Surgical instruments using adaptive configuration control

Abstract

To provide surgical instruments. [Solution] A surgical instrument receives instructions to provide adaptive control of its functions. The instructions may indicate providing an adaptable staple height operating range, controlling a motor associated with tissue compression, and / or operating using operating parameters associated with a previous surgical procedure. The surgical instrument may determine the values ​​of parameters associated with the identified function and adapt the control of the identified function based on the determined parameters. The surgical instrument may adapt the indication of the staple height operating range based on a parameter indicating the size of the anvil head. The surgical instrument may control a motor associated with tissue compression based on a parameter indicating the force applied to the instrument. The surgical instrument may operate according to operating parameters identified by the surgical hub.

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application relates to the following applications filed concurrently, the contents of which are incorporated herein by reference. ●Agent reference number END9287USNP1, title METHOD FOR OPERATING TIERED OPERATION MODES IN A SURGICAL SYSTEM, ●Agent reference number END9287USNP8, title SURGICAL INSTRUMENT WITH ADAPTIVE FUNCTION CONTROLS, and ●Agent reference number END9287USNP9, title SURGICAL INSTRUMENT WITH ADAPTIVE MOTOR CONTROL. [Background technology]

[0002] Surgical instruments often include components or systems that operate to provide functions associated with the operation of the surgical instrument. For example, a surgical stapler may include a display adapted to provide the operator with feedback regarding tissue compression. A surgical stapler may include a first motor that can provide force for clamping the tissue and a second motor that can provide force for driving the staple into the tissue. [Overview of the project] [Means for solving the problem]

[0003] A surgical stapler may receive instructions for configuring it based on operating parameters associated with previously performed surgical procedures. The surgical stapler may communicate characteristics associated with it to a surgical hub. For example, the surgical hub may communicate information indicating that the surgical stapler is configured with an end effector having a relatively small anvil head. In response, the surgical stapler may receive operating parameters for configuring it. These operating parameters may be associated with one or more previously performed surgical procedures. The surgical stapler may configure itself to operate based on the received operating parameters.

[0004] This “Summary of the Invention” is provided to introduce the selection of concepts in a concise form, which will be further described below in the “Modes for Carrying Out the Invention.” This summary is not intended to identify any important or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Other features are described herein.

[0005] According to various embodiments of the present invention, the following examples are provided.

[0006] 1. Surgical instruments, Receiving instructions for configuring surgical instruments based on operating parameters associated with previously performed surgical procedures, To communicate the characteristics associated with surgical instruments, A surgical instrument comprising a processor configured to receive operating parameters for configuring a surgical instrument, wherein the operating parameters are associated with one or more previously performed surgical procedures, and to configure the surgical instrument based on the received operating parameters.

[0007] 2. The surgical instrument according to Example 1, wherein a processor configured to communicate characteristics associated with the surgical instrument is configured to communicate data relating to the end effector.

[0008] 3. The surgical instrument according to Example 2, wherein a processor configured to receive operating parameters for configuring the surgical instrument is configured to receive operating parameters associated with an adaptable staple height operating range.

[0009] 4. The surgical instrument according to Example 3, wherein a processor configured to configure the surgical instrument based on received operating parameters is configured to configure an adaptable staple height operating range.

[0010] 5. A surgical instrument according to any one of Examples 1 to 4, wherein a processor configured to communicate characteristics associated with the surgical instrument is configured to communicate characteristics associated with tissue compressed by the surgical instrument.

[0011] 6. The surgical instrument according to Example 5, wherein a processor configured to receive operating parameters for configuring the surgical instrument is configured to receive operating parameters associated with the operation of one or more motors.

[0012] 7. A processor configured to receive operating parameters associated with the operation of one or more motors, Receiving operating parameters for configuring the operation of a first motor associated with the force applied by the anvil to compress the tissue, The surgical instrument according to Embodiment 6, further configured to receive operating parameters for configuring the operation of a second motor associated with the application of force for inserting a surgical staple.

[0013] 8. A surgical circular stapler, The first motor and The second motor, A processor, receiving an instruction for configuring a surgical circular stapler based on operation parameters associated with a previously performed surgical operation, communicating characteristics associated with tissue compressed by the surgical circular stapler, receiving operation parameters for configuring a first motor and a second motor, the operation parameters being associated with one or more previously performed surgical operations, configured to perform: configuring the operations of the first motor and the second motor based on the received operation parameters, a surgical circular stapler comprising the processor.

[0014] 9. The operation parameters for configuring the first motor include operation parameters for configuring the first motor so as to generate a force applied by an anvil to compress tissue, The operation parameters for configuring the second motor include operation parameters for configuring the second motor so as to generate a force applied to insert a surgical staple, the surgical circular stapler according to Example 8.

[0015] 10. Further comprising a sensor adapted to sense tissue characteristics, The processor is further configured to receive operation parameters for configuring the sensor, the surgical circular stapler according to Example 8 or Example 9.

[0016] 11. A computing system, A processor, maintaining a data store of operation parameters for a surgical instrument, the operation parameters being associated with a previously performed surgical operation, receiving characteristics associated with a planned surgical operation, reading out from the data store operation parameters corresponding to the received characteristics, A computing system comprising a processor, configured to transmit read operating parameters to surgical instruments for use in configuring them to perform a planned surgical procedure.

[0017] 12. The computing system according to Embodiment 11, wherein a processor configured to receive characteristics associated with a planned surgical procedure is configured to receive characteristics associated with a surgical instrument for the planned surgical procedure.

[0018] 13. The computing system according to Example 12, wherein the properties associated with a surgical device for a planned surgical procedure include the properties associated with a surgical circular stapler.

[0019] 14. The computing system according to Example 13, wherein the read-out operating parameters include operating parameters for an adaptable staple height operating range.

[0020] 15. The computing system according to Example 13, wherein the read-out operating parameters include operating parameters for the operation of one or more motors.

[0021] 16. The computing system according to Example 15, wherein the operating parameters for the operation of one or more motors include an operating parameter for a first motor associated with a force applied by an anvil to compress tissue, and an operating parameter for a second motor associated with the application of a force for inserting surgical staples.

[0022] 17. Operating parameters for surgical instruments are stored in relation to the operator of the surgical instrument. A processor configured to receive characteristics associated with a planned surgical procedure is configured to receive characteristics that specify an operator for the planned surgical procedure. A computing system according to any one of Examples 11 to 16, wherein a processor configured to read operational parameters corresponding to received characteristics is configured to read operational parameters corresponding to an operator for a planned surgical procedure.

[0023] 18. The computing system according to any one of Examples 11 to 17, wherein a processor configured to read operational parameters corresponding to received characteristics from a data store is configured to read operational parameters associated with multiple previously performed surgical procedures.

[0024] 19. A processor configured to receive characteristics associated with a planned surgical procedure is configured to receive specific characteristics associated with a planned surgical procedure. A computing system according to any one of Examples 11 to 18, wherein a processor configured to read operational parameters corresponding to received characteristics from a datastore is configured to read operational parameters corresponding to specific characteristics associated with a planned surgical procedure. 20. A computing system according to any one of Examples 11 to 19, wherein the characteristics associated with the planned surgical procedure include characteristics associated with one or more of the patient, the operator of the surgical instrument, or the intended outcome.

[0025] 21. The processor, It receives queries that specify the characteristics associated with surgical procedures. Read the operating parameters corresponding to the characteristics associated with the surgical procedure from the data store. The computing system according to Example 11, further configured to communicate read operating parameters corresponding to characteristics associated with surgical procedures.

[0026] 22. A surgical instrument according to any one of Examples 1 to 7, or a surgical circular stapler according to any one of Examples 8 to 10, wherein the characteristics associated with the surgical instrument include instructions for the hardware included in the surgical stapler, instructions for the software included in the surgical stapler, and / or information relating to the intended use of the surgical stapler.

[0027] 23. A surgical instrument according to any one of Examples 1 to 7, a surgical circular stapler according to any one of Examples 8 to 10, or a computing system according to any one of Examples 11 to 21, wherein the operating parameters include parameters for controlling the force applied by the surgical instrument over time, the position of the components of the surgical instrument over time, and / or the threshold or range of the sensed or determined characteristics of the surgical instrument or tissue used to control the operation of the surgical instrument.

[0028] 24. A surgical instrument as described in Example 3, or a computing system as described in Example 14, wherein the staple height operating range represents the range of the anvil's stroke position.

[0029] 25. The surgical instrument according to Example 5, wherein the properties associated with the tissue compressed by the surgical instrument include the dimensions of the tissue or the mechanical properties of the tissue.

[0030] As an example above, particularly in Examples 1, 8, and 11, surgical instruments can be dynamically reconfigured for use in a specific procedure based on known configurations associated with previously performed procedures. This ensures consistency in the treatment of patients undergoing a particular procedure, which in turn can lead to better predictability of clinical outcomes. Furthermore, operating parameters may be associated with or derived from previously performed surgical procedures, in particular a set of surgical procedures previously performed with desired clinical outcomes. In this way, the configuration of surgical instruments for a particular procedure can be optimized according to historical data, improving the clinical outcomes of future specific procedures.

[0031] As an example above, particularly in Examples 2-4, surgical instruments can be dynamically configured to be optimized for use with specific end-effector types. In particular, different end-effectors produce different degrees of clamping or compression of the tissue, which in turn influences the optimal configuration of the instrument to ensure that the surgical staple is inserted into the tissue in a manner that it forms properly upon insertion. This reduces the risk that the staple may be either too loose or too tight, which could negatively impact the clinical outcome of the procedure.

[0032] As an example of the above, particularly in Examples 5-7 and 8-10, surgical instruments can communicate characteristics associated with the tissue compressed by the surgical instrument. These characteristics can be inferred from the surgical instrument, for example, from the load current or load power of the drive motor within the surgical instrument, or from one or more sensors within the surgical device. The surgical instrument can then be dynamically reconfigured based on the tissue characteristics and optimized for that tissue based on previously performed surgical procedures on tissues with similar characteristics. This can further optimize the procedure for a particular patient's condition and improve clinical outcomes for each patient or procedure.

[0033] As an example above, particularly in Examples 12-16, the computing system can retrieve characteristics associated with a particular surgical instrument based on historical data. The characteristics may identify the surgical instrument as a specific surgical instrument that is reused across several surgical procedures. In this case, the use of stored operating parameters avoids the need to reconfigure the instrument for each surgical procedure in which it is used. Alternatively, the characteristics may identify the surgical instrument as a specific model of surgical instruments. In this case, the use of stored operating parameters avoids the need to reconfigure a new instrument for a particular surgical procedure. Or, the characteristics may identify the surgical instrument as one of a broad type of surgical instrument that has common operating parameters. In this case, even if a particular model of surgical instrument has not been used previously in a particular surgical procedure, the use of stored operating parameters allows for the use of historical data to improve the configuration of each of the broad types of surgical instruments in that particular surgical procedure.

[0034] As an example of the above, particularly in Example 17, surgical instruments can be reconfigured according to the preferences or training of a specific operator with minimal intervention by the operator. This ensures that the surgical instruments are performed in the manner expected by the operator in a given surgical procedure. Furthermore, the present invention mitigates errors that may occur by reconfiguring surgical instruments each time the operator performs a particular surgical procedure. Thus, this acts to improve the overall safety of the procedure being performed. [Brief explanation of the drawing]

[0035] [Figure 1] This is a block diagram of a computer-implemented interactive surgical system. [Figure 2] This is a diagram illustrating an exemplary surgical system used to perform surgical procedures in an operating room. [Figure 3] This is a diagram of an exemplary surgical hub paired with a visualization system, a robotic system, and intelligent instruments. [Figure 4] This figure shows a surgical data network having a communication hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility specifically equipped for surgical procedures, to the cloud, according to at least one aspect of the present disclosure. [Figure 5] This figure shows an exemplary computer-implemented interactive surgical system. [Figure 6] This figure shows an exemplary surgical hub comprising multiple modules connected to a modular control tower. [Figure 7] This is a diagram illustrating an exemplary surgical instrument or tool. [Figure 8] This figure shows an exemplary surgical instrument or tool having a motor that can be activated to perform various functions. [Figure 9] This is a diagram illustrating an exemplary situational awareness surgical system. [Figure 10] This diagram shows an exemplary surgical procedure and an exemplary timeline of what the surgical hub could infer from the data detected at each stage of the surgical procedure. [Figure 11] This is a block diagram of a computer-implemented interactive surgical system. [Figure 12] This diagram shows the functional architecture of an exemplary computer-implemented interactive surgical system. [Figure 13] This figure shows an exemplary computer-implemented interactive surgical system configured to adaptively generate control program updates for modular devices. [Figure 14] This figure shows an exemplary surgical system including a handle having a controller and a motor, an adapter releasably connected to the handle, and a loading unit releasably connected to the adapter. [Figure 15A] This diagram shows an exemplary flow for determining the operating mode and then operating in that determined mode. [Figure 15B] This diagram shows an exemplary flow for changing the operating mode. [Figure 16] This is a schematic diagram of a surgical instrument configured to operate the surgical tools described herein, according to at least one aspect of this disclosure. [Figure 17] This is a block diagram of a surgical instrument configured to control various functions, according to at least one aspect of the present disclosure. [Figure 18] This is a perspective view of a circular stapled surgical instrument according to at least one aspect of the present disclosure. [Figure 19A] Figure 18 is an enlarged longitudinal cross-sectional view showing the anvil in the open position of the staple head assembly of the device according to at least one aspect of the present disclosure. [Figure 19B] Figure 18 is an enlarged longitudinal cross-sectional view showing the anvil in the closed position of the staple head assembly of the device according to at least one aspect of the present disclosure. [Figure 19C] Figure 18 is an enlarged longitudinal cross-sectional view of the staple fastening head assembly of the instrument, showing the staple driver and blade in the firing position, according to at least one aspect of the present disclosure. [Figure 20] This is an enlarged partial cross-sectional view of a staple formed in contact with an anvil according to at least one aspect of the present disclosure. [Figure 21] This is a partial cross-section of an electric circular stapling device comprising a circular stapling head assembly and an anvil, according to at least one aspect of the present disclosure. [Figure 22] This is a partial top view of a circular staple fastening head assembly shown herein, showing a first row of staples (inner staples) and a second row of staples (outer staples), according to at least one aspect of the present disclosure. [Figure 23] A graphical representation of the viable staple firing range, as indicated by the usable staple height window, based on interstitial gaps, closure force (FTC), or tissue creep stabilization sensed by the apparatus or a combination thereof, according to at least one aspect of the present disclosure. [Figure 24]A graph of a first pair of graphs showing time against anvil gap and tissue compressive force for exemplary firing of a staple fastener, according to at least one aspect of the present disclosure. [Figure 25] A graph of a second pair of graphs showing time against anvil gap and tissue compressive force for exemplary firing of a staple fastener, according to at least one aspect of the present disclosure. [Figure 26] This is a schematic diagram of an electric circular stapling device showing effective tissue gaps, actual gaps, normal range gaps, and out-of-range gaps, according to at least one aspect of the present disclosure. [Figure 27] This is a logical flow diagram of a process representing a control program or logical configuration for providing arbitrary or mandatory lockout according to a parameter sensed and compared to a threshold, according to at least one aspect of the present disclosure. [Figure 28] This figure shows the extent of the interstitial gap and the resulting form of staples according to at least one aspect of the present disclosure. [Figure 29] This is a graph of time for three closing force (FTC) curves according to at least one aspect of the present disclosure. [Figure 30] This is a detailed graph of time relative to the closing force (FTC) curve, according to at least one aspect of the present disclosure. [Figure 31] A graph and a diagram of an associated motorized stapling device showing an anvil closing speed adjustment at a specific key point along the retraction stroke of a trocar, according to at least one aspect of the present disclosure. [Figure 32] A logic flow diagram of a process showing a control program or logic configuration for adjusting the closing speed of the anvil portion of an electric staple fastening device at a specific key point along the retraction stroke of a trocar, according to at least one aspect of the present disclosure. [Figure 33] A graph and a diagram of an associated electric stapling device showing the trocar position over time, according to at least one aspect of the present disclosure. [Figure 34]This is a logic flow diagram of a process representing a control program or logic configuration for detecting multidirectional seating motion on a trocar for driving an anvil to proper seating, according to at least one aspect of the present disclosure. [Figure 35] This is a partial schematic diagram of a circular motorized stapling device according to at least one aspect of the present disclosure, showing an anvil closure on the left and an operating knife 201616 on the right. [Figure 36] This is a graph of the anvil displacement (δAnvil) along the vertical axis as a function of the clamp closing force (FTC) along the horizontal axis, according to at least one aspect of the present disclosure. [Figure 37] Figure 201630 shows the displacement of the knife 201616 (δKnife) along the vertical axis as a function of the knife 201616 velocity (VK mm / sec) along the horizontal axis on the left side, and as a function of the knife 201616 force (FK lbs) along the horizontal axis on the right side, according to at least one aspect of this disclosure. [Figure 38] This is a logical flow diagram of a process showing a control program or logical configuration for detecting interstitial gaps and firing force to adjust knife stroke and velocity, according to at least one aspect of the present disclosure. [Figure 39] This is a logic flow diagram of a process showing a control program or logic configuration for advancing knife 201616 under a high tissue toughness velocity profile with velocity spikes as shown in Figure 37, according to at least one aspect of the present disclosure. [Figure 40] This is a partial perspective view of a circular stapler trocar, which includes a staple cartridge having four predetermined zones, according to at least one aspect of the present disclosure. [Figure 41] This is a partial perspective view of a circular stapler trocar including a staple cartridge having eight predetermined zones, according to at least one aspect of the present disclosure. [Figure 42]This figure shows, on the left, two pieces of tissue including pre-placed staples appropriately arranged on the staple cartridge of Figure 40, and on the right, two pieces of tissue including pre-placed staples appropriately arranged on the staple cartridge of Figure 40, according to at least one aspect of the present disclosure. [Figure 43] This figure shows two structures, including pre-placed staples, appropriately arranged on a staple cartridge, according to at least one aspect of the present disclosure. [Figure 44] Figure 41 shows two structures, including pre-placed staples improperly arranged on a staple cartridge, according to at least one aspect of the present disclosure. [Figure 45] Figure 43 is a graph showing the tissue impedance signature of a well-placed tissue according to at least one aspect of this disclosure. [Figure 46] This is a graph showing the tissue impedance signature of an improperly positioned tissue, according to at least one aspect of the present disclosure. [Figure 47] This is a logical flow diagram of a process showing a control program or logical configuration for selecting an operating mode of a surgical hub, according to at least one aspect of the present disclosure. [Figure 48] This is a logical flow diagram of a process showing a control program or logical configuration for responding to a sensed parameter, according to at least one aspect of the present disclosure. [Figure 49] This is a diagram of a graphical user interface (GUI) for controlling various device parameters, according to at least one aspect of the present disclosure. [Figure 50] A block diagram showing a surgical system according to at least one aspect of the present disclosure. [Figure 51] This figure shows a technology for interacting with a patient's electronic medical record (EMR) database, according to at least one aspect of this disclosure. [Figure 52]This is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 53] This is a diagram illustrating an exemplary analysis system for updating a surgical instrument control program, according to at least one aspect of the present disclosure. [Figure 54] A diagram of a computer-implemented interactive surgical system configured to adaptively generate control program updates for a surgical hub, according to at least one aspect of the present disclosure. [Figure 55] This is a perspective view of an exemplary circular stapler according to at least one aspect of the present disclosure. [Figure 56] Figure 55 is a perspective view of the circular stapler according to at least one aspect of the present disclosure, with the battery pack removed from the housing assembly and the anvil removed from the staple head assembly. [Figure 57] This is a diagram of a control system for a surgical stapling device according to at least one aspect of the present disclosure. [Figure 58] This is a flowchart illustrating an exemplary process for adaptive control of surgical instrument function. [Figure 59] This figure shows an exemplary motorized circular stapling device according to at least one aspect of the present disclosure. [Figure 60] This figure shows an exemplary representation of the adaptable staple height operating range displayed on an exemplary electric circular staple fastener. [Figure 61] This is an exemplary flowchart of an exemplary electric circular staple fastener operating in stroke control mode. [Figure 62] This is an exemplary flowchart of an exemplary motorized circular staple fastener operating in load-controlled mode. [Figure 63] This is an exemplary flowchart of an exemplary motorized circular staple fastener operating in a previous configuration control operation mode. [Figure 64]This is an exemplary diagram showing various embodiments of an exemplary electric circular staple fastener operating using adaptive motor control in a load-controlled operating mode. [Figure 65] This is an exemplary flowchart of an exemplary electric circular staple fastener operating with adaptive motor control in load control operation mode. [Figure 66] This is another exemplary flowchart of an exemplary motorized circular staple fastener operating in load-controlled mode. [Figure 67] This is another exemplary flowchart of an exemplary motorized circular staple fastener operating in load-controlled mode. [Figure 68] This is another exemplary flowchart of an exemplary motorized circular staple fastener operating in a previous configuration control operating mode. [Figure 69] This is another exemplary flowchart of an exemplary motorized circular staple fastener operating in a previous configuration control operating mode. [Figure 70] This is another exemplary flowchart of an exemplary motorized circular staple fastener operating in a previous configuration control operating mode. [Modes for carrying out the invention]

[0036] The applicant of this application owns the following U.S. patent applications, patent publications, and patents, each of which is incorporated herein by reference in its entirety. ● U.S. Patent Application Publication No. 20190200981, titled "METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS" (U.S. Patent Application No. 16 / 209,423, filed on December 4, 2018), was published on July 4, 2019. ●U.S. Patent Application Publication No. 2019-0200844(A1) (U.S. Patent Application No. 16 / 209,385), filed on December 4, 2018, entitled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY, ●Film filed on December 4, 2018, U.S. Patent Application Publication No. 20190206563(A1) (U.S. Patent Application No. 16 / 209,465), entitled "Method for adaptive control schemes for surgical network control and interaction," ●U.S. Patent Application Publication No. 20190206562(A1) (U.S. Patent Application No. 16 / 209,416), filed on December 4, 2018, entitled "Method of hub communication, processing, display, and cloud analytics," ●Film filed on November 6, 2018, U.S. Patent Application Publication No. 20190201034(A1) (U.S. Patent Application No. 16 / 182,240), entitled "Powered stapling device configured to adjust force, advancement speed, and overall stroke of cutting member based on sensed parameter of firing or clamping," ●Film filed on November 6, 2018, entitled ADJUSTMENT OF STAPLE HEIGHT OF AT LEAST ONE ROW OF STAPLES BASED ON THE SENSED TISSUE THICKNESS OR FORCE IN CLOSING, U.S. Patent Application Publication No. 20190200996(A1) (U.S. Patent Application No. 16 / 182,229), ● U.S. Patent Application Publication No. 20190200997(A1) (U.S. Patent Application No. 16 / 182,234), filed on November 6, 2018, entitled "Stapling device with both compulsory and discretionary lockouts based on sensed parameters," ●U.S. Patent Application No. 16 / 458,117, filed on June 30, 2019, entitled "SURGICAL SYSTEM WITH RFID TAGS FOR UPDATING MOTOR ASSEMBLY PARAMETERS" ●Film filed on December 4, 2018, U.S. Patent Application Publication No. 2019-0201137(A1) (U.S. Patent Application No. 16 / 209,407), entitled METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL, ●Film filed on December 4, 2018, U.S. Patent Application Publication No. 2019-0206569(A1) (U.S. Patent Application No. 16 / 209,403), entitled "METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB" ● U.S. Patent Application Publication No. 2017 / 0296213 (U.S. Patent Application No. 15 / 130,590), titled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," was published on October 19, 2017. ● U.S. Patent No. 9,345,481, issued on May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM" ● U.S. Patent Application Publication No. 2014 / 0263552 (U.S. Patent Application No. 13 / 800,067), titled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," was published on September 18, 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OF ACTUATED MEMBERS OF POWERED SURGICAL STAPLER" ●U.S. Patent Application No. 16 / 574,797, filed on September 18, 2019, entitled METHOD FOR CONTROLLING CUTTING MEMBER ACTUATION FOR POWERED SURGICAL STAPLER, ●U.S. Patent Application No. 16 / 574,281, filed on September 18, 2019, entitled METHOD FOR CONTROLLING END EFFECTOR CLOSURE FOR POWERED SURGICAL STAPLER, ●U.S. Patent Application Publication No. 20190201119(A1) (U.S. Patent Application No. 15 / 940,694), filed on March 29, 2018, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION", ● U.S. Patent No. 10,492,783, issued on December 3, 2019, entitled "SURGICAL INSTRUMENT WITH IMPROVED STOP / START CONTROL DURING A FIRING MOTION" ● U.S. Patent Application Publication No. 20190200998(A1) (U.S. Patent Application No. 16 / 209,491), filed on December 4, 2018, entitled "METHOD FOR CIRCULAR STAPLER CONTROL ALGORITHM ADJUSTMENT BASED ON SITUATIONAL AWARENESS," and ● U.S. Patent 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[0037] For example, a system and technology for controlling the communication capability between a surgical instrument, such as a surgical stapler, and a removable component, such as a staple cartridge, is disclosed. The surgical instrument may determine one or more parameters associated with the surgical instrument and the removable component. For example, the surgical instrument may determine a parameter representing the software version associated with one of the surgical instruments or components. Based on one or more parameters, the surgical instrument may determine the type and extent of communication that may take place between the surgical instrument and the removable component. For example, based on a parameter indicating that the surgical instrument and / or removable instrument includes a recent software version, a surgical stapler may determine that bidirectional communication may take place between the surgical instrument and the removable component.

[0038] Referring to Figure 1, the computer-implemented interactive surgical system 100 may include one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 which may include a remote server 113 connected to a storage device 105). Each surgical system 102 may include at least one surgical hub 106 that communicates with the cloud 104 which may include the remote server 113. In one embodiment, as shown in Figure 1, the 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, the surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P are integers of 1 or more.

[0039] In various embodiments, the visualization system 108 may include one or more imaging sensors strategically positioned relative to a sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in Figure 2. In one embodiment, the visualization system 108 may include interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are disclosed under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1) (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, titled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," the entirety of which is incorporated herein by reference.

[0040] As shown in Figure 2, the primary display 119 is positioned in the sterile field so that it is visible to the operator on the operating table 114. In addition, a visualization tower 111 is positioned outside the sterile field. The visualization tower 111 may include a first non-sterile display 107 and a second non-sterile display 109, facing opposite directions from each other. The visualization system 108, guided by the hub 106, is configured to utilize displays 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, the hub 106 may cause the visualization system 108 to display snapshots of the surgical site recorded by the imaging device 124 on the non-sterile displays 107 or 109 while maintaining live video of the surgical site on the primary display 119. The snapshots on the non-sterile displays 107 or 109 may, for example, enable a non-sterile operator to perform diagnostic steps related to the surgical procedure.

[0041] In one embodiment, the hub 106 may be configured to send diagnostic input or feedback entered by a non-sterile operator in the visualization tower 111 to a primary display 119 in the sterile field, which can be viewed by a sterile operator on the operating table. In one embodiment, the input may take the form of modifications to a snapshot displayed on a non-sterile display 107 or 109, which can be sent to the primary display 119 by the hub 106.

[0042] Referring to Figure 2, the surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 may also be configured to coordinate the flow of information to the display of the surgical instrument 112. For example, the disclosure is incorporated herein by reference in U.S. Patent Application Publication No. 2019-0200844(A1) (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, entitled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY. Diagnostic input or feedback entered by a non-sterile operator in the visualization tower 111 is sent by the hub 106 to the surgical instrument display 115 in the sterile field, which can be viewed by the operator of the surgical instrument 112. Exemplary surgical instruments suitable for use with surgical system 102 are described, for example, in U.S. Patent Application Publication No. 2019-0200844(A1) (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, whose disclosure is incorporated herein by reference in whole.

[0043] Figure 2 shows an example of a surgical system 102 used to perform surgery on a patient lying on an operating table 114 in a surgical operating room 116. A robotic system 110 may be used as part of the surgical system 102 in a 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. While the surgeon views the surgical site through the surgeon's console 118, the patient-side cart 120 can manipulate at least one detachably connected surgical tool 117 through a minimally invasive incision in the patient's body. Images of the surgical site are acquired by a medical imaging device 124, which can be operated by the patient-side cart 120 to change the orientation of the imaging device 124. The robotic hub 122 can be used to process images of the surgical site, which can then be displayed to the surgeon through the surgeon's console 118.

[0044] Other types of robotic systems can be readily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use with this disclosure are described in U.S. Patent Application Publication No. 2019-0201137(A1) (U.S. Patent Application No. 16 / 209,407), filed on 4 December 2018, entitled METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL, the disclosure of which is incorporated herein by reference in its entirety.

[0045] Various embodiments of the cloud-based data analysis method implemented by Cloud 104 and suitable for use with the present disclosure are described in U.S. Patent Application Publication No. 2019-0206569(A1) (U.S. Patent Application No. 16 / 209,403), filed on 4 December 2018, entitled "METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB," the disclosure of which is incorporated herein by reference in its entirety.

[0046] In various embodiments, the imaging device 124 may include at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide-semiconductor (CMOS) sensors.

[0047] The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. One or more illumination sources may be directed to illuminate a portion of the surgical field. 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.

[0048] One or more illumination sources may be configured to emit electromagnetic energy in the visible and invisible spectra. The visible spectrum, sometimes also called the light spectrum or emission spectrum, is the portion of the electromagnetic spectrum that is visible to the human eye (i.e., detectable by the human eye), and is sometimes called visible light or simply light. The typical human eye responds to wavelengths in air from approximately 380 nm to approximately 750 nm.

[0049] The invisible spectrum (e.g., the non-emission spectrum) is a portion of the electromagnetic spectrum located below and above the visible spectrum (i.e., wavelengths below approximately 380 nm and above approximately 750 nm). The invisible spectrum is undetectable to the human eye. Wavelengths above approximately 750 nm are longer than the red visible spectrum and consist of invisible infrared (IR), microwaves, and radio electromagnetic radiation. Wavelengths below approximately 380 nm are shorter than the violet spectrum and consist of invisible ultraviolet, X-rays, and gamma-ray electromagnetic radiation.

[0050] In various embodiments, 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, cholangioscopies, colonoscopes, cystoscopes, duodenoscopes, intestinaloscopes, esophagogastroduodenoscopes (gastroscopy), endoscopes, laryngoscopes, nasopharyngolaryngoscopes, sigmoidoscopy, thoracoscopy, and ureteroscopes.

[0051] The imaging device may use multispectral monitoring to identify topography and underlying structures. Multispectral imaging captures image data within a specific wavelength range from the entire electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths, including frequencies beyond the visible light range, such as IR and ultraviolet light. Spectral imaging makes it possible to extract additional information that cannot be captured by the red, green, and blue receptors of the human eye. The use of multispectral imaging is described in detail under the section "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1) (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," whose disclosure is incorporated herein by reference in its entirety. Multispectral monitoring can be a useful tool for repositioning the surgical field after the surgical task is completed to perform one or more of the tests described above on the treated tissue. It is self-evident that strict sterilization of the operating room and surgical instruments is required in any surgical procedure. The strict hygiene and sterilization conditions required in the “operating room,” i.e., the operating room or treatment room, require the highest possible sterility of all medical devices and instruments. Part of the above sterilization process requires sterilizing everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It will be understood that the sterile field may be considered a specific area that is deemed to be free of microorganisms, such as inside a tray or on a sterile towel, or the sterile field may be considered the area immediately surrounding a patient ready for surgery. The sterile field may include cleaned team members wearing appropriate clothing, as well as all equipment and fixation devices within that area.

[0052] Referring here to Figure 3, a hub 106 is shown that communicates 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 communication module 130, a processor module 132, a storage array 134, and an operating room mapping module 133. In certain embodiments, as shown in Figure 3, the hub 106 further includes a fume extraction module 126 and / or aspiration / irrigation module 128. During surgery, applying energy to tissue for sealing and / or cutting is generally associated with fume extraction, aspiration of excess fluid, and / or tissue irrigation. Fluid lines, power lines, and / or data lines from different sources often become entangled during surgery. Dealing with this problem during surgery can result in the loss of valuable time. Untangling lines may require disconnecting them from their corresponding modules, which may require resetting the modules. The modular enclosure 136 of the hub provides a unified environment for managing power lines, data lines, and fluid lines, reducing the frequency of entanglement between such lines. An aspect of the present disclosure presents a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub enclosure and a combination generator module slidably receivable within a docking station of the hub enclosure. The docking station includes data and power contacts. The combination generator module includes two or more ultrasonic energy generator components, bipolar RF energy generator components, and unipolar RF energy generator components housed in a single unit. In one aspect, the combination generator module also includes a fume exhaust component, at least one energy supply cable for connecting the combination generator module to a surgical instrument, at least one fume exhaust component configured to exhaust smoke, fluid, and / or particulate matter generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the fume exhaust component.In one embodiment, the above-mentioned fluid line is a first fluid line, and a second fluid line extends from a remote surgical site to a suction and irrigation module slidably received within a hub enclosure. In one embodiment, the hub enclosure comprises 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 can be used to seal tissue, while an ultrasonic generator can be used to cut sealed tissue. Embodiments of the present disclosure present a solution in which a modular enclosure 136 of the hub is configured to house various generators and facilitate interactive communication between them. One advantage of the modular enclosure 136 of the hub is that it allows for the rapid removal and / or replacement of various modules. Embodiments of the present disclosure present a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. A modular surgical enclosure includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking station having a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable to electrically engage with the power and data contacts, and the first energy generator module is slidably movable to disengage from 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 different from the first energy for application to tissue, and a second docking station having a second docking port including second data contacts and second power contacts, wherein the second energy generator module is slidably movable to electrically engage with the power and data contacts, and the second energy generator module is slidably movable to disengage from the second power and second data contacts.In addition, the modular surgical enclosure also includes a communication bus between a first docking port and a second docking port, configured to facilitate communication between a first energy generator module and a second energy generator module. Referring to Figure 3, an aspect of the present disclosure is presented for a modular enclosure 136 of a hub that enables modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The modular enclosure 136 of the hub further facilitates interactive communication between modules 140, 126, and 128. The generator module 140 may be a generator module having an integrated unipolar component, a bipolar component, and an ultrasonic component supported in a single housing unit that is slidably inserted into the modular enclosure 136 of the hub. The generator module 140 may be configured to connect to a unipolar device 142, a bipolar device 144, and an ultrasonic device 146. Alternatively, the generator module 140 may comprise a series of unipolar generator modules, bipolar generator modules, and / or ultrasonic generator modules that interact via the modular enclosure 136 of the hub. The modular enclosure 136 of the hub may be configured to facilitate the insertion of multiple generators and interactive communication between generators docked to the modular enclosure 136 of the hub, so that multiple generators function as a single generator.

[0053] Figure 4 shows a surgical data network 201 comprising a modular communication 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 specially equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204 which may include a remote server 213 connected to a storage device 205). In one embodiment, the modular communication hub 203 comprises a network hub 207 and / or a network switch 209 that communicate with a network router. The modular communication hub 203 can also be connected to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switching. A passive surgical data network acts as a data conduit, enabling data to go from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network enables traffic to pass through a monitored surgical data network and includes additional mechanisms that constitute each port in the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.

[0054] Modular devices 1a-1n located in the operating room may be connected to a modular communication hub 203. A network hub 207 and / or a network switch 209 may be connected to a network router 211 to connect devices 1a-1n to a cloud 204 or a local computer system 210. Data associated with devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and operation. Data associated with devices 1a-1n may also be transferred to a local computer system 210 for local data processing and operation. Modular devices 2a-2m located in the same operating room may also be connected to a network switch 209. The network switch 209 may be connected to a network hub 207 and / or a network router 211 to connect devices 2a-2m to a cloud 204. Data associated with devices 2a-2n may be transferred to a cloud 204 via the network router 211 for data processing and operation. Data associated with devices 2a-2m may also be transferred to a local computer system 210 for local data processing and operation.

[0055] It will be understood that the surgical data network 201 can be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. A modular communication hub 203 may be housed in a modular control tower configured to accommodate multiple devices 1a-1n / 2a-2m. A local computer system 210 may also be housed in the modular control tower. The modular communication hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n / 2a-2m, for example, during surgical procedures. In various embodiments, the devices 1a-1n / 2a-2m may include a variety of modules, particularly among modular devices that can be connected to the modular communication hub 203 of the surgical data network 201, such as an imaging module 138 connected to an endoscope, a generator module 140 connected to an energy-based surgical device, a smoke extraction module 126, a suction / irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device connected to a display, and / or a non-contact sensor module.

[0056] In one embodiment, the surgical data network 201 may include a combination of a network hub, network switches, and network routers connecting devices 1a-1n / 2a-2m to the cloud. One or all of the devices 1a-1n / 2a-2m connected to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on sharing computing resources rather than having local servers or personal devices to handle software applications. The term “cloud” can be used as a metaphor for “Internet,” but the term is not limited in that way. Thus, the term “cloud computing” can 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 communication 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 communication hub 203 and / or computer system 210. The cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. The cloud computing service can perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

[0057] By applying cloud computing data processing technology to data collected by devices 1a-1n / 2a-2m, the surgical data network can lead to improved surgical outcomes, reduced costs, and increased patient satisfaction. At least some of devices 1a-1n / 2a-2m can be used to observe the condition of tissue after tissue sealing and cutting procedures and to evaluate leakage or perfusion of sealed tissue. At least some of devices 1a-1n / 2a-2m can be used to examine data, including images of body tissue samples, for diagnostic purposes using cloud-based computing to identify pathologies such as the effects of disease. This may include tissue localization and boundary confirmation, as well as phenotyping. At least some of devices 1a-1n / 2a-2m can be used to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by devices 1a-1n / 2a-2m, including image data, may be transferred to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. The data may be analyzed to improve surgical outcomes by determining whether further treatments, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics, can be carried out for tissue-specific sites and conditions. Such data analysis may also involve further prognostic analysis, and the use of standardized methods can provide useful feedback for either confirming surgical treatment and surgeon behavior, or suggesting modifications to surgical treatment and surgeon behavior.

[0058] Operating room devices 1a-1n may be connected to the modular communication hub 203 via a wired or wireless channel, depending on the configuration of devices 1a-1n to the network hub. In one embodiment, the network hub 207 may be implemented as a local network broadcast device operating on the physical layer of the Open System Interconnection (OSI) model. The network hub can provide connectivity to devices 1a-1n located within the same operating room network. The network hub 207 may collect data in packet form and transmit them to the router in half-duplex mode. The network hub 207 cannot store any media access control / Internet protocol (MAC / Internet Protocol, IP) for transferring device data. Only one of devices 1a-1n can transmit data through the network hub 207 at a time. The network hub 207 has no routing table or knowledge of the destinations of information and can broadcast all network data to each connection and to the remote server 213 (Figure 4) on the cloud 204. While the Network Hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports poses a security risk and could cause bottlenecks.

[0059] Operating room devices 2a-2m can be connected to network switch 209 via a wired or wireless channel. Network switch 209 operates within the data link layer of the OSI model. Network switch 209 may be a multicast device for connecting devices 2a-2m located in the same operating room to a network. Network switch 209 transmits data in the form of frames to network router 211 and may operate in full-duplex mode. Multiple devices 2a-2m can transmit data simultaneously through network switch 209. Network switch 209 stores and uses the MAC addresses of devices 2a-2m to transfer data.

[0060] The network hub 207 and / or network switch 209 may be connected to the network router 211 to connect to the cloud 204. The network router 211 operates within the network layer of the OSI model. The network router 211 creates a route for sending data packets received from the network hub 207 and / or network switch 211 to cloud-based computing 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 networks located in different operating rooms of the same medical facility or different operating rooms of different medical facilities. The network router 211 transmits data in packet form to the cloud 204 and may operate in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to transfer data.

[0061] In one embodiment, the network hub 207 may be implemented as a USB hub that enables multiple USB devices to be connected to a host computer. The USB hub can extend a single USB port into several layers so that there are more ports available for connecting devices to the host system computer. The network hub 207 may include wired or wireless functionality for receiving information via a wired or wireless channel. In one embodiment, a wireless USB short-range high-bandwidth wireless communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in the operating room.

[0062] In the embodiment, the operating room devices 1a-1n / 2a-2m may communicate with the modular communication hub 203 via the Bluetooth radio 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 communication hub 203 via a number of wireless or wired communication 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 Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT and their Ethernet derivatives, as well as any other wireless and wired protocols designated as 3G, 4G, 5G and beyond. A computing module may include multiple communication modules. For example, a first communication module may be dedicated to shorter-range wireless communication such as Wi-Fi and Bluetooth, while a second communication module may be dedicated to longer-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.

[0063] The modular communication hub 203 functions as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and can handle a data type known as a frame. A frame can carry data generated by the devices 1a-1n / 2a-2m. When a frame is received by the modular communication hub 203, it is amplified and transmitted to the network router 211, which then transfers the data to cloud computing resources using a number of wireless or wired communication standards or protocols as described herein.

[0064] The modular communication hub 203 may be used as a standalone device or connected to compatible network hubs and network switches to form a larger network. Because the modular communication hub 203 is generally easy to install, configure, and maintain, it is a good choice for networking operating room equipment 1a-1n / 2a-2m.

[0065] Figure 5 shows 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 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 embodiment, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to multiple operating room devices, such as intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in Figure 6, the modular control tower 236 includes a modular communication hub 203 connected to a computer system 210.

[0066] As shown in the embodiment of Figure 5, the modular control tower 236 can be connected to an imaging module 238 which can be connected to an endoscope 239, a generator module 240 which can be connected to an energy device 241, a fume exhaust module 226, a suction / irrigation module 228, a communication module 230, a processor module 232, a storage array 234, a smart device / instrument 235 which may be optionally connected to a display 237, and a non-contact sensor module 242. The operating room equipment can be connected to cloud computing resources and data storage via the modular control tower 236. The robot hub 222 may also be connected to the modular control tower 236 and cloud computing resources. In particular, the device / instrument 235 and the visualization system 208 may be connected to the modular control tower 236 via wired or wireless communication standards or protocols as described herein. The modular control tower 236 may be connected to a hub display 215 (e.g., a monitor, screen) to display and overlay images received from imaging modules, device / instrument displays, and / or other visualization systems 208. The hub display may also display data received from devices connected to the modular control tower, along with the images and overlaid images.

[0067] Figure 6 shows a surgical hub 206 comprising multiple modules connected to a modular control tower 236. The modular control tower 236 may comprise a modular communication hub 203, such as a network connectivity device, and a computer system 210, for example, local processing, visualization, and imaging. As shown in Figure 6, the modular communication hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203, and data associated with the modules may be transferred to the computer system 210, cloud computing resources, or both. As shown in Figure 6, each network hub / switch within the modular communication hub 203 may include three downstream ports and one upstream port. The upstream network hub / switch may be connected to a processor to provide communication connectivity to cloud computing resources and local displays 217. Communication to the cloud 204 can be done via either a wired communication channel or a wireless communication channel.

[0068] 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 measuring device or a laser non-contact measuring device. The ultrasonic-based non-contact sensor module can scan the operating room by transmitting bursts of ultrasound and receiving echoes as they bounce off the surrounding walls of the operating room, as detailed under the section “Surgical Hub Spatial Awareness Within an Operating Room” in U.S. Patent Application Publication No. 2019-0200844(A1) (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, whose disclosure is incorporated herein by reference in its entirety, and the sensor module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limit. A laser-based non-contact sensor module can, for example, scan an operating room by transmitting laser light pulses, receive the laser light pulses reflected from the outer wall of the operating room, 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.

[0069] The computer system 210 may include a processor 244 and a network interface 245. The processor 244 may be connected via a system bus to a communication module 247, storage 248, memory 249, non-volatile memory 250, and an input / output interface 251. The system bus may be any of several types of bus structures, including a memory bus or memory controller, peripheral bus or external bus, and / or local bus, using any various available bus architectures. Examples of such architectures include, but are not limited to, a 9-bit bus, Industry Standard Architecture (ISA), Microchannel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus.

[0070] The processor 244 may be any single-core or multi-core processor, such as those known by the trade name ARM Cortex from Texas Instruments. In one embodiment, the processor may be, for example, the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. This processor core includes on-chip memory of 256KB of single-cycle flash memory or other non-volatile memory up to 40MHz, a prefetch buffer to improve performance to above 40MHz, 32KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels. Further details are available in the product datasheet.

[0071] In one embodiment, the processor 244 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also from Texas Instruments and known by the trade names Hercules ARM Cortex R4. The safety controller may be configured, in particular, specifically for IEC61508 and ISO26262 safety limit applications, to provide a highly integrated safety mechanism while offering scalable performance, connectivity, and memory options.

[0072] System memory may include volatile memory and non-volatile memory. The Basic Input / Output System (BIOS), which contains basic routines for transferring information between elements within the computer system during startup, is stored in non-volatile memory. Examples of non-volatile memory include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Examples of volatile memory include random access memory (RAM), which functions as external cache memory. Furthermore, RAM is available in many forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync-link DRAM (SLDRAM), and direct rhombus RAM (DRRAM).

[0073] The computer system 210 may also include removable / non-removable volatile / non-volatile computer storage media, such as disk storage devices. Examples of disk storage devices include, but are not limited to, magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, the disk storage device may include the above-mentioned storage media independently or in combination with other storage media. Examples of other storage media include, but are not limited to, optical disk drives such as compact disk ROM devices (CD-ROMs), compact disk recordable drives (CD-R drives), compact disk rewritable drives (CD-RW drives), or digital multi-purpose disk ROM drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of the disk storage device to the system bus.

[0074] It should be understood that the computer system 210 may include software that acts as an intermediary between the user and basic computer resources, as described in a preferred operating environment. Such software may include an operating system. An operating system, which may be stored on disk storage, may function to control and allocate the resources of the computer system. System applications may leverage 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 can be implemented in various operating systems or combinations of operating systems.

[0075] The user can input commands or information to the computer system 210 via input devices connected to the I / O interface 251. Input devices may include, but are not limited to, pointing devices such as mice, trackballs, styluses, and touchpads; keyboards, microphones, joysticks, gamepads; satellite receivers; scanners; TV tuner cards; digital cameras; digital video cameras; and webcams. These and other input devices connect to the processor via interface ports and the system bus. Interface ports include, for example, serial ports, parallel ports, game ports, and USB ports. Output devices use some of the same types of ports as the input devices. Therefore, for example, a USB port may be used to provide input to the computer system and output information from the computer system to the output device. Output adapters are provided to indicate that output devices that may require special adapters may include, among other things, monitors, displays, speakers, and printers. Output adapters include, but are not limited to, video and sound cards that provide means of connection between the output device and the system bus. Note that other devices and / or systems of devices, such as remote computers, may provide both input and output functions.

[0076] Computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computers, or to local computers. Remote cloud computers may 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 in relation to computer systems. For brevity, only memory storage devices are shown along with remote computers. Remote computers may be logically connected to the computer system via a network interface, and subsequently physically connected via communication connections. Network interfaces may encompass communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies may include fiber optic distributed data interfaces (FDDI), copper distributed data interfaces (CDDI), Ethernet / IEEE 802.3, and Token Ring / IEEE 802.5. WAN technologies may include, but are not limited to, point-to-point links, integrated service digital networks (ISDN) and their variations, packet-switched networks, and digital subscriber lines (DSL).

[0077] In various embodiments, the computer system 210 in Figure 6, the imaging module 238 in Figures 5-6, and / or the visualization system 208, and / or the processor module 232 may comprise an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) used for processing digital images. The image processor can increase speed and efficiency using parallel computing with single-instruction multiple data (SIMD) or multiple-instruction multiple data (MIMD) techniques. The digital image processing engine can perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

[0078] A communication connection refers to the hardware / software used to connect a network interface to a bus. For the sake of clarity in the example, the communication connection is shown as being inside the computer system, but the communication connection part may be outside the computer system 210. For illustrative purposes only, hardware / software required for connecting to a network interface may include internal and external technologies such as modems including standard telephone-grade modems, cable modems and DSL modems, ISDN adapters and Ethernet cards.

[0079] Figure 7 shows a logic diagram of a control system 470 for a surgical instrument or tool according to one or more embodiments of the present disclosure. The system 470 may include a control circuit. The control circuit may include a microcontroller 461 having a processor 462 and memory 468. For example, one or more of sensors 472, 474, and 476 provide real-time feedback to the processor 462. A motor 482 driven by a motor driver 492 drives an I-beam knife element by operably connecting a longitudinally movable displacement member. A tracking system 480 may be configured to determine the position of the longitudinally movable displacement member. Position information is 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 position of the firing member, firing bar, and I-beam knife element. Additional motors may be provided to the tool driver interface to control the firing of the I-beam, the movement of the occluder, the rotation of the shaft, and joint movement. A display 473 may display various operating conditions of the instrument and may include touchscreen functionality for data input. The information displayed on display 473 can be overlaid with images acquired via the endoscopic imaging module.

[0080] In one embodiment, the microcontroller 461 may be any single-core or multi-core processor, such as those known by the trade name ARM Cortex from Texas Instruments. In one embodiment, the main microcontroller 461 may be, for example, the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, which includes on-chip memory of 256KB single-cycle flash memory or other non-volatile memory up to 40MHz, a prefetch buffer for improving performance above 40MHz, 32KB single-cycle SRAM, internal ROM with StellarisWare® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs, and / or one or more 12-bit ADCs with 12 analog input channels.

[0081] In one embodiment, the microcontroller 461 may include a safety controller, which may include two controller-based families, such as the TMS570 and RM4x, also from Texas Instruments and known by the trade names Hercules ARM Cortex R4. The safety controller may be configured, in particular, specifically for IEC61508 and ISO26262 safety limit applications, to provide an advanced integrated safety mechanism while offering scalable performance, connectivity, and memory options.

[0082] The microcontroller 461 may be programmed to perform various functions, such as precise control of the speed and position of the knife and joint motion systems. 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 a mechanical coupling to the joint motion or knife system. In one embodiment, the motor driver 492 may be the A3941 available from Allegro Microsystems, Inc. Other motor drivers can be readily substituted for use in the tracking system 480 with an absolute positioning system. A detailed description of the absolute positioning system 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.

[0083] The microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement member and joint motion system. The microcontroller 461 may be configured to calculate the response within its software. The calculated response is compared with the measured response of the actual system to obtain an "observed" response, which is used to determine the actual feedback. The observed response is a suitable adjusted value that balances the smooth and continuous nature of the simulated response with the measured response, and it can detect external influences on the system.

[0084] In some embodiments, the motor 482 may be controlled by a motor driver 492 and used by a surgical instrument or tool launching system. In various forms, the motor 482 may be, for example, a brushed DC-driven motor having a maximum rotational speed of about 25,000 RPM. In some embodiments, 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 a field-effect transistor (FET). The motor 482 may be powered by a power supply assembly removably mounted on a handle assembly or tool housing to supply control power to a surgical instrument or tool. The power supply assembly may include a battery that may include a number of battery cells connected in series, which can be used as a power source for powering a 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 embodiment, the battery cells may be a lithium-ion battery that can be coupled to and detached from the power supply assembly.

[0085] The motor driver 492 may be the A3941, available from Allegro Microsystems, Inc. The A3941 492 may be a full-bridge controller for use with an external N-channel power metal-oxide-semiconductor field-effect transistor (MOSFET) specifically designed for inductive loads such as brushed DC motors. The driver 492 features a built-in charge pump regulator, which provides full (>10V) gate drive to battery voltages down to 7V, allowing the A3941 to operate with reduced gate drive down to 5.5V. Bootstrap capacitors may be used to provide the above battery supply voltage required for the N-channel MOSFET. An internal charge pump for high-side drive enables DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation is possible by either the high-side or low-side FET. The power FETs may be protected from shoot-through by a dead time adjustable with resistors. The integrated diagnostics indicate undervoltage, overtemperature, and power bridge anomalies and can be configured to protect power MOSFETs under most short-circuit conditions. Other motor drivers can be easily substituted for use in the tracking system 480 with an absolute positioning system.

[0086] The tracking system 480 may include a controlled motor drive circuit arrangement comprising a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for the absolute positioning system may provide a unique position signal corresponding to the position of the displacement member. In some embodiments, the displacement member may represent a longitudinally movable drive member comprising a rack of drive teeth for meshing and engaging with a corresponding drive gear of a gear reducer assembly. In some embodiments, the displacement member may represent a launch member which may be adapted and configured to include a rack of drive teeth. In some embodiments, the displacement member may represent a launch 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 to refer in general to any movable member of a surgical instrument or tool, such as a drive member, launch member, launch bar, I-beam, or any element which may be displaced. In one embodiment, a longitudinally movable drive member may be coupled to a launch member, launch bar, and I-beam. Therefore, the absolute positioning system can actually track the linear displacement of the I-beam by tracking the linear displacement of a longitudinally movable drive member. In various embodiments, the displacement member may be connected to any position sensor 472 suitable for measuring linear displacement. Thus, a longitudinally movable drive member, launch member, launch bar, or I-beam, or a combination thereof, may be connected to any suitable linear displacement sensor. The linear displacement sensor may include contact-type or non-contact-type displacement sensors. The linear displacement sensor may include a magnetic sensing system comprising a linear variable differential transformer (LVDT), a differential variable magnetoresistive transducer (DVRT), a slide potentiometer, 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.

[0087] The electric motor 482 may include a rotary shaft that operably interfaces with a gear assembly mounted in meshing engagement with a set of drive teeth or a 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 configuration can be connected to a linear actuator by a rack and pinion configuration, or to a rotary actuator by a spur gear or other connection. A power supply provides power to the absolute positioning system, and an output indicator may display the output of the absolute positioning system. The displacement member may represent a longitudinally movable drive member having a rack of drive teeth formed thereon for meshing engagement with the corresponding drive gear of the gear reducer assembly. The displacement member may represent a longitudinally movable launch member, launch bar, I-beam, or a combination thereof.

[0088] One rotation of the sensor element associated with the position sensor 472 corresponds to a longitudinal linear displacement d1 of the displacement member, where d1 may be the longitudinal linear distance the displacement member moves from point "a" to point "b" after one rotation of the sensor element connected to the displacement member. The sensor mechanism may be connected via a gear reduction that results in the position sensor 472 completing one or more rotations relative to the full stroke of the displacement member. The position sensor 472 can complete multiple rotations relative to the full stroke of the displacement member.

[0089] To provide a unique position signal for two or more rotations of the position sensor 472, a series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction. The state of the switches is fed back to the microcontroller 461, which can apply 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 include an array of analog rotation sensors such as a magnetic sensor or potentiometer, or an array of analog Hall effect elements, which output a unique combination of position signals or values.

[0090] The position sensor 472 may comprise any number of magnetic sensing elements, such as magnetic sensors, which are classified according to whether they measure the total magnetic field or the vector component of the magnetic field. The techniques used to produce both types of magnetic sensors can include numerous aspects of physics and electronics. Techniques used to sense magnetic fields include, among others, probe coils, flux gates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, colossal magnetoresistance, magnetic tunnel junctions, colossal magnetoimpedance, magnetostrictive / piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magneto-optics, and micro-electromechanical system-based magnetic sensors.

[0091] In one embodiment, the position sensor 472 of a tracking system 480 equipped with an absolute positioning system may be equipped with 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 a microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low-voltage, low-power component and may include four Hall effect elements in the area of ​​the position sensor 472 that can be located above the magnet. A high-resolution ADC and a smart power management controller may also be provided on the chip. A coordinate rotation digital computer (CORDIC) processor, also known as the digit-by-digit method and the Boulder algorithm, may be provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that requires only addition, subtraction, bit shifting, and table lookup operations. Angular position, alarm bits, and magnetic field information may be transmitted to the microcontroller 461 via a standard serial communication interface such as a serial peripheral interface (SPI) interface. The position sensor 472 may offer 12-bit or 14-bit resolution. The position sensor 472 may also be an AS5055 chip, available in a small QFN 16-pin 4x4x0.85mm package.

[0092] The tracking system 480, which includes an absolute positioning system, may also include and / or be programmed to implement feedback controllers such as PID, state feedback, and adaptive controllers. The power supply converts signals from the feedback controllers into physical inputs to the system, in this case voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by the position sensor 472, other sensors may be provided to measure physical parameters of the physical system. In some embodiments, other sensors include those described in U.S. Patent 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 connected 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 combinational circuits to combine the calculated response with the measured response, using algorithms such as weighted averaging and theoretical control loops that drive the calculated response toward the measured response. To predict what the state and output of the physical system will be by knowing the input, the calculated response of the physical system may take into account properties such as mass, inertia, viscous friction, and inductive resistance.

[0093] An absolute positioning system, such as one that might be required with a conventional rotary encoder that estimates the position of a device actuator, drive bar, knife, etc., by simply counting the number of forward or backward steps taken by the motor 482 without moving the displacement member back or forward to a reset (zero or home) position, provides the absolute position of the displacement member when the device is powered on.

[0094] For example, a sensor 474, such as a strain gauge or micro-strain gauge, may be configured to measure one or more parameters of an end effector, such as the amplitude of strain exerted on the anvil during clamping, which can indicate the closing force applied to the anvil. The measured strain may be converted into a digital signal and provided to a processor 462. Instead of, or in addition to, sensor 474, a sensor 476, such as a load sensor, may measure the closing force applied to the anvil by the closing drive system. For example, sensor 476, such as a load sensor, may measure the firing force applied to the I-beam during the firing stroke of a surgical instrument or tool. The I-beam is configured to engage with a wedge-shaped thread, which is configured to cam upward a staple driver to push the staple out and deform into contact with the anvil. As the I-beam is advanced distally by the firing bar, the I-beam may also include a sharp cutting edge that can be used to cut tissue. Alternatively, a current sensor 478 may be used to measure the current drawn in by the motor 482. The force required to propel the launching member forward may, for example, correspond to the current drawn in by the motor 482. The measured force can be converted into a digital signal and provided to the processor 462.

[0095] In one embodiment, a strain gauge sensor 474 can be used to measure the force applied to tissue by the end effector. A strain gauge can be connected 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 gripped by the end effector may 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 embodiment, the strain gauge sensor 474 can measure the amplitude or magnitude of strain applied to the jaw members of the end effector during a clamping operation, which may indicate tissue compression. The measured strain can be converted into a digital signal and provided to the processor 462 of the microcontroller 461. A load sensor 476 can measure the force used to operate a knife element, for example, to cut tissue trapped between an anvil and a staple cartridge. A magnetic field sensor can be used to measure the thickness of the trapped tissue. The measurement from the magnetic field sensor can also be converted into a digital signal and provided to the processor 462.

[0096] Measurements of tissue compression, tissue thickness, and / or the force required to close the end effector on the tissue, measured by sensors 474 and 476 respectively, can be used by the microcontroller 461 to characterize the selected position of the launcher and / or the corresponding values ​​of the launcher's velocity. In one example, memory 468 can store techniques, equations, and / or lookup tables that can be used by the microcontroller 461 during evaluation.

[0097] The control system 470 for surgical instruments or tools may also include a wired communication circuit or a wireless communication circuit for communicating with a modular communication hub 203, as shown in Figures 5 and 6.

[0098] Figure 8 shows a surgical instrument or tool equipped with multiple motors that can be activated to perform various functions. In a particular example, the first motor can be activated to perform the first function, the second motor can be activated to perform the second function, the third motor can be activated to perform the third function, the fourth motor can be activated to perform the fourth function, and so on. In a particular example, the multiple motors of the robotic surgical instrument 600 can be activated individually to produce firing, closing, and / or jointing motions in the end effector. The firing, closing, and / or jointing motions can be transmitted to the end effector, for example, via a shaft assembly.

[0099] In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably connected to a firing motor drive assembly 604, which can be configured to transmit the firing motion generated by the motor 602 to an end effector, specifically to displace an I-beam element. In certain examples, the firing motion generated by the motor 602 may, for example, deploy a staple from a staple cartridge into tissue captured by the end effector and / or advance the cutting edge of the I-beam element to cut the captured tissue. The I-beam element can be retracted by reversing the direction of the motor 602.

[0100] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605, which may be configured to specifically displace a closure tube to close the anvil and transmit the closure motion generated by the motor 603 to an end effector to compress tissue between the anvil and the staple cartridge. The closure motion allows the end effector to transition from an open configuration to an approach configuration, for example, to capture tissue. The end effector may be moved to an open position by reversing the direction of the motor 603.

[0101] In certain examples, a surgical instrument or tool may include, for example, one or more articular motion motors 606a, 606b. The motors 606a, 606b may be operably coupled to corresponding articular motion motor drive assemblies 608a, 608b, which may be configured to transmit the articular motion generated by the motors 606a, 606b to an end effector. In certain examples, the articular motion may cause, for example, the end effector to articulate relative to the shaft.

[0102] 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 606a and 606b can be activated to articulate an end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 can be activated to fire multiple staples and / or advance a cutting edge while articulation motor 606 remains stopped. Furthermore, a closure motor 603 may be activated simultaneously with firing motor 602 to advance the closure tube and I-beam element distally, as described in more detail below herein.

[0103] 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 may correspond to one of the multiple motors at a time. For example, the common control module 610 may be individually connectable and disconnectable to multiple motors of the robotic surgical instrument. In certain examples, multiple motors of the surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, multiple motors of the surgical instrument or tool can engage with the common control module 610 individually and selectively. In certain examples, the common control module 610 can selectively switch between interfacing with one of the multiple motors of the surgical instrument or tool and interfacing with another of the multiple motors of the surgical instrument or tool.

[0104] In at least one example, the common control module 610 can be selectively switched between an operable engagement with the articulation motors 606a, 606b and an operable engagement with either the firing motor 602 or the closing motor 603. In at least one embodiment, as shown in Figure 8, the switch 614 can move or transition between multiple positions and / or states. For example, in a first position 616, the switch 614 may electrically connect the common control module 610 to the firing motor 602; in a second position 617, the switch 614 may electrically connect the common control module 610 to the closing motor 603; in a third position 618a, for example, the switch 614 may electrically connect the common control module 610 to the first articulation motor 606a; and in a fourth position 618b, the switch 614 may electrically connect the common control module 610 to the second articulation motor 606b. In certain examples, a separate common control module 610 may also be electrically connected to the launch motor 602, the closing motor 603, and the joint motion motors 606a, 606b. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid switch, or any preferred switching mechanism.

[0105] Each of the motors 602, 603, 606a, and 606b may be equipped with a torque sensor for measuring the output torque on the motor shaft. The force on the end effector may be sensed in any conventional manner, such as by force sensors on the outside of the jaws or by torque sensors on the motors that actuate the jaws.

[0106] In various examples, as shown in Figure 8, the common control module 610 may include a motor driver 626 which may comprise one or more H-bridge FETs. The motor driver 626 may modulate the power transmitted from the power supply 628 to the motor connected to the common control module 610, for example, based on input from a microcontroller 620 ("controller"). In certain examples, as described herein, the microcontroller 620 can be used, for example, to determine the current drawn by the motor while the motor is connected to the common control module 610.

[0107] In certain examples, the microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-temporary computer-readable media or memory units 624 ("memory"). In certain examples, the memory 624 may store various program instructions, which, when executed, cause the processor 622 to perform some of the functions and / or calculations described herein. In certain examples, one or more of the memory units 624 may be linked to the processor 622, for example.

[0108] In certain examples, the power supply 628 can be used to power, for example, a microcontroller 620. In certain examples, the power supply 628 may comprise a battery (or "battery pack" or "power pack"), such as a lithium-ion battery. In certain examples, the battery pack may be configured to be removably attached to a handle in order to power a surgical instrument 600. A number of battery cells connected in series may be used as the power supply 628. In certain examples, the power supply 628 may be, for example, replaceable and / or rechargeable.

[0109] In various examples, the processor 622 can control the motor driver 626 to control the position, direction of rotation, and / or speed of a motor connected to a common control module 610. In specific examples, the processor 622 can signal the motor driver 626 to stop and / or disable a motor connected 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 functions of a computer’s central processing unit (CPU) on one or up to several integrated circuits. A processor can be a multipurpose programmable device that receives digital data as input, processes that data according to instructions stored in memory, and provides the results as output. It may have internal memory and therefore may be an embodiment of sequential digital logic. A processor may operate with numbers and symbols represented in binary.

[0110] The processor 622 may be any single-core or multi-core processor, such as those known by the trade name ARM Cortex from Texas Instruments. In a particular example, the microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes, among other features readily available in the product datasheet, 256KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40MHz, a prefetch buffer to improve performance beyond 40MHz, 32KB of single-cycle SRAM, internal ROM with StellarisWare® software, 2KB 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. Therefore, this disclosure should not be limited to this context.

[0111] Memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600, which can be connected to a common control module 610. For example, memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the joint movement motors 606a, 606b. Such program instructions can cause the processor 622 to control the firing function, closing function, and joint movement function according to input from an algorithm or control program of the surgical instrument or tool.

[0112] For example, one or more mechanisms and / or sensors, such as sensor 630, can be used to alert the processor 622 to program instructions that should be used in a particular setting. For example, sensor 630 can alert the processor 622 to use program instructions related to the firing, closing, and joint movement of the end effector. In a particular example, sensor 630 may include a position sensor that can be used to sense the position of switch 614, for example. Thus, if the processor 622 detects, for example via sensor 630, that switch 614 is in a first position 616, it can use a program instruction associated with the firing of the end effector's I-beam; if the processor 622 detects, for example via sensor 630, that switch 614 is in a second position 617, it can use a program instruction associated with the closing of the anvil; and if the processor 622 detects, for example via sensor 630, that switch 614 is in a third position 618a or a fourth position 618b, it can use a program instruction associated with the joint movement of the end effector.

[0113] Figure 9 shows a diagram of a context-aware surgical system 5100 according to at least one aspect of the present disclosure. In some examples, the data source 5126 may include, for example, a modular device 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular device itself), a database 5122 (e.g., an EMR database containing patient records), and a patient monitoring device 5124 (e.g., a blood pressure (BP) monitor and an electrocardiogram (EKG) monitor). The surgical hub 5104 may be configured to derive contextual information about a surgical procedure from the data, for example, based on a particular combination of received data or a particular order in which data is received from the data source 5126. Contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, a particular step of the surgical procedure being performed by the surgeon, the type of tissue being operated on, or the body cavity being treated. This function relating to some aspects of the surgical hub 5104 for deriving or inferring information about a surgical procedure from received data may also be referred to as “context awareness.” In one example, the surgical hub 5104 may incorporate a context-aware system, which is hardware and / or programming associated with the surgical hub 5104, that derives contextual information related to the surgical procedure from the received data.

[0114] The situational awareness system of the surgical hub 5104 can be configured to derive contextual information from data received from the data source 5126 in various different ways. For example, the situational awareness system may include a pattern recognition system or machine learning system (e.g., an artificial neural network) trained on training data to correlate various inputs (e.g., data from the database 5122, patient monitoring device 5124, and / or modular device 5102) with corresponding contextual information about a surgical procedure. In other words, the machine learning system can be trained to accurately derive contextual information about a surgical procedure from the provided inputs. In an embodiment, the situational awareness system may include a lookup table that stores pre-characterized contextual information about a surgical procedure, associated with one or more inputs (or ranges of inputs) that correspond to that contextual information. In response to a query with one or more inputs, the lookup table can return the corresponding contextual information of the situational awareness system to control the modular device 5102. In the embodiment, context information received by the situation awareness system of the surgical hub 5104 can be associated with a specific control adjustment of one or more modular devices 5102, or a set of control adjustments. In the embodiment, the situation awareness system may include a further machine learning system, a lookup table, or other such system that generates or retrieves one or more control adjustments of one or more modular devices 5102 when context information is provided as input.

[0115] The surgical hub 5104, which incorporates a situational awareness system, can bring many advantages to the surgical system 5100. One advantage may include improved interpretation of sensed and collected data, which improves processing accuracy during the course of surgery and / or the use of the data. Returning to the previous example, the situational awareness surgical hub 5104 can determine what type of tissue has been surgically treated, and therefore, when an unexpectedly high force is detected closing the end effector of a surgical instrument, the situational awareness surgical hub 5104 can correctly accelerate or decelerate the motor of the surgical instrument according to the type of tissue.

[0116] The type of tissue being operated on may affect the adjustments made to the compression speed and load threshold of surgical staple fasteners and cutting instruments for measuring specific interstitial gaps. The situational awareness surgical hub 5104 can infer whether the surgery being performed is a thoracic or abdominal surgery, thereby allowing the surgical hub 5104 to determine whether the tissue clamped by the end effector of the surgical staple fastener and cutting instrument is the lung (in the case of a thoracic surgery) or the stomach (in the case of an abdominal surgery). The surgical hub 5104 can then appropriately adjust the compression speed and load threshold of the surgical staple fastener and cutting instrument to match the type of tissue.

[0117] The type of body cavity being operated on during aeration can affect the function of the fume extractor. The situational awareness surgical hub 5104 can determine whether the surgical site is under pressure (by determining that the surgery is utilizing aeration) and determine the type of procedure. Since any type of procedure can generally be performed in a particular body cavity, the surgical hub 5104 can appropriately control the motor speed of the fume extractor to suit the body cavity being operated on. Thus, the situational awareness surgical hub 5104 can provide a consistent amount of fume extraction for both thoracic and abdominal surgeries.

[0118] The type of procedure being performed can affect the optimal energy level for operation of ultrasonic surgical instruments or radio frequency (RF) electrosurgical instruments. For example, arthroscopy may require a high energy level because the end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is immersed in fluid. The situational awareness surgical hub 5104 can determine whether the surgical procedure is arthroscopy. 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 for operation of ultrasonic surgical instruments or RF electrosurgical instruments. The situational awareness surgical hub 5104 can determine the type of surgical procedure being performed and then customize the energy levels of the ultrasonic surgical instrument or RF electrosurgical instrument, respectively, according to the expected tissue shape for the surgical procedure. Furthermore, the situation-aware surgical hub 5104 can be configured to adjust the energy levels of ultrasonic surgical instruments or RF electrosurgical instruments throughout the course of a surgical procedure, rather than simply per procedure. The situation-aware surgical hub 5104 can determine which stage of the surgical procedure is being performed or will be performed, and then update the control algorithms of the generator and / or ultrasonic surgical instruments or RF electrosurgical instruments to set the energy levels to values ​​appropriate for the expected tissue types according to the course of the surgical procedure.

[0119] In some embodiments, the surgical hub 5104 may also derive data from an additional data source 5126 to improve conclusions drawn from one data source 5126. The contextually aware surgical hub 5104 can enhance data received from the modular device 5102 with contextual information constructed from other data sources 5126 regarding the surgical procedure. For example, the contextually aware surgical hub 5104 may be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) based on video or image data received from a medical imaging device. However, in some cases, video or image data may not be conclusive. Therefore, in one example, the surgical hub 5104 may be further configured to make a determination regarding the integrity of staple lines or tissue welds by comparing physiological measurements (e.g., blood pressure sensed by a BP monitor communicably connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 (Figure 2) communicably connected to the surgical hub 5104). In other words, the context-aware system of the surgical hub 5104 can provide additional context when analyzing visualization data by considering physiological measurement data. This additional context can be useful when the visualization data itself may not be conclusive or may be incomplete.

[0120] For example, the situational awareness surgical hub 5104 may proactively activate the generator to which the RF electrosurgical instrument is connected if it is determined that the instrument needs to be used in a subsequent step of the procedure. By proactively activating the energy source, the instrument can be ready for use as soon as the preceding step of the procedure is completed.

[0121] The situational awareness surgical hub 5104 can determine whether the current or subsequent steps of the surgical procedure require different views or magnifications on the display, according to the characteristics of the surgical site that the surgeon is expected to need to see. The surgical hub 5104 can then actively change the displayed view (for example, supplied by the medical imaging device for the visualization system 108), thereby automatically adjusting the display throughout the surgical procedure.

[0122] The situational awareness surgical hub 5104 can determine which steps of a surgical procedure are being performed or will be performed next, and whether specific data or comparisons between data 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 steps of the surgical procedure being performed, without waiting for the surgeon to request specific information.

[0123] Errors may be checked during the setup of a surgical procedure or during the procedure itself. For example, the situation-aware surgical hub 5104 may determine whether the operating room is properly or optimally set up for the surgical procedure to be performed. The surgical hub 5104 may be configured to determine the type of surgical procedure being performed, read the corresponding checklist, equipment location, or setup requirements (e.g., from memory), and then compare the current operating room layout to a standard layout for the type of surgical procedure being performed determined by the surgical hub 5104. In some examples, the surgical hub 5104 may be configured to compare a list of items for the procedure and / or a list of devices paired with the surgical hub 5104 to a recommended or expected manifest of items and / or devices for a given surgical procedure. If discontinuities exist between lists, the surgical hub 5104 may be configured to provide an alarm indicating that a particular modular device 5102, patient monitoring device 5124, and / or other surgical items are missing. In some examples, the surgical hub 5104 may be configured to determine the relative distance or relative position of the modular device 5102 and the patient monitoring device 5124, for example, by proximity sensors. The surgical hub 5104 can compare the relative positions of the devices to a recommended or expected layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 may be configured to provide an alarm indicating that the current layout of the surgical procedure deviates from the recommended layout.

[0124] The situational awareness surgical hub 5104 can determine whether a surgeon (or other healthcare professional) is making an error or deviating from a set of actions expected during the course of a surgical procedure. For example, the surgical hub 5104 may be configured to determine the type of surgical procedure being performed, read a correspondence list of instrument usage steps or sequences (e.g., from memory), and then compare the steps or instruments being performed or used during the course of the surgical procedure with the expected steps or instruments for the type of surgical procedure being performed determined by the surgical hub 5104. In some examples, the surgical hub 5104 may be configured to provide an alarm indicating that an unexpected action is being performed or an unexpected device is being used at a particular step in the surgical procedure.

[0125] Surgical instruments (and other modular devices 5102) may be adjusted to suit the specific circumstances of each surgical procedure (such as adjustments for different tissue types) and their operation during surgery may be verified. The following 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 circumstances of the procedure.

[0126] Figure 10 shows a timeline 5200 of an exemplary surgical procedure and contextual information that the surgical hub 5104 may derive from data received from data source 5126 at each stage of the surgical procedure. Refer to Figure 9 for the following description of the timeline 5200 shown in Figure 9. The timeline 5200 may illustrate the typical steps that nurses, surgeons, and other healthcare professionals might take during a lung segmentectomy, beginning with setting up the operating room and ending with transferring the patient to the postoperative recovery room. The contextually aware surgical hub 5104 may receive data from data source 5126 throughout the surgical procedure, including data generated each time a healthcare professional uses a modular device 5102 paired with the surgical hub 5104. The surgical hub 5104 receives this data from the paired modular device 5102 and other data sources 5126, and can continuously derive estimations (i.e., contextual information) about the procedure in progress as new data is received, such as which step of the procedure is being performed at any given time. The contextual awareness system of the surgical hub 5104 can, for example, record data about the procedure to generate a report, verify the steps being taken by the healthcare worker, provide data or prompts that may be relevant to a particular procedure step (e.g., via a display screen), adjust the modular device 5102 based on context (e.g., activate a monitor, adjust the FOV of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and perform any other such actions described herein.

[0127] As a first step 5202 in this exemplary procedure, hospital staff may read the patient's EMR from the hospital's EMR database. Based on the patient data selected in the EMR, the surgical hub 5104 determines that the procedure to be performed is a thoracic surgery. In a second step 5204, staff may scan the medical supplies arriving for the procedure. The surgical hub 5104 cross-references the scanned supplies with a list of supplies that may be used in various types of procedures to confirm that the combination of supplies corresponds to a thoracic procedure. Furthermore, the surgical hub 5104 may also determine that the procedure is not a wedge resection (because the arriving supplies either do not include certain supplies required for a thoracic wedge resection or are otherwise not corresponding to a thoracic wedge resection). In a third step 5206, healthcare workers may scan the patient band 5128 via a scanner communicably connected to the surgical hub 5104. The surgical hub 5104 can then verify the patient's identity based on the scanned data. In the fourth part of 5208, a medical professional turns on the auxiliary device. The auxiliary device used may vary depending on the type of surgery and the technique used by the surgeon, but in this exemplary case, examples include a fume exhauster, an air blower, and a medical imaging device. Once activated, the auxiliary device, which is a modular device 5102, can automatically pair with a surgical hub 5104, which may be located within a specific vicinity of the modular device 5102, as part of its initialization process. The surgical hub 5104 can then derive contextual information about the surgery by detecting the type of modular device 5102 that it is paired with during this pre-operative or initialization phase. In this particular embodiment, the surgical hub 5104 may determine that the surgery is a VATS surgery based on this particular combination of paired modular devices 5102. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the type of modular device 5102 connected to the hub, the surgical hub 5104 can roughly estimate the specific procedure that the surgical team will perform.When the surgical hub 5104 knows what particular procedure is being performed, it can then read the steps of that procedure from memory or the cloud, and then cross-reference the data subsequently received from connected data sources 5126 (e.g., modular device 5102 and patient monitoring device 5124) to estimate which steps of the surgical procedure the surgical team is performing. In the 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, it may confirm that the patient is in the operating room, for example, as described in process 5207. In the sixth step 5212, healthcare workers may administer anesthesia to the patient. The surgical hub 5104 can infer that the patient is under anesthesia based on data from the modular device 5102 and / or the patient monitoring device 5124, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Once the sixth step 5212 is completed, the preoperative part of the lung segmentectomy is complete and the surgical part begins.

[0128] In section 7, 5214, the lungs of the patient being operated on may collapse (while ventilation is switched to the contralateral lung). The surgical hub 5104 can infer, for example, that the patient's lungs have collapsed from the ventilator data. The surgical hub 5104 can compare the detection of the patient's lung collapse with the expected steps of the procedure (which can be pre-accessed or read out), so that it can infer that the surgical portion of the procedure has begun and determine that causing the lungs to collapse is the first surgical step in this particular procedure. In section 8, 5216, a medical imaging device 5108 (e.g., a scope) may be inserted and video from the medical imaging device may be initiated. The surgical hub 5104 can 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 can determine that the laparoscopic portion of the surgical procedure has begun. Furthermore, the surgical hub 5104 can determine that a particular procedure being performed is a segmentectomy, as opposed to a lobectomy (note that wedge resections have not been taken into consideration by the surgical hub 5104 based on the data received in the second step 5204 of the procedure). Using data from the medical imaging device 124 (Figure 2), contextual information regarding the type of procedure being performed can be determined in various ways, for example, by determining the angle of the medical imaging device directed towards the visualization of the patient's anatomical structure, by monitoring the number or type of medical imaging device being used (i.e., activated and paired with the surgical hub 5104), and by monitoring the type of visualization device being used. For example, one technique for performing a VATS lobectomy positions the camera above the diaphragm in the anteroinferior corner of the patient's thoracic cavity, while another technique for performing a VATS segmentectomy may position the camera in an anterior intercostal position relative to the segmental fissure. The situational awareness system can be trained, for example, using pattern recognition or machine learning techniques, to recognize the position of the medical imaging device according to the visualization of the patient's anatomical structure. Exemplary techniques for performing VATS lobectomy may utilize a single medical imaging device.An exemplary technique for performing VATS segmentectomy utilizes multiple cameras. The exemplary technique for performing VATS segmentectomy utilizes an infrared light source (which can be communicably connected to a surgical hub as part of the visualization system) to visualize the segmental fissure, but this is not used in VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can determine the specific type of surgery being performed and / or the techniques used in that specific type of surgery.

[0129] In Section 9, 5218, the surgical team may initiate the incision phase of the procedure. The surgical hub 5104 receives data from an RF or ultrasound generator indicating that an energy instrument is being emitted, and can therefore infer that the surgeon is in the process of incising and separating the patient's lung. The surgical hub 5104 can cross-reference the received data with the read-out steps of the surgical procedure to determine that the energy instrument being emitted at this point in the process (i.e., after the completion of the procedure described above) corresponds to the incision phase. In Section 10, 5220, the surgical team may proceed to the ligation phase of the procedure. The surgical hub 5104 may receive data from surgical stapling and cutting instruments indicating that an instrument is being emitted, and can therefore 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 received data from the surgical stapling and cutting instruments with the steps in the read-out process. In Section 11, 5222, the segmental resection phase of the procedure may be performed. The surgical hub 5104 can infer that a surgeon is transversely incising parenchymal tissue based on data from surgical stapling and cutting instruments (including data from their cartridges). The cartridge data may correspond, for example, to the size or type of staples being fired by the instrument. Since different types of staples are used for different types of tissue, the cartridge data may indicate the type of tissue being stapled and / or transversely incised. In this case, the type of staples being fired is used for parenchymal tissue (or other similar tissue types), thereby allowing the surgical hub 5104 to infer that the segmental resection portion of the procedure is being performed. Subsequently, in the twelfth step 5224, the nodule incision step is performed. Based on data received from the generator indicating that an RF or ultrasonic instrument is being fired, the surgical hub 5104 can infer that the surgical team is incising the nodule and performing a leak test. In this particular procedure, the RF or ultrasonic instrument used after the parenchymal tissue has been transversely incised corresponds to the nodule incision step, thereby allowing the surgical hub 5104 to make this inference.It should be noted that different instruments are better suited to specific tasks, and surgeons should periodically switch between surgical stapling / cutting instruments and surgical energy (e.g., RF or ultrasound) instruments depending on the specific stage of the procedure. Therefore, the specific sequence in which stapling / cutting instruments and surgical energy instruments are used can indicate which stage of the procedure the surgeon is performing. Upon completion of the 12th step 5224, incision and closure, as well as the postoperative portion of the procedure, may be initiated.

[0130] In step 13, 5226, the patient may be released from anesthesia. The surgical hub 5104 may estimate that the patient is waking from anesthesia, for example, based on ventilator data (i.e., the patient's respiratory rate begins to increase). Finally, step 14, 5228, may be the step in which a medical professional removes various patient monitoring devices 5124 from the patient. Thus, the surgical hub 5104 may estimate that the patient is being transferred to the 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 may determine or estimate when each step of a given surgical procedure is occurring, according to the data received from various data sources 5126 that are communicably connected to the surgical hub 5104.

[0131] As shown in the first step 5202 of the timeline 5200 shown in Figure 10, in addition to estimating the type of surgical procedure to be performed using patient data from the EMR database, the patient data can also be used by the situation-aware surgical hub 5104 to generate control adjustments for the paired modular device 5102.

[0132] Figure 11 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. In one aspect, the computer-implemented interactive surgical system may be configured to monitor and analyze data relating to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and operating rooms or medical facilities. The computer-implemented interactive surgical system may include a cloud-based analytics system. The cloud-based analytics system, while described as a surgical system, is not necessarily limited to that and may generally be a cloud-based medical system. As shown in Figure 11, the cloud-based analytics 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 connecting the surgical hubs 7006 to a cloud 7004 (which may be the same as or similar to cloud 204). Each of the plurality of surgical hubs 7006 may be communicably connected to one or more surgical instruments 7012. The hub 7006 may also be communicably connected to a cloud 7004 of a computer-implemented interactive surgical system 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 Figure 11, access to the cloud 7004 is achieved via the network 7001, which may be the Internet or another suitable computer network. The surgical hub 7006, which can be connected to the cloud 7004, can be considered the client side of a cloud computing system (i.e., a cloud-based analytics system). Surgical instruments 7012 may be paired with the surgical hub 7006 for the control and execution of various surgical procedures or actions described herein.

[0133] In addition, the surgical instrument 7012 may be equipped with transceivers for data transmission to and from the corresponding surgical hub 7006 (which may also be equipped with transceivers). The combination of the surgical instrument 7012 and the corresponding hub 7006 can indicate a specific location, such as an operating room within a medical facility (e.g., a hospital) for providing medical surgery. For example, the memory of the surgical hub 7006 can store location data. As shown in Figure 11, the cloud 7004 comprises 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 from client surgical hubs 7006 and managing the processing capacity of the cloud 7004 to perform those requests. Each central server 7013 may include one or more processors 7008 connected 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 devices. When executed, the memory device 7010 may include machine-executable instructions that cause the processor 7008 to execute a data analysis module 7034 for cloud-based data analysis, operation, recommendation, and other operations described below. Furthermore, the processor 7008 can execute the data analysis module 7034 independently or in conjunction with a hub application that runs independently by the hub 7006. The central server 7013 may also include a database 2212 of aggregated medical data that may reside in memory 2210.

[0134] Based on connections to various surgical hubs 7006 via network 7001, cloud 7004 can aggregate data from various surgical instruments 7012 and specific data generated by their corresponding hubs 7006. Such aggregated data can be stored in the aggregated medical database 7012 of cloud 7004. Specifically, cloud 7004 can advantageously perform data analysis and operations on the aggregated data to derive insights and / or perform functions that individual hubs 7006 cannot achieve on their own. For this purpose, as shown in Figure 11, cloud 7004 and surgical hubs 7006 are connected in a communicative manner to send and receive information. The I / O interface 7006 is connected to multiple surgical hubs 7006 via network 7001. In this way, the I / O interface 7006 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data database 7011. Thus, the I / O interface 7006 can facilitate read / write operations of the cloud-based analysis system. Such read / write operations may be performed in response to requests from the hub 7006. These requests may be sent to the hub 7006 via the hub application. The I / O interface 7006 may include one or more high-speed data ports, including a Universal Serial Bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting the cloud 7004 to the hub 7006. The hub application server 7002 of the cloud 7004 may be configured to host and supply shared functions to a software application (e.g., the hub application) running on the surgical hub 7006. For example, the hub application server 7002 may manage requests from the hub application through the hub 7006, control access to the aggregated medical data database 7011, and perform load balancing. The data analysis module 7034 will be described in more detail with reference to Figure 12.

[0135] The configurations of the specific cloud computing systems described in this disclosure may be specifically designed to address a variety of problems arising in the context of medical surgeries and procedures performed using medical devices such as surgical instruments 7012, 112, etc. In particular, surgical instrument 7012 may be a digital surgical device configured to interact with the cloud 7004 in order to implement techniques for improving surgical outcomes. Various surgical instruments 7012 and / or surgical hubs 7006 may have a touch-controlled user interface so that a clinician can control the manner of 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.

[0136] Figure 12 is a block diagram showing the functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. The cloud-based analytics system may include a number of data analytics modules 7034 that can be executed by a processor 7008 of the cloud 7004 to provide data analytics solutions to problems that arise particularly in the medical field. As shown in Figure 12, the functionality of the cloud-based data analytics modules 7034 may be supported via a hub application 7014 hosted by a hub application server 7002 that can be accessed on a surgical hub 7006. The cloud processor 7008 and the hub application 7014 may work together to execute the data analytics modules 7034. An application programming interface (API) 7016 may define a set of protocols and routines corresponding to the hub application 7014. In addition, the API 7016 may manage the storage of data in a medical database 7012 aggregated for the operation of the application 7014, and the retrieval of data therefrom. A cache 7018 may also store data (e.g., temporarily) and be linked to the API 7016 for efficient retrieval of data used by the application 7014. The data analysis module 7034 in Figure 12 may include modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, control program updates 7026, patient outcome analysis 7028, recommendations 7030, and data classification and prioritization 7032. Other suitable data analysis modules may also be implemented by the cloud 7004 in several embodiments. In one embodiment, the data analysis module may be used for specific recommendations based on analysis of trends, outcomes, and other data.

[0137] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata), including the identification of prominent features or configurations (e.g., trends), the management of redundant datasets, and the storage of data into paired datasets that can be grouped by surgery but do not necessarily correspond to actual surgical dates and surgeons. In particular, paired datasets generated from the operation of surgical instruments 7012 may involve applying a binary classification, such as bleeding or non-bleeding events. More generally, the binary classification may be characterized as either a desirable event (e.g., a successful surgery) or an undesirable event (e.g., a surgical instrument 7012 misfired or misused). 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 can generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. For this purpose, the processor 7008 can be operationally linked to the hub application 7014 and the aggregated medical data database 7011 in order to execute the data analysis module 7034. The data acquisition and aggregation module 7022 may store the aggregated and organized data in the aggregated medical data database 2212.

[0138] The resource optimization module 7020 can be configured to analyze this aggregated data to determine the optimal use of resources for a particular healthcare facility or group of healthcare facilities. For example, the resource optimization module 7020 can determine the optimal reorder point for surgical staple fasteners 7012 for a group of healthcare facilities based on the corresponding predicted demand for those staple fasteners 7012. The resource optimization module 7020 can also evaluate the resource use or other operational configurations of various healthcare facilities to determine whether resource use can be improved. Similarly, the recommendation module 7030 can be configured to analyze the aggregated data from the data collection and aggregation module 7022 to provide recommendations. For example, the recommendation module 7030 can recommend to a healthcare facility (e.g., a healthcare service provider such as a hospital) that a particular surgical instrument 7012 should be upgraded to an improved version based, for example, on the error rate being higher than predicted. In addition, the recommendation module 7030 and / or the 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 procedures to improve surgical outcomes. Medical facilities can receive such recommendations via the corresponding surgical hub 7006. More specific recommendations regarding the parameters or configurations of various surgical instruments 7012 can also be provided. The hub 7006 and / or the surgical instrument 7012 may each have a display screen that shows data or recommendations provided by the cloud 7004.

[0139] The patient outcome analysis module 7028 can analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 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 the resulting better surgical outcomes, such as better sealing or less bleeding. For example, the suggestion module 7030 may send a suggestion to the surgical instrument 7006 regarding the use of a particular cartridge with the corresponding stapled surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large amounts of collected raw data while controlling for common variables and to provide centralized recommendations across multiple healthcare facilities (favorably determined based on aggregated data). For example, the cloud-based analysis system can analyze, evaluate, and / or aggregate things such as the type of medical procedure, the type of patient, the number of patients, and geographical similarities among healthcare providers using similar types of instruments in a way that a single healthcare facility could not analyze independently. The control program update module 7026 can be configured to implement various surgical instrument 7012 recommendations when the corresponding control program is updated. For example, the patient outcome analysis module 7028 can identify correlations linking specific control parameters to successful (or unsuccessful) outcomes. Such correlations can be addressed when the updated control program is transmitted to the surgical instrument 7012 via the control program update module 7026. Updates to the instrument 7012, which can be transmitted via the corresponding hub 7006, may incorporate aggregated outcome data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. In addition, the patient outcome analysis module 7028 and the recommendation module 7030 can identify improved ways of using the instrument 7012 based on the aggregated outcome data.

[0140] The cloud-based analytics system may include security features implemented by Cloud 7004. These security features may be managed by the authorization and security module 7024. Each surgical hub 7006 may have associated unique credentials, such as a username, password, and other preferred security credentials. These credentials may be stored in memory 7010 and associated with permitted cloud access levels. For example, based on providing accurate credentials, a surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., to send or receive certain defined types of information). For this purpose, the aggregated medical data database 7011 of Cloud 7004 may include a database of certified credentials to verify the accuracy of the provided credentials. Different credentials may be associated with various levels of authorization for interaction with Cloud 7004, such as a predetermined access level for receiving data analysis generated by Cloud 7004. Furthermore, for security purposes, the cloud may maintain databases 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 non-conformity or other specified criteria. In this way, counterfeit medical devices and the improper reuse of such devices across the entire cloud-based analysis system can be identified and addressed.

[0141] The surgical instrument 7012 may use a wireless transceiver to transmit a wireless signal that may represent, for example, authorization credentials for access to the corresponding hub 7006 and the cloud 7004. A wired transceiver can also be used to transmit a signal. Such authorization credentials can be stored in the respective memory devices of the surgical instrument 7012. The authorization and security module 7024 can determine whether the authorization credentials are accurate or forged. The authorization and security module 7024 may also dynamically generate authorization credentials for enhanced security. The credentials may also be encrypted, for example, by using hash-based encryption. Upon transmitting appropriate authorization, the surgical instrument 7012 may signal to the corresponding hub 7006 and ultimately the cloud 7004 to indicate that the instrument 7012 is ready to acquire and transmit medical data. In response, the cloud 7004 may transition to a state in which it can receive medical data for storage in the aggregated medical data database 7011. This readiness for data transmission can be indicated, for example, by an optical indicator on the instrument 7012. Cloud 7004 can also send signals to surgical instruments 7012 to update their associated control programs. Cloud 7004 can send signals directed to specific categories of surgical instruments 7012 (e.g., electrosurgical instruments) to ensure that software updates for control programs are sent only to the appropriate surgical instruments 7012. Furthermore, Cloud 7004 may be used to implement system-wide solutions to address local or global issues based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 are identified as having a common manufacturing defect, Cloud 7004 may modify the authorization credentials corresponding to this group to implement operational lockout for that group.

[0142] A cloud-based analytics system can 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 suggestion module 2030). Thus, the processor 7008 of Cloud 7004 can analyze data associated with individual healthcare facilities to identify facilities and aggregate that data with other data associated with other healthcare facilities. Groups may be defined, for example, based on similar operational practices or geographical location. In this way, Cloud 7004 can provide a wide range of analytics and recommendations to healthcare facility groups. The cloud-based analytics system can also be used for enhanced contextual awareness. For example, the processor 7008 may predictively model the effect of cost and effectiveness recommendations for a particular facility (compared to overall operations and / or various medical procedures). The cost and effectiveness associated with that particular facility can also be compared to the corresponding local areas of other facilities or any other equivalent facilities.

[0143] The data classification and prioritization module 7032 may prioritize and classify data based on severity (e.g., the severity, unexpectedness, or suspiciousness of the medical event associated with the data). This classification and prioritization may be used in conjunction with the functionality of other data analysis modules 7034 described herein to improve the cloud-based analysis 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 increased priority for rapid response, special processing, exclusion from the aggregated medical data database 7011, or other preferred responses. Furthermore, if necessary, the cloud 7004 may send requests (e.g., push messages) via the hub application server for additional data from the corresponding surgical instrument 7012. Push messages may result in notifications displayed on the corresponding hub 7006 to request support or additional data. This push message may be needed in situations where the cloud detects a significant anomaly or outlier and is unable to determine the cause of that anomaly. 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 a predicted value by a predetermined threshold, or when security is suspected to be involved.

[0144] Further illustrative details regarding the various functions described are provided in the following description. Each of the various descriptions may utilize a cloud architecture, as shown in Figures 11 and 12, as an example of hardware and software implementation.

[0145] Figure 13 illustrates a block diagram of a computer-implemented adaptive surgical system 9060 configured to adaptively generate control program updates for modular devices 9050 according to at least one aspect of the present disclosure. In some examples, the surgical system may include a surgical hub 9000, a plurality of modular devices 9050 communicably connected to the surgical hub 9000, and an analysis system 9100 communicably connected to the surgical hub 9000. Although a single surgical hub 9000 is shown, it should be noted that the surgical system 9060 may include any number of surgical hubs 9000 that can be connected to form a network of surgical hubs 9000 communicably connected to the analysis system 9010. In some examples, the surgical hub 9000 may include a processor 9010 connected to memory 9020 for executing stored instructions, and a data relay interface 9030 to 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 queries entered by the user, suggestions for products or mixtures of products for use in a given procedure, and / or instructions for actions performed before, during, or after a surgical procedure. The surgical hub 9000 may further include an interface 9040 for communicatively connecting modular devices 9050 to the surgical hub 9000. In one embodiment, the interface 9040 may include transceivers that can be communicatively connected to the modular devices 9050 via a wireless communication protocol. The modular devices 9050 may include, for example, surgical staple fasteners and cutters, electrosurgical instruments, ultrasound instruments, inflators, ventilators, and display screens. In some examples, the surgical hub 9000 can be further connected to one or more patient monitoring devices 9052, such as an EKG monitor or BP monitor, in a communicative manner.In some examples, the surgical hub 9000 can be further connected to communicate with one or more databases 9054, such as the EMR database of the medical facility where the surgical hub 9000 is located, or with an external computer system.

[0146] When the modular device 9050 is connected to the surgical hub 9000, the surgical hub 9000 can sense or receive perioperative data from the modular device 9050 and then 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 the surgical procedure. The procedure outcome data includes data associated with the outcome from the surgical procedure (or its process), which may include whether the surgical procedure (or its process) had a positive or negative outcome. For example, outcome data may include whether the patient suffered a postoperative complication from a particular procedure, or whether there was leakage (e.g., bleeding or air leakage) at a particular staple or incision line. The surgical hub 9000 can obtain surgical procedure outcome data by receiving data from an external source (e.g., from the EMR database 9054), by directly detecting the outcome (e.g., via one of the connected modular devices 9050), or by inferring the occurrence of the outcome through a situational awareness system. For example, data on postoperative complications can be read from the EMR database 9054, and data on staple or incision line leakage may be directly detected or inferred by the situational awareness system. Surgical procedure outcome data can be inferred by the situational awareness system from data received from various data sources, including the modular device 9050 itself, the patient monitoring device 9052, and the database 9054 to which the surgical hub 9000 is connected.

[0147] The surgical hub 9000 can transmit data and result data from associated modular devices 9050 to the analysis system 9100 for processing. By transmitting both perioperative data indicating how the modular devices 9050 are controlled and procedure result data, the analysis system 9100 can correlate different modes of control of the modular devices 9050 with surgical outcomes for specific procedure types. In some examples, the analysis system 9100 may include a network of analysis servers 9070 configured to receive data from the surgical hub 9000. Each analysis server 9070 may include memory and a memory-coupled processor 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 the 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.

[0148] Further details regarding the computer-implemented interactive surgical system 9060, including the surgical hub 9000 and various modular devices 9050 that can be connected thereto, are described in relation to Figures 5 and 6.

[0149] Figure 14 provides a surgical system 6500 according to the present disclosure, which may include a surgical instrument 6502 capable of communicating with a console 6522 or portable device 6526 via a wired or wireless connection through a local area network 6518 or a cloud network 6520. In various embodiments, the console 6522 and portable device 6526 may be any suitable computing device. The surgical instrument 6502 may include a handle 6504, an adapter 6508, and a loading unit 6514. The adapter 6508 is releasably coupled to the handle 6504, and the loading unit 6514 is releasably coupled to the adapter 6508 so that the adapter 6508 transmits force from the drive shaft to the loading unit 6514. The adapter 6508 or the loading unit 6514 may include force gauges (not explicitly shown) disposed therein for measuring the force exerted on the loading unit 6514. The loading unit 6514 may include an end effector 6530 having a first jaw 6532 and a second jaw 6534. The loading unit 6514 may be an in-situ loading or multi-fire loading unit (MFLU) that allows a clinician to fire multiple fasteners multiple times without the loading unit 6514 having to be removed from the surgical site for reloading.

[0150] The first and second jaws 6532, 6534 may be configured to clamp tissue between them, fire fasteners through the clamped tissue, and cut the clamped tissue. The first jaw 6532 may be configured to fire at least one fastener multiple times, or may be configured to include a replaceable 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 may include an anvil that deforms the fastener or otherwise secures it around the tissue as the fastener is ejected from the multi-fire fastener cartridge.

[0151] The handle 6504 may include a motor connected to the drive shaft so as to affect the rotation of the drive shaft. The handle 6504 may include a control interface for selectively operating the motor. The control interface may include buttons, switches, levers, sliders, touchscreens, and any other suitable input mechanisms or user interfaces, which can be engaged by a clinician to start the motor.

[0152] The control interface of the handle 6504 communicates with the controller 6528 of the handle 6504 to selectively activate the motor and affect the rotation of the drive shaft. The controller 6528 may be located within the handle 6504 and is configured to receive input from the control interface and adapter data from the adapter 6508 or loading unit data from the loading unit 6514. The controller 6528 may analyze the input from the control interface and the data received from the adapter 6508 and / or loading unit 6514 to selectively activate the motor. The handle 6504 may also include a display that can be viewed by a clinician while the handle 6504 is in use. The display may be configured to show portions of the adapter or loading unit data before, during, or after firing the instrument 6502.

[0153] The adapter 6508 may include an adapter identification device 6510 disposed therein, and the loading unit 6514 may include a loading unit identification device 6516 disposed therein. The adapter identification device 6510 may communicate with the controller 6528, and the loading unit identification device 6516 may communicate with the controller 6528. It will be understood that the loading unit identification device 6516 may communicate with the adapter identification device 6510 which relays or passes communications from the loading unit identification device 6516 to the controller 6528.

[0154] The adapter 6508 may also include a plurality of sensors 6512 (one shown) disposed around it to detect various conditions of the adapter 6508 or the environment (e.g., when the adapter 6508 is connected to a loading unit, when the adapter 6508 is connected to a handle, when the drive shaft is rotating, the torque of the drive shaft, the strain of the drive shaft, the temperature inside the adapter 6508, the number of times the adapter 6508 has fired, the peak force of the adapter 6508 during firing, the total amount of force applied to the adapter 6508, the peak recoil force of the adapter 6508, the number of pauses of the adapter 6508 during firing, etc.). The plurality of sensors 6512 may provide input to the adapter identification device 6510 in the form of data signals. The data signals from the plurality of sensors 6512 may be stored in the adapter identification device 6510 or used to update adapter data stored in the adapter identification device 6510. The data signals from the plurality of sensors 6512 may be analog or digital. Multiple sensors 6512 may include force gauges for measuring the force exerted on the loading unit 6514 during firing.

[0155] The handle 6504 and adapter 6508 can be configured to interconnect the adapter identification device 6510 and the loading unit identification device 6516 with the controller 6528 via an electrical interface. The electrical interface may be a direct electrical interface (i.e., including electrical contacts that engage with each other to transmit energy and signals between them). Additionally or alternatively, the electrical interface may be a non-contact electrical interface for wirelessly transmitting energy and signals between them (e.g., inductively). It is also intended that the adapter identification device 6510 and the controller 6528 may be able to wirelessly communicate with each other via a wireless connection separate from the electrical interface.

[0156] 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., LAN 6518, cloud 6520, console 6522, or 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 a mounting adapter attached to the handle 6504 (e.g., adapter 6508), the serial number of a loading unit attached to the adapter (e.g., loading unit 6514), and the serial number of a multi-shot fastener cartridge (e.g., multi-shot fastener) loaded into the loading unit. The console 6522 may then send data (e.g., cartridge data, loading unit data, or adapter data) associated with the mounting cartridge, loading unit, and adapter, respectively, back to the controller 6528. The controller 6528 can display a message on the local device display, or transmit a message via the transmitter 6506 to the console 6522 or portable device 6526, which can then display the message on the display 6524 or portable device screen, respectively.

[0157] Figure 15A shows an exemplary flow for determining the operating mode and operating in the determined mode. Computer-implemented interactive surgical systems and / or components and / or subsystems of computer-implemented interactive surgical systems may be configured to be updatable. Such updates may include a mix of features and benefits that were not available to the user before the update. These updates may be established by any method of hardware, firmware, and software updates suitable for introducing functionality to the user. For example, computer-implemented interactive surgical systems and / or components and / or subsystems of computer-implemented interactive surgical systems may be updated using replaceable / swappable (e.g., hot-swappable) hardware components, flashable firmware devices, and updatable software systems.

[0158] Renewal may be conditional on any appropriate criteria or set of criteria. For example, renewal may be conditional on one or more hardware capabilities of the system, such as processing power, bandwidth, or resolution. For example, renewal may be conditional on one or more software aspects, such as the purchase of specific software code. For example, renewal may be conditional on a purchased service tier. A service tier may represent the functions and / or sets of functions that a user is entitled to use in connection with a computer-implemented interactive surgical system. A service tier may be determined by a license code, e-commerce server authentication interaction, hardware key, username / password combination, biometric authentication interaction, public / private key exchange interaction, etc.

[0159] In 10704, system / device parameters may be identified. System / device parameters may be any element or set of elements on which updates are conditional. For example, a computer-implemented interactive surgical system may detect a specific bandwidth of communication between a modular device and a surgical hub. For example, a computer-implemented interactive surgical system may detect instructions for purchasing a specific service tier.

[0160] In 10708, the operating mode may be determined based on identified system / device parameters. This determination may be made by a process that maps system / device parameters to operating modes. The process may be manual and / or automated. The process may be the result of local and / or remote calculations. For example, the operating mode may be determined based on identified system / device parameters using client / server interaction. For example, the operating mode may be determined based on identified system / device parameters using local software and / or locally embedded firmware. For example, the operating mode may be determined based on identified system / device parameters using a hardware key, such as a secure microprocessor.

[0161] In 10710, operation may proceed according to a determined operating mode. For example, the system or device may proceed to operate in the default operating mode. For example, the system or device may proceed to operate in an alternative operating mode. The operating mode may be indicated by control hardware, firmware, and / or software already present in the system or device. The operating mode may also be indicated by newly installed / updated control hardware, firmware, and / or software.

[0162] Figure 15B shows an exemplary functional block diagram for changing the operating 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 operating 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 operating 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 user 10730 to determine the operating 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 operating 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 for a hardware key to determine, for example, the operating mode.

[0163] An upgradeable element 10714 may include one or more operational components 10720, 10722, 10726, 10728 and an operational pointer 10724. An initialization component 10716 may instruct the operational pointer 10724 to instruct the operational components 10720, 10722, 10726, 10728 corresponding to the determined operational mode to operate the upgradeable element 10741. The initialization component 10716 may also instruct the operational pointer 10724 to instruct the default operational component 10720 to operate the upgradeable element. For example, the default operational component 10720 may be selected on the condition that no other alternative operational modes have been determined. For example, the default operational component 10720 may be selected on the condition of a failure of the initialization component and / or an interaction failure. The initialization component 10716 may instruct the operation pointer 10724 to instruct the resident operation component 10722 to operate the upgradeable element 10714. For example, a particular function may reside in the upgradeable element 10714, but may require startup to operate. The initialization component 10716 may also instruct the operation pointer 10724 to instruct the operation of the upgradeable element 10714 to install a new operation component 10728 and / or a newly installed operation component 10726. For example, new software and / or firmware may be downloaded. The new software and / or firmware may include code that enables the function represented by the selected operating mode. For example, a new hardware component may be installed to enable the selected operating mode.

[0164] Figure 16 is a schematic diagram of a surgical instrument 700 configured to operate a surgical tool described herein, according to one aspect of the present disclosure. The surgical instrument 700 may be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of a closure tube, rotation of a shaft, and joint movement using one or more joint movement drive couplings. In one aspect, the surgical instrument 700 may be programmed or configured to independently control a launching member, a closure member, a shaft member, and / or one or more joint movement members. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven launching member, a closure member, a shaft member, or one or more joint movement members. In one aspect, the surgical instrument 700 represents a handheld surgical instrument. In another aspect, the surgical instrument 700 represents a robotic surgical instrument. In yet another aspect, the surgical instrument 700 represents a combination of a handheld and a robotic surgical instrument. In various embodiments, the surgical stapler 700 may represent a linear stapler or a circular stapler.

[0165] In one embodiment, the surgical instrument 700 includes a control circuit 710 configured to control, via a plurality of motors 704a to 704e, the anvil 716 and knife 714 (or cutting element including a sharp cutting edge) portion of the end effector 702, a removable staple cartridge 718, a shaft 740, and one or more articulated members 742a, 742b. A position sensor 734 may be configured to provide the control circuit 710 with position feedback of the knife 714. Other sensors 738 may be configured to provide feedback to the control circuit 710. A timer / counter 731 provides timing and count information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a to 704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a to 704e can be operated individually by the control circuit 710 in open-loop or closed-loop feedback control.

[0166] In one embodiment, the control circuit 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions to cause one or more tasks to be performed by a processor(s). In one embodiment, the timer / counter 731 provides the control circuit 710 with an output signal such as elapsed time or a digital count to correlate the position of the knife 714 determined by the position sensor 734 with the output of the timer / counter 731, so that the control circuit 710 can determine the position of the knife 714 at a specific time (t) relative to the starting position or time (t) when the knife 714 is at a specific position relative to the starting position. The timer / counter 731 may be configured to measure elapsed time, count an external event, or measure the duration of an external event.

[0167] In one embodiment, the control circuit 710 may be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or a closing control program based on the tissue conditions. The firing control program can describe the distal motion of the displacement member. Different firing control programs can be selected to better treat different tissue conditions. For example, when thick tissue is present, the control circuit 710 may be programmed to translate the displacement member at a low speed and / or with low power. When thin tissue is present, the control circuit 710 may be programmed to translate the displacement member at a high speed and / or with high power. A closing control program can control the closing force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and the articulated members 742a, 742b.

[0168] In one embodiment, the control circuit 710 can generate a motor setpoint signal. The motor setpoint signal can be provided to various motor controllers 708a to 708e. The motor controllers 708a to 708e may comprise one or more circuits configured to provide motor drive signals to the motors 704a to 704e in order to drive the motors 704a to 704e as described herein. In some embodiments, the motors 704a to 704e may be brushed DC electric motors. For example, the speed of the motors 704a to 704e may be proportional to their respective motor drive signals. In some embodiments, the motors 704a to 704e may be brushless DC electric motors, and their respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a to 704e. Also in some embodiments, the motor controllers 708a to 708e may be omitted, and the control circuit 710 may generate the motor drive signals directly.

[0169] In one embodiment, the control circuit 710 may initially operate each of the motors 704a to 704e in an open-loop configuration for a first open-loop portion of the stroke of the displacement member. Based on the response of the surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program in a closed-loop configuration. The instrument response may include the translational distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy supplied to one of the motors 704a to 704e during the open-loop portion, and the sum of the pulse widths of the motor drive signals. After the open-loop portion, the control circuit 710 may implement the selected firing control program for a second portion of the stroke of the displacement member. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a to 704e in a closed-loop configuration based on translational data describing the position of the displacement member, thereby translating the displacement member at a constant speed.

[0170] In one embodiment, motors 704a to 704e may receive power from an energy source 712. The energy source 712 may be a DC power supply driven by a main AC power source, a battery, a supercapacitor, or any other suitable energy source. Motors 704a to 704e may be mechanically coupled to individual movable mechanical elements such as the knife 714, anvil 716, shaft 740, joint movement 742a, and joint movement 742b via their respective transmission devices 706a to 706e. Transmission devices 706a to 706e may include one or more gears or other coupling components for coupling motors 704a to 704e to the movable mechanical elements. A position sensor 734 may sense the position of the knife 714. The position sensor 734 may be any type of sensor capable of generating position data indicating the position of the knife 714, or may include such a sensor. In some embodiments, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the knife 714 translates distally and proximally. The control circuit 710 may track the pulses to determine the position of the knife 714. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors can provide other signals indicating the motion of the knife 714. Also, in some embodiments, the position sensor 734 may be omitted. If any of the motors 704a to 704e are stepper motors, the control circuit 710 may track the position of the knife 714 by aggregating the number and direction of steps that the motor 704 is instructed to perform. The position sensor 734 may be located in the end effector 702 or in any other part of the device. Each output of the motors 704a to 704e includes torque sensors 744a to 744e for sensing force and has an encoder for sensing rotation of the drive shaft.

[0171] In one embodiment, the control circuit 710 is configured to drive a firing element, such as the knife 714 portion of the end effector 702. The control circuit 710 provides a motor setpoint to a motor control 708a that provides a drive signal to the motor 704a. The output shaft of the motor 704a is connected to a torque sensor 744a. The torque sensor 744a is connected to a transmission device 706a which is connected to the knife 714. The transmission device 706a includes a rotating element and movable mechanical elements such as a firing element for controlling the distal and proximal movement of the knife 714 along the longitudinal axis of the end effector 702. In one embodiment, the motor 704a may be connected to a knife gear assembly including a knife gear reduction set, which includes a first knife drive gear and a second knife drive gear. The torque sensor 744a provides the control circuit 710 with a firing force feedback signal. The firing force signal represents the force required to fire or displace the knife 714. The position sensor 734 may be configured to provide the control circuit 710 with a feedback signal of the position of the knife 714 or the position of the firing member along the firing stroke. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 may provide a firing signal to the motor control 708a. In response to the firing signal, the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from the proximal stroke start position to the stroke end position distal to the stroke start position. As the firing member translates distally, the knife 714, with a cutting element positioned at the distal end, advances distally to cut the tissue located between the staple cartridge 718 and the anvil 716.

[0172] In one embodiment, the control circuit 710 is configured to drive a closing member, such as the anvil 716 portion of the end effector 702. The control circuit 710 provides a motor setpoint to a motor control 708b, which provides a drive signal to the motor 704b. The output shaft of the motor 704b is connected to a torque sensor 744b. The torque sensor 744b is connected to a transmission device 706b, which is connected to the anvil 716. The transmission device 706b includes movable mechanical elements, such as a rotating element and a closing member, for controlling the movement of the anvil 716 from an open position and a closed position. In one embodiment, the motor 704b is connected to a closing gear assembly, which includes a closing reduction gear set that is meshed with and supported by a closing spur gear. The torque sensor 744b provides the control circuit 710 with a closing force feedback signal. The closing force feedback signal represents the closing force applied to the anvil 716. A position sensor 734 may be configured to provide the control circuit 710 with the position of the closing member as a feedback signal. An additional sensor 738 within the end effector 702 can provide a closing force feedback signal to the control circuit 710. The pivotable anvil 716 is positioned on the opposite side of the staple cartridge 718. When ready for use, the control circuit 710 can provide a closing signal to the motor control 708b. In response to the closing signal, the motor 704b advances the closing member that grips the tissue between the anvil 716 and the staple cartridge 718.

[0173] In one embodiment, the control circuit 710 is configured to rotate a shaft member, such as a shaft 740, in order to rotate the end effector 702. The control circuit 710 provides a motor setpoint to a motor control 708c, which provides a drive signal to the motor 704c. The output shaft of the motor 704c is connected to a torque sensor 744c. The torque sensor 744c is connected to a transmission device 706c, which is connected to the shaft 740. The transmission device 706c includes movable mechanical elements, such as a rotating element, for controlling the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one embodiment, the motor 704c is connected to a rotary transmission device assembly that includes a tubular gear segment formed on (or mounted on) the proximal end of a proximal closure tube, so as to be operably engaged by a rotary gear assembly operably supported on a tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.

[0174] In the implementation of a circular stapler, a transmission element 706c is connected to the trocar to move the trocar forward or backward. In one embodiment, the shaft 740 is part of a closing system comprising a trocar 201904 and a trocar actuator 201906, as described in detail below herein with reference to Figures 19A-19C. Accordingly, the control circuit 710 controls the motor control circuit 708c to control the motor 704c to move the trocar forward or backward. A torque sensor 744c is provided to measure the torque applied by the shaft of the motor 704c to the transmission element 706c used when moving the trocar forward and backward. The position sensor 734 may include various sensors for tracking the position of the trocar, anvil 716, or knife 714, or any combination thereof. Other sensors 738 may be used to measure various parameters, including the position or velocity of the trocar, anvil 716, or knife 714, or any combination thereof. The torque sensor 744c, position sensor 734, and sensor 738 are connected to the control circuit 710 as inputs to various processes for controlling the operation of the surgical instrument 700 in a desired manner.

[0175] In one embodiment, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor setpoint to the motor control 708d, which provides a drive signal to the motor 704d. The output shaft of the motor 704d is connected to a torque sensor 744d. The torque sensor 744d is connected to a transmission device 706d, which is connected to the articulation member 742a. ​​The transmission device 706d includes movable mechanical elements, such as articulation elements, for controlling the articulation of the end effector 702 by ±65°. In one embodiment, the motor 704d is connected to an articulation nut, which is rotatably supported on the proximal end portion of the distal spine portion and rotatably driven on the proximal end portion of the distal spine portion by an articulation gear assembly. The torque sensor 744d provides the control circuit 710 with an articulation force feedback signal. The joint motion force feedback signal represents the joint motion force applied to the end effector 702. A sensor 738, such as a joint motion encoder, may provide the control circuit 710 with the joint motion position of the end effector 702.

[0176] In another embodiment, the articular motion function of the robotic surgical system 700 may comprise two articular motion members or links 742a, 742b. These articular motion members 742a, 742b are driven by separate disks on a robotic interface (rack) driven by two motors 708d, 708e. When a separate launch motor 704a is provided, each of the articular motion links 742a, 742b can be driven antagonistically to the other link to provide resistive holding motion and load to the head when the head is not moving, and to provide articular motion when the head is articulated. The articular motion members 742a, 742b are attached to the head at a predetermined radius when the head rotates. Thus, the mechanical benefit of the push-pull connection changes as the head rotates. This change in mechanical benefit may be more pronounced in other articular motion connection drive systems.

[0177] In one embodiment, one or more motors 704a to 704e may comprise a brushed DC motor comprising a gearbox and a mechanical connection to a launching member, a closing member, or an articulating member. Another example is an electric motor 704a to 704e that operates movable mechanical elements such as displacement members, articulating connections, closing tubes, and shafts. External influences are unmeasured, unpredictable influences of tissue, surrounding bodies, and friction on the physical system. Such external influences can be called drag forces acting against one of the electric motors 704a to 704e. External influences such as drag forces can cause the operation of the physical system to deviate from the desired operation of the physical system.

[0178] In one embodiment, the position sensor 734 may be implemented as an absolute positioning system. In one embodiment, the position sensor 734 may comprise a magnetic rotational absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotational position sensor available from Austria Microsystems, AG. The position sensor 734 may interface with a control circuit 710 to provide an absolute positioning system. The position may include multiple Hall effect elements positioned above the magnet and coupled to a CORDIC processor, also known as digit-by-digit method and Boulder algorithm, which is provided to implement a simple and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bit shifts, and table lookup operations.

[0179] In one embodiment, the control circuit 710 may communicate with one or more sensors 738. The sensors 738 may be positioned on the end effector 702 and adapted to work with the surgical instrument 700 to measure various derivation parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Sensor 738 may comprise inductive sensors such as magnetic sensors, magnetic field sensors, strain gauges, load cells, pressure sensors, force sensors, torque sensors, eddy current sensors, resistance sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 702. Sensor 738 may include one or more sensors. Sensor 738 may be positioned on the deck of the staple cartridge 718 to determine the location of tissue using divided electrodes. Torque sensors 744a-744e may, among other things, be configured to sense forces such as firing force, closing force, and / or joint movement force. Therefore, the control circuit 710 can sense (1) the closure load experienced by the distal occluder and its location, (2) the launching member in the rack and its location, (3) which part of the staple cartridge 718 has tissue on it, and (4) the load and location on both articular movement rods.

[0180] In one embodiment, one or more sensors 738 may include strain gauges, such as micro-strain gauges, configured to measure the magnitude of strain in the anvil 716 while it is clamped. The strain gauges provide an electrical signal whose amplitude varies with the magnitude of strain. Sensor 738 may also include pressure sensors configured to detect the pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. Sensor 738 can be configured to detect the impedance of a portion of the tissue located between the anvil 716 and the staple cartridge 718, the impedance indicating the thickness and / or density of the tissue located between them.

[0181] In one embodiment, the sensor 738 may be implemented as, among other things, one or more limit switches, electromechanical devices, solid switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, or magnetometers. In other implementations, the sensor 738 may be implemented as a solid switch that operates under the influence of light, such as an optical sensor, an IR sensor, or an ultraviolet sensor. Furthermore, the switch may be a solid device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include, among other things, an electrically conductive-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.

[0182] In one embodiment, the sensor 738 may be configured to measure the force exerted on the anvil 716 by the closing drive system. For example, one or more sensors 738 may be positioned at the interaction point between the closing tube and the anvil 716 to detect the closing force applied to the anvil 716 by the closing tube. The force exerted on the anvil 716 may represent the tissue compression experienced by a portion of the tissue trapped between the anvil 716 and the staple cartridge 718. One or more sensors 738 can be positioned at various interaction points along the closing drive system to detect the closing force applied to the anvil 716 by the closing drive system. One or more sensors 738 may be sampled in real time during the clamping operation by the processor of the control circuit 710. The control circuit 710 receives the real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the anvil 716 in real time.

[0183] In one embodiment, a current sensor 736 can be used to measure the current drawn by each of the motors 704a to 704e. The force required to advance any of the movable mechanical elements, such as the knife 714, corresponds to the current drawn by one of the motors 704a to 704e. The force is converted into a digital signal and provided to the control circuit 710. The control circuit 710 can be configured to simulate the actual system response of the instrument in the controller's software. The displacement member can be actuated to move the knife 714 in the end effector 702 to a target speed or near thereto. The surgical instrument 700 may include a feedback controller, which may be any feedback controller, including but not limited to PID, state feedback, linear-quadratic (LQR), and / or adaptive controllers. The surgical instrument 700 may include a power supply to convert the signal from the feedback controller into physical inputs such as case voltage, PWM voltage, frequency-modulated voltage, current, torque, and / or force. Further details are disclosed in U.S. Patent Application No. 15 / 636,829, filed June 29, 2017, entitled "Closed Loop Velocity Control Techniques for Robotic Surgical Instrument," which is incorporated herein by reference in its entirety.

[0184] The surgical instrument 700 may be equipped with a wired or wireless communication circuit for communicating with a modular communication hub, as shown in Figures 1 to 6 and Figures 9 to 13. The surgical instrument 700 may also be an electric circular stapling device 201800 (Figure 18), 201000 (Figures 21 to 22).

[0185] Figure 17 shows a block diagram of a surgical instrument 750 configured to control various functions according to one aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control the distal translation of a displacement member such as a knife 764 or other preferred cutting element. The surgical instrument 750 comprises an anvil 766, a knife 764 (including a sharp cutting edge), and an end effector 752 which may include a removable staple cartridge 768.

[0186] The position, movement, displacement, and / or translation of a linear displacement member such as a knife 764 can be measured by an absolute positioning system, a sensor mechanism, and a position sensor 784. Since the knife 764 is connected to a longitudinally movable drive member, the position of the knife 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and / or translation of the knife 764 can be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control the translation of a displacement member such as a knife 764. In some embodiments, the control circuit 760 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions to cause one or more processors to control the displacement member, e.g., the knife 764, in the manner described herein. In one embodiment, the timer / counter 781 provides an output signal, such as elapsed time or a digital count, to the control circuit 760 so that the position of the knife 764 determined by the position sensor 784 is correlated with the output of the timer / counter 781, and as a result the control circuit 760 can determine the position of the knife 764 at a specific time (t) relative to the starting position. The timer / counter 781 may be configured to measure elapsed time, count external events, or time external events.

[0187] The control circuit 760 may generate a motor setpoint signal 772. The motor setpoint signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to drive the motor 754 by providing a motor drive signal 774 to the motor 754, as described herein. In some examples, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor, and the motor drive signal 774 may include a PWM signal provided to one or more stator windings of the motor 754. Also in some examples, the motor controller 758 may be omitted, and the control circuit 760 may generate the motor drive signal 774 directly.

[0188] The motor 754 can receive power from an energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the knife 764 via a transmission device 756. The transmission device 756 may include one or more gears or other coupling components for coupling the motor 754 to the knife 764. In one embodiment, the transmission device is coupled to a trocar actuator of a circular stapler to move the trocar forward or backward. A position sensor 784 can sense the position of the knife 764, the trocar, or the anvil 766, or a combination thereof. The position sensor 784 may be or include any type of sensor capable of generating position data indicating the position of the knife 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to a control circuit 760 as the knife 764 translates distally and proximal. The control circuit 760 may track the pulses to determine the position of the knife 764. Other suitable position sensors, including, for example, proximity sensors, may be used. Other types of position sensors may provide other signals indicating the movement of the knife 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuit 760 can track the position of the knife 764 by summing the number and direction of steps that the motor 754 is instructed to perform. The position sensor 784 may be located in the end effector 752 or in any other part of the device.

[0189] In the implementation of a circular stapler, the transmission element 756 may be connected to the trocar to advance or retract the trocar, to the knife 764 to advance or retract the knife 764, or to the anvil 766 to advance or retract the anvil 766. These functions may be performed by a single motor using a suitable clutch mechanism, or by using separate motors, for example, as shown with reference to Figure 16. In one embodiment, the transmission element 756 is part of a closing system comprising a trocar 201904 and a trocar actuator 201906, as will be described in detail below herein with reference to Figures 19A to 19C. Thus, the control circuit 760 controls the motor control circuit 758 to control the motor 754 to advance or retract the trocar. Similarly, the motor 754 may be configured to advance or retract the knife 764 and to advance or retract the anvil 766. A torque sensor may be provided to measure the torque applied by the motor 754 shaft to the transmission component 756 used to move the trocar, knife 764, or anvil 766, or any combination thereof, forward and backward. The position sensor 784 may include various sensors for tracking the position of the trocar, knife 764, or anvil 766, or any combination thereof. Other sensors 788 may be used to measure various parameters, including the position or velocity of the trocar, knife 764, or anvil 766, or any combination thereof. The torque sensor, position sensor 784, and sensors 788 are connected to the control circuit 760 as inputs to various processes for controlling the operation of the surgical instrument 750 in a desired manner.

[0190] The control circuit 760 may communicate with one or more sensors 788. The sensor 788 may be positioned on the end effector 752 and may be adapted to work with the surgical instrument 750 to measure various derivation parameters such as time against gap distance, time against tissue compression, and time against anvil strain. The sensor 788 may include any other suitable sensor for measuring one or more parameters of the end effector 752, such as an inductive sensor such as a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an eddy current sensor, a resistance sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor. The sensor 788 may include one or more sensors. In one embodiment, the sensor 788 may be configured to determine the position of the trocar of a circular stapler.

[0191] One or more sensors 788 may include strain gauges, such as micro-strain gauges, configured to measure the magnitude of strain in the anvil 766 while it is clamped. The strain gauges provide an electrical signal whose amplitude varies with the magnitude of strain. Sensor 788 may also include pressure sensors configured to detect the pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. Sensor 788 may also be configured to detect the impedance of a portion of the tissue located between the anvil 766 and the staple cartridge 768, the impedance indicating the thickness and / or density of the tissue located between them.

[0192] Sensor 788 may be configured to measure the force exerted on the anvil 766 by the closing drive system. For example, one or more sensors 788 may be positioned at the interaction point between the closing tube and the anvil 766 to detect the closing force applied to the anvil 766 by the closing tube. The force exerted on the anvil 766 may represent the tissue compression experienced by a portion of the tissue trapped between the anvil 766 and the staple cartridge 768. One or more sensors 788 can be positioned at various interaction points along the closing drive system to detect the closing force applied to the anvil 766 by the closing drive system. One or more sensors 788 may be sampled in real time during the clamping operation by the processor of the control circuit 760. The control circuit 760 receives the real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the anvil 766 in real time.

[0193] A current sensor 786 can be used to measure the current drawn in by the motor 754. The force required to move the knife 764 forward corresponds to the current drawn in by the motor 754. The force is converted into a digital signal and supplied to the control circuit 760.

[0194] The control circuit 760 can be configured to simulate the actual system response of the instrument in the controller software. A displacement member can be actuated to move the knife 764 in the end effector 752 to a target speed or near it. The surgical instrument 750 may include a feedback controller, which may be any feedback controller, including but not limited to PID, state feedback, LQR, and / or adaptive controllers. The surgical instrument 750 may include a power supply to convert the signal from the feedback controller into a physical input, such as case voltage, PWM voltage, frequency-modulated voltage, current, torque, and / or force.

[0195] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or knife 764 by a brushed DC motor with a gearbox and mechanical connections to the articulation and / or knife system. Another example is the electric motor 754 that operates, for example, the displacement member and articulation driver of an interchangeable shaft assembly. External influences are unmeasured, unpredictable influences of tissue, surrounding bodies, and friction on the physical system. Such external influences may be referred to as interferences acting against the electric motor 754. External influences such as interferences can cause the operation of the physical system to deviate from the desired operation of the physical system.

[0196] Various exemplary embodiments relate to a surgical instrument 750 comprising an end effector 752 having motor-driven surgical stapling and cutting means. For example, a motor 754 may drive a displacement member distally and proximally along the longitudinal axis of the end effector 752. The end effector 752 may comprise a pivotable anvil 766 and, if configured for use, a staple cartridge 768 located opposite the anvil 766. A clinician can grasp tissue between the anvil 766 and the staple cartridge 768 as described herein. When the instrument 750 is ready to be used, the clinician can provide a firing signal, for example, by pressing the trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke start position to a stroke end position distal to the stroke start position. As the displacement member is translated distally, the knife 764, which has a cutting element positioned at its distal end, can cut the tissue between the staple cartridge 768 and the anvil 766.

[0197] In various embodiments, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as a knife 764, based on one or more tissue conditions. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a firing control program based on the tissue conditions. The firing control program can describe the distal motion of the displacement member. Different firing control programs can be selected to better treat different tissue conditions. For example, if thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a slower speed and / or with lower power. If thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a faster speed and / or with higher power.

[0198] In some examples, the control circuit 760 may first operate the motor 754 in an open-loop configuration for the first open-loop portion of the stroke of the displacement member. Based on the response of the instrument 750 during the open-loop portion of the stroke, the control circuit 760 may select a firing control program. The instrument response may include the translational distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy supplied to the motor 754 during the open-loop portion, and the sum of the pulse widths of the motor drive signals. After the open-loop portion, the control circuit 760 may implement the selected firing control program for the second portion of the stroke of the displacement member. For example, during the closed-loop portion of the stroke, the control circuit 760 may modulate the motor 754 in a closed-loop manner based on translational data describing the position of the displacement member, thereby translating the displacement member at a constant speed. Further details are disclosed in U.S. Patent Application No. 15 / 720,852, filed September 29, 2017, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," which is incorporated herein by reference in its entirety.

[0199] The surgical instrument 750 may be equipped with a wired or wireless communication circuit for communicating with a modular communication hub, as shown in Figures 1 to 6 and Figures 9 to 13. The surgical instrument 750 may also be an electric circular stapling device 201800 (Figure 18), 201000 (Figures 21 to 22).

[0200] Figure 18 shows an exemplary electric circular stapling device 201800. The device 201800 in this example comprises a stapling head assembly 201802, an anvil 201804, a shaft assembly 201806, a handle assembly 201808, and a rotary knob 201812. The stapling head assembly 201802 selectively connects with the anvil 201804. The stapling head assembly 201802 is operable to clamp tissue between the staple pocket and the staple-forming pocket of the anvil 201804. The stapling head assembly 201802 includes a cylindrical knife operable to cut the tissue trapped between the stapling head assembly 201802 and the anvil 201804. The staple-fastening head assembly 201802 drives staples through the tissue trapped between the staple-fastening head assembly 201802 and the anvil 201804. The staple-fastening device 201800 can be used to create a fixed anastomosis (e.g., end-to-end anastomosis) in the patient's gastrointestinal tract or other locations. The outer tubular member 201810 is connected to the actuator handle assembly 201808. The outer tubular member 201810 provides a mechanical ground between the staple-fastening head assembly 201802 and the handle assembly 201808.

[0201] The staple head assembly 201802 is operable to clamp, cut, and staple tissue in response to a single rotational input transmitted via the shaft assembly 201806. Thus, although the staple head assembly 201802 may include a translational clutch mechanism, a linearly translational actuation input through the shaft assembly 201806 is not required for the staple head assembly 201802. As merely an example, at least a portion of the staple head assembly 201802 may be constructed in accordance with at least a portion of the teachings of U.S. Patent Application No. 13 / 716,318, “Motor Driven Rotary Input Circular Stapler with Modular End Effector,” filed on 17 December 2012 and published on 19 June 2014 as U.S. Patent Application Publication No. 2014 / 0166728, whose disclosure is incorporated herein by reference in its entirety. Other preferred configurations of the staple head assembly 201802 will become apparent to those skilled in the art in light of the teachings herein.

[0202] The shaft assembly 201806 connects the handle assembly 201808 to the staple-fastening head assembly 201802. The shaft assembly 201806 includes a rotary driver actuator, which is a single actuation mechanism. Further details relating to the handle assembly 201808 and the rotary driver actuator are disclosed in U.S. Patent Application No. 16 / 182,229, filed November 6, 2018, entitled "Adjustment of Staple Height of At Least One Row of Staples Based on the Sensed Tissue Thickness or Force in Closing," which is incorporated herein by whole reference.

[0203] Next, referring to Figures 19A to 19C, in this embodiment, the instrument 201800 comprises a closure system and a firing system. The closure system comprises a trocar 201904, a trocar actuator 201906, and a rotary knob 201812 (Figure 18). As previously mentioned, the rotary knob 201812 may be connected to a motor to rotate the rotary knob 201812 in a clockwise or counterclockwise direction. The anvil 201804 may be connected to the distal end of the trocar 201904. The rotary knob 201812 translates the trocar 201904 longitudinally with respect to the staple-holding head assembly 201802, thereby enabling the anvil 201804 to translate and clamp tissue between the anvil 201804 and the staple-holding head assembly 201804 when the anvil 201804 is connected to the trocar 201904. The firing system comprises a trigger, a trigger actuation assembly, a driver actuator 201908, and a staple driver 201910. The staple driver 201910 includes cutting elements such as a knife 201912 configured to cut tissue when the staple driver 201910 is actuated longitudinally. In addition, when the staple driver 201910 is actuated longitudinally, the staple 201902 is positioned distal to one of the multiple staple driving members 201914 of the staple driver 201910 so that the staple driver 201910 also drives the staple 201902 distal to the staple fastening head assembly 201802. Therefore, when the staple driver 201910 is actuated via the driver actuator 201908, the knife member 201912 drives the staple 201902 into the tissue distal to the staple fastening head assembly 201802, while substantially simultaneously cutting the tissue 201916. Next, we will describe in more detail the components and functionality of the locking and launching systems.

[0204] As shown in Figures 19A to 19C, the anvil 201804 is selectively connectable to the instrument 201800 to provide a surface, against which the staple 201902 can be bent to staple the material contained between the staple-fastening head assembly 201802 and the anvil 201804. The anvil 201804 in this embodiment is selectively connectable to a trocar or pointed rod 201904 extending distally to the staple-fastening head assembly 201802. Referring to Figures 19A to 19C, the anvil 201804 is selectively connectable via the proximal shaft 201918 of the anvil 201904 through the coupling at the distal tip of the trocar 201904. Anvil 201804 comprises a generally circular anvil head 201920 and a proximal shaft 201918 extending proximal from the anvil head 201920. In the illustrated example, the proximal shaft 201918 includes a tubular member 201922 having an elastically biased retaining clip 201924 for selectively connecting anvil 201804 to trocar 201904, but this is merely optional, and it should be understood that other retaining mechanisms may be used to connect anvil 201804 to trocar 201904. For example, C-clips, clamps, threads, pins, adhesives, etc., may be used to connect anvil 201804 to trocar 201904. In addition, although the anvil 201804 is described as being selectively connectable to the trocar 201904, in some modifications, the proximal shaft 201918 may be provided with a unidirectional coupling mechanism so that, once the anvil 201804 is attached, it cannot be removed from the trocar 201904. Examples of unidirectional functions include a return, a unidirectional snap, a collet, a collar, a tab, a band, etc. Naturally, other configurations for connecting the anvil 201804 to the trocar 201904 will become apparent to those skilled in the art by considering the teachings herein. For example, the trocar 201904 may instead be a hollow shaft, and the proximal shaft 201918 may be provided with a pointed rod that can be inserted into this hollow shaft.

[0205] The anvil head 201920 in this example includes a plurality of staple-forming pockets 201936 formed on the proximal surface 201940 of the anvil head 201920. Therefore, as shown in Figure 19C, when the anvil 201804 is in the closed position and the staple 201902 is driven from the staple-fastening head assembly 201802 into the staple-forming pockets 201936, the legs 201938 of the staple 201902 are bent to form a completed staple.

[0206] In the case of anvil 201804 as a separate component, it should be understood that anvil 201804 may be inserted into and secured to a portion of tissue 201916 before being connected to the staple-fastening head assembly 201802. For illustrative purposes only, anvil 201804 may be inserted into and secured to the first tubular portion of tissue 201916, while instrument 201800 is inserted into and secured to the second tubular portion of tissue 201916. For example, the first tubular portion of tissue 201916 may be sutured to or around a portion of anvil 201804, and the second tubular portion of tissue 201916 may be sutured to or around trocar 201904.

[0207] As shown in Figure 19A, the anvil 201804 is then connected to the trocar 201904. In this example, the trocar 201904 is shown in its most distal working position. This extended position of the trocar 201904 provides a larger area to which the tissue 201916 can be connected before the anvil 201804 is attached. In addition, the extended position of the trocar 201904 makes it easier to attach the anvil 201804 to the trocar 201904. The trocar 201904 further comprises a tapered distal tip. Such a tip can puncture the tissue and / or assist in the insertion of the anvil 201804 into the trocar 201904, but the tapered distal tip is merely optional. For example, in other modifications, the trocar 201904 may have a blunt tip. In addition, or instead, the trocar 201904 may include a magnetic portion (not shown) that can attract the anvil 201804 toward the trocar 201904. Naturally, further configurations and arrangements of the anvil 201804 and the trocar 201904 will become apparent to those skilled in the art by considering the teachings herein.

[0208] When the anvil 201804 is connected to the trocar 201904, the distance between the proximal surface of the anvil 201804 and the distal surface of the staple head assembly 201802 defines the gap distance d. In this embodiment, the trocar 201904 is longitudinally translatable relative to the staple head assembly 201802 via an adjustment knob 201812 (Figure 18) located at the proximal end of the actuator handle assembly 201808 (Figure 18), as will be described in detail below. Consequently, when the anvil 201804 is connected to the trocar 201904, the gap distance d is expanded or contracted by rotating the adjustment knob 201812 by acting the anvil 201804 relative to the staple head assembly 201802. For example, as shown sequentially in Figures 19A and 19B, the anvil 201804 is shown to be actuated proximal to the actuator handle assembly 201808 from the initial open position to the closed position, thereby reducing the gap distance d and the distance between the two parts of the tissue 201916 to be joined. Once the gap distance d is within a predetermined range, the stapling head assembly 201802 is launched, as shown in Figure 19C, to staple and cut the tissue 201916 between the anvil 201804 and the stapling head assembly 201802. The stapling head assembly 201802 is operable to staple and cut the tissue 201916 by triggering the actuator handle assembly 201808, as will be described in more detail below.

[0209] Referring again to Figures 19A-19C, the user sutures a portion of tissue 201916 around the tubular member 201944 so that the anvil head 201920 is positioned within the portion of tissue 201916 to be stapled. Once tissue 201916 is mounted on the anvil 201804, the retaining clip 201924 and a portion of the tubular member 201922 protrude outward from tissue 201916 so that the user can connect the anvil 201804 to the trocar 201904. With tissue 201916 connected to the trocar 201904 and / or another portion of the staple head assembly 201802, the user mounts the anvil 201804 to the trocar 201904 and acts the anvil 201804 proximal toward the staple head assembly 201802 to reduce the gap distance d. Once the device 201800 is within its range of motion, the user then staples the ends of the tissue 201916 together, thereby forming a substantially continuous tubular portion of the tissue 201916.

[0210] An example of the present invention, a staple fastening head assembly 201802, comprises a slidable staple driver 201910 connected to the distal end of a shaft assembly 201806, and a tubular casing 201926 housing a plurality of staples 201902 contained within staple pockets 201928. The shaft assembly 201806 of this embodiment comprises an outer tubular member 201942 and a driver actuator 201908. The staples 201902 and staple pockets 201928 are arranged in a circular arrangement around the tubular casing 201926. In this embodiment, the staples 201902 and staple pockets 201928 are arranged as a pair of concentric circular rows consisting of staples 201902 and staple pockets 201928. The staple driver 201910 is operable to act longitudinally within the tubular casing 201926 in response to the rotation of the actuator handle assembly 201808 (Figure 18). As shown in Figures 19A–19C, the staple driver 201910 comprises a flared cylindrical member having a trocar opening 201930, a central recess 201932, and a plurality of members 201914 arranged circumferentially around the central recess 201932 and extending distally to the shaft assembly 201806. Each member 201914 is configured to contact and engage with a corresponding staple 201902 from a plurality of staples 201902 in the staple pocket 201928. Therefore, when the staple driver 201910 acts distally to the actuator handle assembly 201808, each member 201914 drives the corresponding staple 201902 out of its staple pocket 201928 through the staple hole 201934 formed at the distal end of the tubular casing 201926. Since each member 201914 extends from the staple driver 201910, multiple staples 201902 are driven from the staple fastening head assembly 201802 substantially simultaneously.When anvil 201804 is in the closed position, staple 201902 is driven into the staple-forming pocket 201936, bending the leg portion 201938 of staple 201902, thereby stapling the material located between anvil 201804 and staple-fastening head assembly 201808. Figure 20 shows, as an example, staple 201902 being driven into the staple-forming pocket 201928 of anvil 201804 by member 201914, bending the leg portion 201938.

[0211] Referring to Figures 18 to 21, the motorized circular stapling devices 201800, 201000 described herein may be controlled using any of the control circuits described in relation to Figures 7 to 8 and Figures 16 to 17. For example, the control system 470 described with reference to Figure 7. Furthermore, the motorized circular stapling devices 201800 may be used in hub and cloud environments, as described in relation to Figures 1 to 6 and Figures 9 to 13.

[0212] Figure 21 is a partial section view of an electric circular stapling device 201000 comprising a circular stapling head assembly 201002 and an anvil 201004, according to at least one aspect of the present disclosure. The electric circular stapling device 20100 is shown to clamp a first portion of tissue 201006 and a second portion of tissue 201008 between the anvil 201004 and the circular stapling head assembly 201002. The compression of tissues 201006 and 201008 between the anvil 201004 and the circular stapling head assembly 201002 is measured by a sensor 201018, such as a strain gauge. The circular staple fastening head assembly 201002 also includes a knife 201019, which can advance at different speeds after the inner row 201010 and outer row 201014 of staples have been launched and formed against the corresponding staple-forming pockets 201011, 201015 of the anvil 201004, to cut through the tissue 201006, 201008 clamped between the anvil 201004 and the circular staple fastening head assembly 201002.

[0213] Figure 22 is a partial top view of the circular staple fastening head assembly 201002 shown in Figure 21, showing a first row staple 201010 (inner staple) and a second row staple 201014 (outer staple) according to at least one aspect of the present disclosure. The inner row staple 201010 and the second row staple 201014 are independently operable by a first staple driver 201012 and a second staple driver 201016.

[0214] Referring here to Figures 21 and 22, when the tissues 201006 and 201008 are clamped between the anvil 201004 and the circular staple fastening head assembly 201002, a first gap δ1 is set to the inner row staple 201010 and a second gap δ2 is set to the outer row staple 201014. The nominal staple height in the center of the window is adjusted when the tissue compression increases or when the tissue gaps δ1 and δ2 decrease. The first staple driver 201012 drives the inner row staple 201010 through the tissues 201006 and 201008, and the inner row staple 201010 is formed against the anvil 201004. Subsequently, the second staple driver 201016 independently drives the outer row staples 201010 through the tissues 201006 and 201008, and the outer row staples 201014 are formed against the anvil 201004.

[0215] Independently operable staple rows 201010, 201014 may be formed based on the FTC clamped by anvil 201004 on the tissue 201006, 201008, or based on the tissue gaps δ1, δ2 between the anvil 201004 clamp and the circular staple-fastening head assembly 201002. Adjustment of the staple height of at least one row of staples based on the sensed tissue thickness or FTC focuses on adjusting the selection window based on the thickness / load when closing the tissue 201006, 201008. In other embodiments, the user-adjustable range of selectable staple heights may be changed based on the tissue load detected during the retraction operation of anvil 201004. When tissue compression (e.g., FTC) increases, or when the tissue gaps δ1, δ2 decrease, the nominal staple height in the center of the window may be adjusted as described herein with reference to Figure 23. In other embodiments, adjustments to the acceptable staple window range are indicated when compression increases or interstitial gaps decrease. In other embodiments, once tissue compression and subsequent tissue stabilization are complete, the acceptable range can be further adjusted based on the tissue creep rate and waiting time.

[0216] Figure 24 is a graph of a first pair of graphs 202000, 202020 illustrating time against the anvil gap and tissue compressive force F for exemplary firing of a staple fastener according to at least one aspect of the present disclosure. The tissue compressive force F may also be expressed as the closing force (FTC). The upper graph 202000 shows three distinct anvil gap curves 202002, 202004, and 202006 representing the closing of the anvil gap over time at three distinct tissue compressive forces, with the anvil gap δ shown along the vertical axis and time shown along the horizontal axis, as shown in the lower graph 202020. Anvil gap curves 202002, 202004, and 202006 represent the anvil closure of the motorized circular staple fastener 202080 (Figure 26) as a function of time t for variable tissue stiffness, constant thickness, and constant anvil gap δ, until the anvil gap δ is adjusted by a control algorithm. The control algorithm, implemented by any of the control circuits described herein with reference to Figures 7-8 and 16-17, can be configured to adjust the anvil gap according to a sensed tissue compressive force F compared to one or more different thresholds. Further details relating to the control circuits are disclosed in U.S. Patent Application No. 16 / 182,229, filed November 6, 2018, entitled ADJUSTMENT OF STAPLE HEIGHT OF AT LEAST ONE ROW OF STAPLES BASED ON THE SENSED TISSUE THICKNESS OR FORCE IN CLOSING, which is incorporated herein by reference in whole.

[0217] Briefly referring here to Figure 26, a schematic diagram of an electric circular stapling device 202080 is shown, according to at least one aspect of the present disclosure, showing the effective tissue gap δy, the actual gap δactual, the normal range gap δ2, and the out-of-range gap δ3. The electric circular stapling device 202080 comprises a circular stapler 202082 and an anvil 202084, the anvil 202084 retracting from an open position to a closed position to clamp the tissue between the anvil 201084 and the stapler 202082. When the anvil 202084 is fully clamped on the tissue, there is a defined gap δ between the anvil 202084 and the stapler 202082. When the circular stapler 202082 is fired (e.g., activated), stapling depends on the tissue gap δ. As shown in Figure 26, for a normal range gap δ2, staples 202088 are well formed. When the gap δ is too small, staples 202086 are formed too densely, and when the gap δ is too large, staples 202090 are formed too sparsely.

[0218] Returning to Figure 24 and referring to the upper and lower graphs 202000, 202020, and Figure 26, at time t0, anvil 201084 is initially open beyond the maximum anvil gap δmax before anvil 201084 reaches the initial tissue contact point 202008 at time t1. As shown in the figure, due to a constant tissue thickness, t1 is a common tissue contact point for tissues with variable tissue stiffness. At time t1, the anvil gap δ is still outside the ideal launch zone 202016, which is shown between the maximum anvil gap δmax defining the upper launch lockout threshold 202012 and the minimum anvil gap δmin 202014 defining the lower launch lockout threshold 202014. As anvil 201084 continues to close, the tissue compressive force F begins to increase from the initial tissue contact point 202008 at time t1. The tissue compressive force F will vary as a function of the biomechanical properties of the tissue in terms of stiffness. As shown in graph 202020 below, normally stiff tissues are represented by the first tissue compressive force curve 202022, highly stiff tissues are represented by the second tissue compressive force curve 202024, and low stiff tissues are represented by the third tissue compressive force curve 202026.

[0219] As anvil 201084 continues to close between the maximum anvil gap δmax and the minimum anvil gap δmin, the anvil gap δmin reaches a constant anvil gap point 202018 at time t2. As shown in graph 202020 below, at time t2, the tissue compressive force F for a tissue of normal stiffness, represented by the first tissue compressive force curve 202022, is within the range of the ideal launch zone 202036 defined between the maximum compressive force Fmax that defines the upper warning threshold 202032 and the minimum compressive force Fmin that defines the lower warning threshold 202034. At time t2, the tissue compressive force F for the highly rigid tissue represented by the second tissue compressive force curve 202024 exceeds the upper warning threshold 202032 outside the ideal launch zone 202036, while the tissue compressive force F for the low-rigidity tissue represented by the third tissue compressive force curve 202026 is below the lower warning threshold 202034 outside the ideal launch zone 202036.

[0220] From time t2 to time t3, the anvil 201084 is maintained at a constant gap δ, as shown in the upper graph 202000 by the three anvil gap curves 202002, 202004, and 202006. This period of the constant gap δ enables tissue creep, and as shown by the three tissue compression force curves 202022, 202024, and 202026 in the lower graph 202020, the average tissue compression force F slowly decreases during this tissue creep. Tissue creep is the stage that occurs after the average tissue compression force F reaches a predetermined threshold and the closing movement of the anvil 201084, so that the anvil 201084 and the stapler 202082 hold the tissue between them for a predetermined time before starting the firing stage where the tissue is grasped and the staples and knife are deployed. During the tissue creep stage, the average tissue compression force F decreases over the period between t2 and t3. The tissue tends to stretch when compressed, partly because it is composed of solid and liquid materials. One way to account for this property is "tissue creep". When the tissue is compressed, a certain amount of tissue creep can occur. Therefore, when the tissue is compressed, benefits can result from the appropriate time under certain circumstances to achieve tissue creep. One benefit can be proper staple formation. This can contribute to a consistent staple line. Therefore, a specific time can be given to enable tissue creep before firing.

[0221] Referring also to FIG. 17 here, after the period during which the anvil gap δ is maintained constant to allow tissue creep, at time t3, before deploying the staple, at point 202010, the control circuit 760 determines whether any possible adjustment of the anvil 766 (anvil 201804 and stapler 202084 of FIG. 26) with respect to the staple cartridge 764 is necessary. Thus, the control circuit 760 determines whether the tissue compression force F is within the ideal firing zone 202036, above the maximum compression force Fmax threshold 202032, or below the minimum compression force Fmin threshold 202034, and makes any necessary adjustment to the anvil gap δ. If the tissue compression force F is within the ideal firing zone 202036, the control circuit 760 deploys the staples within the staple cartridge 768 and deploys the knife 764.

[0222] If the tissue compression force F exceeds the maximum compression force Fmax threshold 202032, the control circuit 760 is configured to register a warning that the compression force is too strong and to adjust the anvil gap δ, increase the pre-firing waiting time, decrease the firing speed, or enable a firing lockout, or any combination thereof. The control circuit 760 can adjust the anvil gap δ by advancing the anvil 766 distally, for example, in a direction away from the staple cartridge 768 (anvil 201804 and stapler 202084 of FIG. 26), to increase the anvil gap δ as shown by the segment of the anvil gap curve 2002004 beyond time t3. After the control circuit 760 increases the anvil gap δ, the tissue compression force F decreases towards the ideal firing zone 202036 as shown by the segment of the tissue compression force curve 202024 beyond time t3.

[0223] If the tissue compressive force F falls below the minimum compressive force Fmin threshold 202034, the control circuit 760 is configured to register a warning that the compressive force is too weak and to adjust the anvil gap δ, proceed with caution, enable a launch lockout, or any combination thereof. The control circuit 760 is configured to adjust the anvil gap δ by retracting the anvil 766 proximal, for example toward the staple cartridge 768 (anvils 201804 and stapler 202084 in Figure 26), thereby reducing the anvil gap δ as shown by the segment of the anvil gap curve 2002006 beyond time t3, and after reducing the anvil gap δ as shown by the segment of the tissue compressive force curve 202026 beyond time t3, the tissue compressive force F increases toward the ideal launch zone 202036.

[0224] Proceeding to Figure 25, a second pair of graphs 202040, 202060 are shown, illustrating time against the anvil gap and tissue compressive force F for exemplary firing of a staple fastener according to at least one aspect of the present disclosure. Graph 202040 above shows three distinct anvil gap curves 202042, 202046, 202046 representing the closure of the anvil gap over time at three distinct tissue thicknesses, with the anvil gap δ shown along the vertical axis and time shown along the horizontal axis. The anvil gap curves 202042, 202044, 202046 represent the anvil closure of the motorized circular staple fastener 202080 (Figure 26) as a function of time t with respect to variable tissue thickness, constant stiffness, and a constant anvil gap δ until the anvil gap δ is adjusted by a control algorithm. A control algorithm implemented by any of the control circuits described herein, with reference to Figures 7-8 and 16-17, can be configured to adjust the anvil gap according to a sensed tissue compressive force F compared to one or more different thresholds.

[0225] Referring here to graphs 202040 above and 202060 below, and Figure 26, at time t1, when the tissue compressive force curve 202064 for thick tissue begins to increase, anvil 201084 first opens beyond the maximum anvil gap δmax at time t0, before anvil 201084 reaches the first tissue contact point 202048 for thick tissue. At time t1, the anvil gap δ is still outside the ideal launch zone 202056, which is defined between the maximum anvil gap δmax that defines the upper launch lockout threshold 202052 and the minimum anvil gap δmin that defines the lower launch lockout threshold 202054. As shown in the figure, due to constant tissue stiffness and variable tissue thickness, anvil 201084 contacts the tissue at different times. For example, time t1 is the first tissue contact point 202048 with respect to the thick tissue, time t2 is the second tissue contact point with respect to the tissue of normal thickness, and time t3 is the third tissue contact point 202058 with respect to the thin tissue.

[0226] The first tissue compressive force curve 202062 represents the compressive force for tissue of normal thickness, and begins to increase at time t2 when the normal-thickness tissue first comes into contact with anvil 201804. The second tissue compressive force curve 202064 represents thick tissue, and begins to increase at time t1 when the thick tissue first comes into contact with anvil 201804. The third tissue compressive force curve 202066 represents thin tissue, and begins to increase at time t3 when the thin tissue first comes into contact with anvil 201804. At the second and third tissue contact points at times t2 and t3, the anvil gap δ for normal and thin tissues lies within the ideal firing zones 202056 and 202076. The tissue compressive force F will vary as a function of the biomechanical properties of the tissue thickness. As shown in graph 202040 below, a normal thickness microstructure is represented by the first microstructure compressive force curve 202042, a thick microstructure is represented by the second microstructure compressive force curve 202044, and a low-rigidity microstructure is represented by the third microstructure compressive force curve 202066. From the initial microstructure contact point at times t1, t2, and t3, as the anvil 201084 continues to close, the microstructure compressive force for each curve 202062, 202064, and 2020066 begins to increase until time t4 when the anvil gap reaches a predetermined value, and remains constant between t4 and t5 until the stapler 202082 is ready to fire.

[0227] As anvil 201084 continues to close between the maximum anvil gap δmax and the minimum anvil gap δmin, the anvil gap δ reaches a point of constant anvil gap at time t4. As shown in graph 202060 below, at time t4, the tissue compressive force F for a tissue of normal thickness, represented by the first tissue compressive force curve 202062, is within the range of the ideal launch zone 202076 defined between the maximum compressive force Fmax that defines the upper warning threshold 202072 and the minimum compressive force Fmin that defines the lower warning threshold 202074. At time t4, the tissue compressive force F for thick tissue, represented by the second tissue compressive force curve 202064, exceeds the upper warning threshold 202072 outside the ideal launch zone 202076, while the tissue compressive force F for thin tissue, represented by the third tissue compressive force curve 202066, is below the lower warning threshold 202074 outside the ideal launch zone 202076.

[0228] From time t4 to time t5, anvil 201084 is maintained at a constant gap δ, as shown in graph 202040 above, by three anvil gap curves 202042, 202044, and 202046. This period of constant gap δ allows for tissue creep, during which the average tissue compressive force F slowly decreases, as shown by three tissue compressive force curves 202062, 202064, and 202066, as shown in graph 202060 below. Tissue creep is the stage entered after the average tissue compressive force F reaches a predetermined threshold and the closing motion of anvil 201084, so that anvil 201084 and stapler 202082 hold the tissue between them for a predetermined time, before initiating the launch phase in which the tissue is grasped and the staples and knives are deployed. During the tissue creep phase, the average tissue compressive force F decreases over the period between t2 and t3. Microstructures tend to stretch under compression, partly because they are composed of solid and liquid materials. One method that takes this property into account is "microstructure creep." When a microstructure is compressed, a certain amount of microstructure creep can occur. Therefore, when a microstructure is compressed, benefits can be obtained by allowing the right amount of time under specific circumstances to achieve microstructure creep. One benefit may be proper stapling, which can contribute to consistent stapling lines. Thus, a certain amount of time can be given to enable microstructure creep before firing.

[0229] Referring again to Figure 17, at time t5, after a period in which the anvil gap δ is kept constant to allow tissue creep, before deploying the staples, at point 202050, the control circuit 760 determines whether any possible adjustments to the anvil 766 (anvil 201804 and stapler 202084 in Figure 26) relative to the staple cartridge 764 are necessary. Thus, the control circuit 760 determines whether the tissue compressive force F is between the ideal launch zones 202076, above the maximum compressive force Fmax threshold 202072, or below the minimum compressive force Fmin threshold 202074, and makes any necessary adjustments to the anvil gap δ. If the tissue compressive force F is between the ideal launch zones 202076, the control circuit 760 deploys the staples in the staple cartridge 768 and deploys the knife 764.

[0230] If the tissue compressive force F exceeds the maximum compressive force Fmax threshold 202072, the control circuit 760 is configured to register a warning that the compressive force is too strong and to adjust the anvil gap δ, increase the pre-launch waiting time, decrease the launch rate, enable launch lockout, or any combination thereof. The control circuit 760 can adjust the anvil gap δ by advancing the anvil 766 distally, for example, away from the staple cartridge 768 (anvils 201804 and stapler 202084 in Figure 26), thereby increasing the anvil gap δ as shown by the segment of the anvil gap curve 2002044 beyond time t5. After the control circuit 760 has increased the anvil gap δ, the tissue compressive force F decreases towards the ideal launch zone 202076 as shown by the segment of the tissue compressive force curve 202064 beyond time t5.

[0231] If the tissue compressive force F falls below the minimum compressive force Fmin threshold 202074, the control circuit 760 is configured to register a warning that the compressive force is too weak and can adjust the anvil gap δ, proceed cautiously, enable a launch lockout, or any combination thereof. The control circuit 760 is configured to adjust the anvil gap by retracting the anvil 766 proximal, for example toward the staple cartridge 768 (anvils 201804 and stapler 202084 in Figure 26), thereby reducing the anvil gap δ as shown by the segment of the anvil gap curve 202046 beyond time t5. After reducing the anvil gap δ, the tissue compressive force F increases toward the ideal launch zone 202076 as shown by the segment of the tissue compressive force curve 202066 beyond time t5.

[0232] Referring to Figures 24 and 25, in one embodiment, the anvil gap δ may be determined by the controller 620 based on a reading from the closing motor 603, as illustrated with reference to Figure 8, for example. In one embodiment, the anvil gap δ may be determined by the control circuit 710 based on a reading from a position sensor 734 connected to the anvil 716, as illustrated with reference to Figure 16, for example. In one embodiment, the anvil gap δ may be determined by the control circuit 760 based on a reading from a position sensor 784 connected to the anvil 766, as illustrated with reference to Figure 17, for example.

[0233] Referring to Figures 24 and 25, in one embodiment, the tissue compressive force F may be determined by the controller 620 based on a reading from the closing motor 603, as described with reference to Figure 8. For example, the tissue compressive force F may also be determined based on the motor's draw current, with a higher draw current while the anvil is closing being associated with a higher tissue compressive force. In one embodiment, the tissue compressive force F may be determined by the control circuit 710 based on a reading from a sensor 738, such as a strain gauge connected to the anvil 716 or staple cartridge 718, as described with reference to Figure 16, for example. In one embodiment, the tissue compressive force F may be determined by the control circuit 760 based on a reading from a sensor 788, such as a strain gauge connected to the anvil 766, as described with reference to Figure 17, for example.

[0234] Figure 27 is a logic flowchart of process 202100 showing a control program or logic configuration for providing arbitrary or forced lockout according to a sensed parameter compared to a threshold, according to at least one aspect of the present disclosure. As shown in Figure 27, according to a comparison of a measured anvil gap against one or more thresholds and a measured tissue compressive force F (differently referred to as FTC) against one or more thresholds, the control algorithm can cause the instrument to fire indefinitely (e.g., activate), to perform an arbitrary lockout (e.g., provide a warning to the user), or to perform a forced lockout of the instrument.

[0235] Accordingly, referring to Figures 17, 26, and 27, process 202100 is described with reference to Figures 17 to 25. The control circuit 760 implements an algorithm to perform process 202100, in which the anvil 766 in Figure 17 is shown as the anvil 202084 in Figure 26, and the staple cartridge 768 in Figure 17 is shown as the stapler 202082 in Figure 26. Further details regarding the configuration and operation of the motorized circular stapling device 202080 are described herein with reference to Figures 18 to 20. Returning to process 202100, the control circuit 760 determines the anvil gap δ based on readings from the position sensor 784 coupled to the anvil 766, as described in relation to Figures 24 and 25. When the anvil gap δ is δ3 > δMax, the anvil gap is out of range, and the control circuit 760 engages a forced lockout 202104. When the anvil gap δ is δMaX > δ2 > δMin, the anvil gap δ is within the range, and the control circuit 760 determines the tissue compressive force F(FTC) as described with reference to Figure 29. As described above, the tissue compressive force may be determined by the control circuit 760 based on readings from strain gauge sensors 788 connected to anvil 766 or staple cartridge 768. Alternatively, the tissue compressive force may be determined based on the draw current by motor 754.

[0236] Referring to Figures 27 and 29, when the FTC is less than the ideal FTC threshold (X1 < ideal FTC), i.e., in zone A of Figure 29, the control circuit 760 performs an unlimited electronic lockout. When the FTC is between the maximum FTC threshold and the ideal FTC threshold (maximum > X2 > ideal), i.e., in zone B of Figure 29, the control circuit 760 performs an unlimited arbitrary electronic lockout. In one embodiment, under this condition, the control circuit 760 issues a warning in the form of a message or alert (auditory, visual, tactile, etc.). When the FTC is greater than the maximum FTC threshold (X3 > limit), i.e., in zone C of Figure 29, the control circuit performs an arbitrary electronic lockout with limitations. Under this condition, the control circuit 760 issues a warning in the form of a message or alert (auditory, visual, tactile, etc.) and applies a waiting period before firing. In various embodiments, the motorized circular stapling device 202080 includes an adjustable electronic lockout, as described herein, which can prevent the operation of the stapler or adjust the function of the motorized circular stapling device 202080 based on sensed conditions and secondary measurements.

[0237] In one embodiment, the control algorithm for the motorized circular stapling device 202080, described herein as process 202100, can be configured to initiate arbitrary lockouts and forced lockouts based on limit and requirement conditions for the operation of the motorized circular stapling device 202080. In one embodiment, process 202100 for the motorized circular stapling device 202080 can be configured to implement both arbitrary lockouts and forced lockouts based on sensed parameters in the system. An arbitrary lockout pauses the automatic execution of sequential processing, but may be disabled, for example, by user input. A forced lockout prevents the next sequential process, allowing the user to stop the process midway, for example, by clearing the lockout condition that triggered the lockout. In one embodiment, both arbitrary lockouts and forced lockouts may have both upper and lower thresholds. Thus, the motorized circular stapling device 202080 can include combinations of arbitrary lockouts and forced lockouts.

[0238] In one embodiment, the control algorithm for the motorized circular stapling device 202080, described herein as process 202100, may be configured to adjust an electronic lockout that can prevent the system from operating or adjust its function based on sensed conditions and secondary measurements. The sensed conditions may be FTC, anvil displacement, gap δ, or staple formation, and secondary measurements may be, for example, failure severity, user input, or a predetermined comparative lookup table.

[0239] In one embodiment, the response to a mandatory electronic lockout is to disable the function of the motorized circular stapling device 202080 until the situation is resolved. Conversely, the response to an optional lockout may be less pronounced. For example, an optional lockout could include a warning instruction, an alert requesting user consent to continue, a change in the speed or force of the activation or standby time, or the prohibition of a specific function until the situation is resolved or stabilized. During operation, essential conditions for the motorized circular stapling device 202080 could include, for example, having a fully seated anvil 202084 before clamping, or having staples loaded into the stapler cartridge before firing. A viable condition for the motorized circular stapling device 202080 could include, for example, being within an acceptable staple height with respect to a given tissue thickness or minimum tissue compression. Furthermore, various conditions could have the same parameters, for example, both an arbitrary level threshold and a mandatory level threshold for the power level in the battery pack.

[0240] In one embodiment, the motorized circular stapling device 202080 can be configured to implement various control mechanisms for preventing or adjusting the function of the motorized circular stapling device 202080 based on the lockout type. In one embodiment, the forced lockout is considered to be simply an electronic, mechanical interlock, or a combination of both. In various embodiments having two lockouts, the lockouts are considered to be redundant or to be used selectively based on the device settings. In one embodiment, the optional lockout may be an electronic lockout, which may be adjustable based on sensed parameters. For example, the optional lockout may be a mechanical interlock that is electronically disabled, or it may be simply an electronic lockout.

[0241] FIG. 28 is a diagram showing the range of anvil gaps and corresponding staple formation according to at least one aspect of the present disclosure. When anvil gap 202120 is between an upper limit 202126 and a lower limit 202128, staple formation is appropriate and within an acceptable range of staple height for a given range of tissue thickness or minimum tissue compression force. When anvil gap 202122 is greater than upper limit 202126, staple formation becomes loose. When anvil gap 202124 is less than lower limit 202128, staple formation becomes tight.

[0242] FIG. 29 is a graph 202150 of time versus three closing force (FTC) curves 202152, 202154, 202156 according to at least one aspect of the present disclosure. FTC curves 202152, 202154, 202156 are divided into three stages: clamp, standby, and fire. The clamp stage has a common starting point, which means that the tissue has a common thickness and variable tissue stiffness, as described in detail in FIG. 24. At the end of the clamp stage, there is a standby period before starting the fire stage, taking into account tissue creep.

[0243] The first FTC curve 202152 corresponds to tissue having low tissue stiffness. During the clamp stage, the FTC curve 202152 shows an increase in tissue compression force with a peak below the ideal FTC threshold 202158 in zone A. At the end of the clamp stage, the electric circular stapling device 202080 (FIG. 26) waits for a user control period 202162 before starting the fire stage, taking into account tissue creep.

[0244] The second FTC curve 202154 corresponds to tissue having normal tissue stiffness. During the clamp stage, the FTC curve 202154 shows an increase in tissue compression force with a peak between the ideal FTC threshold 202158 and the maximum FTC threshold 202160 in zone B. At the end of the clamp stage, the electric circular stapling device 202080 (FIG. 26) waits for a user control period 202164 before starting the fire stage, taking into account tissue creep.

[0245] The third FTC curve 202154 corresponds to a tissue with high tissue rigidity. During the clamping phase, the FTC curve 202156 shows an increase in tissue compressive force with a peak in zone C that exceeds the maximum FTC threshold 202160. At the end of the clamping phase, the motorized circular stapling device 202080 (Figure 26) controls a waiting period 202166 before initiating the firing phase, taking tissue creep into account.

[0246] Figure 30 is a detailed graph of time relative to the FTC curve 202172, according to at least one aspect of the present disclosure. As shown, the FTC curve 202172 is divided into three phases: a clamp phase, a standby phase, and a launch phase. During the clamp phase, the FTC curve 202172 exhibits and increases tissue compressive force, as indicated by segment 202174 of the clamp phase. After the clamp phase, there is a standby phase 202176 before the launch phase begins. The standby phase 202176 may be controlled by either the user or the device, depending on the value of the tissue compressive force relative to the ideal compressive force threshold and the maximum compressive force threshold. During the launch phase, the tissue compressive force increases and then decreases, as indicated by segment 202178 of the FTC curve.

[0247] In various embodiments, the closing speed and / or direction of a circular stapler, or a combination thereof, can be adjusted relative to the fully mounted state of the anvil based on the sensed mounting. In one embodiment, the Disclosure provides a digitally enabled circular stapler algorithm for determining a change in the closing speed of the anvil at a key location on the trocar to ensure that the anvil is properly seated on the trocar. Figure 31 is Figure 201500 of the motorized stapling device 201502 and Graph 201504, showing the adjustment of the closing speed of the anvil portion 201514 of the motorized stapling device 201502 at a specific key point along the retraction stroke of the trocar 201510, according to at least one embodiment of the Disclosure. The motorized stapling device 201502 is similar to the motorized circular stapling device 201800 described herein with reference to Figures 18-20, and may be controlled using any of the control circuits described in relation to Figures 7-8 and 16-17, and may be used in hub and cloud environments as described in relation to Figures 1-6 and 9-13. The anvil 201514 includes an anvil head 201515 and an anvil shank 201517. The trocar 201510 can be advanced and retracted in the direction indicated by arrow 201516. In one embodiment, when the trocar 201510 is partially but not fully seated on the anvil 201514, the closing speed of the anvil 210514 can be adjusted at a specific key point along the retraction stroke of the trocar 201510 to improve the final seating of the anvil 201514 on the trocar 201510.

[0248] The motorized stapling device 201502, shown on the left side of Figure 31, includes a circular stapling head assembly 201506 having a seating collar 201508 that receives a trocar 201510 through its interior. The trocar 201510 engages with an anvil 201514 via a locking feature 201512. The trocar 201510 is movable in the direction indicated by the arrow 201516, for example, forward and backward. A cutting element, such as a knife 201519, cuts the tissue when the circular stapling head assembly 201506 is driven toward the anvil 201514. In one embodiment, the closing speed of the anvil 201514 can be adjusted at specific key points along the retraction stroke of the anvil 201510 to improve the final seating of the anvil 201514 on the trocar 210510, for example, when the trocar 210510 is only partially seated on the anvil 201514 but not fully seated. Thus, the closing speed of the anvil 201514 can be varied at key points to ensure proper seating. The position or displacement of the trocar 210510 as it moves forward or backward by a motor-coupled trocar actuator can be detected by a plurality of proximity sensors arranged along the displacement path of the trocar 210510. In some embodiments, the position or displacement of the trocar 210510 may be tracked using a tracking system 480 (Figure 7) or position sensors 734, 784 (Figures 16, 17).

[0249] On the right side of Figure 31, Graph 201504 shows the closing rate of anvil 201514 as a function of the position of trocar 201510 at specific key points labeled “δ trocar” along the vertical axis and “V closure mm / sec” along the horizontal axis, according to at least one aspect of the present disclosure. The anvil 201514 closing rate profile curve 201505 is plotted as a function of the position of trocar 201510. The closing rate of anvil 201514 may be slowed in a first zone 201518 to ensure proper mounting of trocar 210510 to anvil 201514, faster in a second zone 201520 during closure, slowed again in a third zone 201522 to confirm mounting, and then slowed further in a fourth zone 201524 during application of high closing load.

[0250] The adjustment of the closing speed of the anvil 201514 at specific key points along the retraction stroke of the trocar 201510 improves the final seating of the anvil 201514 on the trocar 201510 when the trocar is only partially seated but not fully seated. At position δ0 of the trocar 201510, the anvil 201514 is in the fully open position 201521, and at position δ4 of the trocar 201510, the anvil 201514 is in the fully closed position 201523. Between the fully open position 201521δ0 and the fully closed position δ4 of the trocar 201510, the closing speed of the anvil 201514 is adjusted based on the position of the trocar 201510. For example, in the first zone 201518, when the trocar 201510 moves from the fully open position 201521 δ0 to position δ1 of the first trocar 201510, the closing speed of the anvil 201514 is slow (between 0 and 2 mm / sec) to ensure proper attachment of the anvil 201514 to the trocar 201510. In the second zone 201520, when the trocar 201510 moves from δ1 to δ2, the anvil 201514 closes at a constant rapid closing speed (3 mm / sec). In the third zone 201522, when the trocar 201510 moves from position δ2 to position δ3, the closing speed of the anvil 201514 is slowed to ensure complete attachment of the anvil 201514 to the trocar 201510. Finally, when trocar 201510 moves from position δ3 to δ4 in the fourth zone 201524, the closing rate of anvil 201514 slows down again during high closing load.

[0251] Figure 32 is a logic flow diagram of process 201700, showing a control program or logic configuration for adjusting the closing speed of an anvil 201514 portion of an electric stapling device 201502 at a specific key point along the retraction stroke of a trocar 201510, according to at least one aspect of this disclosure. This process 201700 may be carried out in conjunction with any of the control circuits described with reference to Figures 7-8 and 16-17. This process 201700 may be carried out in a hub or cloud computing environment, for example, as described with reference to Figures 1-6 and 9-13.

[0252] Specifically, process 201700 shown in Figure 32 will be described with reference to the control circuit 760 in Figure 17. The control circuit 760 determines the position of the trocar 201510 based on information received from the position sensor 784. Alternatively, the position of the trocar 201510 may be determined based on information received from sensor 788, a timer / counter circuit 781, or a combination thereof. Based on the position of the trocar 201510, the control circuit 760 controls the closing rate (Vclosure mm / sec) of the anvil 201514 as a function of the position of the trocar 201510 at a particular key point, according to at least one aspect of this disclosure. Therefore, when the position of trocar 201510 is within the first zone 201518, to which anvil 201514 is attached, process 201700 continues along the yes (Y) branch, and control circuit 760 sets the closing speed of anvil 201514 to slow 201704 to ensure proper attachment of trocar 210510 to anvil 201514. Alternatively, process 201700 continues along the no (N) branch. When the position of trocar 201510 is within the second zone 201520, referred to as the rapid overall closing zone, process 201700 continues along the yes (Y) branch, and control circuit 760 sets the closing speed of anvil 201514 to fast 201706 to rapidly close anvil 201514. Alternatively, process 201700 continues along the No (N) branch. When the position of trocar 201510 is within a third zone 201522, referred to as the confirmation zone, the process continues along the Yes (Y) branch, and the control circuit 760 sets the closing speed of anvil 201514 to a slower speed than the previous confirmation zone 201522 during the application of the high closing load. Alternatively, process 201700 continues along the No (N) branch. When the position of trocar 201510 is within a fourth zone 201524, referred to as the high closing load zone, process 201700 continues along the Yes (Y) branch, and the control circuit 760 sets the closing speed of anvil 201514 to a slower speed than the previous confirmation zone 201522 during the application of the high closing load.Once the anvil 201514 completely closes the trocar 201510 and traps the tissue between them, the control circuit 760 activates the knife 201519 to cut the tissue.

[0253] In one embodiment, the Disclosure provides a digitally possible circular stapler adaptive algorithm for determining multi-directional seating motion on a trocar to properly seat an anvil. Figure 33 is Figure 201530 of a motorized stapling device 201532 and graph 201534, illustrating the detection of closing speeds of a trocar 201540 and an anvil 201544 according to at least one embodiment of the Disclosure. The motorized stapling device 201532 is similar to the motorized circular stapling device 201800 described herein with reference to Figures 18-21, and may be controlled using any of the control circuits described in relation to Figures 7-8 and 16-17, and may be used in hub and cloud environments as described in relation to Figures 1-6 and 9-13. The anvil 201544 includes an anvil head 201545 and an anvil shank 201547. The trocar 201540 can move forward and backward in the direction indicated by arrow 201546. In one embodiment, if loose tension is detected in the anvil shank 201547 from the trocar 201540, the motorized stapling device 210530 may stop retracting or move backward or backward towards the open position 201541 until the seating instability of the anvil 201544 is resolved. If the anvil 201544 is completely detached, the motorized stapling device 210530 may fully open 201541, indicating to the user that it will attempt to reattach the anvil shank 201547 to the trocar 201540.

[0254] The motorized stapling device 201532, shown on the left side of Figure 33, includes a circular stapling head assembly 201536 having a seating collar 201538 that receives through a trocar 201540. The trocar 201540 engages with an anvil 201544 via a locking feature 201542. The trocar 201540 is movable in the direction indicated by the arrow 201546, for example, forward and backward. A cutting element, such as a knife 201548, cuts the tissue when the circular stapling head assembly 201536 is driven toward the anvil 201544.

[0255] In one embodiment, the closing speeds of the trocar 201540 and the anvil 201544 can be detected, and any mismatch between the closing speeds of the two components may cause the trocar 201540 to automatically extend, and then retract to fully seat the anvil 201544 on the trocar 201540. In one embodiment, any mismatch between the closing speeds of the trocar 201540 and the anvil 201544 may be provided to a control circuit or processor to operate a motor coupled to the trocar 201540 to automatically extend, and then retract to fully seat the anvil 201544 on the trocar 201540. If the anvil shank 201547 detects loose tension from the trocar 201540, the smart motorized staple fastener 201532 may be configured to stop retracting or, conversely, move forward towards the open position until the instability causing the anvil 201544 to seat is resolved. If the anvil 201544 is completely detached, it may be fully opened, indicating to the user that an attempt will be made to reattach the anvil shank 201547 to the trocar 201540. If detachment of the anvil 201544 is detected before the attachment of the anvil 201544 is reconfirmed, as shown in Figure 33, the control algorithm is configured to return the trocar 201540 towards the open position 201541 to reset the anvil 201544, and once it is confirmed that the anvil 201544 is attached, it can proceed as normal.

[0256] Therefore, the system may be configured for multi-directional seating motion on the trocar 201540 in order to properly seat the anvil 201544. For example, if the anvil shank 201547 detects loose tension from the trocar 201540, the smart motorized stapler 201530 may be configured to stop retracting or, conversely, to move forward in the open direction until the instability causing the anvil 201544 to seat is resolved. If the anvil 201544 is completely detached, the smart motorized stapler 201532 may be configured to fully release the anvil shank 201547, instructing the user to attempt to reattach it to the trocar 201540.

[0257] On the right side of Figure 33, Graph 201534 shows the position of Trocar 201510 as a function of time at a specific key point, labeled “δ Trocar” along the vertical axis and “t” along the horizontal axis, according to at least one aspect of the present disclosure. The Trocar 201540 position profile curve 201549 is plotted as a function of time (t). Referring to the Trocar 201540 position profile curve 201549, Trocar 201540 moves from a fully open position 201541 towards a fully closed position 201543 over a first period 201556 at a rapid closing rate. During the second period 201558, the trocar 201540 moves slowly to the confirmation zone 201547 where the anvil lock feature 201542 engages with the seating collar 201538, to confirm that the anvil lock feature 201542 has properly engaged with the seating collar 201538. In the shown embodiment, the start of detachment of the anvil 201544 is sensed at time 201552. Upon sensing that the anvil 201544 has been detached, the trocar 201540 moves forward toward the open position and returns over the third period 201560. The trocar 201540 then moves slowly over the fourth period 201562 until the anvil 201544 is confirmed or verified to be attached to the trocar 201540 at time 201554. Subsequently, the trocar 201540 moves very slowly towards the closed position 201543 during a fifth period 201564 under a high tissue load, before the knife 201548 advances to cut the tissue trapped between the anvil 201544 and the circular staple-fastened head assembly 201536.

[0258] Figure 34 is a logic flow diagram of process 201720, which shows a control program or logic configuration for detecting multidirectional seating motion on trocar 201540 to drive anvil 201544 to proper seating, according to at least one aspect of this disclosure. Process 201720 may be carried out using any control circuit described herein with reference to Figures 7-8 and 16-17. Process 201720 may be carried out in a hub or cloud computing environment, for example, as described with reference to Figures 1-6 and 9-13.

[0259] Specifically, the process shown in Figure 34 will be described with reference to the control circuit 760 in Figure 17. The control circuit 760 determines the closing speed of the trocar 201540 based on the information received from the position sensor 784. The control circuit 760 then determines the closing speed of the anvil 201544 based on the information received from the position sensor 784. Alternatively, the closing speed of the trocar 201540 or the anvil 201544 may be determined based on information received from the sensor 788 or the timer / counter 781 circuit or a combination thereof. The control circuit 760 compares the closing speeds of the trocar 201540 and the anvil 201544. If there is no mismatch between the closing speeds of trocar 201540 and anvil 201544, process 201720 continues along the no (N) branch and loops until a mismatch exists between the closing speeds of trocar 201540 and anvil 201544. When a mismatch exists between the closing speeds of trocar 201540 and anvil 201544, process 201720 continues along the yes (Y) branch, and control circuit 760 extends and retracts trocar 201540 207128 and resets anvil 201544. Process 201720 then verifies the mounting of trocar 201540 and anvil 201544 201130. If attachment is confirmed, process 201720 continues along the yes (Y) branch, and control circuit 760 slows down the closing speed of the trocar 201540 under tissue load 207132. If attachment is not confirmed, process 201720 continues along the no (N) branch and loops until attachment of the trocar 201540 to the anvil 201544 is confirmed. Once the anvil 201544 is fully closed on the trocar 201540 and the tissue is trapped between them, control circuit 760 activates the knife 201548 to cut the tissue.

[0260] In various embodiments, the knife speed of a circular stapler and endpoints can be adjusted based on the sensed toughness or thickness of the tissue between the anvil and the cartridge. Therefore, a circular stapler control algorithm may be configured to detect tissue gaps and firing force in order to adjust the knife stroke and speed. In one embodiment, the Disclosure provides a digitally capable circular stapler adaptive algorithm for detecting tissue gaps and firing force in order to adjust the knife stroke and knife speed, according to at least one embodiment of the Disclosure.

[0261] Generally, Figures 35–37 represent a circular motorized stapling device 201610 according to at least one aspect of the present disclosure, and a series of graphs showing the force closing the clamp (FTC) relative to the position (δAnvil) of the anvil 201612, the velocity (VK) of the knife 201616 relative to the position (δKnife) of the knife 201616, and the force (FK) of the knife 201616. Using data sensed at different points along the length of the shank 201621, a control algorithm can generate a map of the interstitial gap or reaction force vector of the anvil 201612, monitoring the high or low side when compressed on the tissue. At firing, the system measures the force acting on the compression element 201620, including a force sensor, and adjusts it to act evenly along the force vector of the shank to provide a uniform and complete cut.

[0262] Specifically, Figure 35 is a partial schematic diagram of a circular motorized stapling device 201610 according to at least one aspect of the present disclosure, showing the closing portion of an anvil 201612 on the left and the operating knife 201616 on the right. The circular motorized stapling device 201610 comprises an anvil 201612 that is movable from a fully open position δA2 to a fully closed position δA0. An intermediate position δA1 represents the point where the anvil 201612 contacts the tissue located between the anvil 201612 and the circular stapler 201614. One or more position sensors located along the length of the anvil shank 201621 monitor the position of the anvil 201612. In one aspect, the position sensors may be located within a seating collar 201618. The compression element 201620 may be equipped with force sensors, such as strain gauges, to monitor the force applied to the tissue and detect the initial contact of the anvil 201612 with the tissue, as shown at the intermediate position δA1. The position and force sensors interface with one of the control circuits described herein with reference to Figures 7-8 and 16-17, for example, to implement a circular stapler control algorithm. The circular electric stapler 201610 also includes a movable cutting element, such as a knife 201616, which is movable from a fully retracted position δA0 to a fully extended position δA2 to achieve complete tissue cutting. The intermediate position δA1 of the knife 201616 represents the point at which the knife 201616 contacts the compression element 201620, which is equipped with strain gauges or other contact or proximity sensors.

[0263] The power stapling device 201610 includes a motor, sensors, and a control circuit, as described herein in relation to Figures 7-8 and 16-20. The motor is controlled by the control circuit to move the anvil 201612 and the knife 201616. One or more position sensors located on the power stapling device 201610 provide the control circuit with the positions of the anvil 201612 and the knife 201616. Additional sensors, such as force sensors 201620, also provide the control circuit with the tissue contacts and forces acting on the anvil 201612 and the knife 201616. The control circuit uses the position of the anvil 201612, the position of the knife 201616, the initial tissue contacts, or forces acting on the anvil 201612 or the knife 201616 to implement the circular stapler control algorithm described below in relation to Figure 38.

[0264] Figure 36 is a graph of the displacement of the anvil 201612 (δAnvil) along the vertical axis as a function of the force (FTC) closing the clamp along the horizontal axis, according to at least one aspect of this disclosure. The vertical line represents the FTC threshold 201606, which indicates tissue toughness. To the left of the FTC threshold 201606 represents tissue with normal toughness, and to the right of the FTC threshold 201606 represents tissue with high toughness. When the anvil 201612 is retracted from the fully open position δA2 to the intermediate position δA1 where the anvil 201612 first contacts the tissue, the FTC is substantially low (about 0). If the anvil 201612 continues to close from the position δA0, where it has fully retracted beyond this point toward the circular stapler 201614, to a position minus the thickness of the compressed tissue, the FTC becomes nonlinear. Each tissue type from normal to high toughness will produce a different FTC curve. For example, the first FTC curve 201604, shown by the dashed line, ranges from approximately 0 to approximately 100 lbs, with the maximum FTC below the FTC threshold 201606. The second FTC curve 201602, shown by the solid line, ranges from approximately 0 to approximately 200 lbs, with the maximum FTC exceeding the FTC threshold 201606. As previously discussed, the FTC is measured by a force sensor located within the compression element 201620 and connected to the control circuit.

[0265] Figure 37 is a graph of the displacement of the knife 201616 (δKnife) along the vertical axis, on the left as a function of the knife 201616 velocity (VK mm / sec) along the horizontal axis, and on the right as a function of the knife 201616 force (FK lbs) along the horizontal axis, according to at least one aspect of this disclosure. The left side is a graph of the displacement of the knife 201616 (δKnife) along the vertical axis, on the left as a function of the knife 201616 velocity (VK mm / sec) along the horizontal axis, on the right as a function of the knife 201616 force (FK lbs) along the vertical axis, on the right as a graph of the displacement of the knife 201616 (δKnife) along the vertical axis, on the right as a function of the knife 201616 force (FK lbs) along the horizontal axis, on the right as a graph of the displacement of the knife 201616 (δKnife) along the vertical axis, on the left as a function of the knife 201616 velocity (VK mm / sec) along the horizontal function of the knife 201616 velocity (FK lbs) along the horizontal axis, on the right as a graph of the displacement of the knife 201616 (δKnife) along the vertical axis, on the left as a function of the knife 201616 velocity (VK mm / sec) along the horizontal axis In graph representations 201632 and 201634, the dashed curves 201638 and 20142 represent normal tough tissue, while the solid curves 201636 and 201640 represent tough tissue.

[0266] As shown by the knife speed profile of normal tissue 201638, and referring to the graph figure 201632 on the left for normal tissue toughness, the initial speed of knife 201616 for normal tissue toughness starts at a first speed of just over 4 mm / second at the initial knife position δK0, for example. Knife 201616 maintains that speed until it reaches knife position δK1, at which point knife 201616 makes contact with the tissue and completes the cut, and knife 201616 slows down as it cuts through the tissue until it reaches knife position δK2, indicating that the control circuit stops the motor and therefore stops knife 201616. As shown by the knife force curve of normal tissue 201642, and referring to the graph 201634 on the right for normal tissue toughness, the force acting on knife 201616 is 0 lbs at the initial knife position δK0 and changes nonlinearly until knife 201616 reaches knife position δK2, where the cut is completed.

[0267] As shown by the knife velocity profile 201636 for thick tissue, and referring to graph 201632 on the left for high tissue toughness, the initial velocity of knife 201616 for high tissue toughness starts at a second velocity, for example, just over 3 mm / sec, which is lower than the first velocity at the initial knife position δK0 and below the initial velocity for normal tissue toughness. Knife 201616 maintains its velocity until it reaches the knife position δK1 where knife 201616 makes contact with the tissue. At this point, the velocity of knife 201616 begins to decelerate nonlinearly as it cuts through the tissue due to the short displacement of knife 201616. The control circuit detects when the knife 201616 has made contact with the tissue and, in response, increases the motor speed to increase the speed of the knife 201616 to, for example, its initial speed, until the knife 201616 reaches position δ, which indicates that the cutting is complete and the control circuit will stop the motor and therefore the knife 201616 will stop. This is shown as a speed spike 201644 that improves the cutting of tough tissue. Referring to graph figure 201634 on the right for high tissue toughness, as shown by the knife force curve 201640 for thick tissue, the force acting on the knife 201616 is 0 lbs at the initial knife position δK0 and changes nonlinearly until the knife 201616 reaches knife position δK2, where the cutting is complete. A comparison of normal and high tissue knife force curves 201640 and 201642 shows that, by adding a velocity spike 201644 immediately after tissue contact with the knife 201616 at a lower velocity, the knife 201616 experiences lower forces when cutting high-toughness tissue than it does when cutting normal-toughness tissue.

[0268] Figure 38 is a logic flow diagram of process 201720, which shows a control program or logic configuration for detecting tissue gaps and firing force to adjust knife stroke and velocity, according to at least one aspect of this disclosure. Process 201750 may be carried out in conjunction with any of the control circuits described with reference to Figures 7-8 and 16-17. Process 201750 may be carried out in a hub or cloud computing environment, for example, as described with reference to Figures 1-6 and 9-13.

[0269] Specifically, the process 201750 shown in Figure 38 will be described with reference to the control circuit 760 in Figure 17 and the circular motorized stapling device 201610 shown in Figures 35-37. The control circuit 760 monitors the displacement of the anvil 201612 based on position feedback received from the position sensor 784. As previously considered, in one embodiment, the position sensor 784 may be embedded in the shank 201612 of the anvil 201612. When the anvil 201612 is displaced, the control circuit 760 monitors the contact between the anvil 201612 and the tissue positioned between the anvil 201612 and the circular stapler 201614. In one embodiment, tissue contact may be provided by a force sensor embedded in a compression element 201620. The force sensor is represented as the sensor element 788 of the surgical instrument 790 shown in Figure 17. Force sensor 788 is used to monitor the clamp closing force (FTC), which is the closing force of the anvil 201612 onto the tissue positioned between the anvil 201612 and the circular stapler 201614. Control circuit 760 compares the FTC to a predetermined threshold. When the FTC is below the predetermined threshold, control circuit 760 sets the speed of motor 754 to advance the knife 201616 using a normal tissue toughness velocity profile, as shown in Figure 37. When the FTC is above the predetermined threshold, control circuit 760 sets the speed of motor 754 to advance the knife 201616 using a high tissue toughness velocity profile, as shown in Figure 37, with a velocity spike.

[0270] Figure 39 is a logic flow diagram of process 201762, showing a control program or logic configuration for advancing a knife 201616 under a high tissue toughness velocity profile 201636 having velocity spikes 201644 as shown in Figure 37, according to at least one aspect of this disclosure. This process 201762 may be carried out in conjunction with any of the control circuits described with reference to Figures 7-8 and 16-17. This process 201750 may be carried out in a hub or cloud computing environment, for example, as described with reference to Figures 1-6 and 9-13.

[0271] Specifically, the process 201762 shown in Figure 39 will be described with reference to the control circuit 760 in Figure 17 and the circular electric stapling device 201610 shown in Figures 35-37. When high tissue toughness is detected, the control circuit 760 sets the initial speed of the knife 201616 to a lower knife speed than the knife speed used to cut normal tissue toughness 201770. In one embodiment, a slower knife speed in a high tissue toughness state promotes better cutting. The control circuit 760 monitors when the knife 201616 makes contact with the tissue 201772. As previously considered, tissue contact may be detected by a force sensor embedded in the compression element 201620. As shown in Figure 37, when the knife 201616 makes contact with the tissue, the knife 201616 decelerates naturally. Therefore, when the control circuit 760 detects that the knife 201616 has come into contact with tissue, the control circuit 760 increases the speed of the motor 754 to increase the speed of the knife 201616 cutting through the tissue. The control circuit 760 monitors for completion of the cut and maintains the speed of the motor 740 until completion of the cut is detected, and then stops the motor 740.

[0272] Referring to Figures 40-44, not only the quantity and location of tissue, but also its properties, type, or condition can affect the outcome of stapling. For example, irregular tissue distribution is also evident in situations involving stapling pre-stapled tissue, such as end-to-end anastomosis. If the positioning and distribution of pre-stapled tissue within the end effector of the staple cartridge are insufficient, the pre-fired staple lines may concentrate in one zone rather than another within the end effector, which negatively impacts the outcome of such procedures.

[0273] Aspects of this disclosure present a surgical stapling device, including an end effector configured to staple tissue clamped between a first jaw and a second jaw of the end effector. In one aspect, the positioning and orientation of pre-stapled tissue within the end effector is determined by measuring and comparing tissue impedance in several predetermined zones within the end effector. In various aspects, tissue impedance measurements can be used to identify overlapping layers of tissue and their positions within the end effector.

[0274] Figures 40 and 42 show the end effector 25500 of a circular stapler, which includes a staple cartridge 25502 and an anvil 25504, configured to grip tissue between them. The staple cavity 25505 of the anvil 25504 and staple cartridge 25502 has been removed from Figure 40 to highlight other features of the end effector 25500. The staple cartridge 25502 includes four predetermined zones (zone 1, zone 2, zone 3, zone 4) defined by sensing circuits (S1, S2, S3, S4) in accordance with this disclosure.

[0275] Figure 41 shows another end effector 25510 of a circular stapler, including a staple cartridge 25512 and an anvil configured to grasp tissue between them. The staple cavities of the anvil and staple cartridge 25512 have been removed to highlight other features of the end effector 25510. The staple cartridge 25512 includes eight predetermined zones (zones 1 to 8) defined by sensing circuits (S1 to S8) according to this disclosure. The zones defined in each of the circular staplers in Figures 40 and 41 are of equal or at least substantially equal size and are arranged circumferentially around a longitudinal axis extending longitudinally through the shaft of the circular stapler.

[0276] As described above, pre-stapled tissue is tissue that contains staples that have been pre-placed within it. Circular staplers are often used to staple pre-stapled tissue to other pre-stapled tissue, as illustrated in Figure 42 (for example, end-to-end anastomosis).

[0277] Typically, staples have different conductivity than tissue, and therefore the presence of staples within tissue affects tissue impedance. This disclosure presents various tools and techniques for monitoring and comparing tissue impedance in a given zone of a circular stapler's end effector (e.g., end effectors 25500, 25510) to determine the optimal positioning and orientation of pre-stapled tissue relative to the end effector.

[0278] The left-hand embodiment of Figure 42 shows pre-stapled tissue appropriately positioned and oriented within a predetermined zone of a circular stapler. The pre-stapled tissue extends appropriately through the center of the staple cartridge 25502 and intersects the predetermined zone only once. The lower left side of Figure 42 shows the staples 25508 of the staple cartridge 25502 deployed within the appropriately positioned and oriented pre-stapled tissue.

[0279] The right-hand embodiment of Figure 42 shows a pre-stapled tissue that is poorly positioned and oriented. The pre-stapled tissue is off-center or overlapping in one or more predetermined zones. The lower right side of Figure 42 shows staples 25508 of staple cartridge 25502 deployed within the poorly positioned and oriented pre-stapled tissue.

[0280] As used in relation to Figures 40 to 44, the staples may include, but are not limited to, multiple rows of staggered staples, but typically include two or three rows of staggered staples. In the embodiment of Figure 42, the circular stapler of Figure 40 is used to staple two tissues, including pre-positioned staples SL1 and SL2. In the embodiment on the left of Figure 42, showing appropriately positioned and oriented staples SL1 and SL2, each of zones 1 to 4 receives one distinct portion of staples SL1 and SL2. The first staple SL1 extends across zones 2 and 4, while the second staple SL2, which intersects the first staple SL1 at its center point, extends across zones 1 and 3. Thus, the impedances measured in the four zones are equal to, or at least substantially equal to, each lower than the impedance of the unstapled tissue.

[0281] Conversely, in the embodiment on the right of Figure 42, which represents improperly positioned and oriented staple wires SL1 and SL2, the staple wires SL1 and SL2 overlap or substantially extend over each other across zones 1 and 3, resulting in lower impedance measurements in zones 1 and 3 compared to zones 2 and 4.

[0282] Figures 43 and 44 show staple lines SL1 and SL2 in an end-to-end anastomosis procedure performed by a circular stapler end effector 25510, which includes eight predetermined zones (zones 1 to 8) defined by eight sensing circuits S1 to S8, as described above. The anvil of the end effector 25510 and the staple cavity of the staple cartridge 25512 have been removed from Figures 43 and 44 to highlight other features of the end effector 25510.

[0283] Figures 45 and 46 show the measured tissue impedance based on sensor signals from sensing circuits S1 to S8. Each measurement defines a tissue impedance signature. The vertical axes 25520 and 25520' represent the orientation angle (θ), and the vertical axes 25522 and 25522' enumerate the corresponding predetermined zones (zones 1 to 8). The tissue impedance (Z) is plotted on the horizontal axes 25524 and 25524'.

[0284] In the embodiments shown in Figures 43 and 45, the impedance measurements represent appropriately positioned and oriented staple wires SL1 and SL2. As shown in Figure 43, staple wires SL1 and SL2 extend through zones 1, 3, 5, and 7, overlapping only at the center point of the staple cartridge 25512. Since the pre-stapled tissue is evenly distributed among zones 1, 3, 5, and 7, the tissue impedance measurements in these zones are of the same magnitude, or at least substantially the same, and are significantly lower than the tissue impedance measurements in zones 2, 4, 6, and 8, which did not receive pre-stapled tissue.

[0285] Conversely, in the embodiments shown in Figures 44 and 46, the impedance measurements represent improperly positioned and oriented staple wires SL1 and SL2. As shown in Figure 143, staple wires SL1 and SL2 overlap each other and extend only through zones 1 and 5. Consequently, the tissue impedance measurements in zones 1 and 5 are significantly lower in magnitude than in the remaining zones that did not accept pre-stapled tissue.

[0286] Figure 47 shows a logical flowchart of process 206520, which represents a control program or logical configuration for selecting the operating mode of the surgical hub 5104 according to the determined progress of the surgical procedure. Process 2065520 may be carried out by any suitable control circuit, such as the control circuit of the surgical hub 5104. Data may be received from at least one data source 206522, and may include patient data 206532 from a patient monitoring device, surgical staff data 206534 from a surgical staff detection device, modular device data 206536 from one or more modular devices, and / or hospital data 206538 from a hospital database. The received data 206522 is processed by the surgical hub 5104 to determine the progress of the surgical procedure. Further details regarding the determination of whether or not a surgical procedure is progressing are disclosed in U.S. Patent Application No. 16 / 209,465, filed on 4 December 2018, entitled "Method for adaptive control schemes for surgical network control and interaction," which is incorporated herein by reference in its entirety.

[0287] As shown in Figure 47, the received data 206522 can be used by the surgical hub 5104 to determine whether or not a surgical procedure is in progress 206523. If not, the surgical hub 5104 activates or selects the previous procedure / network interaction mode 206524. However, if the surgical hub 5104 has determined that a surgical procedure is in progress 206523, it further determines whether or not a surgical procedure is in progress 206525. If not, the surgical hub 5104 activates or selects the interactive / configurable control mode 206526. However, if the surgical hub 5104 has determined that a surgical procedure is in progress 206525, the surgical hub 5104 activates or selects the instrument display control and procedure display mode 206528.

[0288] Mode 206524 is more restrictive than Mode 206526, and Mode 206526 is more restrictive than Mode 206528. This arrangement is designed to account for user errors, for example, in the form of accidental commands. Before the start of surgery, Mode 206524 allows only limited interaction with cloud-based systems 104, 204, for example, access to previous procedure data. During preoperative procedures, but before the start of surgery, Mode 206526 provides a less restrictive interface that allows the user to access and / or configure various parameters and / or controls, in a state where such controls cannot be used or activated. In the least restrictive Mode 206528, available only during surgery, the user can use or activate controls for specific modular devices depending on the surgical procedure being performed.

[0289] The surgical hub receives data that determines the context parameters of a surgical procedure and, in response, can adjust its response to the sensed parameters based on the determined context parameters. In at least one embodiment, as shown in Figure 48, the sensed parameter may be detecting a security threat. In other embodiments, the sensed parameter may be detecting a surgeon. In other embodiments, the sensed parameter may be detecting an instrument malfunction, such as a modular device.

[0290] In addition to the above, responding to detected security threats depends on whether surgery is in progress, which can be determined as described above in relation to Figure 47. If it is determined that surgery is in progress, an independent operating mode can be activated. If surgery is not in progress, the current security level can be escalated to a higher security level, and the detected security threat can be addressed by taking an appropriate response. Further details regarding the determination of whether surgery is in progress are disclosed in U.S. Patent Application No. 16 / 209,465, filed December 4, 2018, entitled Method for adaptive control schemes for surgical network control and interaction.

[0291] In various embodiments, the isolation operation mode 206553 includes, for example, interrupting communication with external systems such as cloud-based systems 104, 204. In certain embodiments, the communication interruption excludes local in-operating communications, such as instrument-to-instrument communication, instrument-to-surgical hub 106, 206, and / or communication between a remote controller and an instrument.

[0292] Referring further to Figure 48, the response to the detected surgeon depends on whether a surgical procedure is in progress, which may be determined as described above in relation to Figure 47. If it is determined that a surgical procedure is in progress, the linked instruments may be set to predefined parameters, for example, based on the detected surgeon's previous usage configuration. However, if the surgical procedure is not in progress, previously captured data and / or previous surgical data may be retrieved, for example. Further details regarding the determination of whether a surgical procedure is in progress are disclosed in U.S. Patent Application No. 16 / 209,465, filed December 4, 2018, entitled Method for adaptive control schemes for surgical network control and interaction, whose disclosure is incorporated herein by reference in whole.

[0293] Referring further to Figure 48, the response to the detected instrument failure depends on whether a surgical procedure is in progress, and further depends on whether a surgical procedure is in progress, which can be determined as described above in relation to Figure 47. The instrument may be, for example, a modular device. If it is determined that a surgical procedure is in progress, and further depends on whether a surgical procedure is in progress, the limping mode can be activated for the instrument. However, if a surgical procedure is not in progress, the lockout of the surgical instrument can be engaged to prevent the surgical instrument from being used. Furthermore, if a surgical procedure is in progress, but it is determined that a surgical procedure is not in progress, the surgical hub 5104 can issue a warning or alarm to the surgical staff, for example, recommending an option.

[0294] Figure 49 shows a GUI that displays a series of menus containing selectable options to assist a clinician when operating a particular surgical instrument, such as instrument 208100 (shown in Figure 50). In the illustrated embodiment, the first series of displays 208010 shows multiple selectable menu options, in which case a particular surgeon is selected, a particular instrument is selected, and a particular function is selected. In such cases, a particular surgeon can be selected so that a control circuit, such as control circuit 208103, can load specific settings, such as learned adaptive limits for that particular surgeon. For example, the control circuit can be selected to load a specific control program so that it can operate a particular instrument, such as instrument 208100. This may include a specific adaptive limit program corresponding to the particular instrument and the particular surgeon. All of the selected options can be considered by the control circuit to load the correct control program and / or settings for operating the desired device. In the illustrated example, the firing function of Dr. Jones' stapler 2 is selected. These options may be automatically sensed by the control circuit, or in at least one example, not selected. For example, information may already be delivered by a surgical hub (e.g., 102, 202) to a control circuit in a package corresponding to a particular surgery. In another example, the surgeon may wear a...

Claims

1. A computing system, It is a processor, Maintaining a data store of operating parameters for surgical instruments, wherein the operating parameters are associated with previously performed surgical procedures. Receiving characteristics associated with planned surgical procedures, Reading the operating parameters corresponding to the received characteristics from the data store, To transmit the read operating parameters to the surgical instrument for use when setting up the surgical instrument to perform the planned surgical procedure, A processor configured to perform the following actions: A computing system equipped with [the following features].

2. The computing system according to claim 1, wherein the processor configured to receive the characteristics associated with the planned surgical procedure is configured to receive characteristics associated with the surgical apparatus for the planned surgical procedure.

3. The computing system according to claim 2, wherein the properties associated with the surgical apparatus for the planned surgical procedure include properties associated with a surgical circular stapler.

4. The computing system according to claim 3, wherein the read-out operating parameters include operating parameters for an adaptable staple height operating range.

5. The computing system according to claim 3, wherein the read-out operating parameters include operating parameters for the operation of one or more motors.

6. The computing system according to claim 5, wherein the operating parameters for the operation of one or more motors include operating parameters for a first motor associated with a force applied by an anvil to compress tissue, and operating parameters for a second motor associated with the application of a force for inserting surgical staples.

7. The operating parameters for the surgical instrument are stored in relation to the operator of the surgical instrument. The processor, configured to receive the characteristics associated with the planned surgical procedure, is configured to receive characteristics specifying an operator for the planned surgical procedure, The computing system according to any one of claims 1 to 6, wherein the processor configured to read the operating parameters corresponding to the received characteristics is configured to read the operating parameters corresponding to the operator for the planned surgical procedure.

8. The computing system according to any one of claims 1 to 7, wherein the processor configured to read the operating parameters corresponding to the received characteristics from the data store is configured to read operating parameters associated with a plurality of previously performed surgical procedures.

9. The processor, configured to receive the characteristics associated with the planned surgical procedure, is configured to receive specific characteristics associated with the planned surgical procedure. The computing system according to any one of claims 1 to 8, wherein the processor configured to read the operating parameters corresponding to the received characteristics from the data store is configured to read the operating parameters corresponding to the specific characteristics associated with the planned surgical procedure.

10. The computing system according to any one of claims 1 to 9, wherein the characteristics associated with the planned surgical procedure include characteristics associated with one or more of the patient, the operator of the surgical instrument, or the intended outcome.

11. The aforementioned processor, It receives queries that specify the characteristics associated with surgical procedures. The operating parameters corresponding to the characteristics associated with the surgical procedure are read from the data store. The read-out operating parameters corresponding to the characteristics associated with the surgical procedure are communicated. The computing system according to claim 1, further configured as follows.

12. A surgical circular stapler, The first motor and The second motor, It is a processor, Receiving instructions for setting the surgical circular stapler based on operating parameters associated with previously performed surgical procedures, To communicate the characteristics associated with the tissue compressed by the aforementioned surgical circular stapler, Receiving operating parameters for setting the first motor and the second motor, wherein the operating parameters are associated with one or more previously performed surgical procedures. Based on the received operating parameters, the operation of the first motor and the second motor is set, A processor configured to perform the following actions: A surgical circular stapler equipped with [a specific feature].

13. The operating parameters for setting the first motor include the operating parameters for setting the first motor such that it generates a force applied by the anvil to compress the tissue, The surgical circular stapler according to claim 12, wherein the operating parameter for setting the second motor includes an operating parameter for setting the second motor such that it generates a force applied for inserting a surgical staple.

14. It also includes sensors that adapt to sense tissue characteristics, The surgical circular stapler according to claim 12 or 13, wherein the processor is further configured to receive operating parameters for setting the sensor.

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