Extended clamp for relaxation for medical stapling systems

Abstract

Medical circular stapling systems that perform operations such as initiating a first clamping phase by activating the motor to move the anvil assembly towards the cartridge assembly; receiving strain gauge data from the strain gauge assembly over a relaxation period; based on the strain gauge data indicating a tissue relaxation threshold has been reached, automatically initiating a second clamping phase by activating the motor to move the anvil assembly towards the cartridge assembly until one of a set distance, a minimum clamp gap distance, or a maximum clamp force is reached; receiving a firing activation subsequent to the second clamping phase; and firing staples from the cartridge assembly in response to receiving the firing activation.

Description

PATENT APPLICATION Attorney Docket No,: A0011895WQ01 EXTENDED CLAMP FOR RELAXATION FOR MEDICAL STAPLING SYSTEMSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 778,760, filed March 27, 2025, which is incorporated herein by reference in its entirety.BACKGROUND

[0001] Powered surgical stapling devices include a handle assembly, an adapter assembly including a proximal portion supported on the handle assembly, and a tool assembly supported on the distal portion of the adapter assembly. The tool assembly often includes a reload assembly and an anvil assembly moveably positioned relative to the reload assembly to clamp tissue therebetween. The stapling device may also include a strain gauge for measuring characteristics of tissue being clamped and / or stapled, e.g., tissue thickness, tissue compression, etc., and / or parameters related to staple formation or tissue cutting, e.g., cutting force, firing force, etc.SUMMARY

[0002] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0003] The technology disclosed herein relates to a medical stapling system that provides for efficient stapling procedures while still allowing for tissue relaxation and post-relaxation clamping to promote improved staple formation, tissue health, and surgeon confidence. As an example, upon a selection to initiate clamping of the tissue, a first clamping phase is initiated that causes the tissue to be clamped to a first clamping force threshold and / or first clamp gap distance between the anvil and the cartridge. Subsequent to the first clamping phase, a relaxation period is initiated during which the clamping force is actively analyzed to determine when sufficient tissue relaxation has occurred. Upon the occurrence of sufficient tissue relaxation, a second clamping phase (e.g., a post-relaxation clamping phase) may be performed that allows for increased confidence to clinician that the clamp force is sufficient. This post-relaxation clamping phase may be for a set127207095.2Attorney Docket No,: A0011895WQ01distance or until other force or gap thresholds are met. The distance or amount of additional clamping may be less than the amount of clamping in the first clamping phase, and the speed at which the post-relaxation clamping is performed may also be less than the speed at which the first clamping phase is performed. Subsequent to the post-relaxation clamping phase, the stapling device may then be fired.

[0004] It is to be understood that both the foregoing general description and the following Detailed Description are explanatory and are intended to provide further aspects and examples of the disclosure as claimed.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The following drawing figures, which form a part of this application, are illustrative of aspects of systems and methods described below and are not meant to limit the scope of the disclosure in any manner, which scope shall be based on the claims.

[0006] FIG. 1 is a side perspective view of an example surgical stapling device including an example adapter assembly having a strain gauge assembly.

[0007] FIG. 2 is a side perspective view of the example adapter assembly shown in FIG. 1 with an example trocar assembly and strain gauge assembly shown in phantom.

[0008] FIG. 3 is a side perspective view of a distal portion of the adapter assembly shown in FIG. 2, with an outer sleeve removed and a tension gauge support separated from the example adapter assembly.

[0009] FIG. 4 is a side perspective view of the trocar assembly shown in FIG. 2 and a tension gauge housing and tension gauge anchor of the strain gauge assembly.

[0010] FIGs. 5A-5B depicts an example method for implementing a firing of the example surgical stapling device.

[0011] FIG. 6 depicts another example method for implementing a firing of the example surgical stapling device.

[0012] While examples of the disclosure are amenable to various modifications and alternative forms, specific aspects have been shown by way of example in the drawings and are described in detail below. The intention is not to limit the scope of the disclosure to the particular aspects described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure and the appended claims.Attorney Docket No,: A0011895WQ01DETAILED DESCRIPTION

[0013] The disclosed surgical stapling device will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. The devices and methods for performing the functions describe herein are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein the term “distal” refers to that portion of the component farther from the user, while the term “proximal” refers to that portion of the component closer to the user. In addition, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel. As used herein, the term “about” means that the numerical value is approximate and small variations would not significantly affect the practice of the disclosed aspects of the disclosure. Where a numerical limitation is used, unless indicated otherwise by the context, “about” means the numerical value can vary by ±10% of the stated value and remain within the scope of the disclosure.

[0014] During a stapling procedure with a manual stapling instrument, when clamping tissue some surgeons wait a specified period of time, e.g., fifteen seconds or more, after achieving a tissue gap between the anvil assembly and the cartridge assembly. This waiting period provides the clamped tissue with time to relax, e.g., allows fluid to travel out of the clamped tissue into surrounding tissue. Tissue relaxation is intended promote better staple formation and tissue healing. In some instances, however, some surgeons believe that this tissue relaxation may reduce the clamping force to an amount where further clamping may be beneficial.

[0015] The technology disclosed herein addresses the above considerations, among other things, by providing a medical stapling system that provides for efficient stapling procedures while still allowing for tissue relaxation and post-relaxation clamping to promote improved staple formation, tissue health, and surgeon confidence. As an example, upon a selection to initiate clamping of the tissue, a first clamping phase is initiated that causes the tissue to be clamped to a first clamping force threshold and / or first clamp gap distance between the anvil and the cartridge. Subsequent to the first clamping phase, a relaxation period is initiated during which the clamping force is actively analyzed to determine when sufficient tissue relaxation has occurred. Upon the occurrence of sufficient tissue relaxation, a second clamping phase (e.g., a post-relaxation clamping phase) may be performed that allows for increased confidence to clinician that the clamp force is sufficient. This post-relaxation clamping phase may be for a set distance or until otherAttorney Docket No,: A0011895WQ01force or gap thresholds are met. The distance or amount of additional clamping may be less than the amount of clamping in the first clamping phase, and the speed at which the post-relaxation clamping is performed may also be less than the speed at which the first clamping phase is performed. Subsequent to the post-relaxation clamping phase, the stapling device may then be fired.

[0016] FIGS. 1-4 depict various view of the example stapling device as discussed above in the brief description of the drawings. FIG. 1 illustrates a circular stapling device 110 including a handle assembly 112, an elongate body or adapter assembly 114, a reload assembly 116 releasably supported on the adapter assembly 114, and an anvil assembly 118 releasably supported for movement in relation to the reload assembly 116 between an open position and a clamped position. Although the methods and functions are described with reference to a circular stapling device, aspects of the disclosure may be modified for use in surgical stapling devices having alternative configurations.

[0017] The circular stapling device 110 is illustrated as an electrically powered stapling device including an electrically powered handle assembly 112 that may support one or more batteries. The adapter assembly 114 translates power from the handle assembly 112 to the reload and anvil assemblies 116, 118, respectively, to staple and cut tissue. Examples of electrically powered stapling devices can be found in U.S. Pat. Nos. 9,055,943 and 9,023,014, and U.S. Publication Nos. 2018 / 0125495 and 2017 / 0340351. Alternately, aspects of the disclosure may be incorporated into a stapling device that is configured for use with a robotic system, such as the robotic system as disclosed in U.S. Pat. No. 9,962,159. In such examples, the circular stapling device 110 may not include a handle assembly. However, the circular stapling device 110 and / or the robotic system may include computational elements, display screen(s), and / or feedback elements to allow for performances of the methods and processes discussed herein.

[0018] The handle assembly 112 of the circular stapling device 110 includes a stationary grip 112a that supports actuation buttons 113 for controlling operation of various functions of the circular stapling device 110, including, for example, approximation of the reload assembly 116 and anvil assembly 118, firing of staples from the reload assembly 116, and cutting or coring of tissue.

[0019] The handle assembly 112 may include one or more motors 129 for performing the various functions. For instance, activation of a first motor (of the motors 129) may controlAttorney Docket No,: A0011895WQ01approximation of the reload assembly 116 and anvil assembly 118 (e.g., pulling the anvil assembly towards the cartridge assembly). Activation of a second motor (of the motors 129) may control firing of staples from the reload assembly 116. Activation of a third motor (of the motors 129) may control cutting or coring the tissue by advancing a cutting blade (e.g., knife).

[0020] A processor 120 is disposed within the handle assembly 112 and includes (or is operably connected to) a memory 122. The memory 122 may include one or more of volatile, nonvolatile, magnetic, optical, or electrical media, such as read-only memory (ROM), random access memory (RAM), electrically erasable programmable ROM (EEPROM), non-volatile RAM (NVRAM), or flash memory. The processor 120 may be any suitable processor (e.g., control circuit) adapted to perform the operations, calculations, and / or set of instructions described in the present disclosure including, but not limited to, a hardware processor, a field programmable gate array (FPGA), a digital signal processor (DSP), a central processing unit (CPU), a microprocessor, and combinations thereof. Those skilled in the art will appreciate that the processor may be substituted for by using any logic processor (e.g., control circuit) adapted to execute algorithms, calculations, and / or set of instructions described herein. The memory 122 may store instructions that, when executed by the processor 120, cause the stapling device 110 to perform the operations discussed herein.

[0021] The handle assembly 112 may also include a display 123. The display 123 may provide indicators about the clamping distance and / or the clamping forces during a stapling procedure. The display 123 may also provide different indicia regarding the stapling procedure, such as whether different functions are currently active or available. For instance, based on processes discussed herein, the display 123 may indicate whether firing of the staples is enabled and / or whether additional clamping is possible. In some examples, the display 123 may be a light-emitting diode (LED), liquid crystal display (LCD), or a similar display. In other examples, the display 123 may be one or more lights or indicators, such as LEDs.

[0022] The handle assembly 112 may additionally, or alternatively, include a speaker 125 and / or a haptic generator 127. The speaker 125 may generate audible signals to indicate the same or similar information as the display 123 discussed above. Similarly, the haptic generator 127 may be generate haptic signals to indicate the same or similar information as the display 123 discussed above. The haptic generator 127 may be a vibrational element or other electro-mechanical elementAttorney Docket No,: A0011895WQ01that generates haptic feedback. Collectively, the display 123, speaker 125, and / or the haptic generator 127 may be referred to as feedback elements.

[0023] The adapter assembly 114 includes a proximal portion 114a that can be releasably coupled to the handle assembly 112. The reload assembly 116 includes a proximal portion that is releasably coupled to a distal portion 114b of the adapter assembly 114. A staple cartridge 124 (also referred to as a cartridge assembly 124) is supported on a distal portion of the reload assembly 116 and supports a plurality of surgical staples. A trocar assembly 140 is supported within the distal portion 114b of the adapter assembly 114 and extends through the reload assembly 116. The trocar assembly 140 includes a trocar member 128 for releasably securing and positioning the anvil assembly 118 relative to the reload assembly 116. The trocar assembly 140 may be operatively coupled to one of the motors 129 such that activation of the respective motor 129 causes the trocar assembly 140 to retract, thus causing the anvil assembly 118 to move towards to the staple cartridge 124. Similarly, the reload assembly 116 may be operative coupled to one of the motors 129 such that activation of the respective motor 129 causes staples to be fired from the staple cartridge 124 towards the anvil assembly 118.

[0024] FIGS. 2-4 illustrate a strain gauge assembly 130 supported within the distal portion 114b of the adapter assembly 114 (FIG. 2) and a trocar assembly 140 received through and supported by the strain gauge assembly 130. In the example depicted, the strain gauge assembly 130 is positioned between the trocar assembly 140 and the reload assembly 116. With the strain gauge data provided by the strain gauge assembly 130, the clamping force between the staple cartridge 124 of the reload assembly 116 and the anvil assembly 118 can be calculated. The trocar assembly 140 releasably secures the anvil assembly 118 (FIG. 1) to the circular stapling device 110 and operates to advance and retract the anvil assembly 118 relative to the reload assembly 116. The software in the handle assembly 112 uses the strain gauge measurements to determine the clamping force over time. As will be described in further detail below, tissue relaxation occurs when the clamping force, e.g., the force on the tissue, stabilizes.

[0025] The strain gauge assembly 130 includes a tension gauge housing 132, a tension gauge anchor 134, and a tension gauge support 136 (FIG. 3). A plurality of strain gauges 138 may be supported on an extension portion 132a (FIG. 4) of the tension gauge housing 132. For a detailed description of an example strain gauge assembly, please refer to U.S. Patent Publication No.2021 / 0275273 Al, titled “Strain Gage Fixation in Tension,” and assigned to Covidien LP.Attorney Docket No,: A0011895WQ01Although the example depicted is shown as the strain gauge assembly 130, other types of strain gauges or clamp force sensors may be used to implement the methods and processes discussed herein.

[0026] FIGs. 5A-5B depicts an example method 500 for implementing clamping and firing of the example surgical stapling device. The method 500 may be performed by the medical stapling devices and systems discussed herein. For instance, the memory of the medical stapling system may store instructions that, when executed by one or more processors of the system, cause one or more of the operations of method 500 to be performed.

[0027] At operation 502, a first selection is received to clamp tissue between the anvil assembly and the cartridge assembly. The first selection may be received via a depression of one the actuation buttons of the stapling device. For example, after the clinician has positioned the tissue between the anvil and the cartridge, the clinician may depress the actuation button to cause clamping of the tissue between the anvil and the staple cartridge.

[0028] At operation 504, in response to receiving the first selection, a motor is activated to cause the anvil assembly to move towards the anvil assembly, thus causing clamping of the tissue therebetween. For example, the motor may be operatively coupled to the trocar and anvil such that activation of the motor causes the trocar and anvil to retract. The motor is activated until a threshold clamp gap and / or threshold clamp force is reached.

[0029] At operation 506, upon the anvil assembly reaching the threshold clamp gap and / or the threshold clamp force, strain gauge data (e.g., clamp force data) continues to be received from the strain gauge over a relaxation period. For example, once the tissue has been initially clamped to the threshold clamp force and / or threshold clamp gap, the tissue is allowed to relax prior to firing the staples or performing further clamping. As discussed above, such relaxation of the tissue may allow for better stapling results when the staples are ultimately fired. The relaxation period may have a set maximum duration.

[0030] During the relaxation period, the strain gauge data continues to be received and monitored to determine if sufficient relaxation of the tissue has occurred. Once that relaxation of tissue is identified or the relaxation period expires, the stapling device provides indicia to the clinician regarding further clamping or firing functions that are available. In some examples, the stapling device allows the clinician to fire the staples at any time during the relaxation period. In other examples, however, the stapling device may lockout or prevent firing of the stapling deviceAttorney Docket No,: A0011895WQ01prior to sufficient relaxation of the tissue or expiration of the set duration of the relaxation period. Examples of these operations are detailed below.

[0031] At operation 508, a determination is made as to whether a firing-enablement selection has been received. As discussed above, in some examples, the clinician may enable the firing of the stapling device at any time during the relaxation period. The firing-enablement selection may be received as a selection of one of the buttons on the stapling device itself, such as a button on the side of the device.

[0032] If the firing-enablement selection is received at operation 508, the method 500 flows to operation 510 where the stapling device enables firing of the staples. The enabling of firing may include adjusting the functions associated with the respective actuation buttons and / or locking out (e.g., preventing) other functions from being performed. For example, a first actuation button (e.g., trigger button) may be initially used for causing or controlling clamping of the stapling device. Upon enabling of firing after receiving the firing-enablement selection, that first actuation button then controls firing of the stapling device (rather than clamping).

[0033] At operation 511, a firing activation is received. The firing activation received in operation 511 may be received as a selection of one of the actuation buttons (e.g., the trigger button). At operation 512, in response to receiving the firing activation in operation 511, the stapling device fires staples from the cartridge assembly. Firing of the staples from the cartridge assembly may include activating a motor, which is operatively coupled to the stapling cartridge, to cause the staples to be fired. For instance, a first motor may be used for clamping of the tissue, and a second motor may be used for firing the staples.

[0034] Returning to operation 508, if the firing-enablement selection is not received, the method 500 flows to operation 514. At operation 514, a determination is made as to whether a tissue relaxation threshold has been reached (e.g., whether the tissue has sufficiently relaxed). This determination may be made based on the strain gauge data that is received during the relaxation period. The tissue relaxation threshold may be a percentage of the initial strain (e.g., clamp force) that was measured at the start of the relaxation period. In other examples, the rate of change of the clamp force may be analyzed, and the tissue relaxation threshold may be based on a rate-of-change threshold. For instance, as the tissue begins to relax at the beginning of the relaxation period, the clamp force (e.g., strain data) changes more rapidly than when the tissue is more sufficiently relaxed. Thus, when the clamp force is changing by a relatively small amount (e.g.,Attorney Docket No,: A0011895WQ01below a rate-of-change threshold), the tissue may be considered to be sufficiently relaxed. Other examples of determining tissue relaxation are discussed in U.S. Patent No. 11,653,925, titled “Tissue Relaxation Monitoring for Optimized Tissue Stapling.”

[0035] If the tissue relaxation threshold has been reached in operation 514, the method 500 flows to operation 518 (FIG. 5B), as discussed further below. If the tissue relaxation threshold has not been reached in operation 514, the method 500 flows to operation 516.

[0036] At operation 516, a determination is made as to whether a time threshold has been reached since the start of the relaxation period. For example, the time threshold may be the set duration of the relaxation period. Thus, when the clamping stops and the relaxation period starts at operation 506, a timer may be started for the duration of the relaxation period. If that timer expires prior to the relaxation of the tissue being identified in operation 514, then the method effectively proceeds under the assumption that the tissue has sufficiently relaxed. Thus, at operation 516, if the time threshold has been reached, the method 500 flows to operation 518 (FIG.5B), discussed further below. If, at operation 516, the time threshold has not been reached, the method 500 flows back to operation 508, where operations 508-516 are repeated (respectively) until either the firing-enablement selection is received, the tissue relaxation threshold is reached, or the time threshold has been reached.

[0037] At operation 518 (FIG. 5B), based on either the time threshold being reached in operation 516 or the tissue relaxation threshold being reached in operation 514, the stapling system surfaces indicia indicating that a staple firing function is available and a further clamping function is available. Surfacing the indicia may include displaying the indicia via the display, activating the haptic generator to convey the indicia, and / or generating the indicia audibly via the speaker. For example, the indicia may include multiple icons or visual graphics indicating that (1) firing is available (e.g., the stapling device may be fired or firing may be enabled) and (2) further clamping is available (e.g., the tissue may be further clamped). The clinician may then provide additional inputs to either enable the firing or further clamp the tissue. In the example method 500, further clamping is elected and performed.

[0038] At operation 520, a second selection is received to further clamp the tissue between the anvil assembly and the cartridge assembly. The second selection may be the receipt of a depression of one of the actuation buttons. For instance, the same actuation button that was used for the first selection to clamp (in operation 502) may be depressed again to provide the second selection.Attorney Docket No,: A0011895WQ01

[0039] At operation 522, in response to the second selection, the stapling device further clamps the tissue. Further clamping of the tissue may include activating the motor to further move the anvil assembly further towards the cartridge assembly to further reduce the clamp gap between the anvil assembly and the cartridge assembly. This reduced clamp gap after the further clamping may be referred to as a second clamp gap. The speed at which the motor operates for this further, postrelaxation clamping may be less than the speed at which the motor operates for the initial clamping performed in operation 504. For example, the post-relaxation clamping is slower than the initial clamping.

[0040] The amount of additional clamping performed may vary in different examples. In some examples, this further post-relaxation clamping is a set distance (e.g., a programmed or predetermined distance). The set distance may be a few thousandths of an inch (e.g., between 0.001-0.005 inches), although the other ranges or distances are also possible. This full set distance may only be traveled if other maximum safety thresholds are not reached, such as a maximum clamp force or a minimum gap distance. In other examples, the additional clamping continues (e.g., the motor remains active) until a gap threshold (e.g., the minimum gap distance) or a clamp force threshold (e.g., maximum clamp force) is reached. Example operations for performing such functionality are discussed below.

[0041] At operation 524, while the motor is active and clamping is occurring, a determination is made as to whether a minimum clamp gap distance has been reached. For instance, if the clamp gap is too small, firing of the staples may not be possible. As such, a minimum clamp gap distance may need to be maintained. If the minimum clamp gap distance is reached at operation 524, the method 500 flows to operation 530, discussed further below. If the minimum clamp gap distance is not reached at operation 524, the method 500 flows to operation 526.

[0042] At operation 526, a determination as to whether a maximum clamp force has been reached. This determination may be made based on the strain gauge data. If the maximum clamp force has been reached, the method 500 flows to operation 530, discussed further below. If the maximum clamp force has not been reached at operation 526, the method 500 flows to operation 528.

[0043] At operation 528, a determination is made as to whether the set distance for the postrelaxation clamping has been reached. For instance, as discussed above, the post-relaxation clamping may have a set distance. The motor operates for a duration that corresponds to that setAttorney Docket No,: A0011895WQ01distance. If the set distance has been reached at operation 528, the method 500 flows to operation 530, discussed further below. If the set distance has not been reached at operation 528, the method 500 flows to operation 524, where operations 524 are repeated until the minimum gap distance is reached, the maximum clamp force is reached, or the set distance is reached.

[0044] At operation 530, a second indicator or indicia are surfaced that indicate that the staple fire function is available. The second indicia may be surfaced in the same or similar manner as the indicia in operation 518. For example, surfacing the indicia may include displaying the indicia via the display, activating the haptic generator to convey the indicia, and / or generating the indicia audibly via the speaker. The second indicia my not convey that additional clamping is available, as the stapling device may only provide for one post-relaxation clamping phase. In such examples, no further clamping may be available. For instance, additional depression of the actuation button for clamping causes no further clamping. In some examples, the second indicia may include an indicator that indicates that no further clamping is available (e.g., a clamping icon with a strikethrough).

[0045] At operation 532, a stapling stroke distance and / or a cutting stroke distance is adjusted based on the current clamp gap distance (e.g., the second clamp gap distance) after the postrelaxation clamping performed over operations 522-526. The stapling stroke distance is the distance that the staples are pushed through the stapling cartridge by the stapling device. As should be appreciated, this distance should change based on the clamp gap between the anvil and the staple cartridge. Similarly, the cutting stroke distance is the distance the cutting blade is translated distally to cut or core the tissue. As should be similarly appreciated, this distance should also change based on the clamp gap between the anvil and the staple cartridge.

[0046] At operation 534, a firing-enablement selection and subsequent firing activation are received. Operation 534 may be similar to or the same as operations 510-511. At operation 536, the staples are fired from the cartridge assembly. Firing of the staples from the cartridge assembly may include activating a second motor, coupled to the cartridge assembly, that causes the staples to be pushed from the cartridge assembly towards the anvil assembly. The second motor may be operated for a duration corresponding to the adjusted stapling stroke distance that was set / adjusted in operation 532. For example, a depression of the corresponding actuation button (e.g., trigger) may cause the second motor to activate for a duration that causes the staples to be pushed the adjusted stapling stroke distance.Attorney Docket No,: A0011895WQ01

[0047] While in the above example of method 500, only one post-relaxation clamping phase is available, in other examples, multiple post-relaxation clamping phases may be available and performed. For instance, in such examples, at operation 530, the second indicia may also indicate that further clamping is available. Operations 520-530 may then be repeated for a second postrelaxation clamping function. In such examples, the set distance that the anvil travels during the second post-relaxation clamping function may be less than the set distance that the anvil travels during the first post-relaxation clamping function.

[0048] Also, in some examples, after the post-relaxation clamping (e.g., upon or just prior operation 530 being reached), another relaxation period may be implemented. For instance, operation 506-518 may be performed again after the post-relaxation clamping (e.g., after operations 522-528).

[0049] FIG. 6 depicts another example method for implementing clamping and firing of the example surgical stapling device. The method 500 may be performed by the medical stapling devices and systems discussed herein. For instance, the memory of the medical stapling system may store instructions that, when executed by one or more processors of the system, cause one or more of the operations of method 600 to be performed.

[0050] The method 600 shares some similarities with the method 500 depicted in FIGs. 5A-5B. However, in method 600 both the initial and subsequent clamping phase(s) are performed automatically by the stapling system. For instance, only a single selection (e.g., one user input) may be received for multiple clamping phases to be performed.

[0051] At operation 602, a selection to clamp tissue between the anvil assembly and the cartridge assembly is received. The selection may be the depression of an actuation button or other input received by the stapling system.

[0052] At operation 604, in response to receiving the selection in operation 602, a first clamping phase is initiated. Initiating the first clamping phase may include activating a motor to move the anvil assembly towards the cartridge assembly. The clamping may continue (e.g., the motor operates) until a threshold clamp gap and / or a threshold clamp force is reached.

[0053] At operation 606, upon the anvil assembly reaching the threshold clamp gap and / or the threshold clamp force, a relaxation period begins. The strain gauge data (e.g., clamp force) continues to be received over the relaxation period even though no further movement of the anvil assembly is actively occurring (e.g., clamping is held in place).Attorney Docket No,: A0011895WQ01

[0054] At operation 608, a second clamping phase is automatically initiated. The second clamping phase is a post-relaxation clamping phase. The second clamping phase is automatically initiated based on a tissue relaxation threshold or a time threshold being reached. The evaluation of the tissue relaxation threshold or time threshold may be substantially the same is discussed above with respect to operations 514 and 516. The second clamping phase may be performed automatically after the threshold is met, such that no further user input is required to cause the performance of the second clamping phase. The second clamping phase may include activating the motor to move the anvil assembly towards the cartridge assembly until a set distance, a minimum clamp gap, a maximum clamp force is reached. The clamp gap after the second clamping phase is thus less than the clamp gap after the first clamping phase.

[0055] At operation 610, the stapling cutting stroke distance and / or the cutting stroke distance is adjusting based on the clamp gap distance after the second clamping phase is complete. Adjusting the stroke distance(s) may be the same or similar as operation 532 in method 500.

[0056] At operation 612, a firing-enablement selection and a firing activation are received. At operation 614, staples are fired from the cartridge assembly based on receiving the firing activation. Operation 612-614 may be the same as or similar to operations 534-536 in method 500. For instance, firing of the staples may include operating a second motor for a duration corresponding to the adjusted staple stroke distance from operation 610.

[0057] In some examples, however, the firing of the staples in operation 614 may be performed automatically without the requirement of additional user input (e.g., operation 612 may be omitted). For example, the firing operations may be performed after the second clamping phase is complete.

[0058] While the method 600 is depicted as only having one relaxation period and one postrelaxation clamping phase (e.g., the second clamping phase), additional relaxation periods or clamping phases may be performed. For example, after the second clamping phase, another relaxation period may occur. After such relaxation period, another post-relaxation clamping phase may be performed (e.g., a third clamping phase) may be performed.

[0059] As will be appreciated from the foregoing, the technology disclosed herein provides for at least the following examples in the below numbered paragraphs.

[0060] 1 : A medical circular stapling system may include: a trocar assembly; a strain gauge assembly; a staple cartridge assembly; an anvil assembly releasably secured to the trocar assembly,Attorney Docket No,: A0011895WQ01such that retraction of the trocar assembly moves the anvil assembly towards the cartridge assembly thereby defining a clamp gap distance between the anvil assembly and the cartridge assembly; a motor operatively coupled to the trocar assembly; a processor; and memory storing instructions that, when executed by the processor, cause the circular stapling system to perform operations may include: receiving a selection to clamp tissue between the anvil assembly and the cartridge assembly; in response to receiving the selection, initiating a first clamping phase by activating the motor to move the anvil assembly towards the cartridge assembly until at least one of a threshold clamp gap distance is reached or a threshold clamp force is reached; upon the anvil assembly reaching the at least one of the threshold clamp gap distance or the threshold clamp force, receiving strain gauge data from the strain gauge assembly over a relaxation period; based on the strain gauge data indicating a tissue relaxation threshold has been reached, automatically initiating a second clamping phase by activating the motor to move the anvil assembly towards the cartridge assembly until one of a set distance, a minimum clamp gap distance, or a maximum clamp force is reached; receiving a firing activation subsequent to the second clamping phase; and firing staples from the cartridge assembly in response to receiving the firing activation.

[0061] 2 : The medical circular stapling system as paragraph 1 describes, further may include adjusting at least one of a stapling stroke distance or a cutting stroke distance based on the clamp gap distance after the second clamping phase.

[0062] 3 : The medical circular stapling system as either of paragraphs 1 or 2 describe, where: the motor is a first motor; a stapling stroke distance is adjusted based on the clamp gap distance after the second clamping phase; the medical circular stapling system further may include a second motor operatively coupled to the cartridge assembly; and firing the staples may include activating the second motor for a duration corresponding to the adjusted stapling stroke distance.

[0063] 4 : The medical circular stapling system as any of paragraphs 1-3 describe, where during the second clamping phase, the anvil assembly is moved the set distance.

[0064] 5 : The medical circular stapling system as any of paragraphs 1-4 describe, where the second clamping phase is initiated without further user input after receiving the selection to clamp.

[0065] 6 : The medical circular stapling system as any of paragraphs 1-5 describe, further may include an actuation button, where the selection to clamp tissue is a selection of the actuation button and the firing activation is a selection of the actuation button.Attorney Docket No,: A0011895WQ01

[0066] 7 : A method performed by a medical circular stapling device, the method may include: receiving a first selection to clamp tissue between an anvil assembly and a cartridge assembly; in response to receiving the first selection, activating a motor to move the anvil assembly towards the cartridge assembly until at least one of a threshold clamp gap between the anvil assembly and the cartridge assembly or a threshold clamp force is reached; upon the anvil assembly reaching the threshold clamp gap or the threshold clamp force, receiving strain gauge data for a relaxation period; based on the strain gauge data indicating the tissue clamped between the anvil assembly and the cartridge assembly has relaxed to a threshold relaxation, surfacing indicia indicating that a staple firing function is capable of being enabled and a further clamping function may be performed; receiving a second selection to further clamp the tissue between the anvil assembly and the cartridge assembly; and in response to the second selection, activating the motor to further move the anvil assembly further towards the cartridge assembly to reduce the clamp gap.

[0067] 8 : The method as paragraph 7 describes, where the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move a set distance.

[0068] 9 : The method as either of paragraphs 7 or 8 describe, where the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move until a second threshold clamp gap distance is reached.

[0069] 10: The method as any of paragraphs 7-9 describe, where the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move until a second threshold clamp force is reached.

[0070] 11 : The method as any of paragraphs 7-10 describe, further may include, subsequent to activating the motor in response to the second selection, surfacing second indicia indicating that a staple firing function is capable of being enabled.

[0071] 12: The method as any of paragraphs 7-11 describe, where the second indicia does not indicate that a further clamping function is available.

[0072] 13: The method as any of paragraphs 7-12 describe, where the second indicia also indicates that a further clamping function is available.

[0073] 14: The method as any of paragraphs 7-13 describe, further may include: receiving a third selection to further clamp the tissue between the anvil assembly and the cartridge assembly;Attorney Docket No,: A0011895WQ01and in response to the third selection, activating the motor to further move the anvil assembly further towards the cartridge assembly to reduce the clamp gap.

[0074] 15: The method as any of paragraphs 7-14 describe, where: the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move a first set distance; and the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move a second set distance that is less than the first set distance.

[0075] 16: A medical circular stapling system may include: a first motor operatively coupled to a trocar, where activation of the first motor causes retraction of an anvil coupled to the anvil; a second motor operatively coupled to a staple cartridge, where activation of the second motor causes staples to be fired from the staple cartridge; a processor; and memory storing instructions that, when executed by the processor, cause the circular stapling system to perform operations may include: receiving a first selection to clamp tissue between an anvil assembly and a cartridge assembly; in response to receiving the first selection, activating the first motor to move the anvil assembly towards the cartridge assembly until at least one of a threshold clamp gap between the anvil assembly and the cartridge assembly or a threshold clamp force is reached; upon the anvil assembly reaching the threshold clamp gap or the threshold clamp force, receiving clamp force data for a relaxation period; based on the clamp force data indicating the tissue clamped between the anvil and the staple cartridge has relaxed to a threshold relaxation, surfacing indicia indicating that a staple firing function is capable of being enabled and a further clamping function may be performed; receiving a second selection to further clamp the tissue between the anvil and the staple cartridge; and in response to the second selection, activating the first motor to further move the anvil assembly further towards the cartridge assembly to reduce the clamp gap; receiving a firing activation; and in response to the firing activation, firing the staples in the staple cartridge by activating the second motor.

[0076] 17: The medical circular stapling system as paragraph 16 describes, further may include adjusting a stapling stroke distance based on the clamp gap after activating the first motor in response to the second selection.

[0077] 18: The medical circular stapling system as either of paragraphs 16 or 17 describe, where activating the second motor to fire the staples includes activating the second motor a duration corresponding to the adjusted stapling stroke distance.Attorney Docket No,: A0011895WQ01

[0078] 19: The medical circular stapling system as any of paragraphs 16-18 describe, further may include a display, where surfacing the indicia may include displaying the indicia on the display.

[0079] 20: The medical circular stapling system as any of paragraphs 16-19 describe, where the operations further may include, surfacing second indicia, without waiting another relaxation period, indicating the firing function is available.

[0080] Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects of the disclosure. It is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another without departing from the scope of the disclosure. Also, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described aspects of the disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

[0081] Further, as used herein and in the claims, the phrase “at least one of element A, element B, or element C” is intended to convey any of: element A, element B, element C, elements A and B, elements A and C, elements B and C, and elements A, B, and C. In addition, one having skill in the art will understand the degree to which terms such as “about” or “substantially” convey in light of the measurements techniques utilized herein. To the extent such terms may not be clearly defined or understood by one having skill in the art, the terms “about” and “substantially” shall mean plus or minus ten percent or, if in relation to an angle, plus or minus ten degrees.

[0082] Numerous other changes may be made which will readily suggest themselves to those skilled in the art and which are encompassed in the spirit of the disclosure and as defined in the appended claims. While various aspects have been described for purposes of this disclosure, various changes and modifications may be made which are well within the scope of the disclosure. Numerous other changes may be made which will readily suggest themselves to those skilled in the art and which are encompassed in the spirit of the disclosure and as defined in the claims.

Claims

Attorney Docket No,: A0011895WQ01WHAT IS CLAIMED IS:What is claimed is:

1. A medical circular stapling system comprising:a trocar assembly;a strain gauge assembly;a staple cartridge assembly;an anvil assembly releasably secured to the trocar assembly, such that retraction of the trocar assembly moves the anvil assembly towards the cartridge assembly thereby defining a clamp gap distance between the anvil assembly and the cartridge assembly;a motor operatively coupled to the trocar assembly;a processor; andmemory storing instructions that, when executed by the processor, cause the circular stapling system to perform operations comprising:receiving a selection to clamp tissue between the anvil assembly and the cartridge assembly;in response to receiving the selection, initiating a first clamping phase by activating the motor to move the anvil assembly towards the cartridge assembly until at least one of a threshold clamp gap distance is reached or a threshold clamp force is reached;upon the anvil assembly reaching the at least one of the threshold clamp gap distance or the threshold clamp force, receiving strain gauge data from the strain gauge assembly over a relaxation period;based on the strain gauge data indicating a tissue relaxation threshold has been reached, automatically initiating a second clamping phase by activating the motor to move the anvil assembly towards the cartridge assembly until one of a set distance, a minimum clamp gap distance, or a maximum clamp force is reached;receiving a firing activation subsequent to the second clamping phase; and firing staples from the cartridge assembly in response to receiving the firing activation.Attorney Docket No,: A0011895WQ012. The medical circular stapling system of claim 1, further comprising adjusting at least one of a stapling stroke distance or a cutting stroke distance based on the clamp gap distance after the second clamping phase.

3. The medical circular stapling system of any one of claims 1-2, wherein:the motor is a first motor;a stapling stroke distance is adjusted based on the clamp gap distance after the second clamping phase;the medical circular stapling system further comprises a second motor operatively coupled to the cartridge assembly; andfiring the staples comprises activating the second motor for a duration corresponding to the adjusted stapling stroke distance.

4. The medical circular stapling system of any one of claims 1-3, wherein during the second clamping phase, the anvil assembly is moved the set distance.

5. The medical circular stapling system of any one of claims 1-4, wherein the second clamping phase is initiated without further user input after receiving the selection to clamp.

6. The medical circular stapling system of any one of claims 1-5, further comprising an actuation button, wherein the selection to clamp tissue is a selection of the actuation button and the firing activation is a selection of the actuation button.

7. A method performed by a medical circular stapling device, the method comprising:receiving a first selection to clamp tissue between an anvil assembly and a cartridge assembly;in response to receiving the first selection, activating a motor to move the anvil assembly towards the cartridge assembly until at least one of a threshold clamp gap between the anvil assembly and the cartridge assembly or a threshold clamp force is reached;Attorney Docket No,: A0011895WQ01upon the anvil assembly reaching the threshold clamp gap or the threshold clamp force, receiving strain gauge data for a relaxation period;based on the strain gauge data indicating the tissue clamped between the anvil assembly and the cartridge assembly has relaxed to a threshold relaxation, surfacing indicia indicating that a staple firing function is capable of being enabled and a further clamping function may be performed;receiving a second selection to further clamp the tissue between the anvil assembly and the cartridge assembly; andin response to the second selection, activating the motor to further move the anvil assembly further towards the cartridge assembly to reduce the clamp gap.

8. The method of claim 7, wherein the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move a set distance.

9. The method of any one of claims 7-8, wherein the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move until a second threshold clamp gap distance is reached.

10. The method of any one of claims 7-9, wherein the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move until a second threshold clamp force is reached.

11. The method of any one of claims 7-10, further comprising, subsequent to activating the motor in response to the second selection, surfacing second indicia indicating that a staple firing function is capable of being enabled.

12. The method of claim 11 , wherein the second indicia does not indicate that a further clamping function is available.

13. The method of claim 11, wherein the second indicia also indicates that a further clamping function is available.Attorney Docket No,: A0011895WQ0114. The method of claim 13, further comprising:receiving a third selection to further clamp the tissue between the anvil assembly and the cartridge assembly; andin response to the third selection, activating the motor to further move the anvil assembly further towards the cartridge assembly to reduce the clamp gap.

15. The method of claim 14, wherein:the activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move a first set distance; andthe activating of the motor to further move the anvil, in response to the second selection, causes the anvil to move a second set distance that is less than the first set di

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