End Effector Updates

Abstract

Examples herein describe a powered surgical end effector that may include a controllable jaw configured to operate relative to tissue, an updatable memory having a default actuation algorithm stored therein, and a processor. The processor may be configured to operate in a first mode at a first time, where in the first mode the processor may be configured to operate one aspect of the controllable jaw according to the default actuation algorithm. The processor may receive data that causes the processor to operate in a second mode at a second time after the first time, where in the second mode the processor may be configured to operate one aspect of the controllable jaw according to an alternative actuation algorithm.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is related to the following concurrently filed applications, the contents of each of which are incorporated herein by reference: ●Agent reference number END9287USNP1, titled METHOD FOR OPERATING TIERED OPERATION MODES IN A SURGICAL SYSTEM. [Background technology]

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

[0003] The present disclosure provides various embodiments, including the following list of examples. Example 1. A powered surgical end effector for use in a surgical system, comprising: a controllable jaw configured to act on tissue; an updatable memory containing default operating algorithms; a processor, The processor: operating in a first mode at a first time, wherein in the first mode the processor is configured to operate aspects of the controllable jaws according to a default actuation algorithm; and receiving, at a second time after the first time, data that causes the processor to operate in a second mode, wherein in the second mode, the processor is configured to operate aspects of the controllable jaws according to an alternative actuation algorithm. Example 2. The powered surgical end effector of example 1, further comprising a transmitter and a receiver configured to establish a communication path between the powered surgical end effector and an external device. Example 3. The powered surgical end effector of example 2, wherein the data received at the second time is received from an external device via the receiver. Example 4. The powered surgical end effector of example 3, wherein the external device is a surgical hub. Example 5. The powered surgical end effector of example 3, wherein the external device is a cloud computing system. Example 6. The powered surgical end effector of any one of Examples 1 to 5, wherein the data received at the second time relates to procedure information. Example 7. A powered surgical end effector as described in any one of Examples 1 to 5, wherein the data received at the second time relates to supplemental measurements through situational awareness, hospital input, and / or user input. Example 8. The powered surgical end effector of any one of Examples 1 to 5, wherein the data received at the second time relates to a tissue characteristic. Example 9. The powered surgical end effector of example 8, wherein the second mode updates the clamping pressure, hold time, or firing rate of an aspect of the jaws. Example 10. A powered surgical end effector, comprising: a controllable jaw configured to act on tissue; an updatable memory containing default operating algorithms; a processor, the processor is configured to determine whether to operate in the first mode or the second mode; In a first mode, the processor is configured to operate the jaw features according to a default actuation algorithm; In the second mode, the processor is configured to operate aspects of the jaws according to an alternative actuation algorithm. Example 11. A powered surgical end effector as described in Example 10, further comprising a transmitter and a receiver configured to establish a communication path between the powered surgical end effector and an external device. Example 12. The powered surgical end effector of Example 11, wherein the external device is a surgical hub. Example 13. The powered surgical end effector of Example 11, wherein the external device is a cloud computing system. Example 14. A powered surgical end effector described in any one of Examples 10 to 13, wherein the decision as to whether to operate in the first mode or the second mode is based on treatment information. Example 15. A powered surgical end effector described in any one of Examples 10 to 13, wherein the decision as to whether to operate in the first mode or the second mode is based on supplemental measurements through situational awareness, hospital input, and / or user input. Example 16. A powered surgical end effector described in any one of Examples 10 to 13, wherein the decision as to whether to operate in the first mode or the second mode is related to tissue characteristics. Example 17. A powered surgical end effector as described in Example 16, wherein the second mode updates the clamping pressure, hold time, or firing rate of the jaw configuration. Example 18. A surgical hub, comprising: a transmitter and receiver configured to establish a communication path between the surgical hub and the powered surgical end effector; 1. A processor, comprising: determining whether communication is available with a powered surgical end effector configured to operate in a first mode or a second mode, wherein in the first mode the powered surgical end effector operates aspects of a controllable jaw according to a default actuation algorithm stored in an updatable memory of the powered surgical end effector; receiving data related to the powered surgical end effector via the receiver; determining whether the surgical end effector should operate in a first mode or a second mode based on the received data; and a processor configured to: based on the determination, transmit updated data that causes the powered surgical end effector to operate in a second mode, wherein in the second mode the powered surgical end effector operates aspects of the controllable jaws according to an alternative actuation algorithm. Example 19. A surgical hub as described in Example 18, wherein the determination of whether communication is available is determined by available processing power, memory, bandwidth, software revision, or subscription level. Example 20. The surgical hub of example 18 or 19, wherein the transmitted data relates to procedure information.

[0004] In Examples 1 and 10, an end effector for a powered surgical stapler is provided having an updatable or adaptable actuation algorithm. The actuation algorithm may be updated or adapted from a default actuation algorithm as a result of receiving data, for example, from an external device, which may be a surgical hub or a remote server. The jaw function of the end effector may be controlled by replacing, updating, or adjusting the actuation algorithm. For example, the actuation algorithm controlling the movement of the controllable jaws of the end effector may be replaced or adjusted by importing a new algorithm, or parameters within the algorithm control may be adjusted. The adaptation or update of the control algorithm may be controlled by an algorithm within a surgical hub (e.g., a local hub device or a remote server system) that communicates with the end effector. By providing a default actuation algorithm, the surgical stapler is immediately operable for effective use according to a first mode in numerous surgical situations where surgical stapling is required. By additionally providing updatable memory that can operate the processor according to a second mode with an alternative actuation algorithm, the surgical system may be reconfigured to perform effective surgical stapling for other surgical situations. The ability to switch from a default operating algorithm to an alternate one advantageously allows different types of stapling procedures to be performed quickly, for example, within the same overall surgical procedure, which may improve the overall speed at which stapling is performed during a surgical procedure and therefore the overall effectiveness of the surgical procedure being performed.

[0005] In Examples 2-5 and 11-13, the powered surgical end effector has communication capabilities to receive data from an external device, which may be a surgical hub or a cloud computing system. The interaction between the end effector and the surgical hub allows for dynamic control over jaw movement. In the absence of a connected environment, the end effector's functionality defaults to static functionality. This means that if additional data about the procedure becomes available, it can be used to perform an improved procedure on an ongoing, dynamic basis. However, if additional data is not available or there is a failure in communication with the external device or cloud computing system, the procedure may continue using a default operating algorithm rather than an applicable algorithm being unavailable. In Examples 9 and 17, updated jaw control is applied to the clamping pressure, hold time, or firing rate of the end effector's controllable jaws.

[0006] As in Examples 6-8 and 14-16, the surgical end effector can operate according to updated or adapted actuation algorithms in response to changes in tissue characteristics, instrument conditions, procedure data, and / or supplemental measurements.

[0007] Examples 18-20 provide a surgical hub with dynamic functionality for controlling the replacement or adaptation of actuation algorithms in a surgical end effector. The hub has decision-making algorithms that can be controlled by aspects of intercommunication between systems or by parameters within the hub system itself (e.g., user-related parameters such as available processing power, memory, bandwidth, software revision, or subscription level). The use of actuation algorithms can be selective based on intended use, or automatically selected or deselected based on situational awareness of the procedural step and the magnitude of the expected benefit. Thus, tiered control of algorithm adaptability is enabled, achieving dynamically updated operational control and improved clinical outcomes. For example, in the absence of a connected environment due to a surgical hub communication or hardware failure in the computing system, the stapler's functionality can default to static functionality. In a connected environment, the end effector functionality can be dynamically updated based on operational improvements to achieve improved surgical outcomes, for example, by receiving updated data from the surgical hub.

[0008] According to a further embodiment of the present invention, a powered surgical end effector includes a controllable jaw configured to operate relative to tissue, an updatable memory having a default actuation algorithm stored therein, and a processor configured to: operate in a first mode at a first time, wherein the processor is configured to operate aspects of the controllable jaw according to the default actuation algorithm; and receive data causing the processor to operate in a second mode at a second time after the first time, wherein the processor is configured to operate aspects of the controllable jaw according to an alternative actuation algorithm.

[0009] According to a further embodiment of the present invention, a powered surgical end effector includes controllable jaws configured to operate relative to tissue, an updatable memory having a default actuation algorithm stored therein, and a processor configured to determine whether to operate in a first mode or a second mode, wherein in the first mode the processor is configured to operate aspects of the jaws according to the default actuation algorithm and wherein in the second mode the processor is configured to operate aspects of the jaws according to an alternative actuation algorithm.

[0010] According to a further embodiment of the present invention, a surgical hub includes a transmitter and receiver configured to establish a communication path between the surgical hub and a powered surgical end effector, and a processor configured to: determine whether communication is available with a powered surgical end effector configured to operate in a first mode or a second mode, where in the first mode the powered surgical end effector operates aspects of a controllable jaw according to a default actuation algorithm stored in an updatable memory of the powered surgical end effector; receive data related to the powered surgical end effector via the receiver; determine based on the received data whether the surgical end effector should operate in the first mode or the second mode; and based on the determination, transmit updated data for operating the powered surgical end effector in the second mode, where in the second mode the powered surgical end effector operates aspects of the controllable jaw according to an alternative actuation algorithm. [Brief explanation of the drawings]

[0011] [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 aspect of the present disclosure. [Figure 5] 1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 6] 1 illustrates a surgical hub comprising multiple modules coupled to a modular control tower, according to at least one embodiment of the present disclosure. [Figure 7] 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 8] 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. [Figure 9] 1 shows a diagram of a context-aware surgical system according to at least one aspect of the present disclosure. [Figure 10] 1 illustrates an exemplary timeline of a surgical procedure and inferences that a surgical hub can generate 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] FIG. 1 is a perspective view of a surgical instrument having an interchangeable shaft assembly operably coupled thereto, in accordance with at least one aspect of the present disclosure. [Figure 17] FIG. 17 is an exploded view of a portion of the surgical instrument of FIG. 16, in accordance with at least one embodiment of the present disclosure. [Figure 18] FIG. 1 is an exploded view of a portion of an interchangeable shaft assembly according to at least one aspect of the present disclosure. [Figure 19] FIG. 17 is an exploded view of an end effector of the surgical instrument of FIG. 16, in accordance with at least one embodiment of the present disclosure. [Figure 20A] FIG. 17 is a block diagram of a control circuit for the surgical instrument of FIG. 16, spanning two views, in accordance with at least one embodiment of the present disclosure. [Figure 20B] FIG. 17 is a block diagram of a control circuit for the surgical instrument of FIG. 16, spanning two views, in accordance with at least one embodiment of the present disclosure. [Figure 21] FIG. 17 is a block diagram of a control circuit for the surgical instrument of FIG. 16, showing an interface between the handle assembly and the power supply assembly, and an interface between the handle assembly and the interchangeable shaft assembly, in accordance with at least one aspect of the present disclosure. [Figure 22] 1 depicts an exemplary medical device that may include one or more aspects of the present disclosure. [Figure 23] 1 depicts an exemplary end effector of a medical device surrounding tissue, according to one or more aspects of the present disclosure. [Figure 24] 1 depicts an exemplary end effector of a medical device for compressing tissue, according to one or more aspects of the present disclosure. [Figure 25] 10A-10C depict exemplary forces exerted by an end effector of a medical device compressing tissue, according to one or more aspects of the present disclosure. [Figure 26] 10 also depicts an exemplary force exerted by an end effector of a medical device compressing tissue, according to one or more aspects of the present disclosure. [Figure 27] 1 depicts an exemplary tissue compression sensor system according to one or more aspects of the present disclosure. [Figure 28] FIG. 1 also depicts an exemplary tissue compression sensor system, in accordance with one or more aspects of the present disclosure. [Figure 29] FIG. 1 also depicts an exemplary tissue compression sensor system, in accordance with one or more aspects of the present disclosure. [Figure 30] FIG. 1 is an exemplary circuit diagram according to one or more aspects of the present disclosure. [Figure 31] 1 is also an exemplary circuit diagram in accordance with one or more aspects of the present disclosure. [Figure 32] FIG. 1 is a diagram of a position sensor comprising a magnetic rotary absolute positioning system, according to at least one aspect of the present disclosure. [Figure 33] FIG. 10 is a cross-sectional view of an end effector of a surgical instrument illustrating a firing member stroke against tissue grasped by the end effector, in accordance with at least one aspect of the present disclosure. [Figure 34] 1 shows a block diagram of a surgical system configured to control surgical functions, according to at least one aspect of the present disclosure. [Figure 35] FIG. 1 shows a block diagram of a context-aware surgical system configured to control surgical functions, according to at least one aspect of the present disclosure. [Figure 36]FIG. 10 is a logic flow diagram depicting a situational awareness-based algorithm for controlling surgical functions, according to at least one aspect of the present disclosure. [Figure 37] FIG. 1 illustrates a logic flow diagram of a process for controlling a surgical instrument according to the physiological type of clamped tissue, according to at least one aspect of the present disclosure. [Figure 38] FIG. 10 is a logic flow diagram illustrating the process of a control program or logic configuration for adjusting a closing speed algorithm in accordance with at least one aspect of the present disclosure. [Figure 39] 1 shows a logic flow diagram of a process illustrating a control program of a logic configuration for identifying irregularities in tissue distribution within an end effector of a surgical instrument, in accordance with at least one aspect of the present disclosure. [Figure 40] 1 shows a logic flow diagram of a process depicting a control program or logic configuration for properly positioning pre-stapled tissue within an end effector in accordance with at least one aspect of the present disclosure. [Figure 41] 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 42] 10A-10C illustrate diagrams of an analysis system pushing updates to modular devices via a surgical hub, in accordance with at least one embodiment of the present disclosure. [Figure 43] 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 44] 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 45] 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 46]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 47] FIG. 10 illustrates a logic flow diagram of a process for updating an algorithm of a surgical instrument, according to at least one aspect of the present disclosure. [Figure 48] FIG. 10 illustrates another 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 49] FIG. 10 illustrates another 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 50] 1 illustrates a logic flow diagram of a process for a surgical hub updating algorithms of a surgical instrument, in accordance with at least one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0012] The applicant of this application owns the following U.S. patent applications filed concurrently with this application: These are each incorporated by reference in their entirety: ● U.S. Patent Application No. 16 / 209,423 (Attorney Docket No. END8538USNP), filed December 4, 2018, entitled "METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS" (currently U.S. Patent Application Publication No. 2019 / 0200981); ●U.S. Patent Application No. 15 / 940,636 (Attorney Docket No.: END8506USNP), filed March 29, 2018, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES" (currently U.S. Patent Application Publication No. 2019 / 0206003).

[0013] 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.

[0014] In various aspects, the visualization system 108 may include one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in FIG. 2. In one aspect, the visualization system 108 may include interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1), entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety.

[0015] As shown in FIG. 2 , primary display 119 is positioned in the sterile field so as to be visible to the operator of operating table 114. In addition, visualization tower 111 is positioned outside the sterile field. Visualization tower 111 may include a first non-sterile display 107 and a second non-sterile display 109 facing opposite each other. Visualization system 108, guided by hub 106, is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, hub 106 can cause visualization system 108 to display snapshots of the surgical site recorded by imager 124 on non-sterile displays 107 or 109 while maintaining a live video of the surgical site on primary display 119. The snapshots on non-sterile displays 107 or 109 can, for example, enable a non-sterile operator to perform diagnostic steps related to the surgical procedure.

[0016] In one aspect, the hub 106 may also be configured to send diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to the primary display 119 in the sterile field for viewing by the sterile operator at the operating table. In one example, the input may be in the form of a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be sent by the hub 106 to the primary display 119.

[0017] 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, as described, for example, 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. 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 the operator of the surgical instrument 112 can view the sent diagnostic input or feedback. Exemplary surgical instruments suitable for use with surgical system 102 are described under "Surgical Instrument Hardware" and 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), which is incorporated herein by reference in its entirety.

[0018] 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 and oriented from the patient side cart 120. 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.

[0019] 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.

[0020] 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 entire disclosure of which is incorporated herein by reference.

[0021] In various embodiments, the imager 124 may include at least one image sensor and one or more optical components. Suitable image sensors may include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.

[0022] The optical components of the imager 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.

[0023] 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.

[0024] 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 wave 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.

[0025] In various aspects, the imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngological-nephroscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

[0026] The imaging device may employ multispectral monitoring techniques to distinguish surface irregularities from underlying structures. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths, including frequencies beyond the visible light range, e.g., IR and UV light. Spectral imaging can extract additional information that cannot be captured by the red, green, and blue receptors of the human eye. The use of multispectral imaging is described in more detail under the heading "Advanced Imaging Acquisition Module" 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 entire disclosure of which is incorporated herein by reference. Multispectral monitoring methods can be a useful tool for repositioning the surgical field after the completion of a treatment task 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 treatment room, require the highest possible sterility of all medical devices and equipment. Part of the sterilization process described above includes the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It is understood that the sterile field can be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field can be considered the area immediately surrounding the patient prepared for the surgical procedure. The sterile field can include cleaned team members wearing appropriate clothing, as well as all equipment and fixtures within the area.

[0027] Referring now to FIG. 3 , a hub 106 is shown in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communications module 130, a processor module 132, a storage array 134, and an operating room mapping module 133. In certain embodiments, as shown in FIG. 3 , the hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128. During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly associated with smoke evacuation, the aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular enclosure 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines. An embodiment of the present disclosure presents a surgical hub for use in a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub enclosure and a combination generator module slidably receivable within the hub enclosure's docking station. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one embodiment, the combination generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.In one embodiment, the fluid line is a first fluid line, and a second fluid line extends from a remote surgical site to an aspiration and irrigation module slidably received within the hub enclosure. In one embodiment, the hub enclosure includes a fluid interface. Certain surgical procedures may require the application of two or more energy types to tissue. One energy type may be more beneficial for cutting tissue, while another, different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. An embodiment of the present disclosure provides a solution in which the hub's modular enclosure 136 is configured to house and facilitate interactive communication between various generators. One advantage of the hub's modular enclosure 136 is that it allows for rapid removal and / or replacement of various modules. An embodiment of the present disclosure provides 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 the 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.

[0028] 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 that may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communications hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communications hub 203 can also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 can be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to travel from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features that allow traffic to pass through the monitored surgical data network and configure each port within the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.

[0029] 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.

[0030] 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.

[0031] In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(es), and network router(s) that connect the devices 1a-1n / 2a-2m to the cloud. Any one or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch may collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on sharing computing resources rather than having local servers or personal devices to handle software applications. While the term "cloud" may be used as a metaphor for the "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which various services, such as servers, storage, and applications, are delivered via the Internet to a modular communications hub 203 and / or computer system 210 located in an operating room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and / or computer system 210. The cloud infrastructure may be maintained by a cloud service provider. In this context, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. The cloud computing service may 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.

[0032] 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 and phenotype localization and margin confirmation. At least some of the devices 1a-1n / 2a-2m can be used to identify anatomical structures of the body using various sensors integrated with the imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by 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.

[0033] The operating room devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. The network hub 207, in one aspect, may be implemented as a local network broadcasting device operating on the physical layer of the Open System Interconnection (OSI) model. The network hub may provide connectivity to devices 1a-1n located within the same operating room network. The network hub 207 may collect data in the form of packets, which are transmitted to a router in half-duplex mode. The network hub 207 may not store media access control / Internet Protocol (MAC / IP) information for forwarding any device data. Only one of the devices 1a-1n may transmit data through the network hub 207 at a time. The network hub 207 may not have a routing table or intelligence regarding where to send 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.

[0034] 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 devices 2a-2m located in the same operating room to the network. The network switch 209 may transmit data in the form of frames to the network router 211, but 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.

[0035] The network hub 207 and / or the network switch 209 may be coupled to a network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 may transmit data in the form of packets to the cloud 204, but functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.

[0036] 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.

[0037] In some examples, 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.

[0038] The modular communications hub 203, which may act as a central connection for one or all of the operating room devices 1a-1n / 2a-2m, may handle a data type known as a frame. The frame may carry data generated by the devices 1a-1n / 2a-2m. Once the frame is received by the modular communications hub 203, it is amplified and transmitted to the network router 211, which forwards this data to cloud computing resources using a number of wireless or wired communications standards or protocols, as described herein.

[0039] The modular communications hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communications hub 203 may generally be easy to install, configure, and maintain, making the modular communications hub 203 a good choice for networking the operating room devices 1a-1n / 2a-2m.

[0040] 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.

[0041] 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.

[0042] FIG. 6 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 may comprise a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for local processing, visualization, and imaging. As shown in FIG. 6, the modular communications hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communications hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 6, each of the network hubs / switches in the modular communications hub 203 may include three downstream ports and one upstream port. The upstream network hub / switch may be connected to a processor to provide communications connectivity to cloud computing resources and a local display 217. Communication to the cloud 204 may occur via either a wired or wireless communications channel.

[0043] The surgical hub 206 may use a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room using either an ultrasonic non-contact measurement device or a laser-based non-contact measurement device. The ultrasonic-based non-contact sensor module may scan the operating room by transmitting bursts of ultrasound and receiving echoes as they bounce off the perimeter walls of the operating room, as described under the heading "Surgical Hub Spatial Awareness Within an Operating Room" 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), which is incorporated herein by reference in its entirety, and in which the sensor module is configured to determine the size of the operating room and adjust Bluetooth pairing distance limits. The laser-based non-contact sensor module may, for example, scan the operating room by transmitting laser light pulses, receive laser light pulses that reflect off the perimeter walls of the operating room, and compare the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the Bluetooth pairing distance limit.

[0044] 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 structure(s), 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.

[0045] Processor 244 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. This processor core includes 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product datasheet.

[0046] 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.

[0047] System memory may include both volatile and nonvolatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. RAM is available in many forms, including static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync link DRAM (SLDRAM), and direct RAM (DRRAM).

[0048] 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 may include, but are not limited to, optical disk drives, such as compact disc ROM drives (CD-ROMs), compact disc recordable drives (CD-R drives), compact disc rewritable drives (CD-RW drives), or digital versatile disc ROM drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of disk storage devices to the system bus.

[0049] 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.

[0050] A user may input commands or information into computer system 210 through input device(s) coupled to I / O interface 251. Input devices may include, but are not limited to, pointing devices such as a mouse, trackball, stylus, 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 port(s). Interface port(s) include, for example, serial ports, parallel ports, game ports, and USB. Output device(s) use some of the same types of ports as the input device(s). Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. An output adapter may be provided to illustrate that some output devices may exist, such as monitors, displays, speakers, and printers, among other output devices that may require special adapters. Output adapters may include, by way of example and not limitation, video and sound cards that provide a means of connection between an output device and a system bus. It should be noted that other devices and / or systems of devices, such as remote computer(s), may provide both input and output capabilities.

[0051] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) can be personal computers, servers, routers, network PCs, workstations, microprocessor-based devices, peer devices, or other common network nodes, but typically include many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown with the remote computer(s). The remote computer(s) can be logically connected to the computer system through a network interface, but can then be physically connected through a communications connection. The network interface can encompass communications networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies can include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, and the like. WAN technologies may include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and its variations, packet-switched networks, and Digital Subscriber Lines (DSL).

[0052] In various aspects, 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.

[0053] The communications connection(s) may refer to the hardware / software used to connect the network interface to the bus. For clarity of illustration, the communications connections are shown internal to the computer system, but the communications connections may also be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as regular telephone-grade modems, modems including cable modems and DSL modems, ISDN adapters, and Ethernet cards.

[0054] 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.

[0055] In one embodiment, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, main microcontroller 461 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and / or one or more 12-bit ADCs with 12 analog input channels, details of which are available in the product datasheet.

[0056] In one aspect, 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.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] The motor driver 492 may be the A3941, available from Allegro Microsystems, Inc. The A3941 motor driver 492 may be a full-bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs), specifically designed for inductive loads such as brushed DC motors. The driver 492 may include an intrinsic charge pump regulator, which provides full (>10 V) gate drive for battery voltages down to 7 V, allowing the A3941 to operate with reduced gate drive down to 5.5 V. A bootstrap capacitor may be used to provide the required battery supply voltage for the N-channel MOSFETs. An internal charge pump for the high-side drive allows DC (100% duty cycle) operation. The full-bridge may be driven in fast or slow decay mode using diode or synchronous rectification. In slow decay mode, current recirculation is possible through either the high-side or low-side FET. The power FETs may be protected from shoot-through by a resistor-adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system.

[0061] 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 actually track the linear displacement of an I-beam by tracking the linear displacement of the 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.

[0062] 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. The power source may provide power to the absolute positioning system, while the output indicator may display the output of the absolute positioning system. The displacement member may represent a longitudinally movable drive member with a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reducer assembly. The displacement member may represent a longitudinally movable firing member, a firing bar, an I-beam, or a combination thereof.

[0063] 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.

[0064] 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.

[0065] The 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 encompass 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, optical fiber, magneto-optical, and microelectromechanical systems-based magnetic sensors, among others.

[0066] In one aspect, the position sensor 472 of the tracking system 480 with an absolute positioning system may comprise a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide the absolute positioning system. The position sensor 472 may be a low-voltage, low-power component, but may include four Hall-effect elements in the area of ​​the position sensor 472 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 Volder's 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 communication interface, such as a serial peripheral interface (SPI) interface. The position sensor 472 may provide 12-bit or 14-bit resolution. The position sensor 472 may be an AS5055 chip, provided in a small QFN 16-pin 4x4x0.85mm package.

[0067] A tracking system 480 with an absolute positioning system may include and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply converts a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some embodiments, the other sensor(s) may include sensor arrangements such as those described in U.S. Pat. No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system may take into account properties such as mass, inertia, viscous friction, and induced resistance in order to predict what the state and output of the physical system will be given knowledge of the input.

[0068] The absolute positioning system can provide the absolute position of the displacement member upon powering 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.

[0069] A sensor 474, such as a strain gauge or micro-strain gauge, can be configured to measure one or more parameters of the end effector, such as the amplitude of strain exerted on the anvil during clamping, which can be indicative of the closure force applied to the anvil. The measured strain can be converted to a digital signal and provided to the processor 462. Instead of or in addition to the sensor 474, a sensor 476, such as a load sensor, can measure the closure force applied to the anvil by the closure drive system. For example, the sensor 476, such as a load sensor, can measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sled that cams the staple driver upward, forcing the staples into deforming contact with the anvil. The I-beam can also include a sharp cutting edge that can be used to cut tissue as the I-beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure the current drawn by the motor 482. The force required to advance the firing member may correspond, for example, to the current drawn by motor 482. The measured force may be converted to a digital signal, which may be provided to processor 462.

[0070] 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, which can be 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's measurements can also be converted to a digital signal and provided to the processor 462.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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 I-beam element, as described in more detail herein below.

[0078] 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.

[0079] 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.

[0080] Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor outside the jaws or by a torque sensor on the motor that actuates the jaws.

[0081] 8, common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. Motor driver 626 may modulate power transferred from a power supply 628 to a motor coupled to common control module 610 based on input from, for example, a microcontroller 620 ("controller"). In certain examples, 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.

[0082] 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.

[0083] 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 also be used as power supply 628. In certain examples, power supply 628 may be, for example, replaceable and / or rechargeable.

[0084] 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 has internal memory, it may be an example of sequential digital logic. A processor may operate on numbers and symbols represented in the binary system.

[0085] Processor 622 may be any single-core or multi-core processor, such as those known by the trade name ARM Cortex manufactured by Texas Instruments. In a particular example, microcontroller 620 may be, for example, the LM4F230H5QR 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 analogs, 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.

[0086] 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.

[0087] 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 particular 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.

[0088] 9 shows a diagram of a context-aware surgical system 5100 in accordance with at least one aspect of the present disclosure. In some examples, the data sources 5126 may include, for example, the modular device 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular device itself), a database 5122 (e.g., an EMR database containing patient records), and patient monitoring devices 5124 (e.g., a blood pressure (BP) monitor and an electrocardiogram (EKG) monitor). The surgical hub 5104 may be configured to derive contextual information regarding the surgical procedure from the data based, for example, on the particular combination(s) of data received or the particular order in which data is received from the data sources 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the particular step of the surgical procedure the surgeon is performing, the type of tissue being operated on, or the body cavity that is the target of the procedure. This ability by 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.

[0089] The situation awareness system of the surgical hub 5104 can be configured to derive contextual information from data received from the data sources 5126 in a variety of different ways. In one example, the situation awareness system may include a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data to correlate various inputs (e.g., data from the database 5122, the patient monitoring device 5124, and / or the modular device 5102) with corresponding contextual information about the surgical procedure. In other words, the machine learning system can be trained to accurately derive contextual information about the surgical procedure from provided inputs. In some examples, the situation awareness system may include a lookup table that stores pre-characterized contextual information about the surgical procedure in association with one or more inputs (or ranges of inputs) corresponding to the contextual information. In response to a query with one or more inputs, the lookup table can return corresponding contextual information to the situation awareness system for controlling the modular device 5102. In some examples, the context 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 for one or more modular devices 5102. In some examples, the situational awareness system may include additional machine learning systems, lookup tables, or other such systems that, when provided with the contextual information as input, generate or retrieve one or more control adjustments for one or more modular devices 5102.

[0090] A surgical hub 5104 incorporating a situational awareness system can provide many benefits to the surgical system 5100. One benefit can include improved interpretation of sensed and collected data, which can improve the accuracy of processing 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 accelerate or decelerate the motor of the surgical instrument appropriately for the type of tissue.

[0091] The type of tissue being operated on can affect the adjustments made to the compression speed and load threshold of the surgical stapling and cutting instrument for a particular tissue gap measurement. The context-aware surgical hub 5104 can infer whether the surgical procedure being performed is thoracic or abdominal surgery, which enables the surgical hub 5104 to determine whether the tissue being clamped by the end effector of the surgical stapling and cutting instrument is pulmonary (in the case of thoracic surgery) or stomach (in the case of abdominal surgery). As a result, the surgical hub 5104 can appropriately adjust the compression speed and load threshold of the surgical stapling and cutting instrument to the tissue type.

[0092] 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 types of procedures 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.

[0093] The type of procedure being performed can affect the optimal energy level at which an ultrasonic surgical instrument or a radio frequency (RF) electrosurgical instrument operates. For example, an arthroscopic procedure may require a higher energy level because the end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is immersed in fluid. The context-aware surgical hub 5104 can determine whether the surgical procedure is an arthroscopic procedure. The surgical hub 5104 can then adjust the RF power level or ultrasonic amplitude (i.e., "energy level") of the generator to compensate for the fluid-filled environment. Relatedly, the type of tissue being operated on can affect the optimal energy level at which an ultrasonic surgical instrument or a 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. Additionally, the situation-aware surgical hub 5104 can be configured to adjust the energy level of the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than simply on a procedure-by-procedure basis. The situation-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will continue to be performed, and then update the generator and / or control algorithms of the ultrasonic surgical instrument or RF electrosurgical instrument to set the energy level to a value appropriate for the expected tissue type according to the step of the surgical procedure.

[0094] In some 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 one example, the surgical hub 5104 may be further configured to compare a physiological measurement (e.g., blood pressure sensed by a BP monitor communicatively connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 (FIG. 2) communicatively coupled to the surgical hub 5104) to make a determination regarding the integrity of a staple line or tissue weld. In other words, the situational awareness system of the surgical hub 5104 can take physiological measurement data into account to provide additional context when analyzing the visualization data, which can be useful when the visualization data may not be conclusive or incomplete on its own.

[0095] For example, the situation-aware surgical hub 5104 can proactively activate a generator to which an RF electrosurgical instrument is connected if it is determined that a subsequent step in a procedure will require the use of the instrument. By proactively activating the energy source, the instrument can be ready for use as soon as the previous step in the procedure is completed.

[0096] The situation-aware surgical hub 5104 can determine whether the current or subsequent step of the surgical procedure requires a different view or magnification 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 view (e.g., provided by a medical imaging device for the visualization system 108) appropriately, so that the display automatically adjusts throughout the surgical procedure.

[0097] 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 request specific information.

[0098] 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 can determine whether the surgical field is properly or optimally set up for the surgical procedure to be performed. The surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, product locations, or setup requirements, and then compare the current surgical field layout to a standard layout for the type of surgical procedure the surgical hub 5104 has determined is being performed. The surgical hub 5104 can 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 inventory of items and / or devices for a given surgical procedure. If a discontinuity exists between the lists, the surgical hub 5104 can be configured to provide an alert indicating that a particular modular device 5102, patient monitoring device 5124, and / or other surgical item is missing. In some examples, the surgical hub 5104 can be configured to determine the relative distance or relative position of the modular devices 5102 and the patient monitoring devices 5124, for example, by proximity sensors. The surgical hub 5104 can compare the relative positions of the devices to a recommended or predicted layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide an alert indicating that the current layout of the surgical procedure deviates from the recommended layout.

[0099] The context-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or deviating from an expected sequence of actions during the course of a surgical procedure. For example, the surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) a corresponding list of steps or sequence of equipment use, and then compare the steps being performed or 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.

[0100] The surgical instruments (and other modular devices 5102) may be tailored to the specific context of each surgical procedure (such as for different tissue types) and may be verified for operation during the surgical procedure. Next steps, data, and display adjustments may be provided to the surgical instruments (and other modular devices 5102) in the operating room according to the specific context of the procedure.

[0101] 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 surgical site and concluding with the transport of the patient to the post-operative recovery room. The context-aware surgical hub 5104 may receive data from the data sources 5126 throughout the course of the surgical procedure, including data generated each time a medical personnel uses a modular device 5102 paired with the surgical hub 5104. The surgical hub 5104 receives this data from the paired modular devices 5102 and other data sources 5126 and can continually derive inferences (i.e., contextual information) regarding the ongoing procedure as new data is received, such as which step of the procedure is being performed 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.

[0102] As a first step 5202 in this exemplary procedure, hospital personnel may retrieve the patient's electronic medical record (EMR) from the hospital's EMR database. Based on the selected patient's data in the EMR, the surgical hub 5104 determines that the procedure to be performed is thoracic surgery. In a second step 5204, the personnel may scan the 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 that of 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). In a third step 5206, medical personnel may scan the patient's band via a scanner 5128 communicatively connected to the surgical hub 5104. The surgical hub 5104 can then verify the identity of the patient based on the scanned data. In a fourth step 5208, medical personnel turn on the auxiliary equipment. The auxiliary equipment utilized can vary according to the type of surgical procedure and the technology used by the surgeon, but in this exemplary case includes a smoke evacuator, an insufflator, and a medical imaging device. Once activated, the auxiliary equipment, which is a modular device 5102, can automatically pair with the surgical hub 5104, which can be located within a certain proximity of the modular device 5102, as part of its initialization process. The surgical hub 5104 can then derive contextual information about the surgical procedure by detecting the type of modular device 5102 that is paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 5104 can determine that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices 5102. Based on a combination of data from the patient's EMR, a list of medical supplies to be used in the procedure, and the types of modular devices 5102 connected to the hub, the surgical hub 5104 can roughly estimate the specific procedure to be performed by the surgical team.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 monitoring devices 5124) to deduce which steps of the surgical procedure the surgical team is performing. In a fifth step 5210, personnel attach EKG electrodes and other patient monitoring devices 5124 to the patient. The EKG electrodes and other patient monitoring devices 5124 may be paired with the surgical hub 5104. Once the surgical hub 5104 begins receiving data from the patient monitoring devices 5124, the surgical hub 5104 may confirm that the patient is in the operating room, for example, as described in process 5207. In a sixth step 5212, medical personnel may administer anesthesia to the patient. The surgical hub 5104 can infer that the patient is under anesthesia based on data from the modular devices 5102 and / or the patient monitoring device 5124, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Once the sixth step 5212 is complete, the pre-operative portion of the lung segmentectomy surgery is complete and the surgical portion begins.

[0103] In a seventh step 5214, the patient's lung 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 lung being collapsed with the expected steps of the procedure (which may be accessed or retrieved in advance) and therefore infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung may be the first surgical step in this particular procedure. In an eighth step 5216, a medical imaging device 5108 (e.g., a scope) may be inserted and video footage from the medical imaging device may be initiated. The surgical hub 5104 may receive medical imaging device data (i.e., video or image data) through a connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 5104 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 5104 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that based on the data received in the second step 5204 of the procedure, a wedge resection has not already been taken into account by the surgical hub 5104). Data from the medical imaging device 124 (FIG. 2) may be utilized to determine contextual information regarding the type of procedure being performed in many different 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 of medical imaging devices being utilized (i.e., activated and paired with the surgical hub 5104), and by monitoring the type of visualization device being utilized. For example, one technique for performing a VATS lobectomy may position the camera above the diaphragm in the anterior-inferior corner of the patient's chest cavity, while one technique for performing a VATS segmentectomy may position the camera in an intercostal position anterior to the segmental fissure. The situational awareness system can be trained to recognize the location 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. One exemplary technique for performing a VATS segmentectomy utilizes an infrared light source (which may be communicatively coupled to the surgical hub as part of a visualization system) to visualize the segmental fissure, which is not utilized in a VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can determine the particular type of surgical procedure being performed and / or the technique being used for the particular type of surgical procedure.

[0104] In a ninth step 5218, the surgical team may begin the incision step of the procedure. Because the surgical hub 5104 receives data from the RF or ultrasonic generator indicating that the energy instrument is being fired, it can infer that the surgeon is in the process of incising and separating the patient's lungs. The surgical hub 5104 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the steps of the procedure described above have been completed) corresponds to the incision step. In a tenth step 5220, the surgical team may proceed to the ligation step of the procedure. Because the surgical hub 5104 receives data from the surgical stapling and cutting instrument indicating that the instrument is being fired, it can infer that the surgeon is ligating arteries and veins. As with the previous step, the surgical hub 5104 can derive this inference by cross-referencing the receipt of data from the surgical stapling and cutting instrument with the steps in the retrieved process. In an eleventh step 5222, the segmentectomy portion of the procedure may be performed. The surgical hub 5104 may infer, based on data from the surgical stapling and cutting instrument (including data from its cartridge), that the surgeon is transecting parenchymal tissue. The cartridge data may correspond, for example, to the size or type of staples being fired by the instrument. Because different types of staples are used on different types of tissue, the cartridge data may indicate the type of tissue being stapled and / or transected. In this case, the type of staples being fired is used on parenchymal tissue (or other similar tissue type), thereby allowing the surgical hub 5104 to infer that the segmentectomy portion of the procedure is being performed. Then, in a twelfth step 5224, a nodule dissection step is performed. The surgical hub 5104 may infer, based on data received from the generator indicating that an RF or ultrasonic instrument is being fired, that the surgical team is dissecting 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 nodal incision step, allowing the surgical hub 5104 to make this estimation. Note that the surgeon will periodically alternate between a surgical stapling / cutting instrument and a surgical energy (e.g., RF or ultrasonic) instrument depending on the particular step in the procedure, as different instruments are better suited for specific tasks. Thus, the particular sequence in which the stapling / cutting instrument and the surgical energy instrument 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.

[0105] In a thirteenth step 5226, the patient may be encouraged to emerge from anesthesia. The surgical hub 5104 may estimate that the patient is emerging from anesthesia, for example, based on ventilator data (i.e., the patient's breathing rate begins to increase). Finally, a fourteenth step 5228 may be a step in which medical personnel remove the various patient monitoring devices 5124 from the patient. Thus, the surgical hub 5104 may estimate that the patient is being transferred to a recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices 5124. As can be seen from this exemplary procedure description, the surgical hub 5104 can determine or estimate when each step of a given surgical procedure is occurring according to data received from various data sources 5126 communicatively coupled to the surgical hub 5104.

[0106] As shown in the first step 5202 of the timeline 5200 shown in FIG. 10 , in addition to utilizing patient data from the EMR database(s) to estimate the type of surgical procedure to be performed, the patient data can also be utilized by the situation-aware surgical hub 5104 to generate control adjustments for the paired modular devices 5102.

[0107] FIG. 11 is a block diagram of a computer-implemented interactive surgical system according to at least one embodiment of the present disclosure. In one embodiment, the computer-implemented interactive surgical system may be configured to monitor and analyze data related to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and surgical sites or medical facilities. The computer-implemented interactive surgical system may include a cloud-based analysis system. While the cloud-based analysis system may be described as a surgical system, it may not necessarily be so limited and may generally be a cloud-based medical system. As shown in FIG. 11 , the cloud-based analysis system may include a plurality of surgical instruments 7012 (which may be the same as or similar to 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.

[0108] 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 may indicate a specific location, such as a surgical site within a medical facility (e.g., a hospital) for providing a medical procedure. For example, the memory of the surgical hub 7006 may 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 client surgical hubs 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.

[0109] 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 may advantageously perform data analysis and operations on the aggregated data to provide insights and / or perform functions that individual hubs 7006 cannot accomplish on their own. To this end, as shown in FIG. 11 , the cloud 7004 and the surgical hubs 7006 are communicatively coupled to send and receive information. An I / O interface 7006 is connected to the multiple surgical hubs 7006 via the network 7001. In this manner, the I / O interface 7006 may be configured to transfer information between the surgical hubs 7006 and the aggregated medical data database 7011. Accordingly, the I / O interface 7006 may 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 .

[0110] 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.

[0111] FIG. 12 is a block diagram illustrating the functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. The cloud-based analysis system may include multiple data analysis modules 7034 that may be executed by a processor 7008 of a cloud 7004 to provide data analysis solutions to problems that arise specifically in the medical field. As shown in FIG. 12 , the functionality of the cloud-based data analysis modules 7034 may be supported via a hub application 7014 hosted by a hub application server 7002 that is accessible on a surgical hub 7006. The cloud processor 7008 and the hub application 7014 may work in conjunction to execute the data analysis modules 7034. An application program interface (API) 7016 may define a set of protocols and routines corresponding to the hub application 7014. Additionally, the API 7016 may manage the storage and retrieval of data from a centralized medical database 7012 for operation of the applications 7014. A cache 7018 may also store data (e.g., temporarily) but 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, authentication 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.

[0112] 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.

[0113] 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 point at which to order surgical stapling instruments 7012 for a group of medical facilities based on corresponding predicted demand for the 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 and 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 that will improve surgical outcomes. The medical facility can receive such recommendations via the corresponding surgical hub 7006. More specific recommendations regarding parameters or configurations of various surgical instruments 7012 can also be provided. The hub 7006 and / or surgical instruments 7012 can also each have a display screen that displays the data or recommendations provided by the cloud 7004.

[0114] 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.

[0115] The cloud-based analysis system may include security features implemented by the cloud 7004. These security features may be managed by the authentication 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. Additionally, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices, which may include a "blacklist" of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist may not be permitted to interact with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the corresponding hub 7006. Additionally or alternatively, the cloud 7004 may flag instruments 7012 based on incompatibility or other specified criteria. In this manner, counterfeit medical devices and the inappropriate reuse of such devices across the cloud-based analysis system may be identified and addressed.

[0116] The surgical instrument 7012 may use a wireless transceiver to transmit a wireless signal that may represent, for example, authentication credentials for access to the corresponding hub 7006 and the cloud 7004. A wired transceiver may also be used to transmit the signal. Such authentication credentials may be stored in a memory device of the surgical instrument 7012. The authentication and security module 7024 may determine whether the authentication credentials are accurate or forged. The authentication and security module 7024 may also dynamically generate authentication credentials for enhanced security. The credentials may also be encrypted, such as by using hash-based encryption. Upon transmitting proper authentication, 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 the 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 authentication credentials. For example, if a group of surgical instruments 7012 are identified as having a common manufacturing defect, the cloud 7004 may change the authentication credentials corresponding to this group to implement an operational lockout for this group.

[0117] 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.

[0118] 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 supporting 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.

[0119] 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.

[0120] 13 shows a block diagram of a computer-implemented adaptive surgical system 9060 configured to adaptively generate control program updates for modular devices 9050, in accordance with at least one embodiment of the present disclosure. In some examples, the surgical system may include a surgical hub 9000, a plurality of modular devices 9050 communicatively coupled to the surgical hub 9000, and an analysis system 9100 communicatively coupled to the surgical hub 9000. It should be noted that while a single surgical hub 9000 is shown, 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 to execute instructions stored in the memory 9020, and a data relay interface 9030 via 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 combinations to use in a given procedure, and / or instructions for actions to be taken before, during, or after a surgical procedure. The surgical hub 9000 may further include an interface 9040 for communicatively coupling a modular device 9050 to the surgical hub 9000. In one aspect, the interface 9040 may include a transceiver communicatively connectable to the modular device 9050 via a wireless communication protocol. The modular device 9050 may include, for example, a surgical stapling and cutting instrument, an electrosurgical instrument, an ultrasonic instrument, an aspirator, a ventilator, and a display screen. In some instances, the surgical hub 9000 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.

[0121] When a modular device 9050 is connected to the surgical hub 9000, the surgical hub 9000 can sense or receive perioperative data from the modular device 9050 and then associate the received perioperative data with surgical procedure outcome data. The perioperative data may indicate how the modular device 9050 was controlled during the course of a surgical procedure. The procedure outcome data includes data associated with the results from a surgical procedure (or step thereof), and such data may include whether the surgical procedure (or step thereof) had a positive or negative outcome. For example, the outcome data may include whether a patient bled from a particular procedure or whether there was a leak (e.g., a post-operative complication 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 an outcome (e.g., via one of the connected modular devices 9050), or by inferring the occurrence of an outcome through a situational awareness system. For example, data regarding post-operative complications can be retrieved from the EMR database 9054, and data regarding staple or incision line leakage can be directly detected or inferred by the situational awareness system. Surgical procedure outcome data can be inferred by the situational awareness system from data received from a variety of data sources, including the modular device 9050 itself, the patient monitoring device 9052, and the database 9054 to which the surgical hub 9000 is connected.

[0122] The surgical hub 9000 can transmit data and outcome data for associated modular devices 9050 to the analysis system 9100 for processing there. By transmitting both perioperative data indicating how the modular devices 9050 are controlled and procedural outcome data, the analysis system 9100 can correlate different manners of controlling the modular devices 9050 with procedural 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 instructions stored therein to analyze the received data. In some examples, the analysis servers 9070 may be connected in a distributed computing architecture and / or utilize a cloud computing architecture. Based on this paired data, the analysis system 9100 can then learn optimal or preferred operating parameters for various types of modular devices 9050, generate adjustments to the control programs of the modular devices 9050 in the field, and then transmit (or "push") updates to the control programs of the modular devices 9050.

[0123] 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.

[0124] 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 is detachably coupled to the handle 6504, and the loading unit 6514 is detachably coupled to the adapter 6508 such that the adapter 6508 transfers force from the drive shaft to the loading unit 6514. The adapter 6508 or the loading unit 6514 may include a force gauge (not explicitly shown) disposed therein to measure force exerted on the loading unit 6514. The loading unit 6514 can include an end effector 6530 including a first jaw 6532 and a second jaw 6534. The loading unit 6514 can be a field loading or multi-firing 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 to reload the loading unit 6514.

[0125] The first jaw 6532 and the second jaw 6534 can be configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and cut the clamped tissue. The first jaw 6532 can be configured to fire at least one fastener multiple times or can be configured to include a replaceable multi-fire fastener cartridge containing multiple fasteners (e.g., staples, clips, etc.) that can be fired two or more times before being replaced. The second jaw 6534 can include an anvil that deforms or otherwise secures fasteners around tissue as they are ejected from the multi-fire fastener cartridge.

[0126] 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 used by a clinician to activate the motor.

[0127] The control interface of the handle 6504 may 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 may be disposed within the handle 6504 and configured to receive input from the control interface and adapter data from the adapter 6508 or loading unit data from the loading unit 6514. The controller 6528 may analyze the input from the control interface and the data received from the adapter 6508 and / or the loading unit 6514 to selectively activate the motors. The handle 6504 may also include a display viewable by a clinician while using the handle 6504. The display may be configured to display a portion of the adapter or loading unit data before, during, or after firing of the instrument 6502.

[0128] The adapter 6508 may include an adapter identification device 6510 disposed therein, while 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.

[0129] The adapter 6508 may also include multiple sensors 6512 (one shown) disposed about its periphery that detect various conditions of the adapter 6508 or the surrounding 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 retraction force of the adapter 6508, the number of times the adapter 6508 has 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 adapter data stored in the adapter identification device 210. 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.

[0130] The handle 6504 and adapter 6508 may be configured to interconnect the adapter identification device 6510 and the loading unit identification device 6516 to 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 transfer energy and signals therebetween). Additionally or alternatively, the electrical interface may be a contactless electrical interface for wirelessly transferring (e.g., inductively transferring) energy and signals therebetween. It is also contemplated that the adapter identification device 6510 and the controller 6528 may communicate wirelessly with each other via a wireless connection that is separate from the electrical interface.

[0131] The handle 6504 may include a transmitter 6506 configured to transmit instrument data from the controller 6528 to other components of the system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522, or the portable device 6526). The transmitter 6506 may also receive data (e.g., cartridge data, loading unit data, or adapter data) from other components of the system 6500. For example, the controller 6528 may transmit instrument data to the console 6528 including the serial number of the adapter (e.g., adapter 6508) attached to the handle 6504, the serial number of the loading unit (e.g., loading unit 6514) attached to the adapter, and the serial number of the multi-fire fastener cartridge (e.g., multi-fire fastener cartridge) loaded in the loading unit. The console 6522 may then return data (e.g., cartridge data, loading unit data, or adapter data) associated with the attached cartridge, loading unit, and adapter, respectively, 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.

[0132] 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 incorporating 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 the 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.

[0133] An update may be contingent on any suitable criterion or set of criteria. For example, an update may be contingent on one or more hardware capabilities of the system, such as processing power, bandwidth, resolution, etc. For example, an update may be contingent on one or more software aspects, such as the purchase of certain software code. For example, an update may be contingent on a purchased service tier. A service tier may represent a feature and / or set of features that a user is entitled to use in connection with the computer-implemented interactive surgical system. A service tier may be determined by a license code, an e-commerce server authentication interaction, a hardware key, a username / password combination, a biometric authentication interaction, a public / private key exchange interaction, etc.

[0134] In step 10704, system / device parameters may be identified. System / device parameters may be any element or set of elements upon which the update is conditioned. For example, the computer-implemented interactive surgical system may detect a certain bandwidth of communication between the modular device and the surgical hub. For example, the computer-implemented interactive surgical system may detect an indicator indicative of the purchase of a particular service tier.

[0135] In step 10708, an operational mode may be determined based on the identified system / device parameters. This determination may be made by a process that maps system / device parameters to operational modes. The process may be a manual and / or automatic process. The process may be the result of local and / or remote calculations. 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.

[0136] In step 10710, operation may proceed according to the determined operating mode. For example, the system or device may proceed to operate in a default operating mode. For example, the system or device may proceed to operate in an alternate operating mode. The operating mode may be dictated by control hardware, firmware, and / or software already present in the system or device. The operating mode may also be dictated by newly installed / updated control hardware, firmware, and / or software.

[0137] 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.

[0138] 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 instruct 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 instruct 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 if no other alternative operational mode has been determined. For example, the default operational component 10720 may be selected if the initialization component fails and / or interacts poorly. The initialization component 10716 may instruct the operation pointer 10724 to direct the operation of the upgradeable component 10714 to the resident operation component 10722. For example, a particular function may be resident in the upgradeable component 10714 but may require activation to operate. The initialization component 10716 may instruct the operation pointer 10724 to direct the operation of the upgradeable component 10714 to install new operation components 10728 and / or newly installed operation components 10726. For example, new software and / or firmware may be downloaded. The new software and / or firmware may include code that enables functionality represented by a selected operation mode. For example, new hardware components may be installed to enable the selected operation mode.

[0139] 16 is a perspective view of a surgical instrument 150010 having an operably coupled interchangeable shaft assembly 150200 in accordance with at least one embodiment of the present disclosure. The housing 150012 includes an end effector 150300 having a surgical cutting and fastening device therein configured to operably support a surgical staple cartridge 150304 therein. The housing 150012 may be configured for use with interchangeable shaft assemblies, including end effectors adapted to support various sizes and types of staple cartridges and having various shaft lengths, sizes, and types. The housing 150012 may be used with a variety of interchangeable shaft assemblies, including assemblies configured to apply other motions and other forms of energy, such as radio frequency (RF) energy, ultrasonic energy, and / or motion, to end effector configurations adapted for use in connection with various surgical applications and procedures. The end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system may utilize any suitable fasteners to fasten tissue. For example, a fastener cartridge having a plurality of fasteners removably stored therein may be removably inserted into and / or attached to the end effector of the shaft assembly.

[0140] The handle assembly 150014 may include a pair of interconnectable handle housing segments 150016, 150018 connected to each other by screws, snap mechanisms, adhesive, or the like. The handle housing segments 150016, 150018 cooperate to form a pistol grip portion 150019 that can be grasped and manipulated by a clinician. The handle assembly 150014 operably supports a plurality of drive systems configured to generate and apply controlled motions to corresponding portions of interchangeable shaft assemblies operably attached to the handle assembly. A display may be provided below the cover 150045.

[0141] FIG. 17 is an exploded view of a portion of the surgical instrument 150010 of FIG. 16 in accordance with at least one embodiment of the present disclosure. The handle assembly 150014 may include a frame 150020 that operably supports multiple drive systems. The frame 150020 may operably support a "first" system, i.e., a closure drive system 150030, which may apply a closing and opening motion to the interchangeable shaft assembly 150200. The closure drive system 150030 may include an actuator, such as a closure trigger 150032, pivotally supported by the frame 150020. The closure trigger 150032 is pivotally coupled to the handle assembly 150014 by a pivot pin 150033, allowing the closure trigger 150032 to be operated by a clinician. When a clinician grasps the pistol grip portion 150019 of the handle assembly 150014, the closure trigger 150032 can be pivoted from a starting or "unactivated" position to an "activated" position, more specifically to a fully compressed or fully activated position.

[0142] The handle assembly 150014 and frame 150020 may operably support a firing drive system 150080 configured to apply a firing motion to a corresponding portion of an interchangeable shaft assembly attached thereto. The firing drive system 150080 may use an electric motor 150082 located within the pistol grip portion 150019 of the handle assembly 150014. The electric motor 150082 may be a DC brushed motor having a maximum rotational speed of, for example, approximately 25,000 RPM. In other device configurations, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The electric motor 150082 may be powered by a power supply 150090, which may include a removable power pack 150092. The removable power pack 150092 may include a proximal housing portion 150094 configured to attach to a distal housing portion 150096. The proximal housing portion 150094 and the distal housing portion 150096 are configured to operably support a plurality of batteries 150098 therein. Each of the batteries 150098 may include, for example, lithium-ion (LI) batteries or other suitable batteries. The distal housing portion 150096 is configured to be removably and operably attached to a control circuit board 150100, which is operably coupled to the electric motor 150082. Several batteries 150098 connected in series can power the surgical instrument 150010. The power source 150090 may be replaceable and / or rechargeable. A display 150043, located below a cover 150045, is electrically coupled to the control circuit board 150100. The cover 150045 may be removed to expose the display 150043 .

[0143] The electric motor 150082 may include a rotatable shaft (not shown) that operably interfaces with a gear reducer assembly 150084 that is mounted in meshing engagement with a set or rack of drive teeth 150122 on the longitudinally movable drive member 150120. The longitudinally movable drive member 150120 has a rack of drive teeth 150122 formed thereon for meshing engagement with a corresponding drive gear 150086 of the gear reducer assembly 150084. In use, the voltage polarity provided by the power source 150090 causes the electric motor 150082 to operate in a clockwise direction, while the voltage polarity applied to the electric motor by the battery can be reversed to cause the electric motor 150082 to operate in a counterclockwise direction. When the electric motor 150082 is rotated in one direction, the longitudinally movable drive member 150120 will be driven axially in the distal direction "DD." When the electric motor 150082 is driven in the opposite rotational direction, the longitudinally movable drive member 150120 will be driven axially in the proximal direction "PD." The handle assembly 150014 may include a switch that may be configured to reverse the polarity applied to the electric motor 150082 by the power source 150090. The handle assembly 150014 may include a sensor configured to detect the position of the longitudinally movable drive member 150120 and / or the direction in which the longitudinally movable drive member 150120 is being moved.

[0144] Operation of the electric motor 150082 may be controlled by a firing trigger 150130 that is pivotally supported on the handle assembly 150014. The firing trigger 150130 may pivot between an inactivated position and an activated position.

[0145] 16 , the interchangeable shaft assembly 150200 includes an end effector 150300 having an elongated channel 150302 configured to operably support a surgical staple cartridge 150304 therein. The end effector 150300 may include an anvil 150306 pivotally supported relative to the elongated channel 150302. The interchangeable shaft assembly 150200 may include an articulation joint 150270. The configuration and operation of the end effector 150300 and the articulation joint 150270 are described in U.S. Patent Application Publication No. 2014 / 0263541, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," which is incorporated herein by reference in its entirety. The interchangeable shaft assembly 150200 may include a proximal housing or nozzle 150201 comprised of nozzle portions 150202, 150203. The interchangeable shaft assembly 150200 may include a closure tube 150260 extending along the shaft axis SA, which may be utilized to close and / or open the anvil 150306 of the end effector 150300. Returning to FIG. 16 , in response to actuation of the closure trigger 150032, for example, the closure tube 150260 is translated in a distal direction (direction “DD”) to close the anvil 150306 in the manner described in the above-referenced U.S. Patent Application Publication No. 2014 / 0263541. The anvil 150306 is opened by translating the closure tube 150260 in a proximal direction. In the anvil open position, the closure tube 150260 is moved to its proximal position.

[0146] 18 is another exploded view of a portion of the interchangeable shaft assembly 150200 according to at least one embodiment of the present disclosure. The interchangeable shaft assembly 150200 may include a firing member 150220 supported for axial movement within the spine 150210. The firing member 150220 includes an intermediate firing shaft 150222 configured to attach to a distal cutting portion or knife bar 150280. The firing member 150220 may be referred to as a "second shaft" or "second shaft assembly." The intermediate firing shaft 150222 may include a longitudinal slot 150223 at a distal end configured to receive a tab 150284 on the proximal end 150282 of the knife bar 150280. The longitudinal slot 150223 and the proximal end 150282 may be configured to allow relative movement therebetween and may include a slip joint 150286. The slip joint 150286 can allow the intermediate firing shaft 150222 of the firing member 150220 to articulate the end effector 150300 about the articulation joint 150270 without moving, or at least substantially moving, the knife bar 150280. Once the end effector 150300 is properly oriented, the intermediate firing shaft 150222 can be advanced distally until the proximal sidewall of the longitudinal slot 150223 contacts the tab 150284 to advance the knife bar 150280 and fire a staple cartridge located within the channel 150302. The spine 150210 has an elongated opening or window 150213 therein to facilitate assembly and insertion of the intermediate firing shaft 150222 into the spine 150210. Once the intermediate firing shaft 150222 is inserted therein, the top frame segment 150215 can be engaged with the shaft frame 150212 to enclose the intermediate firing shaft 150222 and the knife bar 150280 therein. Operation of the firing member 150220 can be found in U.S. Patent Application Publication No. 2014 / 0263541. The spine 150210 can be configured to slidably support the firing member 150220 and a closure tube 150260 extending around the spine 150210. The spine 150210 can slidably support the articulation driver 150230.

[0147] The interchangeable shaft assembly 150200 may include a clutch assembly 150400 configured to selectively and removably couple the articulation driver 150230 to the firing member 150220. The clutch assembly 150400 includes a locking collar or locking sleeve 150402 positioned about the firing member 150220 that may be rotated between an engaged position in which the locking sleeve 150402 couples the articulation driver 150230 to the firing member 150220 and a disengaged position in which the articulation driver 150230 is not operably coupled to the firing member 150220. When the locking sleeve 150402 is in its engaged position, distal movement of the firing member 150220 can translate the articulation driver 150230 distally, and correspondingly, proximal movement of the firing member 150220 can translate the articulation driver 150230 proximally. When the locking sleeve 150402 is in its disengaged position, movement of the firing member 150220 is not transmitted to the articulation driver 150230, such that the firing member 150220 can move independently of the articulation driver 150230. The nozzle 150201 can be used to operatively engage and disengage the articulation drive system and the firing drive system in various manners described in U.S. Patent Application Publication No. 2014 / 0263541.

[0148] The interchangeable shaft assembly 150200 can include a slip ring assembly 150600, which can be configured, for example, to conduct power and / or communicate signals to and / or from the end effector 150300. The slip ring assembly 150600 can include a proximal connector flange 150604 and a distal connector flange 150601 positioned within slots defined in the nozzle portions 150202, 150203. The proximal connector flange 150604 can include a first surface, and the distal connector flange 150601 can include a second surface disposed adjacent to and movable relative to the first surface. The distal connector flange 150601 can rotate relative to the proximal connector flange 150604 about the shaft axis SA-SA. The proximal connector flange 150604 can include a plurality of concentric, or at least substantially concentric, conductors 150602 defined in a first surface thereof. The connector 150607 can be mounted proximally to the distal connector flange 150601 and can include a plurality of contacts, each contact corresponding to and in electrical contact with one of the conductors 150602. Such a configuration allows relative rotation between the proximal connector flange 150604 and the distal connector flange 150601 while maintaining electrical contact therebetween. The proximal connector flange 150604 can include, for example, an electrical connector 150606 that can place the conductors 150602 in signal communication with a shaft circuit board. In at least one instance, a wire harness including multiple conductors may extend between the electrical connector 150606 and the shaft circuit board. The electrical connector 150606 may extend proximally through a connector opening defined in the chassis mounting flange. U.S. Patent Application Publication No. 2014 / 0263551, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," is incorporated herein by reference in its entirety.U.S. Patent Application Publication No. 2014 / 0263552, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," is incorporated herein by reference in its entirety. Further details regarding the slip ring assembly 150600 can be found in U.S. Patent Application Publication No. 2014 / 0263541.

[0149] The interchangeable shaft assembly 150200 may include a proximal portion fixably attached to the handle assembly 150014 and a distal portion rotatable about a longitudinal axis. The rotatable distal shaft portion may be rotated relative to the proximal portion about a slip ring assembly 150600. A distal connector flange 150601 of the slip ring assembly 150600 may be positioned within the rotatable distal shaft portion.

[0150] 19 is an exploded view of one embodiment of the end effector 150300 of the surgical instrument 150010 of FIG. 16 , in accordance with at least one embodiment of the present disclosure. The end effector 150300 can include an anvil 150306 and a surgical staple cartridge 150304. The anvil 150306 can be coupled to the elongated channel 150302. An opening 150199 can be defined in the elongated channel 150302 for receiving a pin 150152 extending from the anvil 150306 to enable the anvil 150306 to pivot from an open position to a closed position relative to the elongated channel 150302 and the surgical staple cartridge 150304. The firing bar 150172 is configured to translate longitudinally into the end effector 150300. The firing bar 150172 may be constructed from one solid piece or may include a laminate material, including a stack of steel plates. The firing bar 150172 includes an I-beam 150178 and a cutting blade 150182 at its distal end. The distally protruding end of the firing bar 150172 can be attached to the I-beam 150178 to help space the anvil 150306 away from the surgical staple cartridge 150304 positioned within the elongated channel 150302 when the anvil 150306 is in the closed position. The I-beam 150178 can include a sharp cutting blade 150182 that cuts tissue as the I-beam 150178 is advanced distally by the firing bar 150172. In operation, the I-beam 150178 can fire, or fires, the surgical staple cartridge 150304. The surgical staple cartridge 150304 can include a shaped cartridge body 150194 that holds a plurality of staples 150191 mounted on staple drivers 150192 within respective upwardly opening staple cavities 150195. The wedge-shaped sled 150190 is driven distally by the I-beam 150178 and slides on a cartridge tray 150196 of the surgical staple cartridge 150304.While the cutting blades 150182 of the I-beam 150178 cut the clamped tissue, the wedge-shaped sled 150190 cams the staple drivers 150192 upward, forcing the staples 150191 into deforming contact with the anvil 150306.

[0151] The I-beam 150178 can include an upper pin 150180 that engages the anvil 150306 during firing. The I-beam 150178 can include a center pin 150184 and a lower foot 150186 for engaging the cartridge body 150194, the cartridge tray 150196, and a portion of the elongated channel 150302. When the surgical staple cartridge 150304 is positioned within the elongated channel 150302, the slot 150193 defined in the cartridge body 150194 can be aligned with the longitudinal slot 150197 defined in the cartridge tray 150196 and the slot 150189 defined in the elongated channel 150302. In use, the I-beam 150178 can slide through the aligned longitudinal slots 150193, 150197, and 150189, the lower foot 150186 of the I-beam 150178 can engage with a groove running along the bottom surface of the elongated channel 150302 along the length of the slot 150189, the central pin 150184 can engage with the top surface of the cartridge tray 150196 along the length of the longitudinal slot 150197, and the upper pin 150180 can engage with the anvil 150306. As the firing bar 150172 advances distally to fire staples from the surgical staple cartridge 150304 and / or cut tissue captured between the anvil 150306 and the surgical staple cartridge 150304, the I-beam 150178 can space or limit relative movement between the anvil 150306 and the surgical staple cartridge 150304. The firing bar 150172 and I-beam 150178 can be retracted proximally, thereby opening the anvil 150306 and releasing the two stapled and separated tissue portions.

[0152] 20A and 20B are block diagrams of a control circuit 150700 of the surgical instrument 150010 of FIG. 16 across two views, according to at least one embodiment of the present disclosure. Referring primarily to FIGS. 29A and 29B , the handle assembly 150702 can include a motor 150714, which can be controlled by a motor driver 150715 and utilized by the firing system of the surgical instrument 150010. In various forms, the motor 150714 can be a DC brushed drive motor having a maximum rotational speed of approximately 25,000 RPM. In other configurations, the motor 150714 can include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 150715 can include, for example, an H-bridge driver including a field effect transistor (FET) 150719. The motor 150714 may be powered by a power supply assembly 150706 releasably attached to the handle assembly 150200 to provide control power to the surgical instrument 150010. The power supply assembly 150706 may include a battery that may include several battery cells connected in series that may be used as a power source to power the surgical instrument 150010. Under certain circumstances, the battery cells of the power supply assembly 150706 may be replaceable and / or rechargeable. In at least one example, the battery cells may be lithium ion batteries that may be separately connectable to the power supply assembly 150706.

[0153] The shaft assembly 150704 may include a shaft assembly controller 150722 capable of communicating with the safety controller and power management controller 150716 via an interface while the shaft assembly 150704 and the power supply assembly 150706 are coupled to the handle assembly 150702. For example, the interface may include a first interface portion 150725 that may include one or more electrical connectors for mating engagement with corresponding shaft assembly electrical connectors, and a second interface portion 150727 that may include one or more electrical connectors for mating engagement with corresponding power supply assembly electrical connectors, to enable electrical communication between the shaft assembly controller 150722 and the power management controller 150716 while the shaft assembly 150704 and the power supply assembly 150706 are coupled to the handle assembly 150702. One or more communication signals may be transmitted via the interface to communicate one or more power requirements of the attached interchangeable shaft assembly 150704 to the power management controller 150716. In response, the power management controller may modulate the power output of the batteries of the power supply assembly 150706, as described in further detail below, according to the power requirements of the attached shaft assembly 150704. The connector may include a switch that can be actuated following mechanical coupling engagement of the handle assembly 150702 to the shaft assembly 150704 and / or power supply assembly 150706 to enable electrical communication between the shaft assembly controller 150722 and the power management controller 150716.

[0154] The interface may facilitate the transmission of one or more such communication signals between the power management controller 150716 and the shaft assembly controller 150722, for example, by routing such communication signals through a main controller 150717 mounted within the handle assembly 150702. Under other circumstances, the interface may facilitate a direct communication line between the power management controller 150716 and the shaft assembly controller 150722 via the handle assembly 150702 while the shaft assembly 150704 and power supply assembly 150706 are coupled to the handle assembly 150702.

[0155] The main controller 150717 may be any single-core or multi-core processor, such as that known under the trade name ARM Cortex manufactured by Texas Instruments, Inc. In one aspect, the main controller 150717 may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, Inc., including, for example, 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 Stellaris Ware® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product datasheet.

[0156] The safety controller may be a safety controller platform with two controller base families, such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments, Inc. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

[0157] The power supply assembly 150706 may include power management circuitry, which may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. The power management circuitry may be configured to modulate the power output of the battery based on the power requirements of the shaft assembly 150704 while the shaft assembly 150704 and the power supply assembly 150706 are coupled to the handle assembly 150702. The power management controller 150716 may be programmed to control the power modulator 150738 of the power output of the power supply assembly 150706, while the current sensing circuit 150736 may be used to monitor the power output of the power supply assembly 150706 and provide feedback to the power management controller 150716 regarding the power output of the battery so that the power management controller 150716 can adjust the power output of the power supply assembly 150706 to maintain the desired output. The power management controller 150716 and / or the shaft assembly controller 150722 may each include one or more processors and / or memory units capable of storing a number of software modules.

[0158] The surgical instrument 150010 (FIGS. 16-19) may include an output device 150742, which may include a device for providing sensory feedback to the user. Such devices may include, for example, a visual feedback device (e.g., an LCD display screen, an LED indicator), an audible feedback device (e.g., a speaker, a buzzer), or a tactile feedback device (e.g., a tactile actuator). Under certain circumstances, the output device 150742 may include a display 150743, which may be included in the handle assembly 150702. The shaft assembly controller 150722 and / or the power management controller 150716 may provide feedback to a user of the surgical instrument 150010 via the output device 150742. An interface may be configured to connect the shaft assembly controller 150722 and / or the power management controller 150716 to the output device 150742. The output device 150742 may alternatively be integrated with the power supply assembly 150706. Under such circumstances, while the shaft assembly 150704 is coupled to the handle assembly 150702, communication between the output device 150742 and the shaft assembly controller 150722 can be achieved via an interface. The control circuit 150700 includes circuit segments configured to control the operation of the powered surgical instrument 150010. The safety controller segment (segment 1) includes a safety controller and a main controller 150717 segment (segment 2). The safety controller and / or main controller 150717 are configured to interact with one or more additional circuit segments, such as an acceleration segment, a display segment, a shaft segment, an encoder segment, a motor segment, and a power segment. Each of the circuit segments can be coupled to the safety controller and / or main controller 150717. The main controller 150717 is also coupled to flash memory. The main controller 150717 also includes a serial communication interface. The main controller 150717 has multiple inputs coupled to, for example, one or more circuit segments, a battery, and / or multiple switches.The segmentation circuit may be implemented by any suitable circuit, such as, for example, a printed circuit board assembly (PCBA) within the powered surgical instrument 150010. The term processor, as used herein, should be understood to include any microprocessor, processor, one or more controllers, or other basic computing device that incorporates the functionality of a computer's central processing unit (CPU) onto one integrated circuit or up to several integrated circuits. The main controller 150717 is a general-purpose programmable device that accepts digital data as input, processes it according to instructions stored in memory, and provides the results as output. Because it has internal memory, it is an example of sequential digital logic. The control circuit 150700 may be configured to implement one or more processes described herein.

[0159] The acceleration segment (segment 3) comprises an accelerometer. The accelerometer is configured to detect movement or acceleration of the powered surgical tool 150010. Input from the accelerometer may be used to transition in and out of sleep mode, identify the orientation of the powered surgical tool, and / or identify when the surgical tool has been dropped. In some examples, the acceleration segment is coupled to the safety controller and / or the main controller 150717.

[0160] The display segment (segment 4) includes a display connector coupled to the main controller 150717. The display connector couples the main controller 150717 to a display through one or more integrated circuit drivers for the display. The integrated circuit drivers for the display may be integrated with the display and / or located separately from the display. The display may include any suitable display, such as, for example, an organic light emitting diode (OLED) display, a liquid crystal display (LCD), and / or any other suitable display. In some examples, the display segment is coupled to a safety controller.

[0161] The shaft segment (segment 5) includes controls for an interchangeable shaft assembly coupled to the surgical instrument 150010 and / or one or more controls for an end effector 150300 coupled to the interchangeable shaft assembly 150200. The shaft segment includes a shaft connector configured to couple the main controller 150717 to a shaft PCBA. The shaft PCBA includes a low-power microcontroller having ferroelectric random access memory (FRAM), an articulation switch, a shaft release Hall effect switch, and a shaft PCBA EEPROM. The shaft PCBA EEPROM includes one or more parameters, routines, and / or programs specific to the interchangeable shaft assembly 150200 and / or the shaft PCBA. The shaft PCBA may be coupled to the interchangeable shaft assembly 150200 and / or may be integral to the surgical instrument 150010. In some examples, the shaft segment includes a second shaft EEPROM. The second shaft EEPROM contains a number of algorithms, routines, parameters, and / or other data corresponding to one or more shaft assemblies 150200 and / or end effectors 150300 that may be interfaced with the powered surgical instrument 150010.

[0162] The position encoder segment (segment 6) comprises one or more magnetic angular rotary position encoders configured to determine the rotational position of the motor 150714, the interchangeable shaft assembly, and / or the end effector 150300 of the surgical instrument. In some examples, the magnetic angular rotary position encoders can be coupled to the safety controller and / or the main controller 150717.

[0163] The motor circuit segment (segment 7) comprises a motor 150714 configured to control movement of the powered surgical tool. The motor 150714 is coupled to the main microcontroller processor 150717 by an H-bridge driver comprising one or more H-bridge field effect transistors (FETs) and a motor controller. The H-bridge driver is also coupled to the safety controller. A motor current sensor is coupled in series with the motor to measure the current drawn by the motor. The motor current sensor is in signal communication with the main controller 150717 and / or the safety controller. In some examples, the motor 150714 is coupled to a motor electromagnetic interference (EMI) filter.

[0164] The motor controller controls the first motor flag and the second motor flag to indicate the status and position of the motor 150714 to the main controller 150717. The main controller 150717 provides a pulse width modulation (PWM) high signal, a PWM low signal, a direction signal, a synchronization signal, and a motor reset signal to the motor controller via a buffer. The power segments are configured to provide segment voltages to each of the circuit segments.

[0165] The power segment (segment 8) includes a battery coupled to the safety controller, the main controller 150717, and an additional circuit segment. The battery is coupled to the segmented circuitry by a battery connector and a current sensor. The current sensor is configured to measure the total current drawn by the segmented circuitry. In some examples, one or more voltage converters are configured to provide a predetermined voltage value to one or more circuit segments. For example, in some examples, the segmented circuitry may include a 3.3V voltage converter and / or a 5V voltage converter. The boost converter is configured to provide a boost voltage up to a predetermined amount, such as up to 13V. The boost converter is configured to provide additional voltage and / or current during power-intensive operations and to prevent brownouts or low-power conditions.

[0166] A plurality of switches are coupled to the safety controller and / or main controller 150717. The switches may be configured to control the operation of the segmented circuit, the surgical instrument, and / or indicate the status of the surgical instrument. The emergency escape door switch and the emergency escape Hall effect switch are configured to indicate the status of the emergency escape door. A plurality of articulation switches, such as a left articulation left switch, a left articulation right switch, a left articulation center switch, a right articulation left switch, a right articulation right switch, and a right articulation center switch, are configured to control the articulation of the interchangeable shaft assembly and / or the end effector. The left reversing switch and the right reversing switch are coupled to the main controller 150717. The left switches, including the left articulation left switch, the left articulation right switch, the left articulation center switch, and the left reversing switch, are coupled to the main controller 150717 by a left flexible connector. The right side switches, including a right side articulation left switch, a right side articulation right switch, a right side articulation center switch, and a right side reversing switch, are coupled by a right side flexible connector to the main controller 150717. The fire switch, clamp release switch, and shaft engagement switch are coupled to the main controller 150717.

[0167] The switches may be implemented using any suitable mechanical, electromechanical, or solid-state switches in any combination. For example, the switches may be limit switches operated by the movement of a component associated with a surgical instrument or the presence of an object. Such switches may be used to control various functions associated with the surgical instrument. A limit switch is an electromechanical device consisting of an actuator mechanically coupled to a set of contacts. When an object comes into contact with the actuator, the device operates the contacts to create or break an electrical connection. Due to their ruggedness, ease of installation, and reliable operation, limit switches are used in a variety of applications and environments. Limit switches can determine the presence, absence, passage, placement, and end of movement of an object. In other implementations, the switches may be solid-state switches that operate under the influence of a magnetic field, such as a Hall effect device, a magnetoresistive (MR) device, a giant magnetoresistive (GMR) device, or a magnetometer, among others. In other implementations, the switches may be solid-state switches that operate under the influence of light, such as a light sensor, an infrared sensor, or an ultraviolet sensor, among others. Additionally, the switches may be solid-state devices such as transistors (e.g., FETs, junction FETs, metal oxide semiconductor FETs (MOSFETs), bipolars, etc.) Other switches may include wireless switches, ultrasonic switches, accelerometers, inertial sensors, among others.

[0168] 21 is another block diagram of a surgical instrument's control circuit 150700 showing the interface between the handle assembly 150702 and the power supply assembly 150706, and the interface between the handle assembly 150702 and the interchangeable shaft assembly 150704, in accordance with at least one aspect of the present disclosure. The handle assembly 150702 may include a main controller 150717, a shaft assembly connector 150726, and a power supply assembly connector 150730. The power supply assembly 150706 may include a power management circuit 150734 that may include a power supply assembly connector 150732, a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. The shaft assembly connectors 150730, 150732 form an interface 150727. While the interchangeable shaft assembly 150704 and the power supply assembly 150706 are coupled to the handle assembly 150702, the power management circuit 150734 can be configured to modulate the power output of the battery 150707 based on the power requirements of the interchangeable shaft assembly 150704. The power management controller 150716 can be programmed to control the power modulator 150738 of the power output of the power supply assembly 150706, and the current sense circuit 150736 can be used to monitor the power output of the power supply assembly 150706 and provide feedback to the power management controller 150716 regarding the power output of the battery 150707 so that the power management controller 150716 can adjust the power output of the power supply assembly 150706 to maintain the desired output. The shaft assembly 150704 includes a shaft processor 150720 coupled to a non-volatile memory 150721 and a shaft assembly connector 150728 to electrically couple the shaft assembly 150704 to the handle assembly 150702. The shaft assembly connectors 150726, 150728 form an interface 150725. The main controller 150717, the shaft processor 150720 and / or the power management controller 150716 can be configured to implement one or more of the processes described herein.

[0169] The surgical instrument may include an output device 150742 that provides sensory feedback to the user. Such devices may include visual feedback devices (e.g., LCD display screen, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., tactile actuators). Under certain circumstances, the output device 150742 may include a display 150743 that may be included in the handle assembly 150702. The shaft assembly controller 150722 and / or the power management controller 150716 may provide feedback to a user of the surgical instrument 150010 via the output device 150742. The interface 150727 may be configured to connect the shaft assembly controller 150722 and / or the power management controller 150716 to the output device 150742. The output device 150742 may be integrated with the power supply assembly 150706. While the interchangeable shaft assembly 150704 is coupled to the handle assembly 150702, communication between the output device 150742 and the shaft assembly controller 150722 can be achieved via the interface 150725. Having described a control circuit for controlling the operation of a surgical instrument, the present disclosure now describes various configurations of the surgical instrument and control circuit 150700.

[0170] Referring to FIG. 22 , the surgical stapler 151000 can include a handle component 151002, a shaft component 151004, and an end effector component 151006. The surgical stapler 151000 is constructed and equipped similarly to the motorized surgical cutting and fastening instrument 150010 described in connection with FIG. 16 . Therefore, for the sake of brevity and clarity, details of operation and construction will not be repeated here. The end effector 151006 can be used to compress, cut, or staple tissue. Referring now to FIG. 23 , the end effector 151030 can be positioned by a physician to surround tissue 151032 prior to compressing, cutting, or stapling. As shown in FIG. 23 , no compression may be applied to the tissue while preparing the end effector for use. 24, by actuating the handle (e.g., handle 151002) of the surgical stapler, a physician may compress tissue 151032 using the end effector 151030. In one aspect, the tissue 151032 may be compressed to its maximum threshold, as shown in FIG. 24. With reference to FIG. 25, various forces may be applied to the tissue 151032 by the end effector 151030. For example, when the tissue 151032 is compressed between the anvil 151034 and the channel frame 151036 of the end effector 151030, normal forces F1 and F2 may be applied to the anvil 151034 and the channel frame 151036. With reference to FIG. 26, various diagonal and / or lateral forces may also be applied to the tissue 151032 as it is compressed by the end effector 151030. For example, force F3 may be applied. It may be desirable to sense or calculate various forms of compression being applied to tissue by the end effector for purposes of operating a medical device such as the surgical stapler 151000. For example, knowing the vertical or lateral compression may allow the end effector to apply staple action more precisely or accurately, or may inform the operator of the surgical stapler so that the surgical stapler can be used more appropriately or safely.

[0171] Compression in a direction through the tissue 151032 may be determined from the impedance of the tissue 151032. At various levels of compression, the impedance Z of the tissue 151032 may increase or decrease. By applying a voltage V and a current I to the tissue 151032, the impedance Z of the tissue 151032 may be determined at various levels of compression. For example, the impedance Z may be calculated by dividing the applied voltage V by the current I.

[0172] 27 , in one aspect, an RF electrode 151038 may be positioned on the end effector 151030 (e.g., on a staple cartridge, knife, or channel frame of the end effector 151030). Additionally, an electrical contact 151040 may be positioned on the anvil 151034 of the end effector 151030. In one aspect, the electrical contact may be positioned on the channel frame of the end effector. When tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. The vertical tissue compression 151042 caused by the end effector 151030 may be measured as a function of the impedance Z of the tissue 151032.

[0173] 28 , in one aspect, when the RF electrode 151038 is positioned, the electrical contact 151044 can be positioned at an opposite end of the anvil 151034 of the end effector 151030. When the tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. The lateral tissue compression 151046 caused by the end effector 151030 can be measured as a function of the impedance Z of the tissue 151032.

[0174] 29 , in one aspect, the electrical contacts 151050 may be positioned on the anvil 151034 and the electrical contacts 151052 may be positioned on the opposite end of the end effector 151030 at the channel frame 151036. The RF electrode 151048 may be positioned laterally relative to a central portion of the end effector 151030. When the tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. Lateral compression 151054 or angular compression 151056 on either side of the RF electrode 151048 may be produced by the end effector 151030 and may be measured as a function of the varying impedance Z of the tissue 151032 based on the relative positioning of the RF electrode 151048, the electrical contacts 151050 and 151052.

[0175] As shown in FIG. 30 , the frequency generator 151222 may receive power or current from the power source 151221 and may supply one or more RF signals to one or more RF electrodes 151224. As discussed above, the one or more RF electrodes may be positioned at various locations or components on the end effector or surgical stapler, such as the staple cartridge or channel frame. One or more electrical contacts, such as electrical contacts 151226 or 151228, may be positioned on the channel frame or anvil of the end effector. Additionally, one or more filters, such as filter 151230 or 151232, may be communicatively coupled to the electrical contacts 151226 or 151228. The filters 151230 and 151232 may filter the one or more RF signals supplied by the frequency generator 151222 before combining into a single return path 151234. The voltage V and current I associated with one or more RF signals may be used to calculate an impedance Z associated with tissue that may be compressed and / or communicatively coupled between one or more RF electrodes 151224 and electrical contacts 151226 or 151228.

[0176] 30 , various components of the tissue compression sensor system described herein can be disposed within the handle 151236 of a surgical stapler. For example, as shown in circuit diagram 151220a, a frequency generator 151222 can be disposed within the handle 151236 and receive power from a power source 151221. Additionally, currents I1 and I2 can be measured on return paths corresponding to electrical contacts 151228 and 151226. Using the voltage V applied between the supply and return paths, impedances Z1 and Z2 can be calculated. Z1 can correspond to the impedance of tissue compressed and / or communicatively coupled between one or more of the RF electrodes 151224 and the electrical contacts 151228. Furthermore, Z2 can correspond to the impedance of tissue compressed and / or communicatively coupled between one or more of the RF electrodes 151224 and the electrical contacts 151226. Applying the equations Z1=V / I1 and Z2=V / I2, the impedances Z1 and Z2 corresponding to various compression levels of tissue compressed by the end effector can be calculated.

[0177] 31 , one or more aspects of the present disclosure are described in a circuit diagram 151250. In one implementation, a power source in the handle 151252 of the surgical stapler can provide power to a frequency generator 151254. The frequency generator 151254 can generate one or more RF signals. The one or more RF signals can be multiplexed or overlaid in a multiplexer 151256, which can be present in the shaft 151258 of the surgical stapler. In this manner, two or more RF signals can be overlaid (or, for example, nested or modulated together) and transmitted to the end effector. The one or more RF signals can be energized by one or more RF electrodes 151260 in the end effector 151262 of the surgical stapler (e.g., positioned within a staple cartridge). Tissue (not shown) can be compressed and / or communicatively coupled between the one or more RF electrodes 151260 and one or more electrical contacts. For example, tissue can be compressed and / or communicatively coupled between one or more RF electrodes 151260 and electrical contacts 151264 positioned in a channel frame of the end effector 151262 or electrical contacts 151266 positioned in an anvil of the end effector 151262. A filter 151268 can be communicatively coupled to the electrical contacts 151264, and a filter 151270 can be communicatively coupled to the electrical contacts 151266.

[0178] The voltage V and current I associated with one or more RF signals can be used to calculate the impedance Z associated with tissue that can be compressed between the staple cartridge (and can be communicatively coupled to one or more RF electrodes 151260) and the channel frame or anvil (which can be communicatively coupled to one or more of the electrical contacts 151264 or 151266).

[0179] In one aspect, various components of the tissue compression sensor system described herein can be disposed within the shaft 151258 of the surgical stapler. For example, as shown in circuit diagram 151250 (and in addition to frequency generator 151254), impedance calculator 151272, controller 151274, non-volatile memory 151276, and communication channel 151278 can be disposed within the shaft 151258. In one example, frequency generator 151254, impedance calculator 151272, controller 151274, non-volatile memory 151276, and communication channel 151278 can be located on a circuit board within the shaft 151258.

[0180] Two or more RF signals may be returned on a common path via the electrical contacts. Furthermore, to differentiate between different tissue impedances represented by the two or more RF signals, the two or more RF signals may be filtered before joining the RF signals on the common path. Currents I1 and I2 may be measured on the return paths corresponding to electrical contacts 151264 and 151266. Impedances Z1 and Z2 may be calculated using a voltage V applied between the supply and return paths. Z1 may correspond to the impedance of tissue compressed and / or communicatively coupled between one or more of the RF electrodes 151260 and the electrical contact 151264. Furthermore, Z2 may correspond to the impedance of tissue compressed and / or communicatively coupled between one or more of the RF electrodes 151260 and the electrical contact 151266. Applying the equations Z1 = V / I1 and Z2 = V / I2, impedances Z1 and Z2 corresponding to various compressions of tissue compressed by the end effector 151262 may be calculated. In an embodiment, impedances Z1 and Z2 may be calculated by impedance calculator 151272. Impedances Z1 and Z2 may be used to calculate various compression levels of tissue.

[0181] 32 is a diagram of a position sensor 153200 for an absolute positioning system 153100' comprising a magnetic rotational absolute positioning system, according to at least one embodiment of the present disclosure. The absolute positioning system 153100' is similar in many respects to the absolute positioning system 153100. The position sensor 153200 may be implemented as an AS5055EQFT single-chip magnetic rotational position sensor available from Austria Microsystems, AG. The position sensor 153200 interfaces with a controller 153110 to provide the absolute positioning system 153100'. The position sensor 153200 is a low-voltage, low-power component that includes four Hall-effect elements 153228A, 153228B, 153228C, and 153228D in an area 153230 of the position sensor 153200 located above a magnet positioned on a rotating element associated with a displacement member, such as a knife drive gear and / or closure drive gear, thereby enabling precise tracking of the displacement of the firing member and / or closure member. A high-resolution ADC 153232 and a smart power management controller 153238 are also provided on-chip. A CORDIC (short for Coordinate Rotation Digital Computer) processor 153236, also known as the Digit-by-Digit method and the Boulder algorithm, is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. Angular position, alarm bits, and magnetic field information are transmitted to the controller 153110 via a standard serial communications interface, such as the SPI interface 153234. The position sensor 153200 provides 12-bit or 14-bit resolution and may be an AS5055 chip, which comes in a small QFN 16-pin 4x4x0.85mm package.

[0182] The Hall effect elements 153228A, 153228B, 153228C, and 153228D are positioned directly above the rotating magnet. The Hall effect is a well-known effect and, for convenience, will not be described in detail herein. However, in general, the Hall effect generates a voltage difference (Hall voltage) between an electrical conductor across a current in the conductor and a magnetic field perpendicular to the current. The Hall coefficient is defined as the ratio of the induced electric field to the product of the current density and the applied magnetic field. Because its value depends on the type, number, and properties of the charge carriers that make up the current, the Hall coefficient is characteristic of the material from which the conductor is made. In the AS5055 position sensor 153200, the Hall effect elements 153228A, 153228B, 153228C, and 153228D are capable of generating a voltage signal that indicates the absolute position of the magnet in degrees over one rotation of the magnet. This angle value, which is the unique position signal, is calculated by the CORDIC processor 153236 and stored in registers or memory of the on-board AS5055 position sensor 153200. The angle value, which indicates the position of the magnet through one revolution, is provided to the controller 153110 by a variety of techniques, for example, at power up or when requested by the controller 153110.

[0183] The AS5055 position sensor 153200, when connected to the controller 153110, requires only a few external components to operate. Simple applications using a single power supply require six wires: two for power and four for the SPI interface 153234 to the controller 153110 (153240). A seventh connection may be added to send an interrupt to the controller 153110 to indicate that a new valid angle can be read. On power-up, the AS5055 position sensor 153200 performs a complete power-up sequence, including one angle measurement. Completion of this cycle is indicated by an INT output 153242, and the angle value is stored in an internal register. When this output is set, the AS5055 position sensor 153200 suspends and goes into sleep mode. The controller 153110 can respond to the INT request on the INT output 153242 by reading the angle value from the AS5055 position sensor 153200 via the SPI interface 153234. Once the angle value has been read by the controller 153110, the INT output 153242 is cleared again. Alternatively, the controller 153110 can send a "read angle" command to the position sensor 153200 via the SPI interface 153234, which automatically powers up the chip and initiates another angle measurement. As soon as the controller 153110 has finished reading the angle value, the INT output 153242 is cleared and the new result is stored in the angle register. Completion of the angle measurement is again indicated by setting the INT output 153242 and the corresponding flag in the status register.

[0184] Due to the measurement principle of the AS5055 position sensor 153200, only a single angle measurement is performed very briefly (approximately 600 μs) after each power-on sequence. As soon as one angle measurement is completed, the AS5055 position sensor 153200 pauses and transitions to a power-off state. On-chip filtering of the angle value by digital averaging is not implemented, as this would require multiple angle measurements, resulting in a longer power-on time, which is undesirable for low-power applications. Angle jitter can be reduced by averaging several angle samples within the controller 153110. For example, averaging four samples reduces jitter by 6 dB (50%).

[0185] 33 is a cross-sectional view of an end effector 153502 illustrating the firing stroke of the I-beam 153514 against tissue 153526 grasped within the end effector 153502 in accordance with at least one aspect of the present disclosure. The end effector 153502 is configured to operate with any of the surgical instruments or systems according to the present disclosure. The end effector 153502 includes an anvil 153516 and an elongated channel 153503, with a staple cartridge 153518 positioned within the elongated channel 153503. The firing bar 153520 is translatable distally and proximally along the longitudinal axis 153515 of the end effector 153502. When the end effector 153502 is not articulated, the end effector 153502 is aligned with the instrument shaft. The I-beam 153514, including the cutting blade 153509, is shown at the distal portion of the firing bar 153520. The wedge-shaped sled 153513 is positioned within the staple cartridge 153518. As the I-beam 153514 translates distally, the cutting blade 153509 can contact and sever tissue 153526 positioned between the anvil 153516 and the staple cartridge 153518. The I-beam 153514 also contacts and pushes the wedge-shaped sled 153513 distally, causing the wedge-shaped sled 153513 to contact the staple driver 153511. The staple driver 153511 can be raised into the staple 153505 to advance the staple 153505 through tissue and into the pockets 153507 defined in the anvil 153516 that define the staple 153505.

[0186] The firing stroke of an exemplary I-beam 153514 is illustrated by a chart 153529 aligned with the end effector 153502. Exemplary tissue 153526 is also shown aligned with the end effector 153502. The firing member stroke can include a stroke start position 153527 and a stroke end position 153528. During the firing stroke of the I-beam 153514, the I-beam 153514 can be advanced distally from the stroke start position 153527 to the stroke end position 153528. The I-beam 153514 is shown in one exemplary position at the stroke start position 153527. The firing member stroke chart 153529 of the I-beam 153514 shows five firing member stroke regions 153517, 153519, 153521, 153523, and 153525. In the first firing stroke region 153517, the I-beam 153514 can begin to advance distally. In the first firing stroke region 153517, the I-beam 153514 can contact the wedge-shaped sled 153513 and begin to move it distally. However, while in the first region, the cutting blade 153509 may not contact tissue and the wedge-shaped sled 153513 may not contact the staple driver 153511. After overcoming static friction, the force driving the I-beam 153514 in the first region 153517 can be substantially constant.

[0187] In the second firing member stroke region 153519, the cutting blade 153509 may contact and begin to cut the tissue 153526. Also, the wedge-shaped sled 153513 may begin to contact the staple driver 153511 to drive the staples 153505. The force driving the I-beam 153514 may begin to increase. As shown, the tissue that is initially encountered may be compressed and / or thinner due to the manner in which the anvil 153516 pivots relative to the staple cartridge 153518. In the third firing member stroke region 153521, the cutting blade 153509 may continuously contact and cut the tissue 153526, while the wedge-shaped sled 153513 may repeatedly contact the staple driver 153511. The force driving the I-beam 153514 may plateau within the third region 153521.

[0188] By the fourth firing stroke region 153523, the force driving the I-beam 153514 can begin to decrease. For example, tissue in the portion of the end effector 153502 corresponding to the fourth firing region 153523 may be less compressed than tissue closer to the pivot point of the anvil 153516, requiring less force to cut. Additionally, the cutting blade 153509 and wedge-shaped sled 153513 can reach the end of the tissue 153526 while in the fourth region 153523. When the I-beam 153514 reaches the fifth region 153525, the tissue 153526 can be completely severed. The wedge-shaped sled 153513 can contact one or more staple drivers 153511 at or near the end of the tissue. The force that advances the I-beam 153514 through the fifth region 153525 may be reduced and, in some examples, may be similar to the force that drives the I-beam 153514 in the first region 153517. At the end of the firing member stroke, the I-beam 153514 may reach an end-of-stroke position 153528.

[0189] As discussed above, an electric motor 153120 positioned in the surgical instrument's master controller can be utilized to advance and / or retract the firing system of the shaft assembly, including the I-beam 153514, relative to the end effector 153502 of the shaft assembly to staple and / or cut tissue captured within the end effector 153502. The I-beam 153514 may be advanced or retracted at a desired speed or within a range of desired speeds. The controller 153110 can be configured to control the speed of the I-beam 153514. The controller 153110 can be configured to predict the speed of the I-beam 153514 based on various parameters of the power supplied to the electric motor 153120, such as voltage and / or current, and / or other operating parameters of the electric motor 153120 or external influences. The controller 153110 may also be configured to predict the current speed of the I-beam 153514 based on previous values ​​of the current and / or voltage supplied to the electric motor 153120 and / or previous states of the system, such as speed, acceleration, and / or position. The controller 153110 may be configured to sense the speed of the I-beam 153514 utilizing an absolute positioning sensor system described herein. The controller may be configured to compare the predicted speed of the I-beam 153514 with the sensed speed of the I-beam 153514 to determine whether to increase power to the electric motor 153120 to increase the speed of the I-beam 153514 and / or whether to decrease power to the electric motor 153120 to decrease the speed of the I-beam 153514.

[0190] The force acting on the I-beam 153514 may be determined using various techniques. The force on the I-beam 153514 may be determined by measuring the current of the motor 153120, which is based on the load the I-beam 153514 experiences as it advances distally. The force on the I-beam 153514 may be determined by positioning strain gauges on the drive member, firing member, I-beam 153514, firing bar, and / or on the proximal end of the cutting blade 153509. The force on the I-beam 153514 may be determined by monitoring the actual position of the I-beam 153514, which is moving at a predicted speed based on the current set speed of the motor 153120, after a predetermined elapsed time period T1, and comparing the actual position of the I-beam 153514 to the predicted position of the I-beam 153514 based on the current set speed of the motor 153120 at the end of time period T1. Thus, if the actual position of the I-beam 153514 is less than the expected position of the I-beam 153514, the force on the I-beam 153514 is greater than the nominal force. Conversely, if the actual position of the I-beam 153514 is greater than the expected position of the I-beam 153514, the force on the I-beam 153514 is less than the nominal force. The difference between the actual and expected positions of the I-beam 153514 is proportional to the deviation of the force on the I-beam 153514 from the nominal force.

[0191] Various aspects of the present disclosure are directed to improved safety systems capable of adapting, controlling, and / or synchronizing the internal drive operation of a surgical instrument in response to tissue parameters detected via one or more sensors in the surgical instrument. According to at least one aspect, a force detected via one or more sensors in the jaws of the end effector may be of a magnitude that prevents one or more subsequent / further functions of the end effector from being performed. According to another aspect, a metallic object may be detected via one or more sensors, such as within the jaws of the end effector, that prevents one or more subsequent / further functions of the end effector from being performed. FIG. 34 shows a surgical system 23000 comprising a surgical instrument 23002, a surgical hub 23004, and a user interface 23006. In such embodiments, the surgical instrument 23002 may include one or more sensors 23008, and parameters detected by the one or more sensors 23008 of the surgical instrument 23002 may be transmitted / communicated (e.g., wirelessly) to the control circuitry 23010 of the surgical hub 23004. Further, in such embodiments, the surgical hub 23004 may be configured to determine whether a surgical function (e.g., dissecting, clamping, coagulating, stapling, cutting, rotating, articulating, etc.) associated with a component (e.g., end effector, shaft, etc.) of the surgical instrument 23002 can be safely performed based on the parameters detected by the one or more sensors 23008 of the surgical instrument 23002. Notably, in such embodiments, the surgical hub 23004 may be configured to convey / communicate result(s) associated with that determination (i.e., a warning related to the surgical function, a reason the surgical function is prevented, etc.) to the user interface 23006. Further, according to various aspects, the various user interfaces disclosed herein may include a selectable user interface mechanism (e.g., override element 23012) to proceed with a surgical function despite reasons supporting any warnings and / or inhibitions.Notably, in such embodiments, such user interface features (e.g., override element 23012) may not be displayed (e.g., performing a surgical function may endanger the patient).

[0192] Referring to FIG. 35, according to various aspects of the present disclosure, a surgical system 23100 may include a control circuit (23112, 23122, 23132 and / or 23142, e.g., in phantom to show optional position(s)), a user interface (23118, 23128, 23138, 23148 ​​and / or 23158, e.g., in phantom to show optional positions), and a surgical instrument 23102 including, for example, a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. In such aspects, the control circuitry may be incorporated into one or more components of the surgical instrument 23102 (e.g., the handle assembly 23110, the shaft assembly 23120, and / or the end effector assembly 23130, etc.) (e.g., 23112, 23122, and / or 23132) and / or into a surgical hub 23140 paired (e.g., wirelessly) with the surgical instrument 23102 (e.g., 23142). In particular, according to various aspects, the surgical instrument 23102 and / or the surgical hub 23140 may be a context-aware surgical instrument and / or a context-aware surgical hub. Context awareness refers to the ability of a surgical system, e.g., 23100, to determine or infer information related to the surgical procedure from data received from a database (e.g., historical data related to the surgical procedure, e.g., 23149 and / or 23150) and / or data received from the surgical instrument (e.g., sensor data during the surgical procedure). For example, the determined or inferred information may include the type of procedure being performed, the type of tissue being operated on, the body cavity being treated, etc. Based on such contextual information associated with the surgical procedure, the surgical system may, for example, control the paired surgical instrument 23102 or its components (e.g., 23110, 23120 and / or 23130) and / or provide contextually applicable information or suggestions to the surgeon throughout the course of the surgical procedure (e.g., via user interfaces 23118, 23128, 23138, 23148 ​​and / or 23158). Further details regarding situational awareness may be found, for example, under the heading "Contextual Awareness."

[0193] 35 , according to one embodiment, the context-aware surgical hub 23140 is paired (e.g., wirelessly) with a surgical instrument 23102 utilized to perform a surgical procedure. In such an embodiment, the surgical instrument 23102 may comprise an end effector assembly 23130 including a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor 23134 configured to detect a parameter associated with a function of the end effector 23130 (e.g., dissecting, clamping, coagulating, cutting, stapling, etc.) and transmit the detected parameter to a control circuit 23142 of the surgical hub 23140.

[0194] Moreover, in such aspects, the surgical instrument 23102 may further comprise a shaft assembly 23120 including a sensor 23124 configured to detect a parameter associated with a function (e.g., rotation, articulation, etc.) of the shaft assembly 23120 and transmit the detected parameter to the control circuitry 23142 of the surgical hub 23140. In particular, it should be understood that the sensors referenced herein and in other disclosed aspects may in some cases comprise multiple sensors configured to detect multiple parameters associated with multiple end effector assembly and / or shaft assembly functions. Thus, further, in such aspects, the surgical hub control circuitry 23142 may be configured to receive detected parameters (e.g., sensor data) from such sensors 23134 and / or 23124 throughout the course of a surgical procedure.

[0195] The detected parameters may be received each time a function of the associated end effector assembly 23130 (e.g., dissect, clamp, coagulate, cut, staple, etc.) and / or a function of the associated shaft assembly 23120 (e.g., rotate, articulate, etc.) is performed. The surgical hub control circuit 23142 may be further configured to receive data from an internal database (e.g., the surgical hub database 23149) and / or from an external database (e.g., the cloud database 23150) throughout the course of a surgical procedure. According to various aspects, the data received from the internal and / or external database may include procedure data (e.g., steps of performing the surgical procedure) and / or historical data (e.g., data indicative of predicted parameters based on historical data related to the surgical procedure).

[0196] In various aspects, the procedural data may include a current / recognized standard of care procedure for the surgical procedure, and the historical data may include preferred / ideal parameters and / or preferred / ideal parameter ranges based on historical data (e.g., system-defined constraints) related to the surgical procedure. Based on the received data (e.g., sensor data, internal and / or external data, etc.), the surgical hub control circuitry 23142 may be configured to continuously derive inferences (e.g., contextual information) regarding the ongoing surgical procedure. That is, the context-aware surgical hub may be configured, for example, to record data regarding the surgical procedure for generating reports, verify steps taken by the surgeon to perform the surgical procedure, provide data or prompts (e.g., via user interfaces associated with the surgical hub and / or surgical instrument, e.g., 23148, 23158, 23118, 23128 and / or 23138) that may be related to particular procedural steps, control functions of the surgical instrument, etc. According to various aspects, the context-aware surgical hub 23140 may (e.g., after the first surgical function of the end effector assembly 23130 or shaft assembly 23120 has been performed) estimate the next surgical function to be performed based on procedure data received from the internal database 23149 and / or the external database 23150.

[0197] Further, in such aspects, the context-aware surgical hub 23140 may evaluate the detected parameters (e.g., received from sensors 23134 and / or 23124 in response to the initial surgical function) based on historical data (e.g., preferred / ideal parameters) received from an internal database 23149 and / or an external database 23150. Here, if the detected parameters do not exceed the preferred / ideal parameters and / or are within the respective preferred / ideal parameter ranges, the context-aware surgical hub 23140 may allow the next surgical function to be performed and / or may prevent / not control the next surgical function from being performed. Alternatively, if the detected parameters exceed the preferred / ideal parameters and / or are not within the respective preferred / ideal parameter ranges, the context-aware surgical hub 23140 may proactively prevent the next surgical function from being performed.

[0198] According to another aspect of the present disclosure, the context-aware surgical hub 23140 may receive communication (e.g., from a component of the surgical instrument 23102, e.g., 23130 and / or 23120) that a particular surgical function is being attempted / requested / performed. In such an aspect, the context-aware surgical hub 23140 may compare the particular surgical function to an inferred next surgical function to ensure adherence to a current / recognized standard of care procedure. If so, the context-aware surgical hub 23140 can then evaluate the detected parameters (as described) before allowing the particular surgical function (e.g., as described) to proceed. If not, the context-aware surgical hub 23140 may prevent the particular surgical function from being performed or may prevent the particular surgical function from being performed until an override is received (e.g., via user interfaces 23158, 23148, 23138, 23128, and / or 23118, and see, for example, selectable user interface element 23012 in FIG. 34 ). In such an aspect, if an override is received, the context-aware surgical hub 23140 may then evaluate the detected parameters (as described) before allowing the particular surgical function to proceed.

[0199] 35 , according to another embodiment, a surgical procedure may be performed utilizing a context-aware surgical instrument 23102. In such an embodiment, the surgical instrument 23102 may include a handle assembly 23110, a shaft assembly 23120, and an end effector assembly 23130. The end effector assembly 23130 may include a first jaw, a second jaw pivotally coupled to the first jaw, and a sensor 23134 configured to detect a parameter associated with a function of the end effector assembly 23130 (e.g., dissecting, clamping, coagulating, cutting, stapling, etc.) and transmit the detected parameter to control circuitry (23112, 23122, 23132 and / or 23142, e.g., in phantom to indicate any position(s)).

[0200] For example, in such embodiments, the detected parameters may be transmitted to the control circuitry 23132 of the end effector assembly 23130. Here, the end effector assembly control circuitry 23132 may be configured to receive the detected parameters (e.g., sensor data) from the sensor 23134 throughout the course of a surgical procedure. The detected parameters may be received each time a function of the associated end effector assembly 23130 is performed (e.g., dissecting, clamping, coagulating, cutting, stapling, etc.).

[0201] The end effector assembly 23130 may be further configured to receive data from an internal database (e.g., the end effector memory 23136) and / or an external database (e.g., from the surgical hub database 23149 via the surgical hub 23140 to the cloud database 23150) throughout the course of a surgical procedure. According to various aspects, the data received from the internal and / or external database may include staple cartridge data (e.g., staple sizes and / or types associated with staple cartridges positioned within the end effector assembly) and / or historical data (e.g., data indicative of predicted tissue and / or tissue types to be stapled having such sizes and / or types based on historical data). In various aspects, the received data may include preferred / ideal parameters and / or preferred / ideal parameter ranges associated with such sizes and / or types of staples or such predicted tissue and / or tissue types based on historical data (e.g., system-defined constraints). Based on received data (e.g., sensor data, internal and / or external data, etc.), the end effector control circuit 23132 can be configured to continuously derive inferences (e.g., contextual information) regarding the ongoing surgical procedure. Notably, according to alternative aspects, the sensor 23134 of the end effector assembly 23130 may transmit detected parameters to control circuitry (e.g., 23112 and / or 23122) associated with another surgical instrument 23102 component, such as the handle assembly 23110 and / or shaft assembly 23120. In such aspects, the control circuitry (e.g., 23112 and / or 23122) of the other surgical instrument component may be similarly configured to perform various aspects of the end effector control circuit 23132, as described above.Further, according to various aspects, the shaft assembly 23120 of the surgical instrument 23102 may include a sensor 23124 configured to detect a parameter associated with the function (e.g., rotation, articulation, etc.) of the shaft assembly 23120 and transmit the detected parameter to a control circuit (e.g., 23112) similarly configured to implement various aspects of the end effector control circuit 23132 described above. Finally, the context-aware surgical instrument 23102 may be configured, for example, to alert its user of a discrepancy (e.g., via a user interface 23138 of the end effector assembly 23130, via a user interface (e.g., 23128 and / or 23118) of another component of the surgical instrument 23102 such as the shaft assembly 23120 and / or handle assembly 23110, and / or via a user interface 23148 ​​and / or 23158 associated with a surgical hub 23140 coupled to the surgical instrument 23102). For example, the mismatch may include the detected parameters exceeding preferred / ideal parameters and / or preferred / ideal parameter ranges associated with those sizes and / or types of staples, or their expected tissues and / or tissue types. By way of further example, the context-aware surgical instrument 23102 may be configured to control a function of the surgical instrument 23102 based on the mismatch. According to at least one aspect, the context-aware surgical instrument 23102 may inhibit a surgical function based on the mismatch.

[0202] As emphasized herein, various aspects of the present disclosure relate to a surgical instrument that performs a function (e.g., clamping), detects a parameter associated with that function, utilizes situational awareness aspects to evaluate, via control circuitry, whether the detected parameter is below or above a predefined parameter (e.g., considered ideal / desired) or a predefined range for that parameter (e.g., considered normal), and performs an action (i.e., stops the function(s), alerts the user, informs the user of possible causes, etc.) in response to the detected parameter being outside the predefined parameter and / or predefined parameter range. For example, FIG. 36 illustrates an algorithm 23200 implementing such an aspect, in which the control circuitry receives (step 23202) detected parameter(s) associated with the surgical function to be performed by the surgical instrument and retrieves (step 23204) situational awareness data from an internal and / or external database. The control circuitry then evaluates (step 23206) the detected parameter(s) in light of the situational awareness data and performs (step 23208) an action based on the evaluation.

[0203] According to various aspects of the present disclosure, a force detected at the jaws of the end effector assembly (e.g., via one or more sensors) may be of a magnitude that prevents one or more subsequent / further functions of the end effector assembly from being performed. In such aspects, the sensor may be a strain gauge coupled to the end effector, configured to measure the magnitude / amplitude of strain at the jaw(s) of the end effector, indicative of the closure force being applied to the jaw(s). Further, in such aspects, the sensor may be a load sensor configured to measure the closure force applied to the jaws by a closure drive system. Further, in such aspects, the sensor may be a current sensor configured to measure the current drawn by the motor, which correlates to the closure force applied to the jaws.

[0204] FIG. 37 shows a logic flow diagram of a process 21200 for controlling a surgical instrument according to a physiological type of clamped tissue, according to at least one aspect of the present disclosure. The illustrated process may be performed, for example, by the control circuit 21002 of the surgical instrument 21000. Accordingly, the control circuit 21002 performing the illustrated process 21200 receives tissue contact data and / or signals from the sensor(s) 21004 (step 21202). The received tissue contact data and / or signals of step 21202 indicate whether tissue is contacting at least one of the sensors 21004. Accordingly, the control circuit 21002 can determine an initial contact point between the end effector 21008 and the tissue being clamped (step 21204). In one aspect, the control circuit 21002 determines when initial tissue contact occurs by detecting when at least one of the sensors 21004 located on each of the jaws detects tissue contact thereagainst.

[0205] The control circuit 21002 thus determines the position of the jaws at the initial tissue contact point (step 21206). In one aspect, the control circuit 21002 is communicatively coupled to a Hall Effect sensor disposed on one of the jaws of the end effector 21008 configured to detect the relative position of a corresponding magnetic element disposed on the opposing jaw. Thus, the control circuit 21002 can determine the position of the jaws according to the sensed distance or gap therebetween (step 21206). In another aspect, the control circuit 21002 is communicatively coupled to a position sensor configured to detect the absolute or relative position of a closure tube configured to close the jaws when the closure tube is driven from a first or proximal position to a second or distal position. Thus, the control circuit 21002 can determine the position of the jaws according to the sensed position of the closure tube (step 21206). In yet another aspect, the control circuit 21002 is communicatively coupled to an angle sensor, such as a TLE5012B 360° angle sensor from Infineon Technologies, configured to detect the angle at which at least one of the jaws is oriented. Thus, the control circuit 21002 can determine the position of the jaws according to the sensed angle at which the jaw(s) are oriented (step 21206).

[0206] Accordingly, the control circuit 21002 determines the degree of contact between the grasped tissue and the tissue contacting surface(s) of the jaws (step 21208). The degree of tissue contact may correspond to the number or proportion of sensors 21004 that detected the presence (or absence) of tissue. In one aspect, the control circuit 21002 may determine the degree of tissue contact according to the proportion of sensor(s) 21004 that detected the presence of tissue to sensor(s) 21004 that did not detect the presence of tissue.

[0207] Accordingly, the control circuit 21002 sets control parameters for the motor 21006 according to the determined jaw 21206 position and the determined degree of tissue contact 21208 (step 21210). The motor control parameters may include, for example, a time for closing the jaws and / or a closure threshold(s). In one aspect, the control circuit 21002 may be configured to access a memory (e.g., a look-up table) to retrieve motor control parameters (e.g., jaw closure speed and closure threshold) associated with a particular position of the jaws and a particular degree of tissue contact sensed via various sensors. In various aspects, the control circuit 21002 may control the motor 21006 to adjust the jaw closure time by, for example, adjusting the speed at which the jaws are transitioned from an open position to a closed position, adjusting the length of time the jaws are paused after initial clamping of the tissue (i.e., tissue creep wait time), and / or adjusting a stabilization threshold for concluding the clamping phase. In various aspects, the closure threshold(s) can include, for example, a maximum allowable FTC end effector 21008 or rate of change for FTC (i.e., ΔFTC) at which the control circuit 21002 stops the motor 21006 driving the jaw closure or takes other action, for example, as discussed above in the section "Compression Ratio for Determining Tissue Compliance." The control circuit 21002 can then control the motor 21206 according to the motor control parameter set 21210 via the process 21200.

[0208] The position of the jaws at the initial point of contact with the tissue and the degree of contact with the tissue correspond to the thickness or geometry of the tissue being grasped, which in turn corresponds to the physiological type of the tissue. Accordingly, the control circuit 21002 may be configured to distinguish between tissue types and then set the control parameters of the motor 21006 accordingly (step 21210). For example, the control circuit 21002 may be configured to determine whether parenchymal or vascular tissue is being grasped by the end effector 21008 and then set the motor control parameters appropriate for the detected tissue type (step 21210).

[0209] In some aspects, the jaw closure speed can be selected for each tissue type to maintain a maximum FTC and / or maintain a ΔFTC below a particular closure threshold, and a particular closure threshold can likewise be selected for each tissue type. In one aspect, the control circuit 21002 can be configured to set a minimum clamping ratio so that the jaw closure motion is not permanently stopped. In one aspect, the control circuit 21002 can be configured to control a maximum dwell time to ensure that the jaw closure proceeds at least at a specified rate. In one aspect, the control circuit 21002 can be configured to stop the motor 21006 and / or provide feedback to the user when the closure threshold(s) are exceeded or if the surgical instrument 21000 otherwise stalls during use.

[0210] 37, the steps of certain embodiments of process 21200 are shown as occurring in a particular order or sequence, it should be noted that such depiction is for illustrative purposes only, and no particular order of process 21200 is intended, unless a particular order of certain steps is clearly required from the above description. For example, in other aspects of process 21200, control circuit 21002 can determine the degree of tissue contact (step 21208) before determining the position of the jaws at the point of initial contact (step 21206).

[0211] 38 is a flow diagram 22200 of one embodiment of adjusting a closure speed algorithm by a computer-implemented interactive surgical system 100, according to one embodiment of the present disclosure. In step 22202, a current closure algorithm is determined. This may refer to determining the closure control program currently being executed by the control circuitry 500 of the surgical instrument 112. The current closure algorithm or control program may include a closure threshold function (e.g., a closure threshold parameter) and an applied closure force (FTC) function (e.g., a closure rate of change parameter). Next, the flow diagram 22200 proceeds to step 22204, where pre-operative information is received and analyzed. As discussed above, the pre-operative information may include initial tissue thickness based on the tissue contact sensor 474, patient history including previous diagnoses and treatments (e.g., listed on a patient information EMR record stored in the hub or cloud), clinician history such as the surgeon's typical surgical routine, identified surgical instruments and associated materials, and the identified current surgical procedure. This pre-operative information can be used to determine, estimate, or predict tissue type or tissue characteristics in step 22206.

[0212] For example, the initial tissue thickness before deformation measured by the tissue contact sensor 474 may be used to determine the initial closure algorithm. Preoperative information, such as the patient's history of lung problems, may be used to determine that the current surgical procedure being performed is a thoracic procedure and that the tissue type is lung tissue. This preoperative information may be further used to determine adjustments to the initial closure algorithm. Additionally or alternatively, non-therapeutic (or quasi-non-therapeutic) initial tissue compression measurements and closure member position measurements (e.g., the positions of the first and second jaws of the end effector) may be used in conjunction with the preoperative information. Preoperative information of ventilation received from a ventilator in the operating room may further be used to infer that the current procedure is thoracic. Other preoperative information may also be used to further predict the specific thoracic procedure being performed. For example, based on a patient's EMR records in the cloud indicating that the patient has cancer, step 22206 may infer that the thoracic procedure is a lobectomy and involves removing cancerous tissue within the lung lobe.

[0213] Additionally, the patient EMR record may further indicate that the patient's history indicates that the patient previously underwent radiation therapy for cancer. In such a situation, it may be estimated or predicted that the irradiated lung tissue will be hard and susceptible to application of monopolar RF energy by the surgical instrument 112, for example. This is an example of an estimated tissue characteristic. An estimation that a lobectomy has been performed may also determine that tissue that can be stapled by the surgical instrument 112 includes blood vessels (PA / PV), bronchi, and parenchymal tissue. In step 22208, adjustments to the current closure algorithm are determined and applied based on the preoperative information. As discussed above, the closure threshold and the applied FTC may be adjusted based on the tissue type and tissue characteristics. For example, high tissue stiffness may require a slower, more conservative rate of change of the applied FTC (e.g., as represented by FTC lines 22012, 22112) and a closure threshold that generally outputs a lower maximum threshold (e.g., as represented by FTC L2 22010 and ΔFTCL2 22110).

[0214] The maximum threshold may indicate a threshold at which the first jaw member 152002 and the second jaw member 152004 are sufficiently positioned to fire staples against the surgical instrument 112. Relatively thicker tissue may correspond to, for example, a slower rate of change of closure force and, for example, a generally higher maximum closure threshold. Additionally, tissue type or structure may be estimated based on the surgical procedure and clinician history determined to identify other closure algorithm adjustments in step 22208. For example, the treating surgeon's clinician history may indicate how to initially treat a blood vessel. The tissue type and structure may be estimated to be vascular pulmonary tissue with a high blood content (i.e., high vasculature). Based on this estimated tissue type and characteristic information, it may be determined that an adjustment to a more slowly applied FTC rate of change is beneficial. In summary, in step 22208, adjustments to the current closure algorithm are determined and applied based on the estimated information. Thus, the current surgical procedure may be performed with the surgical instrument 112 using the adjusted current closure algorithm.

[0215] Next, flow diagram 22200 proceeds to decision operation 22210, where it is determined whether any steps of the identified surgical procedure remain. If no steps remain (i.e., the answer to decision operation 22210 is "no"), flow diagram 22200 ends in some aspects. However, if the answer to decision operation 22210 is "yes," further steps of the surgical procedure remain. Thus, the current state of flow diagram 22200 is "intraoperative." In this case, the flow diagram proceeds to step 22212, where intraoperative information may be received and analyzed. For example, the intraoperative information may indicate that the tissue type treated in this step of the surgical procedure is parenchymal tissue. Specifically, the tissue may be estimated to be parenchymal tissue based on, for example, clinician history. This estimation may be made in conjunction with measurements from tissue contact sensor 474 and measurements from load sensor 474 and closure member position. Additionally, the clinician history may indicate that after making an incision with a monopolar RF energy surgical instrument, the treating surgeon routinely completes a pulmonary fissure (a double fold of visceral folds that fold inward to cover the lung parenchyma). In such a situation, it may be inferred that the current step in the surgical procedure is the lung parenchyma based on the previously completed monopolar RF incision.

[0216] Additionally, the surgical hub 106 may determine whether the surgical instrument 112 being used is an appropriate stapler for firing, for example, parenchymal tissue. The initial tissue contact sensor 474 measurements may indicate relatively thick tissue based on the tissue contacting the lengths of the first and second jaw members 152002 and 152004 when the end effector 702 is fully open (at maximum jaw opening), which may be consistent with parenchymal tissue. Furthermore, the load sensor 474 for the closure member position measurements, as represented by the closure compared to the jaw opening curve, may indicate relatively high tissue stiffness. Such stiffness characteristics may be consistent with irradiated parenchymal tissue, a prediction that can be confirmed by referencing the patient EMR data in the cloud. In this manner, for example, in step 22212, the sensor signal and perioperative information may be used in conjunction.

[0217] Based on this received and analyzed intraoperative information, it can be determined at decision operation 22214 that further adjustments are necessary. On the other hand, if the answer at decision operation 22214 is no, the flow diagram returns to decision operation 22210. If the answer at decision operation 22214 is yes, tissue type and tissue characteristics are estimated, such as those that determine the tissue structure and stiffness characteristics of the parenchyma, similar to those described above at step 22206. Subsequently, adjustments to the currently applied closure algorithm can be determined and applied at step 22208. Specifically, an estimation that stiff and brittle parenchyma is being treated can cause the applied closure force to be adjusted to a slower, more conservative rate of change.

[0218] Thus, the current closure algorithm can be adjusted to one that minimizes the closure threshold and rate of change. That is, the adjusted threshold can include a reduced maximum closure force threshold, a more gradual rate of change in closure force, a reduced rate of change in closure force threshold, or some combination or subcombination of the above. In situations where a clinician inadvertently exceeds the closure threshold, for example, a wait period can be implemented. Exceeding the closure threshold may indicate that the tissue or material being compressed is too thick to fire staples, for example, and this wait period may be necessary.

[0219] After applying this modified closure algorithm to the parenchyma in step 22208, the flow diagram again proceeds to decision operation 22210. Here, the answer may again be "yes" because there are remaining steps in the surgical procedure. For example, the lobectomy procedure may then proceed to a vascular stapling step. Again, in step 22212, intraoperative information is received and analyzed. For example, the surgical hub may determine that the clinician has selected a vascular stapler surgical instrument. Also, initial measurements from the tissue contact sensor 474 may indicate that tissue contact occurs almost immediately during closure. Additionally, tissue contact may be determined to encompass a small area of ​​the vascular stapler 112 and may be bounded distal to the stapler 112. The load sensor 474 measurements may also indicate a flexible tissue structure. Furthermore, it may be estimated that the tissue may have a relatively low stiffness, which may be consistent with a pulmonary vessel. Furthermore, the clinician history may indicate that the treating surgeon will use the vascular stapler 112 on the vessel as a step after completing treatment of the pulmonary fissure. In this manner, intraoperative information, for example, in conjunction with closure parameter sensor signals, may be used to estimate tissue type and tissue characteristics. Specifically, vascular tissue may be predicted to be treated based on the particular characteristics of the selected vascular stapler 112. Initial tissue contact and load sensor 474 measurements, for example, may confirm this initial prediction.

[0220] As a result, it may be determined at decision operation 22214 that further adjustments are necessary, causing flow diagram 22200 to proceed to step 22206. In step 22206, the tissue may be estimated to be vascular tissue, which has a relatively low tissue thickness and stiffness. Accordingly, flow diagram 22200 proceeds to step 22208, where the previously applied conservative closure algorithm is adjusted to a normal closure algorithm. The normal closure algorithm may include a constant closure change rate. Additionally, the closure threshold may be higher than that used in the parenchymal control algorithm. In other words, a higher maximum applied closure force may be reached and the closure change rate may be faster in the normal closure algorithm than in the parenchymal tissue control algorithm. The surgical instrument may also notify the clinician of the adjustments to the normal closure algorithm via a suitable indicator, such as a light-emitting diode (LED) indicator that displays a particular color. In another example, in step 22206, it may be determined that the patient has a complete lung fissure. Therefore, no parenchymal staple firings have already been performed in the surgical procedure. In response to this determination, the surgical instrument may prompt the clinician, such as via the surgical instrument's display, to confirm that this estimate is correct. The clinician may then manually select an appropriate closure control algorithm for this step or phase of the surgical procedure. Additionally or alternatively, the surgical instrument 112 may default to a conservative closure algorithm, since the estimate made in step 22206 may not be final. In either case, the adjusted closure algorithm is applied in step 22208.

[0221] Continuing with the description of the example lobectomy procedure, the flow diagram proceeds to decision operation 22210. At decision operation 22210, it may be determined that there are remaining steps in the surgical procedure. Accordingly, at step 22212, intraoperative information is received and analyzed. Based on the intraoperative information, it may be estimated that the tissue type being treated is bronchial tissue. Furthermore, the initial tissue contact sensor 474 readings may indicate that the tissue grasped between the end effectors 702 almost immediately contacts the first jaw member 152002 and the second jaw member 152004 during initial closure of the end effectors 702, and that such contact corresponds to a small area of ​​the stapling surgical instrument 112. Furthermore, such contact is demarcated on both sides of the jaw members 152002, 152004.

[0222] As a result, this tissue contact scenario may be predicted to correspond to bronchial tissue. As discussed above, these initial tissue contact sensor 474 measurements may be non-therapeutic or quasi-non-therapeutic. Furthermore, the closure load sensor 474 measurements, represented by closure compared to the jaw opening curve, may indicate a stiff tissue structure consistent with bronchial tissue. A surgical history indicating that the vascular stapler 112 has already been used in the surgical procedure may also mean that parenchymal staple firing has likely occurred, resulting in significant monopolar RF energy usage. For example, this surgical history, considered along with the clinician history, may be used to predict that the surgeon will treat bronchial tissue. This prediction would be consistent with the surgeon's usual practice of stapling the bronchus as the final step in a lobectomy procedure. Based on analyzing this type of and other suitable intraoperative information in step 22212, it may be determined at decision operation 22214 that further adjustments are needed. Since the answer to decision operation 22214 is YES, the flow diagram proceeds to step 22206 where the treated tissue is presumed to be bronchial tissue with normal tissue stiffness and thickness.

[0223] In one aspect, the surgical instrument 112 may be configured only for a specific tissue type, which may facilitate concluding that the treated tissue is bronchial tissue. For example, the surgical instrument 112 may be adaptable to fire staples used for bronchial tissue. Conversely, the surgical instrument 112 may be adaptable to fire staples used for parenchymal tissue. In that scenario, a warning may be generated by the surgical instrument 112 as the surgeon attempts to treat bronchial tissue with staples used for parenchymal tissue. This warning may be an audible warning, a visual warning, or some other appropriate warning. In another example, a warning may be provided by the vascular stapler 112 when the vascular stapler 112 is selected for use with bronchial tissue. As discussed above, it may be determined based on perioperative information that the tissue being treated is bronchial tissue and that the vascular stapler is contraindicated. Similarly, other perioperative information, such as closure load and stapler cartridge selection, may be used to provide a warning when the surgical instrument 112 is used against an incompatible tissue type or characteristic. As mentioned above, inferences made using perioperative information may be made in conjunction with closure parameter sensor signals. In all circumstances, safety checks may be performed to ensure that the surgical instrument 112 being used is safe for the tissue being treated.

[0224] According to the estimated tissue type and characteristics, adjustments are made to the current closure algorithm in step 22208. While a constant closure speed may be determined to be suitable, the closure speed may be adjusted to be faster or slower depending on the estimated tissue characteristics, for example, of the bronchus. The closure threshold may be modified in the same or similar manner. Furthermore, the current closure algorithm may be adjusted so that a longer wait time is automatically enabled or suggested if the surgical instrument 112 exceeds the immediately applicable closure threshold. For example, this wait time for bronchial tissue may be longer than the wait time used for parenchymal tissue. As discussed above, the surgeon notifies the closure algorithm of the selected adjustment, for example, via an LED indicator. A clinician override of the longer wait time is also possible so that the surgeon may be permitted to fire the stapler surgical instrument 112 in appropriate circumstances. Flow diagram 22200 then proceeds to step 22212, where it may be determined that, in one aspect, flow diagram 22200 may be implemented by control circuitry. However, in other aspects, flow diagram 22200 may be implemented by the surgical hub 106 or the cloud 104. Additionally, steps 22204 and 22212 are described with respect to pre-operative and intra-operative information, respectively, but are not limited to such. Specifically, peri-operative information may be received and analyzed holistically, rather than specific pre-operative or intra-operative information. As discussed above, peri-operative information encompasses pre-operative, intra-operative, and post-operative information. Furthermore, sensor signals may be used in conjunction with peri-operative information for contextual and inferential closure algorithm adjustment. Also, no further steps of the surgical procedure remain at this point.

[0225] 39 shows a logic flow diagram of a process 25030 illustrating a control program or logic controller for identifying irregularities in tissue distribution within an end effector 25002 of a surgical instrument, in accordance with at least one embodiment of the present disclosure. In one embodiment, the process 25030 is performed by a control circuit. In another embodiment, the process 25030 may be performed by a combinational logic circuit. In yet another embodiment, the process 25030 may be performed by a sequential logic circuit.

[0226] The process 25030 includes receiving sensor signals from sensor circuits of the sensing circuit assembly 25471 that correspond to predetermined zones (e.g., zone 1, zone 2, and zone 3) within the end effector 25002 (step 25032), and calculating a tissue impedance Z of the tissue portions in those zones based on the received sensor signals. tissue and determining (step 25034).

[0227] 40 shows a logic flow diagram of a process 25600 depicting a control program or logic configuration for properly positioning pre-stapled tissue within an end effector (e.g., end effector 25500, 25510) of a surgical stapler. In one aspect, process 25600 is performed by control circuitry. In another aspect, process 25600 is performed by combinational logic circuitry. In yet another aspect, process 25600 is performed by sequential logic circuitry.

[0228] For purposes of illustration, the following description depicts process 25600 as being executable by control circuitry including controller 461, which includes processor 461. Memory 468 stores program instructions executable by processor 461 to implement process 25600.

[0229] The process 25600 determines the type of surgical procedure being performed by the surgical stapler (step 25602). The type of surgical procedure can be determined using various techniques described under the heading "Context Awareness." The processor 25600 then selects a tissue impedance signature of properly positioned pre-stapled tissue based on the determined type of surgical procedure (step 25604). As described above, properly positioned pre-stapled tissue, for example, in a J-pouch procedure, will include a different tissue impedance signature than that in, for example, an end-to-end anastomosis procedure.

[0230] Process 25600 then determines whether the tissue impedance measured within the predetermined zone corresponds to the selected tissue impedance signature (step 25606). If not, processor 461 may alert the user (step 25608) and / or override the tissue treatment (step 25610). In one aspect, processor 461 may alert the user through display 473 (step 25608). Additionally, processor 461 may override the tissue treatment by preventing the end effector from completing its firing, which may be accomplished by, for example, having the motor driver stop the motor (step 25610).

[0231] However, if the tissue impedance measured within the predetermined zone corresponds to the selected tissue impedance signature, the processor 461 allows the end effector to proceed with tissue treatment (step 25612).

[0232] 41 shows a logic flow diagram of a process 9200 for updating a control program of a modular device 9050, according to at least one aspect 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 processor(s) and / or control circuit(s) performing the described steps of process 9200.

[0233] The analysis system 9100 receives perioperative data and surgical procedure outcome data for modular devices 9050 from one or more surgical hubs 9000 communicatively connected to the analysis system 9100 (step 9202). The perioperative data includes pre-operative, intra-operative, and / or post-operative data detected by the modular devices 9050 in association with a given surgical procedure. With respect to the modular devices 9050, or with respect to particular functions of the modular devices 9050 that are manually controlled, the perioperative data is indicative of how surgical staff members have previously operated the modular devices 9050. With respect to the modular devices 9050, or with respect to particular functions of the modular devices 9050 that are controlled by their control programs, the perioperative data is indicative of how the control programs have previously operated the modular devices 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 9050's control program) may be referred to as the "operating behavior" exhibited by the modular device 9050. Perioperative data of the modular device 9050 includes data regarding the state of the modular device 9050 (e.g., the firing or closure force of a surgical stapling and cutting instrument, or the power output of an electrosurgical or ultrasonic instrument), tissue data measured by the modular device 9050 (e.g., impedance, thickness, or stiffness), and other data that may be sensed by the modular device 9050. The perioperative data indicates how the modular device 9050 performed in response to various sensed 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.

[0234] Surgical procedure outcome data includes data regarding the overall results of a surgical procedure (e.g., whether there were any complications during the surgical procedure) or data regarding the results 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), determined or inferred by a situational awareness system of the surgical hub 9000 (as described in U.S. Patent Application Publication No. 2019 / 0201140 A1), or by the surgical hub 9000 or the analysis system 9100. The procedure outcome data may include whether each result represented by the data was a positive or negative result. Whether each result was positive or negative 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 received perioperative data. For example, treatment outcome data for a bleeding staple line may include that bleeding indicated a negative result. Similarly, treatment outcome data for a non-bleeding staple line may include that no bleeding indicated a positive result. In another example, analysis system 9100 may be configured to determine whether the treatment result is a positive result or a negative result based on the received treatment outcome data. In some examples, by correlating modular device 9050 data with a positive or negative treatment outcome, analysis system 9100 can determine whether a control program update should be generated (step 9208).

[0235] Once the analysis system 9100 receives the data (step 9202), it analyzes the modular device 9050 and treatment outcome data to determine whether the modular device 9050 is being suboptimally utilized (used less than optimally) in connection with a particular treatment or a particular step of a treatment (step 9204). A modular device 9050 may not be optimally controlled if the particular way in which the modular device 9050 is controlled repeatedly causes errors, or if alternative ways of controlling the modular device 9050 are superior under the same conditions. Thus, the analysis system 9100 can determine whether a modular device 9050 is being suboptimally controlled (either manually or by its control program) by comparing the rate of positive and / or negative results generated by the modular device 9050 to established thresholds or the performance of other modular devices 9050 of the same type.

[0236] For example, analysis system 9100 may determine whether a certain type of modular device 9050 is performing suboptimally if the rate of negative procedural 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 specific example, analysis system 9100 may analyze whether a control program for a surgical stapling instrument that prescribes a particular firing force (or range of firing forces) is suboptimal for a particular tissue thickness and tissue type (step 9204). If analysis system 9100 determines that the instrument produces an abnormally high rate of leaking staple lines (e.g., resulting in poor staple formation, incomplete penetration of tissue, or tearing of tissue) relative to an average or threshold staple line leak rate when fired at a particular force, analysis system 9100 may determine that the control program for the surgical stapling instrument is performing suboptimal stapling given tissue conditions.

[0237] As another example, the analysis system 9100 may determine whether a certain type of modular device 9050 is not performing optimally if the rate of positive results produced by an alternative control method under a particular set of conditions associated with a particular operating behavior exceeds the rate of positive results produced by the control method analyzed under the same conditions. In other words, if one subpopulation of modular devices 9050 of a certain type exhibits a first operating behavior under a particular set of conditions and a second subpopulation 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 exhibits a higher correlation with a positive treatment outcome. As a specific example, the analysis system 9100 may analyze whether a control program for an RF electrosurgical or ultrasonic instrument that prescribes a particular energy level is not optimal for a particular tissue type and environmental conditions (step 9204). 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., the instrument is located in a liquid-filled environment, as in an arthroscopic procedure), the analysis system 9100 can determine that the control program for the electrosurgical or ultrasonic instrument that prescribes the first energy level is not performing optimally (is performing less than optimally) for the given tissue and environmental conditions.

[0238] After analyzing the data (step 9204), the analysis system 9100 determines whether to update the control program (step 9206). If the analysis system 9100 determines that the modular device 9050 is being controlled less than optimally, 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 being controlled less than optimally, the process 9200 continues along the "yes" branch, and the analysis system 9100 generates a control program update (step 9208). The generated control program update (step 9208) 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.

[0239] The type of control program update generated by analysis system 9100 (step 9208) depends on the particular suboptimal behavior exhibited by modular device 9050 identified by analysis system 9100. For example, if analysis system 9100 determines that a particular force at which a surgical stapling instrument is fired results in an increased staple line leakage rate, analysis system 9100 may generate a control program update that adjusts the firing force from a first value to a second value corresponding to a higher force, non-leaking staple line, or a staple line with a lower leakage rate (step 9208). As another example, if analysis system 9100 determines that a particular energy level of an electrosurgical or ultrasonic instrument results in a low hemostatic rate when the instrument is used in a liquid-filled environment (e.g., due to the energy dissipation effects of the liquid), analysis system 9100 may generate 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 (step 9208).

[0240] The type of control program update generated by analysis system 9100 (step 9208) also depends on whether the suboptimal behavior exhibited by modular device 9050 is caused by manual control or by control program control of modular device 9050. If the suboptimal behavior is caused by manual control, the control program update can be configured to provide warnings, recommendations, or feedback to the user based on the manner in which the user is operating modular device 9050. Alternatively, the control program update can change the manually controlled behavior of modular device 9050 to behavior controlled by the control program of 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 that the surgeon has manually set the RF electrosurgical instrument to a less-than-optimal energy level for a particular tissue type or procedure type (step 9204), the analysis system 9100 may generate a control program update (step 9208) that provides an alert (e.g., to the surgical hub 9000 or to the RF electrosurgical instrument itself) recommending that the energy level be changed. In another example, the generated (step 9208) control program update may automatically set the energy level to a default or recommended level given a particular detected situation, and then allow this automatically set level to be changed as desired by medical facility staff. In yet another example, the generated (step 9208) control program update may automatically set the energy level to a set level determined by the analysis system 9100, but do 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 may change how the control program functions under a particular set of circumstances in which the control program is running suboptimally.

[0241] Once a control program update is generated by the analysis system 9100 (step 9208), the analysis system 9100 then transmits or pushes the control program update to all of the modular devices 9050 of the associated type connected to the analysis system 9100 (step 9210). 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 by the analysis system 9100 (step 9208). When a 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 (step 9202) and analyzing (step 9204) data from the modular devices 9050 as described above.

[0242] In one aspect, the surgical system 9060 is configured to push down software parameter validation and updates if the modular device 9050 is detected as out of date in the surgical hub 9000 data stream. FIG. 42 shows a diagram of an analysis system 9100 pushing updates to the modular device 9050 via 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.

[0243] 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 remove from consideration (i.e., ignore) data generated by a modular device 9050 or surgical hub 9000 that is controlled by an older control program, and / or cause an updated version of the control program to be pushed to the modular device 9050 or surgical hub 9000.

[0244] 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 determines 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 version of the associated control program to the surgical hub 9000.

[0245] In one example, the surgical hub 9000 and / or modular device 9050 can be configured to automatically download any software updates. In another example, the surgical hub 9000 and / or modular device 9050 can be configured to provide a prompt to the user asking whether they want to update out-of-date control program(s) at the next setup step (e.g., between surgical procedures). In another example, the surgical hub 9000 can be programmable by the user to never allow updates. Alternatively, it can be programmable by the user to only allow updates to the modular device 9050, and not the surgical hub 9000 itself.

[0246] 43 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 a population may arise as a result of the surgical hubs 9000's control programs being customized or programmed differently by on-site surgical staff, causing the surgical hubs 9000 to run different versions of their control programs, or as a result of on-site 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 operational behavior and a second subpopulation 9314 exhibiting a second operational 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 may perform include, for example, controlling a surgical instrument or analyzing a data set in a particular manner.

[0247] 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. The preoperative data can include, for example, patient-specific information, such as patient demographics, medical history, pre-existing 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 No. 13 / 631,095, U.S. Patent Application No. 13 / 828,809, and U.S. Patent No. 8,476,227, each of which is incorporated by reference herein to the extent that it describes patient-specific information. The pre-operative data may also include, for example, information specific to each operating room, such as 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.

[0248] Intraoperative data can include, for example, utilization of the modular device 9050 (e.g., number of fires by a surgical stapling instrument, number of fires by an RF electrosurgical or ultrasonic instrument, or number and type of stapler cartridges utilized), modular device 9050 operating parameter data (e.g., FTF curve of the surgical stapling instrument, FTC curve of the surgical stapling instrument, energy output of the generator, 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 procedure type), adjunctive therapy administered to the patient, and utilization of equipment other than the modular device 9050 (e.g., 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.

[0249] Post-operative data may include, for example, flags for when a patient does not leave the operating room and / or is sent for non-standard post-operative care (e.g., a patient undergoing a routine bariatric procedure is sent to the ICU after the procedure), post-operative patient assessments for the surgical procedure (e.g., data regarding spirometry after a respiratory procedure, or data regarding staple line leaks after a bowel or bariatric procedure), data regarding post-operative complications (e.g., blood transfusion or air leaks), or the patient's length of stay at the medical facility after the procedure. As hospitals are increasingly graded on readmission rates, complication rates, average length of stay, and other such surgical quality metrics, post-operative data sources, alone or in combination with surgical procedure outcome data (described below), may be monitored by the analysis system 9100 to evaluate and initiate updates to the control programs of the surgical hub 9000 and / or modular devices 9050.

[0250] 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 positive or negative outcome. In some examples, the surgical procedure outcome data can include time-stamped images of the procedure steps performed by the modular device 9050 and / or performance of the modular device 9050, a flag indicating whether the modular device 9050 functioned properly, notes from medical facility staff, or a flag indicating poor, suboptimal, or unacceptable performance of the modular device 9050. Surgical outcome data may, for example, be detected directly by modular device 9050 and / or surgical hub 9000 (e.g., a medical imaging device may visualize or detect bleeding), determined or inferred by a situational awareness system of surgical hub 9000 (as described in U.S. Patent Application Publication No. 2019 / 0201140 A1), or by surgical hub 9000 or analysis system 9100. In some examples, perioperative data including a flag indicating that modular device 9050 failed or otherwise performed poorly during the course of a surgical procedure may be preferentially transmitted to and / or analyzed by analysis system 9100.

[0251] In one example, perioperative data may be collected for each procedure, uploaded by surgical hub 9000 to analysis system 9100, and analyzed by analysis system 9100. The perioperative data is indicative of how the surgical hub 9000 was programmed to operate or manually controlled in connection with a surgical procedure (i.e., the operational behavior of the surgical hub 9000) because such data indicates what actions the surgical hub 9000 took in response to various detected conditions, how the surgical hub 9000 controlled the modular devices 9050, and how the situation-aware surgical hub 9000 drew inferences 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 subpopulations, as appropriate.

[0252] 44 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 should be understood that analysis system 9100 includes processor(s) and / or control circuit(s) performing the described steps of process 9300.

[0253] Analysis system 9100 executing process 9300 receives perioperative data from a surgical hub 9000 communicatively coupled to analysis system 9100 (step 9302). 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 may include, or be transmitted to analysis system 9100 in association with, surgical outcome data. The surgical outcome data may include data regarding the overall results 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).

[0254] After analysis system 9100 executing process 9300 receives perioperative data (step 9302), analysis system 9100 then analyzes the data (step 9304) 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 during a particular step in a certain type of surgical procedure, a control program update should be generated that automatically activates the energy generator during that procedure step. In another example, the update condition includes whether the percentage of positive procedure outcomes (or lack of negative procedure outcomes) correlated with a particular operational behavior exceeds a threshold value (e.g., the average percentage of positive procedure outcomes for the procedure 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 the associated rate of hemostasis (i.e., lack of bleeding) at that energy level for a particular tissue type exceeds a threshold rate. In another example, the update conditions include whether the rate of positive treatment outcomes (or lack of negative treatment outcomes) for a particular operating behavior is higher than the rate of positive treatment outcomes (or lack of negative treatment outcomes) for a related operating behavior. In other words, if one subpopulation of surgical hubs 9000 exhibits a first operating behavior under a particular set of conditions and a second subpopulation of surgical hubs 9000 exhibits a second operating 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 operating behavior or the second operating behavior is more highly correlated with a positive treatment outcome. In another example, analysis system 9100 analyzes the data (step 9304) to determine whether multiple update conditions are met.

[0255] If the update condition is not met, process 9300 continues along the “no” branch and analysis system 9100 continues receiving (step 9302) and analyzing (step 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 a control program update (step 9308). The nature of the control program update generated (step 9308) corresponds to the particular operational behavior of surgical hub 9000 identified by analysis system 9100 as triggering the update condition. In other words, the control program update adds, removes, or otherwise modifies functions performed by surgical hub 9000, such that the surgical hub operates differently under the conditions that gave rise to the identified operational behavior.

[0256] 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 can be configured to provide alerts, recommendations, or feedback to the user based on how 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 for a step in a surgical procedure will improve the outcome, the analysis system 9100 may generate a control program update (step 9308) to provide 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 next. Alternatively, the control program update can 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 is set to a particular view by surgical staff during a particular step of the vast majority of surgical procedures, 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 results 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 a poor or negative outcome under a particular set of conditions, analysis system 9100 may cause surgical hub 9000 to generate a control program update that causes surgical hub 9000 to adjust the energy level of a connected instrument to a different value when that set of conditions is detected (e.g., when surgical hub 9000 determines that an arthroscopic procedure is being performed) (step 9308).

[0257] The analysis system 9100 then transmits the control program update to the entire population of surgical hubs 9000, or to a subpopulation or subpopulations of surgical hubs 9000 that are performing the operational behavior identified by the analysis system 9100 as triggering the update condition (step 9310). In one example, the surgical hubs 9000 are configured to download the control program update from the analysis system 9100 each time an update is generated by the analysis system 9100 (step 9308). In one example, the analysis system 9100 can then continue with process 9300 by analyzing (step 9304) the data received from the surgical hubs 9000 (step 9302), as described above.

[0258] FIG. 45 shows a representative implementation of process 9300 shown in FIG. 44. FIG. 45 shows 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. In one example, like process 9300 shown in FIG. 44, process 9400 shown in FIG. 45 can be performed by analysis system 9100. In one example of adaptive surgical system 9060 depicted in FIG. 43, a first subpopulation 9312 of surgical hubs utilizes a first data analysis algorithm and a second subpopulation 9314 of surgical hubs utilizes a second data analysis algorithm. For example, the first subpopulation 9312 of surgical hubs can utilize a normal continuous probability distribution to analyze a particular data set, and the second subpopulation 9314 of surgical hubs can utilize a bimodal distribution to analyze the same particular data set. In this example, analysis system 9100 receives perioperative data from a first subset 9312 and a second subset 9314 of surgical hubs corresponding to respective data analysis algorithms (steps 9402, 9404). Analysis system 9100 then analyzes the perioperative data sets (step 9406) to determine whether one of the perioperative data sets satisfies one or more update conditions. The update conditions may include, for example, a particular analysis method being utilized by a threshold percentage of the overall population of surgical hub 9000 (e.g., 75%) and a particular analysis method being correlated to positive surgical procedure outcomes in a threshold percentage of cases (e.g., 50%).

[0259] In this example, analysis system 9100 determines whether one of the data analysis algorithms utilized by first subset 9312 and second subset 9314 of surgical hubs satisfies both of the update conditions (step 9408). If the update conditions are not met, process 9400 proceeds along the “no” branch and analysis system 9100 continues receiving (steps 9402, 9404) and analyzing (step 9406) perioperative data from first subset 9312 and second subset 9314 of surgical hubs. If the update conditions are met, process 9400 proceeds along the “yes” branch and analysis system 9100 generates a control program update according to which of the data analysis algorithms, as determined by analysis 9406, meet the update conditions (step 9412). In this example, the control program update involves causing surgical hub 9000 to utilize the data analysis algorithm that met the update conditions when performing the corresponding analysis type. Analysis system 9100 then transmits the generated (step 9412) control program update to the population of surgical hubs 9000 (step 9414). In one example, the control program update is transmitted to the entire population of surgical hubs 9000 (step 9414). In another example, the control program update is transmitted to a subpopulation of surgical hubs 9000 that did not utilize the data analysis algorithm that satisfied the update conditions (step 9414). In other words, if analysis system 9100 analyzes the perioperative data (step 9406) and determines (step 9408) that the second (bimoda...

Claims

1. 1. A surgical hub comprising: a transmitter and receiver configured to establish a communication path between the surgical hub and a powered surgical end effector; 1. A processor, comprising: determining whether communication is available with the powered surgical end effector configured to operate in a first mode or a second mode, wherein in the first mode the powered surgical end effector operates aspects of a controllable jaw according to a default actuation algorithm stored in an updatable memory of the powered surgical end effector; receiving data related to the powered surgical end effector via the receiver; determining whether the surgical end effector should operate in the first mode or the second mode based on the received data; and a processor configured to: based on the determination, send updated data to operate the powered surgical end effector in the second mode, wherein in the second mode the powered surgical end effector operates the aspect of the controllable jaw according to an alternative actuation algorithm.

2. The surgical hub of claim 1 , wherein the determination of whether communication is available is determined by available processing power, memory, bandwidth, software revision, or subscription level.

3. The surgical hub of claim 1 or 2, wherein the transmitted data relates to procedure information.

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