modular communications hub 203 can act as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and can handle data types known as frames. The frames can carry data generated by the devices 1a-1n / 2a-2m. Once the frames are received by the modular communications hub 203, they are amplified and transmitted to the network router 211, which forwards this data to cloud computing resources using a number of wireless or wired communications standards or protocols, as described herein.

[0037] 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 operating room devices 1a-1n / 2a-2m.

[0038] FIG. 5 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 6, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210.

[0039] As shown in the embodiment of FIG. 5 , modular control tower 236 may be coupled to an imaging module 238 that may be coupled to an endoscope 239, a generator module 240 that may be coupled to an energy device 241, a smoke evacuation module 226, a suction / irrigation module 228, a communications module 230, a processor module 232, a storage array 234, a smart device / instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. Operating room equipment may be coupled to cloud computing resources and data storage via modular control tower 236. Robotic hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices / instruments 235, visualization system 208, among others, may be coupled to modular control tower 236 via wired or wireless communication standards or protocols as described herein. Modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from the imaging module, device / instrument display, and / or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with the images and overlaid images.

[0040] FIG. 6 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 may comprise a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for local processing, visualization, and imaging. As shown in FIG. 6, the modular communications hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communications hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 6, each of the network hubs / switches in the modular communications hub 203 may include three downstream ports and one upstream port. The upstream network hub / switch may be connected to a processor to provide communication connectivity to cloud computing resources and a local display 217. Communication to the cloud 204 may occur via either a wired or wireless communication channel.

[0041] The surgical hub 206 can use a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the surgical site using either an ultrasonic or laser-based non-contact measurement device. In U.S. Patent Application Publication No. 2019-0200844(A1), filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), the entire contents of which are incorporated herein by reference, a sensor module is configured to determine the size of the operating room and adjust distance limits for Bluetooth pairing. As described in the section entitled "Surgical Hub Spatial Awareness Within an Operating Room," an ultrasound-based non-contact sensor module can scan the operating room by transmitting bursts of ultrasound and receiving echoes when the bursts of ultrasound reflect off the exterior walls of the operating room. For example, a laser-based non-contact sensor module can scan an operating room by transmitting laser light pulses, receiving laser light pulses that reflect off the exterior walls of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust Bluetooth pairing distance limits.

[0042] 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.

[0043] 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, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product data sheet.

[0044] In one aspect, the processor 244 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

[0045] System memory can 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).

[0046] The computer system 210 may also include removable / non-removable, volatile / non-volatile computer storage media, such as disk storage devices. Disk storage devices may include, but are 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 devices may include the above storage media, 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 disk storage devices to the system bus.

[0047] 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.

[0048] A user can input commands or information into the computer system 210 through input devices coupled to the I / O interface 251. Input devices can include, but are not limited to, pointing devices such as a mouse, trackball, stylus, or touchpad; keyboards; microphones; joysticks; gamepads; satellite dishes; scanners; TV tuner cards; digital cameras; digital video cameras; webcams; and the like. These and other input devices connect to the processor through the system bus via interface ports. Interface ports include, for example, serial ports, parallel ports, game ports, and USB. Output devices use some of the same types of ports as input devices. Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. Output adapters may be provided to illustrate the existence of several output devices, such as monitors, displays, speakers, and printers, among other output devices that may require special adapters. Output adapters can include, by way of example and not limitation, video and sound cards that provide a means of connection between the output device and the system bus. It should be noted that other devices and / or systems of devices, such as remote computers, may provide both input and output capabilities.

[0049] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as a cloud computer. A remote cloud computer can be a personal computer, a server, a router, a network PC, a workstation, a microprocessor-based device, a peer device, or other common network node, but typically includes many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown with the remote computer. A remote computer may be logically connected to the computer system through a network interface and then physically connected through a communications connection. The network interface may encompass communications networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies may include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, 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 variants, packet-switched networks, and Digital Subscriber Lines (DSL).

[0050] 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 dedicated 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.

[0051] The communications connection may refer to the hardware / software used to connect the network interface to the bus. While the communications connection is shown internal to the computer system for clarity of illustration, the communications connection may also be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as regular telephone-grade modems, modems including cable modems and DSL modems, ISDN adapters, and Ethernet cards.

[0052] FIG. 7 shows a logic diagram of a surgical instrument or tool control system 470 according to one or more embodiments of the present disclosure. The system 470 may include control circuitry. The control circuitry may include a microcontroller 461 with a processor 462 and a memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482, driven by a motor driver 492, operably couples a longitudinally movable displacement member to drive the I-beam knife element. A tracking system 480 may be configured to determine the position of the longitudinally movable displacement member. The position information may be provided to the processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member, as well as the positions of the firing member, firing bar, and I-beam knife element. Additional motors may be provided to the tool driver interface to control I-beam firing, closure tube movement, shaft rotation, and articulation. A display 473 may display 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.

[0053] In one embodiment, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, main microcontroller 461 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and / or one or more 12-bit ADCs with 12 analog input channels, details of which are available in the product datasheet.

[0054] 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.

[0055] 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.

[0056] The microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement members and articulation system. The microcontroller 461 may be configured to calculate a response within the microcontroller 461 software. The calculated response may be compared to the measured response of the actual system to obtain an "observed" response, which is used to determine actual feedback. The observed response may be a suitably adjusted value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.

[0057] In some examples, the motor 482 may be controlled by a motor driver 492 and may be used by the surgical instrument or tool firing system. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In some examples, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including field effect transistors (FETs). The motor 482 may be powered by a power supply assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery, which may include multiple battery cells connected in series, that may be used as a power source to power the surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and / or rechargeable. In at least one example, the battery cells may be a lithium-ion battery, which may be connectable to and separable from the power supply assembly.

[0058] The motor driver 492 may be the A3941 available from Allegro Microsystems, Inc. The A3941 492 may be a full-bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs), specifically designed for inductive loads such as brushed DC motors. The driver 492 may include an intrinsic charge pump regulator, which can provide full (>10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive down to 5.5V. A bootstrap capacitor may be used to provide the required battery supply voltage 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.

[0059] The tracking system 480 may include a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for an absolute positioning system may provide a unique position signal corresponding to the position of the displacement member. In some examples, the displacement member may represent a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In some examples, the displacement member may represent a firing member that may be adapted and configured to include a rack of drive teeth. In some examples, the displacement member may represent a firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Thus, as used herein, the term displacement member may be used generally to refer to any movable member of a surgical instrument or tool, such as a drive member, firing member, firing bar, I-beam, or any element that can be displaced. In one aspect, a longitudinally movable drive member may be coupled to a firing member, firing bar, and I-beam. Thus, the absolute positioning system may, in effect, track the linear displacement of an I-beam by tracking the linear displacement of a longitudinally movable drive member. In various aspects, the displacement member may be coupled to any suitable position sensor 472 for measuring linear displacement. Thus, the longitudinally movable drive member, firing member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor. The linear displacement sensor may include a linear variable differential transformer (LVDT), a differential variable reluctance transducer (DVRT), a slide potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical detection system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical detection system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.

[0060] The electric motor 482 may include a rotatable shaft operably interfaced with a gear assembly mounted in meshing engagement with a set of drive teeth or rack on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to several linear longitudinal translations of the displacement member. The gearing and sensor arrangement may be connected to a linear actuator by a rack and pinion arrangement or to a rotary actuator by a spur gear or other connection. A power source may provide power to the absolute positioning system, and an output indicator may display the output of the absolute positioning system. The displacement member may represent a longitudinally movable drive member having 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.

[0061] One revolution of the sensor element associated with position sensor 472 may correspond to a longitudinal linear displacement d1 of the displacement member, where d1 is the longitudinal linear distance traveled by the displacement member from point "a" to point "b" after one revolution of the sensor element coupled to the displacement member. The sensor mechanism may be coupled via a gear reduction that results in the position sensor 472 completing one or more revolutions relative to the full stroke of the displacement member. The position sensor 472 may complete multiple revolutions relative to the full stroke of the displacement member.

[0062] A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for two or more revolutions of the position sensor 472. The state of the switches may be fed back to the microcontroller 461, which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+...dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor mechanism may comprise a magnetic sensor, an analog rotation sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.

[0063] Position sensor 472 may comprise any number of magnetic sensing elements, such as 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 search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetodiodes, magnetotransistors, fiber optics, magneto-optics, and microelectromechanical systems-based magnetic sensors, among others.

[0064] In one embodiment, 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 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

[0065] A tracking system 480 with an absolute positioning system may include and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply converts a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensors may be provided to measure physical parameters of the physical system. In some embodiments, other sensors may include sensor arrangements such as those described in U.S. Pat. No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system may take into account properties such as mass, inertia, viscous friction, and induced drag in order to predict what the state and output of the physical system will be given knowledge of the input.

[0066] 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.

[0067] A sensor 474, such as a strain gauge or micro-strain gauge, can be configured to measure one or more parameters of the end effector, such as the amplitude of strain exerted on the anvil during clamping, which can be indicative of the closure force applied to the anvil. The measured strain can be converted to a digital signal and provided to the processor 462. Instead of or in addition to the sensor 474, a sensor 476, such as a load sensor, can measure the closure force applied to the anvil by the closure drive system. For example, the sensor 476, such as a load sensor, can measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sled, which is configured to cam the staple driver upward and drive the staples into deforming contact with the anvil. The I-beam can also include a sharp cutting edge that can be used to cut tissue as the I-beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure the current drawn by the motor 482. The force required to advance the firing member may correspond, for example, to the current drawn by motor 482. The measured force may be converted to a digital signal and provided to processor 462.

[0068] 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, which can be 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, the common control module 610 can accommodate one of the multiple motors at a time. For example, the common control module 610 may be individually connectable and detachable to multiple motors of a robotic surgical instrument. In certain examples, the multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, the multiple motors of a surgical instrument or tool can be individually and selectively engaged with the common control module 610. In certain examples, the common control module 610 can selectively switch from interfacing with one of the multiple motors of the surgical instrument or tool to interfacing with another of the multiple motors of the surgical instrument or tool.

[0077] In at least one example, common control module 610 can be selectively switched between operative engagement with articulation motors 606 a, 606 b and operative engagement with either firing motor 602 or closure motor 603. In at least one embodiment, as shown in FIGURE 8, switch 614 can be moved or transitioned between multiple positions and / or states. For example, in a first position 616, switch 614 can electrically couple common control module 610 to firing motor 602, in a second position 617, switch 614 can electrically couple common control module 610 to closure motor 603, in a third position 618 a, for example, switch 614 can electrically couple common control module 610 to first articulation motor 606 a, and in a fourth position 618 b, switch 614 can electrically couple common control module 610 to second articulation motor 606 b. In certain examples, a separate common control module 610 may be electrically coupled to the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b at the same time. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.

[0078] 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.

[0079] 8, common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. Motor driver 626 may modulate power transferred from a power supply 628 to a motor coupled to common control module 610, for example, based on input from a microcontroller 620 ("controller"). In certain examples, 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.

[0080] 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.

[0081] In certain examples, power supply 628 may be used to, for example, power microcontroller 620. In certain examples, power supply 628 may include a battery (or "battery pack" or "power pack"), such as, for example, a lithium-ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power surgical instrument 600. Multiple battery cells connected in series may be used as power supply 628. In certain examples, power supply 628 may be, for example, replaceable and / or rechargeable.

[0082] In various examples, the processor 622 can control the motor drivers 626 to control the position, direction of rotation, and / or speed of the motors coupled to the common control module 610. In certain examples, the processor 622 can signal the motor drivers 626 to stop and / or disable the motors coupled to the common control module 610. The term "processor," as used herein, should be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a computer's central processing unit (CPU) on one integrated circuit or up to a few integrated circuits. A processor may be a general-purpose programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides a result as output. Because it may have internal memory, it may be an example of sequential digital logic. A processor may operate on numbers and symbols represented in the binary system.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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 monitors 5124 (e.g., a blood pressure (BP) monitor and an electrocardiogram (EKG) monitor). The surgical hub 5104 may be configured to derive contextual information regarding the surgical procedure from the data based, for example, on a particular combination of the received data or a particular order in which the data is received from the data sources 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the particular step of the surgical procedure the surgeon is performing, the type of tissue being operated on, or the body cavity being treated. This ability of some aspects of the surgical hub 5104 to derive or infer information regarding 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 the surgical procedure from received data.

[0087] The situation awareness system of the surgical hub 5104 can be configured to derive context information from data received from the data sources 5126 in a variety of different ways. In one example, the situation awareness system may include a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data to correlate various inputs (e.g., data from the database 5122, the patient monitor 5124, and / or the modular device 5102) with corresponding context information related to the surgical procedure. In other words, the machine learning system can be trained to accurately derive context information related to the surgical procedure from provided inputs. In an example, the situation awareness system may include a lookup table that stores pre-characterized context information related to the surgical procedure in association with one or more inputs (or ranges of inputs) corresponding to the context information. In response to querying with one or more inputs, the lookup table can return corresponding context information for the situation awareness system to control the modular device 5102. In examples, the contextual information received by the situational awareness system of the surgical hub 5104 may be associated with a particular control adjustment or set of control adjustments of one or more modular devices 5102. In examples, the situational awareness system may include a further machine learning system, lookup table, or other such system that generates or retrieves one or more control adjustments of one or more modular devices 5102 when provided with the contextual information as input.

[0088] A surgical hub 5104 incorporating a situational awareness system can provide many benefits to the surgical system 5100. One benefit may include improved interpretation of sensed and collected data, which 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 the surgical instrument is detected, the situational aware surgical hub 5104 can properly accelerate or decelerate the motor of the surgical instrument to match the tissue type.

[0089] 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.

[0090] The type of body cavity being operated on during an insufflation procedure can affect the function of the smoke evacuator. The situation-aware surgical hub 5104 can determine whether the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the type of procedure. Generally, certain procedure types can be performed within specific body cavities, so the surgical hub 5104 can control the smoke evacuator motor speed appropriately for the body cavity being operated on. Thus, the situation-aware surgical hub 5104 can provide a consistent amount of smoke evacuation for both thoracic and abdominal procedures.

[0091] 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, arthroscopic surgery 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 arthroscopic. 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 surgical procedure. 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 type of tissue expected according to the step of the surgical procedure.

[0092] 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 the data received from the modular device 5102 with contextual information constructed about the surgical procedure from other data sources 5126. For example, the context-aware surgical hub 5104 may be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) according to video or image data received from a medical imaging device. However, in some cases, the video or image data may be inconclusive. Thus, in certain examples, the surgical hub 5104 may be further configured to compare a physiological measurement (e.g., blood pressure sensed by a BP monitor communicatively connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 (FIG. 2) communicatively coupled to the surgical hub 5104) to make a determination regarding the integrity of a staple line or tissue weld. In other words, the situational awareness system of the surgical hub 5104 can take physiological measurement data into account to provide additional context when analyzing the visualization data, which can be useful when the visualization data may not be conclusive or incomplete on its own.

[0093] For example, the situation-aware surgical hub 5104 may proactively activate a generator to which an RF electrosurgical instrument is connected if it is determined that a subsequent step in a procedure will require the use of the instrument. By proactively activating the energy source, the instrument may be ready for use as soon as the previous step in the procedure is completed.

[0094] The situation-aware surgical hub 5104 can determine whether the current or subsequent steps in the surgical procedure require different views or magnifications on the display according to the 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 a medical imaging device for the visualization system 108) appropriately, so that the display automatically adjusts throughout the surgical procedure.

[0095] 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.

[0096] Errors may be checked during the setup of a surgical procedure or during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 may determine whether the operating room is properly or optimally set up for the surgical procedure to be performed. The surgical hub 5104 may be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, product locations, or setup requirements, and then compare the current operating room layout to a standard layout for the type of surgical procedure the surgical hub 5104 has determined is being performed. In some examples, the surgical hub 5104 may be configured to compare the list of items for the procedure and / or the list of devices paired with the surgical hub 5104 to a recommended or expected manifest of items and / or devices for a given surgical procedure. If a discontinuity exists between the lists, the surgical hub 5104 may be configured to provide an alert indicating that a particular modular device 5102, patient monitor 5124, and / or other surgical item is missing. In some examples, the surgical hub 5104 can be configured to determine the relative distance or relative position of the modular device 5102 and the patient monitor 5124, for example, by a proximity sensor. The surgical hub 5104 can compare the relative positions of the devices to a recommended or predicted layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide an alert indicating that the current layout of the surgical procedure deviates from the recommended layout.

[0097] The situation-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or deviating from an expected sequence of actions during the course of a surgical procedure. For example, the surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) a corresponding list of steps or sequences of equipment use, and then compare the steps being performed or the equipment being used during the course of 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.

[0098] The surgical instruments (and other modular devices 5102) may be tailored to the specific circumstances of each surgical procedure (e.g., for different tissue types) and may be verified for operation during the surgical procedure. Subsequent steps, data, and display adjustments may be provided to the surgical instruments (and other modular devices 5102) within the surgical site according to the specific circumstances of the procedure.

[0099] 10 illustrates a timeline 5200 of an exemplary surgical procedure and the contextual information that the surgical hub 5104 can derive from data received from the 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 operating room and ending with the transfer of the patient to a post-operative recovery room. The context-aware surgical hub 5104 can receive data from the data sources 5126 throughout the course of 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 receives this data from the paired modular devices 5102 and other data sources 5126 and can continually derive inferences (i.e., contextual information) regarding the ongoing procedure as new data is received, such as which step of the procedure is occurring at any given time. The situational awareness system of the surgical hub 5104 may be able to, for example, record data regarding the procedure to generate reports, verify steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be relevant to particular procedure steps, adjust the modular device 5102 based on the context (e.g., activate a monitor, adjust the FOV of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and any other such actions described herein.

[0100] As a first step 5202 in this exemplary procedure, hospital personnel can retrieve the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, the surgical hub 5104 determines that the procedure to be performed is thoracic surgery. Second, 5204, the personnel can scan incoming medical supplies for the procedure. The surgical 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 surgical 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 otherwise not compatible with a thoracic wedge resection). Third, 5206, medical personnel can scan the patient band via a scanner 5128 communicatively connected to the surgical hub 5104. The surgical hub 5104 can then verify the patient's identity based on the scanned data. In a fourth step 5208, medical personnel turn on the auxiliary devices. The auxiliary equipment utilized may vary according to the type of surgical procedure and the techniques used by the surgeon, but in this exemplary case includes a smoke evacuator, an insufflator, and a medical imaging device. Once activated, the auxiliary device, which is a modular device 5102, may automatically pair with the surgical hub 5104, which may be located within a certain proximity of the modular device 5102, as part of its initialization process. The surgical hub 5104 may then derive contextual information regarding the surgical procedure by detecting the type of modular device 5102 paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 5104 may determine that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices 5102. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the types of modular devices 5102 connecting to the hub, the surgical hub 5104 may roughly deduce the particular procedure the surgical team will be performing.Once the surgical hub 5104 knows what particular procedure is being performed, it can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources 5126 (e.g., modular 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 in the operating room, for example, as described in process 5207. In a sixth step 5212, medical personnel can administer anesthesia to the patient. The surgical hub 5104 can infer that the patient is under anesthesia based on data from the modular device 5102 and / or the patient 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.

[0101] In seventh 5214, the lung of the patient being operated on may be collapsed (while ventilation is switched to the contralateral lung). The surgical hub 5104 may, for example, infer from ventilator data that the patient's lung has been collapsed. The surgical hub 5104 may compare the detection of the patient's collapsed lung with the expected steps of the procedure (which may be accessed or retrieved in advance) and therefore infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung may be the first surgical step in this particular procedure. In eighth 5216, a medical imaging device 5108 (e.g., a scope) may be inserted and video footage from the medical imaging device may be initiated. The surgical hub 5104 may receive medical imaging device data (i.e., video or image data) through a connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 5104 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 5104 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that based on the data received in the second step 5204 of the procedure, a wedge resection has not already been taken into account by the surgical hub 5104). Data from the medical imaging device 124 (FIG. 2) may be utilized to determine contextual information regarding the type of procedure being performed in various ways, such as by determining the angle of the medical imaging device pointed relative to visualization of the patient's anatomy, by monitoring the number or medical imaging devices being utilized (i.e., activated and paired with the surgical hub 5104), and by monitoring the type of visualization device being utilized. For example, one technique for performing a VATS lobectomy may position the camera above the diaphragm in the anterior-inferior corner of the patient's chest cavity, while one technique for performing a VATS segmentectomy places the camera in an intercostal position anterior to the segmental fissure. The situational awareness system can be trained to recognize the position of the medical imaging device according to a visualization of the patient's anatomy, for example, using pattern recognition or machine learning techniques.An exemplary technique for performing a VATS lobectomy may utilize a single medical imaging device. An exemplary technique for performing a VATS segmentectomy utilizes multiple cameras. An exemplary technique for performing a VATS segmentectomy utilizes an infrared light source (which may be communicatively coupled to the surgical hub as part of a visualization system) to visualize the segmental fissure, which is not utilized in a VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can determine the particular type of surgical procedure being performed and / or the technique being used for the particular type of surgical procedure.

[0102] At ninth 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 separating 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. At tenth 5220, the surgical team may proceed to the ligation step of the procedure. Because the surgical hub 5104 may receive data from the surgical stapling and severing instrument indicating that the instrument is being fired, it 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. At eleventh 5222, the segmentectomy portion of the procedure may be performed. Based on data from the surgical stapling and severing 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 (e.g., RF or ultrasonic) instruments depending on the particular step in the procedure, as different instruments are better suited for particular tasks. Thus, the particular sequence in which the stapling / 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.

[0103] In a thirteenth step 5226, the patient may be awakened from anesthesia. The surgical hub 5104 may estimate that the patient is awakening from anesthesia, for example, based on ventilator data (i.e., the patient's breathing rate begins to increase). Finally, a fourteenth step 5228 may be a step in which medical personnel disconnect the patient from the various patient monitors 5124. Thus, the surgical hub 5104 may estimate that the patient is being transported 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 the various data sources 5126 communicatively coupled to the surgical hub 5104.

[0104] As shown in the first step 5202 of the timeline 5200 shown in FIG. 10 , in addition to utilizing patient data from the EMR database to estimate the type of surgical procedure to be performed, the patient data can also be utilized by the situation-aware surgical hub 5104 to generate control adjustments for the paired modular devices 5102.

[0105] FIG. 11 is a block diagram of a computer-implemented interactive surgical system according to at least one embodiment of the present disclosure. In one embodiment, the computer-implemented interactive surgical system may be configured to monitor and analyze data related to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and operating rooms 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 also be a cloud-based medical system. As shown in FIG. 11 , the cloud-based analysis system may include a plurality of surgical instruments 7012 (which may be the same as or similar to instrument 112), a plurality of surgical hubs 7006 (which may be the same as or similar to hub 106), and a surgical data network 7001 (which may be the same as or similar to network 201) for coupling the surgical hubs 7006 to cloud 7004 (which may be the same as or similar to cloud 204). Each of the plurality of surgical hubs 7006 may be communicatively coupled to one or more surgical instruments 7012. The hub 7006 may also be communicatively coupled to a cloud 7004 of computer-implemented interactive surgical systems via a network 7001. The cloud 7004 may be a remote, centralized source of hardware and software for storing, manipulating, and communicating data generated based on the operation of various surgical systems. As shown in FIG. 11 , access to the cloud 7004 may be achieved via the network 7001, which may be the Internet or other suitable computer network. The surgical hub 7006, which may be coupled to the cloud 7004, may be considered the client side of a cloud computing system (i.e., a cloud-based analysis system). A surgical instrument 7012 may be paired with the surgical hub 7006 for control and performance of the various surgical procedures or operations described herein.

[0106] 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 an operating room 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 magnetic storage. 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.

[0107] 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 an individual hub 7006 cannot accomplish on its 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 in response to requests from the hub 7006. These requests may be sent to the hub 7006 via a hub application. The I / O interface 7006 may include one or more high-speed data ports, which may include a universal serial bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting the cloud 7004 to the hub 7006. The hub application server 7002 of the cloud 7004 may be configured to host and provide shared functionality to software applications (e.g., hub applications) executed by the surgical hub 7006. For example, the hub application server 7002 may manage requests by the hub application through the hub 7006, control access to the database 7011 of aggregated medical data, and perform load balancing. The data analysis module 7034 is described in more detail with reference to FIG. 12 .

[0108] 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.

[0109] 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 store data (e.g., temporarily) and may be coupled to the API 7016 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.

[0110] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata), including identifying notable features or configurations (e.g., trends), managing redundant data sets, and storing data in paired data sets that may be grouped by procedure but not necessarily matched to actual surgical procedure dates and surgeons. In particular, paired data sets generated from the operation of the surgical instrument 7012 may include applying a binary classification, such as a bleeding or non-bleeding event. More generally, the binary classification may be characterized as either a desired event (e.g., a successful surgical procedure) or an undesired event (e.g., a misfired or misused surgical instrument 7012). The aggregated self-describing data may correspond to individual data received from various groups or subgroups of the surgical hub 7006. Thus, the data collection and aggregation module 7022 may generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. To this end, the processor 7008 may be operatively coupled to the hub application 7014 and the database of aggregated medical data 7011 for executing the data analysis module 7034. The data collection and aggregation module 7022 may store the aggregated, organized data in the database of aggregated medical data 2212.

[0111] The resource optimization module 7020 can be configured to analyze this aggregated data to determine optimal use of resources for a particular medical facility or group of medical facilities. For example, the resource optimization module 7020 can determine an optimal order point for surgical stapling instruments 7012 for a group of medical facilities based on corresponding predicted demand for surgical stapling instruments 7012. The resource optimization module 7020 can also evaluate resource usage or other operating configurations of various medical facilities to determine whether resource usage can be improved. Similarly, the recommendation module 7030 can be configured to analyze the aggregated organizational data from the data collection and aggregation module 7022 to provide recommendations. For example, the recommendation module 7030 can recommend to a medical facility (e.g., a health care provider such as a hospital) that a particular surgical instrument 7012 should be upgraded to an improved version based, for example, on a higher than expected error rate. Additionally, the recommendation module 7030 and / or resource optimization module 7020 can recommend better supply chain parameters, such as product reorder points, and provide suggestions for different surgical instruments 7012, their use, or procedural steps to improve surgical outcomes. The medical facility can receive such recommendations via the corresponding surgical hub 7006. More specific recommendations regarding the parameters or configurations of various surgical instruments 7012 can also be provided. The hub 7006 and / or surgical instruments 7012 can each have a display screen that displays the data or recommendations provided by the cloud 7004.

[0112] The patient outcome analysis module 7028 may analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 may also analyze and evaluate other potential operating parameters. In this regard, the recommendation module 7030 may use these other potential operating parameters to make recommendations based on resulting in better surgical outcomes, such as a better seal or less bleeding. For example, the suggestion module 7030 may be able to send suggestions to the surgical 7006 regarding when to use a particular cartridge with a corresponding stapling surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large-scale collected raw data and provide centralized recommendations (advantageously determined based on aggregated data) across multiple medical facilities while controlling for common variables. For example, the cloud-based analysis system may analyze, evaluate, and / or aggregate type of medical procedure, type of patient, number of patients, geographic similarities between medical providers using similar types of instruments, etc., in ways that no single medical facility could analyze independently. The control program update module 7026 can be configured to implement recommendations for various surgical instruments 7012 when the corresponding control programs are updated. For example, the patient outcome analysis module 7028 can identify correlations linking particular control parameters to successful (or unsuccessful) outcomes. Such correlations can be addressed when an updated control program is sent to the surgical instrument 7012 via the control program update module 7026. Updates to the instrument 7012, which can be sent via the corresponding hub 7006, may incorporate aggregated performance data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and recommendation module 7030 can identify improved ways to use the instrument 7012 based on the aggregated performance data.

[0113] The cloud-based analysis system may include security features implemented by the cloud 7004. These security features may be managed by the authorization and security module 7024. Each surgical hub 7006 may have associated unique credentials, such as a username, password, and other suitable security credentials. These credentials may be stored in memory 7010 and associated with an authorized cloud access level. For example, based on providing accurate credentials, the surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., send or receive certain defined types of information). To this end, the cloud 7004's aggregated medical data database 7011 may include a database of certified credentials to verify the accuracy of the provided credentials. Different credentials may be associated with various levels of permission for interaction with the cloud 7004, such as a predetermined access level for receiving data analyses generated by the cloud 7004. Furthermore, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices, which may include a "blacklist" of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist may not be permitted to interact with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the corresponding hub 7006. Additionally or alternatively, the cloud 7004 may flag instruments 7012 based on incompatibility or other specified criteria. In this manner, counterfeit medical devices and the inappropriate reuse of such devices across the cloud-based analysis system may be identified and addressed.

[0114] 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 the cloud 7004. A wired transceiver may also be used to transmit the signal. Such authorization credentials may be stored in a respective memory device of the surgical instrument 7012. The authorization and security module 7024 may determine whether the authorization credentials are accurate or forged. The authorization and security module 7024 may also dynamically generate authorization credentials for enhanced security. The credentials may also be encrypted, such as by using hash-based encryption. Upon transmitting the appropriate authorization, the surgical instrument 7012 may transmit a signal to the corresponding hub 7006 and ultimately the cloud 7004 indicating that the instrument 7012 is ready to acquire and transmit medical data. In response, the cloud 7004 may transition to a state capable of receiving medical data for storage in the aggregated medical data database 7011. This readiness to transmit data may be indicated, for example, by a light indicator on the instrument 7012. The cloud 7004 may also send signals to the surgical instruments 7012 to update their associated control programs. The cloud 7004 may send signals directed to a particular class of surgical instruments 7012 (e.g., electrosurgical instruments) so that software updates to control programs are sent only to the appropriate surgical instruments 7012. Additionally, the cloud 7004 may be used to implement system-wide solutions to address local or global issues based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 are identified as having a common manufacturing defect, the cloud 7004 may change the authorization credentials corresponding to this group to implement an operational lockout for this group.

[0115] The cloud-based analytics system may enable monitoring of multiple healthcare facilities (e.g., healthcare facilities such as hospitals) to determine improved practices and recommend changes accordingly (e.g., via the suggestions module 2030). Thus, the processor 7008 of the cloud 7004 may analyze data associated with an individual healthcare facility to identify the facility and aggregate that data with other data associated with other healthcare facilities. Groups may be defined, for example, based on similar operational behavior or geographic location. In this manner, the cloud 7004 may provide broader analysis and recommendations for groups of healthcare facilities. The cloud-based analytics system may also be used for enhanced situational awareness. For example, the processor 7008 may predictively model the effect of recommendations on cost and effectiveness for a particular facility (compared to overall operations and / or various healthcare procedures). The costs and effectiveness associated with that particular facility may also be compared to the corresponding local area of ​​other facilities or any other comparable facilities.

[0116] The data classification and prioritization module 7032 may prioritize and classify data based on criticality (e.g., the severity, surprise, or suspiciousness of the medical event associated with the data). This classification and prioritization may be used in conjunction with other data analysis module 7034 functionality described herein to improve the cloud-based analyses and operations described herein. For example, the data classification and prioritization module 7032 may assign priorities to data analyses performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels may result in specific responses from the cloud 7004 (corresponding to the level of urgency), such as elevation for rapid response, special handling, exclusion from the aggregated medical data database 7011, or other suitable responses. Additionally, if necessary, the cloud 7004 may send a request (e.g., a push message) via the hub application server for additional data from the corresponding surgical instrument 7012. The push message may result in a notification being displayed on the corresponding hub 7006 to request support or additional data. This push message may be needed in situations where the cloud detects a significant irregularity or outlier and the cloud 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 suspected.

[0117] 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.

[0118] 13 shows a block diagram of a computer-implemented adaptive surgical system 9060 configured to adaptively generate control program updates for a modular device 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 configurations 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 modular devices 9050 to the surgical hub 9000. In one aspect, the interface 9040 may include a transceiver communicatively connectable to the modular devices 9050 via a wireless communication protocol. The modular devices 9050 may include, for example, surgical stapling and cutting instruments, electrosurgical instruments, ultrasonic instruments, aspirators, insufflators, and display screens. In some instances, the surgical hub 9000 may further be communicatively coupled to one or more patient monitoring devices 9052, such as an EKG monitor or a BP monitor.In some examples, the surgical hub 9000 may further be communicatively coupled to one or more databases 9054 or external computer systems, such as an EMR database of the medical facility in which the surgical hub 9000 is located.

[0119] When the modular devices 9050 are connected to the surgical hub 9000, the surgical hub 9000 can sense or receive perioperative data from the modular devices 9050 and then associate the received perioperative data with surgical procedure outcome data. The perioperative data can indicate how the modular devices 9050 were controlled during the course of a surgical procedure. The procedure outcome data includes data associated with the results from the surgical procedure (or steps thereof), which can include whether the surgical procedure (or steps thereof) had a good or bad outcome. For example, the outcome data can include whether a patient developed a post-operative complication from a particular procedure or whether there was a leak (e.g., bleeding or air leak) at a particular staple or incision line. The surgical hub 9000 can obtain the surgical procedure 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 stapling or incision line leakage 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 various data sources, such as the modular device 9050 itself, the patient monitor 9052, and the database 9054 to which the surgical hub 9000 is connected.

[0120] The surgical hub 9000 can transmit data and outcome data for associated modular devices 9050 to the analysis system 9100 for processing therein. By transmitting both perioperative data indicating how the modular devices 9050 are controlled and procedural outcome data, the analysis system 9100 can correlate different modalities of controlling the modular devices 9050 with surgical outcomes for particular procedural 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 stored instructions 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 different types of modular devices 9050, generate adjustments to the control programs of modular devices 9050 in the field, and then transmit (or "push") updates to the control programs of the modular devices 9050.

[0121] 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.

[0122] 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 having 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 having to remove the loading unit 6514 from the surgical site and reload the loading unit 6514.

[0123] The first and second jaws 6532, 6534 can be configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and sever 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.

[0124] 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.

[0125] The control interface of the handle 6504 can be in communication with a controller 6528 of the handle 6504 to selectively activate the motors to affect rotation of the drive shaft. The controller 6528 can be disposed within the handle 6504 and configured to receive input from the control interface and adapter data from the adapter 6508 or loading unit data from the loading unit 6514. The controller 6528 can analyze the input from the control interface and the data received from the adapter 6508 and / or the loading unit 6514 to selectively activate the motors. The handle 6504 can also include a display viewable by a clinician while using the handle 6504. The display can be configured to display portions of the adapter or loading unit data before, during, or after firing of the instrument 6502.

[0126] The adapter 6508 may include an adapter identification device 6510 disposed therein, and the loading unit 6514 includes a loading unit identification device 6516 disposed therein. The adapter identification device 6510 may be in communication with a controller 6528, and the loading unit identification device 6516 may be in communication with the controller 6528. It will be appreciated that the loading unit identification device 6516 may be in communication with the adapter identification device 6510, which relays or passes through communications from the loading unit identification device 6516 to the controller 6528.

[0127] 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., whether the adapter 6508 is connected to a loading unit, whether the adapter 6508 is connected to a handle, whether 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 6510. The data signals of the multiple sensors 6512 may be analog or digital. The plurality of sensors 6512 may include a force gauge for measuring the force exerted on the loading unit 6514 during firing.

[0128] The handle 6504 and the adapter 6508 may be configured to interconnect the adapter identification device 6510 and the loading unit identification device 6516 with the controller 6528 via an electrical interface. The electrical interface may be a direct electrical interface (i.e., including electrical contacts that engage with each other to transmit energy and signals therebetween). Additionally, or alternatively, the electrical interface may be a contactless electrical interface for wirelessly transmitting (e.g., inductively transmitting) energy and signals therebetween. It is also contemplated that the adapter identification device 6510 and the controller 6528 may communicate with each other wirelessly via a wireless connection separate from the electrical interface.

[0129] 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 a 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.

[0130] 15A shows an exemplary flow for determining an operating mode and operating in the determined mode. The computer-implemented interactive surgical system and / or components and / or subsystems of the computer-implemented interactive surgical system may be configured to be updated. Such updates may include the inclusion of features and benefits that were not available to 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 components and / or subsystems of the computer-implemented interactive surgical system.

[0131] 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 a 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.

[0132] 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.

[0133] 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 manual and / or automatic. The process may be the result of local and / or remote computing. 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.

[0134] 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 be dictated by newly installed / updated control hardware, firmware, and / or software.

[0135] FIG. 15B shows an example functional block diagram for changing the operational mode. The upgradeable element 10714 may include an initialization component 10716. The initialization component 10716 may include any hardware, firmware, and / or software suitable for determining the operational mode. For example, the initialization component 10716 may be part of a system or device startup procedure. The initialization component 10716 may 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.

[0136] The upgradeable element 10714 may include one or more operational components 10720, 10722, 10726, 10728 and an operational pointer 10724. The initialization component 10716 may direct the operational pointer 10724 to direct operation of the upgradeable element 10741 to the operational components 10720, 10722, 10726, 10728 corresponding to the determined operational mode. The initialization component 10716 may direct the operational pointer 10724 to direct operation of the upgradeable element to the default operational component 10720. For example, the default operational component 10720 may be selected in the condition that no other alternative operational mode has been determined. For example, the default operational component 10720 may be selected in the condition of a failure and / or interaction failure of the initialization component. The initialization component 10716 may direct the operational pointer 10724 to direct operation of the upgradeable element 10714 to the resident operational component 10722. For example, a particular feature may reside in the upgradeable component 10714 but require activation in order to operate. The initialization component 10716 may instruct the operation pointer 10724 to direct operation of the upgradeable element 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, a new hardware component may be installed to enable the selected operational mode.

[0137] 16 shows a logic flow diagram of a process 9200 for updating a control program of a modular device 9050, according to at least one embodiment of the present disclosure. Process 9200 can be performed by one or more processors of an analysis server 9070 of an analysis system 9100, for example. In one example, analysis system 9100 can be a cloud computing system. For economy, the following description of process 9200 will be described as being performed by analysis system 9100; however, it should be understood that analysis system 9100 includes a processor and / or control circuitry performing the described steps of process 9200.

[0138] The analysis system 9100 receives 9202 perioperative data and surgical procedure outcome data for the modular device 9050 from one or more of the surgical hubs 9000 communicatively connected to the analysis system 9100. The perioperative data includes pre-operative, intra-operative, and / or post-operative data detected by the modular device 9050 in association with a given surgical procedure. With respect to the modular device 9050 or a particular function of the modular device 9050 that is manually controlled, the perioperative data indicates the manner in which a surgical staff member operated the modular device 9050. With respect to the modular device 9050 or a particular function of the modular device 9050 that is controlled by a modular device's control program, the perioperative data indicates the manner in which the control program operated the modular device 9050. The manner in which the modular device 9050 functions under a particular set of conditions (either due to manual control or control by the modular device's 9050's control program) may be referred to as the “operational behavior” exhibited by the modular device 9050. The perioperative data of the modular device 9050 includes data regarding the status of the modular device 9050 (e.g., the firing or closing force of a surgical stapling and severing instrument, or the output of an electrosurgical or ultrasonic instrument), tissue data measured by the modular device 9050 (e.g., impedance, thickness, or hardness), and other data that may be detected by the modular device 9050. The perioperative data indicates how the modular device 9050 performed in response to various detected conditions, and therefore indicates the manner in which the modular device 9050 was programmed or manually controlled to operate during the course of a surgical procedure.

[0139] The surgical procedure outcome data may include data regarding the overall outcome of the surgical procedure (e.g., whether there were any complications during the surgical procedure) or data regarding the outcome of a particular step within the surgical procedure (e.g., whether a particular staple line bled or leaked). The procedure outcome data may be detected directly by the modular device 9050 and / or the surgical hub 9000 (e.g., a medical imaging device may visualize or detect bleeding), may be determined or inferred by a situational awareness system of the surgical hub 9000 such as described in U.S. Patent Application Publication No. 2019 / 0201140 A1, or may be retrieved from a database 9054 (e.g., an EMR database) by the surgical hub 9000 or the analysis system 9100. The procedure outcome data may include whether each outcome represented by the data was a good or bad outcome. Whether each outcome was good or bad may be determined by the modular device 9050 itself and included in the perioperative data sent to the surgical hub 9000, or may be determined or inferred by the surgical hub 9000 from the received perioperative data. For example, procedure outcome data for a bleeding staple line may include that bleeding indicated a bad outcome. Similarly, procedure outcome data for a non-bleeding staple line may include that no bleeding indicated a good outcome. In another example, the analysis system 9100 may be configured to determine whether the procedure result was a good or bad outcome based on the received procedure outcome data. In some examples, by correlating the modular device 9050 data with a good or bad procedure outcome, the analysis system 9100 can determine whether a control program update should be generated (9208).

[0140] Once the analysis system 9100 receives the data (9202), it analyzes the modular device 9050 and treatment outcome data to determine (9204) whether the modular device 9050 is being utilized suboptimally in connection with a particular treatment or step of a particular treatment. A modular device 9050 may be suboptimally controlled if the particular manner in which the modular device 9050 is controlled repeatedly causes errors, or if an alternative way of controlling the modular device 9050 is superior under the same conditions. Thus, the analysis system 9100 can determine (manually or by its control program) whether the modular device 9050 is being controlled suboptimally by comparing the rate of good and / or bad outcomes produced by the modular device 9050 to set thresholds or the performance of other modular devices 9050 of the same type.

[0141] For example, analysis system 9100 may determine whether a certain type of modular device 9050 is operating suboptimally if the rate of poor procedure outcomes produced by the modular device 9050 under a particular set of conditions associated with a particular operating behavior exceeds an average or threshold level. As a particular example, analysis system 9100 may analyze whether a control program of a surgical stapling instrument, which commands a particular firing force (or range of firing forces), is suboptimal for a particular tissue thickness and tissue type (9204). If analysis system 9100 determines that the instrument produces an abnormally high percentage of leaking staple lines relative to an average or threshold staple line leak rate when fired with a particular force (e.g., causing the staples to misshapen, not fully penetrate the tissue, or tear the tissue), analysis system 9100 can determine that the control program of the surgical stapling instrument is performing suboptimally given the tissue condition.

[0142] As another example, the analysis system 9100 may determine whether a type of modular device 9050 is operating suboptimally if the rate of good outcomes produced by an alternative control modality under a particular set of conditions associated with a particular operating behavior exceeds the rate of good outcomes produced by the control modality analyzed under the same conditions. In other words, if one subset of modular devices 9050 of a type exhibits a first operating behavior under a particular set of conditions and a second subset of modular devices 9050 of the same type exhibits a second operating behavior under the same set of conditions, the analysis system 9100 may determine whether to update the control program of the modular device 9050 according to whether the first operating behavior or the second operating behavior more highly correlates with good treatment outcomes. As a particular example, the analysis system 9100 may analyze (9204) whether a control program for an RF electrosurgical or ultrasonic instrument that prescribes a particular energy level is suboptimal for a particular tissue type and environmental conditions. If the analysis system 9100 determines that a first energy level produces a lower rate of hemostasis than a second energy level given a set of tissue and environmental conditions (e.g., an instrument located in a fluid-filled environment, such as in arthroscopic surgery), the analysis system 9100 can determine that the control program of the electrosurgical or ultrasonic instrument that prescribes the first energy level is performing suboptimally for the given tissue and environmental conditions.

[0143] After analyzing the data (9204), the analysis system 9100 determines (9206) whether to update the control program. If the analysis system 9100 determines that the modular device 9050 is not being controlled suboptimally, the process 9200 continues along the "no" branch, and the analysis system 9100 continues analyzing (9204) the received (9202) data, as described above. If the analysis system 9100 determines that the modular device 9050 is controlling suboptimally, the process 9200 continues along the "yes" branch, and the analysis system 9100 generates (9208) a control program update. The generated (9208) control program update may include, for example, a new version of the control program for the particular type of modular device 9050 to overwrite the previous version, or a patch that partially overwrites or supplements the previous version.

[0144] The type of control program update generated (9208) by the analysis system 9100 depends on the particular suboptimal behavior exhibited by the modular device 9050 identified by the analysis system 9100. For example, if the analysis system 9100 determines that a particular force at which a surgical stapling instrument fires results in an increased percentage of leaking staple lines, the analysis system 9100 may generate (9208) a control program update that adjusts the firing force from a first value to a second value corresponding to a higher percentage of non-leaking staple lines or a lower percentage of leaking staple lines. As another example, if the analysis system 9100 determines that a particular energy level of an electrosurgical or ultrasonic instrument results in a lower rate of hemostasis when the instrument is used in a liquid-filled environment (e.g., due to the energy dissipation effects of the liquid), the analysis system 9100 may generate (9208) a control program update that adjusts the energy level of the instrument when utilized in a surgical procedure in which the instrument is immersed in liquid.

[0145] The type of control program update generated 9208 by the analysis system 9100 also depends on whether the suboptimal behavior exhibited by the modular device 9050 is caused by manual control or by control by the control program of the modular device 9050. If the suboptimal behavior is caused by manual control, the control program update may be configured to provide a warning, recommendation, or feedback to the user based on the manner in which the user is operating the modular device 9050. Alternatively, the control program update may change the manual control behavior of the modular device 9050 to behavior controlled by the control program of the modular device 9050. The control program update may or may not allow the user to override the control program's control of certain functions. In one example, if the analysis system 9100 determines 9204 that the surgeon has manually set the RF electrosurgical instrument to a suboptimal energy level for a particular tissue type or procedure type, the analysis system 9100 can generate 9208 a control program update that provides an alert (e.g., to the surgical hub 9000 or to the RF electrosurgical instrument itself) recommending a change in the energy level. In another example, the generated 9208 control program update can automatically set the energy level to a default or recommended level given the particular detected situation, which can then be changed as desired by medical facility staff. In yet another embodiment, the generated 9208 control program update can automatically set the energy level to a set level determined by the analysis system 9100 and not allow medical facility staff to change the energy level. If the suboptimal behavior is caused by the control program of the modular device 9050, the control program update can change how the control program functions under the particular set of circumstances in which the control program is performing suboptimally.

[0146] Once a control program update is generated (9208) by the analysis system 9100, the analysis system 9100 then transmits (9210) or pushes the control program update to all of the modular devices 9050 of the relevant type connected to the analysis system 9100. The modular devices 9050 may be connected to the analysis system 9100, for example, through a surgical hub 9000. In one example, the surgical hub 9000 is configured to download control program updates for various types of modular devices 9050 from the analysis system 9100 each time an update is generated (9208) by it. When the modular device 9050 is subsequently connected or paired to the surgical hub 9000, the modular device 9050 automatically downloads any control program updates therefrom. In one example, the analysis system 9100 can then continue receiving (9202) and analyzing (9204) data from the modular devices 9050 as described above.

[0147] In one aspect, the surgical system 9060 is configured to push down software parameters and update verification if the modular device 9050 is detected to be out of date in the surgical hub 9000 data stream. FIG. 17 shows a diagram of an analysis system 9100 pushing updates to the modular device 9050 through the surgical hub 9000, in accordance with at least one aspect of the present disclosure. In one example, the analysis system 9000 is configured to send to the surgical hub 9000 control program updates generated for a particular type of modular device 9050. In one aspect, each time the modular device 9050 connects to the surgical hub 9000, the modular device 9050 determines whether an updated version of its control program is on or otherwise accessible via the surgical hub 9000. If the surgical hub 9000 has an updated control program for a particular type of modular device 9050 (or an updated control program is available from the analysis system 9100), the modular device 9050 downloads the control program update from there.

[0148] In one example, any data set sent to the analysis system 9100 includes the unique ID of the surgical hub 9000 and the current version of its control program or operating system. In one example, any data set sent to the analysis system 9100 includes the unique ID of the modular device 9050 and the current version of its control program or operating system. The unique ID of the surgical hub 9000 and / or modular device 9050 associated with the uploaded data allows the analysis system 9100 to determine whether the data corresponds to the most recent version of the control program. The analysis system 9100 can, for example, choose to subtract (or ignore) data generated by a modular device 9050 or surgical hub 9000 that is controlled by an outdated control program, and / or have control program update versions pushed to the modular device 9050 or surgical hub 9000.

[0149] In one example, the operational versions of all modular devices 9050 for which the surgical hub 9000 has updated control software may also be included in the surgical hub 9000's status data block that is periodically transmitted to the analysis system 9100. If the analysis system 9100 identifies that the operational version of the control program of any of the surgical hub 9100 and / or connectable modular devices 9050 is out of date, the analysis system 9100 may push the latest revision of the associated control program to the surgical hub 9000.

[0150] In one example, the surgical hub 9000 and / or modular device 9050 may be configured to automatically download any software updates. In another example, the surgical hub 9000 and / or modular device 9050 may be configured to provide a prompt to the user during the next setup step (e.g., during a surgical procedure) asking whether the user wants to update an out-of-date control program. In another example, the surgical hub 9000 may be programmable by the user to never allow updates or to only allow updates to the modular device 9050 and not the surgical hub 9000 itself.

[0151] 18 shows a diagram of a computer-implemented adaptive surgical system 9060 configured to adaptively generate control program updates for surgical hubs 9000 in accordance with at least one embodiment of the present disclosure. The surgical system 9060 includes several surgical hubs 9000 communicatively coupled to an analysis system 9100. Subpopulations of surgical hubs 9000 (each of which may include an individual surgical hub 9000 or a group of surgical hubs 9000) within the overall population connected to the analysis system 9100 may exhibit different operational behavior during the course of a surgical procedure. Differences in operational behavior between groups of surgical hubs 9000 within the population may arise from the surgical hubs 9000 running different versions of their control programs, from the control programs of the surgical hubs 9000 being customized or programmed differently by local surgical staff, or from local surgical staff manually controlling the surgical hubs 9000 differently. In the illustrated example, the population of surgical hubs 9000 includes a first subpopulation 9312 exhibiting a first operating behavior and a second subpopulation 9314 exhibiting a second operating behavior for a particular task. Although the surgical hubs 9000 are divided into a pair of subpopulations 9312, 9314 in this particular example, there is no practical limit to the number of different behaviors exhibited within a population of surgical hubs 9000. Tasks that the surgical hub 9000 can perform include, for example, controlling a surgical instrument or analyzing a data set in a particular manner.

[0152] The surgical hub 9000 can be configured to transmit perioperative data regarding the operational behavior of the surgical hub 9000 to the analysis system 9100. The perioperative data can include preoperative, intraoperative, and postoperative data. Preoperative data can include patient-specific information such as demographic characteristics, medical history, pre-existing medical conditions, preoperative workup, medication history (i.e., current and previous medications), genetic data (e.g., SNP or gene expression data), EMR data, advanced imaging data (e.g., MRI, CT, or PET), metabolomics, and microbiome. Various additional types of patient-specific information that can be utilized by the analysis system 9100 are described in U.S. Patent No. 9,250,172, U.S. Patent Application Nos. 13 / 631,095, 13 / 828,809, and 8,476,227, each of which is incorporated by reference herein to the extent that it describes patient-specific information. Pre-operative data may also include operating room specific information such as, for example, geographic information, hospital location, operating room location, surgical staff performing the surgical procedure, the attending surgeon, the number and type of modular devices 9050 and / or other surgical equipment that may potentially be used in a particular surgical procedure, the number and type of modular devices 9050 and / or other surgical equipment expected to be used in a particular surgical procedure, patient identification information, and the type of procedure being performed.

[0153] Intraoperative data can include, for example, utilization of the modular device 9050 (e.g., the number of fires by the surgical stapling instrument, the number of fires by the RF electrosurgical or ultrasonic instrument, or the number and type of stapler cartridges utilized), modular device 9050 operating parameter data (e.g., the FTF curve of the surgical stapling instrument, the FTC curve of the surgical stapling instrument, the energy output of the generator, the internal pressure or pressure differential of the smoke evacuator), unexpected utilization of the modular device 9050 (i.e., detection of utilization of a modular device that is not standard for the type of procedure), adjunctive therapy administered to the patient, and utilization of equipment other than the modular device 9050 (e.g., a sealant to address a leak). Intraoperative data can also include, for example, detectable misuse of the modular device 9050 and detectable off-label use of the modular device 9050.

[0154] Post-operative data may include, for example, flags for when a patient does not leave the operating room and / or is sent to non-standard post-operative care (e.g., a patient undergoing routine bariatric surgery is sent to the ICU after the procedure), post-operative patient assessments for the surgical procedure (e.g., data regarding spirometry after thoracic surgery, or data regarding staple line leaks after bowel or bariatric surgery), data regarding post-operative complications (e.g., blood transfusion or air leak), or the patient's length of stay at the medical facility after the procedure. With increasing ratings for hospitals regarding readmission rates, complication rates, average length of stay, and other such metrics of surgical quality, post-operative data sources may be monitored by the analysis system 9100, alone or in combination with surgical procedure outcome data (described below), to evaluate and trigger updates to the control programs of the surgical hub 9000 and / or modular devices 9050.

[0155] In some examples, the intraoperative and / or postoperative data can further include data regarding the outcome of each surgical procedure or step of a surgical procedure. The surgical procedure outcome data can include whether a particular procedure or a particular step of a procedure had a good or bad outcome. In some examples, the surgical procedure outcome data can include procedure step and / or time-stamped images of the modular device 9050 performance, a flag indicating whether the modular device 9050 performed properly, notes from medical facility staff, or a flag indicating poor, suboptimal, or unacceptable modular device 9050 performance. The surgical procedure outcome data can be detected directly by the modular device 9050 and / or surgical hub 9000 (e.g., a medical imaging device can visualize or detect bleeding), determined or inferred by the surgical hub 9000 or analysis system 9100, by a situational awareness system in the surgical hub 9000, such as that described in U.S. Patent Application Publication No. 2019 / 0201140 A1. In some examples, intraoperative data including a flag indicating that modular device 9050 failed or otherwise malfunctioned during the course of a surgical procedure may be prioritized for communication to and / or analysis by analysis system 9100.

[0156] In one example, perioperative data may be aggregated by procedure and uploaded by surgical hub 9000 to and analyzed by analysis system 9100. The perioperative data indicates how surgical hub 9000 was programmed to operate or manually controlled in connection with a surgical procedure (i.e., the operational behavior of surgical hub 9000) to indicate what actions the surgical hub 9000 took in response to various detected conditions, how the surgical hub 9000 controlled modular devices 9050, and how situation-aware surgical hub 9000 inferences derived from received data. Analysis system 9100 may be configured to analyze various types and combinations of pre-operative, intra-operative, and post-operative data to determine whether control program updates should be generated and then push the updates to the entire population of surgical hubs 9000 or one or more subsets, as needed.

[0157] 19 shows a logic flow diagram of a process 9300 for updating a control program of a surgical hub 9000 in accordance with at least one embodiment of the present disclosure. Process 9200 may be performed by one or more processors of an analysis server 9070 of an analysis system 9100, for example. In one example, analysis system 9100 may be a cloud computing system. For economy, the following description of process 9300 will be described as being performed by analysis system 9100; however, it will be understood that analysis system 9100 includes a processor and / or control circuitry performing the described steps of process 9300.

[0158] Analysis system 9100 executing process 9300 receives 9302 perioperative data from a surgical hub 9000 communicatively coupled to analysis system 9100. The perioperative data indicates the manner in which surgical hub 9000 is programmed to operate via its control program or controlled by surgical staff during a surgical procedure. In some aspects, the perioperative data can be included in or transmitted to analysis system 9100 in association with surgical outcome data. Surgical outcome data can include data regarding the overall outcome of the surgical procedure (e.g., whether there were any complications during the surgical procedure) or data regarding particular steps within the surgical procedure (e.g., whether a particular staple line bled or leaked).

[0159] After analysis system 9100 executing process 9300 receives perioperative data (9302), analysis system 9100 then analyzes (9304) the data to determine whether an update condition has been met. In one example, the update condition includes whether a threshold number or percentage of surgical hubs 9000 in a population exhibit a particular operational behavior. For example, analysis system 9100 may determine that when a majority of surgical hubs 9000 are utilized to activate an energy generator at a particular step in a type of surgical procedure, a control program update should be generated to automatically activate the energy generator at that procedure step. In another example, the update condition includes whether the rate of good procedure outcomes (or lack of bad procedure outcomes) correlated with a particular operational behavior exceeds a threshold (e.g., the average rate of good procedure outcomes for a procedural step). For example, analysis system 9100 may determine that a control program update should be generated to recommend that the energy generator be set to a particular energy level when an associated rate of hemostasis (i.e., lack of bleeding) for a particular tissue type exceeds a threshold rate. In another example, the update conditions include whether the rate of good treatment outcomes (or lack of bad treatment outcomes) for a particular operating behavior is higher than the rate of good treatment outcomes (or lack of bad treatment outcomes) for a related operating behavior. In other words, if one subpopulation of surgical hubs 9000 exhibits a first treatment behavior under a particular set of conditions and a second subpopulation of surgical hubs 9000 exhibits a second treatment behavior under the same set of conditions, analysis system 9100 may determine whether to update the control program of surgical hub 9000 according to whether the first treatment behavior or the second treatment behavior is more highly correlated with good treatment outcomes. In another example, analysis system 9100 analyzes (9304) the data to determine whether multiple update conditions are met.

[0160] If the update condition is not met, process 9300 continues along the “no” branch and analysis system 9100 continues receiving (9302) and analyzing (9304) perioperative data from surgical hub 9000 to monitor for the occurrence of the update condition. If the update condition is met, process 9300 continues along the “yes” branch and analysis system 9100 proceeds to generate (9308) a control program update. The nature of the control program update generated (9308) corresponds to the particular operational behavior of surgical hub 9000 identified by analysis system 9100 as causing the update condition. In other words, the control program update adds, removes, or otherwise modifies the functions performed by surgical hub 9000, such as the surgical hub of U.S. Patent Application Publication No. 2019 / 0206003(A1).

[0161] The surgical hub 9000 operates differently under the conditions that caused the identified operational behavior. Furthermore, the type of control program update also depends on whether the identified operational behavior results from manual control or from control by the surgical hub 9000's control program. If the identified operational behavior results from manual control, the control program update may be configured to provide alerts, recommendations, or feedback to the user based on the manner in which the user is operating the surgical hub 9000. For example, if the analysis system 9100 determines that taking a particular action or utilizing a particular instrument at a step during a surgical procedure will improve the outcome, the analysis system 9100 may generate a control program update that provides a prompt, or alert, to surgical staff when the surgical hub 9000 determines that the specified step in the surgical procedure is occurring or will occur later (9308). Alternatively, the control program update may change one or more functions of the surgical hub 9000 from being manually controllable to being controlled by the surgical hub 9000's control program. For example, if analysis system 9100 determines that the visualization system's display has been set to a particular view by surgical staff during numerous surgical procedures in a particular procedure, analysis system 9100 may generate a control program update that causes surgical hub 9000 to automatically change the display to that view under those conditions. If the identified operating behavior arises from the surgical hub 9000's control program, the control program update may modify how the control program functions under the set of circumstances that cause the identified operating behavior. For example, if analysis system 9100 determines that a particular energy level of an RF electrosurgical instrument or an ultrasonic instrument correlates with poor or adverse outcomes under a particular set of conditions, analysis system 9100 may generate a control program update (9308) that causes the energy level of an instrument connected to surgical hub 9000 to be adjusted to a different value when the set of conditions is detected (e.g., when surgical hub 9000 determines that an arthroscopic procedure is being performed).

[0162] The analysis system 9100 then transmits (9310) the control program update to the entire population of surgical hubs 9000 or to a subset of surgical hubs 9000 that are performing the operational behavior identified by the analysis system 9100 as triggering the update condition. In one example, the surgical hub 9000 is configured to download the control program update from the analysis system 9100 each time an update is generated (9308) by it. In one example, the analysis system 9100 can then continue with process 9300 of analyzing (9304) the data received (9302) from the surgical hub 9000, as described above.

[0163] FIG. 20 illustrates an exemplary implementation of process 9300 shown in FIG. 19 . FIG. 20 illustrates a logic flow diagram of a process 9400 for updating a data analysis algorithm of a control program of a surgical hub 9000 in accordance with at least one embodiment of the present disclosure. Like process 9300 shown in FIG. 19 , process 9400 shown in FIG. 20 may, in one example, be performed by analysis system 9100. In one example of adaptive surgical system 9060 shown in FIG. 18 , a first surgical hub subpopulation 9312 utilizes a first data analysis algorithm and a second surgical hub subpopulation 9314 utilizes a second data analysis algorithm. For example, the first surgical hub subpopulation 9312 may utilize a normal continuous probability distribution to analyze a particular data set, and the second surgical hub subpopulation 9314 may utilize a bimodal distribution to analyze the particular data set. In this example, analysis system 9100 receives perioperative data from first and second surgical hub subpopulations 9312, 9314 corresponding to respective data analysis algorithms (9402, 9404). Analysis system 9100 then analyzes (9406) the perioperative data sets to determine whether one of the perioperative data sets meets one or more update conditions. The update conditions may include, for example, a particular analysis method being utilized by a threshold percentage of surgical hubs 9000 in the overall population (e.g., 75%) and a particular analysis method being correlated to good surgical outcomes in a threshold percentage of cases (e.g., 50%).

[0164] In this example, the analysis system 9100 determines (9408) whether one of the data analysis algorithms utilized by the first and second surgical hub subpopulations 9312, 9314 satisfies both of the update conditions. If the update conditions are not met, process 9400 proceeds along the “no” branch and analysis system 9100 continues receiving (9402, 9404) and analyzing (9406) perioperative data from the first and second surgical hub subpopulations 9312, 9314. If the update conditions are met, process 9400 proceeds along the “yes” branch and analysis system 9100 generates (9412) a control program update according to which of the data analysis algorithms the analysis (9406) determined met the update conditions. In this example, the control program update includes causing surgical hub 9000 to utilize the data analysis algorithm that met the update conditions when performing the corresponding analysis type. The analysis system 9100 then transmits 9414 the generated 9412 control program update to the population of surgical hubs 9000. In one example, the control program update is transmitted 9414 to the entire population of surgical hubs 9000. In another example, the control program update is transmitted 9414 to the subset of surgical hubs 9000 that did not utilize the data analysis algorithm that satisfied the update condition. In other words, if the analysis system 9100 analyzes 9406 the perioperative data and determines 9408 that the second (bimodal) data analysis method satisfies the update condition, then the generated 9412 control program update is transmitted 9414 to the first subset of surgical hubs 9000, in this example. Additionally, the control program update may cause the updated surgical hub 9000 to utilize a second (bimodal) data analysis algorithm when analyzing a particular data set, or may cause the updated surgical hub 9000 to warn or recommend to the user that a second (bimodal) data analysis algorithm be used under given conditions (allowing the user to choose whether to follow the recommendation).

[0165] This approach improves the performance of surgical hubs 9000 by updating control programs generated from data aggregated from across the network of surgical hubs 9000. In effect, each surgical hub 9000 can be adjusted according to knowledge shared or learned across the surgical hub 9000 network. This approach also provides the analysis system 9100 with knowledge of the devices being utilized in each type of surgical procedure across the surgical hub 9000 network, allowing the analysis system 9100 to determine when an unexpected device (e.g., modular device 9050) is utilized during the course of a surgical procedure.

[0166] 21 illustrates a system 21000 for communication between a surgical instrument 21002, a surgical hub 21004, and a cloud computing system 21006, in accordance with at least one embodiment of the present disclosure. The surgical instrument 21002 may include a transmitter 21008 and a receiver 21010. The transmitter 21008 and the receiver 21010 may be configured to establish communication paths 21012 and 21014 between at least one external device. For example, the communication path 21012 may be between the surgical instrument 21002 and the surgical hub 21004. The communication path 21014 may be between the surgical instrument 21002 and the cloud computing system 21006. The surgical instrument 21002 may include a control algorithm 21016. The control algorithm 21016 may be updated based on new data received. The surgical instrument 21002 may include a processor 21018. The processor 21018 can update the control algorithm 21016. The control algorithm 21016 can execute a series of actions based on control parameters in the form of input data. The control algorithm 21016 can transmit the input data to an output signal. The input data may be aggregated by the cloud computing system 21006, as described above. For example, the input data may relate to use setup, EMR information, treatment information, and / or product configuration. In some examples, the aggregated data may relate to compiled use steps and / or treatment plans. In some examples, the aggregated data can be used to determine trends in outcomes, use, and / or products. In some examples, the aggregated data is used as an education and process improvement system. While FIG. 21 shows a surgical instrument 21002, it may also include the surgical instrument 112 (FIG. 1), the surgical instrument 600 (FIG. 8), the surgical instrument 7012 (FIG. 11), and / or the surgical instrument 6502 (FIG. 14).

[0167] The surgical hub 21004 may include a transmitter 21026 and a receiver 21028 that may be configured to establish a communication path between the surgical hub 21004 and at least one external device. For example, the communication path 21012 may be between the surgical hub 21004 and the surgical instrument 21002, and the communication path 21024 may be between the surgical hub 21004 and the cloud computing system 21006. The surgical hub 21004 may include a control algorithm 21030 that may be updated based on new data received. The surgical hub 21004 may include a processor 21032 that may update the control algorithm 21030. FIG. 21 shows surgical hub 21004, which may include surgical hub 205 (FIG. 5), surgical hub 206 (FIG. 6), surgical hub 5104 (FIG. 9), surgical hub 7006 (FIG. 11), and / or surgical hub 9000 (FIG. 13).

[0168] The cloud computing system 21006 may constitute a cloud-based analysis system and may include one or more networked computing resources. The cloud computing system 21006 may be communicatively coupled to the surgical hub 21004 via communication path 21024 and to the surgical instrument 21002 via communication path 21014. The cloud computing system 21006 can quickly and efficiently identify data based on specific criteria. In some situations, the cloud computing system 21006 may aggregate data determined from multiple surgical sites. The cloud computing system 21006 may process the aggregated data by data classification, prioritization, and other types of data processing based on specific criteria or thresholds. FIG. 21 illustrates the cloud computing system 21006, which may include the analysis system 9100 described in FIG. 16.

[0169] 22 shows a logic flow diagram of a process 22000 for updating a control algorithm of a surgical hub 21004 in accordance with at least one aspect of the present disclosure. At 22002, the process 22000 can configure the surgical hub 21004 to seek communication with a cloud computing system 21006. A transmitter 21026 and a receiver 21028 can be configured to establish a communication path 21024 between the surgical hub 21004 and the cloud computing system 21006. For example, the transmitter 21026 of the surgical hub 21004 may send a communication request to the cloud computing system 21006. At 22004, the surgical hub 21004 may determine whether communication with the cloud computing system 21006 is available. For example, determining whether communication with the cloud computing system 21006 is available can be determined by system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and / or power capacity. The cloud computing system 21006 may be configured to aggregate data from multiple surgical devices. If communication is not available, the surgical hub 21004 may be configured to operate in a default operating mode when communication with the cloud computing system is not available and may later seek communication with the cloud computing system 21006 at 22002. If communication is available, the surgical hub 21004 may receive aggregated data from the cloud computing system 21006 via the receiver 21028 at 22006. In some examples, the aggregated data may relate to setup, EMR information, treatment information, and / or use of product configurations. In some examples, the aggregated data may relate to compiled use steps and / or treatment plans. In some examples, the aggregated data may be used to determine trends in outcomes, use, and / or products. In some examples, the aggregated data is used as an education and process improvement system. At 22008, the surgical hub 21004 may update one or more control algorithms based on the received aggregated data.At 22010, the surgical hub 21004 may determine whether additional updates are available from the cloud computing system 21006. If additional updates are not available, the surgical hub 21004 may, for example, seek communication with the cloud computing system 21006 at a later time, at 22002. If additional updates are available, the surgical hub 21004 may continue to communicate with the cloud computing system 21006 to receive additional updates, at 22012, which additional updates relate to updated aggregate data determined by the cloud computing system 21006. In some examples, the surgical hub 21004 may include the upgradable element 3014 described above in FIG. 15B. The upgradable element 3014 may operate to update the operating mode of one or more control algorithms of the surgical hub 21004 based on the received aggregate data.

[0170] 23 shows a logic flow diagram of a process 23000 for updating an algorithm of a surgical instrument 21002 in accordance with at least one aspect of the present disclosure. At 23002, the process 23000 can configure the surgical instrument 21002 to seek communication with a cloud computing system 21006. The transmitter 21008 and receiver 21010 can be configured to establish a communication path between the surgical instrument 21002 and the cloud computing system 21006. For example, the transmitter 21008 of the surgical instrument 21002 can send a communication request to the cloud computing system 21006. At 23004, the surgical instrument 21002 can determine whether communication with the cloud computing system 21006 is available. For example, determining whether communication with the cloud computing system 21006 is available can be determined by system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and / or power capacity. The cloud computing system 21006 may be configured to aggregate data from multiple surgical devices. If communication is not available, the surgical instrument 21002 may be configured to operate in a default operating mode when communication with the cloud computing system is not available, for example, and may later seek communication with the cloud computing system 21006 at 23002. If communication is available, the surgical instrument 21002 may receive aggregated data from the cloud computing system 21006 via the receiver 21010 at 23006. In some examples, the aggregated data may relate to setup, EMR information, treatment information, and / or use of product configurations. In some examples, the aggregated data may relate to compiled use steps and treatment plans. In some examples, the aggregated data may be used to determine trends in outcomes, use, and / or products. In some examples, the aggregated data is used as an education and process improvement system. At 23008, the surgical instrument 21002 may update one or more control algorithms based on the received aggregated data.At 23010, the surgical instrument 21002 may determine whether additional updates are available from the cloud computing system 21006. If additional updates are not available, the surgical instrument 21002 may, for example, seek communication with the cloud computing system 21006 at a later time at 23002. If additional updates are available, the surgical instrument 21002 may, at 23012, continue to communicate with the cloud computing system 21006 to receive additional updates, the additional updates related to updated aggregate data determined by the cloud computing system 21006. In some examples, the surgical instrument 21004 may include the upgradable element 3014 described above in FIG. 15B. The upgradable element 3014 may operate to update the operating mode of one or more control algorithms of the surgical instrument 21002 based on the received aggregate data.

[0171] 24 shows a logic flow diagram of a process 24000 for updating a surgical system in accordance with at least one aspect of the present disclosure. At 24002, the process 22000 can configure the surgical hub 21004 to seek communication with a cloud computing system 21006. The transmitter 21026 and the receiver 21028 can be configured to establish a communication path between the surgical hub 21004 and the cloud computing system 21006. For example, the transmitter 21026 of the surgical hub 21004 may send a communication request to the cloud computing system 21006. At 24004, the surgical hub 21004 may determine whether communication with the cloud computing system 21006 is available. For example, the determination of whether communication with the cloud computing system 21006 is available may be determined by system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and / or power capacity. The cloud computing system 21006 may be configured to aggregate data from multiple surgical devices. If communication is not available, the surgical hub 21004 may be configured to operate in a default operating mode when communication with the cloud computing system is not available, for example, and may later seek communication with the cloud computing system 21006 at 24002. If communication is available, the surgical hub 21004 may receive aggregated data from the cloud computing system 21006 via the receiver 21028 at 24006. In some examples, the aggregated data may relate to setup, EMR information, treatment information, and / or use of product configurations. In some examples, the aggregated data may relate to compiled use steps and treatment plans. In some examples, the aggregated data may be used to determine trends in outcomes, use, and / or products. In some examples, the aggregated data is used as an education and process improvement system. At 24008, the surgical hub 21004 may update one or more control algorithms based on the received aggregated data.At 24010, the surgical hub 21004 may determine whether additional updates are available from the cloud computing system 21006. If additional updates are not available, the surgical hub 21004 may, for example, seek communication with the cloud computing system 21006 at a later time at 24002. If additional updates are available, the surgical hub 21004 may continue to communicate with the cloud computing system 21006 at 24012 to receive additional updates, which are related to updated aggregate data determined by the cloud computing system 21006. In some examples, the surgical system may include the upgradable element 3014 described above in FIG. 15B. The upgradable element 3014 may operate to update the operating mode of one or more control algorithms of the surgical hub 21004 and / or the surgical instrument 21002 based on the received aggregate data.

[0172] After the surgical instrument 21004 receives the additional updates, at 24014, the process 24000 may configure the surgical instrument 21002 to seek communication with the surgical hub 21004 and / or direct communication with the cloud computing system 21006. The transmitter 21008 and receiver 21010 may be configured to establish a communication path between the surgical instrument 21002 and the surgical hub 21004, and a communication path between the surgical instrument 21002 and the cloud computing system 21006. For example, the transmitter 21008 of the surgical instrument 21002 may send a communication request to the surgical hub 21004 and / or the cloud computing system 21006. At 24016, the surgical instrument 21002 may determine whether communication with the surgical hub 21004 and / or the cloud computing system 21006 is available. For example, a determination of whether communication with the surgical hub 21004 and / or cloud computing system 21006 is available may be determined by system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and / or power capacity. The surgical hub 21004 may be configured to store aggregated data received from the cloud computing system 21006. The cloud computing system 21006 may be configured to aggregate data from multiple surgical devices. If communication is not available, the surgical instrument 21002 may be configured to operate in a default operating mode when communication with the surgical hub 21004 or cloud computing system 21006 is not available, and may later seek communication with the surgical hub 21004 or cloud computing system 21006, for example, in 23002. If communication is available, at 24018, the surgical instrument 21002 may receive aggregated data from the surgical hub 21004 via the receiver 21010 or directly from the cloud computing system 21006. In some examples, the aggregated data may relate to setup, EMR information, treatment information, and / or use of product configurations. In some examples, the aggregated data may relate to compiled use steps and treatment plans.In some examples, the aggregated data can be used to determine trends in outcomes, usage, and / or products. In some examples, the aggregated data is used as an education and process improvement system. At 24020, the surgical instrument 21002 may update one or more control algorithms based on the received aggregated data. At 24022, the surgical instrument 21002 may determine whether additional updates are available from the surgical hub 21004 or directly from the cloud computing system 21006. If additional updates are not available, the surgical instrument 21002 may seek communication with the surgical hub 21004 or the cloud computing system 21006, for example, at a later time, at 24002. If additional updates are available, the surgical instrument 21002 may continue to communicate with the surgical hub 21004 and / or the cloud computing system 21006 to receive additional updates at 24024, the additional updates related to the updated aggregated data determined by the cloud computing system 21006.

[0173] The cloud computing system 21006 can provide data monitoring with monthly / quarterly reports and utilize data collected at specific facilities compared to any country / region / local area. The cloud computing system 21006 can provide recommendations to either reduce risk, improve safety, shorten surgery time, and / or reduce total product usage. In one aspect, the cloud computing system 21006 can provide an inventory management method. For example, the cloud computing device 21006 can provide guidance based on demographic characteristics, usage, and / or procedure type to optimize inventory. For example, at the end of a surgery, the cloud computing system 21006 can report all devices and cartridges used so that individual hospitals know what was used and if any need to be ordered. In one aspect, the cloud computing system 21006 can track all items placed at a location to ensure items are placed in their current location.

[0174] The cloud computing system 21006 may provide services to monitor surgeries and provide floor plan and resource reconfigurations that can reduce surgical time / room usage. For example, the cloud computing system 21006 may be linked to systems / apps that provide instant answers, such as mobile device apps, for questions about devices, procedures, and training. For example, the cloud computing system 21006 may provide access to databases and message boards, allowing users to ask questions, view questions asked by other users, and the answers to those questions. In one aspect, the cloud computing system 21006 may provide services based on data that can create specific training programs tailored to the best possible treatment, which may be location-specific.

[0175] Examples of the present disclosure The following is a non-exhaustive list of examples of layered remote server analysis capabilities: 1. A surgical hub comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and a cloud computing system configured to aggregate data from a plurality of surgical devices; a processor, wherein the processor: determining whether communication with a cloud computing system is available; receiving, from the cloud computing system via the receiver, aggregated data from the plurality of surgical devices; updating one or more control algorithms based on the received aggregated data; and A surgical hub configured to receive updates from the cloud computing system, the updates relating to updated aggregated data. The data provided by the multiple surgical devices in Example 1 and the following examples may include one or more of surgical instrument data, patient outcome data, performance characteristics, EMR information, and procedure videos. Updates from the cloud computing system to the surgical hub or connected surgical instruments in Example 1 and the following examples may be provided in a hierarchical structure, with multiple levels or hierarchies of updates being provided by the cloud computing system. For example, the level or tier of updates may be determined by the cloud computing system based on one or more control parameters. For example, the control parameters may relate to one or more requirements such as system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity. 2. The surgical hub of Example 1, wherein the surgical hub is configured to use aggregate data to determine trends in outcomes, usage, and products. 3. The surgical hub of example 1, wherein the aggregated data relates to use of setup, EMR information, procedure information, and product configuration. For example, a cloud computing system or surgical hub may be configured to aggregate one or more of: setup information, EMR information, instrument and procedure information, such as procedure videos and product configuration usage. 4. The surgical hub described in Example 1, wherein the aggregated data relates to a compiled use procedure and treatment plan. For example, the cloud computing system or surgical hub may be configured to provide suggestions and recommendations regarding instruments, medical procedures, and operating rooms, such as suggestions for alternate product use, application steps, treatment plans, trocar locations, and / or operating room settings. 5. The surgical hub of example 1, wherein the surgical hub is configured to use the aggregated data for an education and process improvement system. 6. A surgical hub described in any one of Examples 1 to 5, wherein the processor is configured to operate in a default operating mode if communication with the cloud computing system is not available. 7. A surgical hub described in any one of Examples 1 to 6, wherein the determination of whether communication with a cloud computing system is available is determined according to one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity. For example, the tiers provided may be based on various levels of requirements, which may relate to hardware, software, and communications networks, such as system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity. 8. A surgical instrument comprising: a transmitter and a receiver configured to establish a communication path between the surgical instrument and a cloud computing system configured to aggregate data from a plurality of surgical devices; a processor, wherein the processor: determining whether communication with a cloud computing system is available; receiving, from the cloud computing system via the receiver, aggregated data from the plurality of surgical devices; updating one or more control algorithms based on the received aggregated data; and A surgical instrument configured to receive updates from a cloud computing system, the updates relating to updated aggregated data. 9. The surgical instrument of Example 8, wherein aggregate data is used to determine trends in outcomes, usage, and product. 10. The surgical instrument of example 8, wherein the aggregate data relates to use of setup, EMR information, procedure information, and product configuration. 11. The surgical instrument of Example 8, wherein the aggregate data relates to a compiled use process and treatment plan. 12. The surgical instrument of example 8, wherein the aggregate data can be used for education and process improvement systems. 13. A surgical instrument described in any one of Examples 8 to 12, wherein the processor is configured to operate in a default operating mode if communication with a cloud computing system is not available. 14. A surgical instrument described in any one of Examples 8 to 13, wherein the determination of whether communication with a cloud computing system is available is determined by one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity. 15. A surgical system comprising: a cloud computing system configured to aggregate data from a plurality of surgical devices; 1. A surgical hub comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and the cloud computing system; a processor, wherein the processor: determining whether communication with a cloud computing system is available; receiving, from the cloud computing system via the receiver, aggregated data from the plurality of surgical devices; updating one or more surgical hub control algorithms based on the received aggregated data; and a surgical hub configured to receive updates from the cloud computing system, the updates relating to updated aggregated data; A surgical instrument comprising: a transmitter and a receiver configured to establish a communication path between the surgical instrument and the cloud computing system; a processor, wherein the processor: determining whether communications with a cloud computing system and a surgical hub are available; receiving aggregate data related to the plurality of surgical devices from a cloud computing system or a surgical hub via a receiver on the surgical instrument; updating one or more surgical tool control algorithms based on the received aggregated data; and A surgical system comprising: a surgical instrument configured to receive updates from a cloud computing system or a surgical hub, the updates relating to updated aggregate data. 16. The surgical system of example 15, wherein the aggregated data relates to setup, EMR information, procedure information, and product configuration usage. By way of further example, the cloud computing system or surgical hub is configured to aggregate one or more of setup information, EMR information, procedure video, and product configuration usage. 17. The surgical system of Example 15, wherein the aggregated data relates to a compiled use procedure and treatment plan. 18. The surgical system of Example 15, wherein the surgical hub is configured to use aggregate data to determine trends in outcomes, usage, and products. 19. The surgical system of Example 15, wherein the surgical hub is configured to use the aggregated data in an education and process improvement system. 20. A surgical system described in any one of Examples 15 to 19, wherein the determination of whether communication with a cloud computing system is available is determined by one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity.

[0176] As at least examples 1, 8, and 18, a system with multiple levels or "tiers" of data analysis is provided. The cloud computing system has data aggregation capabilities for aggregating data from multiple surgical devices. The cloud computing system also provides updates to the local hub and / or connected devices for setup and other uses. As an example of the above, updates may be provided to the surgical devices directly or via the local hub. As an example of the above, the cloud computing system has analytical capabilities. The cloud computing system aggregates data and looks for trends in outcomes, usage, and products. The cloud computing system can aggregate setup, EMR information, procedure videos, and product configuration usage. The cloud computing system can also suggest alternate product usage, usage steps, procedure plans, trocar locations, and operating room settings.

[0177] The scope of updates can vary from simple updates to the control algorithms of the hub and its connected equipment, which may be provided by a "push" from the cloud computing system, to more elaborate interactive communication and data transfer with the devices and HCPs. As an example of the above, the cloud computing system may selectively provide multiple levels of updates, thereby providing the appropriate level of update based on dynamic requirements such as system capacity, data capacity, or power capacity. This allows for controlled usage aggregation and system updates, which in turn contributes to further device improvement and treatment success.

[0178] The present disclosure includes the following embodiments. 1. A surgical hub comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and a cloud computing system; and a processor, wherein the processor is configured to determine whether communication with a cloud computing system configured to aggregate data from a plurality of surgical devices is available; receive aggregated data from the plurality of surgical devices via the receiver; update one or more control algorithms based on the received aggregated data; and continue communicating with the cloud computing system to receive additional updates, the additional updates related to the updated aggregated data determined by the cloud computing system. 2. The surgical hub of embodiment 1, wherein aggregate data is used to determine trends in outcomes, usage, and products. 3. A surgical hub as described in embodiment 1, wherein the aggregated data relates to use of setup, EMR information, procedure information, and product configuration. 4. A surgical hub as described in embodiment 1, wherein the aggregated data relates to a compiled use process and treatment plan. 5. A surgical hub as described in embodiment 1, wherein the aggregated data is used as an education and process improvement system. 6. A surgical hub as described in embodiment 1, wherein the processor is configured to operate in a default operating mode if communication with the cloud computing system is not available. 7. A surgical hub as described in embodiment 1, wherein the determination of whether communication with a cloud computing system is available is determined by system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity. 8. A surgical instrument comprising: a transmitter and a receiver configured to establish a communication path between the surgical instrument and a cloud computing system; and a processor, wherein the processor is configured to determine whether communication with a cloud computing system configured to aggregate data from a plurality of surgical devices is available; receive aggregated data from the plurality of surgical devices via the receiver; update one or more control algorithms based on the received aggregated data; and continue communication with the cloud computing system to receive additional updates, the additional updates related to the updated aggregated data determined by the cloud computing system. 9. The surgical instrument of embodiment 8, wherein aggregate data is used to determine trends in outcomes, usage, and products. 10. A surgical instrument as described in embodiment 8, wherein the aggregate data relates to use of setup, EMR information, procedure information, and product configuration. 11. A surgical instrument as described in embodiment 8, wherein the aggregated data relates to a compiled use process and treatment plan. 12. The surgical instrument of embodiment 8, wherein the aggregated data is used as an education and process improvement system. 13. A surgical instrument as described in embodiment 8, wherein the processor is configured to operate in a default operating mode if communication with the cloud computing system is not available. 14. A surgical instrument as described in embodiment 8, wherein the determination of whether communication with a cloud computing system is available is determined by system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity. 15. A surgical system comprising: a cloud computing system configured to aggregate data from a plurality of surgical devices; a surgical hub configured to establish a communication path between the surgical hub and the cloud computing system, the surgical hub having a transmitter and a receiver; and a processor, wherein the processor is configured to determine whether communication with the cloud computing system is available, receive aggregated data from the plurality of surgical devices via the receiver, update one or more surgical hub control algorithms based on the received aggregated data, and continue communication with the cloud computing system to receive additional updates, the additional updates being related to the updated aggregated data as determined by the cloud computing system. a surgical hub; a surgical instrument, the transmitter and receiver configured to establish a communication path between the surgical instrument and a cloud computing system; and a processor, wherein the processor is configured to determine whether communication with the cloud computing system and the surgical hub is available, receive aggregate data related to a plurality of surgical devices from the cloud computing system or the surgical hub via the receiver, update one or more surgical instrument control algorithms based on the received aggregate data, and continue communication with the cloud computing system and the surgical hub to receive additional updates, the additional updates being related to the updated aggregate data determined by the cloud computing system. 16. A surgical system as described in embodiment 15, wherein the aggregated data relates to use of setup, EMR information, procedure information, and product configuration. 17. A surgical system as described in embodiment 15, wherein the aggregated data relates to a compiled use process and treatment plan. 18. A surgical system as described in embodiment 15, wherein aggregated data from the surgical hub is used to determine outcomes, usage, and products. 19. A surgical system as described in embodiment 15, wherein the aggregated data of the surgical hub is used as an education and process improvement system. 20. A surgical system as described in embodiment 15, wherein the determination of whether communication with a cloud computing system is available is determined by system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity.

[0179] [Embodiment] (1) A surgical hub, a transmitter and receiver configured to establish a communication path between the surgical hub and a cloud computing system configured to aggregate data from a plurality of surgical devices; a processor, the processor determining whether communication with the cloud computing system is available; receiving aggregated data from a plurality of surgical devices from the cloud computing system via the receiver; updating one or more control algorithms based on the received aggregated data; and A surgical hub configured to receive updates from the cloud computing system, the updates relating to updated aggregated data. (2) A surgical hub as described in embodiment 1, wherein the surgical hub is configured to use the aggregate data to determine trends in outcomes, usage, and products. (3) A surgical hub as described in embodiment 1 or 2, wherein the aggregated data relates to use of setup, EMR information, procedure information, and product configuration. (4) A surgical hub as described in any one of embodiments 1 to 3, wherein the aggregated data relates to compiled usage steps and treatment plans. (5) A surgical hub as described in any one of embodiments 1 to 4, wherein the surgical hub is configured to use the aggregated data for an education and process improvement system.

[0180] (6) A surgical hub described in any one of embodiments 1 to 5, wherein the processor is configured to operate in a default operating mode if communication with the cloud computing system is not available. (7) A surgical hub as described in any one of embodiments 1 to 6, wherein the determination of whether communication with the cloud computing system is available is determined according to one or more parameters including system generation, software revision, system capability, type of interconnected devices, level of networking, data capacity, and power capacity. (8) A surgical instrument, a transmitter and receiver configured to establish a communication path between the surgical instrument and a cloud computing system configured to aggregate data from multiple surgical devices; a processor, the processor determining whether communication with the cloud computing system is available; receiving aggregate data from the plurality of surgical devices from the cloud computing system via the receiver; updating one or more control algorithms based on the received aggregated data; and A surgical instrument configured to receive updates from the cloud computing system, the updates relating to updated aggregated data. (9) The surgical instrument of claim 8, wherein the aggregate data is used to determine trends in outcomes, usage, and products. (10) The surgical instrument of any one of claims 8 to 9, wherein the aggregated data relates to setup, EMR information, procedure information, and product configuration usage.

[0181] (11) A surgical instrument according to any one of claims 8 to 10, wherein the aggregated data relates to a compiled use process and treatment plan. (12) The surgical instrument of any one of claims 8 to 11, wherein the aggregated data is usable for education and process improvement systems. (13) A surgical instrument according to any one of embodiments 8 to 12, wherein the processor is configured to operate in a default operating mode if communication with the cloud computing system is not available. (14) The surgical instrument according to any one of embodiments 8 to 13, wherein the determination of whether communication with the cloud computing system is available is determined by one or more parameters including system generation, software revision, system capability, types of interconnected devices, level of networking, data capacity, and power capacity. (15) A surgical system, comprising: a cloud computing system configured to aggregate data from a plurality of surgical devices; 1. A surgical hub comprising: a transmitter and receiver configured to establish a communication path between the surgical hub and the cloud computing system; a processor, the processor determining whether communication with the cloud computing system is available; receiving the aggregated data from the plurality of surgical devices from the cloud computing system via the receiver; updating one or more surgical hub control algorithms based on the received aggregated data; and a surgical hub configured to receive updates from the cloud computing system, the updates relating to updated aggregated data; A surgical instrument comprising: a transmitter and a receiver configured to establish a communication path between the surgical instrument and the cloud computing system; a processor, the processor determining whether communications with the cloud computing system and the surgical hub are available; receiving the aggregated data related to the plurality of surgical devices from the cloud computing system or the surgical hub via the receiver of the surgical instrument; updating one or more surgical tool control algorithms based on the received aggregated data; and a surgical instrument configured to receive updates from the cloud computing system or the surgical hub, the updates relating to updated aggregate data.

[0182] (16) The surgical system of embodiment 15, wherein the aggregated data relates to one or more of setup, EMR information, procedure information, and product configuration usage. (17) A surgical system as described in embodiment 15 or 16, wherein the aggregated data relates to a compiled use procedure and treatment plan. (18) A surgical system according to any one of claims 15 to 17, wherein the surgical hub is configured to use the aggregated data to determine trends in outcomes, usage, and products. (19) A surgical system described in any of embodiments 15 to 18, wherein the surgical hub is configured to use the aggregated data in an education and process improvement system. (20) A surgical system described in any of embodiments 15 to 19, wherein the determination of whether communication with the cloud computing system is available is determined by one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity.

Claims

1. A surgical hub communicatively connected to a plurality of surgical devices, a transmitter and receiver configured to establish a communication path between the surgical hub and a cloud computing system configured to aggregate data from a plurality of surgical devices; a processor, the processor determining whether communication with the cloud computing system is available; operating the surgical hub in a default mode of operation when communication with the cloud computing system is not available, and receiving aggregated data from the plurality of surgical devices from the cloud computing system via the receiver when communication with the cloud computing system is available; updating one or more control algorithms based on the received aggregated data; and A surgical hub configured to receive updates from the cloud computing system, the updates relating to updated aggregated data.

2. The surgical hub of claim 1, wherein the surgical hub is configured to use the aggregated data to determine trends in outcomes, usage, and products.

3. The surgical hub of claim 1 or 2, wherein the aggregated data relates to use of setup, EMR information, procedure information, and product configuration.

4. The surgical hub of any one of claims 1 to 3, wherein the aggregated data relates to a compiled application process and treatment plan.

5. The surgical hub of any one of claims 1 to 4, wherein the surgical hub is configured to use the aggregated data for an education and process improvement system.

6. 6. The surgical hub of claim 1, wherein the determination of whether communication with the cloud computing system is available is determined according to one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity.

7. A surgical instrument comprising: a transmitter and receiver configured to establish a communication path between the surgical instrument and a cloud computing system configured to aggregate data from multiple surgical devices including the surgical instrument; a processor, the processor determining whether communication with the cloud computing system is available; operating the surgical instrument in a default operating mode when communication with the cloud computing system is not available, and receiving aggregate data from the plurality of surgical devices from the cloud computing system via the receiver when communication with the cloud computing system is available; updating one or more control algorithms based on the received aggregated data; and A surgical instrument configured to receive updates from the cloud computing system, the updates relating to updated aggregated data.

8. The surgical instrument of claim 7 , wherein the aggregate data is used to determine trends in outcomes, usage, and products.

9. The surgical instrument of claim 7 or 8, wherein the aggregated data relates to use of setup, EMR information, procedure information, and product configuration.

10. The surgical instrument of any one of claims 7 to 9, wherein the aggregated data relates to a compiled use process and treatment plan.

11. The surgical instrument of any one of claims 7 to 10, wherein the aggregated data is usable in education and process improvement systems.

12. 12. The surgical instrument of claim 7, wherein the determination of whether communication with the cloud computing system is available is determined by one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity.

13. 1. A surgical system comprising: a cloud computing system configured to aggregate data from a plurality of surgical devices, including surgical instruments; a surgical hub communicatively coupled to the plurality of surgical devices, a transmitter and receiver configured to establish a communication path between the surgical hub and the cloud computing system; a processor, the processor determining whether communication with the cloud computing system is available; operating the surgical hub in a default mode of operation when communication with the cloud computing system is not available, and receiving aggregated data from the plurality of surgical devices from the cloud computing system via the receiver when communication with the cloud computing system is available; updating one or more surgical hub control algorithms based on the received aggregated data; and a surgical hub configured to receive updates from the cloud computing system, the updates relating to updated aggregated data; The surgical instrument comprises: a transmitter and receiver configured to establish a communication path between the surgical instrument and the surgical hub and the cloud computing system; a processor, the processor determining whether communications with the cloud computing system and the surgical hub are available; operating the surgical instrument in a default operating mode when communication with the cloud computing system and the surgical hub is not available, and receiving the aggregated data related to the plurality of surgical devices including the surgical instrument from the cloud computing system or the surgical hub via the receiver of the surgical instrument when communication with the cloud computing system and the surgical hub is available; updating one or more surgical tool control algorithms based on the received aggregated data; and a surgical instrument configured to receive updates from the cloud computing system or the surgical hub, the updates relating to updated aggregate data.

14. The surgical system of claim 13 , wherein the aggregated data relates to one or more of setup, EMR information, procedure information, and product configuration usage.

15. The surgical system of claim 13 or 14, wherein the aggregated data relates to a compiled application process and treatment plan.

16. The surgical system of any one of claims 13 to 15, wherein the surgical hub is configured to use the aggregate data to determine trends in outcomes, usage, and products.

17. The surgical system of any one of claims 13 to 16, wherein the surgical hub is configured to use the aggregated data in an education and process improvement system.

18. 18. The surgical system of claim 13, wherein the determination of whether communication with the cloud computing system is available is determined by one or more parameters including system generation, software revision, system capabilities, types of interconnected devices, level of networking, data capacity, and power capacity.

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