Systems and methods for detecting suture failure during surgical stapling
By integrating strain gauges and controllers into surgical staplers, suture failure can be detected in real time, solving the problem of difficult suture failure detection in existing technologies and achieving reliable anastomosis and leakage prevention.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-07-23
- Publication Date
- 2026-04-10
AI Technical Summary
Existing surgical staplers make it difficult to detect suture failure in real time during anastomosis procedures, leading to potential leakage or incomplete loop formation.
By integrating strain gauges and controllers into surgical staplers, tissue clamping forces can be measured in real time to determine if suture failure has occurred. If failure is detected, the stapler process can be stopped, and warnings or adjustments can be issued.
It effectively prevents leakage caused by suture failure, ensures the integrity and reliability of the anastomosis, and provides real-time operational guidance.
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Figure CN113974729B_ABST
Abstract
Description
[0001] Cross Reference to Related Applications
[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 056,765, filed July 27, 2020, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD
[0003] The present disclosure relates generally to powered surgical stapling instruments, and more particularly to a method for controlling a surgical stapling instrument based on detecting a suture failure and a surgical stapling instrument for performing the method. BACKGROUND
[0004] Anastomosis is the surgical joining of separate sections of hollow organs. Typically, an anastomosis procedure is performed after a surgical procedure in which a diseased or defective portion of an organ is removed and the remaining end sections of the organ are joined by a surgical stapling instrument. Depending on the anastomosis procedure required, the remaining end sections can be joined by, for example, circular or side-to-side organ reconstruction methods.
[0005] In a circular anastomosis procedure, the remaining end sections of an organ are joined by a surgical stapling instrument that drives an array of circular staples through the remaining end sections and simultaneously cores any tissue inside the driven array of circular staples to release a tubular passage within the organ. During the procedure, a purse string suture can be tied on one or both sides of the surgical stapling instrument to enhance the integrity of the anastomosis and help prevent leakage. In some cases, due to the skill of the surgeon or tissue characteristics, the purse string suture can fail during clamping of the tissue by the surgical stapling instrument. When the purse string suture fails, the entire tissue donut can not be captured by the device and can leak, or an incomplete donut can be formed.
[0006] There is a continuing need for stapling instruments that can determine when a purse string suture fails during tissue clamping. SUMMARY
[0007] According to the present disclosure, a computer-implemented method for controlling a surgical stapling instrument for stapling tissue includes advancing an anvil assembly relative to a cartridge to a first position defining a tissue gap between the cartridge and the anvil assembly and clamping tissue therebetween, the clamped tissue including a suture passing therethrough, measuring a first tissue compression force of the tissue clamped within the tissue gap by the anvil assembly at a first time point, determining whether the measured first force is greater than a predetermined threshold, in response to a determination that the first force is greater than the predetermined threshold, measuring a second tissue compression force of the tissue clamped within the tissue gap at a second time point, determining whether the suture has failed based on the measured second tissue compression force being less than the measured first tissue compression force by a predetermined amount, and stopping advancement of the anvil assembly based on a determination that the suture has failed.
[0008] In an aspect, the first tissue compression force and the second tissue compression force can be measured by a strain gauge.
[0009] In another aspect, determining whether the suture has failed can be further based on a shape of a curve of the force applied to the clamped tissue over time.
[0010] In yet another aspect, the method can further include preventing firing of the staples when the second tissue compression force is less than the first tissue compression force.
[0011] In an aspect, the method can further include displaying a warning in response to determining that the suture has failed.
[0012] In another aspect, the displayed warning can include at least one of a warning to check a surgical site or to loosen the tissue.
[0013] In yet another aspect, the method can further include generating an audio warning when the suture is determined to have failed.
[0014] In yet another aspect, the predetermined threshold can be greater than a predetermined tissue compression acceptable range.
[0015] In yet another aspect, the method can further include determining a decrease in the tissue clamping force between the first tissue compression force and the second tissue compression force.
[0016] In yet another aspect, measuring the first tissue compression force of the tissue clamped within the tissue gap by the anvil assembly at the first time point can include measuring the first tissue compression force when the anvil assembly is not within a predetermined distance range of the cartridge.
[0017] According to the present disclosure, a surgical stapling instrument includes an anvil assembly including an anvil head and an anvil center rod extending proximally from the anvil head, a reload assembly including an annular cartridge of staples, a processor, and a memory. The memory includes instructions stored thereon that, when executed by the processor, cause the surgical stapling instrument to advance the anvil assembly relative to the cartridge of staples to a first position defining a tissue gap between the cartridge of staples and the anvil assembly and clamp tissue therebetween, the clamped tissue including a suture passing therethrough, measure a first tissue compression force of the tissue clamped within the tissue gap by the anvil assembly at a first point in time, determine whether the measured first force is greater than a predetermined threshold, in response to a determination that the first force is greater than the predetermined threshold, measure a second tissue compression force of the tissue clamped within the tissue gap at a second point in time, determine whether the suture has failed based on the measured second tissue compression force being less than the measured first tissue compression force by a predetermined amount, and stop advancement of the anvil assembly based on a determination that the suture has failed.
[0018] In an aspect, the first tissue compression force and the second tissue compression force can be measured by a strain gauge.
[0019] In another aspect, determining whether the suture has failed can be further based on a shape of a curve of the force applied to the clamped tissue over time.
[0020] In yet another aspect, the instructions, when executed by the processor, can further cause the surgical stapling instrument to prevent staple firing when the measured second tissue compression force is less than the first tissue compression force.
[0021] In yet another aspect, the instructions, when executed by the processor, can further cause the surgical stapling instrument to issue a warning in response to the suture failure being determined.
[0022] In yet another aspect, the displayed warning can include at least one of a warning to check a surgical site or to loosen the tissue.
[0023] In yet another aspect, the instructions, when executed by the processor, can further cause the surgical stapling instrument to produce an audio warning upon determining the suture failure.
[0024] In yet another aspect, the predetermined threshold can be greater than a predetermined tissue compression acceptable range.
[0025] In another aspect, the instructions, when executed by the processor, can further cause the surgical stapling instrument to determine a decrease in tissue clamping force between the first tissue compression force and the second tissue compression force.
[0026] According to the present disclosure, a non-transitory computer readable medium storing instructions that, when executed by a processor, cause the processor to perform a method for controlling a surgical stapling instrument, the method comprising advancing an anvil assembly relative to a cartridge to a first position defining a tissue gap between the cartridge and the anvil assembly and clamping tissue therebetween, the clamped tissue including a suture passing therethrough, measuring a first tissue compression force of the tissue clamped within the tissue gap by the anvil assembly at a first point in time, determining whether the measured first force is greater than a predetermined threshold, in response to a determination that the first force is greater than the predetermined threshold, measuring a second tissue compression force of the tissue clamped within the tissue gap at a second point in time, determining whether the suture has failed based on the measured second tissue compression force being less than the measured first tissue compression force by a predetermined amount, and stopping the advancement of the anvil assembly based on the determined suture failure. BRIEF DESCRIPTION OF DRAWINGS
[0027] Disclosed herein with reference to the accompanying drawings are systems and methods for controlling a surgical stapling instrument to clamp and staple to a force, wherein:
[0028] Figure 1 is a perspective view of a surgical stapling instrument according to the present disclosure;
[0029] Figures 2A-2B is an illustration of the surgical stapling instrument of Figure 1 in an open and clamped position;
[0030] Figure 3A is a block diagram of a controller provided according to the present disclosure and configured for use with the surgical system of Figure 1 ;
[0031] Figure 3B is a block diagram of a handle assembly, an adapter assembly, and a reload assembly of the surgical system of Figure 1 according to the present disclosure;
[0032] Figure 4 is a flowchart of a method for controlling a surgical stapling instrument to staple according to the present disclosure;
[0033] Figure 5 is a graph illustrating strain gauge curves during tissue clamping according to the present disclosure; and
[0034] Figure 6 is an illustration of purse string suturing provided according to the present disclosure and configured for use with the surgical system of Figure 1 . DETAILED DESCRIPTION
[0035] The disclosed surgical devices will now be described in detail with reference to the drawings, in which like reference numerals designate each of the several views and in which: However, it is understood that aspects of the present disclosure are merely exemplary of the disclosure and can be embodied in various forms. In order to avoid needless detail on an overly broad scope obscuring the present disclosure, well-known functions or constructions are not described in detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted in a limiting manner, but merely as a representative basis for teaching one skilled in the art to differen tly employ the present disclosure in virtually any appropriate detailed structure. Further, directional terms such as front, rear, upper, lower, top, bottom, distal, proximal, and the like are used for purposes of aiding understanding of the description, and are not intended to limit the present disclosure.
[0036] The present disclosure relates to a surgical stapling instrument that controls stapling of tissue based in part on distinguishing between staple formations that can prevent leakage and staple formations that are not sufficiently closed.
[0037] Figure 1 A surgical stapling instrument is illustrated, generally shown as surgical stapling instrument 10. Surgical stapling instrument 10 is a circular stapling instrument and includes handle assembly 20, adapter assembly 100 extending distally from handle assembly 20, reload assembly 16 supported on a distal portion of adapter assembly 100, anvil assembly 50 operably coupled to adapter assembly 100, and controller 300 supported within handle assembly 20. Figure 3A Reload assembly 16 supports annular staple cartridge 48 that includes a plurality of staples (not shown). Anvil assembly 50 includes anvil head 28 that includes staple forming surface 29. Figure 2A
[0038] Handle assembly 20 is illustrated as a powered assembly and includes fixed grip 22, actuation button 24 for controlling firing of staples (not shown) from staple cartridge 48 of reload assembly 16, and approach buttons 26a, 26b for controlling axial displacement of anvil assembly 50 toward and away from staple cartridge 48 of reload assembly 16 between an open position and a clamped position. For a detailed description of the structure and function of an exemplary powered handle assembly, reference can be made to U.S. Patent Application Publication Nos. 2020 / 0015820 and 2019 / 0343517. Although the present disclosure illustrates a powered assembly, it is contemplated that the advantages of the present disclosure, as described in detail below, can also apply to robotically actuated surgical instruments and / or manually operated staplers that include force sensors that provide an indication that an acceptable clamping force has been achieved when performing a manual approach.
[0039] Figure 2A and 2B A surgical stapling instrument 10 is illustrated in an open and clamped position. In the open position Figure 2A ), the anvil assembly 50 is spaced apart from the cartridge 48 of the reload assembly 16 to facilitate placement of tissue between the staple-forming surface 29 of the anvil head 28 of the anvil assembly 50 and the cartridge 48 of the reload assembly 16. In the clamped position, the anvil assembly 50 is moved into juxtaposed alignment with the cartridge 48 to define a tissue gap "G" between the staple-forming surface 29 of the anvil head 28 of the anvil assembly 50 and the cartridge 48 of the reload assembly 16. In prior manual and powered stapling instruments, the stapling instrument includes a lockout to prevent firing of the stapling instrument unless the tissue gap "G" is within a predetermined range. The predetermined range is determined based in part on the size of the staples to be formed and ensures that the anvil head 28 of the anvil assembly 50 is close enough to the cartridge 48 to properly form the staples. The predetermined tissue gap range is defined by a maximum acceptable gap G max and a minimum acceptable tissue gap G min .
[0040] The handle assembly 20 can include an electrical assembly, such as a strain gauge 360 Figure 3A in communication with a controller 300 Figure 3A and configured to determine a load on a motor (not shown) of the surgical stapling instrument 10 due to tissue being clamped between the anvil assembly 50 and the cartridge 48. This determination can be used to determine a compression force on the tissue clamped between the anvil assembly 50 and the cartridge 48.
[0041] With continued reference to Figure 1 , the adapter assembly 100 includes an interface portion 232 that is detachably coupled to the handle assembly 20, a tubular shaft 234 that extends distally from the interface portion 232, a drive link assembly (not shown) movably supported within the adapter assembly 100, and a drive shaft (not shown) that is coupled to the anvil shaft 52 of the anvil assembly 50. The drive link assembly (not shown) is engaged with and driven by the handle assembly 20 to control axial displacement of the drive shaft to move the anvil assembly 50 relative to the cartridge 48 between the open position and the clamped position.
[0042] The reload assembly 16 is supported on a distal portion of the adapter assembly 100 and includes a housing 46 that supports the cartridge 48. In aspects of the present disclosure, the cartridge 48 defines an annular row of staple-receiving pockets 48a Figure 1 . In some aspects of the present disclosure, the reload assembly 16 is releasably coupled to the distal portion of the adapter assembly 100 to facilitate replacement of the annular cartridge 48 after each use.
[0043] Each of the staple-receiving pockets 48a of the staple cartridge 48 supports a staple (not shown) that is ejectable from the staple cartridge 48 upon actuation of the actuating button 24 of the handle assembly 20. The housing 46 of the reload assembly 16 defines an annular cavity 60. The annular cavity 60 supports a staple pusher (not shown) and an annular knife (not shown) that are movable relative to the staple cartridge 48 to eject the staples from the staple cartridge 48 and to dissect or cut tissue positioned within the annulus defined by the staple cartridge 48. As the staples (not shown) are ejected from the staple cartridge 48, the staples are driven into and formed within the staple-forming pockets of the staple-forming surface 29 of the anvil head 28 of the anvil assembly 50.
[0044] Figure 3A A controller 300 according to the present disclosure is illustrated that includes a processor 320 connected to a computer-readable storage medium or memory 330. The computer-readable storage medium or memory 330 can be a volatile type of memory, such as RAM, or a non-volatile type of memory, such as flash memory medium, disk medium, etc. In various aspects of the present disclosure, the processor 320 can be another type of processor, such as but not limited to a digital signal processor, a microprocessor, an ASIC, a graphics processing unit (GPU), a field-programmable gate array (FPGA), or a central processing unit (CPU). In certain aspects of the present disclosure, network inference can also be implemented in a system having weights implemented as memory, chemical, or other inference computations, as opposed to a processor.
[0045] In aspects of the present disclosure, the memory 330 can be a random access memory, a read only memory, a disk memory, a solid state memory, an optical disk memory, and / or another type of memory. In some aspects of the present disclosure, the memory 330 can be separate from the controller 300 and can communicate with the processor 320 through a communication bus of a circuit board and / or through a communication cable, such as a Serial ATA cable or other type of cable. The memory 330 includes computer-readable instructions that are executable by the processor 320 to operate the controller 300. In other aspects of the present disclosure, the controller 300 can include a network interface 340 to communicate with other computers or servers. The storage 310 can be used to store data.
[0046] In aspects of the present disclosure, the strain gauge 360 is coupled to the processor and the disclosed methods are run on the controller 300 or on a user device, including for example a mobile device, an IoT device, or a server system.
[0047] Reference Figure 3BFIG. 1 shows a schematic view of the handle assembly 20, the adapter assembly 200, and the reload assembly 16. For brevity, only one of the motors 152, 154, 156, namely motor 152, is shown. The motor 152 is coupled to the battery 144. In aspects, the motor 152 can be coupled to any suitable power source configured to provide electrical energy to the motor 152, such as an AC / DC transformer.
[0048] The battery 144 and the motor 152 are coupled to a motor controller circuit board 142a having a motor controller 143 that controls operation of the motor 152, including the flow of electrical energy from the battery 144 to the motor 152. The main controller circuit board 142b Figure 1 ) includes a main controller 300 that controls the handle assembly 20. The motor controller 143 includes a plurality of sensors 408a, 408b,... 408n configured to measure operating conditions of the motor 152 and the battery 144. The sensors 408a-n can include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The sensors 408a-408n can measure voltage, current, and other electrical properties of the electrical energy supplied by the battery 144. The sensors 408a-408n can also measure angular velocity (e.g., rotational speed) (revolutions per minute (RPM)), torque, temperature, current draw, and other operating characteristics of the motor 152. Angular velocity can be determined by measuring rotation of the motor 152 or a drive shaft rod 106, 108, 110 Figure 2A ) coupled thereto and rotatable by the motor 152. Various axially movable drive shaft rods' positions can also be determined by using various linear sensors disposed in or proximate to the shaft rods, or extrapolated from the RPM measurements. In aspects, torque can be calculated based on a regulated current draw of the motor 152 at a constant RPM. In further aspects, the motor controller 143 and / or the main controller 300 can measure time and process the above values as a function of time, including integration and / or differentiation, to determine, for example, rates of change of measured values. The main controller 300 is also configured to determine travel distances of various components of the circular adapter assembly 200 and / or the reload assembly 16 by counting revolutions of the motors 152, 154, and 156.
[0049] The motor controller 143 is coupled to a main controller 300 that includes a plurality of inputs and outputs for interfacing with the motor controller 143. In particular, the main controller 300 receives measured sensor signals from the motor controller 143 regarding the operating state of the motor 152 and the battery 144, and in turn outputs control signals to the motor controller 143 to control the operation of the motor 152 based on the sensor readings and specific algorithmic instructions, which are discussed in greater detail below. The main controller 300 is also configured to accept a plurality of user inputs from a user interface, such as switches, buttons, touchscreens, etc. coupled to the main controller 300.
[0050] The main controller 300 is also coupled to the strain gauge 360 of the circular adapter assembly 200 using a wired or wireless connection, and is configured to receive strain measurements from the strain gauge 360 that are used during operation of the handle assembly 20.
[0051] The reload assembly 16 includes a storage device 405 (e.g., chip 464c). The adapter assembly 200 also includes a storage device 407. The storage devices 405 and 407 include non-volatile storage media (e.g., EEPROM) that are configured to store any data regarding the reload assembly 16 and the circular adapter assembly 200, respectively, including but not limited to usage counts, identification information, model numbers, serial numbers, staple sizes, stroke lengths, maximum actuation forces, minimum actuation forces, factory calibration data, etc. In aspects, the data can be encrypted and only decryptable by devices having the appropriate key, such as the main controller 300. The data can also be used by the main controller 300 to authenticate the circular adapter assembly 200 and / or the reload assembly 16. The storage devices 405 and 407 can be configured in read-only or read / write mode, allowing the main controller 300 to read from and write data to the storage devices 405 and 407.
[0052] When the surgical stapling instrument 10 is used to perform a surgical procedure, the surgical stapling instrument 10 is manipulated to position tissue between the cartridge 48 and the anvil assembly 50. Once the surgical instrument is properly positioned relative to the tissue to treat the tissue, the handle assembly 20 is actuated to move the anvil assembly 50 toward the clamped position to G min position.
[0053] Figure 4 A flowchart illustrating a computer-implemented method 400 for controlling a surgical stapling instrument and detecting suture failure during tissue clamping is shown. During a surgical procedure, a purse string suture 600 Figure 6 may be tied on one or both sides of the tissue covering the surgical stapling instrument to enhance the integrity of the anastomosis and help prevent leakage. During the first clamping stage, the anvil assembly 50 Figure 1) relative to the cartridge 48 from the open position to the clamped position in which a tissue gap defined between the anvil assembly 50 and the cartridge 48 is within a predetermined acceptable gap range to facilitate proper formation of the staples. More particularly, in the first clamping stage, the anvil assembly 50 is approximated relative to the cartridge 48 of the reload assembly 16 to define a tissue gap G max . In aspects of the present disclosure, G max may be about 0.037 inches to about 0.024 inches. However, the value of G max may vary depending on the size of the staples within the cartridge 48. The clamped tissue includes the suture.
[0054] Once the anvil assembly 50 is moved relative to the cartridge 48 until the tissue gap G max is achieved, the tissue compression force on the tissue clamped between the cartridge 48 and the anvil assembly 50 is measured at a first time point (step 404). As discussed above, the clamping force of the tissue clamped between the anvil assembly 50 and the cartridge 48 of the housing assembly can be measured using the strain gauge 360 in communication with the controller 300. Alternatively, any other force or strain measuring device can be used to measure the clamping force of the tissue clamped between the anvil assembly 50 and the cartridge 48. For example, the current drawn on the motor 154 consumed in the handle assembly 20 that drives the drive shaft rod 106 Figure 2A ) can be used to measure the clamping force. If the compression force on the tissue is greater than a predetermined threshold (step 406), the surgical stapling instrument 10 continues to advance the anvil assembly 50 relative to the cartridge 48. The predetermined threshold can vary based on the type and thickness of the tissue being compressed and can be automatically set by the instrument 10 or by the user.
[0055] The tissue compression force on the tissue clamped between the cartridge 48 and the anvil assembly 50 is measured at a second time point (step 408). If the compression force at the second time point is less than the compression force at the first time point, the controller determines that the purse string suture has failed (step 410). The purse string suture failure can include the following non-limiting list, for example, a break in the suture, a failure of the suture material, and / or a shedding of the suture from the tissue. The compression force at the second time point can be dramatically reduced from the compression force at the first time point (see, for example, the curve 502), which indicates a failure of the purse string suture. Figure 5
[0056] Figure 5 is a graph showing strain gauge curves during tissue clamping. For example, these forces can be seen when the anvil assembly 50 is from about 1.500" to about 0.460" from the cartridge 48. Curve 502 represents clamped tissue that triggers a jam force limit error due to the force seen as the purse string suture fails during clamping. All other curves 504 show normally clamped tissue without incident. These curves represent five different surgical procedures in the colorectal space.
[0057] In various aspects, the compression force can be monitored over time, for example as a curve. In various aspects, the controller 300 can analyze the shape of the curve, including the rate of change, shape, etc., and compare the curve to a stored database of curves, and determine a suturing failure based on the difference between the measured curve and the characteristics of the stored curves. In various aspects, the controller can use measured compression force values measured when the anvil assembly 50 is within a first predetermined range of the staple cartridge 48 and not within a second predetermined range relative to the staple cartridge 48. For example, the first predetermined range can be when the anvil assembly 50 is from about 1.500" to about 0.9" from the staple cartridge 48, for example, a range of distances where the tissue compression force is typically below a threshold value, indicating that the tissue is not being compressed, and the second predetermined range can be when the anvil assembly 50 is from about 0.7" to about 0.45" from the staple cartridge 48, for example, a range of distances where the tissue compression force is typically above a threshold value, indicating that the tissue is being compressed.
[0058] If the controller determines a suturing failure, the surgical stapling instrument 10 does not enter the firing mode. As such, the surgical stapling instrument 10 is prevented from entering the firing mode, and the controller can provide a warning on a display 146( Figure 1 ) on the handle assembly of the surgical stapling instrument, for example, to alert the surgeon that the compression force is too high and to stop clamping the tissue so that the surgeon can reposition the surgical stapling instrument 10 on the tissue and replace the suturing line. In some aspects, the warning can alert the surgeon to check the surgical site. In various aspects, the surgical stapling instrument 10 can produce an audible warning, such as a beeping sound, a tone, or a spoken phrase. For example, the spoken phrase can alert the surgeon to check the surgical site for a suturing failure.
[0059] While the present disclosure relates to powered surgical stapling instruments, it is contemplated that the principles of the present disclosure are applicable to manual powered stapling instruments. For example, as the stapling instrument moves through a predetermined acceptable tissue gap range, the clamping force on the tissue clamped between the anvil assembly and the staple cartridge of the stapling instrument can be measured. In such a device, an indicator, such as a light, can be provided on the instrument. When the clamping force on the tissue enters a predetermined acceptable compression range and the instrument is within a predetermined acceptable gap range, the indicator can be activated to inform the surgeon that the instrument is ready to fire.
[0060] It is contemplated that although aspects of the present disclosure are illustrated in connection with circular stapling instruments, aspects of the present disclosure are equally applicable to other types of stapling instruments, including linear stapling devices, vessel sealing devices, and other devices for joining together segments of tissue.
[0061] Those skilled in the art will understand that one or more operations of the method 500 can be performed in a different order, repeated, and / or omitted without departing from the scope of the present disclosure. In various aspects, the illustrated method 500 can be operated in the controller 300( Figure 3A ), in a remote device, or in another server or system. Other variations are considered within the scope of the present disclosure. The operations of the method 500 will be described with respect to a controller, such as the controller 3A00( Figure 3A ) of the surgical stapling instrument 10( Figure 3A ), but it should be understood that the illustrated operations can also apply to other systems and components thereof.
[0062] Those skilled in the art will understand that the instruments and methods specifically described herein, and illustrated in the figures, are non-limiting. It is contemplated that elements and features can be combined with another element and feature without departing from the scope of the present disclosure. Likewise, those skilled in the art will appreciate other features and advantages of the present disclosure.
Claims
1. A surgical stapling instrument, comprising: an anvil assembly including an anvil head and an anvil center rod extending proximally from the anvil head; a reload assembly including an annular staple cartridge including a plurality of staples; a processor; and a memory including instructions stored thereon that, when executed by the processor, cause the surgical stapling instrument to: advance the anvil assembly relative to the staple cartridge to a first position defining a tissue gap between the staple cartridge and the anvil assembly and clamp the tissue therebetween, the clamped tissue including a suture passing therethrough; measure a first tissue compression force of the tissue clamped within the tissue gap with the anvil assembly at a first point in time; determine whether the measured first force is greater than a predetermined threshold; in response to determining that the first force is greater than the predetermined threshold, measure a second tissue compression force of the tissue clamped within the tissue gap at a second point in time; determine a suture failure based on the measured second tissue compression force being less than the measured first tissue compression force; and stop the advancement of the anvil assembly based on the determined suture failure.
2. The surgical stapling instrument of Claim 1, wherein the first tissue compression force and the second tissue compression force are measured by a strain gauge.
3. The surgical stapling instrument of Claim 1, wherein determining the suture failure is further based on a shape of a curve of the force applied to the clamped tissue over time.
4. The surgical stapling instrument of Claim 1, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to prevent staple firing when the measured second tissue compression force is less than the first tissue compression force.
5. The surgical stapling instrument of Claim 1, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to issue a warning in response to the suture failure being determined.
6. The surgical stapling instrument of Claim 5, wherein the displayed warning includes at least one of a warning to inspect a surgical site or to loosen the tissue.
7. The surgical stapling instrument of Claim 1, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to produce an audio warning when the suture failure is determined.
8. The surgical stapling instrument of Claim 1, wherein the predetermined threshold is greater than a predetermined acceptable tissue compression range.
9. The surgical stapling instrument of Claim 1, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to determine a decrease in tissue clamping force between the first tissue compression force and the second tissue compression force.
10. A non-transitory computer readable medium storing instructions that, when executed by a processor, cause the processor to perform a method for controlling a surgical stapling instrument, the method comprising: advancing an anvil assembly relative to a staple cartridge to a first position defining a tissue gap between the staple cartridge and the anvil assembly and clamping the tissue therebetween, the clamped tissue including a suture passing therethrough; measuring a first tissue compression force of the tissue clamped within the tissue gap with the anvil assembly at a first point in time; determining whether the measured first force is greater than a predetermined threshold; in response to determining that the first force is greater than the predetermined threshold, measuring a second tissue compression force of the tissue clamped within the tissue gap at a second point in time; determining a suturing failure based on the measured second tissue compression force being less than the measured first tissue compression force; and stopping the advancement of the anvil assembly based on the determined suturing failure.
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