Surgical instruments using adaptive functional control

Abstract

The surgical instrument receives instructions for providing adaptive control of surgical instrument functions. The instructions may indicate providing an adaptive staple height operating range, controlling a motor associated with tissue compression, and / or operating using operating parameters associated with a previous surgical operation. The surgical instrument may determine a value of a parameter associated with the identified function and adapt control of the identified function based on the determined parameter. The surgical instrument may adapt a display of the staple height operating range based on a parameter indicative of anvil head size. The surgical instrument may control a motor associated with tissue compression based on a parameter indicative of a 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 TO RELATED APPLICATIONS) This application is related to the following concurrently filed applications, the contents of each of which are incorporated herein by reference: ●Agent reference number END9287USNP1, title METHOD FOR OPERATING TIERED OPERATION MODES IN A SURGICAL SYSTEM, ● Agent Reference Number END9287USNP9, entitled SURGICAL INSTRUMENT WITH ADAPTIVE MOTOR CONTROL, and ●Agent reference number END9287USNP10, entitled SURGICAL INSTRUMENT WITH ADAPTIVE CONFIGURATION CONTROL. [Background technology]

[0002] Surgical instruments often include components or systems that operate to provide functions incidental to the operation of the surgical instrument. For example, a surgical stapler may include a display adapted to provide feedback to the operator regarding tissue compression. The surgical stapler may include a first motor that can provide force to clamp the tissue and a second motor that can provide force to drive the staples into the tissue. Summary of the Invention [Means for solving the problem]

[0003] Systems and techniques for adaptive control of surgical instrument functions are disclosed herein. The surgical instrument may be configured to communicate with an external system, such as a surgical hub. The surgical instrument may receive instructions from the surgical hub for one or more functions to be adaptively controlled by the surgical instrument. For example, a surgical stapler instrument may receive instructions to adaptively control a display of tissue compression. The surgical instrument may determine a value of a parameter associated with the identified function and adapt control of the identified function based on the determined parameter. The surgical stapler may receive instructions from the surgical hub to provide an adaptive representation of a range of motion for tissue compression. In response to receiving the instructions, the surgical stapler may determine one or more parameters associated with the surgical stapler. For example, the surgical stapler may determine a parameter related to the size of the anvil head of the end effector. The surgical stapler may modify the adaptive representation of the range of motion for tissue compression based on the value of the parameter. For example, if the size of the anvil head is relatively small, the surgical stapler may modify the width of a band included in the adaptive representation of the range of motion for tissue compression.

[0004] According to various embodiments of the present invention, the following examples are provided.

[0005] 1. Receive instructions from a surgical hub system to provide one or more controlled functions; determining one or more parameters associated with the one or more controlled functions; A surgical stapler comprising: a processor configured to provide one or more controlled functions based on one or more parameters.

[0006] The one or more controlled functions may be functions that may be performed by the surgical stapler, and one or more parameters associated with the one or more controlled functions may be controlled. For example, the functions may be tissue clamping and / or cutting operations, and the one or more parameters may be parameters that indicate a range or limit of operation of the surgical stapler during the tissue clamping and / or cutting operations.

[0007] 2. the processor is further configured to communicate parameters associated with the surgical stapler to the surgical hub system; 10. The surgical stapler of Example 1, wherein the instructions for providing the one or more controlled functions are based at least in part on parameters associated with the surgical stapler.

[0008] Parameters associated with a surgical stapler are parameters that include information regarding an indication of the hardware included in the surgical stapler, the software included in the surgical stapler, and / or the intended use of the surgical stapler.

[0009] 3. The surgical stapler of Example 1, wherein the processor configured to provide one or more controlled functions based on one or more parameters is configured to modify operation of the one or more controlled functions based on the one or more parameters.

[0010] 4. A surgical stapler as described in Example 1, wherein the instructions for providing one or more controlled functions include instructions for providing one or more of an adaptive staple height operating range, adaptive control of a motor associated with the force applied by the tissue compression anvil, or configuring the surgical stapler based on operating parameters associated with a previously performed surgical procedure.

[0011] 5. The processor configured to receive instructions for providing one or more controlled functions is configured to receive instructions for providing an adaptable staple height operating range; The processor configured to determine one or more parameters associated with the one or more controlled functions is configured to determine a size of an anvil associated with the end effector; A surgical stapler as described in Example 1, wherein the processor configured to provide one or more controlled functions based on one or more parameters is configured to determine that the adaptable staple height operating range is modified relative to a default adaptable staple height operating range based on the size of an anvil associated with the end effector.

[0012] 6. The processor configured to receive instructions for providing one or more controlled functions is configured to receive instructions for providing adaptable control of a motor associated with a force applied by the tissue compression anvil; a processor configured to determine one or more parameters associated with the one or more controlled functions, configured to determine an application of force to insert the surgical staples; 2. The surgical stapler of claim 1, wherein the processor configured to provide one or more controlled functions based on one or more parameters is configured to determine, based on the application of force to insert the surgical staple, to control the motor to apply a force by the tissue compression anvil.

[0013] 7. A surgical circular stapler comprising: The display and a processor communicatively coupled to the display, the processor comprising: receiving instructions for providing an adaptable staple height operating range; determining one or more parameters associated with the surgical circular stapler; determining an adaptable staple height operating range based on one or more parameters of the surgical circular stapler; a processor configured to present an adaptive staple height operating range on a display;

[0014] 8. The surgical circular stapler of Example 7, wherein the processor configured to receive instructions to provide an adaptable staple height operating range is configured to receive instructions from an external system.

[0015] 9. The surgical circular stapler of Example 7, wherein the processor configured to determine one or more parameters associated with the surgical circular stapler is configured to determine a size of the end effector head.

[0016] 10. A surgical circular stapler as described in Example 9, wherein the processor configured to determine an adaptable staple height operating range based on one or more parameters of the surgical circular stapler is configured to determine that the adaptable staple height operating range is modified relative to a default adaptable staple height operating range based on a size of the end effector head.

[0017] 11. A surgical circular stapler as described in Example 10, wherein the processor configured to determine that the adaptable staple height operating range has been modified relative to the default adaptable staple height operating range is configured to determine that the adaptable staple height operating range has been shifted relative to the default adaptable staple height operating range.

[0018] 12. The processor configured to determine one or more parameters associated with the surgical circular stapler is configured to determine a force during tissue compression; A surgical circular stapler as described in Example 7, wherein the processor configured to determine the adaptive staple height operating range based on one or more parameters of the surgical circular stapler is configured to determine that the adaptive staple height operating range is modified relative to a default adaptive staple height operating range based on a force during tissue compression.

[0019] 13. The instructions for providing an adaptable staple height operating range include instructions for providing an adaptable staple height operating range as applied in a previous procedure; a processor configured to determine one or more parameters of the surgical stapler configured to receive, from the surgical hub, one or more operating parameters associated with the adaptable staple height operating range as applied in a previous procedure; a processor configured to determine an adaptable staple height operating range based on one or more parameters of the surgical circular stapler, setting a default adaptive staple height operating range using one or more operating parameters associated with a representation of the adaptive staple height operating range as applied in the previous procedure; The surgical circular stapler of Example 7, wherein the surgical circular stapler is configured to determine the adaptive staple height operating range using a default adaptive staple height operating range.

[0020] 14. A surgical stapler adapted to receive an interchangeable end effector having an anvil head, the surgical stapler comprising: The display and a processor communicatively coupled to the display, receiving instructions for providing an adaptable staple height operating range; Determining one or more parameters associated with the interchangeable end effector; determining an adaptable staple height operating range based on one or more parameters; A surgical stapler comprising: a processor configured to present an adaptive staple height operating range on a display.

[0021] 15.Adaptable staple height operating range an adaptable workable staple height range; an adaptable staple firing range, wherein the adaptable staple firing range is within an adaptable viable staple height range; and Including, The processor: 15. The surgical stapler of Example 14, further configured to determine an adaptable viable staple height range and an adaptable staple firing range based on one or more parameters.

[0022] 16. A surgical stapler as described in Example 15, wherein the one or more parameters associated with the interchangeable end effector include one parameter indicating the size of the anvil head.

[0023] 17. A surgical stapler as described in Example 16, wherein the processor is configured to determine that the anvil head is a first size based on one parameter indicating the size of the anvil head, and based on this determination, determine that the adaptable feasible staple height range is a first feasible staple height range and that the adaptable staple firing range is a first adaptable staple firing range.

[0024] 18. The processor determines that the size of the anvil head is smaller than the first size based on one or more parameters indicating the size of the anvil head, and based on this determination: determining a modified adaptable workable staple height range for the first adaptable workable staple height range; 18. The surgical stapler of Example 17, further configured to determine a modified adaptive staple firing range relative to the first adaptive staple firing range.

[0025] 19. A processor configured to determine a modified adaptable staple height range for a first adaptable staple height range and to determine a modified adaptable staple firing range for a first adaptable staple firing range; determining that the adaptable workable staple height range is substantially similar in width to the first adaptable workable staple height range; 18. The surgical stapler of Example 17, configured to determine that the adaptable staple firing range is wider than the first adaptable staple firing range.

[0026] 20. A surgical stapler as described in Example 18 or Example 19, wherein the processor configured to determine a modified adaptable staple height range relative to the first adaptable staple height range and to determine a modified adaptable staple firing range relative to the first adaptable staple firing range is configured to determine that the adaptable staple height range is shifted downward relative to the first adaptable staple height range.

[0027] 21. The processor determines that the size of the anvil head is larger than the first size based on one or more parameters indicating the size of the anvil head, and based on this determination: determining a modified adaptable workable staple height range for the first adaptable workable staple height range; 18. The surgical stapler of Example 17, further configured to determine a modified adaptive staple firing range relative to the first adaptive staple firing range.

[0028] 22. A processor configured to determine a modified adaptable staple height range for a first adaptable staple height range and to determine a modified adaptable staple firing range for a first adaptable staple firing range; determining that the adaptable workable staple height range is narrower than the first adaptable workable staple height operating range; 22. The surgical stapler of claim 21, configured to determine that the adaptable staple firing range is narrower than the first adaptable staple firing range.

[0029] 23. A surgical stapler as described in Example 21 or 22, wherein the processor configured to determine a modified adaptable staple height range relative to the first adaptable staple height range and to determine a modified adaptable staple firing range relative to the first adaptable staple firing range is configured to determine that the adaptable staple firing range is shifted upward relative to the first adaptable staple firing range.

[0030] 24. The processor: A surgical stapler described in any one of Examples 15 to 23, configured to present an adaptable executable staple height range as a first horizontal band on the display and to present an adaptable staple height firing range as a second horizontal band on the display.

[0031] 25. A surgical stapler according to any one of Examples 14 to 24, wherein the processor is further configured to present an indication of the current position of the anvil on the display.

[0032] 26. A surgical stapler described in any one of Examples 4 to 25, wherein the adaptable staple height operating range represents a range of stroke positions of the anvil.

[0033] 27. The adaptable viable range of motion represents the range of stroke positions of the anvil at which tissue can be clamped by the anvil; A surgical stapler described in any one of Examples 15 to 25, wherein the adaptable staple firing range represents the range of anvil stroke positions at which staples driven through tissue by the stapler and received by the anvil are successfully formed.

[0034] As examples of the above, particularly in Examples 1, 7, and 14, the functionality of the surgical stapler can be dynamically adapted depending on, for example, the hardware configuration of the stapler itself, the clinical procedure or setting, or patient-related parameters. In this manner, clinicians or users are provided with a surgical stapler specifically adapted for the procedure they are performing, improving their ability to perform that procedure with a corresponding improvement in clinical outcomes for the patient. Furthermore, the stapler can be configured with less user or clinician intervention, reducing procedure duration.

[0035] As an example of the above, particularly in Example 4, the functionality of the surgical stapler can be adjusted based on parameters associated with previously performed surgical procedures. In this manner, the results of previously performed surgical procedures can inform the configuration of the surgical stapler to improve future clinical outcomes.

[0036] As examples of the above, particularly in Examples 5, 7, and 14, the staple height operating range of the device can be dynamically adjusted, which in turn can help ensure that the correct separation is achieved between the anvil and stapler, and that the staples are properly deployed.

[0037] As examples of the above, particularly in Examples 7 and 14, the stapler includes a display that provides a staple height operating range, which allows the clinician or stapler user to know the clinically appropriate range of anvil positions, which in turn can improve the accuracy and effectiveness of staple deployment during surgery.

[0038] As examples above, particularly in Examples 5, 9, and 16, the size of the anvil head can be considered when configuring a surgical stapler. As discussed above, particularly with reference to FIGS. 59 and 60, it has been discovered that due to differences in the area of ​​differently sized anvil heads, different degrees of force must be applied to the captured tissue to effect tissue compression. This affects the staple height operating range of the stapler. By dynamically configuring the device accordingly, the surgical stapler can operate with a range of end effector sizes while still properly deploying surgical staples.

[0039] As examples of the above, in certain embodiments 15-23, the stapler displays to the clinician or user a staple height operating range, including a viable staple height range and a staple firing range. While the staple firing range may be a range of stroke positions that result in ideal or well-formed staples upon deployment, the viable staple height range may be a range of stroke positions at which tissue is clamped. While the latter case may not be ideal for staple deployment in that the staples may not be ideally formed once deployed, this information may nevertheless be important to present to the clinician or device user, as they may desire to deploy loosely formed or tightly formed staples, depending on the clinical situation. Furthermore, in critical situations, deploying staples quickly may be more important than deploying ideally formed staples; in this situation, presenting the viable staple height range to the user may allow them to deploy staples in a more timely manner than if they were presented with only the staple firing height range. [Brief explanation of the drawings]

[0040] [Figure 1] FIG. 1 is a block diagram of a computer-implemented interactive surgical system. [Figure 2]FIG. 1 is a diagram of an exemplary surgical system being used to perform a surgical procedure in an operating room. [Figure 3] FIG. 1 illustrates an exemplary surgical hub paired with a visualization system, a robotic system, and an intelligent instrument. [Figure 4] FIG. 1 illustrates 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 in any room within a medical facility specially equipped for surgical procedures, to a cloud, in accordance with at least one aspect of the present disclosure. [Figure 5] FIG. 1 illustrates an exemplary computer-implemented interactive surgical system. [Figure 6] 1 illustrates an exemplary surgical hub comprising multiple modules coupled to a modular control tower. [Figure 7] 1A-1C illustrate exemplary surgical instruments or tools. [Figure 8] 1A-1C illustrate exemplary surgical instruments or tools having motors that can be activated to perform various functions. [Figure 9] 1 is a diagram of an exemplary situation-aware surgical system. [Figure 10] FIG. 1 illustrates an exemplary timeline of an exemplary surgical procedure and the inferences that a surgical hub may make from data detected at each step of the surgical procedure. [Figure 11] FIG. 1 is a block diagram of a computer-implemented interactive surgical system. [Figure 12] FIG. 1 illustrates the functional architecture of an exemplary computer-implemented interactive surgical system. [Figure 13] FIG. 1 illustrates an exemplary computer-implemented interactive surgical system configured to adaptively generate control program updates for modular devices. [Figure 14]1A and 1B illustrate an exemplary surgical system including a handle having a controller and a motor, an adapter releasably coupled to the handle, and a loading unit releasably coupled to the adapter. [Figure 15A] FIG. 10 illustrates an exemplary flow for determining an operating mode and operating in the determined mode. [Figure 15B] FIG. 10 illustrates an exemplary flow for changing operational modes. [Figure 16] FIG. 1 is a schematic diagram of a surgical instrument configured to operate the surgical tools described herein, according to at least one aspect of the present disclosure. [Figure 17] FIG. 1 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] FIG. 1 is a perspective view of a circular stapling surgical instrument according to at least one embodiment of the present disclosure; [Figure 19A] FIG. 19 is an enlarged longitudinal cross-sectional view of the stapling head assembly of the instrument of FIG. 18 showing the anvil in an open position, in accordance with at least one embodiment of the present disclosure. [Figure 19B] FIG. 19 is an enlarged longitudinal cross-sectional view of the stapling head assembly of the instrument of FIG. 18 showing the anvil in a closed position, in accordance with at least one embodiment of the present disclosure. [Figure 19C] FIG. 20 is an enlarged longitudinal cross-sectional view of the stapling head assembly of the instrument of FIG. 18 showing the staple driver and blade in the fired position, in accordance with at least one aspect of the present disclosure. [Figure 20] FIG. 10 is an enlarged, partial cross-sectional view of a staple formed against an anvil, according to at least one embodiment of the present disclosure. [Figure 21] FIG. 1 is a partial cutaway view of a powered circular stapling device including a circular stapling head assembly and an anvil in accordance with at least one aspect of the present disclosure. [Figure 22]FIG. 10 is a partial top view of a circular stapling head assembly as shown herein showing a first row of staples (inner staples) and a second row of staples (outer staples) in accordance with at least one embodiment of the present disclosure. [Figure 23] FIG. 10 is a graphical illustration of a viable staple firing range, as indicated by a usable staple height window, based on tissue gap, closure force (FTC), or tissue creep stabilization sensed by a device or combination thereof, in accordance with at least one aspect of the present disclosure. [Figure 24] FIG. 10 is a graphical illustration of a first pair of graphs illustrating anvil gap and tissue compression force versus time for an exemplary firing of a stapling instrument in accordance with at least one aspect of the present disclosure. [Figure 25] FIG. 10 is a graphical illustration of a second pair of graphs illustrating anvil gap and tissue compression force versus time for an exemplary firing of a stapling instrument in accordance with at least one aspect of the present disclosure. [Figure 26] FIG. 10 is a schematic illustration of a powered circular stapling device showing an effective tissue gap, an actual gap, a normal range gap, and an out-of-range gap, in accordance with at least one aspect of the present disclosure. [Figure 27] FIG. 1 is a logic flow diagram of a process illustrating a control program or logic configuration for providing discretionary or mandatory lockout according to a sensed parameter compared to a threshold value, in accordance with at least one aspect of the present disclosure. [Figure 28] 10A-10C illustrate the extent of the tissue gap and the resulting staple configuration, according to at least one embodiment of the present disclosure. [Figure 29] FIG. 1 is a graphical representation of three force to close (FTC) curves versus time, according to at least one embodiment of the present disclosure. [Figure 30] FIG. 1 is a detailed graphical illustration of a force to close (FTC) curve versus time, according to at least one embodiment of the present disclosure. [Figure 31]10A-10C are graphs and related powered stapling apparatus illustrating anvil closure speed adjustment at certain key points along the retraction stroke of the trocar, in accordance with at least one embodiment of the present disclosure. [Figure 32] FIG. 10 is a logic flow diagram of a process illustrating a control program or logic configuration for adjusting the closure speed of an anvil portion of a powered stapling device at certain key points along the retraction stroke of the trocar in accordance with at least one aspect of the present disclosure. [Figure 33] 10A-10C are views of a graph and associated powered stapling device showing trocar position over time, in accordance with at least one aspect of the present disclosure. [Figure 34] FIG. 10 is a logic flow diagram of a process illustrating a control program or logic configuration for detecting multi-directional seating motion on a trocar to drive an anvil into proper seating, according to at least one aspect of the present disclosure. [Figure 35] FIG. 16 is a partial schematic view of a circular powered stapling device showing an anvil closure on the left and an actuating knife 201616 on the right, in accordance with at least one embodiment of the present disclosure. [Figure 36] FIG. 10 is a graphical illustration of anvil displacement (δAnvil) along the vertical axis as a function of force to close the clamp (FTC) along the horizontal axis, in accordance with at least one embodiment of the present disclosure. [Figure 37] 201630 is a graphical representation of knife 201616 displacement (δKnife) along the vertical axis as a function of knife 201616 velocity (VK mm / sec) along the horizontal axis on the left, and as a function of knife 201616 force (FK lbs) along the horizontal axis on the right, in accordance with at least one embodiment of the present disclosure. [Figure 38] FIG. 10 is a logic flow diagram of a process illustrating a control program or logic configuration for detecting tissue gap and firing force to adjust knife stroke and velocity, according to at least one aspect of the present disclosure. [Figure 39]FIG. 38 is a logic flow diagram of a process showing a control program or logic configuration for advancing a knife 201616 under a high tissue toughness velocity profile with velocity spikes as shown in FIG. 37 in accordance with at least one embodiment of the present disclosure. [Figure 40] FIG. 12 is a partial perspective view of a circular stapler showing a circular stapler trocar including a staple cartridge having four predetermined zones in accordance with at least one embodiment of the present disclosure. [Figure 41] FIG. 10 is a partial perspective view of a circular stapler showing a circular stapler trocar including a staple cartridge having eight predetermined zones in accordance with at least one embodiment of the present disclosure. [Figure 42] FIG. 41 shows, on the left, two tissues including pre-deployed staples properly disposed on the staple cartridge of FIG. 40, and, on the right, two tissues including pre-deployed staples properly disposed on the staple cartridge of FIG. 40, in accordance with at least one embodiment of the present disclosure. [Figure 43] FIG. 42 illustrates two tissues with pre-deployed staples properly disposed on the staple cartridge of FIG. 41 in accordance with at least one embodiment of the present disclosure. [Figure 44] FIG. 42 illustrates two tissues with pre-deployed staples improperly disposed on the staple cartridge of FIG. 41 in accordance with at least one embodiment of the present disclosure. [Figure 45] FIG. 44 is a graphical illustration of a tissue impedance signature of the properly positioned tissue of FIG. 43, in accordance with at least one embodiment of the present disclosure. [Figure 46] FIG. 45 is a graphical illustration of a tissue impedance signature of the improperly positioned tissue of FIG. 44, in accordance with at least one embodiment of the present disclosure. [Figure 47] FIG. 10 is a logic flow diagram of a process illustrating a control program or logic configuration for selecting an operating mode of a surgical hub, in accordance with at least one aspect of the present disclosure. [Figure 48]FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for responding to sensed parameters in accordance with at least one aspect of the present disclosure. [Figure 49] FIG. 1 is a diagram of a graphical user interface (GUI) for controlling various device parameters, in accordance with at least one aspect of the present disclosure. [Figure 50] FIG. 1 is a block diagram illustrating a surgical system according to at least one aspect of the present disclosure. [Figure 51] FIG. 1 illustrates a technique for interacting with a patient's Electronic Medical Record (EMR) database, in accordance with at least one aspect of the present disclosure. [Figure 52] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 53] FIG. 1 illustrates an exemplary analysis system for updating a surgical tool control program, in accordance with at least one aspect of the present disclosure. [Figure 54] FIG. 1 is a diagram of a computer-implemented interactive surgical system configured to adaptively generate control program updates for a surgical hub, in accordance with at least one aspect of the present disclosure. [Figure 55] FIG. 1 is a perspective view of an exemplary circular stapler according to at least one aspect of the present disclosure. [Figure 56] FIG. 56 is a perspective view of the circular stapler of FIG. 55 with the battery pack removed from the housing assembly and the anvil removed from the stapling head assembly, in accordance with at least one embodiment of the present disclosure. [Figure 57] FIG. 1 is a diagram of a control system for a surgical stapling instrument, according to at least one aspect of the present disclosure. [Figure 58] FIG. 10 is a flowchart diagram of an exemplary process for adaptive control of surgical tool function. [Figure 59] 1A-1C illustrate an exemplary powered circular stapling instrument, in accordance with at least one aspect of the present disclosure. [Figure 60]10A-10C illustrate an exemplary representation of an adaptive staple height operating range displayed on an exemplary powered circular stapling instrument. [Figure 61] 10A-10C are exemplary flow diagrams of an exemplary powered circular stapling instrument operating in a stroke-controlled mode of operation; [Figure 62] 10A-10C are exemplary flow diagrams of an exemplary powered circular stapling instrument operating in a load-controlled mode of operation; [Figure 63] FIG. 10 is an exemplary flow diagram of an exemplary powered circular stapling instrument operating in a previous configuration controlled mode of operation. [Figure 64] 10A-10C are exemplary diagrams illustrating various aspects of an exemplary powered circular stapling instrument operating using adaptive motor control in a load control mode of operation. [Figure 65] FIG. 10 is an exemplary flow diagram of an exemplary powered circular stapling instrument operating with adaptive motor control in a load control mode of operation. [Figure 66] FIG. 10 is another exemplary flow diagram of an exemplary powered circular stapling instrument operating in a load-controlled mode of operation. [Figure 67] FIG. 10 is another exemplary flow diagram of an exemplary powered circular stapling instrument operating in a load-controlled mode of operation. [Figure 68] FIG. 10 is another exemplary flow diagram of an exemplary powered circular stapling instrument operating in a previous configuration controlled mode of operation. [Figure 69] FIG. 10 is another exemplary flow diagram of an exemplary powered circular stapling instrument operating in a previous configuration controlled mode of operation. [Figure 70] FIG. 10 is another exemplary flow diagram of an exemplary powered circular stapling instrument operating in a previous configuration controlled mode of operation. DETAILED DESCRIPTION OF THE INVENTION

[0041] The applicant of the present 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, entitled "METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS," published on July 4, 2019 (U.S. Patent Application No. 16 / 209,423, filed December 4, 2018); U.S. Patent Application Publication No. 2019-0200844(A1), entitled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385); U.S. Patent Application Publication No. 20190206563(A1), entitled "Method for adaptive control schemes for surgical network control and interaction," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,465); ● U.S. Patent Application Publication No. 20190206562(A1), entitled "Method of hub communication, processing, display, and cloud analytics," filed on December 4, 2018 (U.S. Patent Application No. 16 / 209,416); U.S. Patent Application Publication No. 20190201034(A1), entitled "Powered stapling device configured to adjust force, advancement speed, and overall stroke of cutting member based on sensed parameter of firing or clamping," filed November 6, 2018 (U.S. Patent Application No. 16 / 182,240); ● U.S. Patent Application Publication No. 20190200996(A1) entitled "ADJUSTMENT OF STAPLE HEIGHT OF AT LEAST ONE ROW OF STAPLES BASED ON THE SENSED TISSUE THICKNESS OR FORCE IN CLOSING," filed November 6, 2018 (U.S. Patent Application No. 16 / 182,229); U.S. Patent Application Publication No. 20190200997(A1), entitled "Stapling device with both compulsory and discretionary lockouts based on sensed parameters," filed November 6, 2018 (U.S. Patent Application No. 16 / 182,234); ● U.S. Patent Application No. 16 / 458,117, filed June 30, 2019, entitled SURGICAL SYSTEM WITH RFID TAGS FOR UPDATING MOTOR ASSEMBLY PARAMETERS; U.S. Patent Application Publication No. 2019-0201137(A1), entitled METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,407); ● U.S. Patent Application Publication No. 2019-0206569(A1) entitled METHOD OF CLOUD-BASED DATA ANALYTICS FOR USE WITH THE HUB, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,403); • U.S. Patent Application Publication No. 2017 / 0296213, entitled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT, published on October 19, 2017 (U.S. Patent Application No. 15 / 130,590); • U.S. Patent No. 9,345,481, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, issued May 24, 2016; • U.S. Patent Application Publication No. 2014 / 0263552, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, published on September 18, 2014 (U.S. Patent Application No. 13 / 800,067); • U.S. Patent Application Publication No. 20180360452(A1), entitled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed June 20, 2017 (U.S. Patent Application No. 15 / 628,175); • U.S. Patent No. 9,345,481, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, issued May 24, 2016; • U.S. Patent Application Publication No. 20180360452(A1), entitled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed June 20, 2017 (U.S. Patent Application No. 15 / 628,175); ● U.S. Patent Application Publication No. 20190000446(A1) entitled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, filed June 29, 2017 (U.S. Patent Application No. 15 / 636,829); ● U.S. Patent Application Publication No. 20190099180(A1), entitled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT, filed September 29, 2017 (U.S. Patent Application No. 15 / 720,852); • U.S. Patent Application Publication No. 2014 / 0166728 (U.S. Patent Application No. 13 / 716,318), entitled "Motor Driven Rotary Input Circular Stapler with Modular End Effector," published June 19, 2014; ● U.S. Patent No. 9,250,172, entitled "Systems and methods for predicting metabolic and bariatric surgery outcomes," issued on February 2, 2016; U.S. Patent Application Publication No. 20130116218(A1), entitled "Methods and compositions of bile acids," published May 9, 2013 (U.S. Patent Application No. 13 / 631,095); U.S. Patent Application Publication No. 20140087999(A1), entitled "Clinical predictors of weight loss," published March 27, 2014 (U.S. Patent Application No. 13 / 828,809); ● U.S. Patent No. 8,476,227, entitled "Methods of activating a melanocortin-4 receptor pathway in obese subjects," issued on July 2, 2013; ● U.S. Patent Application No. 16 / 574,773, filed September 18, 2019, entitled METHOD FOR CALIBRATING MOVEMENTS OF ACTUATED MEMBERS OF POWERED SURGICAL STAPLER; ● U.S. Patent Application No. 16 / 574,797, filed September 18, 2019, entitled METHOD FOR CONTROLLING CUTTING MEMBER ACTUATION FOR POWERED SURGICAL STAPLER; • U.S. Patent Application No. 16 / 574,281, filed September 18, 2019, entitled METHOD FOR CONTROLLING END EFFECTOR CLOSURE FOR POWERED SURGICAL STAPLER; ● U.S. Patent Application Publication No. 20190201119(A1), entitled CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION, filed on March 29, 2018 (U.S. Patent Application No. 15 / 940,694); ● U.S. Patent No. 10,492,783, entitled SURGICAL INSTRUMENT WITH IMPROVED STOP / START CONTROL DURING A FIRING MOTION, issued December 3, 2019; U.S. Patent Application Publication No. 20190200998(A1), entitled METHOD FOR CIRCULAR STAPLER CONTROL ALGORITHM ADJUSTMENT BASED ON SITUATIONAL AWARENESS, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,491); and ●U.S. Patent Application Publication No. 20190201140(A1), entitled SURGICAL HUB SITUATIONAL AWARENESS, filed March 29, 2018 (U.S. Patent Application No. 15 / 940,654).

[0042] Systems and techniques are disclosed for controlling communication capabilities between a surgical instrument, such as a surgical stapler, and a removable component, such as a staple cartridge. 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 a software version associated with the surgical instrument or one of the components. The surgical instrument may determine the type and extent of communication that may occur between the surgical instrument and the removable component based on the one or more parameters. For example, based on a parameter indicating that the surgical instrument and / or the removable component includes a recent software version, the surgical stapler may determine that bidirectional communication may occur between the surgical instrument and the removable component.

[0043] 1 , a computer-implemented interactive surgical system 100 may include one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 may include at least one surgical hub 106 in communication with the cloud 104, which may include the remote server 113. In one example, as shown in FIG. 1 , a surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112, which are configured to communicate with each other and / or with the hub 106. In some aspects, a surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P are integers greater than or equal to 1.

[0044] In various aspects, the visualization system 108 may include one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in FIG. 2. In one aspect, the visualization system 108 may include interfaces for HL7, PACS, and EMR. The various components of the visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1), entitled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety.

[0045] As shown in FIG. 2 , primary display 119 is positioned in the sterile field so as to be visible to the operator of operating table 114. In addition, visualization tower 111 is positioned outside the sterile field. Visualization tower 111 may include a first non-sterile display 107 and a second non-sterile display 109, facing opposite each other. Visualization system 108, guided by hub 106, is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, hub 106 may enable visualization system 108 to maintain a live video of the surgical site on primary display 119 while displaying snapshots of the surgical site captured by imager 124 on non-sterile displays 107 or 109. The snapshots on non-sterile displays 107 or 109 can, for example, enable a non-sterile operator to perform diagnostic procedures related to the surgical procedure.

[0046] In one aspect, the hub 106 may be configured to send diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to a primary display 119 in the sterile field for viewing by a sterile operator at the operating table. In one example, the input may be in the form of a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be sent by the hub 106 to the primary display 119.

[0047] 2, a surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 can also be configured to coordinate information flow to the display of the surgical instrument 112. See, for example, U.S. Patent Application Publication No. 2019-0200844(A1), entitled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator in the visualization tower 111 is sent by the hub 106 to the surgical instrument display 115 in the sterile field for viewing by the operator of the surgical instrument 112. Exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in U.S. Patent Application Publication No. 2019-0200844(A1), entitled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety.

[0048] FIG. 2 shows an example of a surgical system 102 being used to perform a surgical procedure on a patient lying on an operating table 114 in a surgical operating room 116. A robotic system 110 may be used as part of the surgical system 102 in the surgical procedure. The robotic system 110 may include a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 through a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. Images of the surgical site are acquired by a medical imaging device 124, which can be manipulated by the patient side cart 120 to reorient the imaging device 124. The robotic hub 122 can be used to process and then display the images of the surgical site for the surgeon through the surgeon's console 118.

[0049] Other types of robotic systems can be readily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Patent Application Publication No. 2019-0201137(A1), entitled METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,407), the disclosure of which is incorporated herein by reference in its entirety.

[0050] Various examples of cloud-based analytics methods implemented by the cloud 104 and suitable for use with the present disclosure are described in U.S. Patent Application Publication No. 2019-0206569(A1), entitled METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,403), the disclosure of which is incorporated herein by reference in its entirety.

[0051] In various embodiments, the image capture device 124 may include at least one image sensor and one or more optical components. Suitable image sensors may include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.

[0052] The optical components of the imager 124 may include one or more illumination sources and / or one or more lenses. The one or more illumination sources may be directed to illuminate a portion of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.

[0053] The one or more illumination sources may be configured to emit electromagnetic energy within the visible spectrum as well as the invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or luminous spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and is sometimes referred to as visible light or simply light. The typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.

[0054] The invisible spectrum (e.g., non-radiative spectrum) is the portion of the electromagnetic spectrum located below and above the visible spectrum (i.e., wavelengths less than about 380 nm and greater than about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, which constitutes invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, which constitutes invisible ultraviolet, X-ray, and gamma-ray electromagnetic radiation.

[0055] In various aspects, the imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngological-nephroscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

[0056] Imaging devices can use multispectral monitoring to identify topography and underlying structures. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths, including frequencies beyond the visible light range, e.g., IR and UV light. Spectral imaging can extract additional information that cannot be captured by the red, green, and blue receptors of the human eye. The use of multispectral imaging is described in detail under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1) entitled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring can be a useful tool for repositioning the surgical field after the surgical task is complete to perform one or more of the above-mentioned tests on the treated tissue. It is self-evident that strict sterilization of the operating room and surgical equipment is necessary in any surgical procedure. The strict hygienic and sterilization conditions required in an "operating room," i.e., an operating room or procedure room, require the highest possible sterility of all medical devices and equipment. Part of the sterilization process described above is the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It is understood that the sterile field can be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field can be considered the area immediately surrounding the patient who is prepared for surgery. The sterile field can include cleaned team members wearing appropriate clothing, as well as all equipment and fixtures within the area.

[0057] Referring now to FIG. 3 , a hub 106 is shown in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communications module 130, a processor module 132, a storage array 134, and an operating room mapping module 133. In certain embodiments, as shown in FIG. 3 , the hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128. During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly associated with smoke evacuation, the aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular enclosure 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines. Aspects of the present disclosure present a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub enclosure and a combination generator module slidably receivable within the hub enclosure's docking station. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combination generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.In one aspect, the fluid line is a first fluid line, and a second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received within the hub enclosure. In one aspect, the hub enclosure includes a fluid interface. Certain surgical procedures may require the application of two or more energy types to tissue. One energy type may be more beneficial for cutting tissue, while another, different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the hub's modular enclosure 136 is configured to house and facilitate interactive communication between various generators. One advantage of the hub's modular enclosure 136 is that it allows for rapid removal and / or replacement of various modules. Aspects of the present disclosure present a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. The modular surgical enclosure includes a first energy generator module configured to generate a first energy for application to tissue and a first docking station including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contacts and the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts. In addition to the above, the modular surgical enclosure also includes a second energy generator module configured to generate a second energy, different from the first energy, for application to tissue and a second docking station including a second docking port including second data and second power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts and the second energy generator module is slidably movable out of electrical engagement with the second power and second data contacts.In addition, the modular surgical enclosure also includes a communication bus between the first and second docking ports configured to facilitate communication between the first and second energy generator modules. Referring to FIG. 3 , an embodiment of the present disclosure is presented with a hub modular enclosure 136 that allows for modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The hub modular enclosure 136 further facilitates interactive communication between the modules 140, 126, and 128. The generator module 140 can be a generator module having integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit slidably insertable within the hub modular enclosure 136. The generator module 140 can be configured to connect to a monopolar device 142, a bipolar device 144, and an ultrasonic device 146. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the hub modular enclosure 136. The hub modular enclosure 136 may be configured to facilitate insertion of multiple generators and interactive communication between the generators docked to the hub modular enclosure 136 such that the multiple generators function as a single generator.

[0058] FIG. 4 illustrates a surgical data network 201 comprising a modular communications hub 203 configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility specially equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204, which may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communications hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communications hub 203 can also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to travel from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features that allow traffic to pass through the monitored surgical data network and configure each port within the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.

[0059] Modular devices 1a-1n located in an operating room may be coupled to modular communication hub 203. Network hub 207 and / or network switch 209 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to network switch 209. Network switch 209 may be coupled to network hub 207 and / or network router 211 to connect devices 2a-2m to cloud 204. Data associated with devices 2a-2n may be transferred to cloud 204 via network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to local computer system 210 for local data processing and manipulation.

[0060] It will be appreciated that the surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. The modular communications hub 203 may be housed within a modular control tower configured to receive multiple devices 1a-1n / 2a-2m. A local computer system 210 may also be housed in the modular control tower. The modular communications hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n / 2a-2m, for example, during a surgical procedure. In various embodiments, devices 1a-1n / 2a-2m may include various modules such as, for example, an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communications module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and / or a non-contact sensor module, among other modular devices that may be connected to a modular communications hub 203 of a surgical data network 201.

[0061] In one aspect, the surgical data network 201 may include a combination of a network hub, a network switch, and a network router that connects the devices 1a-1n / 2a-2m to the cloud. Any one or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on sharing computing resources rather than having local servers or personal devices to handle software applications. While the term "cloud" may be used as a metaphor for the "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which various services, such as servers, storage, and applications, are delivered via the Internet to a modular communications hub 203 and / or computer system 210 located in an operating room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and / or computer system 210. The cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located within one or more operating rooms. Cloud computing services can perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located within the operating room. Hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

[0062] By applying cloud computer data processing technology to data collected by the devices 1a-1n / 2a-2m, a surgical data network can result in improved surgical outcomes, reduced costs, and improved patient satisfaction. After tissue sealing and cutting procedures, at least some of the devices 1a-1n / 2a-2m can be used to observe tissue status and evaluate leakage or perfusion of the sealed tissue. Using cloud-based computing, at least some of the devices 1a-1n / 2a-2m can be used to diagnostically examine data, including images of body tissue samples, to identify pathologies, such as the effects of disease. This can include tissue localization and demarcation, as well as phenotyping. At least some of the devices 1a-1n / 2a-2m can be used to identify anatomical structures of the body using various sensors integrated with the imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by the devices 1a-1n / 2a-2m, including image data, can be transferred to the cloud 204 or a local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data may be analyzed to improve surgical outcomes by determining whether further treatments can be performed, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics to tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and the use of standardized techniques can provide useful feedback to either confirm or suggest modifications to surgical treatments and surgeon performance.

[0063] The operating room devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n to the network hub. The network hub 207, in one aspect, may be implemented as a local network broadcasting device operating on the physical layer of the Open System Interconnection (OSI) model. The network hub may provide connectivity to devices 1a-1n located within the same operating room network. The network hub 207 may collect data in the form of packets and send them to a router in half-duplex mode. The network hub 207 may not store any media access control / Internet Protocol (MAC / IP) information for transferring device data. Only one of the devices 1a-1n may transmit data through the network hub 207 at a time. The network hub 207 does not have a routing table or knowledge of where to send the information and may broadcast all network data across each connection and to a remote server 213 (FIG. 4) on the cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose a security risk and cause bottlenecks.

[0064] The operating room devices 2a-2m may be connected to the network switch 209 via wired or wireless channels. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 may be a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 transmits data in the form of frames to the network router 211 and may function in full-duplex mode. Multiple devices 2a-2m may transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to forward data.

[0065] The network hub 207 and / or the network switch 209 may be coupled to a network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 transmits data in the form of packets to the cloud 204 and may function in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.

[0066] In one embodiment, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub can expand a single USB port into several tiers so that more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and 2a-2m located in the operating room.

[0067] In an embodiment, the operating room devices 1a-1n / 2a-2m may communicate with the modular communications hub 203 via the Bluetooth wireless technology standard for exchanging 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 for establishing a personal area network (PAN). The operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via numerous wireless or wired communications standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, New Radio (NR), Long Term Evolution (LTE), and any other wireless and wired protocols designated as Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as 3G, 4G, 5G, and beyond. The computing module may include multiple communication modules, for example, a first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.

[0068] The modular communications hub 203 serves as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and may handle data types known as frames. The frames may carry data generated by the devices 1a-1n / 2a-2m. When the frames are received by the modular communications hub 203, they are amplified and transmitted to the network router 211, which forwards the data to cloud computing resources using a number of wireless or wired communications standards or protocols, as described herein.

[0069] The modular communications hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communications hub 203 may generally be easy to install, configure, and maintain, making the modular communications hub 203 a good choice for networking the operating room devices 1a-1n / 2a-2m.

[0070] FIG. 5 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 6, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210.

[0071] 5 , modular control tower 236 may be coupled to imaging module 238, which may be coupled to endoscope 239, generator module 240, which may be coupled to energy device 241, smoke evacuation module 226, suction / irrigation module 228, communications module 230, processor module 232, storage array 234, smart devices / instruments 235, which may optionally be coupled to display 237, and non-contact sensor module 242. Operating room devices may be coupled to cloud computing resources and data storage via modular control tower 236. Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices / instruments 235, visualization system 208, among others, may be coupled to modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from the imaging 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.

[0072] FIG. 6 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 may comprise a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for local processing, visualization, and imaging. As shown in FIG. 6, the modular communications hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communications hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 6, each of the network hubs / switches in the modular communications hub 203 may include three downstream ports and one upstream port. The upstream network hub / switch may be connected to a processor to provide communication connectivity to cloud computing resources and a local display 217. Communication to the cloud 204 may occur via either a wired or wireless communication channel.

[0073] The surgical hub 206 may use the non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room using either an ultrasonic non-contact measurement device or a laser-based non-contact measurement device. The ultrasonic-based non-contact sensor module can scan the operating room by transmitting bursts of ultrasound and receiving echoes as they bounce off the perimeter walls of the operating room, as described in more detail below, entitled "Surgical Hub Spatial Awareness Within an Operating Room," of U.S. Patent Application Publication No. 2019-0200844(A1) entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, the disclosure of which is incorporated herein by reference in its entirety, and the sensor module is configured to determine the size of the operating room and adjust Bluetooth pairing distance limits. The laser-based non-contact sensor module may, for example, scan the operating room by transmitting laser light pulses, receive laser light pulses that reflect off the exterior walls of the operating room, and compare the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust Bluetooth pairing distance limits.

[0074] Computer system 210 may include a processor 244 and a network interface 245. Processor 244 may be coupled to a communications module 247, storage 248, memory 249, non-volatile memory 250, and input / output interface 251 via a system bus. The system bus may be any of several types of bus structures, including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus using any of a variety of available bus architectures, including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), MicroChannel Architecture (MSA), Enhanced ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus.

[0075] Processor 244 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. This processor core includes 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product datasheet.

[0076] In one aspect, the processor 244 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

[0077] System memory may include both volatile and nonvolatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. RAM is available in many forms, including static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync link DRAM (SLDRAM), and direct RAM (DRRAM).

[0078] The computer system 210 may also include removable / non-removable, volatile / non-volatile computer storage media, such as disk storage devices. Disk storage devices include, but are not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage devices can include the above storage media, either independently or in combination with other storage media. Other storage media include, but are not limited to, optical disk drives, such as compact disc ROM drives (CD-ROMs), compact disc recordable drives (CD-R drives), compact disc rewritable drives (CD-RW drives), or digital versatile disc ROM drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of disk storage devices to the system bus.

[0079] It should be understood that computer system 210 may include software that acts as an intermediary between users and the basic computer resources described in a suitable operating environment. Such software may include an operating system. The operating system, which may be stored on disk storage, may function to control and allocate resources of the computer system. System applications may take advantage of resource management by the operating system through program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein may be implemented with various operating systems or combinations of operating systems.

[0080] A user may input commands or information into computer system 210 through input devices coupled to I / O interface 251. Input devices may include, but are not limited to, pointing devices such as a mouse, trackball, stylus, or touchpad; keyboards; microphones; joysticks; gamepads; satellite dishes; scanners; TV tuner cards; digital cameras; digital video cameras; webcams; and the like. These and other input devices connect to the processor through the system bus via interface ports. Interface ports include, for example, serial ports, parallel ports, game ports, and USB. Output devices use some of the same types of ports as input devices. Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that some output devices may include monitors, displays, speakers, and printers, among other output devices that may require special adapters. Output adapters include, by way of example and not limitation, video and sound cards that provide a means of connection between the output device and the system bus. It should be noted that other devices and / or systems of devices, such as remote computers, may provide both input and output capabilities.

[0081] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as a cloud computer. A remote cloud computer can be a personal computer, a server, a router, a network PC, a workstation, a microprocessor-based device, a peer device, or other common network node, but typically includes many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown with the remote computer. A remote computer may be logically connected to the computer system through a network interface and subsequently physically connected via a communications connection. The network interface may encompass communications networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies may include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, and the like. WAN technologies may include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and its variants, packet-switched networks, and Digital Subscriber Lines (DSL).

[0082] In various embodiments, the computer system 210 of FIG. 6, the imaging module 238 of FIGS. 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 to process digital images. The image processor may employ parallel computing using single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

[0083] The communications connection refers to the hardware / software used to connect the network interface to the bus. While the communications connection is shown internal to the computer system for clarity of illustration, the communications connection may also be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as regular telephone-grade modems, modems including cable modems and DSL modems, ISDN adapters, and Ethernet cards.

[0084] FIG. 7 shows a logic diagram of a surgical instrument or tool control system 470 according to one or more embodiments of the present disclosure. The system 470 may include control circuitry. The control circuitry may include a microcontroller 461 with a processor 462 and memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482, driven by a motor driver 492, operably couples a longitudinally movable displacement member to drive the I-beam knife element. A tracking system 480 may be configured to determine the position of the longitudinally movable displacement member. The position information 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 positions of the firing member, firing bar, and I-beam knife element. Additional motors may be provided to the tool driver interface to control I-beam firing, closure tube movement, shaft rotation, and articulation. A display 473 displays various operating conditions of the instrument and may include touchscreen functionality for data entry. Information displayed on the display 473 can be overlaid with images acquired via the endoscopic imaging module.

[0085] In one embodiment, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, main microcontroller 461 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and / or one or more 12-bit ADCs with 12 analog input channels, details of which are available in the product datasheet.

[0086] In one embodiment, the microcontroller 461 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

[0087] The microcontroller 461 may be programmed to perform various functions, such as precise control over the speed and position of the knife and articulation system. In one embodiment, the microcontroller 461 may include a processor 462 and a memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical linkage to the articulation or knife system. In one embodiment, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be easily substituted for use in the tracking system 480 with an absolute positioning system. A detailed description of absolute positioning systems is provided in U.S. Patent Application Publication No. 2017 / 0296213, published October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety.

[0088] The microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement members and articulation system. The microcontroller 461 may be configured to calculate a response within the microcontroller 461 software. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used to determine the actual feedback. The observed response is a suitably adjusted value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.

[0089] In some embodiments, the motor 482 may be controlled by a motor driver 492 and may be used by a surgical instrument or tool firing system. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In some 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 field effect transistors (FETs). The motor 482 may be powered by a power supply assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery, which may include multiple battery cells connected in series, that may be used as a power source to power the surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and / or rechargeable. In at least one example, the battery cells may be a lithium-ion battery, which may be connectable to and separable from the power supply assembly.

[0090] The motor driver 492 may be the A3941, available from Allegro Microsystems, Inc. The A3941 492 may be a full-bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. The driver 492 includes an intrinsic charge pump regulator that provides full (>10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive down to 5.5V. A bootstrap capacitor may be used to provide the required battery supply voltage for the N-channel MOSFETs. An internal charge pump for the high-side drive allows DC (100% duty cycle) operation. The full-bridge may be driven in fast or slow decay mode using diode or synchronous rectification. In slow decay mode, current recirculation is possible through either the high-side or low-side FET. The power FETs may be protected from shoot-through by a resistor-adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system.

[0091] The tracking system 480 may include a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for an absolute positioning system may provide a unique position signal corresponding to the position of the displacement member. In some embodiments, the displacement member may represent a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In some embodiments, the displacement member may represent a firing member that may be adapted and configured to include a rack of drive teeth. In some embodiments, the displacement member may represent a firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Thus, as used herein, the term displacement member may be used to generally refer to any movable member of a surgical instrument or tool, such as a drive member, firing member, firing bar, I-beam, or any element that can be displaced. In one aspect, the longitudinally movable drive member may be coupled to a firing member, firing bar, and I-beam. Thus, the absolute positioning system can actually track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. In various aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member, firing member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact displacement sensor or a non-contact displacement sensor. The linear displacement sensor may include a linear variable differential transformer (LVDT), a differential variable reluctance transducer (DVRT), a slide potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical 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.

[0092] The electric motor 482 may include a rotatable shaft operably interfaced with a gear assembly mounted in meshing engagement with a set of drive teeth or rack on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to several linear longitudinal translations of the displacement member. The gearing and sensor arrangement may be connected to a linear actuator by a rack and pinion arrangement or to a rotary actuator by a spur gear or other connection. A power source provides power to the absolute positioning system, and an output indicator may display the output of the absolute positioning system. The displacement member may represent a longitudinally movable drive member with a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reducer assembly. The displacement member may represent a longitudinally movable firing member, a firing bar, an I-beam, or a combination thereof.

[0093] One revolution of the sensor element associated with position sensor 472 corresponds to a longitudinal linear displacement d1 of the displacement member, where d1 may be the longitudinal linear distance traveled by the displacement member from point "a" to point "b" after one revolution of the sensor element coupled to the displacement member. The sensor mechanism may be coupled via a gear reduction that results in the position sensor 472 completing one or more revolutions relative to the full stroke of the displacement member. The position sensor 472 may complete multiple revolutions relative to the full stroke of the displacement member.

[0094] A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for two or more revolutions of the position sensor 472. The state of the switches is fed back to the microcontroller 461, which may 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 comprise a magnetic sensor, an analog rotation sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.

[0095] The position sensor 472 may comprise any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or a vector component of the magnetic field. The technologies used to produce both types of magnetic sensors may involve many aspects of physics and electronics. Technologies used to sense magnetic fields may include, among others, search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetodiodes, magnetotransistors, optical fiber, magneto-optical, and microelectromechanical systems-based magnetic sensors.

[0096] In one embodiment, the position sensor 472 of the tracking system 480 with an absolute positioning system may comprise a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide the absolute positioning system. The position sensor 472 is a low-voltage, low-power component and may include four Hall-effect elements in an area of ​​the position sensor 472 that may be located above the magnet. A high-resolution ADC and a smart power management controller may also be provided on-chip. A Coordinate Rotation Digital Computer (CORDIC) processor, also known as the Digit-by-Digit Method and the Boulder algorithm, may be provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. Angular position, alarm bits, and magnetic field information may be transmitted to the microcontroller 461 via a standard serial communications interface, such as a serial peripheral interface (SPI) interface. The position sensor 472 may provide 12-bit or 14-bit resolution and may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

[0097] A tracking system 480 with an absolute positioning system may include and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply converts a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensors may be provided to measure physical parameters of the physical system. In some embodiments, other sensors may include sensor arrangements such as those described in U.S. Pat. No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system may take into account properties such as mass, inertia, viscous friction, and induced resistance in order to predict what the state and output of the physical system will be given knowledge of the input.

[0098] Without retracting or advancing the displacement member to a reset (zero or home) position, such as may be required with conventional rotary encoders that simply count the number of forward or backward steps taken by the motor 482 to estimate the position of the device actuator, drive bar, knife, etc., the absolute positioning system provides the absolute position of the displacement member upon power-up of the instrument.

[0099] A sensor 474, such as a strain gauge or micro-strain gauge, can be configured to measure one or more parameters of the end effector, such as the amplitude of strain exerted on the anvil during clamping, which can be indicative of the closure force applied to the anvil. The measured strain can be converted to a digital signal and provided to the processor 462. Alternatively or in addition to the sensor 474, a sensor 476, such as a load sensor, can measure the closure force applied to the anvil by the closure drive system. For example, the load sensor can measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sled that cams the staple driver upward, forcing the staples into deforming contact with the anvil. The I-beam can also include a sharp cutting edge that can be used to cut tissue when the I-beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure the current drawn by the motor 482. The force required to advance the firing member may correspond, for example, to the current drawn by motor 482. The measured force may be converted to a digital signal and provided to processor 462.

[0100] In one form, a strain gauge sensor 474 can be used to measure the force applied to tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force applied by the end effector to the tissue being treated. A system for measuring the force applied to tissue grasped by the end effector 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 aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the jaw members of the end effector during clamping, which can be indicative of tissue compression. The measured strain can be converted to a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to operate the knife element, for example, to cut tissue captured between the anvil and the staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. The magnetic field sensor measurements can also be converted to a digital signal and provided to the processor 462.

[0101] Measurements of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, measured by sensors 474, 476, respectively, can be used by microcontroller 461 to characterize a selected position of the firing member and / or a corresponding value of firing member velocity. In one example, memory 468 can store techniques, equations, and / or look-up tables that can be used by microcontroller 461 during evaluation.

[0102] The surgical instrument or tool control system 470 may also include wired or wireless communication circuitry for communicating with the modular communications hub 203 as shown in FIGS.

[0103] 8 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions. In certain examples, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain examples, the motors of the robotic surgical instrument 600 can be individually activated to produce firing, closing, and / or articulation motions in the end effector. The firing, closing, and / or articulation motions can be transmitted to the end effector via, for example, a shaft assembly.

[0104] In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transfer the firing motion generated by the motor 602 to the end effector, particularly to displace an I-beam element. In certain examples, the firing motion generated by the motor 602 may, for example, deploy staples from a staple cartridge into tissue captured by the end effector and / or advance a cutting blade of the I-beam element to cut the captured tissue. The I-beam element may be retracted by reversing the direction of the motor 602.

[0105] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605, which may be configured to transmit the closure motion generated by the motor 603 to the end effector, specifically to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closure motion may transition the end effector from an open configuration to an approximation configuration, for example, to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.

[0106] In certain examples, a surgical instrument or tool may include, for example, one or more articulation motors 606 a, 606 b. The motors 606 a, 606 b may be operatively coupled to corresponding articulation motor drive assemblies 608 a, 608 b, which may be configured to transfer articulation motion generated by the motors 606 a, 606 b to an end effector. In certain examples, the articulation motion may, for example, cause the end effector to articulate relative to the shaft.

[0107] As described herein, a surgical instrument or tool may include multiple motors that can be configured to perform various independent functions. In certain examples, multiple motors of a surgical instrument or tool can be activated individually or separately to perform one or more functions while other motors remain stopped. For example, articulation motors 606 a, 606 b can be activated to articulate the end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 can be activated to fire multiple staples and / or advance a cutting blade while articulation motor 606 remains stopped. Additionally, closure motor 603 can be activated simultaneously with firing motor 602 to distally advance a closure tube and an I-beam element, as described in more detail herein below.

[0108] In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, the common control module 610 can accommodate one of the multiple motors at a time. For example, the common control module 610 may be individually connectable and detachable to multiple motors of a robotic surgical instrument. In certain examples, the multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, the multiple motors of a surgical instrument or tool can be individually and selectively engaged with the common control module 610. In certain examples, the common control module 610 can selectively switch from interfacing with one of the multiple motors of the surgical instrument or tool to interfacing with another of the multiple motors of the surgical instrument or tool.

[0109] In at least one example, common control module 610 can be selectively switched between operative engagement with articulation motors 606 a, 606 b and operative engagement with either firing motor 602 or closure motor 603. In at least one embodiment, as shown in FIGURE 8, switch 614 can be moved or transitioned between multiple positions and / or states. For example, in a first position 616, switch 614 can electrically couple common control module 610 to firing motor 602, in a second position 617, switch 614 can electrically couple common control module 610 to closure motor 603, in a third position 618 a, for example, switch 614 can electrically couple common control module 610 to first articulation motor 606 a, and in a fourth position 618 b, switch 614 can electrically couple common control module 610 to second articulation motor 606 b. In certain examples, a separate common control module 610 may be electrically coupled to the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b at the same time. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.

[0110] Each of the motors 602, 603, 606a, 606b may be equipped with a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor outside the jaws or by a torque sensor on the motor that actuates the jaws.

[0111] 8, common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. Motor driver 626 may modulate power transferred from a power supply 628 to a motor coupled to common control module 610 based on input from, for example, a microcontroller 620 ("controller"). In certain examples, the microcontroller 620 may be used to determine, for example, the current drawn by a motor while the motor is coupled to common control module 610, as described herein.

[0112] In particular examples, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In particular examples, memory 624 may store various program instructions that, when executed, cause processor 622 to perform multiple functions and / or calculations described herein. In particular examples, one or more of memory units 624 may be coupled to processor 622, for example.

[0113] In certain examples, power supply 628 can be used, for example, to power microcontroller 620. In certain examples, power supply 628 may comprise a battery (or "battery pack" or "power pack"), such as, for example, a lithium-ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power surgical instrument 600. Multiple battery cells connected in series may be used as power supply 628. In certain examples, power supply 628 may be, for example, replaceable and / or rechargeable.

[0114] In various examples, the processor 622 can control the motor drivers 626 to control the position, direction of rotation, and / or speed of the motors coupled to the common control module 610. In certain examples, the processor 622 can signal the motor drivers 626 to stop and / or disable the motors coupled to the common control module 610. The term "processor," as used herein, should be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a computer's central processing unit (CPU) on one integrated circuit or up to a few integrated circuits. A processor can be a general-purpose programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides a result as output. Because it may have internal memory, it can be an example of sequential digital logic. A processor can operate on numbers and symbols represented in the binary system.

[0115] Processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In a particular example, microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes, among other features readily available in the product datasheet, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with module 4410. Accordingly, the present disclosure should not be limited in this context.

[0116] The memory 624 may include program instructions that control each of the motors of the surgical instrument 600 that are connectable to the common control module 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b. Such program instructions may cause the processor 622 to control the firing, closing, and articulation functions according to inputs from algorithms or control programs of the surgical instruments or tools.

[0117] For example, one or more mechanisms and / or sensors, such as sensor 630, can be used to alert processor 622 to program instructions to use in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In certain examples, sensor 630 can include a position sensor that can be used to sense the position of switch 614, for example. Thus, processor 622 can use program instructions associated with firing an I-beam of the end effector when it detects, for example, via sensor 630, that switch 614 is in first position 616; processor 622 can use program instructions associated with closing an anvil when it detects, for example, that switch 614 is in second position 617 via sensor 630; and processor 622 can use program instructions associated with articulating the end effector when it detects, for example, via sensor 630, that switch 614 is in third position 618a or fourth position 618b.

[0118] 9 shows a diagram of a context-aware surgical system 5100 in accordance with at least one aspect of the present disclosure. In some examples, the data sources 5126 may include, for example, the modular device 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular device itself), a database 5122 (e.g., an EMR database including patient records), and patient monitoring devices 5124 (e.g., blood pressure (BP) monitors and electrocardiogram (EKG) monitors). The surgical hub 5104 may be configured to derive contextual information about the surgical procedure from the data based, for example, on a particular combination of the received data or a particular order in which the data is received from the data sources 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the particular step of the surgical procedure the surgeon is performing, the type of tissue being operated on, or the body cavity being treated. This ability of some aspects of the surgical hub 5104 to derive or infer information about the surgical procedure from the received data may also be referred to as “situational awareness.” In one example, the surgical hub 5104 may incorporate a situational awareness system, which is hardware and / or programming associated with the surgical hub 5104 that derives contextual information related to the surgical procedure from received data.

[0119] The situational awareness system of the surgical hub 5104 can be configured to derive contextual information from data received from the data sources 5126 in a variety of different ways. In one example, the situational awareness system can include a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data to correlate various inputs (e.g., data from the database 5122, the patient monitor 5124, and / or the modular device 5102) with corresponding contextual information about the surgical procedure. In other words, the machine learning system can be trained to accurately derive contextual information about the surgical procedure from provided inputs. In an example, the situational awareness system can include a lookup table that stores pre-characterized contextual information about the surgical procedure in association with one or more inputs (or ranges of inputs) that correspond to the contextual information. In response to a query with one or more inputs, the lookup table can return corresponding contextual information for the situational awareness system to control the modular device 5102. In examples, the contextual information received by the situational awareness system of the surgical hub 5104 can be associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In examples, the situational awareness system can include a further machine learning system, lookup table, or other such system that generates or retrieves one or more control adjustments for one or more modular devices 5102 when provided with the contextual information as input.

[0120] A surgical hub 5104 incorporating a situational awareness system can provide many benefits to the surgical system 5100. One benefit can include improved interpretation of sensed and collected data, which can improve processing accuracy and / or use of the data during the course of a surgical procedure. Returning to the previous example, the situational aware surgical hub 5104 can determine what type of tissue is being operated on, and thus, when an unexpectedly high force closing the end effector of the surgical instrument is detected, the situational aware surgical hub 5104 can properly accelerate or decelerate the motor of the surgical instrument to match the type of tissue.

[0121] The type of tissue being operated on can affect the adjustments made to the compression speed and load threshold of the surgical stapling and severing instrument for a particular tissue gap measurement. The context-aware surgical hub 5104 can infer whether the surgical procedure being performed is thoracic or abdominal surgery, which allows the surgical hub 5104 to determine whether the tissue being clamped by the end effector of the surgical stapling and severing instrument is pulmonary (in the case of thoracic surgery) or stomach (in the case of abdominal surgery). The surgical hub 5104 can then adjust the compression speed and load threshold of the surgical stapling and severing instrument appropriately for the tissue type.

[0122] The type of body cavity being operated on during an insufflation procedure can affect the function of the smoke evacuator. The situation-aware surgical hub 5104 can determine whether the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the procedure type. Since any procedure type can generally be performed within a particular body cavity, the surgical hub 5104 can control the smoke evacuator motor speed appropriately for the body cavity being operated on. Thus, the situation-aware surgical hub 5104 can provide a consistent amount of smoke evacuation for both thoracic and abdominal procedures.

[0123] The type of procedure being performed can affect the optimal energy level at which an ultrasonic surgical instrument or a radio frequency (RF) electrosurgical instrument operates. For example, an arthroscopic procedure may require a high energy level because the end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is immersed in fluid. The context-aware surgical hub 5104 can determine whether the surgical procedure is an arthroscopic procedure. The surgical hub 5104 can then adjust the RF power level or ultrasonic amplitude (i.e., "energy level") of the generator to compensate for the fluid-filled environment. Relatedly, the type of tissue being operated on can affect the optimal energy level at which an ultrasonic surgical instrument or a RF electrosurgical instrument operates. The context-aware surgical hub 5104 can determine what type of surgical procedure is being performed and then customize the energy level of the ultrasonic surgical instrument or the RF electrosurgical instrument, respectively, according to the tissue geometry expected for the surgery. Additionally, the situation-aware surgical hub 5104 can be configured to adjust the energy level of the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than simply on a procedure-by-procedure basis. The situation-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will continue to be performed, and then update the generator and / or the control algorithms of the ultrasonic surgical instrument or RF electrosurgical instrument to set the energy level to a value appropriate for the expected tissue type according to the step of the surgical procedure.

[0124] In embodiments, the surgical hub 5104 may also derive data from additional data sources 5126 to improve conclusions drawn from one data source 5126. The context-aware surgical hub 5104 may augment the data received from the modular device 5102 with contextual information constructed about the surgical procedure from other data sources 5126. For example, the context-aware surgical hub 5104 may be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) according to video or image data received from a medical imaging device. However, in some cases, the video or image data may be inconclusive. Thus, in one example, the surgical hub 5104 may be further configured to compare a physiological measurement (e.g., blood pressure sensed by a BP monitor communicatively connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 (FIG. 2) communicatively coupled to the surgical hub 5104) to make a determination regarding the integrity of a staple line or tissue weld. In other words, the situational awareness system of the surgical hub 5104 can take physiological measurement data into account to provide additional context when analyzing the visualization data, which can be useful when the visualization data may not be conclusive or incomplete on its own.

[0125] For example, the situation-aware surgical hub 5104 may actively activate a generator to which an RF electrosurgical instrument is connected if it is determined that a subsequent step in the procedure requires the use of the instrument. By actively activating the energy source, the instrument can be ready for use as soon as the previous step in the procedure is completed.

[0126] The situation-aware surgical hub 5104 can determine whether the current or subsequent steps in the surgical procedure require different views or magnifications on the display according to the characteristics of the surgical site that the surgeon is expected to need to see. The surgical hub 5104 can then proactively change the displayed views (e.g., provided by medical imaging devices for the visualization system 108) so that the display automatically adjusts throughout the surgical procedure.

[0127] The context-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will be performed next, and whether specific data or 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 step of the surgical procedure being performed, without waiting for the surgeon to request specific information.

[0128] Errors may be checked during surgical setup or during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 may determine whether the operating room is properly or optimally set up for the surgical procedure to be performed. The surgical hub 5104 may be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, supply locations, or setup requirements, and then compare the current operating room layout with a standard layout for the type of surgical procedure being performed as determined by the surgical hub 5104. In some examples, the surgical hub 5104 may be configured to compare the list of items for the procedure and / or the list of devices paired with the surgical hub 5104 with a recommended or expected manifest of items and / or devices for a given surgical procedure. If a discontinuity exists between the lists, the surgical hub 5104 may be configured to provide an alert indicating that a particular modular device 5102, patient monitoring device 5124, and / or other surgical item is missing. In some examples, the surgical hub 5104 can be configured to determine the relative distance or relative position of the modular devices 5102 and the patient monitoring devices 5124, for example, by proximity sensors. The surgical hub 5104 can compare the relative positions of the devices to a recommended or expected layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide an alert indicating that the current layout of the surgical procedure deviates from the recommended layout.

[0129] The situation-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or deviating from the expected sequence of actions during the course of a surgical procedure. For example, the surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) a corresponding list of steps or sequences of equipment use, and then compare the steps being performed or the equipment being used during the course of the surgical procedure with the expected steps or equipment for the type of surgical procedure being performed as determined by the surgical hub 5104. In some examples, the surgical hub 5104 can be configured to provide an alert indicating that an unexpected action is being performed or an unexpected device is being utilized at a particular step in the surgical procedure.

[0130] The surgical instruments (and other modular devices 5102) may be tailored to the specific circumstances of each surgical procedure (such as for different tissue types) and verified for operation during the surgical procedure. Subsequent steps, data, and display adjustments may be provided to the surgical instruments (and other modular devices 5102) in the operating room according to the specific circumstances of the procedure.

[0131] 10 illustrates a timeline 5200 of an exemplary surgical procedure and the contextual information the surgical hub 5104 may derive from data received from the data sources 5126 at each step of the surgical procedure. The following description of the timeline 5200 shown in FIG. 9 also refers to FIG. 9. The timeline 5200 may illustrate the general steps that nurses, surgeons, and other medical personnel may take during the course of a lung segmentectomy, beginning with the setup of the operating room and ending with the transfer of the patient to a post-operative recovery room. The context-aware surgical hub 5104 may receive data from the data sources 5126 throughout the course of the surgical procedure, including data generated each time a medical personnel uses a modular device 5102 paired with the surgical hub 5104. The surgical hub 5104 receives this data from the paired modular devices 5102 and other data sources 5126 and can continually derive inferences (i.e., contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is occurring at any given time. The situational awareness system of the surgical hub 5104 can, for example, record data about the procedure to generate reports, verify steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be relevant to particular procedure steps, adjust the modular device 5102 based on the context (e.g., activate a monitor, adjust the FOV of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such action described herein.

[0132] As a first step 5202 in this exemplary procedure, hospital personnel may retrieve the patient's EMR from the hospital's EMR database. Based on the patient data selected in the EMR, the surgical hub 5104 determines that the procedure to be performed is thoracic surgery. Second, 5204, the personnel 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 utilized in various types of procedures and confirms that the combination of supplies is compatible with a thoracic procedure. Furthermore, the surgical hub 5104 may also determine that the procedure is not a wedge resection (because the incoming supplies either do not include the specific supplies needed for a thoracic wedge resection or are otherwise not compatible with a thoracic wedge resection). Third, 5206, medical personnel may scan 5128 the patient band via a scanner communicatively connected to the surgical hub 5104. The surgical hub 5104 can then verify the patient's identity based on the scanned data. In a fourth step 5208, medical personnel turn on auxiliary devices. The auxiliary devices utilized may vary according to the type of surgical procedure and the technology used by the surgeon, but in this exemplary case include a smoke evacuator, an insufflator, and a medical imaging device. Once activated, the auxiliary device, which is a modular device 5102, may automatically pair with the surgical hub 5104, which may be located within a certain proximity of the modular device 5102, as part of its initialization process. The surgical hub 5104 may then derive contextual information regarding the surgical procedure by detecting the type of modular device 5102 paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 5104 may determine that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices 5102. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the types of modular devices 5102 connecting to the hub, the surgical hub 5104 may roughly deduce the particular procedure the surgical team will be performing.Once the surgical hub 5104 knows what particular procedure is being performed, it can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources 5126 (e.g., modular devices 5102 and patient monitors 5124) to deduce which steps of the surgical procedure the surgical team is performing. In a fifth step 5210, personnel attach EKG electrodes and other patient monitors 5124 to the patient. The EKG electrodes and other patient monitors 5124 may pair with the surgical hub 5104. Once the surgical hub 5104 begins receiving data from the patient monitors 5124, the surgical hub 5104 may confirm that the patient is in the operating room, for example, as described in process 5207. In a sixth step 5212, medical personnel may administer anesthesia to the patient. The surgical hub 5104 can infer that the patient is under anesthesia based on data from the modular device 5102 and / or the patient monitor 5124, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Once the sixth step 5212 is complete, the pre-operative portion of the lung segmentectomy is complete and the surgical portion begins.

[0133] In seventh 5214, the lung of the patient being operated on may be collapsed (while ventilation is switched to the contralateral lung). The surgical hub 5104 may infer, for example, from ventilator data that the patient's lung has been collapsed. The surgical hub 5104 may compare the detection of the patient's lung being collapsed to the expected steps of the procedure (which may be accessed or retrieved in advance) and therefore infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung is the first surgical step in this particular procedure. In eighth 5216, the medical imaging device 5108 (e.g., a scope) may be inserted and video from the medical imaging device may begin. The surgical hub 5104 may receive medical imaging device data (i.e., video or image data) through the connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 5104 may determine that the laparoscopic portion of the surgery has begun. Additionally, the surgical hub 5104 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that a wedge resection has not already been taken into account by the surgical hub 5104 based on the data received in the second step 5204 of the procedure). Data from the medical imaging device 124 (FIG. 2) may be utilized to determine contextual information regarding the type of procedure being performed in various ways, such as by determining the angle of the medical imaging device pointed relative to the visualization of the patient's anatomy, by monitoring the number or medical imaging devices being utilized (i.e., activated and paired with the surgical hub 5104), and by monitoring the type of visualization device being utilized. For example, one technique for performing a VATS lobectomy may position the camera above the diaphragm in the anterior-inferior corner of the patient's thoracic cavity, while one technique for performing a VATS segmentectomy may position the camera in an intercostal position anterior to the segmental fissure. The situational awareness system may be trained to recognize the position of the medical imaging device according to the visualization of the patient's anatomy, for example, using pattern recognition or machine learning techniques. An exemplary technique for performing a VATS lobectomy may utilize a single medical imaging device.An exemplary technique for performing a VATS segmentectomy utilizes multiple cameras. An exemplary technique for performing a VATS segmentectomy utilizes an infrared light source (which may be communicatively coupled to the surgical hub as part of a visualization system) to visualize the segmental fissure, which is not utilized in a VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can determine the particular type of surgical procedure being performed and / or the technique being used for the particular type of surgical procedure.

[0134] At ninth 5218, the surgical team may begin the incision step of the procedure. Because the surgical hub 5104 receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired, it can infer that the surgeon is in the process of incising and separating the patient's lungs. The surgical hub 5104 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the steps of the procedure described above have been completed) corresponds to the incision step. At tenth 5220, the surgical team may proceed to the ligation step of the procedure. Because the surgical hub 5104 may receive data from the surgical stapling and severing instrument indicating that the instrument is being fired, it can infer that the surgeon is ligating arteries and veins. As with the previous step, the surgical hub 5104 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the steps in the retrieved process. At eleventh 5222, the segmentectomy portion of the procedure can be performed. Based on data from the surgical stapling and severing instrument (including data from its cartridge), the surgical hub 5104 can infer that the surgeon is transecting parenchyma. The cartridge data can correspond, for example, to the size or type of staples being fired by the instrument. Because different types of staples are applied to different types of tissue, the cartridge data can indicate the type of tissue being stapled and / or transected. In this case, the type of staples being fired is applied to parenchyma (or other similar tissue type), allowing the surgical hub 5104 to infer that the segmentectomy portion of the procedure is being performed. Subsequently, in a twelfth step 5224, a node dissection step is performed. Based on data received from the generator indicating that an RF or ultrasonic instrument is being fired, the surgical hub 5104 can infer that the surgical team is dissecting nodes and performing a leak test. In this particular procedure, the RF or ultrasonic instrument utilized after the parenchyma has been transected corresponds to the node dissection step, allowing the surgical hub 5104 to make this inference.It should be noted that, because different instruments are better suited for specific tasks, surgeons will routinely alternate between surgical stapling / cutting instruments and surgical energy (e.g., RF or ultrasonic) instruments depending on the particular step in the procedure. Thus, the particular sequence in which the stapling / cutting instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. Once the twelfth step 5224 is completed, the incision and closure and post-operative portion of the procedure can begin.

[0135] In a thirteenth step 5226, the patient may be deanesthetized. The surgical hub 5104 may estimate that the patient is emerging from anesthesia, for example, based on ventilator data (i.e., the patient's breathing rate begins to increase). Finally, a fourteenth step 5228 may be a step in which medical personnel remove the various patient monitors 5124 from the patient. Thus, the surgical hub 5104 may estimate that the patient is being transferred to a recovery room when the hub loses EKG, BP, and other data from the patient monitors 5124. As can be seen from this exemplary procedure description, the surgical hub 5104 can determine or estimate when each step of a given surgical procedure is occurring according to data received from the various data sources 5126 communicatively coupled to the surgical hub 5104.

[0136] As shown in the first step 5202 of the timeline 5200 shown in FIG. 10 , in addition to utilizing patient data from the EMR database to estimate the type of surgical procedure to be performed, the patient data can be utilized by the situation-aware surgical hub 5104 to generate control adjustments for the paired modular devices 5102.

[0137] FIG. 11 is a block diagram of a computer-implemented interactive surgical system according to at least one embodiment of the present disclosure. In one embodiment, the computer-implemented interactive surgical system may be configured to monitor and analyze data related to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and operating rooms or medical facilities. The computer-implemented interactive surgical system may include a cloud-based analysis system. While described as a surgical system, the cloud-based analysis system is not necessarily limited to such and may generally be a cloud-based medical system. As shown in FIG. 11 , the cloud-based analysis system may include a plurality of surgical instruments 7012 (which may be the same as or similar to instrument 112), a plurality of surgical hubs 7006 (which may be the same as or similar to hub 106), and a surgical data network 7001 (which may be the same as or similar to network 201) for coupling the surgical hubs 7006 to cloud 7004 (which may be the same as or similar to cloud 204). Each of the plurality of surgical hubs 7006 may be communicatively coupled to one or more surgical instruments 7012. The hub 7006 may also be communicatively coupled to a cloud 7004 of computer-implemented interactive surgical systems via a network 7001. The cloud 7004 may be a remote, centralized source of hardware and software for storing, manipulating, and communicating data generated based on the operation of various surgical systems. As shown in FIG. 11 , access to the cloud 7004 is achieved via the network 7001, which may be the Internet or other suitable computer network. The surgical hub 7006, which may be coupled to the cloud 7004, may be considered the client side of a cloud computing system (i.e., a cloud-based analysis system). A surgical instrument 7012 may be paired with the surgical hub 7006 for control and performance of the various surgical procedures or operations described herein.

[0138] Additionally, the surgical instrument 7012 may include a transceiver for data transmission to and from a corresponding surgical hub 7006 (which may also include a transceiver). The combination of the surgical instrument 7012 and the corresponding hub 7006 can indicate a specific location, such as an operating room within a medical facility (e.g., a hospital) for providing a medical procedure. For example, the memory of the surgical hub 7006 can store the location data. As shown in FIG. 11 , the cloud 7004 includes a central server 7013 (which may be the same as or similar to the remote server 7013), a hub application server 7002, a data analysis module 7034, and an input / output ("I / O") interface 7006. The central server 7013 of the cloud 7004 collectively manages the cloud computing system, which includes monitoring requests by client surgical hubs 7006 and managing the processing power of the cloud 7004 to execute those requests. Each of the central servers 7013 may include one or more processors 7008 coupled to a suitable memory device 7010, which may include volatile memory, such as random access memory (RAM), and non-volatile memory, such as magnetic storage. The memory device 7010 may include machine-executable instructions that, when executed, cause the processor 7008 to execute a data analysis module 7034 for cloud-based data analysis, actions, recommendations, and other operations described below. Additionally, the processor 7008 may execute the data analysis module 7034 independently or in conjunction with a hub application executed independently by the hub 7006. The central server 7013 may also include a database 2212 of aggregated medical data, which may reside in the memory 2210.

[0139] Based on its connection to the various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from the various surgical instruments 7012 and the particular data generated by their corresponding hubs 7006. Such aggregated data can be stored in an aggregated medical database 7012 of the cloud 7004. Specifically, the cloud 7004 can advantageously perform data analysis and operations on the aggregated data to provide insights and / or perform functions that individual hubs 7006 cannot accomplish on their own. To this end, as shown in FIG. 11 , the cloud 7004 and the surgical hubs 7006 are communicatively coupled to send and receive information. An I / O interface 7006 is connected to the multiple surgical hubs 7006 via the network 7001. In this manner, the I / O interface 7006 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data database 7011. Accordingly, the I / O interface 7006 can facilitate read / write operations of the cloud-based analysis system. Such read / write operations may be performed in response to requests from the hub 7006. These requests may be sent to the hub 7006 via a hub application. The I / O interface 7006 may include one or more high-speed data ports, which may include a Universal Serial Bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting the cloud 7004 to the hub 7006. The hub application server 7002 of the cloud 7004 may be configured to host and provide shared functionality to software applications (e.g., hub applications) executed by the surgical hub 7006. For example, the hub application server 7002 may manage requests by the hub application through the hub 7006, control access to the database 7011 of aggregated medical data, and perform load balancing. The data analysis module 7034 is described in further detail with reference to FIG. 12 .

[0140] The particular cloud computing system configurations described in this disclosure may be specifically designed to address various problems that arise in the context of medical surgeries and procedures performed using medical devices, such as surgical instruments 7012, 112. In particular, the surgical instruments 7012 may be digital surgical devices configured to interact with the cloud 7004 to implement techniques for improving surgical outcomes. The various surgical instruments 7012 and / or the surgical hub 7006 may include touch-controlled user interfaces so that a clinician may control aspects of the interaction between the surgical instruments 7012 and the cloud 7004. Other suitable user interfaces for control, such as auditory-controlled user interfaces, may also be used.

[0141] FIG. 12 is a block diagram illustrating the functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. The cloud-based analysis system may include multiple data analysis modules 7034 that may be executed by a processor 7008 of a cloud 7004 to provide data analysis solutions to problems that arise specifically in the medical field. As shown in FIG. 12 , the functionality of the cloud-based data analysis modules 7034 may be supported via a hub application 7014 hosted by a hub application server 7002 that may be accessed on a surgical hub 7006. The cloud processor 7008 and the hub application 7014 may work in conjunction to execute the data analysis modules 7034. An application program interface (API) 7016 may define a set of protocols and routines corresponding to the hub application 7014. Additionally, the API 7016 may manage the storage and retrieval of data to and from a centralized medical database 7012 for operation of the applications 7014. A cache 7018 may also be coupled to the API 7016 for storing data (e.g., temporarily) and for efficient retrieval of data used by the applications 7014. 12 may include modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, control program updates 7026, patient outcome analysis 7028, recommendations 7030, and data classification and prioritization 7032. Other suitable data analysis modules may also be implemented by the cloud 7004, according to some aspects. In one aspect, the data analysis module may be used to make specific recommendations based on an analysis of trends, outcomes, and other data.

[0142] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata), including identifying notable features or configurations (e.g., trends), managing redundant data sets, and storing data in paired data sets that may be grouped by procedure but not necessarily matched to actual surgical procedure dates and surgeons. In particular, paired data sets generated from the operation of the surgical instrument 7012 may include applying a binary classification, such as a bleeding or non-bleeding event. More generally, the binary classification may be characterized as either a desired event (e.g., a successful surgery) or an undesired event (e.g., a misfired or misused surgical instrument 7012). The aggregated self-describing data may correspond to individual data received from various groups or subgroups of the surgical hub 7006. Thus, the data collection and aggregation module 7022 may generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. To this end, the processor 7008 may be operatively coupled to the hub application 7014 and the database of aggregated medical data 7011 for executing the data analysis module 7034. The data collection and aggregation module 7022 may store the aggregated, organized data in the database of aggregated medical data 2212.

[0143] The resource optimization module 7020 can be configured to analyze this aggregated data to determine optimal use of resources for a particular medical facility or group of medical facilities. For example, the resource optimization module 7020 can determine an optimal order point for surgical stapling instruments 7012 for a group of medical facilities based on corresponding predicted demand for surgical stapling instruments 7012. The resource optimization module 7020 can also evaluate resource usage or other operating configurations of various medical facilities to determine whether resource usage can be improved. Similarly, the recommendation module 7030 can be configured to analyze the aggregated organizational data from the data collection and aggregation module 7022 to provide recommendations. For example, the recommendation module 7030 can recommend to a medical facility (e.g., a health care provider such as a hospital) that a particular surgical instrument 7012 should be upgraded to an improved version based, for example, on a higher than expected error rate. Additionally, the recommendation module 7030 and / or resource optimization module 7020 can recommend better supply chain parameters, such as product reorder points, and provide suggestions for different surgical instruments 7012, their use, or procedural steps to improve surgical outcomes. The medical facility can receive such recommendations via the corresponding surgical hub 7006. More specific recommendations regarding the parameters or configurations of various surgical instruments 7012 can also be provided. The hub 7006 and / or surgical instruments 7012 can each have a display screen that displays the data or recommendations provided by the cloud 7004.

[0144] The patient outcome analysis module 7028 may analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 may also analyze and evaluate other potential operating parameters. In this regard, the recommendation module 7030 may use these other potential operating parameters to make recommendations based on resulting in better surgical outcomes, such as a better seal or less bleeding. For example, the suggestion module 7030 may be able to send suggestions to the surgical 7006 regarding when to use a particular cartridge with a corresponding stapling surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large-scale collected raw data and provide centralized recommendations (advantageously determined based on aggregated data) across multiple medical facilities while controlling for common variables. For example, the cloud-based analysis system may analyze, evaluate, and / or aggregate type of medical procedure, type of patient, number of patients, geographic similarities between medical providers using similar types of instruments, etc., in ways that no single medical facility could analyze independently. The control program update module 7026 can be configured to implement recommendations for various surgical instruments 7012 when the corresponding control programs are updated. For example, the patient outcome analysis module 7028 can identify correlations linking particular control parameters to successful (or unsuccessful) outcomes. Such correlations can be addressed when an updated control program is sent to the surgical instrument 7012 via the control program update module 7026. Updates to the instrument 7012, which can be sent via the corresponding hub 7006, can incorporate aggregated performance data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and recommendation module 7030 can identify improved ways to use the instrument 7012 based on the aggregated performance data.

[0145] The cloud-based analysis system may include security features implemented by the cloud 7004. These security features may be managed by the authorization and security module 7024. Each surgical hub 7006 may have associated unique credentials, such as a username, password, and other suitable security credentials. These credentials may be stored in memory 7010 and associated with an authorized cloud access level. For example, based on providing accurate credentials, the surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., send or receive certain defined types of information). To this end, the cloud 7004's aggregated medical data database 7011 may include a database of certified credentials to verify the accuracy of the provided credentials. Different credentials may be associated with various levels of permission for interaction with the cloud 7004, such as a predetermined access level for receiving data analyses generated by the cloud 7004. Furthermore, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices, which may include a "blacklist" of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist may not be permitted to interact with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the corresponding hub 7006. Additionally or alternatively, the cloud 7004 may flag instruments 7012 based on incompatibility or other specified criteria. In this manner, counterfeit medical devices and the inappropriate reuse of such devices across the cloud-based analysis system may be identified and addressed.

[0146] The surgical instrument 7012 may use a wireless transceiver to transmit a wireless signal that may represent, for example, authorization credentials for access to the corresponding hub 7006 and the cloud 7004. A wired transceiver may also be used to transmit the signal. Such authorization credentials may be stored in a respective memory device of the surgical instrument 7012. The authorization and security module 7024 may determine whether the authorization credentials are accurate or forged. The authorization and security module 7024 may also dynamically generate authorization credentials for enhanced security. The credentials may also be encrypted, such as by using hash-based encryption. Upon transmitting the appropriate authorization, the surgical instrument 7012 may transmit a signal to the corresponding hub 7006 and ultimately the cloud 7004 indicating that the instrument 7012 is ready to acquire and transmit medical data. In response, the cloud 7004 may transition to a state capable of receiving medical data for storage in the aggregated medical data database 7011. This readiness to transmit data may be indicated, for example, by a light indicator on the instrument 7012. The cloud 7004 may also send signals to the surgical instruments 7012 to update their associated control programs. The cloud 7004 may send signals directed to a particular class of surgical instruments 7012 (e.g., electrosurgical instruments) so that software updates to control programs are sent only to the appropriate surgical instruments 7012. Additionally, the cloud 7004 may be used to implement system-wide solutions to address local or global issues based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 are identified as having a common manufacturing defect, the cloud 7004 may change the authorization credentials corresponding to this group to implement an operational lockout for this group.

[0147] The cloud-based analytics system may enable monitoring of multiple healthcare facilities (e.g., healthcare facilities such as hospitals) to determine improved practices and recommend changes accordingly (e.g., via the proposal module 2030). Thus, the processor 7008 of the cloud 7004 may analyze data associated with an individual healthcare facility to identify the facility and aggregate that data with other data associated with other healthcare facilities. Groups may be defined, for example, based on similar operational behavior or geographic location. In this manner, the cloud 7004 may provide broader analysis and recommendations for groups of healthcare facilities. The cloud-based analytics system may also be used for enhanced situational awareness. For example, the processor 7008 may predictively model the effect of recommendations on cost and effectiveness for a particular facility (compared to overall operations and / or various healthcare procedures). The costs and effectiveness associated with that particular facility may also be compared to the corresponding local area of ​​other facilities or any other comparable facilities.

[0148] The data classification and prioritization module 7032 may prioritize and classify data based on criticality (e.g., the severity, surprise, or suspiciousness of the medical event associated with the data). This classification and prioritization may be used in conjunction with other data analysis module 7034 functionality described herein to improve the cloud-based analyses and operations described herein. For example, the data classification and prioritization module 7032 may assign priorities to data analyses performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels may result in specific responses from the cloud 7004 (corresponding to the level of urgency), such as elevation for rapid response, special handling, exclusion from the aggregated medical data database 7011, or other suitable responses. Additionally, if necessary, the cloud 7004 may send a request (e.g., a push message) via the hub application server for additional data from the corresponding surgical instrument 7012. The push message may result in a notification being displayed on the corresponding hub 7006 to request support or additional data. This push message may be needed in situations where the cloud detects a significant irregularity or outlier and is unable to determine the cause of the irregularity. The central server 7013 can be programmed to trigger this push message in certain critical situations, such as when data is determined to differ from expected values ​​by more than a predetermined threshold, or when security is deemed to be involved.

[0149] Further exemplary details regarding the various described functions are provided in the following description, each of which may utilize a cloud architecture, as illustrated in Figures 11 and 12 as one example of a hardware and software implementation.

[0150] 13 illustrates a block diagram of a computer-implemented adaptive surgical system 9060 configured to adaptively generate control program updates for modular devices 9050, in accordance with at least one embodiment of the present disclosure. In some examples, the surgical system may include a surgical hub 9000, a plurality of modular devices 9050 communicatively coupled to the surgical hub 9000, and an analysis system 9100 communicatively coupled to the surgical hub 9000. While a single surgical hub 9000 is shown, it should be noted that the surgical system 9060 may include any number of surgical hubs 9000, which may be connected to form a network of surgical hubs 9000 communicatively coupled to the analysis system 9010. In some examples, the surgical hub 9000 may include a processor 9010 coupled to a memory 9020 for executing stored instructions and a data relay interface 9030 through which data is transmitted to the analysis system 9100. In some examples, the surgical hub 9000 may further include a user interface 9090 having an input device 9092 (e.g., a capacitive touchscreen or keyboard) for receiving input from a user and an output device 9094 (e.g., a display screen) for providing output to the user. The output may include data from a query entered by the user, suggestions for products or product mixes to use in a given procedure, and / or instructions for actions to be taken before, during, or after a surgical procedure. The surgical hub 9000 may further include an interface 9040 for communicatively coupling a modular device 9050 to the surgical hub 9000. In one aspect, the interface 9040 may include a transceiver communicatively connectable to the modular device 9050 via a wireless communication protocol. The modular device 9050 may include, for example, a surgical stapling and severing instrument, an electrosurgical instrument, an ultrasonic instrument, an insufflator, a ventilator, and a display screen. In some examples, the surgical hub 9000 may further be communicatively coupled to one or more patient monitoring devices 9052, such as an EKG monitor or a BP monitor.In some instances, the surgical hub 9000 may further be communicatively coupled to one or more databases 9054 or external computer systems, such as an EMR database of the medical facility in which the surgical hub 9000 is located.

[0151] When a modular device 9050 is connected to the surgical hub 9000, the surgical hub 9000 can sense or receive perioperative data from the modular device 9050 and then associate the received perioperative data with surgical procedure outcome data. The perioperative data can indicate how the modular device 9050 was controlled during the course of a surgical procedure. The procedure outcome data includes data associated with the results from the surgical procedure (or steps thereof), which can include whether the surgical procedure (or steps thereof) had a positive or negative outcome. For example, the outcome data can include whether a patient suffered a post-operative complication from a particular procedure or whether there was a leak (e.g., bleeding or air leak) at a particular staple or incision line. The surgical hub 9000 can obtain the surgical procedure outcome data by receiving data from an external source (e.g., from 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 regarding post-operative complications can be retrieved from the EMR database 9054, and data regarding 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.

[0152] The surgical hub 9000 can transmit data and outcome data for associated modular devices 9050 to the analysis system 9100 for processing on the analysis system. By transmitting both perioperative data indicating how the modular devices 9050 are controlled and procedure outcome data, the analysis system 9100 can correlate different ways of controlling 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 of the analysis servers 9070 may include a memory and a processor coupled to the memory that executes instructions stored therein to analyze the received data. In some examples, the analysis servers 9070 may be connected in a distributed computing architecture and / or utilize a cloud computing architecture. Based on this paired data, the analysis system 9100 can then learn optimal or preferred operating parameters for various types of modular devices 9050, generate adjustments to the control programs of the modular devices 9050 in the field, and then transmit (or "push") updates to the control programs of the modular devices 9050.

[0153] Further details regarding the computer-implemented interactive surgical system 9060, including the surgical hub 9000 and various modular devices 9050 connectable thereto, are described in connection with Figures 5-6.

[0154] 14 provides a surgical system 6500 according to the present disclosure and may include a surgical instrument 6502 that may communicate with a console 6522 or a portable device 6526 through a local area network 6518 or a cloud network 6520 via a wired or wireless connection. In various aspects, the console 6522 and the portable device 6526 may be any suitable computing device. The surgical instrument 6502 may include a handle 6504, an adapter 6508, and a loading unit 6514. The adapter 6508 releasably couples to the handle 6504, and the loading unit 6514 releasably couples to the adapter 6508 such that the adapter 6508 transfers force from the drive shaft to the loading unit 6514. The adapter 6508 or the loading unit 6514 may include a force gauge (not explicitly shown) disposed therein to measure the force exerted on the loading unit 6514. The loading unit 6514 can include an end effector 6530 having a first jaw 6532 and a second jaw 6534. The loading unit 6514 can be an in-situ loading or multi-fire loading unit (MFLU) that allows a clinician to fire multiple fasteners multiple times without the loading unit 6514 having to be removed from the surgical site to reload it.

[0155] The first and second jaws 6532, 6534 can be configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and cut the clamped tissue. The first jaw 6532 can be configured to fire at least one fastener multiple times or can be configured to include a replaceable multi-fire fastener cartridge containing multiple fasteners (e.g., staples, clips, etc.) that can be fired two or more times before being replaced. The second jaw 6534 can include an anvil that deforms or otherwise secures fasteners around tissue as they are ejected from the multi-fire fastener cartridge.

[0156] The handle 6504 can include a motor coupled to the drive shaft to affect rotation of the drive shaft. The handle 6504 can include a control interface for selectively activating the motor. The control interface can include buttons, switches, levers, sliders, a touch screen, and any other suitable input mechanism or user interface that can be engaged by a clinician to activate the motor.

[0157] The control interface of the handle 6504 may be in communication with a controller 6528 of the handle 6504 to selectively activate the motors to affect rotation of the drive shaft. The controller 6528 may be disposed within the handle 6504 and configured to receive input from the control interface and adapter data from the adapter 6508 or loading unit data from the loading unit 6514. The controller 6528 may analyze the input from the control interface and the data received from the adapter 6508 and / or the loading unit 6514 to selectively activate the motors. The handle 6504 may also include a display viewable by a clinician while using the handle 6504. The display may be configured to display portions of the adapter or loading unit data before, during, or after firing of the instrument 6502.

[0158] The adapter 6508 may include an adapter identification device 6510 disposed therein, and the loading unit 6514 includes a loading unit identification device 6516 disposed therein. The adapter identification device 6510 may be in communication with a controller 6528, and the loading unit identification device 6516 may be in communication with the controller 6528. It will be appreciated that the loading unit identification device 6516 may be in communication with the adapter identification device 6510, which relays or passes through communications from the loading unit identification device 6516 to the controller 6528.

[0159] The adapter 6508 may also include multiple sensors 6512 (one shown) disposed about its periphery to detect various conditions of the adapter 6508 or the environment (e.g., when the adapter 6508 is connected to the loading unit, when the adapter 6508 is connected to the handle, when the drive shaft is rotating, the torque of the drive shaft, the strain on the drive shaft, the temperature within the adapter 6508, the number of times the adapter 6508 has been fired, the peak force of the adapter 6508 during firing, the total amount of force applied to the adapter 6508, the peak retract force of the adapter 6508, the number of times the adapter 6508 has been dwelled during firing, etc.). The multiple sensors 6512 may provide input to the adapter identification device 6510 in the form of data signals. The data signals of the multiple sensors 6512 may be stored in the adapter identification device 6510 or may be used to update the adapter data stored in the adapter identification device 6510. The data signals of the multiple sensors 6512 may be analog or digital. The plurality of sensors 6512 may include a force gauge for measuring the force exerted on the loading unit 6514 during firing.

[0160] The handle 6504 and adapter 6508 can be configured to interconnect the adapter identification device 6510 and the loading unit identification device 6516 with the controller 6528 via an electrical interface. The electrical interface may be a direct electrical interface (i.e., including electrical contacts that engage with each other to transmit energy and signals therebetween). Additionally or alternatively, the electrical interface may be a contactless electrical interface for wirelessly transmitting (e.g., inductively transmitting) energy and signals therebetween. It is also contemplated that the adapter identification device 6510 and the controller 6528 may wirelessly communicate with each other via a wireless connection that is separate from the electrical interface.

[0161] The handle 6504 may include a transmitter 6506 configured to transmit instrument data from the controller 6528 to other components of the system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522, or the portable device 6526). The transmitter 6506 may also receive data (e.g., cartridge data, loading unit data, or adapter data) from other components of the system 6500. For example, the controller 6528 may transmit instrument data to the console 6528 including the serial number of the mounting adapter (e.g., adapter 6508) attached to the handle 6504, the serial number of the loading unit (e.g., loading unit 6514) attached to the adapter, and the serial number of the multi-fire fastener cartridge (e.g., multi-fire fastener) loaded in the loading unit. The console 6522 may then transmit data (e.g., cartridge data, loading unit data, or adapter data) associated with the attached cartridge, loading unit, and adapter, respectively, back to the controller 6528. The controller 6528 can display a message on the local instrument display or send a message via transmitter 6506 to the console 6522 or portable device 6526 to display the message on the display 6524 or portable device screen, respectively.

[0162] 15A illustrates an exemplary flow for determining an operating mode and operating in the determined mode. The computer-implemented interactive surgical system and / or its components and / or subsystems may be configured to be updated. Such updates may include a mix of features and benefits that were not available to the user prior to the update. These updates may be established by any method of hardware, firmware, and software update suitable for introducing functionality to the user. For example, replaceable / swappable (e.g., hot-swappable) hardware components, flashable firmware devices, and updatable software systems may be used to update the computer-implemented interactive surgical system and / or its components and / or subsystems.

[0163] An update may be contingent on any suitable criterion or set of criteria. For example, an update may be contingent on one or more hardware capabilities of the system, such as processing power, bandwidth, resolution, etc. For example, an update may be contingent on one or more software aspects, such as the purchase of specific software code. For example, an update may be contingent on a purchased service tier. A service tier may represent a feature and / or set of features that a user is entitled to use in connection with the computer-implemented interactive surgical system. A service tier may be determined by a license code, an e-commerce server authentication interaction, a hardware key, a username / password combination, a biometric authentication interaction, a public / private key exchange interaction, etc.

[0164] At 10704, a system / device parameter may be identified. A system / device parameter may be any element or set of elements upon which an update is conditioned. For example, the computer-implemented interactive surgical system may detect a particular bandwidth of communication between a modular device and a surgical hub. For example, the computer-implemented interactive surgical system may detect an indication to purchase a particular service tier.

[0165] At 10708, an operational mode may be determined based on the identified system / device parameters. This determination may be made by a process that maps system / device parameters to operational modes. The process may be a manual and / or automatic process. The process may be the result of local and / or remote computation. For example, a client / server interaction may be used to determine the operational mode based on the identified system / device parameters. For example, local software and / or locally embedded firmware may be used to determine the operational mode based on the identified system / device parameters. For example, a hardware key, such as a secure microprocessor, may be used to determine the operational mode based on the identified system / device parameters.

[0166] At 10710, operation may proceed according to the determined operating mode. For example, the system or device may proceed to operate in a default operating mode. For example, the system or device may proceed to operate in an alternate operating mode. The operating mode may be dictated by control hardware, firmware, and / or software already present in the system or device. The operating mode may be dictated by newly installed / updated control hardware, firmware, and / or software.

[0167] FIG. 15B shows an example functional block diagram for changing the operational mode. The upgradeable element 10714 may include an initialization component 10716. The initialization component 10716 may include any hardware, firmware, and / or software suitable for determining the operational mode. For example, the initialization component 10716 may be part of a system or device startup procedure. The initialization component 10716 may be involved in interactions to determine the operational mode of the upgradeable element 10714. For example, the initialization component 10716 may interact with, for example, a user 10730, an external resource 10732, and / or a local resource 10718. For example, the initialization component 10716 may receive a license key from the user 10730 to determine the operational mode. The initialization component 10716 may query an external resource 10732, such as a server, using the serial number of the upgradeable device 10714 to determine the operational mode. For example, the initialization component 10716 may query local resources 10718, such as a local query to determine the amount of available bandwidth and / or a local query of a hardware key to determine the operating mode, for example.

[0168] The upgradeable element 10714 may include one or more operational components 10720, 10722, 10726, 10728 and an operational pointer 10724. The initialization component 10716 may direct the operational pointer 10724 to direct the operation of the upgradeable element 10741 to the operational components 10720, 10722, 10726, 10728 corresponding to the determined operational mode. The initialization component 10716 may direct the operational pointer 10724 to direct the operation of the upgradeable element to the default operational component 10720. For example, the default operational component 10720 may be selected in the condition that no other alternative operational mode has been determined. For example, the default operational component 10720 may be selected in the condition of an initialization component failure and / or interaction failure. The initialization component 10716 may direct the operation pointer 10724 to direct the operation of the upgradeable component 10714 to the resident operational component 10722. For example, a particular feature may be present in the upgradeable component 10714 but may require activation to operate. The initialization component 10716 may direct the operation pointer 10724 to direct the operation of the upgradeable component 10714 to install new operational components 10728 and / or newly installed operational components 10726. For example, new software and / or firmware may be downloaded. The new software and / or firmware may include code that enables the functionality represented by the selected operational mode. For example, new hardware components may be installed to enable the selected operational mode.

[0169] 16 is a schematic diagram of a surgical instrument 700 configured to operate the surgical tools described herein, according to one embodiment 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 an obturator tube, shaft rotation, and articulation using either single or multiple articulation drive couplings. In one embodiment, the surgical instrument 700 may be programmed or configured to independently control a firing member, a closure member, a shaft member, and / or one or more articulating members. The surgical instrument 700 includes a control circuit 710 configured to control a motorized firing member, a closure member, a shaft member, or one or more articulating members. In one embodiment, the surgical instrument 700 represents a handheld surgical instrument. In another embodiment, the surgical instrument 700 represents a robotic surgical instrument. In other embodiments, the surgical instrument 700 represents a combination handheld and robotic surgical instrument. In various aspects, surgical stapler 700 may represent a linear stapler or a circular stapler.

[0170] In one aspect, the surgical instrument 700 includes a control circuit 710 configured to control the anvil 716 and knife 714 (or cutting element including a sharp cutting blade) portions of the end effector 702, a removable staple cartridge 718, a shaft 740, and one or more articulating members 742a, 742b via multiple motors 704a-704e. A position sensor 734 may be configured to provide position feedback of the knife 714 to the control circuit 710. Other sensors 738 may be configured to provide feedback to the control circuit 710. A timer / counter 731 provides timing and counting information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e can be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.

[0171] In one aspect, control circuitry 710 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the processor(s) to perform one or more tasks. In one aspect, timer / counter 731 provides an output signal, such as an elapsed time or digital count, to control circuitry 710 to correlate the position of knife 714 determined by position sensor 734 with the output of timer / counter 731 so that control circuitry 710 can determine the position of knife 714 at a particular time (t) relative to a starting position or time (t) when knife 714 is at a particular position relative to the starting position. Timer / counter 731 may be configured to measure elapsed time, count an external event, or time an external event.

[0172] In one aspect, 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 closure control program based on the tissue condition. The firing control program can describe the distal movement 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 slower speed and / or with lower power. When thin tissue is present, the control circuit 710 may be programmed to translate the displacement member at a faster speed and / or with higher power. The closure control program may control the closure force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and articulating members 742a, 742b.

[0173] In one aspect, the control circuit 710 can generate motor set point signals. The motor set point signals can be provided to various motor controllers 708a-708e. The motor controllers 708a-708e can include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e as described herein. In some embodiments, the motors 704a-704e can be brushed DC electric motors. For example, the speed of the motors 704a-704e can be proportional to the respective motor drive signals. In some embodiments, the motors 704a-704e can be brushless DC electric motors, and the respective motor drive signals can include PWM signals provided to one or more stator windings of the motors 704a-704e. Also, in some embodiments, the motor controllers 708a-708e can be omitted, and the control circuit 710 can generate the motor drive signals directly.

[0174] In one aspect, the control circuit 710 may initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the displacement member stroke. 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 for a closed-loop configuration. The instrument response may include the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, the total pulse width of the motor drive signal, etc. After the open-loop portion, the control circuit 710 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity.

[0175] In one aspect, the motors 704a-704e may receive power from an energy source 712. The energy source 712 may be a DC power supply driven by a mains AC power supply, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to respective movable mechanical elements, such as the knife 714, the anvil 716, the shaft 740, the articulation 742a, and the articulation 742b, via respective transmissions 706a-706e. The transmissions 706a-706e may include one or more gears or other coupling components for coupling the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the knife 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the knife 714. In some embodiments, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuitry 710 as the knife 714 translates distally and proximally. The control circuitry 710 may track the pulses to determine the position of the knife 714. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the knife 714. Also, in some examples, the position sensor 734 may be omitted. If any of the motors 704a-704e are stepper motors, the control circuitry 710 may track the position of the knife 714 by compiling the number and direction of steps the motor 704 is commanded to perform. The position sensor 734 may be located within the end effector 702 or in any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and an encoder for sensing rotation of the drive shaft.

[0176] In one aspect, the control circuit 710 is configured to drive a firing member, such as the knife 714 portion of the end effector 702. The control circuit 710 provides a motor setpoint to a motor control 708a, which provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a, which is coupled to the knife 714. The transmission 706a includes a movable mechanical element, such as a rotating element and a firing member, for controlling the movement of the knife 714 distally and proximally along the longitudinal axis of the end effector 702. In one aspect, the motor 704a can be coupled to a knife gear assembly including a knife gear reduction set including a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. 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 position of the knife 714 or the firing member along the firing stroke as a feedback signal to the control circuit 710. 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 a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the firing member translates distally, the knife 714, which includes a cutting element positioned at its distal end, advances distally to cut tissue located between the staple cartridge 718 and the anvil 716.

[0177] In one aspect, the control circuit 710 is configured to drive a closure member, such as the anvil 716 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor control 708b, which provides a drive signal to a motor 704b. The output shaft of the motor 704b is coupled to a torque sensor 744b. The torque sensor 744b is coupled to a transmission 706b, which is coupled to the anvil 716. The transmission 706b includes a movable mechanical element, such as a rotating element and a closure member, for controlling movement of the anvil 716 from open and closed positions. In one aspect, the motor 704b is coupled to a closure gear assembly including a closure reduction gear set supported in meshing engagement with a closure spur gear. The torque sensor 744b provides a closure force feedback signal to the control circuit 710. The closure force feedback signal is indicative of the closure force applied to the anvil 716. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 can provide a closure force feedback signal to the control circuit 710. The pivotable anvil 716 is positioned opposite the staple cartridge 718. When ready for use, the control circuit 710 can provide a closure signal to the motor control 708b. In response to the closure signal, the motor 704b advances a closure member that grasps tissue between the anvil 716 and the staple cartridge 718.

[0178] In one aspect, the control circuit 710 is configured to rotate a shaft member, such as the shaft 740, 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 coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission 706c, which is coupled to the shaft 740. The transmission 706c comprises a movable mechanical element, such as a rotating element, for controlling the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is coupled to a rotational transmission assembly including a tubular gear segment formed on (or attached to) the proximal end of the proximal closure tube for operably engaging with a rotary gear assembly operably supported on the tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal is indicative of the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure 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.

[0179] In a circular stapler implementation, a transmission element 706c is coupled to the trocar to advance or retract the trocar. In one aspect, the shaft 740 is part of a closure system including a trocar 201904 and a trocar actuator 201906, as described in detail herein below with reference to FIGS. 19A-19C. Accordingly, the control circuit 710 controls the motor control circuit 708c to control the motor 704c to advance or retract the trocar. A torque sensor 744c is provided to measure the torque applied by the shaft of the motor 704c to the transmission element 706c used in advancing and retracting the trocar. The position sensor 734 may include various sensors for tracking the position of the trocar, the anvil 716, or the knife 714, or any combination thereof. Other sensors 738 may be used to measure various parameters, including the position or velocity of the trocar, the anvil 716, or the knife 714, or any combination thereof. Torque sensor 744c, position sensor 734 and sensor 738 are coupled to control circuit 710 as inputs to various processes for controlling the operation of surgical instrument 700 in a desired manner.

[0180] In one aspect, control circuit 710 is configured to articulate end effector 702. Control circuit 710 provides a motor set point to motor control 708d, which provides a drive signal to motor 704d. The output shaft of motor 704d is coupled to torque sensor 744d. Torque sensor 744d is coupled to transmission 706d, which is coupled to articulation member 742a. ​​Transmission 706d comprises a movable mechanical element, such as an articulation element, for controlling the articulation of end effector 702 by ±65°. In one aspect, motor 704d is coupled to an articulation nut, which is rotatably journaled on a proximal end portion of the distal spine portion and rotatably driven by an articulation gear assembly on the proximal end portion of the distal spine portion. Torque sensor 744d provides an articulation force feedback signal to control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.

[0181] In another embodiment, the articulation function of the robotic surgical system 700 may include two articulation members or links 742a, 742b. These articulation members 742a, 742b are driven by separate disks on a robot interface (rack) driven by two motors 708d, 708e. When a separate firing motor 704a is provided, each of the articulation links 742a, 742b can be driven antagonistically relative to the other link to provide resistive holding motion and load to the head when the head is not moving and articulation motion when the head is articulated. The articulation members 742a, 742b are attached to the head at a defined radius as the head rotates. Therefore, the mechanical advantage of the push-pull connection changes as the head rotates. This change in mechanical advantage may be more pronounced with other articulation connection drive systems.

[0182] In one aspect, one or more of the motors 704a-704e may comprise a brushed DC motor with a gearbox and a mechanical linkage to a firing member, closure member, or articulation member. Another example includes electric motors 704a-704e that operate moving mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are the unmeasured and unpredictable effects of things like tissue, surroundings, and friction on a physical system. Such external influences can be referred to as drag forces acting against one of the electric motors 704a-704e. External influences, such as drag forces, can cause the operation of a physical system to deviate from the desired operation of the physical system.

[0183] 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 rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 734 may be interfaced with the control circuit 710 to provide the absolute positioning system. The position may include multiple Hall effect elements positioned above a magnet and coupled to a CORDIC processor, which is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations, also known as the digit-by-digit method and the Boulder algorithm.

[0184] In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensor 738 may be positioned on the end effector 702 and adapted to operate with the surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensor 738 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 may include one or more sensors. The sensor 738 may be positioned on the deck of the staple cartridge 718 to determine the position of the tissue using split electrodes. The torque sensors 744a-744e may be configured to sense forces, such as firing force, closure force, and / or articulation force, among others. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member in the rack and its position, (3) which portion of the staple cartridge 718 has tissue thereon, and (4) the load and position on both articulation rods.

[0185] In one aspect, the one or more sensors 738 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of strain in the anvil 716 during the clamped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of strain. The sensor 738 may comprise a pressure sensor configured to detect pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. The sensor 738 may be configured to detect the impedance of a portion of the tissue located between the anvil 716 and the staple cartridge 718, which impedance is indicative of the thickness and / or fullness of the tissue located therebetween.

[0186] In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, among others. In other implementations, the sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, or an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include a non-electrical conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.

[0187] In one aspect, the sensor 738 can be configured to measure the force exerted by the closure drive system on the anvil 716. For example, one or more sensors 738 can be located at an interaction point between a closure tube and the anvil 716 to detect the closure force exerted by the closure tube on the anvil 716. The force exerted against the anvil 716 can be representative of tissue compression experienced by a portion of tissue captured between the anvil 716 and the staple cartridge 718. One or more sensors 738 can be positioned at various interaction points along the closure drive system to detect the closure force applied to the anvil 716 by the closure drive system. The one or more sensors 738 can be sampled by a processor in the control circuit 710 in real time during the clamping operation. The control circuit 710 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force applied to the anvil 716 in real time.

[0188] In one aspect, a current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the moving mechanical elements, such as the knife 714, corresponds to the current drawn by one of the motors 704a-704e. The force is converted to 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 software. The displacement member can be actuated to move the knife 714 in the end effector 702 at or near a target velocity. The surgical instrument 700 can include a feedback controller, which can be any one of any feedback controllers, including, but not limited to, a PID, a state feedback, a linear-quadratic (LQR), and / or an adaptive controller. The surgical instrument 700 can include a power supply for converting a signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force. Additional 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.

[0189] The surgical instrument 700 may include wired or wireless communication circuitry for communicating with the modular communications hub as shown in Figures 1-6 and 9-13. The surgical instrument 700 may be a powered circular stapling instrument 201800 (Figure 18), 201000 (Figures 21-22).

[0190] 17 shows a block diagram of a surgical instrument 750 configured to control various functions, according to one embodiment of the present disclosure. In one embodiment, the surgical instrument 750 is programmed to control the distal translation of a displacement member or other suitable cutting element, such as a knife 764. The surgical instrument 750 includes an anvil 766, a knife 764 (including a sharp cutting blade), and an end effector 752, which may include a removable staple cartridge 768.

[0191] The position, movement, displacement, and / or translation of a linear displacement member, such as knife 764, can be measured by an absolute positioning system, a sensor mechanism, and a position sensor 784. Because knife 764 is coupled to a longitudinally movable drive member, the position of knife 764 can be determined by measuring the position of the longitudinally movable drive member using position sensor 784. Accordingly, in the following description, the position, displacement, and / or translation of knife 764 can be achieved by position sensor 784 as described herein. Control circuitry 760 can be programmed to control the translation of a displacement member, such as knife 764. In some embodiments, control circuitry 760 can comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause a processor or processors to control a displacement member, e.g., knife 764, in the manner described. In one aspect, the timer / counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuit 760 to correlate the position of the knife 764 determined by the position sensor 784 with the output of the timer / counter 781 so that the control circuit 760 can determine the position of the knife 764 at a particular time (t) relative to a starting position. The timer / counter 781 may be configured to measure elapsed time, count external events, or time external events.

[0192] The control circuit 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may comprise one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive 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 directly generate the motor drive signal 774.

[0193] The motor 754 can receive power from an energy source 762. The energy source 762 can be or can include a battery, a supercapacitor, or any other suitable energy source. The motor 754 can be mechanically coupled to the knife 764 via a transmission 756. The transmission 756 can include one or more gears or other coupling components for coupling the motor 754 to the knife 764. In one aspect, the transmission is coupled to a trocar actuator of a circular stapler to advance or retract the trocar. The 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 can be or include any type of sensor capable of generating position data indicative of the position of the knife 764. In some examples, the position sensor 784 can include an encoder configured to provide a series of pulses to the control circuitry 760 as the knife 764 translates distally and proximally. The control circuitry 760 can track the pulses to determine the position of the knife 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of knife 764. Also, in some embodiments, position sensor 784 may be omitted. If motor 754 is a stepper motor, control circuit 760 may track the position of knife 764 by tallying the number and direction of steps motor 754 is commanded to take. Position sensor 784 may be located within end effector 752 or in any other portion of the instrument.

[0194] In a circular stapler implementation, the transmission 756 element may be coupled to a trocar to advance or retract the trocar, to a knife 764 to advance or retract the trocar, or to an anvil 766 to advance or retract the anvil 766. These functions may be performed by a single motor using a suitable clutch mechanism, or may be performed using separate motors, as shown, for example, with reference to FIG. 16 . In one aspect, the transmission 756 is part of a closure system that includes a trocar 201904 and a trocar actuator 201906, as described in detail herein below with reference to FIGS. 19A-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 shaft of the motor 754 to the transmission component 756 used in advancing and retracting the trocar, knife 764, or anvil 766, or any combination thereof. 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 coupled to the control circuit 760 as inputs to various processes for controlling the operation of the surgical instrument 750 in a desired manner.

[0195] The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derived parameters, such as time to gap distance, time to tissue compression, and time to anvil strain. The sensors 788 may include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 752. The sensors 788 may include one or more sensors. In one aspect, the sensors 788 may be configured to determine the position of a trocar of a circular stapler.

[0196] The one or more sensors 788 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of strain in the anvil 766 during the clamped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of strain. The sensor 788 may comprise a pressure sensor configured to detect pressure generated by the presence of tissue compressed between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of a portion of the tissue located between the anvil 766 and the staple cartridge 768, which impedance is indicative of the thickness and / or fullness of the tissue located therebetween.

[0197] The sensors 788 may be configured to measure the force exerted on the anvil 766 by the closure drive system. For example, one or more sensors 788 may be located at an interaction point between a closure tube and the anvil 766 to detect the closure force applied to the anvil 766 by the closure tube. The force exerted against the anvil 766 may be representative of tissue compression experienced by a portion of tissue captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force applied to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled by a processor in the control circuitry 760 in real time during the clamping operation. The control circuitry 760 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force applied to the anvil 766 in real time.

[0198] A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the knife 764 corresponds to the current drawn by the motor 754. The force is converted to a digital signal and provided to the control circuit 760.

[0199] The control circuitry 760 can be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the knife 764 in the end effector 752 at or near a target velocity. The surgical instrument 750 can include a feedback controller, which can be one of any feedback controller, for example, but not limited to, a PID, state feedback, LQR, and / or adaptive controller. The surgical instrument 750 can include a power supply for converting a signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force.

[0200] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or knife 764 via a brushed DC motor with a gearbox and mechanical linkage to the articulation and / or knife system. Another example is an electric motor 754 that operates, for example, the displacement member and articulation driver of an interchangeable shaft assembly. External influences are the unmeasured and unpredictable effects of things like tissue, surroundings, and friction on a physical system. These external influences are sometimes referred to as obstacles that act against the electric motor 754. External influences, such as obstacles, can cause the operation of a physical system to deviate from the desired operation of the physical system.

[0201] Various exemplary embodiments are directed to a surgical instrument 750 including an end effector 752 having a motor-driven surgical stapling and cutting means. For example, a motor 754 may drive a displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable anvil 766 and, if configured for use, a staple cartridge 768 disposed 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 depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 can drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the displacement member translates distally, a knife 764 having a cutting element disposed at its distal end can cut tissue between the staple cartridge 768 and the anvil 766 .

[0202] 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 condition. The firing control program may dictate the distal movement of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when 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. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and / or with higher power.

[0203] In some examples, the control circuit 760 may initially operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's stroke. 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 translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to the motor 754 during the open-loop portion, the total pulse width of the motor drive signal, etc. After the open-loop portion, the control circuit 760 may implement the selected firing control program for a second portion of the displacement member's stroke. 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 translation data describing the position of the displacement member to translate the displacement member at a constant velocity. Additional 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.

[0204] The surgical instrument 750 may include wired or wireless communication circuitry for communicating with the modular communications hub as shown in Figures 1-6 and 9-13. The surgical instrument 750 may be a powered circular stapling instrument 201800 (Figure 18), 201000 (Figures 21-22).

[0205] 18 illustrates an exemplary powered circular stapling instrument 201800. The instrument 201800 in this example includes a stapling head assembly 201802, an anvil 201804, a shaft assembly 201806, a handle assembly 201808, and a rotation knob 201812. The stapling head assembly 201802 selectively couples to the anvil 201804. The stapling head assembly 201802 is operable to clamp tissue between the staple pockets and staple forming pockets of the anvil 201804. The stapling head assembly 201802 includes a cylindrical knife operable to cut tissue captured between the stapling head assembly 201802 and the anvil 201804. The stapling head assembly 201802 drives staples through tissue captured between the stapling head assembly 201802 and the anvil 201804. The stapling instrument 201800 can be used to create a fixed anastomosis (e.g., an end-to-end anastomosis) in the gastrointestinal tract or elsewhere in a patient. The outer tubular member 201810 is coupled to the actuator handle assembly 201808. The outer tubular member 201810 provides a mechanical ground between the stapling head assembly 201802 and the handle assembly 201808.

[0206] The stapling head assembly 201802 is operable to clamp tissue, cut tissue, and staple tissue in response to a single rotational input transmitted through the shaft assembly 201806. Thus, although the stapling head assembly 201802 may include a translational clutch mechanism, a linear translational actuation input through the shaft assembly 201806 is not required for the stapling head assembly 201802. By way of example only, at least a portion of the stapling head assembly 201802 may be configured in accordance with at least a portion of the teachings of U.S. Patent Application No. 13 / 716,318, entitled "Motor Driven Rotary Input Circular Stapler with Modular End Effector," filed December 17, 2012, and published June 19, 2014 as U.S. Patent Application Publication No. 2014 / 0166728, the disclosure of which is incorporated herein by reference in its entirety. Other suitable configurations for the stapling head assembly 201802 will be apparent to those skilled in the art in view of the teachings herein.

[0207] The shaft assembly 201806 couples the handle assembly 201808 to the stapling head assembly 201802. The shaft assembly 201806 includes a single actuation mechanism, a rotary driver actuator. Further details regarding the handle assembly 201808 and the rotary driver actuator are disclosed in U.S. patent application Ser. No. 16 / 182,229, filed Nov. 6, 2018, entitled "ADJUSTMENT OF STAPLE HEIGHT OF AT LEAST ONE ROW OF STAPLES BASED ON THE SENSED TISSUE THICKNESS OR FORCE IN CLOSING," the disclosure of which is incorporated herein by reference in its entirety.

[0208] 19A-19C, in this embodiment, the instrument 201800 includes a closure system and a firing system. The closure system includes a trocar 201904, a trocar actuator 201906, and a rotation knob 201812 (FIG. 18). As previously described, the rotation knob 201812 may be coupled to a motor for rotating the rotation knob 201812 in a clockwise or counterclockwise direction. The anvil 201804 may be coupled to a distal end of the trocar 201904. The rotation knob 201812 is operable to longitudinally translate the trocar 201904 relative to the stapling head assembly 201802, thereby translating the anvil 201804 to clamp tissue between the anvil 201804 and the stapling head assembly 201804 when the anvil 201804 is coupled to the trocar 201904. The firing system includes a trigger, a trigger actuation assembly, a driver actuator 201908, and a staple driver 201910. The staple driver 201910 includes a cutting element, such as a knife 201912, configured to cut tissue when the staple driver 201910 is actuated longitudinally. Additionally, the staples 201902 are positioned distally of the plurality of staple drive members 201914 of the staple driver 201910 such that when the staple driver 201910 is actuated longitudinally, the staple driver 201910 also drives the staples 201902 distally. Thus, when the staple driver 201910 is actuated via the driver actuator 201908, the knife 201912 members 201914 substantially simultaneously cut the tissue 201916 while driving the staples 201902 distally relative to the stapling head assembly 201902 and into the tissue. The components and functionality of the closure and launch systems will now be described in more detail.

[0209] As shown in FIGS. 19A-19C , the anvil 201804 is selectively coupleable to the instrument 201800 to provide a surface against which the staples 201902 may be bent to staple material contained between the stapling head assembly 201802 and the anvil 201804. The anvil 201804 in this embodiment is selectively coupleable to a trocar or pointed rod 201904 that extends distally relative to the stapling head assembly 201802. Referring to FIGS. 19A-19C , the anvil 201804 is selectively coupleable to a proximal shaft 201918 of the anvil 201904 via a coupling at the distal tip of the trocar 201904. The anvil 201804 includes a generally circular anvil head 201920 and a proximal shaft 201918 extending proximally from the anvil head 201920. In the illustrated example, the proximal shaft 201918 includes a tubular member 201922 having a resiliently biased retaining clip 201924 for selectively coupling the anvil 201804 to the trocar 201904, although it should be understood that this is merely optional and that other retention mechanisms may also be used for coupling the anvil 201804 to the trocar 201904. For example, a C-clip, a clamp, a thread, a pin, an adhesive, or the like may be used to couple the anvil 201804 to the trocar 201904. Additionally, although the anvil 201804 has been described as being selectively connectable to the trocar 201904, in some variations, the proximal shaft 201918 may include a one-way connection mechanism such that the anvil 201804 cannot be removed from the trocar 201904 once the anvil 201804 is attached. By way of example, one-way features include barbs, one-way snaps, collets, collars, tabs, bands, and the like. Of course, still other configurations for connecting the anvil 201804 to the trocar 201904 will be apparent to those skilled in the art in view of the teachings herein. For example, the trocar 201904 may instead be a hollow shaft, and the proximal shaft 201918 may include a pointed rod insertable into the hollow shaft.

[0210] The anvil head 201920 of the present example includes a plurality of staple forming pockets 201936 formed in a proximal face 201940 of the anvil head 201920. Thus, as shown in FIG. 19C , when the anvil 201804 is in the closed position and staples 201902 are driven from the stapling head assembly 201802 into the staple forming pockets 201936, the legs 201938 of the staples 201902 are bent to form completed staples.

[0211] In the case of the anvil 201804 as a separate component, it should be understood that the anvil 201804 may be inserted into and secured to a portion of the tissue 201916 before being coupled to the stapling head assembly 201802. By way of example only, the anvil 201804 may be inserted into and secured to a first tubular portion of the tissue 201916, with the instrument 201800 inserted into and secured to a second tubular portion of the tissue 201916. For example, the first tubular portion of the tissue 201916 may be sutured to or around a portion of the anvil 201804, and the second tubular portion of the tissue 201916 may be sutured to or around the trocar 201904.

[0212] As shown in FIG. 19A , the anvil 201804 is then coupled to the trocar 201904. The trocar 201904 in this example is shown in its distal-most, operative position. This extended position of the trocar 201904 provides a larger area onto which tissue 201916 can be coupled prior to attaching the anvil 201804. Additionally, the extended position of the trocar 20190400 may make it easier to load the anvil 201804 onto the trocar 201904. The trocar 201904 further includes a tapered distal tip. While such a tip can aid in piercing tissue and / or inserting the anvil 201804 into the trocar 201904, the tapered distal tip is merely optional. For example, in other variations, the trocar 201904 may have a blunt tip. Additionally or alternatively, the trocar 201904 may include a magnetic portion (not shown) that can attract the anvil 201804 toward the trocar 201904. Of course, still other configurations and arrangements for the anvil 201804 and trocar 201904 will be apparent to those skilled in the art in view of the teachings herein.

[0213] When the anvil 201804 is coupled to the trocar 201904, the distance between the proximal face of the anvil 201804 and the distal face of the stapling head assembly 201802 defines the gap distance d. The trocar 201904 of this embodiment is longitudinally translatable relative to the stapling head assembly 201802 via an adjustment knob 201812 ( FIG. 18 ) located at the proximal end of the actuator handle assembly 201808 ( FIG. 18 ), as described in detail below. Consequently, when the anvil 201804 is coupled to the trocar 201904, actuation of the anvil 201804 relative to the stapling head assembly 201802 causes rotation of the adjustment knob 201812 to increase or decrease the gap distance d. For example, as shown sequentially in FIGURES 19A and 19B, the anvil 201804 is shown being actuated proximally relative to the actuator handle assembly 201808 from an initial open position to a closed position, thereby decreasing the gap distance d and the distance between the two portions of tissue 201916 to be joined. Once the gap distance d is within a predetermined range, the stapling head assembly 201802 can be fired to staple and cut the tissue 201916 between the anvil 201804 and the stapling head assembly 201802, as shown in FIGURE 19C. The stapling head assembly 201802 is operable to staple and cut the tissue 201916 by triggering the actuator handle assembly 201808, as described in more detail below.

[0214] 19A-19C, a user sutures a portion of the tissue 201916 around the tubular member 201944 so that the anvil head 201920 is positioned within the portion of the tissue 201916 to be stapled. Once the tissue 201916 is attached to the anvil 201804, the retaining clip 201924 and a portion of the tubular member 201922 protrude outward from the tissue 201916 so that a user can couple the anvil 201804 to the trocar 201904. With the tissue 201916 coupled to the trocar 201904 and / or another portion of the stapling head assembly 201802, a user attaches the anvil 201804 to the trocar 201904 and actuates the anvil 201804 proximally toward the stapling head assembly 201802 to reduce the gap distance d. Once the instrument 201800 is within the operating range, the user then staples the ends of the tissue 201916 together, thereby forming a substantially continuous tubular portion of tissue 201916.

[0215] The stapling head assembly 201802 of this example is coupled to a distal end of a shaft assembly 201806 and includes a tubular casing 201926 that houses a slidable staple driver 201910 and a plurality of staples 201902 contained within staple pockets 201928. The shaft assembly 201806 of this example includes an outer tubular member 201942 and a driver actuator 201908. The staples 201902 and staple pockets 201928 are disposed in a circular array about the periphery of the tubular casing 201926. In this example, the staples 201902 and staple pockets 201928 are disposed as a pair of concentric circular rows of staples 201902 and staple pockets 201928. The staple driver 201910 is operable to actuate longitudinally within the tubular casing 201926 in response to rotation of the actuator handle assembly 201808 ( FIG. 18 ). As shown in FIGS. 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 circumferentially disposed about the central recess 201932 and extending distally relative to the shaft assembly 201806. Each member 201914 is configured to contact and engage a corresponding staple 201902 of the plurality of staples 201902 in the staple pocket 201928. Thus, when the staple driver 201910 is actuated distally relative to the actuator handle assembly 201808, each member 201914 drives a corresponding staple 201902 from its staple pocket 201928, through a staple hole 201934 formed in the distal end of the tubular casing 201926. As each member 201914 extends from the staple driver 201910, multiple staples 201902 are driven from the stapling head assembly 201802 substantially simultaneously.When the anvil 201804 is in the closed position, the staples 201902 are driven into the staple forming pockets 201936, bending the legs 201938 of the staples 201902, thereby stapling material located between the anvil 201804 and the stapling head assembly 201808. FIG. 20 shows, by way of example, the staples 201902 being driven by the member 201914 into the staple forming pockets 201928 of the anvil 201804, bending the legs 201938.

[0216] 18-21, the powered circular stapling instruments 201800, 201000 described herein may be controlled using any of the control circuits described in connection with Figures 7-8 and 16-17, such as control system 470 described in connection with Figure 7. Additionally, the powered circular stapling instrument 201800 may be used in a hub and cloud environment as described in connection with Figures 1-6 and 9-13.

[0217] 21 is a partial cutaway view of a powered circular stapling apparatus 201000 including a circular stapling head assembly 201002 and an anvil 201004, in accordance with at least one embodiment of the present disclosure. The powered circular stapling apparatus 20100 is shown clamping a first portion of tissue 201006 and a second portion of tissue 201008 between the anvil 201004 and the circular stapling head assembly 201002. Compression of the tissue 201006, 201008 between the anvil 201004 and the circular stapling head assembly 201002 is measured with a sensor 201018, such as, for example, a strain gauge. The circular stapling head assembly 201002 also includes a knife 201019 that can advance at different speeds to cut through the tissue 201006, 201008 clamped between the anvil 201004 and the circular stapling head assembly 201002 after the inner and outer rows of staples 201010, 201014 have been fired and formed against corresponding staple forming pockets 201011, 201015 in the anvil 201004.

[0218] 22 is a partial top view of the circular stapling head assembly 201002 shown in FIG. 21 illustrating a first row of staples 201010 (inner staples) and a second row of staples 201014 (outer staples) in accordance with at least one embodiment of the present disclosure. The inner row of staples 201010 and the second row of staples 201014 are independently actuatable by a first staple driver 201012 and a second staple driver 201016.

[0219] 21 and 22, when tissue 201006, 201008 is clamped between the anvil 201004 and the circular stapling head assembly 201002, a first gap δ1 is set between the inner row of staples 201010 and a second gap δ2 is set between the outer row of staples 201014. As tissue compression increases or as the tissue gaps δ1, δ2 decrease, the nominal staple height in the center of the window adjusts. The first staple driver 201012 drives the inner row of staples 201010 through the tissue 201006, 201008, causing the inner row of staples 201010 to form against the anvil 201004. Thereafter, the second staple driver 201016 independently drives the outer row of staples 201010 through the tissue 201006 , 201008 and the outer row of staples 201014 is formed against the anvil 201004 .

[0220] The independently actuable staple rows 201010, 201014 can be formed based on the FTC clamped by the anvil 201004 on the tissue 201006, 201008, or the tissue gap δ1, δ2 between the anvil 201004 clamp and the circular stapling head assembly 201002. Adjusting the staple height of at least one row of staples based on the sensed tissue thickness or FTC focuses on adjusting a selection window based on the thickness / closing load of the tissue 201006, 201008. In other aspects, the user-adjustable range of selectable staple heights can be changed based on tissue load detected during retraction of the anvil 201004. As tissue compression (e.g., FTC) increases or the tissue gap δ1, δ2 decreases, the nominal staple height at the center of the window can be adjusted as described herein with reference to FIG. 23 . In other aspects, adjustment of the acceptable staple window range is indicated as compression increases or the tissue gap decreases. In other aspects, once tissue compression and then tissue stabilization is complete, the acceptable range can be further adjusted based on tissue creep rate and wait time.

[0221] 24 is a graphical illustration of a first pair of graphs 202000, 202020 depicting anvil gap and tissue compression force F versus time for an exemplary firing of a stapling instrument in accordance with at least one embodiment of the present disclosure. Tissue compression force F may also be expressed as force to close (FTC). Top graph 202000 shows three separate anvil gap curves 202002, 202004, 202006 representing closure of the anvil gap over time at three separate tissue compression forces as shown in bottom graph 202020, where anvil gap δ is shown along the vertical axis and time is shown along the horizontal axis. Anvil gap curves 202002, 202004, 202006 represent anvil closure of a powered circular stapling apparatus 202080 (FIG. 26) as a function of time t for variable tissue stiffness, constant thickness, and constant anvil gap δ until an adjustment of the anvil gap δ is made by the control algorithm. The control algorithm implemented by any of the control circuits described herein with reference to FIGS. 7-8 and 16-17 can be configured to adjust the anvil gap according to a sensed tissue compression force F compared to one or more various thresholds. Further details regarding the control circuit are disclosed in U.S. patent application Ser. No. 16 / 182,229, filed Nov. 6, 2018, entitled "ADJUSTMENT OF STAPLE HEIGHT OF AT LEAST ONE ROW OF STAPLES BASED ON THE SENSED TISSUE THICKNESS OR FORCE IN CLOSING," the disclosure of which is incorporated herein by reference in its entirety.

[0222] Referring now briefly to FIG. 26 , a schematic diagram of a powered circular stapling device 202080 is shown illustrating an effective tissue gap δy, an actual gap δactual, a normal range gap δ2, and an out-of-range gap δ3, in accordance with at least one embodiment of the present disclosure. The powered circular stapling device 202080 includes a circular stapler 202082 and an anvil 202084, which retracts from an open position to a closed position to clamp tissue between the anvil 202084 and the stapler 202082. When the anvil 202084 is fully clamped on the tissue, a defined gap δ exists between the anvil 202084 and the stapler 202082. When the circular stapler 202082 is fired (e.g., actuated), staple formation is dependent on the tissue gap δ. As shown in FIG. 26 , for a normal range gap δ2, the staple 202088 is successfully formed. When the gap δ is too small, the staples 202086 are formed too densely, and when the gap δ is too large, the staples 202090 are formed too sparsely.

[0223] Returning now to FIG. 24 and referring to the upper and lower graphs 202000, 202020, and FIG. 26, at time t0, the anvil 201084 initially opens past the maximum anvil gap δ before the anvil 201084 reaches the initial tissue contact point 202008 at time t1. As shown, due to 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 firing zone 202016, defined between the maximum anvil gap δ, which defines the upper firing lockout threshold 202012, and the minimum anvil gap δ, which defines the lower firing lockout threshold 202014. As the anvil 201084 continues to close, the tissue compression 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 the graph 202020 below, normal stiffness tissue is represented by the first tissue compressive force curve 202022, high stiffness tissue is represented by the second tissue compressive force curve 202024, and low stiffness tissue is represented by the third tissue compressive force curve 202026.

[0224] As the anvil 201084 continues to close between the maximum anvil gap δmax and the minimum anvil gap δmin, the anvil gap δmin reaches a point of constant anvil gap 202018 at time t2. As shown in graph 202020 below, at time t2, the tissue compressive force F for normal stiffness tissue represented by first tissue compressive force curve 202022 is within an ideal firing zone 202036 defined between a maximum compressive force Fmax that defines an upper warning threshold 202032 and a minimum compressive force Fmin that defines a lower warning threshold 202034. At time t2, the tissue compression force F for the high stiffness tissue represented by the second tissue compression force curve 202024 exceeds the upper warning threshold 202032 outside the ideal firing zone 202036, and the tissue compression force F for the low stiffness tissue represented by the third tissue compression force curve 202026 is below the lower warning threshold 202034 outside the ideal firing zone 202036.

[0225] 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 constant gap δ allows for tissue creep, during which the average tissue compressive force F slowly decreases, as shown in the lower graph 202020 by the three tissue compressive force curves 202022, 202024, and 202026. Tissue creep is the phase entered after the average tissue compressive force F reaches a predetermined threshold and the closing movement of the anvil 201084 so that the anvil 201084 and stapler 202082 hold the tissue therebetween for a predetermined period of time before initiating the firing phase in which the tissue is grasped and the staples and knife are deployed. During the tissue creep phase, the average tissue compressive force F decreases over the period of time between t2 and t3. Tissue tends to stretch when compressed, in part because it is composed of solid and liquid materials. One way to consider this characteristic is "tissue creep." When tissue is compressed, a certain amount of tissue creep can occur. Therefore, when tissue is compressed, the proper time under certain circumstances to achieve tissue creep can be beneficial. One benefit can be proper staple formation, which can contribute to a consistent staple line. Therefore, a specific amount of time can be allowed to enable tissue creep prior to firing.

[0226] 17 , after a period during which the anvil gap δ is held constant to allow for tissue creep, at time t3, and prior to deploying the staples, the control circuit 760 determines at point 202010 whether a possible adjustment of the anvil 766 (anvil 201804 and stapler 202084 of FIG. 26 ) relative to the staple cartridge 764 is necessary. Thus, the control circuit 760 determines whether the tissue compression force F is between the ideal firing zone 202036, exceeds the maximum compression force Fmax threshold 202032, or is below the minimum compression force Fmin threshold 202034, and makes any necessary adjustments to the anvil gap δ. If the tissue compression force F is between the ideal firing zone 202036, the control circuit 760 deploys the staples in the staple cartridge 768 and deploys the knife 764.

[0227] 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 adjust the anvil gap δ, increase the wait time before firing, decrease the firing rate, or enable a fire 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 (anvil 201804 and stapler 202084 in FIG. 26 ), to increase the anvil gap δ, as shown by the segment of the anvil gap curve 2002004 that exceeds time t3. After the control circuit 760 increases the anvil gap δ, the tissue compression force F decreases toward the ideal firing zone 202036, as shown by the segment of the tissue compression force curve 202024 that exceeds time t3.

[0228] If the tissue compression force F falls below the minimum compression force Fmin threshold 202034, the control circuit 760 is configured to register a warning that the compression force is too weak and adjust the anvil gap δ, proceed with caution, or enable firing lockout, or any combination thereof. The control circuit 760 is configured to adjust the anvil gap δ by retracting the anvil 766 proximally, for example, toward the staple cartridge 768 (anvil 201804 and stapler 202084 in FIG. 26 ), to decrease the anvil gap δ as shown by the segment of the anvil gap curve 2002006 beyond time t3, where after decreasing the anvil gap δ, the tissue compression force F increases into the ideal firing zone 202036, as shown by the segment of the tissue compression force curve 202026 beyond time t3.

[0229] 25, shown is a graphical illustration of a second pair of graphs 202040, 202060 illustrating anvil gap and tissue compression force F versus time for an exemplary firing of a stapling instrument in accordance with at least one embodiment of the present disclosure. The top graph 202040 shows three separate anvil gap curves 202042, 202046, 202046 representing anvil gap closure over time at three separate 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 anvil closure of the powered circular stapling apparatus 202080 (FIG. 26) as a function of time t for variable tissue thicknesses, constant stiffness, and a constant anvil gap δ until an adjustment of the anvil gap δ is made by the 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 the sensed tissue compression force F compared to one or more various thresholds.

[0230] 26, the anvil 201084 first opens beyond the maximum anvil gap δ at time t before the anvil 201084 reaches the first tissue contact point 202048 for the thick tissue at time t where the tissue compression force curve 202064 for the thick tissue begins to increase. At time t, the anvil gap δ is still outside the ideal firing zone 202056 defined between the maximum anvil gap δ, which defines the upper firing lockout threshold 202052, and the minimum anvil gap δ, which defines the lower firing lockout threshold 202054. As shown, with constant tissue stiffness and variable tissue thickness, the anvil 201084 contacts the tissue at different times. For example, time t1 is the first tissue contact point 202048 for thick tissue, time t2 is the second tissue contact point for normal thickness tissue, and time t3 is the third tissue contact point 202058 for thin tissue.

[0231] The first tissue compression force curve 202062 represents the compression force for normal thickness tissue and begins to increase at time t2 when the normal thickness tissue first contacts the anvil 201804. The second tissue compression force curve 202064 represents thick tissue and begins to increase at time t1 when the thick tissue first contacts the anvil 201804. The third tissue compression force curve 202066 represents thin tissue and begins to increase at time t3 when the thin tissue first contacts the anvil 201804. At the second and third tissue contact points at times t2 and t3, the anvil gap δ is within the ideal firing zone 202056, 202076 for normal and thin tissue. The tissue compression force F will vary as a function of the biomechanical properties of the tissue thickness. As shown in graph 202040 below, normal thickness tissue is represented by first tissue compression force curve 202042, thick tissue is represented by second tissue compression force curve 202044, and low stiffness tissue is represented by third tissue compression force curve 202066. From the initial tissue contact points at times t1, t2, and t3, as the anvil 201084 continues to close, the tissue compression force per curves 202062, 202064, and 202066 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.

[0232] As the 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 normal thickness tissue represented by first tissue compressive force curve 202062 is within an ideal firing zone 202076 defined between a maximum compressive force Fmax that defines an upper warning threshold 202072 and a minimum compressive force Fmin that defines a lower warning threshold 202074. At time t4, the tissue compression force F for the thick tissue represented by the second tissue compression force curve 202064 exceeds the upper warning threshold 202072 outside the ideal firing zone 202076, and the tissue compression force F for the thin tissue represented by the third tissue compression force curve 202066 is below the lower warning threshold 202074 outside the ideal firing zone 202076.

[0233] From time t4 to time t5, the anvil 201084 is maintained at a constant gap δ, as shown in the top graph 202040 by the 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 in the bottom graph 202060 by the three tissue compressive force curves 202062, 202064, and 202066. Tissue creep is the phase entered after the average tissue compressive force F reaches a predetermined threshold and the closing movement of the anvil 201084 so that the anvil 201084 and stapler 202082 hold the tissue therebetween for a predetermined period of time before initiating the firing phase in which the tissue is grasped and the staples and knife are deployed. During the tissue creep phase, the average tissue compressive force F decreases over the period of time between t2 and t3. Tissue tends to stretch when compressed, in part because it is composed of solid and liquid materials. One way to consider this characteristic is "tissue creep." When tissue is compressed, a certain amount of tissue creep can occur. Therefore, when tissue is compressed, the proper time under certain circumstances to achieve tissue creep can be beneficial. One benefit can be proper staple formation, which can contribute to a consistent staple line. Therefore, a specific amount of time can be allowed to enable tissue creep prior to firing.

[0234] 17 , after a period during which the anvil gap δ is held constant to allow for tissue creep, at time t5, prior to deploying the staples, at point 202050, the control circuit 760 determines whether a possible adjustment of the anvil 766 (anvil 201804 and stapler 202084 of FIG. 26 ) relative to the staple cartridge 764 is necessary. Thus, the control circuit 760 determines whether the tissue compression force F is between the ideal firing zone 202076, exceeds the maximum compression force Fmax threshold 202072, or is below the minimum compression force Fmin threshold 202074, and makes any necessary adjustments to the anvil gap δ. If the tissue compression force F is between the ideal firing zone 202076, the control circuit 760 deploys the staples in the staple cartridge 768 and deploys the knife 764.

[0235] If the tissue compression force F exceeds the maximum compression force Fmax threshold 202072, the control circuit 760 is configured to register a warning that the compression force is too strong and adjust the anvil gap δ, increase the wait time before firing, decrease the firing rate, enable a fire 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 (anvil 201804 and stapler 202084 in FIG. 26 ), to increase the anvil gap δ, as shown by the segment of the anvil gap curve 2002044 that exceeds time t5. After the control circuit 760 increases the anvil gap δ, the tissue compression force F decreases toward the ideal firing zone 202076, as shown by the segment of the tissue compression force curve 202064 that exceeds time t5.

[0236] If the tissue compression force F falls below the minimum compression force Fmin threshold 202074, the control circuit 760 is configured to register a warning that the compression force is too weak and can adjust the anvil gap δ, proceed with caution, or enable firing lockout, or any combination thereof. The control circuit 760 is configured to adjust the anvil gap by retracting the anvil 766 proximally, for example, toward the staple cartridge 768 (anvil 201804 and stapler 202084 in FIG. 26 ), thereby decreasing the anvil gap δ, as shown by the segment of the anvil gap curve 202046 that exceeds time t5. After decreasing the anvil gap δ, the tissue compression force F increases toward the ideal firing zone 202076, as shown by the segment of the tissue compression force curve 202066 that exceeds time t5.

[0237] 24 and 25 , in one aspect, the anvil gap δ may be determined by the controller 620 based on readings from the closure motor 603, for example, as described with reference to FIG. 8 . In one aspect, the anvil gap δ may be determined by the control circuitry 710 based on readings from a position sensor 734 coupled to the anvil 716, for example, as described with reference to FIG. 16 . In one aspect, the anvil gap δ may be determined by the control circuitry 760 based on readings from a position sensor 784 coupled to the anvil 766, for example, as described with reference to FIG. 17 .

[0238] 24 and 25 , in one aspect, tissue compression force F may be determined by controller 620 based on readings from closure motor 603, as described with reference to FIG. 8 . For example, tissue compression force F may be determined based on a motor draw current, with higher draw current during anvil closure being associated with higher tissue compression force. In one aspect, tissue compression force F may be determined by control circuit 710 based on readings from a sensor 738, such as a strain gauge, coupled to anvil 716 or staple cartridge 718, as described with reference to FIG. 16 . In one aspect, tissue compression force F may be determined by control circuit 760 based on readings from a sensor 788, such as a strain gauge, coupled to anvil 766, as described with reference to FIG. 17 .

[0239] 27 is a logic flow diagram of a process 202100 illustrating a control program or logic configuration for providing optional or mandatory lockout according to sensed parameters compared to thresholds, according to at least one embodiment of the present disclosure. As shown in FIG. 27, according to a comparison of the measured anvil gap against one or more thresholds and the measured tissue compression force F (otherwise referred to as FTC) against one or more thresholds, the control algorithm can cause the instrument to fire (e.g., activate) indefinitely, implement optional lockout (e.g., provide a warning to the user), or implement mandatory lockout of the instrument.

[0240] 17, 26, and 27, process 202100 will be described with reference to FIGS. 17-25. Control circuit 760 implements an algorithm that performs process 202100, where anvil 766 of FIG. 17 is shown as anvil 202084 in FIG. 26, and staple cartridge 768 of FIG. 17 is shown as stapler 202082 in FIG. 26. Further details regarding the construction and operation of powered circular stapling device 202080 are described herein with reference to FIGS. 18-20. Returning to process 202100, control circuit 760 determines anvil gap δ based on readings from position sensor 784 coupled to anvil 766, as described in connection with FIGS. 24 and 25. When anvil gap δ is δ3 > δMax, the anvil gap is out of range, and control circuit 760 engages force 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 202106 the tissue compression force F(FTC), as described with reference to FIGURE 29. As described above, the tissue compression force may be determined by the control circuit 760 based on readings from a strain gauge sensor 788 coupled to the anvil 766 or staple cartridge 768. Alternatively, the tissue compression force may be determined based on the current drawn by the motor 754.

[0241] 27 and 29, when the FTC is less than the ideal FTC threshold (X1 < Ideal FTC), i.e., in Zone A of FIG. 29, the control circuit 760 implements 202108 an unlimited electronic lockout. When the FTC is between the maximum FTC threshold and the ideal FTC threshold (Max > X2 > Ideal), i.e., in Zone B of FIG. 29, the control circuit 760 implements 202110 an unlimited discretionary electronic lockout. In one aspect, 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 FIG. 29, the control circuit implements 202112 a discretionary electronic lockout with a limit. 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 aspects, the powered circular stapling device 202080 includes an adjustable electronic lockout as described herein that can prevent actuation of the 202082 stapler or adjust the functionality of the powered circular stapling device 202080 based on sensed conditions and secondary measurements.

[0242] In one aspect, the control algorithm of the powered circular stapling apparatus 202080, described herein as process 202100, can be configured to initiate optional and mandatory lockouts based on threshold conditions and requirements for operation of the powered circular stapling apparatus 202080. In one aspect, the process 202100 for the powered circular stapling apparatus 202080 can be configured to implement both optional and mandatory lockouts based on sensed parameters within the system. An optional lockout pauses automatic execution of a sequence but may be overridden by, for example, user input. A mandatory lockout prevents the next sequential step and forces the user to abort the operation, for example, by overriding the lockout condition that triggered the lockout. In one aspect, both optional and mandatory lockouts can have both upper and lower thresholds. Thus, the powered circular stapling apparatus 202080 can include a combination of optional and mandatory lockouts.

[0243] In one aspect, the control algorithm of the powered circular stapling apparatus 202080 described herein as process 202100 can be configured to adjust an electronic lockout that can prevent operation of the system or adjust its function based on sensed conditions and secondary measurements. The sensed conditions can be FTC, anvil displacement, gap δ, staple formation, and the secondary measurements can include, for example, fault severity, user input, or a predetermined comparison lookup table.

[0244] In one aspect, the response of a mandatory electronic lockout is to prohibit function of the powered circular stapling device 202080 until the condition is resolved. Conversely, the response to a discretionary lockout may be more subtle. For example, a discretionary lockout could include a warning indication, an alert requiring user consent to proceed, a change in the speed or force of actuation or wait time, or prohibition of certain functions until the condition is resolved or stabilized. During operation, a mandatory condition for the powered circular stapling device 202080 could include, for example, having a fully seated anvil 202084 before clamping or having staples loaded in the stapler cartridge before firing. A viable condition for the powered circular stapling device 202080 could include, for example, being within an allowable staple height for a given tissue thickness or minimum tissue compression. Furthermore, various conditions could have both a discretionary level threshold and a mandatory level threshold for the same parameter, for example, the power level in the battery pack.

[0245] In one aspect, the powered circular stapling device 202080 can be configured to implement various control mechanisms to prevent or adjust the functionality of the powered circular stapling device 202080 based on the lockout type. In one aspect, a mandatory lockout can be considered simply an electronic, mechanical interlock, or a combination of the two. In various aspects having two lockouts, the lockouts can be considered redundant or optionally used based on the device settings. In one aspect, any lockout can be an electronic lockout, such that it can be adjustable based on sensed parameters. For example, any lockout can be considered a mechanical interlock that is electronically disabled, or simply an electronic lockout.

[0246] 28 is a diagram illustrating anvil gap ranges and corresponding staple formation, according to at least one embodiment of the present disclosure. When the anvil gap 202120 is between the upper limit 202126 and the lower limit 202128, staple formation is adequate and within the acceptable range of staple heights for a given range of tissue thickness or minimum tissue compression force. When the anvil gap 202122 is greater than the upper limit 202126, staple formation is loose. When the anvil gap 202124 is less than the lower limit 202128, staple formation is tight.

[0247] 29 is a graph 202150 of three force to close (FTC) curves 202152, 202154, 202156 versus time, in accordance with at least one embodiment of the present disclosure. The FTC curves 202152, 202154, 202156 are divided into three phases: clamping, waiting, and firing. The clamping phases have a common starting point, meaning that the tissue has a common thickness and variable tissue stiffness, as described in detail in FIG. 24. At the end of the clamping phase, there is a waiting period before initiating the firing phase to account for tissue creep.

[0248] The first FTC curve 202152 corresponds to tissue having low tissue stiffness. During the clamping phase, the FTC curve 202152 shows an increase in tissue compressive force that peaks below the ideal FTC threshold 202158 in Zone A. At the end of the clamping phase, the powered circular stapling apparatus 202080 (FIG. 26) waits a user-controlled period 202162 before beginning the firing phase to account for tissue creep.

[0249] The second FTC curve 202154 corresponds to tissue with normal tissue stiffness. During the clamping phase, the FTC curve 202154 shows an increase in tissue compressive force that peaks between the ideal FTC threshold 202158 and the maximum FTC threshold 202160 in Zone B. At the end of the clamping phase, the powered circular stapling apparatus 202080 (FIG. 26) waits a user-controlled period 202164 before beginning the firing phase to account for tissue creep.

[0250] The third FTC curve 202154 corresponds to tissue with high tissue stiffness. During the clamping phase, the FTC curve 202156 shows an increase in tissue compressive force with a peak above the maximum FTC threshold 202160 in Zone C. At the end of the clamping phase, the powered circular stapling device 202080 (FIG. 26) controls the wait period 202166 before commencing the firing phase to account for tissue creep.

[0251] 30 is a detailed graphical illustration 202170 of an FTC curve 202172 versus time, in accordance with at least one embodiment of the present disclosure. As shown, the FTC curve 202172 is divided into three phases: a clamping phase, a wait phase, and a firing phase. During the clamping phase, the FTC curve 202172 exhibits and increases tissue compression force, as indicated by the clamping phase segment 202174. After the clamping phase, there is a wait period 202176 before initiating the firing phase. The wait period 202176 can be either user or device controlled depending on the tissue compression force values ​​relative to the ideal and maximum compressive force thresholds. During the firing phase, the tissue compression force increases and then decreases, as indicated by the FTC curve segment 202178.

[0252] In various aspects, the closure speed or direction of the circular stapler, or a combination thereof, can be adjusted relative to the fully attached state of the anvil based on the sensed attachment. In one aspect, the present disclosure provides a digitally enabled circular stapler algorithm for determining changes in the closure speed of the anvil at key locations on the trocar to ensure proper seating of the anvil on the trocar. FIGURE 31 is a diagram 201500 of a powered stapling apparatus 201502 and a graph 201504 illustrating closure speed adjustments of the anvil 201514 portion of the powered stapling apparatus 201502 at specific key points along the retraction stroke of the trocar 201510 in accordance with at least one aspect of the present disclosure. The powered stapling device 201502 is similar to the powered circular stapling instrument 201800 described herein with reference to Figures 18-20 and may be controlled using any of the control circuits described in connection with Figures 7-8 and 16-17 and may be used in a hub and cloud environment as described in connection with 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 aspect, the speed of closure of the anvil 201514 can be adjusted at certain key points along the retraction stroke of the trocar 201510 to improve final seating of the anvil 201514 on the trocar 201510 when the trocar 201510 is slightly, but not fully, attached to the anvil 201514.

[0253] The powered stapling device 201502 shown on the left side of FIG. 31 includes a circular stapling head assembly 201506 having a seating collar 201508 that receives a trocar 201510 therethrough. The trocar 201510 engages with an anvil 201514 via a locking feature 201512. The trocar 201510 is movable in the directions indicated by arrow 201516, e.g., advanced and retracted. A cutting element, such as a knife 201519, cuts tissue as the circular stapling head assembly 201506 is driven toward the anvil 201514. In one aspect, the closure speed of the anvil 201514 can be adjusted at certain key points along the retraction stroke of the anvil 201510 to improve the final seating of the anvil 201514 on the trocar 201510, for example, when the trocar 210510 is slightly but not fully attached to the anvil 201514. Thus, the closure speed of the anvil 201514 can be varied at key locations to ensure proper seating. The position or displacement of the trocar 210510 as it is advanced or retracted by a trocar actuator coupled to a motor can be detected by multiple proximity sensors disposed along the displacement path of the trocar 210510. In some aspects, the position or displacement of the trocar 210510 may be tracked using the tracking system 480 (FIG. 7) or position sensors 734, 784 (FIGS. 16, 17).

[0254] On the right side of FIG. 31 , a graph 201504 shows the closure speed of the anvil 201514 as a function of the position of the trocar 201510 at certain cardinal points labeled "δ trocar" along the vertical axis and "V closure mm / sec" along the horizontal axis, in accordance with at least one embodiment of the present disclosure. Anvil 201514 closure speed profile curve 201505 is plotted as a function of the position of the trocar 201510. The closure speed of the anvil 201514 may be slowed in a first zone 201518 to ensure proper attachment of the trocar 210510 to the anvil 201514, faster in a second zone 201520 during closure, slowed again in a third zone 201522 to confirm attachment, and then slowed even more in a fourth zone 201524 during application of a high closure load.

[0255] Adjusting the closure 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 slightly but not fully seated. At trocar 201510 position δ0, the anvil 201514 is in a fully open position 201521, and at trocar 201510 position δ4, the anvil 201514 is in a fully closed position 201523. Between the fully open position 201521 δ0 and the fully closed position δ4 of the trocar 201510, the closure speed of the anvil 201514 is adjusted based on the position of the trocar 201510. For example, in the first zone 201518, as the trocar 201510 moves from the fully open position 201521 δ0 to the first trocar 201510 position δ1, 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, as 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, as the trocar 201510 moves from the δ2 ​​position to the δ3 position, the closing speed of the anvil 201514 is slowed to ensure full attachment of the anvil 201514 to the trocar 201510. Finally, as the trocar 201510 moves from position δ3 to position δ4 in the fourth zone 201524, the closure rate of the anvil 201514 slows again during high closure loads.

[0256] 32 is a logic flow diagram of a process 201700 illustrating a control program or logic configuration for adjusting the closure speed of the anvil 201514 portion of the powered stapling apparatus 201502 at specific key points along the retraction stroke of the trocar 201510, in accordance with at least one embodiment of the present disclosure. This process 201700 may be implemented in conjunction with any of the control circuits described with reference to FIGS. 7-8 and 16-17. This process 201700 may be implemented within a hub or cloud computing environment, for example, as described with reference to FIGS. 1-6 and 9-13.

[0257] Specifically, the process 201700 shown in Figure 32 will be described with reference to the control circuit 760 of Figure 17. The control circuit 760 determines 201702 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 the sensor 788 or the timer / counter 781 circuit, or a combination thereof. Based on the position of the trocar 201510, the control circuit 760 controls the closure speed (Vclosure mm / sec) of the anvil 201514 as a function of the position of the trocar 201510 at certain cardinal points, in accordance with at least one embodiment of the present disclosure. Thus, when the position of the trocar 201510 is within a first zone 201518 in which the anvil 201514 is attached to the trocar 201510, the process 201700 continues along the YES (Y) branch and the control circuit 760 sets 201704 the closure speed of the anvil 201514 to slow down to ensure proper attachment of the trocar 201510 to the anvil 201514. Alternatively, the process 201700 continues along the NO (N) branch. When the position of the trocar 201510 is within a second zone 201520, referred to as the rapid total closure zone, the process 201700 continues along the YES (Y) branch and the control circuit 760 sets 201706 the closure speed of the anvil 201514 to fast to rapidly close the anvil 201514. Alternatively, the process 201700 continues along the NO (N) branch. When the position of the 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 201708 the closure speed of the anvil 201514 to a slower speed to confirm full attachment of the anvil 201514 to the trocar 201510. Alternatively, the process 201700 continues along the NO (N) branch. When the position of the trocar 201510 is within a fourth zone 201524, referred to as the high closure load zone, the process 201700 continues along the YES (Y) branch, and the control circuit 760 sets 201710 the closure speed of the anvil 201514 to a slower speed than the previous confirmation zone 201522 during application of the high closure load.Once the anvil 201514 has fully closed the trocar 201510 and captured tissue therebetween, the control circuit 760 actuates the knife 201519 to cut the tissue.

[0258] In one aspect, the present disclosure provides a digitally enabled circular stapler adaptive algorithm for determining multi-directional seating motion on the trocar to properly seat the anvil. FIG. 33 is a diagram 201530 of a powered stapling device 201532 and a graph 201534 illustrating detection of closure speed of a trocar 201540 and anvil 201544 in accordance with at least one aspect of the present disclosure. The powered stapling device 201532 is similar to the powered circular stapling instrument 201800 described herein with reference to FIGS. 18-21 and may be controlled using any of the control circuits described in connection with FIGS. 7-8 and 16-17 and may be employed in a hub and cloud environment as described in connection with FIGS. 1-6 and 9-13. The anvil 201544 includes an anvil head 201545 and an anvil shank 201547. The trocar 201540 can be advanced and retracted in the direction indicated by arrow 201546. In one aspect, if the anvil shank 201547 detects loose tension from the trocar 201540, the powered stapling apparatus 210530 can stop retraction or retract or reverse advance toward the open position 201541 until the seating instability of the anvil 201544 is resolved. If the anvil 201544 is fully disengaged, the powered stapling apparatus 210530 can fully open 201541 indicating to the user to attempt to reattach the anvil shank 201547 to the trocar 201540.

[0259] The powered stapling apparatus 201532 shown on the left side of FIGURE 33 includes a circular stapling head assembly 201536 having a seating collar 201538 received through a trocar 201540. The trocar 201540 engages an anvil 201544 via a locking feature 201542. The trocar 201540 is movable in the directions indicated by arrow 201546, e.g., advanced and retracted. A cutting element, such as a knife 201548, cuts tissue as the circular stapling head assembly 201536 is driven toward the anvil 201544.

[0260] In one aspect, the closure speed of the trocar 201540 and the anvil 201544 can be detected, and any discrepancy between the closure speeds of the two components can cause automatic extension of the trocar 201540, followed by retraction of the trocar 201540 to fully seat the anvil 201544 on the trocar 201540. In one aspect, any discrepancy between the closure speeds of the trocar 201540 and the anvil 201544 can be provided to a control circuit or processor to operate a motor coupled to the trocar 201540 to cause automatic extension of the trocar 201540, followed by retraction of the anvil 201544 to fully seat the trocar 201540. If the anvil shank 201547 detects loose tension from the trocar 201540, the smart powered stapling device 201532 can be configured to stop retraction or reverse and advance toward the open position until the instability seating the anvil 201544 is resolved. If the anvil 201544 is fully disengaged, it may be fully opened, indicating to the user to attempt to reattach the anvil shank 201547 to the trocar 201540. As shown in FIG. 33 , if disengagement of the anvil 201544 is sensed before reconfirming anvil 201544 attachment, the control algorithm can be configured to move the trocar 201540 back toward the open position 201541 to reset the anvil 201544, and once the anvil 201544 is confirmed attached, processing can proceed normally.

[0261] Thus, the system can be configured for multi-directional seating motion on the trocar 201540 to properly seat the anvil 201544. For example, if the anvil shank 201547 detects loose tension from the trocar 201540, the smart powered stapling device 201530 can be configured to stop retraction or reverse and advance toward open until the instability in seating the anvil 201544 is resolved. If the anvil 201544 is fully pulled away, the smart powered stapling device 201532 can be configured to fully open, indicating to the user to attempt to reattach the anvil shank 201547 to the trocar 201540.

[0262] 33, a graph 201534 shows the position of the trocar 201510 as a function of time at certain cardinal points labeled "δ Trocar" along the vertical axis and "t" along the horizontal axis, in accordance with at least one embodiment of the present disclosure. A trocar 201540 position profile curve 201549 is plotted as a function of time (t). Referring to the trocar 201540 position profile curve 201549, the trocar 201540 moves from a fully open position 201541 toward a fully closed position 201543 at a rapid closing velocity over a first period 201556. During a second time period 201558, the trocar 201540 moves slowly to a confirmation zone 201547 where the anvil locking feature 201542 engages the seating collar 201538 to confirm that the anvil locking feature 201542 has properly engaged with the seating collar 201538. In the embodiment shown, the initiation of disengagement of the anvil 201544 is sensed at time 201552. Upon sensing that the anvil 201544 has disengaged, the trocar 201540 advances toward the open position and returns over a third time period 201560. The trocar 201540 then moves slowly during a fourth time period 201562 until it is determined or confirmed that the anvil 201544 is attached to the trocar 201540 at time 201554. The trocar 201540 then moves very slowly toward the closed position 201543 under high tissue load during a fifth period 201564 before the knife 201548 advances to cut the tissue captured between the anvil 201544 and the circular stapling head assembly 201536.

[0263] 34 is a logic flow diagram of a process 201720 illustrating a control program or logic configuration for detecting multi-directional seating motion on the trocar 201540 to drive the anvil 201544 to proper seating, according to at least one embodiment of the present disclosure. This process 201720 may be implemented using any of the control circuitry described herein with reference to FIGS. 7-8 and 16-17. This process 201720 may be implemented within a hub or cloud computing environment, for example, as described with reference to FIGS. 1-6 and 9-13.

[0264] Specifically, the process 201720 shown in FIG. 34 will be described with reference to the control circuit 760 of FIG. 17. The control circuit 760 determines 201722 the closure rate of the trocar 201540 based on information received from the position sensor 784. The control circuit 760 then determines 201724 the closure rate of the anvil 201544 based on information received from the position sensor 784. Alternatively, the closure rate 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 207126 the closure rates of the trocar 201540 and the anvil 201544. If there is no mismatch between the closure speeds of the trocar 201540 and the anvil 201544, the process 201720 continues along the no (N) branch and loops until there is a mismatch between the closure speeds of the trocar 201540 and the anvil 201544. When there is a mismatch between the closure speeds of the trocar 201540 and the anvil 201544, the process 201720 continues along the yes (Y) branch and the control circuit 760 extends and retracts 207128 the trocar 201540 and resets the anvil 201544. The process 201720 then confirms 201130 the attachment of the trocar 201540 and the anvil 201544. If attachment is confirmed, the process 201720 continues along the yes (Y) branch and the control circuit 760 slows 207132 the closure rate of the trocar 201540 under tissue load. If attachment is not confirmed, the 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 has fully closed on the trocar 201540, capturing tissue therebetween, the control circuit 760 actuates the knife 201548 to cut the tissue.

[0265] In various aspects, the circular stapler and endpoint knife speed can be adjusted based on the sensed toughness or thickness of the tissue between the anvil and the cartridge. Accordingly, the circular stapler control algorithm can be configured to detect tissue gap and firing force to adjust knife stroke and speed. In one aspect, the present disclosure provides a digitally enabled circular stapler adaptive algorithm for detecting tissue gap and firing force to adjust knife stroke and knife speed in accordance with at least one aspect of the present disclosure.

[0266] 35-37 depict a circular powered stapling device 201610 and a series of graphs illustrating clamp closing force (FTC) versus anvil 201612 position (δAnvil), knife 201616 velocity (VK) versus knife 201616 position (δKnife), and knife 201616 force (FK) in accordance with at least one embodiment of the present disclosure. Using data sensed at different points along the length of the shank 201621, a control algorithm can generate a map of the tissue gap or reaction force vector of the anvil 201612 that monitors high and low sides when compressed on tissue. Upon firing, the system measures the force acting on the compression element 201620, which includes a force sensor, and adjusts it to act evenly along the shank's force vector to provide a uniform and complete cut.

[0267] 35 is a partial schematic view of a circular powered stapling apparatus 201610 showing the anvil 201612 closure on the left and the actuating knife 201616 on the right, in accordance with at least one embodiment of the present disclosure. The circular powered stapling apparatus 201610 includes an anvil 201612 that is movable from a fully open position δA2 to a fully closed position δA0. The intermediate position δA1 represents the point at which the anvil 201612 contacts 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 embodiment, the position sensors may be located within the seating collar 201618. The compression element 201620 may include a force sensor, such as, for example, a strain gauge, to monitor the force applied to the tissue and detect initial contact of the anvil 201612 with the tissue, as shown at intermediate position δA1. The position and force sensors interface with, for example, any of the control circuits described herein with reference to FIGS. 7-8 and 16-17 that implement the circular stapler control algorithm. The circular powered stapling device 201610 also includes a movable cutting element, such as a knife 201616, that is movable from a fully retracted position δA0 to a fully extended position δA2 to achieve a complete tissue cut. 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 a strain gauge or other contact or proximity sensor.

[0268] The powered stapling apparatus 201610 includes a motor, a sensor, and a control circuit as described herein in connection with 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 powered stapling apparatus 201610 provide the positions of the anvil 201612 and the knife 201616 to the control circuit. Additional sensors, such as a force sensor 201620, also provide the tissue contact points and forces acting on the anvil 201612 and the knife 201616 to the control circuit. The control circuit uses the position of the anvil 201612, the position of the knife 201616, the initial tissue contact points, or the forces acting on the anvil 201612 or the knife 201616 to implement the circular stapler control algorithm described below in connection with Figure 38.

[0269] FIG. 36 is a graphical illustration 201600 of anvil 201612 displacement (δAnvil) along a vertical axis as a function of clamp closing force (FTC) along a horizontal axis, according to at least one embodiment of the present disclosure. The vertical line represents an FTC threshold 201606, which indicates tissue toughness. The left side of the FTC threshold 201606 represents tissue with normal toughness, while the right side of the FTC threshold 201606 represents tissue with toughness. When the anvil 201612 is retracted from a fully open position δA2 to an intermediate position δA1 where the anvil 201612 first contacts the tissue, the FTC is substantially low (approximately 0). As the anvil 201612 continues to close beyond this point toward the circular stapler 201614 from a fully retracted position δA0 minus the thickness of the compressed tissue, the FTC becomes non-linear. Each tissue type, from normal to tough, will produce a different FTC curve. For example, a first FTC curve 201604, shown as a dashed line, ranges from about 0 to about 100 lbs, with a maximum FTC below the FTC threshold 201606. A second FTC curve 201602, shown as a solid line, ranges from about 0 to about 200 lbs, with a maximum FTC above the FTC threshold 201606. As previously discussed, the FTC is measured by a force sensor located within the compression element 201620 and coupled to the control circuitry.

[0270] 37 illustrates, on the left, a graphical representation 201630 of knife 201616 displacement (δKnife) along the vertical axis as a function of knife 201616 velocity (VK mm / sec) along the horizontal axis, and on the right, a graphical representation 201632 of knife 201616 displacement (δKnife) along the vertical axis as a function of knife 201616 velocity (VK mm / sec) along the horizontal axis. On the right, a graphical representation 201634 of knife 201616 displacement (δKnife) along the vertical axis as a function of knife 201616 force (FK lbs) along the horizontal axis, in accordance with at least one embodiment of the present disclosure. The dashed 201638, 20142 curves in each of the graphical representations 201632, 201634 represent normal tough tissue, and the solid 201636, 201640 curves represent tough tissue.

[0271] Referring to the graph 201632 on the left for normal tissue toughness, as shown by the knife speed profile 201638 for normal tissue, the initial speed of the knife 201616 for normal tissue toughness starts at an initial knife position δK0, for example, at a first speed of just over 4 mm / sec. The knife 201616 continues at that speed until it reaches knife position δK1, where it slows the speed of the knife 201616 as it cuts through the tissue, until it reaches knife position δK2, indicating that the knife 201616 has contacted the tissue, completed the cut, and the control circuit stops the motor, thus stopping the knife 201616. Referring to the graph 201634 on the right for normal tissue toughness, as shown by the knife force curve 201642 for normal tissue, the force acting on the knife 201616 is 0 lbs at the initial knife position δK0 and varies non-linearly until the knife 201616 reaches knife position δK2 where the cut is complete.

[0272] Referring to the graph 201632 on the left for high tissue toughness, as shown by the knife speed profile 201636 for thick tissue, the initial speed of the knife 201616 for high tissue toughness starts at a second speed, e.g., just over 3 mm / sec, which is lower than the first speed and less than the initial speed for normal tissue toughness at an initial knife position δK0. The knife 201616 continues at that speed until it reaches a knife position δK1 where the knife 201616 contacts the tissue. At this point, the speed of the knife 201616 begins to decelerate non-linearly as it cuts the tissue due to the short displacement of the knife 201616. The control circuit detects that the knife 201616 has contacted tissue and, in response, increases the speed of the motor, e.g., increasing the speed of the knife 201616 to an initial speed until the knife 201616 reaches a position δ indicating that the cut has been completed and the control circuit stops the motor, thus stopping the knife 201616. This is shown as a speed spike 201644, which improves cutting of tough tissue. Referring to the graph 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 an initial knife position δK0 and varies non-linearly until the knife 201616 reaches a knife position δK2 where the knife 201616 completes the cut. A comparison of the normal and high tissue knife force curves 201640, 201642 shows that by applying 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 experiences when cutting normal toughness tissue.

[0273] 38 is a logic flow diagram of a process 201720 illustrating a control program or logic configuration for detecting tissue gap and firing force to adjust knife stroke and velocity, according to at least one aspect of the present disclosure. This process 201750 may be implemented with any of the control circuits described with reference to FIGS. 7-8 and 16-17. This process 201750 may be implemented within a hub or cloud computing environment, for example, as described with reference to FIGS. 1-6 and 9-13.

[0274] Specifically, the process 201750 shown in FIG. 38 will be described with reference to the control circuit 760 of FIG. 17 and the circular powered stapling apparatus 201610 shown in FIGS. 35-37. The control circuit 760 monitors 201752 the displacement of the anvil 201612 based on position feedback received from a position sensor 784. As previously discussed, in one aspect, the position sensor 784 may be embedded in the shank 201614 of the anvil 201612. As the anvil 201612 is displaced, the control circuit 760 monitors 201754 contact of the anvil 201612 with tissue positioned between the anvil 201612 and the circular stapler 201614. In one aspect, tissue contact may be provided by a force sensor embedded in the compression element 201620. The force sensor is represented as the sensor 788 element of the surgical instrument 790 shown in FIG. 17. The force sensor 788 is used to monitor 201756 the force to close the clamp (FTC), which is the closing force of the anvil 201612 on tissue positioned between the anvil 201612 and the circular stapler 201614. The control circuit 760 compares 201758 the FTC to a predetermined threshold. When the FTC is below the predetermined threshold, the control circuit 760 sets the speed of the motor 754 to advance 201760 the knife 201616 using a normal tissue toughness speed profile 201638, as shown in FIG. 37. When the FTC is above the predetermined threshold, the control circuit 760 sets the speed of the motor 754 to advance 201762 the knife 201616 using a high tissue toughness speed profile 201636 with a speed spike 201644, as shown in FIG.

[0275] Figure 39 is a logic flow diagram of a process 201762 showing a control program or logic configuration for advancing 201762 the knife 201616 under a high tissue toughness velocity profile 201636 having a velocity spike 201644 as shown in Figure 37, in accordance with at least one embodiment of the present disclosure. This process 201762 may be implemented with any of the control circuitry described with reference to Figures 7-8 and 16-17. This process 201750 may be implemented within a hub or cloud computing environment, for example, as described with reference to Figures 1-6 and 9-13.

[0276] Specifically, the process 201762 shown in FIG. 39 will be described with reference to the control circuit 760 of FIG. 17 and the circular powered stapling device 201610 shown in FIGS. 35-37. When high tissue toughness is detected, the control circuit 760 sets 201770 the initial speed of the knife 201616 to a lower knife speed relative to the knife speed used to cut normal tissue toughness. In one aspect, a slower knife speed in conditions of high tissue toughness promotes better cutting. The control circuit 760 monitors 201772 when the knife 201616 contacts tissue. As previously discussed, tissue contact may be detected by a force sensor embedded in the compression element 201620. As shown in FIG. 37, when the knife 201616 contacts tissue, the knife 201616 naturally decelerates. Thus, when the control circuit 760 detects that the knife 201616 has come into contact with tissue, tissue contact is detected and the control circuit 760 increases 201774 the speed of the motor 754, increasing the speed of the knife 201616 cutting the tissue. The control circuit 760 monitors 201776 for completion of the cut and maintains 201778 the speed of the motor 740 until completion of the cut is detected, then stops 201780 the motor 740.

[0277] 40-44, not only the amount and location of tissue, but also the nature, type, or condition of the tissue can affect the outcome of stapling. For example, irregular tissue distribution is also manifest in situations involving stapling pre-stapled tissue, such as end-to-end anastomosis procedures. Poor positioning and distribution of pre-stapled tissue within the end effector of the staple cartridge can cause pre-fired staple lines to be more concentrated in one zone than another within the end effector, which can adversely affect the outcome of such procedures.

[0278] Aspects of the present disclosure present a surgical stapling instrument including an end effector configured to staple tissue clamped between first and second jaws 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 at several predetermined zones within the end effector. In various aspects, tissue impedance measurements can be utilized to identify superimposed layers of tissue and their locations within the end effector.

[0279] 40 and 42 illustrate a circular stapler end effector 25500 that includes a staple cartridge 25502 and an anvil 25504 configured to grasp tissue therebetween. The anvil 25504 and the staple cavities 25505 of the staple cartridge 25502 have been removed from FIG. 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 the present disclosure.

[0280] FIG. 41 shows another end effector 25510 of a circular stapler including a staple cartridge 25512 and an anvil configured to grasp tissue therebetween. The anvil and staple cavities of the staple cartridge 25512 have been removed to highlight other features of the end effector 25510. The staple cartridge 25512 includes eight predetermined zones (Zone 1 through Zone 8) defined by sensing circuits (S1 through S8) in accordance with the present disclosure. The defined zones in each of the circular staplers of FIGS. 40 and 41 are equal, or at least substantially equal, in size and are circumferentially arranged about a longitudinal axis extending longitudinally through the shaft of the circular stapler.

[0281] As noted above, pre-stapled tissue is tissue that includes staples pre-deployed therein. Circular staplers are often utilized in stapling pre-stapled tissue to other pre-stapled tissue (e.g., end-to-end anastomosis procedures), as illustrated in FIG.

[0282] The presence of staples in tissue affects tissue impedance because staples typically have a different conductivity than tissue. This disclosure presents various tools and techniques for monitoring and comparing tissue impedance at predetermined zones of a circular stapler end effector (e.g., end effectors 25500, 25510) to determine optimal positioning and orientation of pre-stapled tissue relative to the end effector.

[0283] The example on the left side of Figure 42 shows pre-stapled tissue properly positioned and oriented relative to a predetermined zone of the circular stapler. The pre-stapled tissue properly extends through the center of the staple cartridge 25502 and intersects the predetermined zone only once. The bottom left side of Figure 42 shows the staples 25508 of the staple cartridge 25502 deployed within the properly positioned and oriented pre-stapled tissue.

[0284] The example on the right side of Figure 42 shows 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 bottom right side of Figure 42 shows the staples 25508 of the staple cartridge 25502 deployed within pre-stapled tissue that is poorly positioned and oriented.

[0285] As used in connection with FIGS. 40-44, a staple line may include multiple rows of staggered staples, and typically includes, but is not limited to, two or three rows of staggered staples. In the example of FIG. 42, the circular stapler of FIG. 40 is used to staple two pieces of tissue including pre-deployed staple lines SL1, SL2. In the example on the left side of FIG. 42, which depicts properly positioned and oriented staple lines SL1, SL2, each of Zones 1-4 receives a separate portion of one of the staple lines SL1, SL2. A first staple line SL1 extends across Zones 2 and 4, while a second staple line SL2, which intersects the first staple line SL1 at a center point, extends across Zones 1 and 3. Thus, the impedance measured in the four zones will be equal, or at least substantially equal, to each other and less than the impedance of unstapled tissue.

[0286] Conversely, in the example on the right of FIG. 42, which depicts improperly positioned and oriented staple lines SL1, SL2, staple lines SL1, SL2 overlap or extend substantially over each other across zones 1 and 3, resulting in lower impedance measurements in zones 1 and 3 compared to zones 2 and 4.

[0287] 43 and 44 illustrate staple lines SL1, SL2 in an end-to-end anastomosis procedure performed by a circular stapler end effector 25510 that includes eight predetermined zones (Zone 1 through Zone 8) defined by eight sensing circuits S1 through S8, as described above. The anvil of the end effector 25510 and the staple cavities of the staple cartridge 25512 have been removed from FIGS. 43 and 44 to highlight other features of the end effector 25510.

[0288] 45 and 46 show measured tissue impedance based on sensor signals from sensing circuits S1-S8. Individual measurements define a tissue impedance signature. Vertical axes 25520, 25520' represent the angle of orientation (θ), and vertical axes 25522, 25522' list the corresponding predetermined zones (Zone 1-Zone 8). Tissue impedance (Z) is plotted on horizontal axes 25524, 25524'.

[0289] 43 and 45, the impedance measurements represent properly positioned and oriented staple lines SL1, SL2. As shown in FIG. 43, staple lines SL1, SL2 extend through zones 1, 3, 5, and 7, overlapping only at the center point of the staple cartridge 25512. Because the pre-stapled tissue is evenly distributed among zones 1, 3, 5, and 7, the tissue impedance measurements in these zones are the same, or at least substantially the same, in magnitude and significantly lower than the tissue impedance measurements in zones 2, 4, 6, and 8, which did not receive pre-stapled tissue.

[0290] 44 and 46, the impedance measurements represent improperly positioned and oriented staple lines SL1, SL2 that overlap one another and extend only through Zones 1 and 5. Thus, the tissue impedance measurements in Zones 1 and 5 are significantly lower in magnitude than the remaining zones that did not receive pre-stapled tissue.

[0291] 47 shows a logic flow diagram of a process 206520 illustrating a control program or logic configuration for selecting an operational mode of the surgical hub 5104 during a surgical procedure in response to a determined progress of the surgical procedure. The process 2065520 may be implemented by any suitable control circuitry, such as, for example, control circuitry of the surgical hub 5104. Data may be received 206522 from at least one data source 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 206522 data is processed by the surgical hub 5104 to determine the progress of the surgical procedure. Further details regarding determining whether a surgical procedure is in progress are disclosed in U.S. patent application Ser. No. 16 / 209,465, filed Dec. 4, 2018, entitled "Method for adaptive control schemes for surgical network control and interaction," the disclosure of which is incorporated herein by reference in its entirety.

[0292] 47 , the received 206522 data can be utilized by the surgical hub 5104 to determine 206523 whether a surgical procedure is in progress. If not, the surgical hub 5104 activates or selects the previous procedure / network interaction mode 206524. However, the surgical hub 5104 determines 206523 that a surgical procedure is in progress and further determines 206525 whether a surgical procedure is in progress. If not, the surgical hub 5104 activates or selects the interactive / configurable control mode 206526. However, if the surgical hub 5104 determines 206525 that a surgical procedure is in progress, the surgical hub 5104 activates or selects the instrument display control and procedure display mode 206528.

[0293] Mode 206524 is more restrictive than mode 206526, which is more restrictive than mode 206528. This arrangement is designed to account for user error, for example, in the form of accidental commands. Before a surgical procedure begins, mode 206524 allows only access to previous procedure data and limited interaction with the cloud-based system 104, 204, for example. During the pre-operative process, but before a surgical procedure begins, mode 206526 provides a less restrictive interface that allows the user to access and / or configure various parameters and / or controls without being able to use or activate such controls. In the least restrictive mode 206528, available only during a surgical procedure, the user can use or activate certain modular device controls depending on the surgical procedure being performed.

[0294] The surgical hub may receive data determining a situation parameter of the surgical procedure and, in response, adjust a response to the sensed parameter based on the determined situation parameter. In at least one embodiment, the sensed parameter may be detecting a security threat 206552, as shown in FIG. 48. In other embodiments, the sensed parameter may be detecting a surgeon 206554. In other embodiments, the sensed parameter may be detecting an instrument failure 20559, for example, with a modular instrument.

[0295] In addition to the above, responding to a detected 206552 security threat depends on whether a surgical procedure is in progress, which may be determined 206525 as described above in connection with FIG. 47. If it is determined 206525 that a surgical procedure is in progress, an independent operating mode 206553 may be activated. If a surgical procedure is not in progress, the current security level may be escalated 206551 to a higher security level, and an appropriate reaction or response may be taken to address the detected 206552 security threat. Further details regarding determining whether a surgical procedure is in progress are disclosed in U.S. patent application Ser. No. 16 / 209,465, filed December 4, 2018, entitled "Method for adaptive control schemes for surgical network control and interaction."

[0296] In various embodiments, the isolated operating mode 206553 includes suspending communications with external systems, such as, for example, a cloud-based system 104, 204. In certain embodiments, the suspension of communications excludes local communications within the operating room, such as, for example, instrument-to-instrument communications, instrument-to-surgical hub 106, 206 communications, and / or remote controller-to-instrument communications.

[0297] With further reference to FIG. 48, responding to the detected 206554 surgeon depends on whether a surgical procedure is in progress, which may be determined 206523 as described above in connection with FIG. 47. If a surgical procedure is determined 206523 to be in progress, the linked instruments may be set 206557 to predefined parameters, for example, based on the detected 206554 surgeon's previous use configuration. However, if a surgical procedure is not in progress, for example, previously captured data and / or previous surgical data may be recalled 206555. Further details regarding determining whether a surgical procedure is in progress are disclosed in U.S. patent application Ser. No. 16 / 209,465, filed December 4, 2018, entitled "Method for adaptive control schemes for surgical network control and interaction," the disclosure of which is incorporated herein by reference in its entirety.

[0298] With further reference to FIG. 48 , responding to a detected 206556 instrument failure depends on whether a surgical procedure is in progress, and further depends on whether a surgical procedure is in progress, which may be determined 206523, 206525 as described above in connection with FIG. 47 . The instrument may be, for example, a modular device. If a surgical procedure is determined 206523 to be in progress, and further if a surgical procedure is determined 206525 to be in progress, a limp mode may be activated 206565 for the instrument. However, if a surgical procedure is not in progress, a surgical instrument lockout may be engaged 206561 to prevent the surgical instrument from being used. Furthermore, if a surgical procedure is in progress but it is determined 206523 that a surgical procedure is not in progress, a warning or alert may be issued 206563 by the surgical hub 5104 to surgical staff, for example, advising options.

[0299] FIG. 49 illustrates a GUI displaying a series of menus containing selectable options to assist a clinician in operating a particular surgical instrument, such as instrument 208100 (shown in FIG. 50). In the illustrated example,...

Claims

1. receiving instructions from the surgical hub system to provide one or more controlled functions; determining one or more parameters associated with the one or more controlled functions; providing the one or more controlled functions based on the one or more parameters. a processor configured to: A surgical stapler comprising: the processor configured to receive instructions for providing the one or more controlled functions is configured to receive instructions for providing an adaptable staple height operating range; the processor configured to determine the one or more parameters associated with the one or more controlled functions is configured to determine a size of an anvil associated with an end effector; the processor configured to provide the one or more controlled functions based on the one or more parameters is configured to determine, based on the size of the anvil associated with the end effector, that an adaptable staple height operating range is modified relative to a default adaptable staple height operating range.

2. receiving instructions from the surgical hub system to provide one or more controlled functions; determining one or more parameters associated with the one or more controlled functions; providing the one or more controlled functions based on the one or more parameters. a processor configured to: A surgical stapler comprising: the processor configured to receive instructions for providing the one or more controlled functions is configured to receive instructions for providing adaptable control of a motor associated with a force applied by a tissue compression anvil; the processor configured to determine the one or more parameters associated with the one or more controlled functions is configured to determine an application of force to insert a surgical staple; the processor configured to provide the one or more controlled functions based on the one or more parameters is configured to determine, based on the application of the force to insert the surgical staple, to control the motor to apply the force by the tissue compression anvil.

3. the processor is further configured to communicate parameters associated with the surgical stapler to the surgical hub system; The surgical stapler of claim 1 or 2, wherein the instructions for providing the one or more controlled functions are based at least in part on the parameters associated with the surgical stapler.

4. 3. The surgical stapler of claim 1, wherein the processor configured to provide the one or more controlled functions based on the one or more parameters is configured to modify operation of the one or more controlled functions based on the one or more parameters.

5. 3. The surgical stapler of claim 1, wherein the instructions for providing the one or more controlled functions include instructions for providing one or more of: an adaptable staple height operating range; and adaptable control of a motor associated with a force applied by a tissue compression anvil.

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